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Operation

Manual

OPERATION MANUAL

SMART SERVO-VENTILATOR

Equipment code: 201050037

HM Registration No.: 10229820088

Manual Code: 204010210_003

Date: (JUNE/2006)

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This Operation Manual has the information that is necessary for the proper usage of the SMART servo-ventilator.

Manufacturer:

K. Takaoka Indstria e Comrcio LTDA

Av. Bosque da Sade, 519So Paulo SP

ZIP: 04142-091Telephone: (55 11) 5586 1000Fax: (55 11) 5589 7313

Website: www.takaoka.com.brE-mail: [email protected]

CGC: 61.489.381/0001-09I.E.: 103.735.350.115

Suggestions, doubts or complaints:

Call Center: (55 11) 5586 1010

Product Registration at the Health Ministry:

Technical Name: Pressure and Volume Ventilator

Trade Name: SMART servo-ventilatorRegistration Number at the Health Ministry: 10229820088

Product Classification:

NBR IEC-60601-1/97 (1994) & Erratum No. 1 (1997) & Amendment No. 1 (1997) (Electromedical equipment Part 1:

General Safety Prescriptions)

NBR IEC 60601-2-12/2004 (particular prescriptions for pulmonary ventilation equipment safety in medical use.

Equipment Class - Energized Internally).

NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General prescriptions for safety - 2. Collateral Norm:

Electromagnetic compatibility - Prescriptions and assays);

Equipment Class 1 Energized Internally

Type B IPX1 Continuous Operation

Technician in Charge :

Eng. Mauricio ChiaroniCREA: Registration number 5061714921

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Product Installation Form

EQUIPMENT: ______________________________ Code: _____________ Serial Number:___________

DESCRIPTION CODE SERIAL NUMBER1

23

4

5

67

89

ACCESSORIE

S

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 No

2. Did products and accessories match the order? Yes No3. Was the package damaged in any way? Yes No

4. Was there any difficulty in installing the equipment? Yes No

5. Is (are) the device(s) and accessories working properly? Yes No

6. Were there any accessory, tube, and cable connection problems? Yes No

7. Were the data, values, product description, amount, and payment conditions on theinvoice correct?

Yes No

8. Mention any possible inconveniences:

Installation by: _________________________ Date ____/ ____ /_____ Sig.: _____________________(Technician Name)

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

Send this form to Fax (55 11) 5589 8072, or via registered mail to K. Takaoka.

ATTENTION: THE WARRANTEE WILL GO INTO EFFECT AS OF THE CONFIRMATIONOF 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 (55 11) 5586 1010

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TABLE OF CONTENTS

DEFINITIONS ...................................................................................................................................................................................... 9

THE COMPANY................................................................................................................................................................................. 10

1 INTRODUCTION..................................................................................................................................................................... 12

2 WARNINGS.............................................................................................................................................................................13

3 GENERAL DESCRIPTION...................................................................................................................................................... 17

3.1 VENTILATION MONITOR.........................................................................................................................................................19

4 TECHNICAL SPECIFICATIONS ............................................................................................................................................. 20

4.1 VENTILATION MONITOR SPECIFICATIONS...............................................................................................................................22

5 OPERATING PRINCIPLE...................................................................... .................................................................................24

5.1 FLOW SERVO-VALVES ..........................................................................................................................................................24 5.2 ELECTRONIC BLENDER .........................................................................................................................................................25 5.3 ELECTROMAGNETIC VALVE....................................................................................................................................................25 5.4 FLOW AND VOLUME MEASU REMENT.......................................................................................................................................25 5.5 OXYGEN MEASUREMENT......................................................................................................................................................26 5.6 VENTILATION MONITOR PARAMETERS...................................................................................................................................26

6 CONTROLS AND COMPONENTS........................................................ .................................................................................27

6.1 LIST OF COMPONENTS..........................................................................................................................................................27 6.2 FRONT VIEW ........................................................................................................................................................................28 6.3 FRONT CONNECTION PANEL .................................................................................................................................................33 6.4 BACK VIEW ..........................................................................................................................................................................34 6.5 LEFT-SIDE VIEW ...................................................................................................................................................................36 6.6 ELECTRONIC HEATED HUMIDIFIER (OPTIONAL).......................................................................................................................37

6.6.1 Safety measures for Heated Humidifier 6060 use...................................................................................................376.7 EXPIRATORY VALVE.............................................................................................................................................................38 6.8 DRAINS................................................................................................................................................................................39 6.9 NEBULIZER (OPTIONAL).........................................................................................................................................................396.10 TGI................................................................................................................................................................................406.11 BATTERY........................................................................................................................................................................41 6.12 MOBILE BASE .................................................................................................................................................................42

7 ASSEMBLING AND PREPARING THE VENTILATOR...................................................................................................... ....437.1 VENTILATOR MOUNTING............................................................................................................................................................43 7.2 SUPPLY....................................................................................................................................................................................43 7.3 RESPIRATORY CIRCUIT.........................................................................................................................................................44 7.4 FLOW SENSOR.....................................................................................................................................................................46 7.5 O2SENSOR..........................................................................................................................................................................47

7.5.1 Calibrating the O 2sensor before use.......................................................................................................................487.5.2 After calibrating the O2sensor.................................................................................................................................48

8 CONTROL AND MONITORING DISPLAY..............................................................................................................................50

8.1 START-UP SCREENS.............................................................................................................................................................50 8.2 MAIN SCREEN ......................................................................................................................................................................52

8.2.1 Ventilation Parameters ............................................................................................................................................ 536.2.2 Message Line.......................................................................................................................................................... 548.2.3 Alphanumeric Window.............................................................................................................................................56

8.2.4 Monitor Graphical Window....................................................................................................................................... 578.3 CONFIGURATION SCREEN .....................................................................................................................................................60 8.3.1 Parameter set-up.....................................................................................................................................................618.3.2 Monitoring................................................................................................................................................................628.3.3 Alarm Set-up............................................................................................................................................................63

8.4 SETUP PROCEDURE.............................................................................................................................................................63 8.5 ALARM SYSTEM ...................................................................................................................................................................64

9 OPERATION ........................................................................................................................................................................... 68

9.1 INITIAL TESTS AND PROCEDURES...........................................................................................................................................68 9.2 SPONTANEOUS AND MANDATORY CYCLES.............................................................................................................................69

9.2.1 Mandatory cycles.............................. .......................................................................................................................699.2.2 Spontaneous cycles ................................................................................................................................................ 69

9.3 SELECTING VENTILATION MODES..........................................................................................................................................70

10 VENTILATION MODES........................................................................................................................................................... 71

10.1 VCV VOLUME CONTROLLED VENTILATION.....................................................................................................................7110.2 PCV - PRESSURE-CONTROLLED VENTILATION .................................................................................................................72

10.2.1 PLV - pressure-limited ventilation............................................................................................................................7310.3 PCV/AV- PRESSURE CONTROLVENTILATION /ASSUREDVOLUME..................................................................................74

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10.4 SIMV/V - SYNCHRONIZED INTERMITTENT MANDATORYVENTILATION WITH VOLUME CONTROL............................................7510.5 SIMV/P - SYNCHRONIZED INTERMITTENT MANDATORYVENTILATION WITH PRESSURE CONTROL......................................7610.6 BIPV - SPONTANEOUS VENTILATION WITH TWO PRESSURE LEVELS.................................................................................7710.7 CPAP - CONTINUOUS POSITIVEAIRWAY PRESSURE VENTILATION ....................................................................................7810.8 PSV - PRESSURE SUPPORTVENTILATION........................................................................................................................78

11 SPECIAL FEATURES.............................................................................................................................................................80

12 CLEANING AND STERILIZATION.................. .......................................................................................................................82

13 MAINTENANCE......................................................................................................................................................................87

14 MEASUREMENT METHODS .................................................................................................................................................. 89

14.1 VOLUME.........................................................................................................................................................................89 14.2 RATE .............................................................................................................................................................................89 14.3 I:E RATIO .......................................................................................................................................................................89 14.4 INSPIRATORY AND EXPIRATORY TIMES.............................................................................................................................90 14.5 MAXIMUM, AVERAGE, PLATEAU ,AND PEEP PRESSURE...................................................................................................9014.6 RESISTANCE...................................................................................................................................................................90 14.7 COMPLACENCIES............................................................................................................................................................91 14.8 INSPIRATORY WORK.......................................................................................................................................................91

15 SYMBOLS...............................................................................................................................................................................92

16 EMERGENCY ACTIONS ........................................................................................................................................................ 97

17 TERMS OF WARRANTY................................. .......................................................................................................................98

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DEFINITIONS

Warning

Warns the user about the possibil ity of injury, death or other serious adverse reactions associated with

equipment m isuse.

AttentionWarns the user about possible problems w ith the equipment associated with i ts misuse, such as equipm ent

malfunct ion o r fai lure, damage to the equ ipment 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 its efforts to the hospital equipment industry, always in close

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

K. TAKAOKAis proud of its leading position in the market and has a wide range of products.

With one of its priorities being 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 devices, and this 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 a firm foothold in the international market, K. TAKAOKA has deserved its customers

trust 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 improve our PRODUCTS, SERVICES and PROCESSES, involve our EMPLOYEES and VENDORS, and obtain our

CLIENT and SHAREHOLDER satisfaction.

K. TAKAOKA IND. E COM. LTDA.Av. Bosque da Sade, 519

So Paulo SP CEP: 04142-091

Telephone: (55 0xx11) 5586-1000Fax: (55 0xx11) 5589-7313

E-mail: [email protected]: http://www.takaoka.com.br

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Figure 1: SMART servo-ventilator

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1 INTRODUCTION

The SMART micro-processed servo-ventilator performs mechanical ventilation aimed at providing temporary, complete, or partial

gas to the patient, maintaining the appropriate gas exchanges in adult/pediatric/neonate patient respiratory failure. It has an

integrated ventilation monitor.

The unique modes and features allow Interactive Respiratory Therapy that is appropriate for the needs of neonatal, pediatric or

adult patient needs.

SMART is one of the K. Takaoka Servo-ventilator family members that brings together high performance ventilation, a daring design

and a complete ventilation monitoring.

It has a servo valve system that ensures more flow and allows immediate responses in spontaneous ventilation cycles. It has

an intelligent flow measurement system that exempts constant care with cleaning and moisture, in addition to digital control with

DSP (Digital Signal Processing) technology, which allows more fidelity for the parameters that are set.

It is an intelligent option for those in search of versatility, feature variety, and low cost, without, however, any loss in technology

and performance.

The device has 8 ventilation modes: VCV/ASSISTED, ASSISTED PCV/PLV (neonatal), PCV/AV, SIMV/V, SIMV/P, BIPV,

CPAP, and PSV. It has an apnea-protection system in the modes that demand inspiratory efforts to begin the cycles, with a backup

controlled mode. Cycles may be triggered by pressure or flow.

In the BIPV mode, by properly setting Inspiratory Time and Frequency (inverse ratio), one can obtain the APRV mode characteristics.

The SMART ventilator has inbuilt monitoring with numerical values for Rate, Inspiratory Time, Expiratory Time, I/E Ratio, Inspiratory

Flow, Maximum Inspiratory and Plateau Pressure, Expiration Volume, Dynamic and Static Compliance, Airway Resistance, Tobin

Index, P0,1 (Airway Occlusion Pressure), PEEP, and Intrinsic PEEP (Auto PEEP), FiO2. It also has VxP and FxV loop and Pxt, Vxt

and Fxt curve display.

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2 WARNINGS

The Servo-ventilatorSMARTis a medical device designed to combine the most advanced technology with extreme ease of use. Only

professionals who are qualified and trained in its use should operate it. Carefully review the warnings and recommendations provided

below. The SMART servo-ventilator is a life-support device, as such, it must only be serviced by authorized K. Takaoka technicians.

Biocompatibility

v According to the ISO 10993-1, the equipment is classified as a device that has no direct and/or indirect contact with thepatients body; therefore it is not included in this norms scope (Clause 4.2.1).

Ventilation

v Once you switch the Ventilator on, enter the patient's ideal weight so the equipment can pre-calculate the appropriateventilation parameters.

v For patients 6 kg (newborn and/or premature), the ventilator only has the pressure mode available.

v When ventilation is restricted by the inspiratory limit-pressure control in the VCV, SIMV/V, MMV or PSV/AV modes, the valuefor the actual volume supplied to the patient must not exceed the value adjusted in the tidal volume control. The message

LIMITED PRESSUREindicates this condition in the display.

v After you start ventilation, check that the ventilation parameters as indicated by the monitoring display are properly set.

v Make sure all ventilator menu alarm limits have been set properly.

v The respiratory pressure is measured within the ventilator; however, the required corrections will be made to represent thepatients maximum pressure.

v To ensure all condensed water within the breathing circuit flows back to the drains and does not reach the patient, the tubesupport must be placed near the Y-shaped connector and in a position below the level of the patient's mouth (Support 5.7).

v To prevent accidental gas disconnection or leakage in the breathing circuit, make sure all connections have been tightly secured.Tightly close the 6060 Heated Humidifier caps threaded lid.

v Check the endotracheal tube connection tightness frequently.

v Do not use anti-static or electrically-conductive hoses or tubes.

v When the ventilator is in use, an alternative means of ventilation must be available.

v If the pneumatic and electric supplies fail, the ventilator will allow spontaneous ventilation at a resistance of 0.45 cmH2O/lpm,0.25 cmH2O/lpm, and 0.50 cmH2O/lpm in the 60-, 30-, and 5-lpm flows, respectively.

Assembly

v Closely follow the mounting instructions provided in the explanatory pamphlet provided with the equipment and also guideyourself using Chapter 8 Ventilator Mounting and Preparation.

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Flow Sensor

v Attach the proper type of flow sensor requested by ventilator during its startup. This will be the most suitable type for theselected weight of the patient (adult or pediatric).

v Check the correct flow sensor assembly position in the respiratory system.

v Only use the flow sensor K. TAKAOKA supplies for the SMART Servo-ventilator.

v The SMART servo-ventilator is equipped with a rinse flow system in the flow sensor tubes aiming at avoiding liquid andsecretion accumulation in the sensor tubes.

v During ventilator use, check the flow sensors cleanliness as often as the physician in charge stipulates based on the patients state.

v When changing any parameter or mode, check flow sensor and line cleanliness.

Power Supply and Internal Battery

v Only attach the power cord to an outlet that is properly grounded and approved for hospital use. The female tap should bea 3-pin Nema 5-15P type outlet (item 7.2).

v Keep the internal battery charged at all times so the ventilator keeps working even when the power mains fails. To do this, theventilator must beconnected to the power mains , even when it is switched off.

v Recharge the battery after using the ventilator with no power supply so it is ready for the next use.

v Fully recharge the battery when the ventilator is left unused and disconnected from the power mains for more than

20 (twenty) days.

v The heated humidifier is not supplied by the ventilators internal battery or by the 12-VDC inlet.

v If the ventilators internal battery is powering it and the low battery alarm goes off, the ventilator must be connected to themains immediately.

v If the battery LED is on, urgent action is required to reestablish the ventilator's inlet voltage. This condition indicates animminent risk of total failure in the ventilator.

vThe auxiliary outlet is only used to connect the heated humidifier.

v Connecting another device to the backup network outlet when the safety ground conductor is damaged may increase theleakage current through the patient to amounts that exceed the limits allowed.

v The ventilator should be operated using the internal power supply when there is any doubt as to the reliability of the safetyground conductor installation.

v The detachable power cable should be attached with a strap to prevent accidental disconnection.

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Miscellaneous

v The Ventilator must undergo an annual inspection by an authorized K. TAKAOKA technician to be re-calibrated. Not complyingwith this recommendation implies in the loss of guarantee and exempts K. TAKAOKA from the legal responsibilities resulting

from technical failures the equipment may present.

v Do not use the ventilator if the automatic test indicates any irregularity (item 6.1). Solve the detected problem.

v Make sure the ventilator is set-up properly and that the alarms have been adjusted correctly before using the device.

v While the ventilator is on STAND BY (and the flow sensor is connected between the Y connector and the patient), the patient willcontinue being monitored and all alarms will be silent, except for the out-of-operation alarm that indicates the STAND BYcondition.

v When filling the Nebulizer's container, do not exceed the reservoir's maximum medication capacity.

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

v The SMART Servo-ventilator is not approved for use with flammable anesthetic agents.

v Set up an appropriate cleaning and sterilization routine for the ventilators components (Chapter 11).

v Continuously watch if the inhalation pressure gauge indicates the proper values.

v Keep the patient under constant observation. Frequently watch the patient's pulmonary expansion and free exhalation.

v The parts that are used are defibrillation-proof, except for the temperature sensor cable, which must be removed from theworking area (as it might cause burns to the patient) when the defibrillator is used near the ventilator.

v All parts used in the Ventilator are made of inert, non-toxic material that does not cause irritation or allergic reaction in the patient.

v All device parts that had contact with any fluids originating from patients (e.g.: breathing circuit, flow sensor, expiratory valvediaphragm, etc.) may be potentially contaminated after use. 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.

v Read this Operation Manual very carefully in order to use the equipment properly and to take full advantage of all of its features.

v Read the Operation Manual for the Heated Humidifier 6060.

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

v The operation of this equipment is not affected by the nearby use of other equipment such as high-frequency surgicalequipment (diathermy), defibrillators or short-wave therapy equipment. Electromagnetic compatibility assays have been

performed by an accredited laboratory.

v This equipment does not emit electromagnetic waves that may interfere with the operation of nearby equipment.

Electromagnetic compatibility assays have been performed by an accredited laboratory.

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v In this manual and on the ventilator, the pressure unit is shown in water centimeters (cmH2O) and not in Pascal (Pa),its corresponding unit in the International System (IS). 1 Pa equals 0.0102 cmH2O.

v In this manual and on the ventilator, respiratory flow is shown in breaths per minute (bpm) and not in Hertz (Hz),its corresponding unit in the International System (IS). 1 Hz equals 60 bpm.

v In this manual and on the ventilator, the volume unit is shown in milliliters (ml) or liters (l) ,and not in cubic meters (m3),

its corresponding unit in the International System (IS). 1-6m3equals 1 ml or 0,001 l.

v When the equipment and its accessories are delivered, check their integrity. If there is any apparent damage to the equipmentor its accessories, immediately contact a K. TAKAOKA authorized representative since there are different warranty periods for

different components, see Chapter 16.

v This product was manufactured according to Good Manufacturing Procedures (GMP), with silicone rubber that complies withthe required for correlates / contact with food goods. During usage, the customer must take the necessary hygiene or

sterilization cares, in addition to tests to ensure the product is appropriate and safe for the intended application since the users

product usage approaches and c onditions are not within our control.

v The ventilator cannot be covered or used in places that block air circulation in order to keep it from overheating.

v The ventilators stability is limited. It must not be transported or used on surfaces with inclinations equal or superior to 5 o, asthis may cause the device to topple over.

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3 GENERAL DESCRIPTION

The SMART Servo-ventilator is an electronic respirator designed for intensive therapy respiratory failure applications in the ICU.

Due to its several ventilation modes, this equipment may be applied to a broad range of medical procedures. The ventilator can be

applied to all kinds of patients, from premature to adults.

The Table below shows the ventilation modes available in the SMART Servo-ventilator. The modes requiring the patient's

inspiratory effort to trigger respiration rely on a safety system against apnea with automatic switch to another backup mode. This

feature provides increased safety for the patient.

Adjustedmode Description Apnea Ventilation (Backup)

1. VCV Volume-Controlled Ventilation Not Applicable

2.PCVPLV

Pressure-Controlled VentilationPressure-limited Ventilation Not Applicable

3. PCV/AV Pressure Control Ventilation /Assured Volume Not Applicable

4. SIMV/V Synchronized Intermittent Mandatory Ventilation with Volume Control IMV (non-synchronized)

5. SIMV/P Synchronized Intermittent Mandatory Ventilation with Pressure Control IMV (non-synchronized)

6. BIPV Spontaneous Ventilation with Two Pressure Levels Not Applicable

7. CPAP Continuous Positive Airway Pressure Ventilation Unavailable PSV may beused if necessary

8. PSV Pressure Support Ventilation PCV (adult, pediatric)PLV (neonatal)

Servo-ventilator SMART has a single display where actual adjustments are made to the ventilation parameters, to the patients

breathing mechanic curves and also to the data to monitor ventilation parameters. The display is in liquid crystal and it has

high-contrasting lighting for perfect viewing.

Notes:The SMART Servo-ventilator can only be used with its Ventilation Monitor functions. The Mechanical Ventilation functionsmust be deactivated by means of the STANDBY control. In this condition, all alarms will be muted, except for theinoperative alarm that indicates a STANDBY state. The operator may change the ventilation parameters, however.

A few other SMART Servo-ventilator features are described below.

v Direct digital controls for the main ventilation parameters, including tidal volume, breathing rate, inspiratory time, inspiratory

pause, pressures, maximum inspiratory flow, etc. There are quick-access keys to adjust ventilation parameters.

v Only active controls are shown in each ventilation mode, following the sequence they should be adjusted in. This featureprovides increased ease and safety when adjusting the Ventilator.

v Changing to any other mode implies the adjustment of each of the active parameters in this mode before it is put into operation.

v Digital oxygen concentration control in the air/O2mixture supplied to the patient.

v The pressure control is measured directly in cmH20 to make it easier to set the ventilator.

v Electronic endotracheal pressure gauge with graphical view by means of a linear bar display (bar graph). The pressure gaugeshows the last inhalations maximum pressure value during the expiratory phase, allowing better viewing for this parameter.

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v Complete system of audio-visual alarms for ventilation parameters with adjustable limits set by the operator. These alarms canindicate a number of irregularities during ventilation, which significantly increases therapy safety.

v Audiovisual alarms to detect possible failures of the ventilator's supply systems including oxygen, compressed air, and lowinternal battery systems.

v Safety system against apnea in modes requiring the patients inspiratory effort to begin cycles. This system performs theautomatic switch to a different backup mode.

v Barotrauma safety system using an over-pressure valve.

v Flow or pressure-assisted cycle triggering. The flow-trigger feature also enables neonatal patients to trigger ventilator cycles.

v STANDBY condition activated manually at any time to prevent audible alarms during patient preparation or any other specialevent. Except for the inoperative alarm that indicates the STANDBY condition.

v Automatic mode selection for the patient - adult, infant, or neonate - according to his/her weight as entered by the operatorwhen the Ventilator is switched on (item 6.1).

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

v Nebulizer for medication - nebulizer flow is automatically compensated when setting the tidal volume. The Nebulizer is anoptional accessory.

v TGI (Tracheal Gas Insufflation) function available for adult patients in controlled ventilations.

v Special inspiratory pause functions for 5 seconds, 100%-oxygen supply for 90 seconds, auto-PEEP measurement andprogrammed sigh.

v Electronic manual cycle button.

v Main electronic on/off switch.

v Electronically controlled expiratory valve easily disassembled for internal cleaning and inspection of its diaphragm.

vHighly accurate system to control the inspiratory flow and the air/oxygen mixture by means of two servo-valvescontrolled electronically.

v Built-in pressure control valves for oxygen and compressed air.

v Safety valves to prevent asphyxia and high pressure.

v Heated humidifier with electronic temperature control and digital thermometer (optional).

v Articulated support arm for corrugated tubes which can be set up on either side of the ventilator, depending on whichside the patient is.

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v Rechargeable internal battery for power failure or transportation situations, when the battery will automatically supplythe ventilator.

v Electric supply with 100-240 VAC network (automatic commutation) to operate the ventilator and recharge the internal battery.A 12 VDC inlet enables the ventilator to be supplied by an external battery.

v Internal battery or electric distribution network supply visual indicators.

v Ergonomic panel with membrane keyboard and advanced design.

v Silent operation.

v Front grip allowing for the proper positioning of the SMART Servo-ventilator.

v Mobile base with hooks for extensions, transportation handle, and mobile trolley with brakes.

v Upper shelf to support electronic monitors.

3.1 Ventilation Monitor

The Ventilation Monitor built into the SMART Servo-ventilator has multiple functions for monitoring the mechanical ventilation. A

graphic monitoring display shows numerical values in real time for all measured parameters as well as several options for

endotracheal pressure, tidal volume, flow, etc. 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.

A few other important Ventilation Monitor features are described below.

v Audiovisual alarms for measured parameters with minimum and maximum limits adjustable by the operator.

v Flow, volume and inspiratory pressure measurement by means of the flow sensor placed in the respiratory system. The flowsensor is highly accurate and has a low response time.

v FiO2 Measurement.

v Tobin Index and P0.1 measurement.

v Inspired/expired tidal volume and volume-per-minute measurement.

v Real-time graphs with automatic scale adjustment and image freezing control.

v 2-minute alarm silencing key (except for the inoperative alarm activated by the STANDBY key).

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4 TECHNICAL SPECIFICATIONS

Classification

NBR IEC-60601-1/97 (1994) & Errata No. 1 (1997) & Amendment No. 1 (1997) (Electromedical device Part 1:

General Safety Prescriptions)

NBR IEC 60601-2-12/2004 (particular prescriptions for pulmonary ventilation equipment safety in medical use. Equipment Class -

Energized Internally).NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General prescriptions for safety - 2. Collateral Norm:

Electromagnetic compatibility - Prescriptions and assays);

Equipment Class 1 Energized Internally

Type B IPX1 Continuous Operation

Ventilation Modes

1 VCV ................................................................................................................................................Volume-Controlled Ventilation

2. PCV ..............................................................................................................................................Pressure-Controlled Ventilation

2.1 PLV ........................................................................................................................................................ pressure-limited ventilation

3. PCV/AV.................................................................................................................Pressure Control Ventilation/Assured Volume

4. SIMV/V................................................................ .................synchronized intermittent mandatory ventilation with volume control

5. SIMV/P ...............................................................................pressure-controlled mandatory intermittent-synchronized ventilation

6. BIPV...................................................................................................................spontaneous ventilation with two pressure levels

7. CPAP........................... .................................................................................ventilation with continuous positive airway pressure

8. PSV.................................................................................................................................................... pressure support ventilation

Ventilation Parameters

Parameter Range Resolution

Rate (rpm) 1 to 150 1

Inspiratory time(s)0.10 to 0.70

0.70 to 1.00

1.00 to 5.50

0.01

0.05

0.10

Oxygen concentration (%) 21 to 100 1

Maximum limited pressure (cmH2O) 0 to 100 1

Maximum work pressure (cmH2O) 0 to 100 1

PEEP/CPAP (cm H2O) 0 to 50 1

Support pressure (cmH2O) 0 to 80 1

Inspiratory pause(s): 0.1 to 5.5 0.1

Tidal volume in adults (ml)200 to 1000

1000 to 2000

10

50

Tidal volume for children (ml) 20 to 300 10

Flow (l/min) 4 to 120 1Sensitivity per Flow (l/min) OFF, 1 to 20 1

Sensitivity per Pressure (cm H2O) OFF, -1 to -20 1

Sigh (cycles) OFF, 5 to 100 1

Patient Weight (kg)0.3 to 5.0

5.0 to 20.0

20.0 to 200.0

0.1

0.5

1.0

Volume/weight ratio (ml/kg) 5 to 12 1

Inspiratory time in BIPV (s)

0.01 to 0.70

0.70 to 1.00

1.00 to 9.90

0.01

0.05

0.10

Base flow (l/min) OFF, 4 to 40 1

Audible alarm silencer (s) 120 fixed

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Inspiratory pressure gauge

electronic bar graph (cm H2O)-10 to 100 2.5

NoteSub-atmospheric pressure is not available in the expiratory phase.

Nebulizer

Capacity for medication....................................................................................................................................................................7 ml

Nebulizer flow....................... .................................................................5 to 10 l/min synchronized with the beginning of the inhalation

TGI

Insufflation flow ....................................................................................5 to 10 l/min synchronized with the beginning of the exhalation

Special Features

v Backup modes in cases of apnea;

v Complete alarm system;

v Types of curve: squared, decelerated, accelerated and sinusoid;

v Differential pressure flow sensor;

v Electronic inspiratory pressure manometer with bar graph, on a scale of -10 to 100, 2.5 cmH 2O resolution and exactnessof (2 cmH2O + 4% of the measurement);

v Automatic compensation for breathing circuit compliance;

v Electronic on/off switch;

v Electronic & synchronized manual inhalation

v Pressure regulating valves;

v Anti-asphyxia safety valve with resistance between 0.3 and 0.5 (cm H2O/lpm);

v Electronic overpressure valve fixated at the set limit pressure;

v Flow sensor tube rinse flow between 2 and 10 (ml/min).

Gas Supply

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

Supply pressure................................................................................................ ................................... 45 to 150 psi (280 to 1035 kPa)

Pressure regulated by the equipment..........................................................................................................................35 PSI (241 kPa)

Supply flow........................................................................................................ ................................................................50 to 70 l/min

Threaded connections.................................................................................................................... according to norm NBR12188/2003

Extension/Hose..........................................................................................................................................according to norm ISO 5359

Notes:The SMART Servo-ventilator is equipped with internal pressure regulation valves, which may be connected directly to the

hospital gas network outlet installed as per the norm in effect, ISO 7396. Therefore, it is not recommended to use an

external adjustment valve.

The gas inlet connections have unidirectional internal valves that ensure reverse gas flow limitation.

WarningUsing a high pressu re inlet on the patient may be hazardous fo r him/her.

Others

Conical connections................................................................................................................................. ..according to norm ISO 5356

Corrugated tubes............................................................................................... .........................................according to norm ISO 5367

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Electrical Features

Supply............................................................................ 100 to 220 VAC with automatic switching, 50/60 Hz, power mains according

to the NBR-13534/95 regulation, or 12-VDC 2.2 Ah external battery

(ventilator only it does not power the Humidifier)

Network connector........................................... Three-pin Nema 5-15P type electrical , where the round central pin is the ground pin.

Power mains inlet fuses ................................................................................................... 20 - 1,0 A / 250 VAC mm, made out of glass

Humidifier inlet fuse.......................................................................................................... 20 - 2.0 A / 250 VAC mm, made out of glassInternal power source fuse............................................................................................... 20 - 3.0 A / 250 VAC mm, made out of glass

Power consumed by the Ventilator.............................................................................................................................30 VA (maximum)

Power consumed by the Humidifier............................................................................................................................90 VA (maximum)

Internal battery...................................................................sealed lead/acid, 12 VDC, 2,2 Ah, and maximum required current of 0.6A.

Internal battery autonomy...................................................approximately 120 minutes for an average ventilation condition in VCV,

tidal volume=500 ml and respiratory rate = 12 rpm

Full battery recharge time................................................................................ approximately 10 hours with the ventilator switched off.

Graphic display .............................................................................................high-contrast liquid crystal with a cold cathode light bulb.

Notes:

The internal rechargeable batteries may only be replaced by the authorized K. TAKAOKA Technical Assistance.The internal battery may be tested, turning the ventilator on while disconnected from the power mains and checking the

charge indication on the display (Figure 8.21).

The hospital's electrical system should be properly grounded and in accordance with the ABNT NBR 13534 norm -

Electric installations in health assistance establishments - Safety requisites. Failure to comply with this recommendation

can result in injury to the patient, operator or damage to the device, in addition to voiding the ventilator warranty.

Dimensions and Weight

Ventilator only With mobile base and accessoriesHeight........................................385 mm............................................................1360 mm

Width.................................... .....372 mm..............................................................390 mm

Depth.........................................250 mm..............................................................430 mm

Weight.......................................... 12 kgf................................................................ 29 kgf

Packaging

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

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

Environmental Use Conditions

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

4.1 Ventilation Monitor Specifications

Parameters measured in ATPD (ambiance temperature and pressure dry)

Parameter Range Resolution Accuracy

Average exhaled tidal volume (ml) 100 to 2600 5 (15% or 20 ml)

Minute volume (I) 0.1 to 50 0.01 (15% or 0.5 l/min)

Respiratory rate (rpm) 1 to 200 1 (1 s-1or 10%)

Maximum inspiratory pressure (cmH2O) -30 to 120 1(2 cm H2O + 4%

of the average)

Plateau inspiratory pressure (cmH2O) -30 to 120 1(2 cm H2O + 4%

of the average)

End-expiratory pressure (PEEP) (cm H2O) -30 to 120 1(2 cm H2O + 4%

of the average)

Average inspiratory pressure (cmH2O) -30 to 120 1(2 cm H2O + 4%

of the average)

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Static pulmonary complacency (Cstat) (ml/cm H2O) 1.00 to 100.00 0.01 10%

Dynamic pulmonary complacency (Cdyn) (ml/cm

H2O)1.00 to 100.00 0.01 10%

Airway resistance (Raw) (cm H2O/l/min) 1.0 to 100.0 0.1 10%

Inspiratory time(s) 0.01 to 20 0.01 0.2 s

I:E Ratio 6:1 to 1:10 0.1 30%

FIO2(%) 14 to 100 1 5%

Intrinsic end-expiratory pressure (ipeep) (cm H2O) -30 to 120 1(2 cm H2O + 4%

of the average)

Occlusion pressure (P0.1) (cmH2O) -30 to 120 1(2 cm H2O + 4%

of the average)

Tobin Index (iT) 0 to 500 1 5%

Notes:The SMART servo-ventilator only monitors tidal volumes exhaled above 100 ml due to the sensitivity of the flow sensor

that is used.

The FiO2monitor complies with norm ISO 7767.

Graph Options

Graph UnitFlow x time ................................................................................................................................................................................l/min x s

Pressure x Time .................................................................................................................................................................... cmH2O x s

Volume x time ...............................................................................................................................................................................ml x s

Flow x Volume......................................................................................................................................................................... l/min x ml

Volume x Pressure...............................................................................................................................................................ml x cmH2O

Alarm Setting

Parameter Range ResolutionApnea Time Alarm (s): OFF, 4 to 60 1

Audio volume alarm 2 to 10 1

Cell calibration with 21% O2OFF (do not calibrate)

ON (calibrate)Na

Cell calibration with 100% O2OFF (do not calibrate)

ON (calibrate)Na

Low Pressure Alarm (cmH2O) OFF, 1 to 125 1

High Pressure Alarm (cmH2O) OFF, 1 to 125 1

Low PEEP Alarm (cmH2O) OFF, 1 to 60 1

High PEEP Alarm (cmH2O) OFF, 1 to 60 1

High Minute Volume Alarm (l) OFF, 0.1 to 30.0 0,1

Low Minute Volume Alarm (l) OFF, 0.1 to 30.0 0,1

Low Rate Alarm (rpm) OFF, 1 to 180 1

High Rate Alarm (rpm) OFF, 1 to 180 1

Low FiO2Alarm (%) OFF, 15 to 100 1

High FiO2Alarm (%) OFF, 15 to 100 1

Na does not apply

Note:The SMART servo-ventilator alarm system has the characteristics specified in ISO 9703-1, ISO 9703-2, and ISO 9703-3.

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5 OPERATING PRINCIPLE

Oxygen (O2) and compressed air flow into the SMART Ventilator down their respective threaded connections. Pressure is reduced

by means of a set of regulating valves. Then each gas flows to its corresponding flow control servo-valve, which is controlled

electronically in order to supply the exact amount of gas at each instant. The oxygen and compressed air flows are then mixed and

supplied to the breathing circuit during the inspiratory phase. During the expiratory phase the amount of flow that is supplied will

depend on the ventilation mode selected and the parameters adjusted in the equipment.

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: Ventilator operating principle

5.1 Flow Servo-valves

The flow servo-valve converts the current signal to flow when pressurized gas is present in the inlet. In Figure 5.2, one can see that

by maintaining the current in the valve at zero, the outlet flow is also zero, since its regular position is NORMALLY CLOSED (NC).

The valve is kept closed by a calibrated s pring, which exerts sufficient pressure for the needle to keep the gas supply closed. Whena current flows over the needle, it compresses the spring, which allows the gas to move from the inlet to the outlet.

This flow servo-valve is also called the Proportional Valve since the gas flow is directly proportional to the current applied.

Re-supply

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Figure 5.2: Flow servo-valves (I = tidal)

5.2 Electronic Blender

Gas mixture is controlled electronically by means of two servo-valves to which currents are applied in direct proportion to the total

flow desired.

ITotal Flow = IO2 + IAir

5.3 Electromagnetic valve

Figure 5.3 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. A pin that moves along

with the mobile coil that moves inside a magnet performs diaphragm control. The diaphragm closing force is dependent on the

electric current applied to the coil and it is electronically controlled by means of a feedback system.

Figure 5.3: Electromagnetic valve.

5.4 Flow and volume measurement

The SMART Servo-ventilator has two flow sensors to measure the flow and volume of gases. One is internal and the other is

external, being attached to the respiratory system. An adapter with two conical connections composes each differential pressure

flow sensor. There is a resistance to flow passage in it (Figure 5.4). Two lateral tubes lead the inlet and outlet pressure signals from

the flow sensor to a differential pressure transducer located inside the ventilator cabinet. The value of the inhaled or exhaled flow is

measured at each instant in terms of the pressure difference through the sensor. The flow sensor also detects the Ventilators

cycling instants.

Knowing the amount of flow at each instant allows the tidal volumes being inhaled and exhaled to be calculated by flow data

integration over the time. This data integration is performed by a microprocessor.

Figure 5.4: Flow sensor. (?P = pressure variation)

I = 0 I > 0

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6 CONTROLS AND COMPONENTS

6.1 List of Components

The following components are provided with the SMART Servoventilator, and are to be used solely with it:

Code Item Quantity

202010588 Complete silicone adult breathing circuit 01

202011542 1800-mm flow sensor tube 01

203100149 Adult flow sensor 01

202011182 O2Extension 01

202012068 Air Extension 01

202010614 Compressed air filter 01

201050003 Heated Humidifier 01

202010612 Articulated arm 01

202011152 Expiratory valve diaphragm 01

202012085 FiO2 Kit 01

203060031 Luer lock lid 01204010210 Operation manual 01

Code: 202010588 Code: 202011542 Code: 203100149

Code: 202011182 Code: 202012068 Code: 202010614

Code: 201050003 Code: 202010612 Code: 202011152

Code: 202012085 Code: 203060031 Code: 204010210

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Optional items (exclusive use):

202010621 Nebulizer for medication 01

202011153 Expiratory Valve Block

202011033 Complete silicone respiratory circuit - pediatric 01

202010632 Complete silicone respiratory circuit - neonatal 01

202011938 O2filter 01

203100150 Pediatric flow sensor 01

Code: 202010621 Code: 202011153 Code: 202011033

Code: 202010632 Code: 202011938 Code: 2031000150

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

representative immediately, as there are different warranty periods for the various components. See Chapter 16.

To purchase optional or replacement parts, contact the authorized K.TAKAOKA distributor.

K. TAKAOKA has a full range of equipment and optional accessories for Intensive Care. Contact your authorized K. TAKAOKA

representative for further information.

6.2 Front View

The items below refer to the front view of the SMART Servo-ventilator (Figures 6.1 and 6.2).

1 Endotracheal Pressure Gauge

Bar graph-type linear manometer indicating endotracheal pressure variations through a horizontal bar ranging from

-10 to 100 cmH2O. The pressure gauge continues showing the maximum pressure value of the last inhalation during the expiratory

phase allowing this parameter to be better seen. Over and beyond this graphical display, the inspiratory pressure is also indicated

digital and graphically in the alphanumerical and graphical windows, respectively, of the ventilator display.

2 Alarm Muting Indicator

If a stop alarm condition is activated by the RESET (3) key, this indicator is continuously lit.

3 Alarm Muting Ke y

By pressing this key when any alarm is triggered, the alarm system will be muted for 2 minutes. The visual RESET indicator (2) will

remain on continuously as long as there is a temporary alarm muting condition. Except for the inoperative alarm activated by the

STANDBY key.

4 Manual Inhalation Button

This button triggers a new inspiratory phase when quickly pressed. Furthermore, the button is used to activate a few of the

SMART Servo-ventilators special functions, as described in Chapter 10.

5 Distribution Network Supply Indicator - Network(green)

As long as the ventilator's power supply is performed through a 100-240 VAC distribution network, this light will remain on. If the

mains fail, this light will be turned off.

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Figure 6.2. Front view Ventilator Control and Monitoring Panel.

8 Control and Monitoring Display

Liquid crystal display that centralizes the following functions: Ventilation parameter control, alarm message and graph display, in

addition to the display of other information regarding ventilator operation conditions. This displays resources are detailed in Chapter 6-

"Control Display."

9 Oxygen Concentration Key

Key to adjust the oxygen concentration of the gases supplied to the patient. When pressed, this key highlights the oxygen

concentration value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys.

Setting is done on a scale ranging from 21 to 100% O 2.

10 Inspiratory Pause Key

Key to adjust the inspiratory pause time to provide an inspiratory plateau in the ventilation modes with volume controlled. When

pressed, this key highlights the inspiratory time value in the display so this numerical value can be adjusted by means of the

increase (13) and decrease (19) keys. The adjustment is directly performed in seconds.

Note:The I/E ratio value will be affected by any adjustment made in the inspiratory pause control. After starting ventilation,

check if the I/E ratio value, as shown in the alphanumerical screen, is appropriate.

11 Pressure-Assisted Sensitivity Key

Key to set the necessary negative pressure (trigger) level so the patient can trigger a ventilator cycle. This control is available in all

ventilation modes. When pressed, this key highlights the sensitivity value in the display so this numerical value can be set by means

of the increase (13) and decrease (19) keys. The adjustment is made directly in cmH 2O (negative pressure).

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Notes:The value adjusted by this control refers to the level of negative pressure belowthe PEEP value. In a few modes, this

control can be deactivated by adjusting it to "- - - -".

The triggering of cycles by the patient can be done either by measuring the pressure drop (pressure trigger) or by

measuring the inhaled flow (flow trigger) depending on the pressure and flow sensitivities adj usted. Flow sensitivity

is adjusted in the menu screen of the control display (item 6.3.1). The condition that will prevail is the first to happen,

either pressure trigger or flow trigger.

In order to facilitate the correct sensitivity adjustment, an assisted or spontaneous trigger message briefly appears in the

control display each time the patient succeeds in triggering a ventilator cycle.

12 Pressure Support Ventilation Key

Key to set the pressure support ventilation used in several ventilation modes. When pressed, this key highlights the pressure support

ventilation value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The

adjustment is made directly in cmH2O.

13 Control Display Increase Key

Key that increases the ventilation parameter value (item 6.2.1) highlighted on the display. On the ventilator's setup screen (item 6.3),

this key increases the parameter value highlighted in the display. To change the value slowly, press this key intermittently. Tochange the value quickly, keep this key pressed.

14 Control Display Confirmation Key - ENTER

Key used to confirm the adjustments performed by the operator in ventilator controls. This key should be pressed in the following cases:

1) After mode selection, using the MODE key (15).

2) After the value adjustment of each ventilation parameter, using the increase (13) and decrease (19) keys.

3) In the set-up screen, keep pressing ENTER successively so the items are highlighted, allowing their individual adjustment.

If any parameter is not confirmed by the ENTER key within 30 seconds after being changed, it will be reset.

15 Mode Key - MODE

This key selects the ventilation mode from among the following options when weight is 6 kg: VCV, PCV, PCV/AV, SIMV/V,

SIMV/P, BIPV, CPAP, and PSV; and for weights 6 kg: PLV, SIMV/P, BIPV, CPAP, and PSV. Press this key repeatedly until the

desired mode is highlighted in the control display and then press the ENTER key (14) to confirm the selection.

16 Key to Change the Control Display Screen - MENU

This key puts the ventilators display (8) in the configuration mode. The detailed procedure for performing these adjustments can be

found in items 6.3,6.4, and 6.5. The display returns to the main screen by pressing the MENU key (16).

17 Graph Change Key - GRAPH

Key that changes the graph shown on the graphics screen. The available graph options are described in the item 6.2.4 of this manual.

18 Standby Key - STAND BY

When this key is pressed for 2 seconds, the ventilator enters the STANDBY mode and a message will appear on the display. Theventilator will remain inactive ; however, it will be possible to set the ventilation parameters. To cancel this condition, the operator

must press STANDBY again. 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.

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Notes:Patient monitoring will keep operating as long as the ventilator is in the STANDBY mode. However, all alarms will be muted.

By activating the STANDBY mode, the SMART Servo-ventilator can only be used with its Ventilation Monitor functions.

19 Control Display Decrement Key

Key that reduces the ventilation parameter value (item 6.2.1) highlighted on the display. On the ventilator's setup screen (item 6.3),

this key reduces the parameter value highlighted in the display. To change the value slowly, press this key intermittently. To change

the value quickly, keep this key pressed.

20 PEEP/CPAP Key

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

can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is made directly in cmH 2O. In the CPAP

mode, this control regulates the continuous positive airway pressure (CPAP). In other modes, this control regulates the positive

end-expiratory pressure (PEEP) value.

21 Limit Inspiratory Pressure Key

Key to set the maximum inspiratory pressure limit. When pressed, this key highlights the value for the maximum inspiratory pressure

limit in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is

made directly in cmH2O.

Note:In the PCV/PLV, level 2 BIPV and SIMV/Pmodes, this control regulates the inspiratory pressure value. In the VCV,

SIMV/V, and PSV/AV modes, this control acts as a safety limit against barotrauma caused by excessive pressure.

22 Maximum Inspiratory Flow Key

Key to set the maximum flow value during the inspiratory phase. When pressed, this key highlights the Maximum Inspiratory Flow

value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment

is performed directly in liters per minute.

Notes:In the VCV and SIMV/V modes, the Maximum Inspiratory Flow and the Tidal Volume will determine the inspiratory time.

After starting the ventilation, check whether the resulting value for the inspiratory time indicated by the ventilator's display

is appropriate.

In the controlled modes, the Maximum Inspiratory Flow key is not active, and the maximum inspiratory flow supplied by

the equipment during inspiration is FREE, according to the need to keep the pressure set in the ventilator control panel,

except for modes available for neonatal patients (weight = 6 kg), where the operator may adjust the flow.

23 Inspiratory Time Key

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

value can be adjusted by means of the increase (13) and decrease (19) keys. The adjustment is directly performed in seconds.

Notes:The inspiratory time key is not enabled in the VCV and SIMV/V modes when the inspiratory time results from adjusting

other ventilator controls.

The I/E ratio value will be affected by any adjustment made in the inspiratory time control. After starting the ventilation,

check if the I/E ratio value the ventilator's display indicates is appropriate.

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24 Breathing Rate Key

Key to set the breathing rate. When pressed, this key highlights the rate value in the display so this numerical value can be adjusted

by means of the increase (13) and decrease (19) keys. The adjustment is made directly in breaths per minute.

Notes:In the VCV and SIMV/V modes, the breathing rate will determine the I/E ratio. After starting ventilation, check whether the

I/E ratio indicated by the ventilator's display is adequate.

In a few modes, the patient will normally determine the rate, and the adjustment of this control will merely set a backup

respiratory rate value.

25 Volume Key

In the VCV, PCV/AV, and SIMV/V modes, this key regulates the desired tidal volume. When pressed, this key highlights the tidal

volume value in the display so this numerical value can be adjusted by means of the increase (13) and decrease (19) keys. The

adjustment is directly performed in millimeters.

AttentionWhen venti lat ion is being l imited by the ins piratory l imit pressu re (21), the contro l di splay (8) wi l l show the

LIMITED PRESSURE mes sage (in the VCV, SIMV/V, and PSV/AVmo des), and the v alue for the actual t idal

volume su ppl ied to the patient wi l l be smal ler than the one indicated by this t idal volum e control.

6.3 Front Connection Panel

The items below refer to the SMART Servo-ventilator front connection panel (Figure 6.3).

1 Connector for Flow Sensor Tube (Blue)

Inlet for the blue flow sensor tube. The other end of the tube must be attached to the flow sensor nozzle, next to the side of the

sensor that has the largest diameter (female). Only use the sensor supplied by TAKAOKA.

2 Connector for Flow Sensor Tube (Transparent)

Inlet for the transparentflow sensor tube. The other end of the tube must be attached to the flow sensor nozzle on the side of thesensor that has the smallest diameter (male). Only use the sensor supplied by TAKAOKA.

AttentionThe two tubes mu st be assembled in the correct posi t ion acc ording to th e color codes loc ated at the venti lator 's

conn ectors. The tubes have dif ferent colors for quick ident i f icat ion. See item 7.4 for mo re information.

3 Expiratory Valve Block

This block contains the expiratory valve and two conical connectors for the corrugated tubes of the breathing circuit. 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 5.7.

4 Connector for the Nebulizer Tube or the TGI Catheter

Inlet for the medication Nebulizer tube, which is an optional SMART Servo-ventilator accessory. The other end of this tube must be

connected to the lower part of the Nebulizer container. Inlet for the TGI catheter. The required catheter for the procedure is not

supplied with the equipment.

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Figure 6.3. Front connection panel SMART Servo-ventilator.

6.4 Back View

The items listed below refer to the back view of the SMART Servo-ventilator (Figure 6.4).

AttentionControls (8), (10), (12) and (14) should only be adjusted b y techn icians wh o have b een trained and auth orized

by K. TAKAOKA.

1 Humidifier Outlet Fuses

Compartment with a fuse to protect the electrical parts of the Humidifier 6060.

2 Serial Outlet (Optional)

Serial outlet for ventilator synchronization in the ILV function through the appropriate cable (this item is optional).

Note:Parts for signal outlet or for signal inlet are only used to connect the device according to Norm NBR IEC 60601-1.

The serial cable is not provided with the SMART servo-ventilator, and is an optional accessory. For information on the

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

3 12 VDC Power Tap

Electric socket to supply electricity to the SMART Servo-ventilator by means of an external 12-VDC battery. This is useful for

transportation or as an spare source of energy. The Heated Humidifier will not work with this type of power supply.

5 Electric Tap for the Heated Humidifier

Electrical outlet socket for power supply to Heated Humidifier 6060, with voltage and rate equal to the 100 to 240-VAC mains inletcable. (The Heated Humidifier has an automatic voltage converter). This source only supplies power. See the technical

specifications for more information.

6 Inlet Connection - Oxygen

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

supplys pressure and flow must comply with the technical specification.

7 Pressure Regulating Valve - Oxygen

This valve reduces the oxygen pressure that supplies the ventilator to 45 PSI (310 kPa).

8 Socket for Pressure Calibrator - Oxygen

Tap for the pressure calibrator gauge to measure the pressure value as controlled by the valve (9). It is designed to facilitate the

maintenance performed by an authorized K. TAKAOKAtechnician.

2 3

41

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9 Pressure Regulating Valve - Oxygen

This valve reduces the oxygen pressure that supplies the ventilator to 35 PSI (241 kPa).

10 Socket for Pressure Calibrator - Oxygen



11 Pressure Regulating Valve - Compressed Air

Valve that reduces the oxygen pressure feeding the ventilator to 45 PSI (310 kPa).

12 Pressure Calibrator Socket - Compressed Air



13 Pressure Regulating Valve - Compressed Air

Valve that reduces the oxygen pressure feeding the ventilator to 35 PSI (241 kPa).

14 Pressure Calibrator Socket - Compressed Air



15 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 supplys pressure and f low must comply with the technical specification.

16 On/Off main switch

Electro-pneumatic key which, when on the OFFposition, cuts the gas flow and automatically turns the SMART Servo-ventilator and

Heated Humidifiers electric circuits off. When switched to ON, the ventilator and the Heated Humidifier are switched on.

17 Power Cable Inlet - 100-240 VAC

Inlet to attach the Ventilator to a 100 to 240VAC power supply by means of a removable power cable provided with the ventilator.

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

Notes:The ventilator can be supplied with voltage between 100 and 240VAC as it has automatic voltage conversion.

Follow the power supply recommendations described in item 7.2.

18 Ventilator inlet fuse

Compartment with a fuse to protect the ventilators electrical parts.

19 Identification Tag

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

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Figure 6.4. Back view SMART Servo-ventilator

6.5 Left-side View

The items listed below refer to the SMART Servo-ventilators left side view (Figure 6.5).

1 Audible Device

Outlet for the alarm system's audible signal.

2 Contrast Button for the Control Display

Button to set the ventilators display contrast. This button should be adjusted until you achieve the best screen view.

3 FiO2 Connector

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Figure 6.5. Left-side view - SMART Servo-venti lator.

6.6 Electronic Heated Humidifier (optional)

Note:Read the 6060 Heated Humidifier Instruction Manual carefully.

The 6060 Heated Humidifier (Figure 6.6) was designed specifically for use with respiratory circuits. It has an electronic temperature

control, a digital thermometer, pilot and electric resistance operation lights, on/off switch, and a transparent chamber with capacity

for 400 ml of sterile water. The gas temperature is measured near the patient's mouth by means of an electronic thermometer.

The SMART Servo-ventilators on/off switch also switches the Heated Humidifiers power supply on and off.

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.

Water 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.

6.6.1 Safety measures for Heated Humidifier 6060 use

1. 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 6.7).

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

The Heated Humidifiers chamber can be easily disassembled for disinfectingsince 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.

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Figure 6.6. Heated Humidifier 6060.

Exp.

Insp.

Right

Wrong

Heatedhumidifier

Water draining

Water to patient

Patient

Figure 6.7. Corrugated tube positioning.

6.7 Expiratory Valve

The expiratory valve is an electro-magnetic valve that sets the SMART Servo-ventilator inspiratory and expiratory phases. During

the expiratory phase, the valve is opened to allow the release of exhaled gases.

The expiratory valve block is attached to the ventilators front connection panel (item 5.3). This allows the breathing circuit's tubes to

be directed to either side of the ventilator depending on which side the patient is.

Figure 6.8 shows the cross-section assembly of the components from the expiratory valve block. This block has two conical

connections in its body for the corrugated tubes of the breathing circuit.

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.

AttentionPeriodical ly check the cleanl iness and the c ondit ion of the expiratory valve diaphragm . In case there is any

f issure or other abno rmal i ty in this com pon ent, replace it with a new one.

Periodical ly check state of the seal ing ring (O-ring ).

The block mu st be tight ly fastened to the venti lator s front co nnect ion p anel so there is no g as leakage.

1. Chamber Outlet Connection (Patient)2. Humidifier Chamber Lid (autoclavable)3. Humidifier Chamber (autoclavable)4. Chamber Mounting Clamps

5. Chamber Mounting Button6. Temperature display7. Heating Control8. Pilot Light (Heater On)

9. Heating Light (Power On)10. Re-supply inlet

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NUTHUMIDIFIER

PATIENT

BLOCK

DIAPHRAGM

PIN

O-RING

Figure 6.8. Assembling of the expiratory valve.

6.8 Drains

The SMART Servo-ventilators respiratory circuit has 2 (two) drains to collect the water that 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 6.9).

BODY

PLUNGER

CUP

Figure 6.9. Breathing circuit drain.

6.9 Nebulizer (optional)

The Nebulizer is an optional accessory of the SMART Servo-ventilator to administer medication to the patient by means of a gas

flow that enters the breathing circuit during the inspiratory phase. The Nebulizer's reservoir has a 7-ml medication capacity.

The configuration screen of the ventilators control display allows the operator to turn the nebulizer function on or off (item 6.3).

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Another option is to assemble it between the flow sensor and the mask or endotracheal tube (6.10).

The nebulizer supply tube should be connected to the respective NEBULIZER connection nozzle located on the front connection

panel of the ventilator (item 5.3).

Notes:The Nebulizer is for use with adult, infant and neonatal patients, although only in some modes.

The nebulizer flow is automatically adjusted when the tidal volume is defined.When filling the Nebulizer's container, do not exceed the reservoir's maximum medication capacity.

The FiO2may be influenced while the nebulizer is used.

When filling the Nebulizer's container, do not exceed the reservoir's maximum medication capacity.

AttentionHumid ifier fi lters and/or heaters shou ld not b e placed after the nebulizer when this resou rce is in use. These

f i l ters m ay cause a c onsiderable increase in respiratory resistance.

Never leave the supply tube connected to the front p anel when the nebul izer resource is not being used, even if

the reservoir is empty.

Figure 6.10. Nebulizer assembled between the flow sensor and the patient.

6.10 TGI

TGI (tracheal gas insufflation) is a resource available in the SMART Servo-ventilator to raise the release of CO 2aided by the

anatomic dead space cleaning.

The TGI runs by means of a flow of fresh gas that is injected in synchronization with the end of the exhalation into the trachea

(though a special catheter placed inside the endotracheal tube). This flow is intended to push the anatomical dead space volume

out, which is rich in CO2, ensuring that at each inspiratory cycle, the volume supplied to the patient is only formed by fresh gases

containing no CO2.

The ventilators control display set-up screen allows the operator to turn the TGI function on or off (item 6.3).

The TGI catheter must be coupled to the NEBULIZER's nozzle located on the ventilator's front connection panel (item 5.3).

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Notes:The TGI is intended to be used only in adult patients (weighting 26 kg or more).

The TGI feature is available only in controlled modes (VVC, PVC, and PCV/AV).

The TGI flow is automatically compensated for during tidal volume determination; thus, the exhaled volume will be slightly

bigger tha

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