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This Operation Manual contains the information necessary for the correct utilization of the CARMEL Servoventilator.

Manufacturer:K. TAKAOKA Indstria e Comrcio LTDA.

Av. Bosque da Sade, 519

So Paulo SP

CEP: 04142-091

Tel: (55 0xx11) 5586 1000Fax: (55 0xx11) 5589 7313

Web site: www.takaoka.com.br

e-mail: [email protected]

CGC: 61.489.381/0001-09

I.E.: 103.735.350.115

For suggestions, questions or complaints:

Call Center: (55 0xx11) 5586 1010

Product Register in the Ministry of Health:

Commercial Name: CARMEL Servoventilator

Number of the Register in the Ministry of Health: 10229820091

Product Classification:

NBR IEC-60601-1/97 (1994) & Correction no. 1 (1997) & Amendment no. 1 (1997) (Electromedical Equipment Part 1: General

Safety Prescriptions)

NBR IEC 60601-2-12/2004 (specific prescriptions for the safety of lung ventilation equipment in medical utilization Equipment Class

1 Internally Energized)

NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General Safety Prescriptions 2. Collateral Standard:

Electromagnetic Compatibility Prescriptions and tests)

Equipment Class 1 Internally Energized

Type B IPX0 Continuous Operation

Responsible Technician:

Eng. Mauricio Chiarioni

CREA: Register no. 5061714921

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Product Installation Form

EQUIPMENT: ___________________________ Code: _____________ Serial Number: _______________

DESCRIPTION CODE SERIAL NUMBER123456789

COMPONENT

S

10

BILL OF SALE: Original K.TAKAOKA [ ] YES _____________________ [ ] NO ______________________Bill Number * Dealer Name

ENTITY:

Company Name: ______________________________________C.N.P.J*.: __________________________

Address: ________________________________________________ _______________________________

City: ________________________________________ State: __________MAIL CODE: ________________

Person responsible for the information*:_________________________ Position: ______________________

Sector: ________________________ Tel*.:____________________ email: __________________________(*) Mandatory Field s

YOUR OPINION:

1. Was the product(s) delivery made in time regarding the agreed upon date? Yes No

2. Were the product(s) and component(s) according to the order? Yes No

3. Was the packaging in any way damaged? Yes No

4. Was there any problem to install the equipment? Yes No

5. Is the equipment and/or components working properly? Yes No

6. Was there any problem to connect the components, tubes and cables? Yes No

7. Is the bill of sale data correct, regarding your data, amounts, product description, quantitiesand payment conditions?

Yes No

8. Please enter any additional comment:

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

Dealer: _________________________________________ Date ____ / ____ / _____ Sig.: _____________

Please send this form to the Fax No. (55 0xx11) 5589 8072 or by registered mail to K. TAKAOKA

WARNING: THE WARRANTY PERIOD WILL START UPON THE CONFIRMATION OF THE INFORMATIONCONTAINED IN THIS TERM. THIS TERM SHALL BE SENT WITHIN A MAXIMUM TIME OF THIRTY (30) DAYS,

AS STATED IN THE OPERATION MANUALIf there is any doubt or you need more information please contact: SAC (55 0xx11) 5586 1010

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CONTENTS

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

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

1 IMPORTANT NOTES .............................................................................................................................................................. 122 GENERAL DESCRIPTION...................................................................................................................................................... 16

2.1 Ventilation Monitor ........................................................................................................................................................ 183 TECHNICAL SPECIFICATIONS ............................................................................................................................................. 19

3.1 Ventilation Monitor Specifications ................................................................................................................................. 224 OPERATION PRINCIPLE...................................................................... .................................................................................24

4.1 Flow Servo-Valves........................................................................................................................................................ 244.2 Electronic Mixer ............................................................................................................................................................ 254.3 Electromagnetic Valve..................................................................................................................................................254.4 Flow and Volume Measurement ................................................................................................................................... 264.5 Oxygen Measurement................................................................................................................................................... 26

5 CONTROLS AND COMPONENTS........................................................ .................................................................................27

5.1 Components List...........................................................................................................................................................275.2 Optional Items ............................................................................................................................................................... 285.3 Front View.....................................................................................................................................................................29

5.3.1 LCD Monitor............................................................................................................................................................305.3.2 Control Panel...........................................................................................................................................................30

5.4 EASY TOUCH Button ................................................................................................................................................... 305.5 Front Connection Panel ................................................................................................................................................ 305.6 Rear View ..................................................................................................................................................................... 325.7 Heated Humidifier.........................................................................................................................................................345.8 Expiration valve............................................................................................................................................................. 355.9 Drains ........................................................................................................................................................................... 365.10 Nebulizer (optional)...................................................................... .................................................................................365.11 TGI - Tracheal Gas Insufflation.................................................... .................................................................................375.12 Battery..........................................................................................................................................................................38 5.13 Movable Base...............................................................................................................................................................38

6 ASSEMBLY AND PREPARATION OF THE CARMEL ...........................................................................................................396.1 Assembly of the CARMEL ............................................................................................................................................. 396.2 Power Source...............................................................................................................................................................406.3 Respiration loop........................................................................... .................................................................................416.4 Flow Sensor..................................................................................................................................................................436.5 Cell/O2 Sensor..............................................................................................................................................................44

6.5.1 Calibration before using the O2Sensor....................................................................................................................456.5.2 After calibrating the O2sensor.................................................................................................................................45

7 CONTROL PANELS........................................ .......................................................................................................................47

7.1 Control panel.................................................................................................................................................................478 Configuration of the Ventilation Parameters.......................................................................................................................49

8.1 Self-test Screen............................................................................................................................................................498.2 Initialization Screens.................................................................... .................................................................................49

8.3 Main Screen..................................................................................................................................................................538.4 Messages ..................................................................................................................................................................... 538.5 Monitoring Functions..................................................................................................................................................... 558.6 Graphics Window................................... .......................................................................................................................558.7 Trend Screen (Graphic) ................................................................................................................................................ 568.8 Database......................................................................................................................................................................57

9 OPERATION ........................................................................................................................................................................... 59

9.1 Initial Procedures and Tests..........................................................................................................................................599.2 Adjustment of the Ventilation Parameters.....................................................................................................................60

10 ALARM SYSTEM...... .............................................................................................................................................................. 65

10.1 Alarm Priority Levels..................................................................................................................................................... 6511 VENTILATION MODES........................................................................................................................................................... 68

11.1 Mandatory and Spontaneous Cycles............................................................................................................................ 6811.2 Selection of the Ventilation Modes......... .......................................................................................................................6911.3 VCV - volume-controlled ventilation.................................................................................... ..........................................6911.4 PCV - pressure-controlled ventilation............................................................................................................................7011.5 PLV pressure-limited ventilation................................................. .................................................................................71

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11.6 PCV/AV - volume ventilation ensured by pressure control.......................................................................................... 7211.6.1 Initialization sequence - PCV/AV...........................................................................................................................73

11.7 SIMV/V - synchronized intermittent mandatory ventilation with volume control.............................................................7311.8 SIMV/P - synchronized intermittent mandatory ventilation with pressure control.........................................................7411.9 BIPV - spontaneous ventilation with two pressure levels.............................................................................................7511.10 CPAP - ventilation with continuous positive pressure in the aerial passages................................................................7611.11 PSV - pressure support ventilation................................................................................................................................ 76

12 SPECIAL FUNCTIONS ........................................................................................................................................................... 78

12.1 Inspiration Pause and Expiration Pause....................................................................................................................... 7812.2 Auto-PEEP Measurement.............................................................................................................................................7812.3 100% of Oxygen...........................................................................................................................................................7812.4 Relief.............................................................................................................................................................................7812.5 Measurement of the Tobin Index (iT) ............................................................................................................................ 7812.6 Measurement of the P0.1 Occlusion Pressure of the Aerial Passages .........................................................................78

13 CLEANING AND STERILIZATION......................................................................................................................................... 79

14 MAINTENANCE......................................................................................................................................................................84

14.1 Internal Rechargeable Battery............... .......................................................................................................................8514.2 Fuse Replacement....................................................................... .................................................................................85

14.2.1 Fuse replacement instructions (built-in in the outlet)................................................................................................8514.2.2 Fuse replacement instructions (individual)...............................................................................................................85

15 TROUBLESHOOTING ............................................................................................................................................................ 86

15.1 Message in the Monitor.................................................................................................................................................8615.2 Occurrences..................................................................................................................................................................8716 MEASUREMENT METHODS .................................................................................................................................................. 88

16.1 Volumes........................................................................................................................................................................8816.2 Frequency.....................................................................................................................................................................8816.3 I:E Ratio........................................................................................................................................................................ 8816.4 Inspiration and Expiration Time..................................................................................................................................... 8916.5 Maximum, Medium, Plateau and PEEP Pressure.........................................................................................................8916.6 Resistance....................................................................................................................................................................8916.7 Complacency................................................................................................................................................................9016.8 Inspiration work.............................................................................................................................................................90

17 SYMBOLOGY ......................................................................................................................................................................... 91

18 EMERGENCY ACTIONS ........................................................................................................................................................ 96

19

WARRANTY TERM................................................................................ .................................................................................97

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DEFINITIONS

CautionAlerts the user about the poss ibil i ty of injury, death or other serious adverse react ions asso ciated to the bad use

of the equipm ent.

WarningAlerts the user about the possibil i ty of problems with the equipment associated to bad use, such as equipment

malfunct ion , equipment failure, damaged equipm ent or damages to third-party property.

Note:Highlights an important information

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THE COMPANY

A K. TAKAOKA is a company dedicated for more than 48 years to the segment of hospital equipment, always in close cooperation

with the medical class. It acts mainly in the areas of Anesthesia, Intensive Care, Monitoring and Oxygen Therapy and is proud of

having achieved a leading position in the market, it counts with an extensive line of products.

It holds as one of its priorities the permanent investment in the research and development of new ideas and solutions. It is wellknown for the constant introduction of technological advances and industrial innovations to its product line, comparable to the main

domestic and international industries of the segment.

The company designs and manufactures with the help of sophisticated equipment the majority of the components used in its

products, which are submitted to a strict quality control. It is also concerned in providing a high level of support to all users by means

of its Sales and Technical Assistance departments.

It counts with distributors all around the national territory and is also present in the international market. K. TAKAOKA has therefore

achieved, along the years, the confidence of its clients on its strict quality standards and on the high efficiency of its products and services.

Vision:

To become a global company.

Mission:

To become a national leader in the segments of anesthesia apparatus, lung ventilators, vital signal monitors and oxygen

therapy, thus contributing to the preservation of life, offering high technology and the best service to our clients.

Quality Policy:

Continually improve our PRODUCTS, SERVICES and PROCESSES, involving our COLLABORATORS

and SUPPLIERS in obtaining the satisfaction of our CLIENTS and SHAREHOLDERS.

K. TAKAOKA IND. E COM. LTDA.

Av. Bosque da Sade, 519

So Paulo - SP - CEP: 04142-091

Tel: (55 0xx11) 5586-1000

Fax: (55 0xx11) 5589-7313

E-mail: [email protected]

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

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1 IMPORTANT NOTES

Note:This Operation Manual is destined to the commercially available model of the CARMEL Servoventilator. The several

components possibly compatible with the CARMEL are clearly highlighted in the text as optional items.

The CARMEL Servoventilator is a medical apparatus designed to join the most advanced technology to an easy to use apparatus,

which shall be only operated by qualified professionals specifically trained on its utilization. The warnings and recommendations

described below shall be carefully observed.

Biocompatibility

v According to ISO 10993-1 this equipment is classified as a device without direct and/or indirect contact with the patients body,therefore it is not included in the scope of this standard (Clause 4.2.1).

Ventilation

vWhen turning the ventilator on, adjust the volume per kg and the weight of the patient so the ventilator will display the currentcalculated volume. Select the initial mode and the ventilator will suggest the parameter value.

v When the ventilation is limited by the control of the inspiration pressure limit, in the VCV, SIMV/V and PCV/AV modes, thevalue of the actual volume supplied to the patient is lower than the one adjusted in the current volume control, being such

condition displayed on the monitor through the message LIMITED PRESSURE.

v After starting the ventilation, please check whether the ventilation parameters shown on the monitoring display are adequate.

v Check the proper adjustment of all the alarm limits.

v To ensure that all the water condensed in the respiration loop returns to the drains and does not reach the patient, the tubesupport shall be placed close to the intermediate Y piece and in a position lower than the patients mouth.

v In order to avoid an accidental disconnection or gas leaks in the respiration loop, all connections shall be firmly secured. Closetightly the threaded lid of the Heated Humidifier.

v Check frequently the tightness of the endotracheal tube connection.

v Do not use antistatic hoses or electrically conductive tubes.

v When the ventilator is in use, an alternate ventilation means shall be available.

v In case of failure of the pneumatic and power sources the ventilator will allow spontaneous ventilation with a resistance of 0.45cmH2O/lpm, 0.25 cmH2O/lpm and 0.50 cmH2O/lpm with flows of 60 lpm, 30 lpm and 5 lpm respectively.

Oxygen Analyzer

v The Oxygen Analyzer shall be calibrated in ambient air (21% of O2) or pure Oxygen (100% of O2) before each utilization of theCARMEL Servoventilator.

v The Oxygen Analyzer shall always be kept in a hermetically closed package when not in use, to prevent the reduction of its

service life.

v Use only the Oxygen Analyzer specified by K. TAKAOKA.

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Flow Sensor

v Connect the type of flow sensor most adequate to the selected patient weight (adult or infantile).

v Observe the correct assembly position of the flow sensor in the respiration system.

v Use only the flow sensor supplied by K. TAKAOKA for the CARMEL Servoventilator.

v When using the ventilator, check the flow sensor for cleanlinessfrequently.

Power Source and Internal Battery

v Connect the power cable only to a properly grounded outlet, approved for hospital use. The plug shall have threeNema 5-15P pins (item 6.2).

v Keep the internal battery always charged, so the ventilator will continue to operate even in case the electric network fails.

Therefore, the ventilator shall be left constantly connected to the electric network , even when turned off, to keep the internalbattery fully charged.

v Recharge the battery after using the ventilator while not connected to the electric network, to prepare it for the nextutilization period.

v Perform a complete battery recharge when the ventilator was not in use and disconnected from the network for a period longerthan 20 (twenty) days.

v The Heated Humidifier is powered neither by the ventilator internal battery nor by the 12 Vdc source.

v If the internal battery is powering the ventilator and the high-priority alarm of BATTERY LOW is activated, the ventilator mustthen be immediately connected to the electric network.

v If there is any doubt about the integrity of the installation of the protection ground conductor, the ventilator shall be operatedfrom the internal power source.

v The connection of other equipment to the auxiliary network outlet may increase the current drain through the patient up tovalues that exceed the allowable limits, in the case of a defective protection ground conductor.

v When the NETWORK (1) visual indicator (on the keyboard) is off, an urgent action is required to reestablish the ventilators

input voltage, because there is the imminent risk of a ventilator stop.

v The detachable network cord (power cable) must be fastened with a clamp ring to avoid accidental disconnection.

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

Miscellaneous

v The ventilator shall be submitted to an annual inspection carried out by a technician authorized by K. TAKAOKA, for re-calibration.

v Check whether the ventilator is correctly configured and if the alarms are properly adjusted before using the equipment.

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v When filling the glass of the Nebulizer, do not exceed the maximum medicine capacity in the reservoir. Do not leave itconnected when not in use.

v Do not press any key with surgical instruments or tools. Use only your fingertips to press the keys. Sharp or hard objects maydamage the keys.

v The CARMEL Servoventilator is not approved for use with flammable anesthetic agents.

v Establish an adequate cleaning and sterilization routine for the ventilator components (Chapter 13).

v Observe constantly if the inspiration pressure manometer is displaying adequate values.

v Keep the patient under constant observation. Observe frequently his/her lung expansion and free expiration.

v All parts of the equipment in contact with patient fluids (as respiration loops, flow sensors, expiration valve diaphragms, etc.) maybe potentially contaminated after use. If considered semi-critical, they must be submitted, before discarding (at the end of their

service life), to a high-level disinfection process or sterilization, or they must be discarded as potentially infected hospital garbage.

v The applied parts are defibrillation-proof, with exception of the temperature sensor cable, which must be removed from thework area (because the patient may get burned) when the defibrillator is used close to the ventilator.

v All the applied parts of the ventilator are built of inert and non-toxic material, to prevent sores or allergy in the patient.

v Please read this Operation Manual very carefully, in order to use the equipment correctly and to take the maximum advantageof all its features.

v Please also read the Heated Humidifier 6060 Operation Manual, supplied together with the CARMEL Servoventilator.

v Any necessary repair in the ventilator shall only be carried out by qualified technicians duly authorized by K. TAKAOKA.

v The operation of this equipment is not affec ted when used close to other equipment, as high -frequency surgical equipment(diathermy), defibrillators or short-wave therapy equipment. An accredited laboratory carried out electromagnetic compatibility tests.

v This equipment does not emit electromagnetic waves that might interfere with the operation of nearby equipment. Anaccredited laboratory carried out electromagnetic compatibility tests.

v In this manual and in the ventilator, the pressure unit shown is in centimeters of water (cmH2O) and not in Pascal (Pa), its

corresponding unit in the International System (IS). Being 1 Pa equal to 0.0102 cmH2O.

v In this manual and in the ventilator, the respiration frequency unit shown is in respirations per minute (rpm) and not in Hertz (Hz) itscorresponding unit in the International System (IS). Being 1 Hz equal to 60 rpm.

v In this manual and in the ventilator, the volume unit shown is in milliliters (ml) or liters (l) and not in cubic meters (m3) itscorresponding unit in the International System (IS). Being 1 -6 m3 equal to 1ml or 0.001 l.

v Upon reception please check the integrity of the equipment and its components. Should the equipment or its components showany apparent damage, please contact an authorized K. TAKAOKA dealer immediately, because there are different warranty

periods for the several components, refer to Chapter 19.

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v This product was manufactured following good manufacturing practices and procedures (BPF or GMP), using silicone rubberthat meets the regulations required for similar equipment / contact with food. During the operation the client shall take the

necessary hygiene or sterilization precautions, in addition to tests to ensure that the product is adequate and safe for the

desired specific application, because the utilization methods and conditions practiced by the users are beyond our control.

v The ventilator cannot be covered or kept in places with poor air circulation, in order to avoid overheating.

v The ventilator has limited stability and can neither be transported nor used on surfaces with inclination equal to or above 5,to avoid tipping.

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2 GENERAL DESCRIPTION

The Table below presents the ventilation modes available in the CARMEL Servoventilator. The modes requiring an inspiration effort

from the patient to start the respiration cycles count with a protection system against apnea, with the automatic change to another

reserve mode (backup). This feature results in increased safety for the patient.

Adjusted Mode Description Ventilation in Apnea(Backup)

1. VCV/ ASSISTED Volume-Controlled Ventilation Not Applicable

PCV/ ASSISTED Pressure-Controlled Ventilation Not Applicable

2.

PLV/ ASSISTED Pressure-Limited Ventilation Not Applicable

3. PCV/AV Ventilation Volume ensured by Pressure Control Not Applicable

4. SIMV/VMandatory Intermittent Ventilation synchronized

with Volume Control IMV (not synchronized)

5. SIMV/PMandatory Intermittent Ventilation synchronized

with Pressure ControlIMV (not synchronized)

6. BIPV Spontaneous Ventilation with Two Pressure Levels Not Applicable

7. CPAPVentilation with Continuous Positive Pressure

in the Air PassagesNot available if needed

use PSV

8. PSV Ventilation with Pressure Support PCV

The CARMEL Servoventilator has all its monitored controls and parameters displayed on a 15 color LCD monitor, with a resolution

of 1024 x 768 that allows simultaneous visualization of all the ventilation curves in addition to the numeric values, and also features

position, rotation and inclination adjustments.

Types of curves: pressure x time, flow x time, volume x time; and types of loops: volume x pressure and flow x volume.

Other characteristics of the CARMEL Servoventilator are described below.

v Direct digital controls for the main ventilation parameters, including current volume, respiration frequency, inspiration time,inspiration pause, pressures, maximum inspiration flow, etc.

vOnly the active controls are displayed in each ventilation mode, in the correct sequence for their adjustment. This resourcemakes the ventilator adjustment much easier and safer.

v Digital control of the oxygen concentration in the AIR/O2 mixture supplied to the patient, with automatic switching of the oxygenconcentration according to the gas networks.

v Pressure control directly in cmH2O, making the ventilator adjustment easier.

v Electronic manometer for the endotracheal pressure, with graphic display on a 15 color LCD monitor with resolutionof 1024 x 768. The value of the maximum pressure in the last inspiration is kept in the manometer display during the expiration

phase, for a better visualization of this parameter.

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v Complete system of audiovisual alarms for ventilation parameters, with limits adjustable by the operator. These alarms arecapable of pointing out a series of irregularities during the ventilation, thus greatly increasing the therapy safety.

v Audiovisual alarms that show eventual failures in the ventilators gas feeding systems, including the oxygen and compressedair networks, and that automatically switch to another O2 concentration to ensure the patients ventilation.

v Audiovisual alarms that point out eventual failures in the ventilators power source systems, including the electric networkand low internal battery.

v Pressure-assisted or flow -assisted cycle triggering. The flow trigger feature allows newborn patients to trigger theventilation cycles.

v The STAND BY condition can be manually activated at any time, to prevent audio alarms during the preparation of the patientor any other special event.

v Automatic selection of the adult, infantile or newborn patient modes, depending on the patients weight informed by the

operator when the ventilator is turned on (item 8.2).

v Nebulizer for medicines, where the nebulizer flow is automatically compensated during the determination of the current volumeand synchronized with the inspiration phase.

v TGI resource (Tracheal Gas Charger) available for adult patients in the controlled modes.

v ILV resource (Independent Lung Ventilation), communication between 2 ventilators through an appropriate serial cable, whichis an optional component.

v Highly accurate inspiration and air/oxygen mixture flow control, with two electronically controlled servo-valves.

v Rinsing flow system in the flow sensor tubes to eliminate the accumulation of secretions and humidity, which are the mainsources of errors during the monitoring of the ventilation parameters. The rinsing flow is automatically compensated during the

determination of the current volume.

v Electronically controlled expiration valve that can be easily disassembled for internal cleaning and diaphragm inspection.

v Special functions: inspiration pause during 5 seconds, supply of 100% of oxygen during 90 seconds, auto-PEEP measurement(through expiration pause) and programmed relief.

v Electronic button for manual inspiration.

v Electronic master on/off switch.

v Highly sensibility flow sensor, for ventilation control and monitoring of parameters.

v Automatic continuous flow for low current volume condition, for the ventilation of newborn patients. For adult/infantile patients,the operator can adjust manually the rinsing flow of the respiration loop.

vBuilt-in pressure-regulation valves for oxygen and compressed air. Eliminating the use of valves external.

v Anti-asphyxia safety valves.

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v Over pressure valve (high pressure) with automatic control.

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

v Pivoted arm with support for corrugated tubes, which may be mounted on either of the ventilator sides, according to the side

where the patient was placed.

v Internal rechargeable battery in case of failure of the electric network or for transportation, when the ventilator will automaticallybe powered through the battery.

v Power source network with 110 to 220 Vac, for the ventilator operation and recharge of the internal battery.

v Visual indication of the power source, electric network or internal battery.

v Silent operation.

v Front handle for the adequate positioning of the CARMEL Servoventilator.

v Movable base equipped with hooks to support extensions, pulling handle for transportation and caster wheels with brake.

2.1 Ventilation Monitor

The Ventilation Monitor incorporated to the CARMEL Servoventilator has multiple functions that monitor the mechanical ventilation.

The 15 color LCD monitor, with resolution of 1024 x 768, displays the numeric values in real time for all the measured parameters,

in addition to several options of endotracheal pressure, current volume, flow and other curves, which allow an accurate analysis of

the ventilation. It also prepares a ventilation history using the last values of the parameters - recorded in the monitor memory and

displayed as graphics or table. The knowledge of the parameters displayed by the monitor allows a more accurate follow -up of the

patients ventilation.

Some others important characteristics of the Ventilation Monitor are described below:

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

v Measurement of inspiration flow, volumes and pressure through a flow sensor located in the respiration system.The flow sensor features high precision and low response time.

v Measurement of FiO2, Tobin index and P0.1.

v Measurement of the current inspired and expired volumes and of the minute volume.

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

v RESET key to silence the alarms for a maximum of 2 minutes.

v Serial port connection for the ILV function through an adequate cable (this item is optional).

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3 TECHNICAL SPECIFICATIONS

Classification

NBR IEC-60601-1/97 (1994) & Correction no. 1 (1997) & Amendment no. 1 (1997) (Electromedical Equipment Part 1: General

Safety Prescriptions)

NBR IEC 60601-2-12/2004 (specific prescriptions for the safety of lung ventilation equipment in medical utilization Equipment Class 1

Internally Energized)

NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General Safety Prescriptions 2. Collateral Standard:

Electromagnetic Compatibility Prescriptions and tests)

Equipment Class 1 Internally Energized

Type B IPX0 Continuous Operation

Ventilation Modes

1 VCV.............................................................................................................................................. volume-controlled ventilation

2. PCV ............................................................................................................................................ pressure-controlled ventilation

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

3. PCV/AV...........................................................................................................ventilation volume ensured by pressure control

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

5. SIMV/P......................................................................... synchronized mandatory intermittent ventilation with pressure control

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

7. CPAP.....................................................................................ventilation with continuous positive pressure in the air passages

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

Ventilation Parameters

Parameter Range Resolution

Frequency (rpm) 1 to 150 1

Inspiration Time (s)

0.01 to 0.70

0.70 to 1.00

1.00 to 3.90

0.01

0.05

0.10

Oxygen Concentration (%) 21 to 100 1

Maximum Limited Pressure (cmH2O) 5 to 100 1

Maximum Work Pressure (cmH2O) 5 to 100 1

PEEP/CPAP (cm H2O) 0 to 50 1

Support Pressure (cm H2O) 0 to 80 1

Support Pressure Frequency (% of inspiration flow) 5 to 80 5

Rise Time (s) 0.10 to 0.40 0.05

Inspiration Pause (s)

0.01 to 0.70

0.70 to 1.00

1.00 to 8.10

0.01

0.05

0.10

Current Volume in adults (ml) 150 to 10001000 to 2500

1050

Current Volume in children (ml)20 to 150

150 to 250

5

10

Flow (l/min) 4 to 120 1

Flow Sensibility (l/min) OFF, 1 to 30 1

Pressure Sensibility (cm H2O) OFF,-1 to -20 1

Relief (cycle) 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

Inspiration Time in the BIPV (s)

0.01 to 0.70

0.70 to 1.00

1.00 to 10.00

0.01

0.05

0.10

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Basic Flow (l/min) OFF, 4 to 40 1

Sound Alarm(s) Silencer 120 fixed

Rise Time in the PCV(s) OFF, 0 to 0.40 0.05

NA = Not applicable

Note

Sub-atmospheric pressure is not available in the expiration phase.

Nebulizer

Capacity for medicines............................................................................................................................. ........................................7 ml

Nebulizer flow....................................................................between 5 and 10 l/min, synchronized with the beginning of the inspiration.

TGI

Charging flow ..............................................................................between 5 and 10 l/min, synchronized with the end of the expiration.

Special Characteristics

vReserve modes (backup), in the case of apnea;

v Complete alarm system;

v Types of curve: square, decelerated, accelerated and sinusoidal;

v Differential pressure type Flow Sensor;

v Automatic compensation of the respiration loop complacency;

v Electronic on/off switch;

v Electronic and synchronized manual inspiration;

v Pressure-regulation valves;

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

v Overpressure electronic valve set on the adjusted pressure limit;

v Rinsing flow in the flow sensor tubes between 2 and 10 (ml/min).

Gas Feeding

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

Feed pressure......................................................................................................................................50 to 150 PSI (280 to 1035 kPa)

Pressure adjusted by the apparatus ............................................................................................................................ 35 PSI (241 kPa)

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

Threaded connections.............................................................................................................................per NBR12188/2003 standard

Extension/Hose..................................................................................................................................................per ISO 5359 standard

Notes:The CARMEL Servoventilator is equipped with internal pressure-regulation valves and can be connected directly to the

outlet of the hospital gas networks installed according to the ISO 7396 standard in force. The use of external regulation

valves is not recommended.

The gas input connections are equipped with internal check valves that ensure the absence of the reverse flow of gas.

CautionThe use of a high pressure inpu t in the pat ient brings risks to the same.

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Electric Characteristics

Source............................................................................ 110 to 220 Vac with automatic switching, 50/60 Hz, electric network

according to the NBR-13534/95 standard, or 12 Vdc and 3.0 A external

battery (to prevent the ventilator from feeding the Humidifier)

Electric network connector ...............................................3 (three) pins, Nema 5-15P type, where the round central pin is the ground.

Electric network input fuses................................................................................................ made of glass with 20mm - 3,0 A / 250 Vac

Humidifier input fuses......................................................................................................... made of glass with 20mm - 2,0 A / 250 VacInternal source input fuse................................................................................................... made of glass with 20mm - 4,0 A / 250 Vac

Power consumed by the ventilator.................................................................... .........................................................50 VA (maximum)

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

Internal battery............................................................... sealed, of the lead/acid type, 12 Vdc, 9.0 Ah and a maximum current

of 2.7 A required during charging.

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

current volume=500 ml and respiration frequency =12 rpm

Time to recharge the battery completely ....................................................................... approximately 20 hours, with the ventilator off.

Graphic display .......................................................................................................high contrast liquid crystal, with cold cathode bulb.

Notes:The internal rechargeable batteries can only be replaced by the K.TAKAOKA authorized Technical Assistance.

The hospitals electric installation shall be duly grounded and meet the ABNT NBR 13534 standard - Electric installations

in health care institutions - Safety requirements. The non-compliance with this recommendation may cause damages to

the patient, operator or equipment, in addition to voiding the ventilators warranty.

Others

Conical connections....................................................................................................................... according to the ISO 5356 standard

Corrugated tubes............................................................................................................................ according to the ISO 5367 standard

Dimensions and weight including the movable base and components:

Height....................................................................................................................................................................................... 1330 mm

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

Depth..........................................................................................................................................................................................500 mm

Weight......................................................................... ................................................................................................................. 27 kgf

Packaging

Individual, developed to suit transportation and storage at a temperature of 10C to +70C, a atmospheric pressure of 500 to 1060 hPa

and a relative humidity of 10% to 100% (not condensed).

Ambient Use Conditions

Temperature of 10C to +70C, atmospheric pressure of 500 to 1060 hPa and a relative humidity of 10% to 100% (not condensed).

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3.1 Ventilation Monitor Specifications

Parameters Measured in ATPD (ambient temperature and pressure, dry)

Parameter Range Resolution Accuracy

Current average expired volume (ml) 100 to 2600 5 (15% or 20 ml)

Current average inspired volume (ml)20 to 100

100 to 2600

5 (50% or 10 ml)

(15% or 20 ml)Minute volume (l) 0.1 to 50 0.01 (15% or 0.5 l/min)

Respiration frequency (rpm) 1 to 200 1 (1 s-1 or 10%)

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

of the measured value)

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


Pressure at the end of expiration (PEEP) (cm H2O) -30 to 120 1 (2 cm H2O + 4%


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

of the measured value)Static lung complacency (Cstat) (ml/cm H2O) 1.00 to 100.00 0.01 10%

Dynamic lung complacency (Cdyn) (ml/cm H2O) 1.00 to 100.00 0.01 10%

Resistance of the aerial passages (Raw)

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

Inspiration time (s) 0.01 to 20 0.01 0.2 s

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

FiO2 (%) 14 to 100 1 5%

Intrinsic pressure at the end of expiration (ipeep)

(cm H2O)-30 to 120 1

(2 cm H2O + 4%


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


Inspiration work (WOB) (J/l) -10.00 to 50.00 0.01 10%

Tobin index (iT) 0 to 200 1 5%

Notes:The CARMEL Servoventilator monitors only current exhaled volumes above of 100ml, due to the sensibility of the flow

sensor used.

The FiO2monitor is in compliance with the ISO 7767 standard.

Graphics Options

Graphic Unit

Flow 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

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Alarms and Numeric Adjustments

Parameter Range Resolution

Apnea Time alarm (s) 5 a 60 1

Audio volume alarm 2 a 10 1

Clock (hours) 0 a 23 1

Clock (minutes) 0 a 59 1

Cell calibration with 21% of O2 NCAL (dont calibrate)

CAL (calibrate)

Na

Cell calibration with 100% of O2 NCAL (dont calibrate)

CAL (calibrate)

Na

Low pressure alarm (cmH2O) OFF, 1 to 120 1

High pressure alarm (cmH2O) OFF, 1 to 120 1

Low PEEP alarm (cmH2O) OFF, 1 to 70 1

High PEEP alarm (cmH2O) OFF, 1 to 70 1

High Minute Volume alarm (l) OFF, 0,1 to 99,0 0,1

Low Minute Volume alarm (l) OFF, 0,1 to 99,0 0,1

Low Frequency alarm (rpm) OFF, 1 to 160 1High Frequency alarm (rpm) OFF, 1 to 160 1

Low FiO2 alarm (%) OFF, 0 to 100 1

High FiO2 alarm (%) OFF, 0 to 100 1

Notes:The ventilators alarm system meets the ISO 9703-1, ISO 9703-2 and ISO 9703-3 standards.

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4 OPERATION PRINCIPLE

Oxygen (O2) and compressed air enter the CARMEL Servoventilator through their respective threaded connections.

The pressures are then reduced by a set of regulation valves. Each gas then follows to its respective flow control servo-valve, which

is driven by an electronic control in order to supply the exact quantity of each gas in every moment, which are then mixed and

forwarded to the respiration loop during the inspiration phase. During the inspiration phase, the flow value supplied will depend on

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

An electromagnetic valve acting in the respiration loop, which is controlled by a microprocessed electronic system, carries out the

inspiration pressure control.

Figure 4.1: Operation principle of the ventilator

4.1 Flow Servo-Valves

The Flow Servo-Valve converts the current signal into flow, when there is a pressurized gas in its inlet. Figure 4.2 shows that when

the current applied to the valve in zero is maintained, the flow in the outlet is zero, because its natural status is NORMALLY

CLOSED (NF). What keeps the valve closed is a calibrated spring that exerts enough force for the needle to maintain the gas

passage closed. When a current is applied to the needle, it compresses the spring, allowing the passage of the gas from the inlet

to the outlet.

This Flow Servo-Valve of is also called "Proportional Valve", because the flow of gas is directly proportional to the current applied.

Resupply

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Figure 4.2: Flow Servo-Valves. (I = current)

4.2 Electronic Mixer

The mixture of gases is electronically controlled by means of the two servo-valves to which currents proportional to the total flow

desired are applied.

I Total Flow= IO2 + Iair

Figure 4.3: Electronic blender.

4.3 Electromagnetic Valve

Figure 4.4 shows schematically the electromagnetic valve construction, which counts with a simple and safe operating principle. The

diaphragm controls the flow passage and isolates the inside part of the valve to avoid contamination. The diaphragm drive is carried

out through a pin that moves together with the movable coil that, by its turn, moves along the inside of a magnet. The diaphragm

closing force depends on the electric current applied to the coil, which is electronically controlled with the help of a resupply system.

Figure 4.4: Electromagnetic valve.

Flow ( lpm)

Current (mA)

Total Flow = F_Air + F_O2

I_AirI_O2

Blender % O2

I = 0 I > 0

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4.4 Flow and Volume Measurement

The CARMEL Servoventilator counts with two flow sensors for the measurement of the gas flows and volumes, being one internal

and the other external, coupled to the respiration system. Each flow sensor of the differential pressure type is composed by an

adapter w ith two conical connections, having inside a resistance to the passage of the flow (Figure 4.5). Two side tubes conduct the

pressure signals in the inlet and in the outlet of the flow sensor up to a differential pressure transducer located inside the

Servoventilator housing. The value of the inspired or expired flow is measured at every instant, depending on the pressure

difference through the sensor. The flow sensor also makes the detection of the Servoventilators cycling instants.

When the flow value is known at every instant, the current inspired and expired volumes can be calculated by a flow integration

along time, being such integration carried out by a microprocessor.

Figure 4.5: Flow Sensor. (?P = pressure variation)

4.5 Oxygen Measurement

The Oxygen Analyzer incorporated to the CARMEL Servoventilator (Figure 4.6) measures the Oxygen percentage in the gaseous

mixture in contact with its sensor.

The O2 sensor includes a galvanic cell with an electrode system that, by means of electrochemical reactions, supplies, to the

CARMEL Servoventilator electronic circuit, an electric voltage signal proportional to the Oxygen concentration in the mixture. This

signal is analyzed by the microprocessor and later converted into a digital value representing the Oxygen volumetric percentage.

Figure 4.6: Oxygen analyzer.

Please find below the definitions of some of the parameters measured by the Ventilation Monitor:

v Resistance of the aerial passages (Jonson Method): pressure at the end of the inspiration - PEEP/ maximum expired flow.

v Static lung complacency: current inspired volume / (plateau pressure - PEEP)

v Dynamic lung complacency: current inspired volume / (peak pressure - PEEP)

v Inspiration work: integral of the pressure along the inspiration, in volume.v P0.1(occlusion pressure of the aerial passages): inspiration pressure after 100 milliseconds after the occlusion

v Tobin index: spontaneous respirations/minute/liters

1 O2 Sensor2 Cable

3 Connector

2

1

3

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5 CONTROLS AND COMPONENTS

The following components are supplied together with the CARMEL Servoventilator, and shall be exclusively used with the same:

5.1 Components List

The following items compose the CARMEL:

CODE Description Quant.

201050003 Heated Humidifier 6060 1

202011639 Pivoted arm 1

202010614 Compressed air filter for ICU ventilator 1

202011152 Expiration valve diaphragm 1

202011182 3 m extension for O2 (2 9/16 x 18F female threads) 1

202011665 400 mm flow sensor tube made of silicone w/ terminal 1

202011669 Adult silicone respiration loop ICU Mont. Carmel 1

202012068 3 m extension for air (2 female dis. threads) 1

203060031 Luer lock lid 1

203100149 Adult Flow Sensor (engraved) 1

202012085 O2 measurement cell with intermediate piece and cable. 1

204010258 Operation Manual 1

Code: 201050003 Code: 202011639 Code: 202010614

Code: 202011152 Code: 202011182 Code: 202011665

Code: 202011669 Code: 202012068 Code: 203060031

Code: 203100149 Code: 202012085 Code: 204010258

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5.2 Optional Items

CODE Description Quant.

202011670 Infantile silicone respiration loop 1

202011671 Newborn silicone respiration loop 1

202011938 Line filter for O2 1203100150 Infantile Flow Sensor 1

429090245 ILV Cable 1

Code: 202011670 Code: 202011671 Code: 202011938

Code: 203100150 Code: 429090245

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5.3 Front View

The items below refer to the front side of the CARMEL Servoventilator.

Figure 5.1 Front view CARMEL Servoventilator

LCD ColorMonitor

Easy TouchButton

ControlPanel

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5.3.1 LCD Monitor

15 color LCD Monitor (crystal liquid display) that allows simultaneous visualization, with a resolution of 1024 x 768, of all the

ventilation curves, pressure x time, flow x time and volume x time, loops of: volume x pressure and flow x volume, in addition to the

numeric values, functions, alarms and the visualization of the navigation. The monitor allows position and inclination adjustment in

addition to the and image configuration adjustments.

5.3.2 Control Panel

The control panel contains the keys for access to the special functions and the quick access keys.

Notes:The keys in the panel only highlight the parameter values in the ventilator, so they may be adjusted and confirmed

through the increment, decrement and confirmation EASY TOUCH button. Thus characterizing a safety system that

prevents undesired adjustments.

5.4 EASY TOUCH Button

Programming Button (Easy Touch)

On the side of the CARMEL Servoventilator control panel, this button allows the simple and quick

adjustment of the ventilation parameters. This button shall be operated in the sequence described

below, for the adjustment of each one of the ventilation parameters shown highlighted in the display:

Turn the button clockwise or counter-clockwise, until the cursor (green circle) is placed over the parameter to be adjusted.

Press this button again. The parameter is highlighted in the display (blue background).

Turn the button to adjust the numeric value desired for the parameter. Turning it clockwise the value increases and turning

it counter-clockwise the value decreases.

Press the button again to confirm the adjustment made, thus making effective the new parameter value. The parameter

is removed from highlight in the display.

5.5 Front Connection Panel

Figure 5.2. Front Connection Panel CARMEL Servoventilator.

ENTER

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The items below refer to the Front Connection Panel of the CARMEL Servoventilator (Figure 6.2).

1 - Connector for the Flow Sensor tube (Blue)

Entrance for the flow sensor tube with blue stripe. The other end of this tube shall be connected to the largest diameter nozzle

connected to the flow s ensor. Use only the sensor supplied by K. TAKAOKA.

Warning

The two tubes must be mo unted in the correct posi t ion, according to the color coding found in the vent i la tor

conn ectors. The tubes have dif ferent colors fo r quick id ent if icat ion. Get more inform ation in i tem 6.4.

2 - Connector for the Nebulizer tube or TGI Catheter

Entrance for the medicine Nebulizer tube, which is an optional component of the CARMEL Servoventilator. The other end of this

tube must be connected to Nebulizer glass.

Entrance for the TGI catheter. The catheter necessary for the procedure is not included in the equipment.

3 - Expiration Valve Block

The block containing the expiration valve and two conical connectors for the respiration loop corrugated tubes. The expiration valve

performs the control of the inspiration and expiration phases. This set can be disassembled for the cleaning and sterilization of its

diaphragm, and its assembly must be carried out correctly according to the instructions of item 6.5.

4 - Connector for the Flow Sensor tube (colorless)

Entrance to the colorless flow sensor tube. The other end of this tube must be coupled to the nozzle with lower diameter connected

to the flow sensor. Use only the sensor supplied by K. TAKAOKA.

5 - Connector for the FiO2 sensor

A sensor used to conduct the FiO2 measurement through an oxygen analyzer.

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5.6 Rear View

Figure 5.3 Rear Connection Panel CARMEL Servoventilator

1 On/Off Master Switch

The electro-pneumatic master switch interrupts the gas flow in the OFF position and automatically disconnects the electric portion of

the CARMEL Servoventilator and of the Heated Humidifier. When in the ON position, the ventilator and the Heated Humidifier are

connected. Check the symbol table.

2 Power cable entrance with entrance fuse

A compartment housing a fuse that protects the electric portion of the ventilator.

Entrance for the connection of the ventilator to an electric network, by means of the detachable power cable supplied together with

the ventilator. This cable has a 3-pin connector for connection to a duly grounded electric network. Refer to the technical

specifications for more information.

Notes:The ventilator can be equally powered with voltages between 110 and 220 Vac, because it has an automatic voltage converter.

The recommendations about power source described in item 6.2. must be followed.

3 Clip

A nylon clip used to fasten the power source cable to prevent accidental disconnection.

4 Pressure Regulation Valve

A valve that reduces the pressure that feeds the ventilator. Not adjustable.

4

5

1

2

3

6

7

9

10

11

12

13

14

15

161819 17

8

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5 Entrance Connection - Compressed Air

A threaded connection to the compressed air filter supplied with the ventilator. The filter inlet must be connected to the source of the

respective gas through a compressed air extension included in the equipment. The compressed air source pressure and flow shall

meet the technical specification.


A valve that reduces the pressure that feeds the ventilator to 35 PSI - 248 KPa.

7 Outlet for Measurement of the Regulated Pressure

A connection to the pressure regulation manometer, for the measurement of the value of the pressure regulated by valve (6). The

measured pressure must be 35 PSI (241 kPa). This outlet is used to make the equipments maintenance procedure easier, which

can only be carried out by an authorized K. TAKAOKA technician.

8 Oxygen Entrance Connection

A threaded connection for the oxygen extension supplied with the ventilator, for connection to the source of the respective gas. The

oxygen source pressure and flow shall meet the technical specification.


A valve that reduces the pressure that feeds the ventilator. Not adjustable.

10 Electric Outlet for the Heated Humidifier

An electric outlet that powers the Heated Humidifier 6060 with the same voltage and frequency connected to the entrance cable (the

Heated Humidifier has automatic voltage conversion). This outlet only supplies electric power. Refer to the technical specification for

more information.

11 110V Electric Outlet for the 15 LCD Monitor

An electric outlet that powers the CARMEL 15 monitor. The Heated Humidifier does not work with this type of connection and source.

12 Outlet for the Network Communication Interface

An Ethernet port. To be connected to an equipment with NBR IEC 60601-1 certification. (Item for future implementation).

13 Symbol for Read the Attached Documents

14 Serial Port 3 for the Communication Interface with External Devices

Serial port, with communication interface to external devices, according to the NBR IEC 60601-1.

Note:The serial cable and the external devices are not included in the CARMEL Servoventilator, they constitute optional

components. To obtain more information about the necessary software and hardware requirements, contact an authorized

K. TAKAOKA distributor.

15 Video

Entrance connector for the LCD Monitor video cable.

16 / 17 Outlet for the Communication Interface with External Devices

Serial ports used during the updating/maintenance carried out by the duly trained technicians.

18 / 19 2 (two) Outlet Fuses for the Humidifier

Compartment with fuses for the protection of the electric portion of the Humidifier 6060, one fuse is positioned in the phase and the

other in the neutral. Refer to the technical specification for more information.

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5.7 Heated Humidifier

Note:Read carefully the Instruction Manual of the Heated Humidifier 6060.

The Heated Humidifier 6060 (Figure 5.4) was specifically designed for use in the respiration loops. It counts with electronic

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

with capacity for 400 ml of sterile water. The temperature of the gases is measured close to the patients mouth, through an

electronic temperature sensor.

The CARMEL Servoventilator on/off master switch also turns on and off the Heated Humidifier power source.

The Heated Humidifier heats and saturates with water vapor the inspiration flow that crosses its chamber. The gases follow a path

between the chamber outlet and the patient, through two corrugated tubes with drains.

It is common for water to condense inside the corrugated tube that reaches the patient, due to the cooling of the gases between the

humidifier outlet and the intermediate Y piece. The quantity of water condensed in the loop increases together with an increase in

the humidifiers heat.

SAFETY MEASURES FOR THE USE OF THE HEATED HUMIDIFIER 6060:

1. It is necessary to prevent the water condensed in the loop from flowing to the patient, because it could reach the lungs. In

order to force all the water condensed in the loop to flow back to the drains, the corrugated tubes shall present an upwards or

horizontal direction towards the patient (Figure 5.5).

2. If the condensation of water in the loop is excessive, the humidifier shall have its temperature decreased.

The Heated Humidifier chamber can be easily disassembled fordisinfection, because its cover is only screwed to the glass. When

assembling the chamber again, make sure that the rubber seal in the cover is correctly positioned and in perfect conservation

condition, to avoid the leakage of gases during ventilation. Close the cover tightening it firmly.

Figure 5.4. Heated Humidifier 6060.

1. Chamber Outlet Connection (Patient)

2. Humidification Chamber Cover (autoclavvel)

3. Humidification Chamber (autoclavvel)

4. Chamber Fastening Clamps

5. Chamber Fastening Button

6. Temperature display

7. Heating control

8. Pilot lamp (Heater On)

9. Heating lamp (Power On)

10. Entrance for replenishing

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EXP.

INSP.

HUMIDIFIERHEATED

WATER DRAINAGE

WATER FOR PATIENTS

PATIENT

RIGHT

WRONG

Figure 5.5. Positioning of the corrugated tubes.

5.8 Expiration valve

An electromagnetic valve that defines the inspiration and expiration phases of the CARMEL Servoventilator composes the

expiration valve. During the expiration phase, the valve is opened to allow the exit of the expired gases.

The expiration valve block is fastened to the Front Connection Panel of the Servoventilator (item 5.3). This allows the respiration

loop tubes to be directed to either of the two Servoventilator sides, depending on the side where the patient is placed.

Figure 5.6 shows a scheme of the assembly of the expiration valve block components. This block has in its body two conical

connections to the respiration loop corrugated tubes.

The expiration valve is easily disassembled for the disinfection of the components, inspection or the replacement of the

diaphragm . After each assembly of the expiration valve with its diaphragm correctly positioned, the Servoventilator shall be turned

on and a test procedure conducted to ensure its perfect operation.

Warning

Check regular ly the cleanliness and the perfect conservat ion o f the expirat ion valve diaphragm. In case any

f issure or other irregular ity is foun d in this compo nent, it shall be replaced for a new one.

Check regular ly the perfect con servat ion of the sealing ring (O-r ing ).

The fastening of the block to th e Front Connect ion Panel of the Servovent ilator shall be very t ight to avoid

ga s leaks.

Figure 5.6. Mounting of the expiration valve.

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5.9 Drains

The CARMEL Servoventilator respiration loop counts with 2 (two) drains that collect the water condensed inside the corrugated

tubes, being one drain located in the inspiration branch and the other in the expiration branch.

Its is very important to use the drains in order to avoid the inconveniences caused by the water build-up in the respiration loop.

Draining

Draining is carried out by removing the drain threaded glass and emptying the accumulated water, and then screwing the glass backto the drain body. This operation does not disturb the patients ventilation, because the drain counts with an automatic closing

system when the glass is removed.

Disinfection

The drain is easily disassembled for disinfection, by removing the threaded glass and then the plunger set (Figure 5.7).

BODY

PLUNGE

GLASS

Figure 5.7. Respiration loop drain.

5.10 Nebulizer (optional)

The Nebulizer (Figure 5.8) is an optional component of the CARMEL Servoventilator and is used to administer medicines to

the patient through a flow of gas that enters the respiration loop during the inspiration phase. O Nebulizer reservoir has capacity for

7 ml of medicine.

Figure 5.8. Nebulizer for medicines.

The monitor located in the Servoventilator control region allows the operator to turn on and off the nebulizing function (Chapter 8).

The Nebulizer can be mounted close to the endotracheal mask or tube or in the inspiration branch.

The tube that feeds the Nebulizer shall be connected to the respective NEBULIZER connection nozzle located in the Front Connection

Panel of the ventilator.

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5.12 Battery

The CARMEL Servoventilator is equipped with an internal battery that allows its operation in case of failure of the electric network.

The CARMEL Servoventilator internal battery is rechargeable, sealed, of the lead/acid type, 12 Vdc and 9.0 Ah, and there is no

need to remove it even when the equipment remains out of use for long periods.

Duration

The duration time of the ventilators internal battery charge depends on the mode of use and on the adjustment of the ventilation

parameters.

Example: When fully charged, the battery is able to keep the ventilator operating for approximately 120minutes in an average

ventilation condition.

RechargingThe full recharging of the battery takes approximately 20 hours with the Servoventilator off and connected to the electric network. To

ensure longer battery service life, keep the battery always when possible with maximum charge. Constant battery discharging

reduces its service life.

AlarmWhen the electric network is down, the Servoventilator is automatically switched to the internal battery. When the ventilator is being

powered by the internal battery, the display will show the message ELECTRIC NETWORK DOWN BATTERY IN USE, the electricnetwork led will turn off and the network cable symbol in the lower left corner will be replaced by the battery symbol, which confirms

that the ventilator is now being powered by the internal battery. In order to indicate the battery capacity, the battery symbol has

three statuses that are shown in the figure below.

Battery 1 - Battery above 40% Battery 2 - Battery between 40% and 20% Battery 3 - Battery below 20%

When the battery is above 40% of its capacity, the Battery 1 figure will be displayed; when it is between 40% and 20% of its

capacity, the Battery 2 figure will be displayed and when the battery is below 20% of its capacity, the Battery 3 figure will be

displayed. When the battery is below 40% of its capacity a medium priority alarm will sound and when the capacity falls below 20 %

a high priority alarm will be displayed, indicating that the electric power must be immediately reestablished.

WarningKeep the internal battery always charged. Therefore, the Servovent ilator can be left permanent ly c onnected to the

electr ic network, even with the on/off switch in the off posit io n.

The battery must be recharged after any ut il izat ion t ime of the Servovent ilator with the electr ic network down .

The battery mu st be fully recharged if the Servovent ilator was no t in use and disco nnected from th e electr ic

network for a period longer than 20 (twenty) days.

The Heated Humidif ier does not w ork while the i nternal battery is pow ering the Servovent ilator.

5.13 Movable Base

The CARMEL Servoventilator movable base is equipped with four caster wheels with front brakes that ensure excellent mobility,

hooks that support extensions and a handle that makes the transportation easy.

The Servoventilator is fastened to the upper part of the movable base by means of a set of four screws. The Heated Humidifier is

fastened to the front part of the movable base, through fitting pins.

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6 ASSEMBLY AND PREPARATION OF THE CARMEL

WarningThe assembly instruct ion s provided in the explanatory sheets, supplied together with the equipment, shall be

carefully followed. The details in the follow ing items o f this Chapter also provide gu idance.

6.1 Assembly of the CARMEL

The CARMEL is not supplied fully assembled, the LCD Monitor, the basic unit, the column (movable base) and the pivoted arm

must be assembled as shown in figure 6.

v Four screws fasten the monitor to its base,

v Four screws fasten the basic unit to the movable column,

v The pivoted arm is only fitted to the respective support.

A more detailed assembly guide is supplied together with the equipment, where the user finds orientation regarding the reception

and assembly of the equipment.

Fig. 6 Assembly of the monitor and the pivoted arm

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6.2 Power Source

1. Check initially whether the on/off master switch located in the CARMEL rear panel is in the off position.

2. The O2 and compressed air entrance connections located in the CARMEL rear panel must be connected to the respective

sources of these gases. Use the extensions supplied together with the Servoventilator. The use of the network pressure regulation

valve on the wall is not necessary when the pressures are kept within the specified range.

WarningThe oxyg en and c omp ressed air feed pressu res must be held in the range between 40 and 150 PSI (280 and 1035 kPa).

Connect the air f i l ter supp lied together with the equipment between the Servovent ilator compressed air

connect ion and the respect ive extension. The source com pressed air mu st be free of hum idity, oil and impu rit ies.

3. Connect the CARMEL to an 110 to 220 Vac electric network using the power cable supplied together with the equipment or a 12

Vdc 9.0 Ah source (internal battery).

4. Mount the Heated Humidifier 6060 on the column and connect it to an electric outlet located in the CARMEL Servoventilator rear

panel. The Heated Humidifier only works if a 110 to 220 Vac electric network powers the Servoventilator.

5. The ventilator has an internal rechargeable battery that allows the temporary use of the equipment when not connected to the

electric network. In the case of an electric network failure, the ventilator switches automatically to the internal battery and, therefore,

ventilation continues without interruption. The power source indicator (1) blinks while the internal battery is powering the ventilator.

Note:The switching between the external source (electric network) and the internal source (battery) does not interfere in the

ventilator operation.

RECOMMENDATIONS ABOUT THE POWER SOURCE (*):

v Connect the power cable only to an outlet duly grounded and approved for hospital use, belonging to an electric network thatmeets the ABNT NBR 13534 standard - Electric installations in health care institutions - Safety requirements . The female

three-pin outlet shall be of the Nema 5-15P type, where the central round pin is the ground, as shown in the Figure below.

v Keep the internal battery always charged, so the Servoventilator will continue to operate even if the electric network eventuallyfails. Therefore, the Servoventilator shall be left always connected to the electric network , even when not in use.

v Recharge the battery after using the Servoventilator while not connected to the electric network, thus preparing the battery forthe next utilization period.

v Perform a complete battery recharge when the Servoventilator was not in use and disconnected from the electric network for aperiod longer than 20 (twenty) days.

v The Servoventilator internal battery does not power the Heated Humidifier.

v If the internal battery is powering the Servoventilator and the battery low alarm is activated, the Servoventilator must then beimmediately connected to the electric network.

v The connection of the equipment to the auxiliary network outlet may increase the current drain through the patient up to valuesthat exceed the allowable limits in the case of a defective protection ground conductor.

v When installing the Servoventilator, fasten the power source cable 429020003, with the clamp ring 203060266 and using thescrew 314020013, to the rear panel.

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(*) The non-compliance with these electric recommendations, may result in damages to the patient, operator or equipment, in

addition to voiding the Servoventilator warranty.

Figure 6.1. Three-pin electric outlet, of the Nema 5-15P type.

6.3 Respiration loop

The CARMEL Servoventilator is available with three types of respiration loops: adult, pediatric and newborn. The newborn loop is

equipped with smaller diameters tubes when compared with the adult ones, thus reducing its complacency when used with low flows.

The CARMEL Servoventilator respiration loops are composed by a set of corrugated tubes, two drains, one intermediate Y piece

and one flow sensor with tubes and lines. The drains mounted in the inspiration and expiration branches prevent water build-up in

the loop. A checklist of items that must be periodically checked is given below:

1. Check whether the drain glasses are empty. If not, they must be emptied (item 5.9).

2. Be sure of the correct and tight coupling of the expiration valve block to the Front Connection Panel of the Servoventilator (item 5.5).

3. Check whether all the respiration loop components were submitted to the adequate disinfection procedures, including the

corrugated tubes, intermediate pieces, drains, humidifier chamber and flow sensor.

4. Read carefully the Heated Humidifier 6060 instruction manual to ensure a correct assembly and utilization.

5. Fasten the pivoted arm to one of the respective side supports of the Servoventilator, to properly accommodate the corrugated

tubes. The pivoted arm can be mounted to either side of the equipment, depending on which side the patient is placed.

6. Mount the CARMEL Servoventilator respiration loop according to the diagrams of Figures 6.2, 6.3 and 6.4.

7. When desired, assemble correctly the medicine Nebulizer, which is an optional component (item 5.10).The spiral tube that feeds

the Nebulizer must coupled to the respective connection nozzle located in the Servoventilator Front Connection Panel (item 5.5).

8. If the TGI resource is used (item 5.11), its catheter (optional) shall be coupled to the connection nozzle located in the

Servoventilator Front Connection Panel. (item 5.5).

9. Be sure of the correct and tight coupling of the electronic temperature sensor of the Humidifier 6060 to its respective connection

in the intermediate Y piece of the respiration loop.

10. The emptying of the drain glass is easily accomplished without interruption of the ventilation, because the drain is equipped with

an automatic closing system when the glass is removed. Empty the drains before they are filled with water (item 5.9).

1

3

2

CONNECTION

PIN 110V2