Manual Operation - Takaoka Color Servo

Operation
Manual
OPERATION MANUAL
COLOR SERVO-VENTILATOR
Equipment Code: 201050025

MS Registry No.: 10229820083
Manual Code: 204010201_007
Date: (Jan 2009)
Formulário de Instalação do Produto
This Operation manual contains the information required for the correct use of the COLOR Servo-
Ventilator.
Manufacturer:
K. TAKAOKA IND. E COM. LTDA.
Rua General Izidoro Dias Lopes, 121/141
Bairro Vila Paulicéia - São Bernardo do Campo / SP
Postal Code 09687-100 - Brasil
Phone: + 55 11 4176-3500
Fax: + 55 11 4176-3570
Web site: www.takaoka.com.br
e-mail: kt@takaoka.com.br
CNPJ : 61.489.381/0001-09
I.E.: 103.735.350.115
Suggestions, questions or complaints:
Call Center: + 55 11 4176-3600
Product Registration at the Ministry of Health:
• Technical Name: Pressure Pulmonary Ventilator

• Trade name: COLOR SERVO-VENTILATOR
• Ministry of Health Registry Number: 10229820083
Product Classification:
• IEC-60601-1:1988+amendment 1994– (Medical electrical equipment - Part 1: General

requirements for basic safety and essential performance)
• IEC 60601-2-12/2001 (Medical electrical equipment - Part 2-12: Particular requirements for the
safety of lung ventilators - Critical care ventilators)
• IEC 60601-1-2/2006 (Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests)
• EN 794-1:1997 +amendment 2000- ( Lung ventilators - Part 1: Particular requirements for critical
care ventilators)
• EN 475:1995- (Medical Device Electrically generated alarm signals)
• ISO 21647:2004 (Medical electrical equipment — Particular requirements for the basic safety and
essential performance of respiratory gás monitors)
• Class 1 Equipment – Internally Powered
• Type B – IPX1 – Continuous operations
Head Technician:
Alexandre Rodrigues da Silva, Eng.
CREA: Registration No.: 0682082567
COLOR SERVO VENTILATOR

Product Installation Form
Product Installation Form
EQUIPMENT: ___________________________ Code: ____________ Serial Number: _________
DESCRIPTION CODE SERIAL NUMBER

1
2
COMPONENTS
3
4
5
6
7
8
9
10
INVOICE: K.Takaoka Original [ ] YES ____________ [ ] NO ______________________

Invoice Number* Representation Name
INSTITUTION:
Corporate Name: ____________________________________C.N.P.J*.:_____________________________
Address: ________________________________________________________________________________
City: __________________________________________State:_________ Zip Code: ___________________
Person in charge of the information*:_______________________________Position: ____________________
Sector: ________________________Phone*.: _________________ email: __________________________

(*) Required Fields
YOUR OPINION:
1. Was(ere) the product(s) delivered within the agreed delivery time? Yes No
2. Were the product(s) and the accessory(ies) in accordance with the purchase order? Yes No
3. Was the packing damaged in any way? Yes No

4. Was there any difficulty while installing the equipment? Yes No
5. Are the equipment and accessory(ies) operating as expected? Yes No
6. Was there any connection problem with accessories, tubes and cables? Yes No
7. Does the invoice state your correct data, amounts, product description, quantity and Yes No
payment conditions accurately?
8. Please comment in case of eventual inconvenience experienced:
Installation performed by: ____________________Date ____/ ____ /_____ Signature: ______________

(Technician Name)
Representative: ________________________Date ____ / ____ / _____ Signature: _________________
Send this form to Fax + 55 11 4176-3570 or by registered mail to K Takaoka
ATTENTION: THE WARRANTY WILL BECOME EFFECTIVE UPON THE CONFIRMATION OF

INFORMATION CONTAINED IN THIS TERM. THIS TERM SHALL BE SENT WITHIN 30 DAYS, IN
ACCORDANCE TO THE OPERATION MANUAL.
In case of doubt, or to receive further information, please contact: SAC + 55 11 4176-3600

General Index
GENERAL INDEX
1. OBJETIVO ............................................................ ERRO! INDICADOR NÃO DEFINIDO.

2. DOCUMENTO(S) DE REFERÊNCIA ............... ERRO! INDICADOR NÃO DEFINIDO.
3. DOCUMENTO(S) COMPLEMENTAR(ES) ..... ERRO! INDICADOR NÃO DEFINIDO.
4. DEFINIÇÕES ........................................................ ERRO! INDICADOR NÃO DEFINIDO.
1. INTRODUCTION................................................................................................................. 2
2. SAFETY ................................................................................................................................. 3
2.1. USER AND PATIENT SAFETY ............................................................................................. 4
2.2. SAFETY RESOURCES ......................................................................................................... 5
2.2.1. Electromagnetic Susceptibility................................................................................ 5
2.2.2. Emergency cylinders and gas feeding (not supplied by K. TAKAOKA) ................. 5
2.2.3. Important................................................................................................................. 6
2.3. DEFINITION OF SYMBOLS ................................................................................................. 9
2.4. ABBREVIATIONS ............................................................................................................. 14
2.5. WARNINGS ..................................................................................................................... 15
3. CONTROLS AND COMPONENTS ................................................................................. 17
3.1. COMPONENT LIST........................................................................................................... 18
3.2. OPTIONAL ITEMS ............................................................................................................ 20
3.3. MONITOR / CONTROL PANEL / EASY TOUCH BUTTON ................................................ 24
3.4. CONNECTION FRONT PANEL........................................................................................... 26
3.5. CONNECTION REAR PANEL............................................................................................. 28
3.6. HEATED UMIDIFIER ........................................................................................................ 32
4. ASSEMBLY AND PREPARATION................................................................................. 34
4.1. ASSEMBLY OF COLOR SERVO VENTILATOR ................................................................... 35
4.1.1. Mobile Base........................................................................................................... 36
4.2. ELECTRICAL WIRING ...................................................................................................... 37
4.2.1. Battery ................................................................................................................... 38
4.3. RESPIRATORY CIRCUIT ................................................................................................... 41
4.3.1. Drain ..................................................................................................................... 44
4.4. FLOW SENSOR................................................................................................................. 46
4.5. O2 SENSOR ...................................................................................................................... 49
4.5.1. Calibration before using the O2 sensor................................................................. 50
4.5.2. After O2 sensor calibration ................................................................................... 51
4.6. CO2 SENSOR ................................................................................................................... 53
4.7. TEMPERATURE SENSOR .................................................................................................. 56
4.8. GAS CIRCUIT .................................................................................................................. 58
4.9. EXHALING VALVE .......................................................................................................... 60
5. ADULT/PEDIATRIC VENTILATION MODES ............................................................ 63
5.1. INTRODUCTION ............................................................................................................... 64
5.2. VCV – VOLUME CONTROLLED VENTILATION................................................................ 66
5.3. PCV – PRESSURE CONTROLLED VENTILATION .............................................................. 70
5.4. PCV/AV® – PRESSURE CONTROLLED VENTILATION WITH ASSURED VOLUME............. 73

General Index
5.5. SIMV/V – SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION WITH VOLUME

CONTROL .................................................................................................................................... 77
5.6. SIMV/P® – SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION WITH PRESSURE
CONTROL .................................................................................................................................... 79
5.7. MMV - MINIMUM MINUTE VOLUME VENTILATION ....................................................... 81
5.8. BIPV® – BI-LEVEL SPONTANEOUS PRESSURE VENTILATION ......................................... 83
5.9. CPAP/PS – CONTINUOUS POSITIVE AIRWAY PRESSURE / PRESSURE SUPPORT
VENTILATION ............................................................................................................................. 85
5.10. NIV - NON–INVASIVE VENTILATION ......................................................................... 87
5.11. PSV/AV – ASSURED VOLUME VENTILATION BY PRESSURE CONTROL ...................... 88
5.12. VSV - SERVO-VOLUME VENTILATION WITH PRESSURE SUPPORT ............................... 90
6. NEONATAL VENTILATION MODES ........................................................................... 92
6.1. INTRODUCTION ............................................................................................................... 93
6.2. PLV – PRESSURE-LIMITED VENTILATION ...................................................................... 95
6.3. SIMV/P® - SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION WITH PRESSURE
CONTROL - NEONATAL ............................................................................................................... 96
6.4. BIPV® – BI-LEVEL SPONTANEOUS PRESSURE VENTILATION ......................................... 98
6.5. CPAP/PS - CONTINUOUS POSITIVE AIRWAY PRESSURE / PRESSURE SUPPORT
VENTILATION ............................................................................................................................. 99
6.6. NON-INVASIVE VENTILATION ...................................................................................... 100
7. OPERATION..................................................................................................................... 101
7.1. CONTROL PANEL .......................................................................................................... 102
7.2. VENTILATOR AUTO-TEST............................................................................................. 106
7.3. INITIALIZATION SCREENS ............................................................................................. 107
7.4. INITIAL MODES ............................................................................................................ 109
7.5. MAIN CONTROL SCREEN .............................................................................................. 112
7.6. MODES VENTILATION PARAMETERS ADJUSTMENT ........................................................ 113
7.7. MESSAGES .................................................................................................................... 115
7.8. GRAPHIC WINDOW ....................................................................................................... 118
7.9. DATABASE ................................................................................................................... 120
8. ALARM SYSTEM ............................................................................................................ 122
8.1. INTRODUCTION ............................................................................................................. 123
8.2. ALARMS PRIORITY LEVELS .......................................................................................... 124
8.3. ALARMS PRIORITY LEVEL AUDIBLE DIFFERENTIATION ................................................ 125
8.4. ALARMS RELATED TO THE DISPLAY............................................................................. 126
9. CLEANING AND STERILIZATION............................................................................. 130
9.1. CONCEPTS AND DEFINITIONS ....................................................................................... 131
9.2. CLEANING AND STERILIZATION PROCEDURES ............................................................... 133
9.3. FLOWCHART ............................................................................................................ 135
9.4. GUIDELINES ............................................................................................................. 136
10. MAINTENANCE .......................................................................................................... 138
10.1. PREVENTIVE MAINTENANCE .................................................................................... 139
10.1.1. Internal rechargeable battery ............................................................................. 141
10.1.2. Replacing Fuses .................................................................................................. 141
INSTRUCTIONS FOR FUSE REPLACEMENT (BUILT IN THE PLUG)..................................................... 141
INSTRUCTIONS TO REPLACE THE FUSE (INDIVIDUAL) ................................................................... 141
10.2. EMERGENCY ACTIONS.............................................................................................. 143

General Index
11. TECHNICAL INFORMATION.................................................................................. 145

11.1. PACKAGING / ENVIRONMENTAL USE CONDITIONS ................................................... 146
11.2. TECHNICAL SPECIFICATIONS .................................................................................... 147
11.3. VENTILATION MONITOR SPECIFICATIONS ................................................................ 153
11.4. MEASUREMENT METHODS ....................................................................................... 156
12. MANUFACTURER GUIDELINES AND STATEMENTS ...................................... 160
12.1. ELECTROMAGNETIC EMISSIONS ............................................................................... 161
EMISSION ESSAYS .................................................................................................................... 161
12.2. ELECTROMAGNETIC IMMUNITY ................................................................................ 162
RECOMMENDED SEPARATION DISTANCE.................................................................................. 163
12.3. RECOMMENDED SEPARATION DISTANCES AMONG MOBILE RF COMMUNICATION
DEVICES AND THE COLOR SERVO VENTILATOR MODEL VENTILATION SYSTEM....................... 164
13. WARRANTY TERMS.................................................................................................. 165

BRAZILIAN K.TAKAOKA DISTRIBUTORS ..................................................................... 167
TAKAOKA INTERNATIONAL DEALERS ......................................................................... 168
K. TAKAOKA TECHNICAL SERVICES............................................................................. 169
AUTHORIZED K. TAKAOKA TECHNICAL SERVICES................................................. 170
INFORMATION FOR TECHNICAL SERVICES ............................................................... 171

Table Index
TABLE INDEX
TABLE 1A – DEFINITION OF SYMBOLS .............................................................................. 9

TABLE 1B – DEFINITION OF SYMBOLS ............................................................................ 10
TABLE 1C – TABLE OF SYMBOLS....................................................................................... 11
TABLE 1D – TABLE OF SYMBOLS....................................................................................... 12
TABLE 1E – TABLE OF SYMBOLS ....................................................................................... 13
TABLE 2 – TABLE OF ABBREVIATIONS............................................................................ 14
TABLE 3A – COLOR SERVO VENTILATOR COMPONENTS ........................................ 18
TABLE 3B – COLOR SERVO VENTILATOR COMPONENTS......................................... 19
TABLE 4 – OPTIONAL COLOR SERVO VENTILATOR ITEMS..................................... 22
TABLE 5 – RESPIRATORY CIRCUIT – ADULT CONNECTION /
PEDIATRIC/NEONATAL CONNECTION ............................................................................ 41
TABLE 6 – VENTILATION MODES ...................................................................................... 64
TABLE 7 – NEONATAL VENTILATION MODES............................................................... 93
TABLE 8- VOLUME / WEIGHT / TIDAL VOLUME ADJUSTMENTS .......................... 107
TABLE 9 – MODE/TYPE/SENSOR ADJUSTMENTS ACCORDING TO THE WEIGHT
..................................................................................................................................................... 108
TABLE 10 - INITIAL MODES................................................................................................ 109
TABLE 11 – MODE (BASIC/COMPLETE) .......................................................................... 109
TABLE 12 – PARAMETERS (ADJUSTED/PREVIOUS).................................................... 110
TABLE 13 – GRAPH / UNIT TABLE .................................................................................... 118
TABLE 14 - ALARMS PRIORITY LEVEL AUDIBLE DIFFERENTIATION ................ 125
TABLE 15 – GUIDELINES FOR COMPONENTS PROCESSING ................................... 136
TABLE 16 – VENTILATION/RANGE/RESOLUTION PARAMETERS.......................... 149
TABLE 17 - NEBULIZER ....................................................................................................... 149
TABLE 18 - TGI........................................................................................................................ 149
TABLE 19 – GAS FEEDING................................................................................................... 150
TABLE 20 – ELECTRICAL FEATURES.............................................................................. 151
TABLE 21 – TUBES AND CONNECTIONS......................................................................... 151
TABLE 22 – DIMENSIONS AND WEIGHT......................................................................... 152
TABLE 23 - MEASURED PARAMETERS (RANGE / RESOLUTION / ACCURACY) . 153
TABLE 24 – NUMERIC ALARMS AND ADJUSTMENTS (RANGE/RESOLUTION) .. 154
TABLE 25 - MANUFACTURER GUIDELINES AND STATEMENTS –
ELECTROMAGNETIC EMISSIONS.................................................................................... 161

Figure Index
TABLE 26 - MANUFACTURER GUIDELINES AND STATEMENTS –

ELECTROMAGNETIC IMMUNITY.................................................................................... 162
TABLE 27 – MANUFACTURER GUIDELINES AND STATEMENTS –
ELECTROMAGNETIC IMMUNITY (RF FREQUENCY RADIO) .................................. 163
TABLE 28 - RECOMMENDED SEPARATION DISTANCES AMONG MOBILE RF
COMMUNICATION DEVICES AND THE COLOR SERVO VENTILATOR MODEL
VENTILATION SYSTEM. ...................................................................................................... 164
TABLE 29 – COLOR SERVO VENTILATOR COMPONENTS WARRANTY .............. 166

Figure Index
FIGURE INDEX
FIGURE 1 – MEDICATION NEBULIZER............................................................................. 22

FIGURE 2 – MONITOR LCD TOUCH SCREEN / CONTROL PANEL / EASY TOUCH
BUTTON ...................................................................................................................................... 24
FIGURE 3 – CONNECTION FRONT PANEL - COLOR SERVO VENTILATOR........... 26
FIGURE 4 – CONNECTION REAR PANEL.......................................................................... 28
FIGURE 5 – GAS CONNECTIONS ......................................................................................... 30
FIGURE 6 – 6060 HEATED HUMIDIFIER ............................................................................ 32
FIGURE 7 MONITOR AND ARTICULATED ARM ASSEMBLY..................................... 35
FIGURE 8 - ELECTRICAL THREE-PIN PLUG, NEMA 5-15P TYPE............................... 37
FIGURE 9 – REAR CONNECTIONS ...................................................................................... 37
FIGURE 10 – BATTERY WARNING..................................................................................... 39
FIGURE 11 – ADULT RESPIRATORY CIRCUIT................................................................ 42
FIGURE 12 - INFANT RESPIRATORY CIRCUIT ............................................................... 43
FIGURE 13 – NEONATE RESPIRATORY CIRCUIT .......................................................... 43
FIGURE 14 – RESPIRATORY CIRCUIT DRAIN................................................................. 44
FIGURE 15 – FLOW SENSOR ASSEMBLY .......................................................................... 47
FIGURE 16 – INCORRECT FLOW SENSOR ASSEMBLY................................................. 48
FIGURE 17 – CONNECTION OF THE FLOW SENSOR TUBES ON THE COLOR
SERVO VENTILATOR. ............................................................................................................ 48
FIGURE 18 – OXYGEN ANALYZER ..................................................................................... 49
FIGURE 19 – O2 CELL/SENSOR............................................................................................. 49
FIGURE 20 – CORRECT POSITIONING OF THE O2 SENSOR IN THE
RESPIRATORY CIRCUIT ....................................................................................................... 52
FIGURE 21 – ASSEMBLED O2 SENSOR ............................................................................... 52
FIGURE 22 – CO2 SENSOR ...................................................................................................... 53
FIGURE 23 – ADAPTER CABLE OF CO2 SENSOR............................................................. 53
FIGURE 24 – CAPNOGRAPHY SENSOR CONNECTION TO SENSOR ADAPTER ..... 54
FIGURE 25 – MALE CIRCULAR CONNECTOR OF ADAPTOR CABLE CONNECTED
TO CO2 INLET ........................................................................................................................... 54
FIGURE 26: CONNECTION OF AIRWAYS ADAPTER TO CO2 SENSOR READER ... 55
FIGURE 27 – CONNECTION OF CO2 SENSOR TO RESPIRATORY CIRCUIT............ 55
FIGURE 28 – ASSEMBLY OF THE TEMPERATURE SENSOR IN THE Y BRANCH OF
THE CIRCUIT ............................................................................................................................ 56

Figure Index
FIGURE 29 – INCORRECT ASSEMBLY OF THE TEMPERATURE SENSOR IN THE Y

BRANCH OF THE CIRCUIT ................................................................................................... 56
FIGURE 30 – CORRECT REMOVAL OF THE TEMPERATURE SENSOR ................... 57
FIGURE 31 – INCORRECT REMOVAL OF THE TEMPERATURE SENSOR FROM
THE Y BRANCH OF THE CIRCUIT...................................................................................... 57
FIGURE 32 – GASES CONNECTIONS .................................................................................. 58
FIGURE 33 – AIR FILTER COMPONENTS ......................................................................... 59
FIGURE 34 – AIR FILTER DISASSEMBLY ......................................................................... 59
FIGURE 35 – ASSEMBLY OF THE EXHALING VALVE................................................... 60
FIGURE 36 – DIAPHRAGM OF THE EXHALING VALVE - METALLIC DISC ........... 61
FIGURE 37 – CORRECT ASSEMBLY OF THE EXHALING VALVE DIAPHRAGM ... 61
FIGURE 38 – INCORRECT ASSEMBLY OF THE EXHALING VALVE DIAPHRAGM
....................................................................................................................................................... 62
FIGURE 39 - MONITORED PARAMETERS IN EVERY MODE....................................... 65
FIGURE 40 – ADJUSTED ALARMS FOR EVERY MODE ................................................. 65
FIGURE 41 - VCV MODE – PRESSURE X TIME AND FLOW X TIME GRAPHS. ....... 66
FIGURE 42 – ADJUSTABLE PARAMETERS FOR THE VCV MODE............................. 68
FIGURE 43 – PCV MODE – EXAMPLES OF CURVES: PRESSURE X TIME AND
FLOW X TIME ........................................................................................................................... 70
FIGURE 44 – ADJUSTABLE PARAMETERS FOR THE ADULT PCV MODE .............. 71
FIGURE 45 – PCV/AV® MODE: EXAMPLES OF CURVES: PRESSURE X TIME AND
FLOW X TIME ........................................................................................................................... 73
FIGURE 46 - ADJUSTABLE PARAMETERS FOR THE ADULT PCV/AV MODE ........ 74
FIGURE 47 – SIMV/V MODE: ................................................................................................. 77
FIGURE 48 – ADJUSTABLE PARAMETERS FOR THE SIMV/V MODE ....................... 78
FIGURE 49 – SIMV/P MODE:.................................................................................................. 80
FIGURE 50 – ADJUSTABLE PARAMETERS FOR THE SIMV/P MODE........................ 80
FIGURE 51 - MMV MODE – EXAMPLES OF CURVES: PRESSURE X TIME AND
FLOW X TIME. .......................................................................................................................... 81
FIGURE 52 – ADJUSTABLE PARAMETERS FOR THE ADULT MMV MODE ............ 82
FIGURE 53 – BIPV MODE® .................................................................................................... 83
FIGURE 54 – ADJUSTABLE PARAMETERS FOR BIPV® MODE ................................... 84
FIGURE 55 – CPAP/PS MODE ................................................................................................ 85
FIGURE 56 – ADJUSTABLE PARAMETERS FOR CPAP/PS MODE............................... 86
FIGURE 57 – ADJUSTABLE PARAMETERS FOR NIV MODE........................................ 87
FIGURE 58 – PSV/AV® MODE: EXAMPLES OF CURVES: PRESSURE X TIME AND
FLOW X TIME. .......................................................................................................................... 88
FIGURE 59 – ADJUSTABLE PARAMETERS FOR PSV/AV MODE................................. 89

Figure Index
FIGURE 60 - VSV® MODE – EXAMPLES OF CURVES: PRESSURE X TIME AND

FLOW X TIME. .......................................................................................................................... 90
FIGURE 61 – ADJUSTABLE PARAMETERS FOR THE VSV MODE.............................. 91
FIGURE 62 - PARAMETERS MONITORED IN EVERY MODE....................................... 93
FIGURE 63 - ALARMS ADJUSTED FOR EVERY MODE.................................................. 94
FIGURE 64 – ADJUSTABLE PARAMETERS FOR THE PLV MODE.............................. 95
FIGURE 65 – SIMV/P MODE:.................................................................................................. 96
FIGURE 66 - ADJUSTABLE PARAMETERS FOR THE SIMV/P - NEONATAL MODE
....................................................................................................................................................... 97
FIGURE 67 - ADJUSTABLE PARAMETERS FOR BIPV® - NEONATAL MODE .......... 98
FIGURE 68 - ADJUSTABLE PARAMETERS FOR CPAP/PS - NEONATAL MODE ..... 99
FIGURE 69 - ADJUSTABLE PARAMETERS FOR NIV - NEONATAL MODE ............ 100
FIGURE 70 – CONTROL PANEL.......................................................................................... 102
FIGURE 71 – INITIALIZATION SCREEN .......................................................................... 107
FIGURE 72 – INITIALIZATION SCREEN INDICATING TO INSTALL A PEDIATRIC
SENSOR..................................................................................................................................... 108
FIGURE 73 – INITIALIZATION SCREEN INDICATING TO INSTALL AS ADULT
SENSOR..................................................................................................................................... 108
FIGURE 74 - WAYS TO ASSEMBLE THE NEONATAL, PEDIATRIC, AND ADULT
RESPIRATORY CIRCUITS ................................................................................................... 110
FIGURE 75 – MAIN CONTROL SCREEN........................................................................... 112
FIGURE 76 – CONTROL PANEL HIGHLIGHTING THE MODE SELECTION.......... 113
FIGURE 77 – EASY TOUCH BUTTON, TURNING CLOCKWISE,
COUNTERCLOCKWISE AND PRESS ENTER.................................................................. 113
FIGURE 78 – COLOR SCREEN INDICATING THE PARAMETERS SELECTION
MODE. ....................................................................................................................................... 114
FIGURE 79 – PLACE WHERE THE MASSAGES APPEAR............................................. 115
FIGURE 80 – DATABASE....................................................................................................... 121
FIGURE 81 – ALARMS AREA............................................................................................... 126
FIGURA 82 – LUER LOCK CAP INDICATION, IT MUST NOT BE AUTOCLAVED. 137

Company
COMPANY
K. TAKAOKA is a company operating in the hospital equipment manufacturing since 1957, always
cooperating closely with medical professionals. It focuses on the Anesthetics, Intensive Medicine,
Monitoring and Oxygenotherapy areas and is proud to be a market leader, and provides a broad product
line.
One of its priorities is the continued investment in research and development of new ideas and solutions,
standing out for the constant introduction of technological advances and industrial innovations in its
product lines, at the same level as main national and international competitor companies.
Company designs and manufactures with sophisticated equipments most of the components used in its
devices, which explains the strict quality control they are subjected to. Providing a high level support to
all its users is also a concern, by means of its Sales and Technical Assistance Departments.
With distributors among the Brazilian territory and its presence in the international market, K. TAKAOKA
has achieved along the years the loyalty of its clients with its high quality standards and the high efficacy
of its products and services.
Vision:
“To be a global company”.
Mission:
“To be the national leader in the anesthetics and pulmonary ventilators industries, helping to
preserve life, offering high technology and better services to our clients”.
Quality Policy:
“To continuously improve our PRODUCTS, SERVICES and PROCESSES involving our
COLLABORATORS AND PROVIDERS, in order to achieve effectiveness of PRODUCTIVE
PROCESSES, and according to the REGULATORY REQUIREMENTS.”
K. TAKAOKA IND. E COM. LTDA.

Rua General Izidoro Dias Lopes, 121/141
Bairro Vila Paulicéia - São Bernardo do Campo / SP POSTAL
CODE: 09687-100
Phone: + 55 11 5586-1000
Fax: + 55 11 5589-7313
email: kt@takaoka.com.br
Website: http://www.takaoka.com.br
COLOR SERVO-VENTILADOR 1
Introduction
11. INTRODUCTION
The COLOR Servo-Ventilator is a medical device designed to combine the most

advanced technology with a great ease of use. It must be operated only by
qualified professionals specially trained in its utilization.
All controls and monitored parameters are displayed on a 17” graphic touch
screen monitor with 1024 x 768 resolution, which allows the simultaneous display
of all ventilation curves, besides numerical values. It has inclination adjustment.
Curves of: pressure vs. time, flow vs. time, volume vs. time, CO2 vs. time
(optional) and Auxiliary Pressure vs. time (optional); loops of: volume vs.
pressure, flow vs. volume.
Safety
22. SAFETY
2.1. User and Patient Safety

2.2 Safety Resources
2.3 Symbols Definition
2.4 Abbreviations
2.5 Warnings
Safety
2.1. User and Patient Safety
COLOR must be assembled, handled and operated by qualified and trained

personnel, under the direct supervision of a licensed physician.
The FULL READING OF THE OPERATION MANUAL is required BEFORE

using COLOR in patients.
Using the equipment before fully understanding its characteristics and functions
results in risk conditions for the operator, the patient, and the equipment itself.
This product must be periodically checked and shall not be used if any defect is
shown. Preventive inspections and maintenance procedures must be performed
by specialized technicians. If equipment repair is required, the use of original K.
TAKAOKA spare parts is recommended.
Safety
2.2. Safety Resources
2.2.1. Electromagnetic Susceptibility
• The functioning of this equipment is not affected by the use of other equipment
in the proximity, such as high frequency surgery equipment (diathermy),
defibrillators or short wave therapy equipment. Electromagnetic compatibility
tests have been performed by an accredited laboratory.
• This equipment does not send electromagnetic waves which can interfere in the
functioning of other equipment in its proximity. Electromagnetic compatibility tests
have been performed by an accredited laboratory.
•This equipment is not appropriate for use in a magnetic resonance image

environment.
2.2.2. Emergency cylinders and gas feeding (not

supplied by K. TAKAOKA)
• Keep backup cylinder valves sealed while using the gas supply, avoiding the
risk of accidentally emptying the cylinders due to leakage.
•When necessary, open the backup cylinder valve slowly to avoid damage to its
pressure regulating valve.
• The gas from the O2 backup cylinder must only be used to provide a continuous
flow of fresh gases or oxygen directly to the Respiratory System. Don’t use this
gas for other purposes, in order to avoid quick emptying of the cylinder.
• Firstly, check if the on/off switch located in COLOR rear panel is in the off
position.
• Interconnect O2 inlets and compressed air connections located in COLOR rear

panel with the respective feeding sources of these gases.
Safety
• Use the extensions that are provided with the Servo Ventilator. The use of a
pressure regulating valve of the supply system in the wall is not necessary when
the pressures are within the specified range.
ATTENTION
Oxygen and compressed air feeding pressures must be in the range between 40
and 150 PSI (280 and 1035 kPa).
Connect the air filter that is provided with the device with the Servo Ventilator
compressed air connection and the respective extension. The compressed air
from the source must be free of moisture, oil and impurities.
2.2.3. Important
• The Servo Ventilator must be subjected to an annual revision for a new
calibration, performed by a technician authorized by K. TAKAOKA.
• Check if the Servo Ventilator is correctly configured and if the alarms are
appropriately adjusted before using the equipment.
• When filling up the Nebulizer cup, do not exceed the maximum medication
capacity of the reservoir. Do not keep it connected while not in use.
• Do not press any key using surgical instruments or tools. Use only your
fingertips to press the keys. Pointed or hard objects can damage the keys.
• The COLOR Servo Ventilator is not approved for use with flammable anesthetic
agents.
• Establish an appropriate cleaning and sterilization procedure for the Servo

Ventilator components.
• Continuously watch the inhaling pressure gauge for adequate values.
• Keep the patient under constant observation. Frequently check its pulmonary
expansion and free exhaling.
Safety
• All parts of the equipment which are in contact with fluids originated from
patients (such as respiratory circuits, flow sensor, exhaling valve diaphragm, etc.)
can be potentially contaminated after use. If classified as semi critical, these
parts should be submitted to a high level of disinfection or sterilization process
before being discarded (at the end of their life cycle) or be discarded as
potentially infected hospital waste.
• All used parts are defibrillation-proof, except for the temperature sensor cable,
which must be removed from the working area (as there may occur burns to the
patient) when a defibrillator is used near the Servo Ventilator.
• All used parts of the Servo Ventilator are made of inert and non-toxic material,
and will not cause irritation or allergy to the patient.
• Carefully read this Operation Manual in order to appropriately use the

equipment and take maximum advantage of all of its resources.
• Any repair required for the Servo Ventilator must only be performed by
specialized technicians, duly authorized by K. TAKAOKA.
• In this manual and the ventilator, the pressure unit is indicated in water
centimeters (cmH2O) and not Pascal (Pa), its corresponding unit in the
International System (IS), where 1 Pa is the same as 0.0102 cmH2O.
In this manual and the ventilator, the respiratory frequency unit is indicated in
respirations per minute (rpm) and not Hertz (Hz), its corresponding unit in the
International System (IS), where 1 Hz is the same as 60 rpm.
• In this manual and the ventilator, the volume unit is indicated in milliliters (ml) or
liters (l) and not in cubic meters (m3), its corresponding unit in the International
System (IS), where 1 E-6 m3 is the same as 1 ml or 0.001 l.
• Upon receipt, check the equipment and component integrity. If there is any
apparent damage to the equipment or its components please contact an
Safety
authorized K. TAKAOKA distributor immediately, as there are different warranty

periods for its different components.
• This product was manufactured according to good manufacturing practices

(GMP and BPF) procedures, with silicon rubber, in accordance to relevant
regulations for correlates / food contact. During its use, the client should perform
required sanitation or sterilization cares, in addition to tests to ensure that his
products is adequate and safe for the desired application, as the methods and
conditions of use of our products by end users are beyond our control.
• The ventilator should not be covered or kept in places with no air circulation in
order to avoid overheating.
• The ventilator has limited stability and must not be transported or used on
surfaces with an inclination equal to or exceeding 5°, due to risk of toppling over.
Safety
2.3. Definition of Symbols

The following symbols are displayed on the device.
SYMBOLS / PORTUGUESE SPANISH ENGLISH

UNIFIED TEXTS
Table 1A – Definition of Symbols
Safety
SYMBOLS /
UNIFIED TEXTS PORTUGUESE SPANISH ENGLISH
PONTO DE CONEXÁO P/ CONNECTION POINT
PUNTO DE CONEXIÓN
CONDUTOR NEUTRO EM POR NEUTRL
N EQUIPAMENTO
INSTALADO
PERMANENTE.
PARA CONDUTOR
NEUTRO, EN EQUIPO
INSTALADO PERMANTE
CONDUCTOR, IN
PEFMANENTLY
INSTALLED EQUIPMENT
TERMINAL OU PONTO TERMINAL O PUNTO DE TERMINAL OR

DE EQUALIZAÇAO ECUALIZACIÓN DE POTENTIAL EOUALIZING
DE POTENCIAL POTENCIAL POINT
SIN PROTECCIÓN WITHOUT PROTECTION

SEM PROTEÇÃO CONTRA
IPX0 PENETRAÇÃO DE ÁGUA
CONTRA PENETRAXIÓN
DEL ÁGUA
AGAINST PENETRATION
OF WATER
IPX1 PROTEGIDO CONTRA

GOTEJAMENTO DE ÁGUA
PROTEGIDO CONTRA
GOTEO DE AGUA
PROTECTED AGAINST
DRIPPING WATER
PROTEGIDO CONTRA PROTEGIDO CONTRA

IPX4 RESPINGOS DE
ÁGUA
SALPICADURAS
DE AGUA
PROTECTED AGAINST
WATER SPRAYS
ATENÇÃO! CONSULTAR ATENCION! CONSULTAR ATTENTION! SEE

DOCUMENTOS DOCUMENTOS ACCOMPANYING
ACOMPANHANTES ADJUNTOS DOCUMENTS
VENT VENTILADOR VENTILADOR VENTILATOR
CONTRASTE CONTRASTE CONTRAST
CONGELA CONGELA FREEZE
TENSAO ELÉTRICA TENSIÓN ELÉCTRICA DANGEROUS

PERIGOSA PELIGROSA FLFCTRICVOLTAGF
FRÁGIL FRÁGIL FRAGILE
FACE SUPERIOR LADO SUPERIOR THIS SIDE

NESTA DIREÇÁO EN ESTA DIRECCIÓN UP
PROTEGER CONTRA PROTEGER CONTRA LA FEARS

UMIDADE HUMEDAD HUMIDITY
QUANTIDADE SEGURA CANTIDAD SEGURA SAFE STACKING

DE EMPILHAMENTO PARA APILAR OUANTITY
LIMITES DE LIMITES DE TEMPEHATURE

TEMPERATURA TEMPERATURA LIMITS
MANTENHA MANTENER KEEP AWAY

PROTEGIDO DO SOL PROTEGIDO DEL SOL FROM HEAT
EQUIPAMENTO DE EQUIPO DE CATEGORY AP

CATEGORIA AP CATEOGORIA AP EQUIPMENT
EOUIPAMENTO DE EQUIPO DE CATEGORY APG

CATEGORIA APG CATEGORIA APG EQUIPMENT
Table 1B – Definition of Symbols
Safety
SYMBOLS /
ASPIRAÇÁO ASPIRACIÓN ASPIRATION
FLUXÓMETRO FLUJOMETRO FLOWMETER
ASPIRADOR ASPIRADOR ASPIRATOR
VENTILADOR VENTILADOR MECHANICAL

MECÂNICO MECÁNICO VENTILATOR
BALÃO BOLSA BAG
PRESSÃO PRESIÓN INSPIRATORY

INSPIRATÓRIO INSPIRATORIA PRESSURE
PRESSÃO PRESIÓN MAXIM
MÁXIMA MÁXIMA PRESSURE
RELAÇÃO RELACIÓN RATIO
FREQÜÊNCIA FRECUENCIA RATE
PLATÓ PLATEAU PLATEAU
FLUXO FLUJO FLOW
PRESSÁO PRESIÓN LIMIT

LIMITE LIMITE PRESSURE
TEMPO TIEMPO INSPIRATORY

INSPIRATÓRIO INSPIRATORIO TIME
PRESSÁO PRESIÓN SUPPORT
SUPORTE SOPORTE PRESSURE
TREND
TENDÊNCIA TENDENCIA TREND
TREND
TRAVAR TRABAR KEYBOARD

TECLADO TECLADO LOCK
SAVE
SALVA ARCHIVA SAVE
LOOP
REPETE REPITE REPEAT
Table 1C – Table of Symbols
Safety
SYMBOLS /
ENTRADA ENTRADA ELECTRIC

ELÉTRICA ELECTRICA INPUT
SAÍDA SALIDA ELECTRIC

ELETRICA ELECTRICA OUTPUT
ALARME ALARMA
PAUSED ALARM
PAUSADO PAUSADA
ALARME AUDIO ALARME AUDIO PAUSED AUDIO

PAUSADO PAUSADA ALARM
CONEXÃO DE
TOMACORRIENTE POWER PLUG
FORÇA
FLUXO DE
FLUJO DE GASES FRESH GAS
F.G.F GASES
FRESCOS FLOW
FRESCOS
LECTURA EM EL
LEITURA NO MEIO READ FROM
MEDIO DE LA
DA ESFERA CENTER OF BALL
ESFERA
BATERIA BATERÍA BATTERY
CICLO CICLO
MANUAL CYCLE
MANUAL MANUAL
GRÁFICO GRAFICO CHART
MOD. MODALIDADE MODALIDAD MODE
PAG. PÁGINA PÁGINA PAGE
CORRENTE CORRIENTE DIRECT

CONTÍNUA CONTINUA CURRENT
CORRENTE CORRIENTE ALTERNATING
ALTERNADA ALTERNADA CURRENT
(REDE) (RED) (POWER)
TERMINAL DE GROUND
TERMINAL DE
CONEXIÓN A TERMINAL FOR
ATERRAMENTO
TIERRA PROTECTION
TERMINAL DE CONEXIÓN TERMINAL FOR
TERMINAL DE
A TIERRA GRAL. GENERAL GROUNDING,
ATERRAMENTO GERAL
INCLUYENDO EL INCLUDING FUNCIONAL
INCLUINDO O FUNCIONAL
FUNCIONAL GROUNDING
Table 1D – Table of Symbols
Safety
SYMBOLS /
LIGA ON ON
DESLIGA OFF OFF
PRONTIDÃO STAND BY STAND BY
EXPIRATÓRIA ESPIRATORIA EXPIRATORY
INSPIRATÓRIA INSPIRATORIA INSPIRATORY
ENCHER LLENAR FILL
DRENAR DRENAR DRAIN
SERIAL SERIAL SERIAL
RED DE
REDE DE DADOS NET
COMUNICACIÓN
TECLADO TECLADO KEYBOARD
MOUSE MOUSE MOUSE
MONITOR MONITOR MONITOR
USB USB USB
IMPRESSORA IMPRESORA PRINT
SAÍDA SALIDA PNEUMATIC

PNEUMÁTICA NEUMÁTICA OUTLET
ENTRADA ENTRADA PNEUMATIC

PNEUMÁTICA NEUMÁTICA INLET
Table 1E – Table of Symbols
Safety
2.4. Abbreviations
Abbreviations Meaning Abbreviations Meaning
COSY Compact respiratory PEEP End Exhalation Positive
System Pressure
FLOW Exhaling Flow PEAK Peak Pressure (airways)
FIO2 O2 inhaling PLAT Airways Plateau Pressure

concentration
Freq Ventilation frequency P.max. Maximum Pressure
adjustment (airways)
Freq Min Minimum Frequency Pr.Sup. Pressure Adjustment in

Support Pressure or
SIMV/PS modes
Manual Manual Ventilation SIMV Synchronized Intermittent
Mandatory Ventilation
N2O Nitrous Oxide SPONT Spontaneous Breathing
O2 Oxygen RATIO Inhaling time / inhaling

time ratio
PAW Airways Pressure Tip : TI Inhaling-pause ratio
time/inhaling time
UPS No-break VAC Vacuum (e.g. for
secretions suction)
Volume Tidal Volume Trig. FI. Flow Sensitivity
Table 2 – Table of Abbreviations
Safety
2.5. Warnings
Using the equipment before fully understanding its characteristics and functions
results in risk conditions for the operator, the patient and the equipment itself.
Paragraphs preceded by the following words should be carefully read: Attention,

Note and Caution. They are applied to the operation, maintenance and tips when
using COLOR.
CAUTION: Indicates conditions which may adversely affect the operator or

patient.
ATTENTION: Indicates conditions which may affect or damage the equipment

or its accessories.
NOTE: Indicates additional information for better understanding the

equipment operation.
ATTENTION
The person responsible for the assembly, operation and maintenance of the Color Servo
Ventilator must be completely familiar with this operation manual.
ATTENTION
The Color Servo Ventilator equipment must not be used stacked on top of another one.
_____________________________________________________________________
ATTENTION
Perform an inspection procedure (check list) before each use of the Color Servo
Ventilator Device. Do not use the equipment if it is not operating perfectly.
Safety
NOTE:
This Operation Manual is used for all commercially available COLOR Servo Ventilator models.
Other COLOR potentially compatible components are clearly indicated in the text as optional
items.
Controls and Components
3
3. CONTROLS AND COMPONENTS
3.1 Component List

3.2 Optional Items
3.3 Monitor / Control Panel / EASY TOUCH Button
3.4 Front Connection Panel
3.5 Rear Connection Panel
3.6 Heated Humidifier
3.1. Component List

The following COLOR Servo Ventilator’ exclusive components are included with the equipment:
ATTENTION
Use only components specified as K. Takaoka components. The use of components other
than the ones specified may result in increased electromagnetic emission or decreased
electromagnetic immunity.
PRODUCT CODE DESCRIPTION AMOUNT
6060 Heated
201050003 Humidifier 1
202011639 Articulated arm 1
Exhaling Valve
202011152 Diaphragm 1
1
3m O2 extension
202011182 (29/16” threads x
18F Female)
Table 3A – Color Servo Ventilator Components
Silicone flow
sensor tube with
202011665 400 mm and 1
terminal
K. Takaoka Exclusive
Silicone adult
respiratory circuit – 1
202011669 ICU Mont. Color
3m Air extension (2
female diss
202012068 threads) 1
203060031 Luer lock cover 1
203100149 Adult flow

sensor(marked) 1
Cell for O2
measurement with
202012085 intermediate and 1
cable
204010146 1
Operation Manual
Table 3B – Color Servo Ventilator Components
3.2. Optional Items
ATTENTION
Use only components specified as K. Takaoka components. The use of components other
than the ones specified may result in increased electromagnetic emission or decreased
electromagnetic immunity.
1.1.
1.2.
1.3.
1.4.
1.5.
202011670 Silicone pediatric respiratory

circuit 1 unit
Silicone neonatal respiratory 1 unit

202011671 circuit
203100150 Pediatric flow sensor 1 unit
429090516 ILV cable 1 unit
436010036 CO2 sensor

1 unit
Adult/pediatric airway
436010040 adapter 25 unit
436010041 Neonatal airway adapter 10 unit

1.6.
Table 4 – Optional Color Servo Ventilator Items
1.7. - Nebulizer – (optional)
Figure 1 – Medication nebulizer
The Nebulizer (Figure 1) is an optional COLOR Servo Ventilator component for the
purpose of administering medications to the patient through a gas flow entering the
respiratory circuit during the inhaling phase. The Nebulizer reservoir has a medication
capacity of 7 ml.
The monitor in the control area of the Servo Ventilator allows the operator to turn the
nebulization function ON/OFF.
The nebulizer can be mounted next to the endotracheal tube or mask, or on the inhaling
branch.
The nebulizer feeding tube is coupled to the respective NEBULIZER connection tip
located in the Ventilator connection front panel.
NOTE:
The nebulizer can be used by adult, pediatric and neonatal patients, but only in some modes.
The nebulization flow is automatically compensated when determining the tidal volume,
therefore, the exhaled volume is slightly larger than the inhaled volume.
When using of the nebulizer, FiO2 may be influenced.
When filling up the Nebulizer cup, do not exceed the maximum medication capacity of the
reservoir.
ATTENTION
The connection of humidifier filters after the nebulizer when this resource is being
used is not recommended, as these filters may cause a substantial increase in the
respiratory resistance.
Never keep the feeding tube connected to the front panel when the nebulizer
resource is not being used, even if the reservoir is empty.
3.3. Monitor / Control Panel / EASY TOUCH Button
Figure 2 – Monitor LCD Touch Screen / Control Panel / EASY TOUCH Button
Monitor
Color LCD (liquid crystal display) monitor which allows display in 1024 x 728
resolution and touch screen function which allows the view of the following ventilation
curves: pressure x time, flow x time, volume x time, CO2 x time and Auxiliary Pressure
x time, loops of: volume x pressure, flow x volume, in addition to numerical values,
functions, alarms, and navigation display. The monitor has position and inclination
adjustments in addition to image adjustments and configurations.
Control Panel
The keys for accessing special functions are located in the control panel, allowing the
access to the parameter values, and highlighting them in the monitor.
NOTE:
The panel keys only highlight parameter values so that they can be adjusted and confirmed
by means of the increase, decrease and confirmation EASY TOUCH button. This safety
system avoids involuntary adjustments.
EASY TOUCH Programming Button
Located besides the COLOR Servo Ventilator control panel, this

button allows the adjusting of ventilator parameters in a simple and
ENTER
quick way. This button must be operated in the sequence described
below for adjusting each of the ventilating parameters exhibited in
the highlight area of the display:
− Turn button clockwise or counterclockwise until placing the cursor (green circle) over
the parameter to be adjusted.
− Press this button again. The parameter is exhibited in the highlight area of the display
(blue background).
− Turn this button to set the desired numeric value for the parameter. Turning the button
clockwise increases the value, and turning it counterclockwise decreases the value.
Press the button again to confirm the adjustment and to put the new parameter value into
effect. The parameter is removed from the display highlight area.
3.4. Connection Front Panel
Figure 3 – Connection Front Panel - COLOR Servo Ventilator
1 - Connector for Flow Sensor (Blue)

Input for flow sensor tube with blue stripe. The other end of this tube must be
coupled to the tip with larger diameter connected to the flow sensor. Use only flow
sensors supplied by K. TAKAOKA.
2 - Connector for Flow Sensor (Colorless)

Input for flow sensor tube with colorless stripe. The other end of this tube must be
coupled to the tip with smaller diameter connected to the flow sensor. Use only flow
sensors supplied by K. TAKAOKA.
ATTENTION
The two tubes must be coupled in the correct position, according to the
color coding of the ventilator connectors. The tubes have different colors for
a quick identification.
3 - Exhaling Valve Block

Block containing the exhaling valve and two conic connectors for the corrugated
tubes of the respiratory circuit. The exhaling valve controls the inhaling and exhaling
phases. This set can be disassembled for cleaning and sterilization of the diaphragm.
4 - Connector for Nebulizer or TGI Catheter

Air flow outlet Connector for nebulization, using a specific circuit for nebulization,
connected to this exit of the Servoventilator Color and to the Nebulizer cup for
administration of medication in inhaled form. This circuit is an optional component of the
Servo ventilator Color.
This connector can also be used as the TGI when it is active, connecting a specific circuit
in the outlet of the Servo ventilator Color and in the endotracheal tube. This circuit is an
optional component of the Servo ventilator Color.
5 - Connector for auxiliary pressure tube (optional)

Using this connector allows the measurement of the esophageal pressure with an
esophageal balloon catheter. The catheter necessary for the procedure is not included in
the equipment.
6 - Connector for CO2 capnography sensor (optional)

By using this connection, and a capnography sensor, EtCO2 value can be measured.
7 - Connector for FiO2 sensor

Sensor used for measuring FiO2 by an oxygen analyzer.
3.5. Connection Rear Panel
Figure 4 – Connection rear panel
1 - Main On/Off Switch

In the OFF position, the main electro-pneumatic switch cuts gas flows and automatically
turns off the electrical part of the COLOR Servo Ventilator and Heated Humidifier. In the
ON position, the ventilator and Heated Humidifier are turned on. Check the symbol table.
2 - Inlet for power cable with inlet fuse

Compartment with fuse for protection of the electrical part of the ventilator. Inlet for
ventilator power supply, by means of a removable power cable provided with the
ventilator. This cable has a 3-pin connector for coupling to the main power appropriately
grounded. Refer to technical specification for further information.
3 / 4 – 2 (two) Outlet Fuses for the Humidifier

Compartment with fuses for 6060 Humidifier electrical parts protection. One fuse is used
for phase and the other for the neutral. Refer to technical specification for further
information.
5 - 110V Plug for LCD monitor

Plug for COLOR monitor power supply. The Heated Humidifier does not work with this
type of connection and feeding.
6- Outlet for communication interface with the Touch Screen monitor

Serial outlet used for communication with the touch screen monitor.
7 - Video
Connector for video cable inlet for the LCD monitor.
8 - Serial Outlet 3 for communication interface with external devices

Serial outlet with communication interface with external devices in conformity with NBR
IEC 60601-1.
9 – Outlet for communication interface with external devices

Serial outlets used for updating/maintenance services performed by duly trained
technicians.
10 - Plug for Heated Humidifier Power Supply

Outlet plug for electrical power supply to the 6060 Heated Humidifier, with voltage and
frequency matching the inlet cable (the Heated Humidifier has an automatic voltage
conversion feature). This plug only supplies electrical power. Refer to technical
specification for further information.
NOTE:
The serial cable and external devices are not included with the COLOR Servo Ventilator and
are optional components. For further information about software and hardware
requirements, contact a K. TAKAOKA authorized distributor.
NOTE:
The ventilator can be fed with any voltage between 110 and 220 VAC, as it has an automatic
voltage conversion feature.
Figure 5 – Gas connections
1 - Inlet Connection – Compressed Air

Threaded connection for the compressed air filter included with the Ventilator. The filter
inlet must be interconnected with the feeding source of this gas by means of the
compressed air extension which is included with the device. The compressed air
pressure and feed flow must be in accordance with the technical specifications.
2 - Pressure Regulating Valve

Valve for reducing the Ventilator feeding pressure. Not adjustable.

Valve for reducing the Ventilator feeding pressure to 35 PSI - 248 kPa.
4 - Plug for measuring regulated pressure

Plug for the pressure calibrator manometer to measure the pressure value regulated by
the valve (6). The measured pressure must be 35 PSI (241 KPa). This plug is used to
facilitate the equipment maintenance procedure, performed only by an authorized K.

TAKAOKA technician.

Valve for reducing the Ventilator feeding pressure. Not adjustable.
6 - Oxygen Inlet Connection

Threaded connection for oxygen extension provided with the Ventilator for the
interconnection to gas feeding source. The oxygen pressure and feed flow must be in
accordance with the technical specifications.
7 - Compressed air supply inlet filter

Performs the role of filtering humidity, oil and impurities released from the compressed air
supply system.
8 - Oxygen supply inlet filter

Performs the role of filtering humidity, oil and impurities from air supply system.
ATTENTION
Oxygen and compressed air feeding pressures must be in the range between 40
and 150 PSI (280 and 1035 kPa).
Connect the air filter that is provided with the device with the Servo Ventilator
compressed air connection and the respective extension. The compressed air form
the source must be free of humidity, oil and impurities.
3.6. Heated Umidifier

1. Chamber Outlet Connection (Patient)
2. Humidification Chamber Cover (can be
autoclaved)
3. Humidification Chamber (can be
autoclaved)
4. Chamber Fixing Clamp
5. Chamber Fixing Button

6. Temperature display
7. Heating Control
8. Pilot Lamp (Heater on)
9. Heat Lamp (Power On)
10. Replenishment inlet
Figure 6 – 6060 Heated Humidifier
The 6060 Heated Humidifier (Figure 6) was specifically designed for use in respiratory
circuits. It presents electronic temperature control, digital thermometer, pilot lights and
electrical resistance functioning indicator, on/off switch and a transparent chamber with
capacity for 400 ml of sterile water. The gases temperature is measured close to the
patient’s mouth, by means of an electronic temperature sensor.
The COLOR Servo Ventilator main on/off switch also turns on and off the power supply
for the Heated Humidifier.
The Heated Humidifier heats and saturates the inhaling flow that passes through its
chamber with water vapor. The gases then are routed by two corrugated tubes with
drains between the chamber exit and the patient.
Water often condenses inside the patient’s corrugated tube due to the cooling of gases
between the humidifier exit and the "Y" intermediary. The condensed water amount in the
circuit increases with increasing humidifier heating adjustments.
SAFETY MEASURES FOR USING THE 6060 HEATED HUMIDIFIER:
1. It is necessary to avoid the condensed water from draining towards the patient, as it
could reach the patient’s lungs. The corrugated tubes must follow an ascending or
horizontal direction up to the patient so that all condensed water in the circuit flows back
to the drains.
2. If the water condensation in the circuit is excessive, the humidifier heating adjustment
must be decreased.
The Heated Humidifier chamber can be easily detached for disinfection, as its cover is
simply threaded to the cup. When assembling the chamber again, make sure the cover
rubber gasket is correctly positioned and well preserved, so that gases leakage does not
occur during ventilation. Close the cover by firmly tightening it.
Assembly and Preparation
44. ASSEMBLY AND PREPARATION
4.1 Assembly of Color Servo Ventilator

4.2 Electrical Wiring
4.3 Respiratory Circuit
4.4 Flow sensor
4.5 O2 sensor
4.6 CO2 Sensor
4.7 Temperature Sensor
4.8 Gases Circuit
4.9 Exhaling Valve
4.1. Assembly of Color Servo Ventilator
The Color is not completely assembled. The LCD monitor, the basic unit, the column
(mobile base) and the articulated arm must be attached, as shown in Figure 7.
Four screws attach the monitor to its base;

Four screws attach the basic unit to the mobile column;
The articulated arm is just inserted in its support.
Figure 7 Monitor and articulated arm assembly
4.1.1. Mobile Base
The mobile base of the COLOR Servo Ventilator has four casters with front brakes to
ensure excellent mobility, hooks for supporting extensions and a handle for easy
transportation.
The Servo Ventilator is attached on the top part of the mobile base with a four screws
set. The Heated Humidifier is attached to the front part of the mobile base by insertion
pins.
Mount the 6060 Heated Humidifier in the column and power it by plugging the power
cable into the outlet located in the back panel of the COLOR Servo Ventilator. The
heated humidifier only operates if the Servo Ventilator is powered by a main power of
110 to 220 VAC.
ATTENTION
The assembly instructions provided must be closely followed. The details in the
following items of this Chapter can also work as guidelines.
4.2. Electrical Wiring

Before installing the equipment, checking the electrical wiring compatibility with the
following specifications is required:
CONNECTION
PIN 110V 220V
1 NEUTRAL PHASE
2 PHASE PHASE
3 GROUND GROUND
Figure 8 - Electrical three-pin plug, Nema 5-15P type
Only connect the power cable to a duly grounded plug approved for hospital use, in an
electric wiring compliant with ABNT NBR 13534 standard - "Electrical wiring in health
care facilities - Safety requirements." The female three-pin outlet must be Nema 5-15P
type, where the central round pin is the earth, as shown in Figure 8.
COLOR can be fed by a 110 and 220VAC main power through the power cable
provided with the equipment or by a 12DC 9.0 Ah internal battery.
Figure 9 – Rear Connections
4.2.1. Battery
COLOR Servo Ventilator has an internal battery, which enables its operation in case of
power failure.
COLOR Servo Ventilator internal battery is a lead/acid 12 VDC 9.0 Ah rechargeable

sealed battery. It is not required to remove it even when the equipment has not been
used for long periods of time.
• Runtime
The Ventilator internal battery charge duration depends on the mode being used
and the ventilator parameters adjustments.
Example: A fully charged battery can keep the Ventilator operating for
approximately 90 minutes in a medium ventilation condition.
• Recharge
A total battery recharge takes approximately 20 hours, with the Servo Ventilator
turned off and connected to the main power. For longer battery lifetime, keep it at
its maximum charge whenever possible. Constant discharges of the battery
reduce its lifetime.
• Alarm
In the event of lack of power, the Servo Ventilator switches automatically to its
internal battery feeding. When the ventilator is being powered by the internal
battery, the message NO MAIN POWER – OPERATING BY BATTERY will be
shown on the display, the main power LED will be turned off and the power cable
symbol in the lower left corner will be replaced by a battery symbol, indicating
that the ventilator is being powered by the internal battery. To indicate the battery
status, the battery symbol has three states as shown in figure 10.
Figure 10 – Battery Warning

1 – Battery Drawing
2 – Warning: AC INPUT FAIL
Battery 1 – Battery over Battery 2 – Battery Battery 3 – Battery below

40% between 40% and 20% 20%
When the battery is above 40% of its capacity, the figure Battery 1 will be shown on the
display. When the battery is between 40% and 20% of its capacity, the figure Battery 2
will be shown on the display, and when the battery capacity is under 20%, the figure
Battery 3 will be shown on the display. When the battery is under 40% of its capacity, an
alarm of medium priority will sound, and when the battery is under 20%, an alarm of
high priority will be shown on the display, indicating that the electrical power must be
restored immediately.
ATTENTION
Keep the internal battery always charged. For that, the Servo Ventilator can be left
permanently connected to the main power, even if its on/off switch is in the off
position.
After using the Servo Ventilator for some time without main power feeding, the
battery must be recharged.
If the Servo Ventilator is not used and is kept disconnected from the electric
network for a period of time exceeding 20 (twenty) days, the battery must be fully
recharged.
ATTENTION:
The Heated Humidifier does not operate while the Servo Ventilator is being fed by
its internal battery.
4.3. Respiratory Circuit
COLOR Servo Ventilator features three types of respiratory circuits: adult, pediatric and
neonatal. The neonatal circuit has tubes with smaller diameters than the ones for adults;
therefore, decreasing its complacence for use with low flows.
The respiratory circuits of the COLOR Servo Ventilator include a set of corrugated
tubes, two drains, a “Y” intermediary, and a flow sensor with tubes and lines. The drains
mounted in the inhaling and exhaling branches avoid the accumulation of water in the
circuit.
ADULT CONNECTION
Y Intermediary Corrugated tubes Flow sensor

Drain
Circuit
PEDIATRIC / NEONATAL CONNECTION
Drain Y Intermediary Corrugated tubes Flow sensor

Circuit
Table 5 – Respiratory Circuit – Adult Connection / Pediatric/Neonatal Connection
ATTENTION
To avoid an accidental disconnection or gas leakage in the respiratory circuit,
attach all connections firmly.
Close the threaded cover of the 6060 Heated Humidifier firmly, making sure its
rubber gasket is present.
The support for corrugated tubes must be positioned close to the Y intermediary
and in a low position in relation to the patient's mouth in order to the condensed
water in the circuit flows back to the drains.
Do not use antistatic or electrically conductive hoses or tubes.
Figure 11 – Adult respiratory circuit
Figure 12 - Infant respiratory circuit
Figure 13 – Neonate respiratory circuit
4.3.1. Drain
The COLOR Servo Ventilator respiratory circuit has 2 (two) drains for collecting
condensed water from inside the corrugated tubes; one drain is for the inhaling branch
and the other for the exhaling branch.
The use of drains is important to avoid issues from the accumulation of water in the
respiratory circuit.
Emptying
To empty the drain, just remove its threaded cup and discharge the accumulated water,
then thread the cup again in the drain body. This operation does not interrupt patient
ventilation, as there is an automatic drain closure system that is activated when the cup
is removed.
Disinfection
The drain is easily disassembled for disinfection by removing its threaded body and
detaching the plunger set (Figure 14).
Figure 14 – Respiratory circuit drain
• Mandatory periodically performed checklists:
1. Check if the drain cups are empty. Emptying the drains cups is easily done
without stopping the ventilation, as there is an automatic drain closure system
which is activated when the cup is removed. Empty the drains before they are
filled with water.
2. Check if the exhaling valve block is firmly and correctly coupled to the
connection front panel of the Servo Ventilator.
3. Check if all components of the respiratory circuit were submitted to appropriate

disinfection procedures, including corrugated tubes, intermediaries, drains,
humidifier chamber and flow sensor.
4. Read the instructions manual of the 6060 Heated Humidifier in order to

perform the correct assembly and use.
5. Attach the articulated arm to one of the respective lateral supports of the Servo
Ventilator in order to properly accommodate the corrugated tubes. The
articulated arm can be mounted in either of the two sides of the equipment,
depending on the side the patient is.
6. Mount the respiratory circuit of the COLOR Servo Ventilator in accordance

with the schemes in Figures 11, 12 and 13.
7. If desired, correctly assemble the medication Nebulizer, which is an optional

component. The nebulizer spiral form feeding tube is coupled to the respective
NEBULIZER connection tip located in connection front panel of the Servo
Ventilator.
8. If TGI resource is used, its catheter (optional) must be coupled to the nebulizer
tip located in the connection front panel of the Servo Ventilator.
9. Ensure that the 6060 Humidifier temperature electronic sensor is correctly and
firmly coupled to its respective connection in the “Y” intermediary of the
4.4. Flow sensor
The COLOR Servo Ventilator measures flow, volumes and pressures through a
flow sensor of a “differential pressure” type. The flow sensor must be assembled
in accordance with the procedure described below.
1. Connect the type of flow sensor requested by the screen during the
initialization of the Servo Ventilator, which shall be the most appropriate
type for the patient’s weight informed by the operator. The two available
options for a flow sensor are: adult and pediatric.
2. Couple the appropriate flow sensor for neonatal patients (≤ 6 kg) between
the Y intermediary of the respiratory system and the endotraqueal mask or
tube. For adult and pediatric patients (> 6 kg) the flow sensor must be
coupled to the exhaling branch of the valve block (distal relative to the
patient).
3. Interconnect the two flow sensor tubes to their respective connectors

located in the connection front panel of the Servo Ventilator, checking their
correct positions and also checking the correct connection of the tubes to
the flow sensor.
NOTE:
The pediatric flow sensor is appropriate for both neonatal and pediatric patients.
NOTE:
The connectors located in the front panel of the Servo Ventilator have a washing flow
system in the flow sensor tubes with the purpose of eliminating the permanence of
secretions and moisture which are the main source of errors during the monitoring of
ventilation parameters. The washing flow is automatically offset when determining current
volume.
Figure 15 – Flow sensor assembly
ATTENTION:
According to figure 16, NEVER connect the silicone tube to the blue elbow
and the blue tube to the yellow elbow as this would interfere with the sensor
reading.
Figure 16 – Incorrect flow sensor assembly
Figure 17 – Connection of the flow sensor tubes on the COLOR Servo Ventilator.
ATTENTION
Check the flow sensor and the tubes color coding for assembling them in the
correct position. The female 15 mm connection (larger) corresponds to the patient
side; the male 15 mm connection (smaller), to the side of the respiratory system
of the ventilation equipment. Both tubes have different colors in order to provide
quick identification.
The flow sensor cleanliness must be frequently checked during the use of the
Servo Ventilator.
4.5. O2 sensor
The COLOR Servo Ventilator measures FiO2 by means of an Oxygen Analyzer using an
O2 sensor. Follow the procedures below in order to perform this assembly:
a) Remove the sensor from its packaging.

b) The packaging must be preserved for later storing.
c) Interconnect the O2 sensor cable connector (Figure 18) to its respective
connection located in the connections front panel of the Color Servo Ventilator
(figure 19). Connect the O2 sensor (duly cleaned or sterilized) to the other end of
this cable.
2 3
1 – O2 Sensor
1 2 – Cable
3 – Conector
Figure 18 – Oxygen Analyzer
Figure 19 – O2 Cell/Sensor
NOTES:
The request for calibration in 21% or 100% of O2 does not imply in automatic change of
oxygen concentration in the ventilator. Adjust the oxygen concentration in the ventilator
before calibrating and make sure it returns to the desired value.
4.5.1. Calibration before using the O2 sensor

The O2 cell calibration must be performed before each use of Color Servo Ventilator, at
O2 concentration of 21% (environment air) and O2 concentration of 100%. When the cell
has been used for long periods (approximately 2000 hours), also perform its
recalibration.
a) Select the MONITOR key successively, until the screen with the activation
options “O2 Cell Cal 21% or 100%” is shown in the monitoring display.
b) Rotate the EASY TOUCH button until the O2 Cell Cal 21% or 100% item is
placed in the highlight area, and then press the button to select the option.
c) Rotate the EASY TOUCH button to change the status from NCAL (do not
calibrate) to CAL (calibrate).
d) Calibrate the oxygen cell by one concentration at a time.
e) After calibrating, the message “FiO2 xx% Calibrated” will appear in the lower part
of the panel. When the calibration fails, the message “FAILURE Calibrating FiO2
xx%” will appear in the lower part of the panel.
ATTENTION
When the calibration fails, check:
• The oxygen cell conditions. The cells have a lifetime of approximately 8,640
hours after being removed from their packing;
• The cable conditions;
• The correct connection of the cable in the oxygen cell and in the ventilator
panel.
4.5.2. After O2 sensor calibration
a) Place the O2 sensor (in a horizontal position) in contact with the gaseous mixture
to be monitored. For this purpose the intermediary “T” is used, coupled between
the exhaling valve block and the corrugated tube of the inhaling branch (Figure
20).
b) Check if the sensor connection is perfectly sealed, to avoid gas leakage.
c) The Servo Ventilator monitoring display then shows the FiO2 concentration in the
gaseous mixture.
ATTENTION
If in doubt about the correct O2 sensor calibration during the use of the ventilator,
repeat the calibration procedure.
Figure 20 – Correct positioning of the O2 sensor in the respiratory circuit
Figure 21 – Assembled O2 Sensor
1 – Sensor cable connected to FIO2.
2 - Inhaling branch connected to the

inhaling branch and the Sensor
connected to the “T” Intermediary.
4.6. CO2 sensor

he COLOR Servo Ventilator performs EtCO2 measurement using a CO2 sensor (Figure
22) connected to a sensor adapter cable (Figure 23), which is connected to the
ventilator frontal part (Figure 25).
Figure 22 – CO2 Sensor
Figure 23 – Adapter cable of CO2 Sensor
Follow the procedures bellow in order to perform the sensor assembly:
a) Fit the female DB9 connector of capnography sensor to male DB9 connector of
adaptor cable (Figure 24) and fit the CO2 inlet (Figure 25) to the other end (male
circular connector), located at the ventilator frontal panel.
Figure 24 – Capnography Sensor Connection to Sensor Adapter
Figure 25 – Male circular connector of adaptor cable connected to CO2 inlet
b) Fit the sensor reader in the airways adaptor until your hear a sound of a “click”
indicating that it is properly fitted (Figure 26).
Figure 26: Connection of Airways adapter to CO2 sensor reader
c) Assemble the CO2 sensor in the respiratory circuit, connecting one airway adapter
end to Y intermediary (Figure 27) and the other end to the mask or endotracheal
tube.
CO2 SENSOR ASSEMBLY IN THE

RESPIRATORY CIRCUIT
1 – Airways adapter
2- CO2 sensor reader
3- “Y” Intermediary
4- Expiratory branch
trachea.
5- Inspiratory branch
Figure 27 – Connection of CO2 sensor to respiratory circuit
4.7. Temperature Sensor
The temperature sensor is designed to measure the temperature of the gases

administrated to the patient. It is part of the humidifier and must be connected to the Y
branch of the circuit, as shown in figure 28.
Figure 28 – Assembly of the temperature sensor in the Y branch of the circuit
ATTENTION
The temperature
sensor should NEVER
be assembled as
indicated in the
picture. That mistake
will result in a false
temperature reading,
due to the room
temperature influence.
Figure 29 – Incorrect Assembly of the temperature sensor in the Y branch of the circuit
The temperature sensor should always be removed from the respiratory circuit by the
connector, as shown in figure 30.
Figure 30 – Correct removal of the temperature sensor
ATTENTION
As shown in figure 31, NEVER remove the temperature sensor from the Y branch of the
circuit by pulling the cable, in order to avoid damage to the sensor.
Figure 31 – Incorrect removal of the temperature sensor from the Y branch of the circuit
4.8. Gas Circuit
Interconnect O2 inlets and compressed air connections located in COLOR rear panel
with the respective feeding sources of these gases. Use the extensions that are
provided with the Servo Ventilator. The use of a pressure regulating valve for the supply
system in the wall is not necessary should the pressures be within the specified range.
Figure 32 – Gases connections
ATTENTION
Compressed air and oxygen feeding sources are adjustable in a range between 40
and 150 PSI (280 and 1035 kPa), through compressed air and O2 internal valves of
the equipment.
ATTENTION
Constantly check the filter, noting if it is not saturated with impurities, having a
dark color. Replace it as shown in Figure 34 should that be confirmed.
Figure 33 – Air filter components
Figure 34 – Air filter disassembly
4.9. Exhaling Valve
The exhaling valve includes an electromagnetic valve, which defines the inhaling and
exhaling phases of the COLOR Servo Ventilator. During the exhaling phase, the valve is
opened to allow the outflow of exhaling gases.
The exhaling valve block is attached to the connections front panel of the Servo
Ventilator. This allows the respiratory circuit tubes to be directed to either one of the two
sides of the Servo Ventilator, depending on the side where the patient is.
Figure 35 schematically shows the assembly of the exhaling valve block components.
This block has two conic connections in its body for the corrugated tubes of the
Figure 35 – Assembly of the exhaling valve

The exhaling valve is easily disassembled for the disinfection of its components,
inspection or the replacement of its diaphragm. After each exhaling valve assembly,
with its aluminum disc (Figure 37) properly fitted in the diaphragm, the Servo Ventilator
must be turned on and a test procedure must be executed to check its perfect
functioning.
Figure 36 – Diaphragm of the exhaling valve - Metallic disc
ATTENTION
Verify the correct assembly of the diaphragm of the exhaling valve (Figure
37), with the perfect groove of the aluminum disc, because the incorrect
assembly ( Figure 38) can cause an inaccurate equipment functioning.
Figure 37 – Correct Assembly of the Exhaling Valve Diaphragm
Figure 38 – Incorrect Assembly of the Exhaling Valve Diaphragm
ATTENTION
Check periodically the cleanliness and perfect conservation of the exhaling valve
diaphragm. Should a crack or any other irregularity be found in this component, it
must be replaced by a new one. Check periodically the perfect conservation of
the O-ring. The attachment of the block in the connection front panel of the Servo
Ventilator must be firmly performed to avoid gas leakage.
Adult/Pediatric Ventilation Modes
55. ADULT/PEDIATRIC
VENTILATION MODES
5.1 Introduction
5.2 VCV - Volume Controlled Ventilation
5.3 PCV - Pressure Controlled Ventilation
5.4 PCV/AV® - Pressure Controlled Ventilation with
Assured Volume
5.5 SIMV/V - Synchronized Intermittent Mandatory

Ventilation with Volume control
5.6 SIMV/P® - Synchronized Intermittent Mandatory

Ventilation with Pressure control
5.7 MMV – Minimum Minute Volume Ventilation
5.8 BIPV® - Bi-level Spontaneous Pressure Ventilation
5.9 CPAP/PS - Continuous Positive Airway Pressure /
Pressure Support Ventilation
5.10 Non-Invasive Ventilation
5.11 PSV/AV - Assured Volume Ventilation by Pressure
Control
5.12 VSV – Servo-Volume Ventilation with pressure
support
5.1. Introduction
The Table below shows the pediatric/adult ventilation modes available in the COLOR
Servo Ventilator. The modes that require a patient inhaling effort to the breathing trigger
have a protection system against apnea, with automatic change to a backup mode. This
feature results in higher safety for the patient.
Adjusted Mode Description
1. VCV Volume Controlled Ventilation
2. PCV Pressure Controlled Ventilation
Assured Volume Ventilation by

3. PCV/AV®
Pressure Control
Synchronized Intermittent Mandatory
4. SIMV/V
5. SIMV/P®
6. MMV Minimum Minute Volume Ventilation
Bi-level Spontaneous Pressure

7. BIPV®
Ventilation
Continuous Positive Airway Pressure /
8. CPAP/ PSV *
9. NIV * Non-Invasive Ventilation
Assured Volume Ventilation by

10. PSV/AV
Pressure Control
Servo-Volume Ventilation with pressure
11. VSV
support
* Modes with backup feature
Table 6 – Ventilation Modes
• Monitored Parameters in every mode
Figure 39 - Monitored Parameters in every mode
• Adjusted Alarms for every mode
Figure 40 – Adjusted alarms for every mode
5.2. VCV – Volume Controlled Ventilation

In this mode, the ventilator provides an adjusted inhaling flow until the tidal volume is
reached. The inhaling pressure is variable and depends on the respiratory mechanics of
the patient.
It provides controlled and assisted cycles. In the controlled cycles, the patient is passive
and the device controls all ventilation. Triggering occurs by time, according to adjusted
breathing frequency.
In assisted cycles, the ventilator responds to the stimuli of the patient respiratory drive
by means of sensibility adjustment by pressure or flow, i.e. the start of every cycle and
the breathing frequency are determined by the patient’s inhaling efforts. An inhaling
pause value can be set where the inhaling flow will remain at zero during the scheduled
time period.
Figure 41 - VCV Mode – Pressure x time and flow x time graphs. The first two cycles correspond to
controlled cycles; the following, to assisted cycles, being the last one with inhaling pause.
Four flow waveform types can be selected: square, descending, ascending, and
sinusoidal.
• Square Wave
The square flow wave has a constant flow characteristic and the flow peak is
equivalent to the calculated flow.
1 Inhaled Volume
2 Inhaling Pause
3 Exhaled Volume
4 Exhaled Time
• Descending Wave
The descending flow wave reaches a peak flow and decreases linearly.
1 Inhaled Volume
2 Inhaling Pause
3 Exhaled Volume
4 Exhaled Time
• Ascending Wave
The ascending flow wave increases linearly until it reaches the adjusted flow value.
1 Inhaled Volume
2 Inhaling Pause
3 Exhaled Volume
4 Exhaled Time
• Onda Senoidal
1 Inhaled Volume
2 Inhaling Pause
3 Exhaled Volume
4 Exhaled Time
The sinusoidal flow wave starts at zero, increases until the adjusted value is
reached and then returns to zero.
The Limit Pressure value corresponds to the pressure limit established for delivery of
the adjusted tidal volume. If the “Limited Pressure” is reached, the alarm will sound and
probably the delivered volume will be lower than the adjusted value. If the pressure
exceeds 5 cmH2O of the adjusted limit pressure the equipment will abort the cycle by
opening the exhaling valve as a safety measure.
• Adjustable Parameters
Figure 42 – Adjustable parameters for the VCV mode
• Base flow: The equipment keeps a continuous flow at exhaling phase set from 4
to 40 l/min. This flow helps in the leakages compensation and in the decrease of
the respiratory circuit resistance.
• Nebulizer: The equipment provides a continuous flow of 07 l/min during the

inhaling phase in order to perform the inhaling procedure, according to ventilation
limits predetermined by the operator. This resource is activated or deactivated
through the display screen.
• TGI: The equipment keeps a continuous flow of 07 l/min at the end of the
exhaling in order to perform the therapy with tracheal gas insufflation.
• Sigh: Automatically provides a tidal volume 50% higher than the adjusted value,
in each preset cycle number. This resource is activated or deactivated through
the configuration screen of control display.
• Recruitment: This maneuver can perform manual or automatic alveolar
recruitment, where all parameters are adjusted and a continuous pressure on the
airways occurs.
Related to the maneuver are:

Interval Recruitment - minutes
Selecting ON, the equipment will operate according to Interval Recruitment
(selected time), a countdown message will be displayed in the lower left corner of
the screen.
A time value must be set in the Interval Recruitment option. That time will remain
depending on the selected option at Recruitment on/manual.
Time Recruitment – seconds
Selecting ON, the equipment will operate according to Time Recruitment (selected
time in seconds).
Recruitment Pressure - cmH2O
Recruitment Pressure corresponds to the pressure that will be sustained
continuously for a determined time, which will be adjusted in Recruitment Time.
Rise Time % Recruitment
The Rise Time allows an inhaling pressurization quickness variation, directly
changing the inhaling flow peak in patients experiencing airways obstruction.
Peep Return - cmH2O
Peep Return, by selecting the Peep value, this will be automatically selected for
the mode initial page, after recruitment accomplishment.
Recruitment on/off/manual
Selecting MANUAL, the recruitment will occur just once. Immediately after the
maneuver being concluded in the set time (Recruitment Time), it will return to
controlled mode.
5.3. PCV – Pressure Controlled Ventilation

The inhaling pressure is kept constant for a predetermined time (inhaling time), with a
flow waveform with a decreasing characteristic and the tidal volume depending on the
respiratory mechanics of the patient.
It provides controlled and assisted cycles. In the controlled cycles, the patient is passive
and the device controls all ventilation. Triggering occurs by time, according to adjusted
breathing frequency. In assisted cycles, the ventilator responds to the stimuli of the
patient respiratory drive by means of sensibility adjustment by pressure or flow, i.e. the
start of every cycle and the breathing frequency are determined by the patient inhaling
efforts.
The Rise Time options allow an inhaling pressurization quickness variation, directly
changing the inhaling flow peak, used for patients experiencing airways obstruction.
Figure 43 – PCV Mode – examples of curves: pressure x time and flow x time
The first cycle is controlled, the second is assisted with pressure sensibility, the third
cycle is assisted with flow sensitivity, with the cycle interrupted due to the pressure
exceeding 5 cmH2O above the set value.
Figure 44 – Adjustable parameters for the adult PCV mode
• Base flow: Base flow: The equipment keeps a continuous flow at exhaling phase
set from 4 to 40 l/min. This flow helps in the leakages compensation and in the
decrease of the respiratory circuit resistance.

• Sigh: The equipment automatically provides an inhaling time 50% higher than
the adjusted one, in each cycle number. This resource is activated or deactivated
through the configuration screen of control display.

airways occurs.
Interval Recruitment – minutes

the screen.
time in seconds).
Recruitment Pressure – cmH2O
changing the inhaling flow peak in patients experiencing airways obstruction. l
Peep Return – cmH2O
controlled mode.
5.4. PCV/AV® – Pressure Controlled Ventilation with

Assured Volume
The ventilation occurs with controlled pressure, however a target tidal volume is
adjusted and the device adjusts the pressure limit in each cycle to reach the intended
tidal volume.
Figure 45 – PCV/AV® Mode: examples of curves: pressure x time and flow x time
Figure 45 – shows pressure and flow curves according to time, in order to assist
PCV/AV® mode understanding.
The start of each inhaling can be operated by the ventilator or by the patient. In the last
case, pressure or flow can trigger the process. At the start of inhaling, the flow reaches
its maximum value and then decreases until the end of the inhaling time. The pressure
is kept constant during each inhaling, and the level of inhaling pressure can be
automatically changed by the ventilator between consecutive cycles to ensure the
delivery of the set tidal volume.
There is a rise time option, which will allow an inhaling pressurization quickness
variation, directly changing the inhaling flow peak, used for patients experiencing
airways obstruction.
Initialization Sequence – PCV/AV®
Cycles 1, 2 and 3, PEEP + 5 cmH2O for measuring the dynamic compliance.

Cycle 4, 60% of the pressure required to ensure the desired volume.
Cycle > 5, Pressure level control required to ensure the desired volume.
Figure 46 - Adjustable parameters for the adult PCV/AV mode
• Base flow: Base flow: The equipment keeps a continuous flow at exhaling phase
set from 4 to 40 l/min. This flow helps in the leakages compensation and in the
decrease of the respiratory circuit resistance.

• Sigh: The equipment automatically provides an inhaling time 50% higher than
the adjusted one, in each cycle number. This resource is activated or deactivated
through the configuration screen of control display.

airways occurs.

Interval Recruitment – minutes
the screen.

time in seconds).
Recruitment Pressure – cmH2O


changing the inhaling flow peak in patients experiencing airways obstruction.
Peep Return – cmH2O

controlled mode.
5.5. SIMV/V – Synchronized Intermittent Mandatory

In this mode, the ventilator provides controlled, assisted and spontaneous cycles by
volume control. For controlled and assisted cycles, the inhaling adjusted flow is
provided until the tidal volume is achieved. This phase is identified in the flow x time
graph by a red stripe that corresponds to synchronism interval. Should a respiratory
drive occur, the equipment will respond with an assisted cycle, if not, with a controlled
cycle.
For spontaneous cycles, the device provides support pressure or CPAP; this phase is
identified by a yellow stripe in the flow x time graph, which corresponds to the
spontaneous interval. In support pressure, cycling can be adjusted, which typically
occurs upon the flow peak 25% fall; there is the possibility to adjust from 5 to 80% of the
initial flow peak for better patient x ventilator synchronism. There is a rise time option,
which will allow an inhaling pressurization quickness variation, directly changing the
inhaling flow peak, used for patients experiencing airways obstruction.
For trigging the spontaneous and assisted cycle (PSV), sensitivity adjustment (trigger)
by pressure or flow is necessary.
Figure 47 – SIMV/V Mode:
Examples of curves: pressure x time and flow x time The first cycle is controlled with a square flow wave;
the second is spontaneous in the CPAP mode. The third indicates a spontaneous cycle with support
pressure, allowing the sensitivity by pressure or flow and the fourth is an assisted cycle triggered int the
synchronism interval with adjustment of inhaling pause.
Figure 48 – Adjustable parameters for the SIMV/V mode
5.6. SIMV/P® – Synchronized Intermittent Mandatory

In this mode, the ventilator provides controlled, assisted and spontaneous cycles
controlled by pressure.
For the assisted and controlled cycles, the inhaling pressure is kept constant for a
predetermined time (inhaling time), with a flow waveform with a decreasing
characteristic and the tidal volume will depend on the respiratory mechanics of the
patient. This phase is identified in the graph by a red stripe that corresponds to
synchronism interval.
occurs upon the flow peak 25% fall; there is the possibility 5-80% adjustment of the
which will allow an inhaling pressurization quickness variation, directly changing the
inhaling flow peak, used for patients experiencing airways obstruction.
For spontaneous cycles, the device provides support pressure; this phase is identified
by a yellow stripe in the flow graph, which corresponds to the spontaneous interval.
Figure 49 – SIMV/P Mode:
Examples of curves: pressure x time and flow x time The first cycle is controlled with decreasing wave
characteristic. The second is spontaneous in the CPAP mode. The third indicates a spontaneous cycle
with support pressure, which indicates the flow peak 25% cycling moment, allowing the sensitivity by
pressure or by flow. The fourth is an assisted cycle, triggered in the synchronism interval.
Figure 50 – Adjustable parameters for the SIMV/P mode
5.7. MMV - Minimum Minute Volume Ventilation
In this mode, the ventilator provides spontaneous cycles with support pressure assuring
an adjusted minimum minute volume. The start of each cycle and the breathing
frequency are determined by the patient’s inhaling effort. It is necessary to adjust the
sensitivity by pressure or flow. In order to assure a minimum minute volume, the device
changes automatically the support pressure cycle to cycle, using PS value from the
adjusted value, and safety maximum value is the limit pressure.
In support pressure, cycling can be adjusted, which typically occurs upon the flow peak
25% fall; there is the possibility to adjust from 5 to 80% of the initial flow peak for better
patient x ventilator synchronism.
Figure 51 - MMV Mode – examples of curves: pressure x time and flow x time.
In the event of apnea, the ventilator starts to operate in the safety mode with volume
controlled backup mode, where adjustment of breathing frequency and flow is
necessary. The tidal volume will be calculated with the target minute volume divided by
adjusted frequency. A respiratory pause can be set for the Backup.
Figure 52 – Adjustable parameters for the adult MMV mode
5.8. BIPV® – Bi-level Spontaneous Pressure Ventilation
This mode provides spontaneous cycles with two pressure levels. Spontaneous
breathing with high level of pressure corresponding to Limit Pressure and spontaneous
breathing with low level of pressure corresponding to PEEP.
Set the inhaling time in order to determine the higher time (high level of pressure) and
set the breathing frequency in order to determine the lower time (low level of pressure).
At the lower time, the patient breaths spontaneously upon a continuous pressure
(CPAP), which is determined by the PEEP or it is also possible to set the support
pressure for these breathings of the low level of pressure.
Figure 53 – BIPV Mode®
Examples of curves: pressure x time. Note that T1 corresponds to spontaneous breathing of high level of
pressure and T2 corresponds, in the first case, to spontaneous breathing with continuous positive
pressure and, in the second case, with support pressure adjustment.
In support pressure, cycling can be adjusted, which typically occurs upon the flow peak
25% fall; there is the possibility to adjust from 5 to 80% of the initial flow peak for better
patient x ventilator synchronism. Adjustment of flow or pressure sensitivity is necessary.
With changes in the higher time adjustment (inhaling time) and in the lower time
(breathing frequency), this mode will have APRV characteristics. Free spontaneous
breathing at a high level of pressure and a low pressure during a short period (relief).
®
Figure 54 – Adjustable parameters for BIPV mode
5.9. CPAP/PS – Continuous Positive Airway Pressure /

In the CPAP mode, the patient breaths spontaneously upon a positive pressure kept
constant in the respiratory circuit. In this mode, the PEEP adjustment, which
corresponds to CPAP (continuous positive pressure) and O2 (FiO2 - Oxygen Inhaled
Faction), is necessary.
On the same screen, there is the PSV mode option, where the patient breaths
spontaneously with the aid of support pressure. Cycling can be adjusted, which typically
initial flow peak for better patient x ventilator synchronism. Adjustment of flow or
pressure sensitivity is necessary.
Figure 55 – CPAP/PS Mode

Examples of curves: pressure x time and flow x time. In the first cycle we can note a spontaneous
breathing with CPAP and in the second cycle, a spontaneous breathing with support pressure.
ATTENTION
In the event of apnea, the ventilator starts to operate in the safety mode with controlled
pressure backup mode, provided the backup is activate. Control of Controlled Pressure,
breathing frequency and Inhaling Time is necessary.
Figure 56 – Adjustable parameters for CPAP/PS mode
5.10. NIV - Non–Invasive Ventilation

It is a mode indicated for use in non-invasive ventilation, providing spontaneous cycles
and using support pressure ventilation. It has the ability of compensating escapes of up
to 40 l/min, ensuring the adjusted pressure.
The cycling (transition from inhaling to exhaling) can occur based on two criteria, i.e., by
adjusting a percentage from 5 to 80% of the peak flow or reaching the preset cycling
time.
variation, directly changing the inhaling flow peak. Sensitivity adjustment (Trigger) by
pressure or flow is necessary.
ATTENTION
In the event of apnea, the ventilator starts to operate in the safety mode with controlled
pressure backup mode, provided the backup is activated. Adjustment of Controlled
Pressure, breathing frequency and Inhaling Time is possible.
Figure 57 – Adjustable parameters for NIV mode
5.11. PSV/AV – Assured Volume Ventilation by Pressure

Control
The device provides spontaneous cycles where the patient breaths with the aid of
support pressure, where a target tidal volume is adjusted. The equipment changes
automatically the support pressure to achieve the adjusted tidal volume.
Cycling is can be adjusted, which typically occurs upon the flow peak 25% fall; there is
the possibility to adjust from 5 to 80% of the initial flow peak for better patient x
ventilator synchronism. Adjustment of flow or pressure sensitivity is necessary.
There is a rise time option, which will allow an inspiratory pressurization quickness
variation, directly changing the peak inspiratory flow, used for patients experiencing
ATTENTION
In the event of apnea, the ventilator starts to operate in the safety mode with volume
controlled backup mode, where adjustment of tidal volume, breathing frequency and flow
and inhaling pause is necessary.
®
Figure 58 – PSV/AV Mode: examples of curves: pressure x time and flow x time.
Figure 58 shows pressure and flow curves according to time, in order to assist in the PSV/AV®
mode understanding. The patient breaths spontaneously with pressure support cycles. The Servo
Ventilator automatically varies the support pressure value among the consecutive cycles to
ensure the delivery of adjusted tidal volume by the operator (P1≠P2≠P3). The spontaneous cycles
are triggered by the patient through sensitivity by pressure ou flow. If the patient stops breathing
for a time perior longer than apnea time, the Sevo Ventilator automatically starts to send VCV
cycles.
Figure 59 – Adjustable parameters for PSV/AV mode
5.12. VSV - Servo-Volume Ventilation with pressure support

The device provides spontaneous cycles where the patient breaths with the aid of
support pressure, where a target tidal volume is adjusted. The equipment changes
automatically the support pressure to achieve the adjusted tidal volume.
Cycling can be adjusted, which typically occurs upon the flow peak 25% fall; there is
the possibility to adjust from 5 to 80% of the initial flow peak for better patient x
ventilator synchronism. Adjustment of flow or pressure sensitivity is necessary.
There is a rise time option, which will allow an inspiratory pressurization quickness
variation, directly changing the peak inspiratory flow, used for patients experiencing
ATTENTION
In the event of apnea, the ventilator starts to operate in the safety mode with assured
volume controlled pressure backup mode, where adjustment of Controlled Pressure,
breathing frequency and Inhaling Time is necessary. The target volume will correspond
to VSV adjusted volume.
®
Figure 60 - VSV Mode – examples of curves: pressure x time and flow x time.
Figure 60 shows pressure and flow curves according to time, in order to assist in the VSV® mode
understanding. The patient breaths spontaneously with pressure support cycles. The Servo
Ventilator automatically varies the support pressure value among the consecutive cycles to
ensure the delivery of adjusted tidal volume by the operator (PS1≠PS2≠PS3). The spontaneous
cycles are triggered by the patient through sensitivity by pressure or flow. If the patient stops
breathing for a time period longer than apnea time, the Sevo Ventilator automatically starts to
send PCV/AV cycles, where the support pressure level is also automatically varied by the Servo
Ventilator (PC1≠PC2≠PC3).
Figure 61 – Adjustable Parameters for the VSV mode
Neonatal Ventilation Modes
6 6. NEONATAL VENTILATION
MODES
6.1 Introduction
6.2 PLV – Pressure-Limited Ventilation
6.3 SIMV/P® – Synchronized Intermittent Mandatory
6.4 BIPV® – Bi-level Spontaneous Pressure Ventilation
6.5 CPAP/PS - Continuous Positive Airway Pressure /
6.6 Non-Invasive Ventilation
6.1. Introduction
The Table below shows the neonatal ventilation modes available in the COLOR Servo
Ventilator.
Adjusted Mode Description
1. PLV Pressure-Limited Ventilation

2 SIMV/P®
3 BIPV® Bi-level Spontaneous Pressure Ventilation
Continuous Positive Airway Pressure /
4 CPAP/ PSV *
5 NIV* Non-Invasive Ventilation
* Modes with backup feature
Table 7 – Neonatal Ventilation Modes
• Parameters Monitored in every mode
Figure 62 - Parameters Monitored in every mode.
• Alarms Adjusted for every mode
Figure 63 - Alarms adjusted for every mode.
6.2. PLV – Pressure-Limited Ventilation
In this mode, the ventilator provides continuous flow, time-cycled with pressure limit.
Exclusive mode for Neonatal ventilation with weight adjustment < or = 6 Kg.
ATTENTION
The flow sensor shall be coupled to the proximal side of the respiratory circuit.
Figure 64 – Adjustable Parameters for the PLV mode.
6.3. SIMV/P® - Synchronized Intermittent Mandatory

Ventilation with Pressure control - Neonatal
In this mode, the ventilator provides controlled, assisted and spontaneous cycles
controlled by limit pressure and continuous flow.
For the assisted and controlled cycles, the inhaling pressure is kept constant for a
predetermined time (inhaling time), with a flow waveform with a decreasing
characteristic and the tidal volume will depend on the respiratory mechanics of the
patient. This phase is identified in the graph by a red stripe that corresponds to
synchronism interval.
which will allow an inspiratory pressurization quickness variation, directly changing the
peak inspiratory flow, used for patients experiencing airways obstruction.
For spontaneous cycles, the device provides support pressure; this phase is identified
by a yellow stripe in the flow graph which corresponds to the spontaneous interval.
Figure 65 – SIMV/P Mode:
Examples of curves: pressure x time and flow x time. The first cycle is controlled with decreasing wave
characteristic. The second is spontaneous in the CPAP mode. The third indicates a spontaneous cycle
with support pressure, which indicates the flow peak 25% cycling moment, allowing the sensitivity by
pressure or by flow. The fourth cycle is assisted, triggered in the synchronism interval.
Figure 66 - Adjustable parameters for the SIMV/P - Neonatal mode
6.4. BIPV® – Bi-level Spontaneous Pressure Ventilation
Same as the mode described in item 5.7 of chapter 5 – Adult/Pediatric Ventilation

Modes.
NOTE:
With changes in the higher time adjustment (inhaling time) and on the lower time
(respiratory frequency), this mode will have APRV characteristics. Free spontaneous
breathing at a high level of pressure and a low pressure during a short period (relief).
®
Figure 67 - Adjustable parameters for BIPV - Neonatal mode
6.5. CPAP/PS - Continuous Positive Airway Pressure /


Modes.
Figure 68 - Adjustable parameters for CPAP/PS - Neonatal mode
6.6. Non-Invasive Ventilation

Modes.
Figure 69 - Adjustable parameters for NIV - Neonatal mode

Operation
77. OPERATION
7.1 Control Panel

7.2 Ventilator Auto-Test
7.3 Initialization Screens
7.4 Initial Modes
7.5 Main Control Screen
7.6 Modes ventilation parameters adjustment
7.7 Messages
7.8 Graphic Window
7.9 Database

Operation
7.1. Control Panel
Figure 70 – Control Panel
1 - Alarm Silencing Key – SILENCE

Pressed while there is an alarm sounding, this key silences the sound alarm
system for 2 minutes. A LED indicator is displayed on the screen and it remains
continuously lit as long as there is an alarm temporary silencing condition.
However, if during this period another alarm condition takes place, it will sound
again. The alarm silence function can be activated by touch screen, just press the
corresponding icon on the LCD screen.
2 - MONITOR key
Quick access key for pages selection of the ventilation monitor and alarm
adjustments, which can be shifted and confirmed through the “easy touch” button.
3 – Lock KEYBOARD key

When pressed, this key disables the keyboard functions, avoiding an accidental
activation of other keys. Press it once to access it, and press it once again to
unlock the keyboard. This function can be activated by pressing the

Operation
corresponding button on the touch screen. It will also disable the touch screen
keys.
4 – FREEZE key
Key that freezes the graph being presented on the monitor, thus allowing for a
more detailed analysis of the curves. When pressed again, this key unfreezes the
graph. When this key is pressed, a symbol (blue circle) is shown on the left lower
side of the monitor, indicating the freezing status of the graph. However, the data
of the alphanumeric window continue to be presented in real time, and the actual
values of ventilation will continue to be executed. This function can be activated
by pressing the corresponding icon on the touch screen.
NOTE:
The ventilator continues to operate normally while the keyboard is locked.
5 - VENTILATOR key
Quick access keys for pages selection where the parameters adjustments
options are, which can be shifted and confirmed through the “easy touch” button.
It can be activated by pressing the touch screen.
6 - SAVE LOOP
This key freezes and records a desired flow x volume loop on the graphs screen,
allowing the verification of patient’s performance improvement or reduction in the
next cycles.

Operation
7 - MONITOR key
Key that performs the ventilation mode selection, including the options: VCV,
PCV, PCV/AV®, SIMV/V, SIMV/P®, MMV, BIPV®, CPAP, PSV, PSV/AV®, VSV®
and PLV (neonatal). This key must be repeatedly pressed until the desired mode
is highlighted on the monitor, then press the ENTER (easy touch) button to
confirm the selection. The mode change can be performed by touch screen,
pressing the corresponding field mode on LCD screen.
8 - Oxygen Concentration key

Enables 100% of O2 temporized in 90 seconds. For canceling press the key
again and it will return to the previously adjusted value.
9 - Hold Insp./Exp. (inhalation/exhalation) key

This key, manually pressed during inhalation phase, provides an inhaling pause
of 15 seconds.
10 – STAND BY key
When this key is pressed for 2 seconds, the ventilator operates on the Stand By
mode, and the respective visual indication on the monitor is displayed. The
ventilator remains inactive; however, adjustments to the ventilation parameters
can be performed. The operator must press the STAND BY key again in order to
cancel this condition,. This mode can be used during the patient preparation or
another special event. This function can be activated by pressing the
corresponding icon on the LCD touch screen.
11 - Manual Cycle Button

When pressed, this button starts a new inhalation phase. When an Alveolar
Recruitment maneuver is being performed, this key can be used to cancel the
recruitment.
12 – Power supply indicator – Main Power (green)

While the ventilator is connected to the 110 to 220 VCA main power, even if it is
turned off, this LED indicator remains lit; in case of main power lack, or
disconnection, this indicator is turned off.

Operation
13 - GRAPH key
This key switches the graphs displayed on the monitor. The available graph
options are Volume X Pressure, Volume X Flow, which will be described below in this
manual.

Operation
7.2. Ventilator Auto-Test
When the Servo Ventilator is turned on, the monitor displays a system and Servo
Ventilator software initialization screen (this screen is similar to the one in a regular
computer). This information is used for the equipment maintenance.
Then, the Servo Ventilator performs a procedure, verifying the presence of compressed
air and oxygen, adjustment of flow sensors and pressure sensor reference, auto-test of
the internal valves, in the following order: O2 valve; air valve; both valves together.
During this auto-test procedure, the behavior of the electronic components integrating
the system is also evaluated.
Eventual failures in the system (pneumatic, electronic, gas network) found during the
auto-test are indicated through alarm messages and audible sign. The auto-test
procedure takes approximately 20 seconds.
ATTENTION:
Do not use the COLOR Servo Ventilator should the auto-test show any irregularities.
Solve the problem before using the device.

Operation
7.3. Initialization Screens
The equipment runs the auto-test, a screen is displayed requesting the operator to
inform the initial adjustments:
Figure 71 – Initialization Screen
1- Volume / Weight / Tidal Volume Adjustments

ITEMS IMAGE VARIATION
Volume / Weight
4 ml/Kg up to 12 ml/Kg
Patient Weight 3.2 Kg up to 200 Kg
It is calculated according to the

Tidal Volume Volume and Weight established.
Tidal Volume = ml/Kg x
Weight
Table 8- Volume / Weight / Tidal Volume Adjustments

Operation
According to entered weight, the equipment will determine in which age-group the initial
modes will be automatically enabled, as follows:
Weight Kg Type Mode Sensor

From 0.3 to 5.5 Pediatric PLV - SIMV/P Neonatal
From 6 to 10 Pediatric VCV – PCV – SIMV/V – SIMV/P Pediatric
From 10 to 25 Pediatric VCV – PCV – SIMV/V – SIMV/P Pediatric
From 26 to 200 Adult VCV – PCV – SIMV/V – SIMV/P Adult
Table 9 – Mode/Type/Sensor adjustments according to the weight
Figure 72 – Initialization screen indicating to install a pediatric sensor.
Figure 73 – Initialization screen indicating to install as adult sensor

Operation
7.4. Initial Modes
Mode Acronyms Patient Type
Volume Controlled
Adult/Pediatric
Ventilation
Pressure Controlled
Adult/Pediatric
Ventilation
Synchronized Intermittent
Mandatory Ventilation with
Adult/Pediatric
Volume control
Adult/Pediatric
Pressure control
Limited-Pressure
Neonatal
Ventilation
Pediatric/Neonatal
Pressure control
Table 10 - Initial Modes
The operator can choose the initial mode by placing the EASY TOUCH button on the
desired mode and pressing it to confirm.
2 Mode
Only the VCV modes. PCV, PCV/AV, SIMV/P, SIMV/V and

CPAP /PSV are available.
Every mode is available.
Table 11 – Mode (Basic/Complete)

Operation
3 Parameters
Uses the parameters according to the weight and volume

recently adjusted.
It redeems the parameters adjusted before turning the

equipment off.
Table 12 – Parameters (Adjusted/previous)

4 Language selection
The language is confirmed by pressing the EASY TOUCH Button for the available
options:
With the previous adjustments performed, their confirmation will be done by pressing
the EASY TOUCH Button on OK. The proper sensor must be coupled according to the
request displayed on the screen.
Figure 74 - Ways to assemble the neonatal, pediatric, and adult respiratory circuits

Operation
Press “Enter” for confirming, then the ventilation and monitoring will automatically start.
ATTENTION
The automatic initial adjustment of the ventilation parameters should not be considered by
the operator as the ideal and definitive adjustment for the patient. Before starting the
ventilation, assure the ideal adjustment of each parameter is performed.
Check the correct position of the external flow sensor, using the distal mode sensor for
adult and pediatric patients and proximal mode for neonatal patients. According to the
weight selected in the table above, the circuit assembling is displayed on the next screen
according to the type of patient.

Operation
7.5. Main Control Screen
After the definition of the respiratory circuit, the main control screen will be displayed with
the adjustable parameters, monitored parameters and graphs.
Figure 75 – Main Control Screen

Operation
7.6. Modes ventilation parameters adjustment

Establishing the values of the ventilation parameters requires:
1- To select the mode type by pressing the select key in the control panel;
Figure 76 – Control panel highlighting the mode selection

2 - Turn the easy touch button to select the desired mode and press “ENTER”
to confirm;
Figure 77 – Easy touch button, turning clockwise, counterclockwise and press ENTER.
Turn the easy touch button until the parameter to be chosen; it will be marked with a
green circle. Then press the easy touch button; the parameter value will be
highlighted in blue. Adjust by turning clockwise the easy touch in order to increase
and counterclockwise to decrease the value and confirm the adjustment by pressing
again the easy touch button.

Operation
Figure 78 – Color screen indicating the parameters selection mode.

Operation
7.7. Messages
The following messages can appear in the lower part of the screen, as Figure 79
shows:
Figure 79 – Place where the massages appear
• NO MAIN POWER – BATTERY IN USE

It indicates that the Ventilator is being supplied by its internal battery, without power
supply from the main power. Connecting the Ventilator to another external power
supply is required, before the battery is discharged (approximately 120 minutes with
maximum battery charge).
• AUDIBLE ALARM TURNED OFF

It indicates that the user requested the audible alarm to be suspended for up to 120
seconds, should no different or new alarm condition occur.

Operation
• ASSISTED - > FLOW TRIGGER / PRESSURE TRIGGER / MANUAL TRIGGER

This message momentarily appears in the lower side of the monitor every time the
patient triggers a cycle of the Servo Ventilator. A red indication also appears in the
place where this option is located, if triggering was due to FLOW, PRESSURE, or
activation of the MANUAL CYCLE key. That message allows visualizing the patient's
ability of triggering the Servo Ventilator cycle in the graphs, making it easy to adjust
pressure and flow sensitivity controls.
• SPONTANEOUS -> FLOW TRIGGER / PRESSURE TRIGGER

That Message momentarily appears in the lower side of the monitor every time the
patient starts a spontaneous breathing cycle with the aid of the support pressure. An
indication of whether the sensitivity was due to FLOW or PRESSURE also appears.
• SPONTANEOUS
That Message momentarily appears in the lower side of the monitor every time the
patient starts a spontaneous breathing cycle with the aid of the support pressure. An
indication of whether the sensitivity was due to FLOW or PRESSURE also appears.
• WINDOW
That message appears in the lower side of the monitor during the period in which the
Servo Ventilator waits for the patient’s inhalation effort for the triggering of a new
breathing.
• AUTO PEEP
Message indicating that there was an air imprisonment larger than the adjusted Auto
peep value.
• MANUAL EXHALING PAUSE

That message indicates that the Servo Ventilator is in exhalation pause during 4
seconds following the exhaling time, for auto-PEEP measurement purpose.
• MANUAL INHALING PAUSE

Message indicating that the special 5-second inhaling pause function is running.

Operation
• APNEA BACKUP PCV /APNEA BACKUP PLV

Message indicating that the Servo ventilator automatically entered the backup mode,
as the patient has stopped breathing spontaneously or is not able to trigger the
Servo Ventilator.
• VCV CONTROLLED, PCV/AV CONTROLLED

Message indicating that servo ventilator automatically entered the backup mode,
because the patient has stopped breathing spontaneously or is not able to trigger
the Servo Ventilator.
• STAND BY
Message indicating that Servo Ventilator is on standby mode, which is activated by
pressing the STAND BY key.
• SIGH
Message indicating that Servo Ventilator is in the programmed sigh feature.
• ALVEOLAR RECRUITMENT
That message indicates that Servo Ventilator is performing a recruitment maneuver.
• NEXT RECRUITMENT _____min

That message indicates the interval up to the next recruitment. The regressively
presented time in the message will be in compliance with the time adjusted by the
operator.

Operation
7.8. Graphic Window

The selection of the graphic to be displayed is done by the key. The graphs
available for presentation are shown in table below.
GRAPH UNIT
Flow x time l/min x s
Pressure x Time cmH2O x s
Volume x Time ml x s
Pressure x Flow cmH2O x l/min
Volume x Pressure ml x cmH2O
CO2 x Time mmHg x s
Auxiliary Pressure x Time cmH2O x s
Table 13 – Graph / Unit Table
Press the quick access key in the control panel in order to switch between the
screens with the available graph types.
In the graphs presented, in the shape of a loop, (Flow x Volume and Volume x
Pressure), the recording of a cycle can be performed at any determined moment, for
later comparison with the current cycles. For this purpose, press the key (SAVA
LOOP) of frontal panel at the desired moment:
1. Clears the screen
2. Displays the curve recorded on the memory
3. Displays three cycles in real time, and returns to item 1 above.
Image freezing
The key (FREEZE) freezes the graph being presented on the monitor, thus allowing
a more detailed analysis of the curves.
When pressed again, this key unfreezes the graph. When this key is pressed, the
symbol in red will appear in the left side of the monitor, indicating the graph freezing
status. However, the data of the monitoring screen continue being displayed in real
time.

Operation
Sending data (optional item)
The Servo Ventilator is provided with a serial port for synchronization with other Color
Servo Ventilator in the ILV function through the proper cable (this is an optional item)
and updating of the equipment software.

Operation
7.9. Database
Checking all the values of monitored parameters can be performed in this screen, in
which each value is stored every 30 seconds during 48 hours, i.e., it has a storage
capacity of 5760 records.
When entering the numeric trend (DATABASE), a table is shown where the columns
correspond to the parameters:
1 Date
2 Hour
3 Mode
4 Tidal Volume
5 Frequency
6 Pressure
7 Plateau Pressure
8 Medical Pressure
9 Auxiliary Pressure
10 PEEP
11 Inhaling Flow
12 Exhaling Flow
13 Work
14 Static Compliance
15 Dynamic Compliance
16 Resistance
17 FIO2
18 EtCO2
19 Alarm 1
20 Alarm 2
21 Alarm 3
22 Record
The quick access key “GRAPH” must be pressed in order to show this screen, until
the table is presented.

Operation
Figure 80 – Database.
The following procedures must be followed in order to access the database values:
1. Select the numeric Trend key using the key.

2. Press the √ icon, with the aid of Easy Touch, or using the Touch Screen.
3. Turn the button to the right or left, in order to switch the data access from +50 to –50,
+100 to –100 or +1000 to –1000;
4. Should an item by item view be desirable, take the cursor up to the button (red), press
ENTER and rotate the Easy Touch to the left or right in order to visualize the
parameters. Press ENTER again to leave.

Alarm System
88. ALARM SYSTEM
8.1 Introduction
8.2 Alarms Priority Levels
8.3 Alarms Priority Level Audible Differentiation
8.4 Alarms Related to the Display

Alarm System
8.1. Introduction
The Color Ventilator has a complete audiovisual alarm system, which provides high
safety during ventilation. In the event of an alarm condition, the Ventilator provides
Audible Signs and written Messages on the screen in order to assist the operator to
promptly identify the event that has generated the alarm.
NOTE:
The ventilator alarm system complies with ISO 9703-1, ISO 9703-2, and ISO 9703-3
standards.
The intensity and intermittence of the alarm indication are directly related to the priority
level of the occurrence, as specified below.

Alarm System
8.2. Alarms Priority Levels
The COLOR Servo Ventilator Alarm System can be activated by two different control
sources: the ventilator and the ventilation monitor incorporated to the equipment. The
alarms with highest priority, active (which interrupts the ventilation cycle), and
considered safety alarms are related to the ventilator; and the secondary alarms,
considered as warning conditions, are related to the ventilation monitor. The alarms
shown on the ventilator display follow this pattern: Medium Priority Alarms are indicated
with Yellow background and Black letters; while the High Priority alarms are indicated
with Red background color and White letters.
Level 1 Priority (high)

1. Fail Comm
2. Low Battery
3. Obstruction (Active)
4. Check Line and Sensor
5. High Pressure (Active)
6. Apnea
7. Disconnection
8. Low O2 Pressure
9. Low Air and O2 Pressure
Level 2 Priority (medium)

1. PEEP Alert – Limit Pressure (no audio)
2. High FiO2
3. Low FiO2
4. I:E > 4:1
5. Alert for inverted I:E Ratio (no audio)
6. Low PEEP
7. High PEEP
8. High Frequency
9. Low Frequency
10. Low Minute Volume
11. High Minute Volume
12. Low Pressure

Alarm System
8.3. Alarms Priority Level Audible differentiation

According to the priority level of the generating event, the alarms have different sound
signals and intermittence, always in a decreasing relevance order:
FAIL COMM Audible Continuous

LOW BATTERY Audible Intermittent tones each 10
seconds
EXHALING OBSTRUCTION Audible Intermittent tones each 10
seconds
Audible Intermittent tones each 10
CHECK LINE AND SENSOR
seconds
HIGH PRESSURE, DISCONNECTION Audible Intermittent tones each 10
seconds
APNEA, O2 PRESSURE Audible Intermittent tones each 10
seconds
AIR PRESSURE Audible Intermittent tones each 10
seconds
Others Alarms1 Audible Intermittent tones each 22
seconds
Table 14 - Alarms Priority Level Audible Differentiation
1
Alarms with Inverted Relation and PEEP=Limit Pressure do not present audible signals

Alarm System
8.4.Alarms Related to the Display
At the inferior part of the screen as the picture 81 can appear the alarms that
are informed bellow:
Figure 81 – Alarms Area
• Fail Comm
Inform a condition of without sent or a fail at the command sent to the main board of the
equipment. In this case, please contact the K. Takaoka Ind. e Com. Ltda technical
assistance attached at the manual.
• Check the O2 Supply

It indicates a low pressure condition in the oxygen supply that feeds the Ventilator. In
this condition, the ventilator starts working with compressed air only, the O2
concentration goes to 21% and is displayed in the Ventilator control panel. When the O2
supply is reestablished, the O2 concentration in the control panel must be reset to the
desired value.

Alarm System
• Check the AIR Supply

It indicates a low pressure condition in the compressed air supply that feeds the
Ventilator. In this condition, the ventilator starts working with O2 only, the O2
concentration goes to 100% and is displayed in the Ventilator control panel. When the
compressed air supply is reestablished, the O2 concentration in the control panel must
be reset to the desired value.
In the Air Compressor configuration (optional), this alarm also indicates a low pressure
condition in its reservoir.
• Disconnection
It indicates a disconnection in the respiratory circuit or in the flow sensor tubes.
• Apnea
It indicates that the patient has spontaneously stopped breathing, thus being necessary
an immediate action by the operator. Depending on the selected mode, the Ventilator
automatically starts to operate in the backup mode.
• High Pressure
1. It indicates that the current inhaling pressure has exceeded the adjusted value of the
limit inhaling pressure control by 5 cmH2O, due to some abnormal operating condition.
This is an active alarm, which automatically interrupts the inhalation to avoid pressure
excess.
2. It indicates that the inhaling pressure has exceeded the adjusted value of the upper
limit of the ventilation monitor alarm.
• Low Pressure
It indicates that the inhaling pressure is not reaching the lower limit established in the
ventilation monitor alarm menu.
• Inverted Ratio (visual alarm)

It indicates an inverted ratio condition on ventilation, with the inhaling time being
superior to exhaling time. This is a visual alarm only; therefore, such condition may
eventually be desirable for the operator.
In volume controlled modes, the ventilator has a safety system that prevents an
adjustment which results in an I:E ratio above 4:1.

Alarm System
• I:E > 4:1

It indicates an inverted ratio condition of ventilation above 4:1, with the inhaling time
higher than or equal to 4 times the exhaling time.
• LIM PRESSURE = PEEP (visual alarm)

It indicates an adjustment condition in which the limit pressure is equal to the PEEP.
This is a visual alarm only; therefore, such condition may eventually be desirable for the
operator.
• High PEEP
It indicates that the final exhaling pressure has exceeded the upper limit established in
the ventilation monitor alarm menu.
• Low PEEP
It indicates that the final exhaling pressure has not reached the lower limit established in
the ventilation monitor alarm menu.
• High Minute Volume

It indicates that the measured minute volume has exceeded the upper limit established
in the ventilation monitor alarm menu.
• Low Minute Volume

It indicates that the measured minute volume has not reached the lower limit
established in the ventilation monitor alarm menu.
• High Frequency
It indicates that the measured breathing frequency has exceeded the upper limit
• Low Frequency
It indicates that the measured breathing frequency has not reached the lower limit
• High FiO2
It indicates that the measured FiO2 has exceeded the upper limit established in the

Alarm System
• Low FiO2
It indicates that the measured FiO2 has not reached the lower limit established in the
• No Main Power – Battery In Use

It indicates that the Ventilator is being supplied by its internal battery, without power
supply from the main power. Connecting the Ventilator to another external power supply
is required, before the battery is discharged (approximately 120 minutes with maximum
battery charge).
• Low Battery
It indicates that the internal battery has low charge, requesting an urgent battery
recharge. The visual indication of this alarm is through the BATTERY visual indicator.
This alarm has medium and high priorities.
NOTE
The Ventilator must be immediately connected to the main power when this message is
displayed, in order to recharge the internal battery.
• EXHALING OBSTRUCTION
It indicates that there was an obstruction in the exhaling valve. This may have been
caused by a fold or obstruction (secretions) in the exhaling branch, or even by problems
in the exhaling valve diaphragm (assembling, integrity, and cleaning).
• Check Line and Sensor

It indicates that a disconnection or obstruction in the flow sensor tubes (blue or colorless
has occurred.

Cleaning and Sterilization
99. CLEANING AND

STERILIZATION
1.8.
1.9.
1.10.
1.11.
9.1 Concepts and Definitions
9.2 Cleaning and sterilization procedures
9.3 Flowchart
9.4 Recommendations

9.1. Concepts and Definitions
• CLEANING - A process that removes dirtness and organic material from any
surface or object. The cleaning is performed by mechanical friction, immersion,
cleaning and ultrasound machines. It is the most important step of
decontamination; each item must be washed before undergoing any disinfection
or sterilization process. No object should be sterilized if it has organic material on
it (oil, fat, blood, etc.). The cleaning must always be performed with soap and
water. When the immersion method is used, use preferentially enzymatic
detergent. This detergent has specific activity on the organic material; it degrades
and dissolves the material in a few minutes. The objects must remain submerged
during 5 minutes.
• DISINFECTION – Thermal or chemical process that kills all the microorganisms,

except sporulated ones. The disinfection is classified into three categories: high,
medium, and low levels.
• HIGH LEVEL DISINFECTION – A process that kills all the microorganisms,

except a great amount of spores (bacteria, almost all the fungi spores, TB
bacillus, virus) with an exposure time between 10 and 30 minutes. Example:
Immersion in Glutaraldehyde.
• INTERMEDIATE LEVEL DISINFECTION – A process that inactivates vegetative

bacteria, fungi, almost all the viruses, except spores. Example: Mechanical
friction with Alcohol at 70%.
• LOW LEVEL DISINFECTION – A process that inactivates most bacteria, some

fungi, some viruses; however, it does not affect more resistant microorganisms
such as the TB bacillus and the spores.
Used only for surfaces. Example: Water and detergent – cleaning.
• THERMAL DISINFECTION - Process that uses thermal-disinfectant liquids

against all vegetative forms, destroying one part of spores when used at a 60-
90ºC temperature. This process is performed in a thermal disinfection machine. It
works with two types of cycles, for sensitive and resistant materials, with the use
of the appropriate detergent.

• STERILIZATION – Process that completely kills all the microorganisms (spores,

bacteria, fungi, and protozoans), and is performed by physical (vapor) or
chemical (glutaraldehyde liquid, ethylene oxide gas, and hydrogen peroxide
plasma) processes. The spore is the most difficult microorganism to inactivate.
Example: Autoclave, Hydrogen peroxide, ethylene oxide, glutaraldehyde
(material exposed for 10 hours).
NOTE
Hydrogen peroxide (oxygenated water) is a sterilization process that takes place at a
maximum temperature of 45ºC, the materials that cannot be autoclaved can be sterilized
with peroxide, except that ones derived from cellulose.

9.2. Cleaning and sterilization procedures
ATTENTION
Turn the Color Servo Ventilator off before cleaning it. Do not submerge the
ventilator in any liquids.
This cleaning, disinfection, and sterilization procedure for the parts that are in contact
with the patient must be performed before the first use and in the following reutilizations.
1. Use a clean and soft cloth, wet with water and soap (detergent) for cleaning the
external parts of the ventilator. Care must be taken in order to prevent cleaning product
residue accumulation in the device connections. Perform drying with a clean, dry, and
soft cloth after cleaning.
2. Use a clean, soft, and lint free cloth to clean the screen of the Servo Ventilator. Do
not use paper towels or rough cloths to avoid scratching the screen surface.
3. Do not use abrasive or corrosive agents when cleaning.
4. The components of the respiratory circuit, if not used with bacterial filter, must be
disassembled after being used by each patient for disinfection or sterilization, including:
corrugated tubes (plastic or silicone), heated humidifier chamber, drains, nebulizer,
exhaling valve, exhaling valve diaphragm, flow sensor, flow sensor tubes and
intermediaries. Use glutaraldehyde, hydrogen peroxide, or ethylene oxide. The
corrugated plastic tubes, the nebulizer, the intermediaries, and the white flow sensor
cap can undergo thermal-disinfection; however, only in sensitive cycle (chemical
thermal-disinfection), i.e., they support low temperatures up to 60ºC. The other
materials can be sterilized in an autoclave, with a maximum temperature of up to136ºC.
Should the respiratory circuit components be used with a bacterial filter, establish a
daily routine (once a day) for their disinfection or sterilization. The Servo Ventilator
circuit components used in ICU must be reprocessed for each patient, whether filter is
used or not.

5. The silicone parts (tubes and tracheas) have silicone intrinsic characteristics of non
deformation (up to 150ºC, and indefinite lifetime), at room temperature, maintaining the
silicone application and properties. It is suggested the storage conditions to be in a
clean and organized area, free from perforating or contaminant materials, preferentially
following the cleaning instructions, good manufacturing organization practices, non
exposure to sunlight, avoiding exposure to temperature above 40ºC or in areas near
heat-related equipment (such as stoves and sterilizers).
NOTE
After start using, it is suggested the tracheas/tubes to have at most a lifetime of up to 50
sterilizations in a vapor sterilization process (autoclave) in 20-minute cycles with 1
bar/15PSI and 121ºC/250ºF.
ATTENTION
Perform visual and functional inspection for the components after the
cleaning/sterilization procedure in order to detect signals of wearing on them.
Dry tubes and/or with cracks and irregular fittings indicate the need for
replacement.
We should pay special attention to the cleaning of the flow sensor; therefore, the
accumulation of liquid or solid substances may interfere with the values
measured and displayed by the ventilation monitor. Thus, a periodicity for
cleaning must be established by the physician or according to the patient status,
or at least every 2 hours.
When using ethylene oxide, the instructions provided by the sterilization
equipment manufacturer must be followed in order to determine the indicated
temperatures and aeration times.

9.3. FLOWCHART
The processing will be performed following a sequence of steps, illustrated in the
FLOWCHART below.
PRESENCE OF ORGANIC MATERIAL OR DIRTNESS
CONSIDER EVERY COMPONENTS AS CONTAMINATED
CLEAN
HUMID CLOTH DETERGENT SOLUTION
RINSE
DRY
DEPENDING ON THE
ARTICLE DESTINATION
IF STERILIZATION IF THE PROCESSING IS IF DISINFECTION

CONCLUDED
PHYSICAL CHEMICAL STORE LIQUID CHEMICAL LIQUID PHYSICAL LIQUID CHEMICAL

PROCESS (VAPOR) PROCESS PROCESS PROCESS THERMAL PROCESS
ALCOHOL 70% DISINFECTION GLUTARALDEHYDE
PACK LIQUID GASEOUS PLASMA MECHANICAL IMMERSE FOR THE IMMERSE THE
(GLUTARALDEHYDE) (ETHYLENE OXIDE) (HYDROGEN FRICTION APPROPRIATED TIME ARTICLE
PEROXIDE) AND TEMPERATURE
STERILIZE FULLY IMMERSE PACK PACK PACK DRY ASSEPTICALLY FILL THE
TUBULATIONS
PACK FILL THE STERILIZE STERILIZE STORE PACK RINSE WITH

TUBULATIONS STERILIZED O2
RINSE WITH STORE STORE STORE DRY

STERILIZED O2 ASSEPTICALTLY
DRY PACK
ASSEPTICALLY
PACK IN A STORE
STERILIZED BOTTLE
STORE
Sequential steps flowchart of the mechanical ventilation and anesthesia

equipment components
Flowchart 1 – Sequential steps of the mechanical ventilation equipment component processing

9.4. GUIDELINES
Methods recommended for processing TAKAOKA Mechanical Ventilation Equipment
Components.
Component Cleaning Disinfection Sterilization

Detergent Thermal disinfection
Humidifier Chamber Solution resistant Vapor
glutaraldehyde
Detergent NOT NOT
Galvanic Cell for Oximeter*
Solution RECOMMENDED RECOMMENDED
Vapor Hydrogen
Resistant thermal
Detergent peroxide
Drains disinfection
Solution
glutaraldehyde
Ethylene oxide,
Sensitive thermal Glutaraldehyde or
Detergent
Y Intermediary (nozzle) disinfection Hydrogen peroxide
Solution
glutaraldehyde
Detergent Glutaraldehyde Ethylene oxide or,

Mask
Solution Alcohol at 70% Glutaraldehyde
Phenol Synthetic NOT
Monitor Module Wet cloth
Alcohol at 70% RECOMMENDED
Alcohol at Phenol Synthetic NOT
Ventilator module
70% Alcohol at 70% RECOMMENDED
Case/Cabinet (external Alcohol at Phenol Synthetic NOT
parts) 70% Alcohol at 70% RECOMMENDED
Ethylene oxide,
Detergent
Mask Strap Glutaraldehyde Glutaraldehyde or
Solution
Hydrogen peroxide
Resistant thermal
Detergent
Flow sensor disinfection Vapor
Solution
glutaraldehyde
Resistant thermal
Detergent
Silicone Trachea ** disinfection Vapor
Solution
glutaraldehyde
Inhaling and ExhalingValve Sensitive thermal Ethylene oxide,
Detergent
Block disinfection Glutaraldehyde or
Solution
glutaraldehyde Hydrogen peroxide
Resistant thermal
Detergent
Flow sensor line disinfection Vapor
Solution
glutaraldehyde
Resistant thermal
Detergent
Exhaling Valve Diaphragm disinfection Vapor
Solution
glutaraldehyde
Table 15 – Guidelines for components processing

NOTE
* Galvanic cell for FiO2 measurement must be cleaned with a cloth damped in water and
soap. It should not be submerged in a solution.
** Silicone tracheas can be autoclaved and subjected to resistant thermal disinfection.
ATTENTION
The Luer lock cap must NOT be autoclaved. Sterilization with glutaraldehyde is otherwise
recommended.
Figura 82 – Luer Lock cap indication, it must not be autoclaved
NOTE
It is recommended the monitor to be always disinfected with alcohol at 70º.

Maintenance
10
10. MAINTENANCE
1.12.
1.13.
10.1 - Preventive Maintenance
10.2 - Emergency Actions

Maintenance
10.1. Preventive Maintenance
• Check if tubes, sensors, cables and other COLOR’s components are not
damaged, worn or cracked at least once every month. If there is any damage,
replace the component. Don’t use damaged components.
• The exhaling valve diaphragm must be carefully inspected and its integrity
checked at least once a month.
• The exhaling valve diaphragm must be replaced at least once every 6 (six)
months, and whenever necessary.
NOTE
The attachment of the exhaling valve block in the connection front panel of the ventilator
must be firmly performed to avoid gas leakage. Check periodically the perfect
conservation of the O-ring.
• The flow sensor tubes must be replaced at least once every 2 (two) months, and
whenever necessary.
• Check periodically the perfect conservation of the rubber gasket of the Heated
Humidifier cover, in order to achieve a perfect seal when closing the chamber. If
needed, replace this gasket with a new one.
• Check the conditions and periodically replace corrugated tubes of the respiratory
circuit, as they are usual wear components.
• If the maximum inhaling pressure does not reach the expected value, initially
check:
if there is no leakage in the respiratory circuit;

if there is no leakage in the humidifier cover;
if all connections are tight;
if the pressure control has not a too low regulation;

Maintenance
if the tidal volume control has not a too low regulation;

if the O2 pressures and compressed air supplies are not too low;
if the exhaling valve assembly is correctly assembled, with a clean
diaphragm in perfect conditions;
if the inhaling flow control has not a too low regulation.
• If the tidal volume does not reach the expected value, initially check:
if there is no leakage in the respiratory circuit;
if there is no leakage in the humidifier cover;
if all connections are tight;
if the pressure control has not a too low regulation;
if the O2 pressures and compressed air supplies are not too low;
if the exhaling valve assembly is correctly assembled, with a clean
diaphragm in perfect conditions;
if the inhaling flow control has not a too low regulation.
• If you cannot normally feed the COLOR with the main power, initially check:
if there is 110 to 220 VAC voltage in the main power outlet;
if the COLOR fuse is not burned.
• The compressed air and oxygen filters must be opened and cleaned two to three
times a year, depending on the Servo Ventilator use rate and the purity of the
medicinal gases. The draining of the filter condensation is automatic.
• Use only the sensors, cables and tubes specified by K. TAKAOKA for the
equipment.
• Do not use the COLOR Servo Ventilator if the self-test shows any irregularity.
Provide a solution for the problem displayed through an authorized K. TAKAOKA
distributor.
• The Servo Ventilator must be submitted to an annual revision for a new
calibration, performed by a technician authorized by K. TAKAOKA.

Maintenance
10.1.1. Internal rechargeable battery
• For longer battery lifetime, keep the internal battery at its maximum
charge whenever possible. Constant battery discharges reduce its
operating time.
• The internal battery is sealed and does not require maintenance. Should
the battery show any functioning problem, contact the Authorized Technical
Assistance.
• If the battery is not being charged normally, check the voltage in the main
power outlet.
10.1.2. Replacing Fuses

Instructions for fuse replacement (built in the plug)
• Disconnect the ventilator from the main power;

• Remove the cable from the ventilator plug;
• Find the fuse case in the lower part of the plug. Press the lock down at the
center of the fuse case and pull it out;
• Replace the fuses according to their technical specification;
• Replace the fuse case in the plug by pushing it until it is locked;
• Reconnect the cable in the ventilator plug.
Instructions to replace the fuse (individual)
• Insert a screwdriver tip in the fuse case slot;

• Turn the screwdriver fully counterclockwise (do not force) to unlock the fuse
case;
• Pull the fuse case out;
• Replace the fuse according to its technical specification;
• Push the fuse case;
• Turn the screwdriver fully counterclockwise (do not force) to lock the fuse
case;
• Reconnect the cable in the ventilator plug.

Maintenance
ATTENTION
Use original K. TAKAOKA spare parts only. Using non-original parts may put the
patient’s safety in danger.
Do not perform any internal service to Color and do not open its box. Contact an
authorized Technical Assistance to perform any internal maintenance or a
periodic revision.
NOTE
Additional documentation can be provided in order to performing preventive/corrective
maintenance if previously agreed.

Maintenance
10.2. Emergency Actions

In case of an adverse event, K. Takaoka suggests the following procedure:
• Contact the manufacturer (Technical Assistance) and inform the device condition.
Do not perform any test or investigation without the presence of an authorized K.
Takaoka technician.
• Record the manufacturer, model and serial number of all devices involved in the
adverse event. Record this information in the patient case report form and/or in an
incident form. If the device is disposable or has disposable components, also record
the classification number and all numbers of all disposable components. It is
important to keep the device and every component involved in the adverse event.
• Do not clean the device, neither subject it to a chemical or physical process or fix
it. These actions may affect its performance and safe use.
• Record the names of all health professionals present at the incident.
• Identify the device, indicating that it has been involved in an adverse event, the
date of event, and name of the person who tagged the device. Indicate in the tag
that the device must not be used, cleaned, fixed or destroyed without consent from
an authority, such as the risk manager. Should the adverse event involve more than
one device, all involved devices should also be tagged and stored.
• Keep the packaging of all disposable components involved in the event and keep it
with the device. The disposable packaging typically includes not only a recorded
device number but also the batch number. Some specifications included in the
package can also be useful for the investigation.
• Before disconnecting the device from the main power or removing the batteries,
check if the device’s memory will not be lost. Many devices have computerized
memories which can be lost if the batteries are removed or if the device is
disconnected from the main power. Experts can use this memory to specifically
determine when and how the adverse events occurred. Read the instructions

Maintenance
manual or contact your clinical engineer in order to determine which devices have
computerized memories and how they must be controlled following an event.
• Store the device and its components in a safe place to avoid subsequent
damages. This will prevent the device to be put into operation again; protected
rooms and devices may need to be used regardless of a previous incident.

Technical Information
11
11. TECHNICAL INFORMATION
9
1.14.
1.15.
11.1 Packaging / Environmental Use Conditions
11.2 Technical Specifications
11.3 Ventilation Monitor Specifications
11.4 Measurement Methods

11.1. Packaging / Environmental Use Conditions
• Packaging
Individual, developed to support transportation and storage at a temperature from

10ºC to +70ºC, atmospheric pressure from 500 to 1060 hPa and relative humidity
from 10% to 100% (non condensing).
• Environmental Use Conditions
Temperature from 10ºC to +70ºC, atmospheric pressure from 500 to 1060 hPa
and relative humidity from 10% to 100% (non condensing).

11.2. Technical Specifications

• IEC-60601-1:1988+amendment 1994– (Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance)
• IEC 60601-2-12/2001 (Medical electrical equipment - Part 2-12: Particular
requirements for the safety of lung ventilators - Critical care ventilators)
• IEC 60601-1-2/2006 (Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests)
• EN 794-1:1997 +amendment 2000- ( Lung ventilators - Part 1: Particular

requirements for critical care ventilators)
• EN 475:1995- (Medical Device Electrically generated alarm signals)
• ISO 21647:2004 (Medical electrical equipment — Particular requirements for the basic safety
and essential performance of respiratory gás monitors)
• Class 1 Equipment – Internally Powered

• Type B – IPX1 – Continuous operations

Ventilation Parameters
Parameters Range Resolution

Adult Frequency (rpm) 1 to 150 1
Neonate Frequency (rpm) 1 to 180 1
0.10 to 0.70 0.01
Inhalation time (s) 0.70 to 1.00 0.05
1.00 to 15.00 0.10
Oxygen Concentration (%) 21 to 100 1
Maximum limited pressure (cmH2O) 5 to 80 1
Maximum operating pressure (cmH2O) 5 to 100 1
PEEP/CPAP (cmH2O) 0 to 50 1
Support pressure (cmH2O) 0 to 80 1
Support Pressure Cycling (% of inhaling flow) 5 to 80 5
Rise time (s) 0.00 to 0.40 0.05
0FF to 0.70 0.01
Inhaling pause (s) 0.70 to 1.00 0.05
1.00 to 47.10 0.10
150 to 1000 10
Adult tidal volume (ml)
1000 to 2500 50
20 to 150 5
Pediatric tidal volume (ml)
150 to 250 10
Adjusted flow (l/min) 4 to 120 1
Spontaneous flow (l/min) 4 to 180 1
Flow Sensitivity (l/min) OFF, 1 to 30 1
Pressure sensitivity (cmH2O) OFF,-1 to -20 1
Sigh (cycle) OFF, 5 to 100 1
0.3 to 5.0 0.1
Patient Weight (kg) 5.0 to 20.0 0.5
20.0 to 200.0 1.0
0.10 to 0.70 0.01
BIPV Inhalation time (s) 0.70 to 1.00 0.05
1.00 to 10.00 0.10
Base flow (l/min) OFF, 4 to 50 1
MMV Minute Volume (l) 0.50 to 20.0 0.5
Audible alarm muffler 120 fixed

Parameter Range Resolution

PVC Rise time (s) 0 to 0.40 0.05
Recruitment interval (min) OFF, 15 to 120 15
Recruitment Time (s) OFF, 1 to 60 1
Recruitment Pressure (cmH2O) OFF, 1 to 60 1
Rise Time in the Recruitment (% of Recruitment
OFF, 1 to 100 1
Time)
Recruitment Return PEEP (cmH2O) OFF, 1 to 50 1
Recruitment: OFF, ON and Manual NA *
* Not applicable
Table 16 – Ventilation/Range/Resolution Parameters
Nebulizer:
Drug capacity 7 ml
Nebulizing flow Between 5 and 10 l/min, synchronized
with inhalation start.
Table 17 - Nebulizer
TGI
Insufflating flow Between 5 and 10 l/min, synchronized
with exhalation end.
Table 18 - TGI
Special Characteristics
• Reserve modes (backup) for apnea cases;
• LCD display with touch screen function;
• Complete alarm system;
• Curve types: square, decelerated, accelerated and sinusoidal;
• Differential pressure type flow sensor;
• Automatic compensation of respiratory circuit compliance;
• Electronic on/off key;
• Manual, electronic and synchronized inhaling;
• Pressure regulating valves;
• Anti-asphyxia safety valves with resistance between 0.3 and 0.5 (cmH2O/l/min);
• Overpressure electronic valve fixed in the adjusted limit pressure;
• Washing flow in the flow sensor tubes between 2 and 10 (ml/min).

Gases Feeding
Gases oxygen and compressed air

Feeding pressure 50 to 150 PSI (280 to 135 kPa)
Device regulated pressure 35 PSI (241 kPa)
Feeding pressure 50 to 70 l/min
Threaded connection in conformity with NBR12188/2003
regulation
Extension / Hose in conformity with ISO 5359 regulation
Table 19 – Gas Feeding
NOTE:
The COLOR Servo Ventilator is equipped with internal pressure regulating valves and it
can be connected directly to the outlets of hospital gas supply set up according to current
ISO 7396 standard. The installation of an external regulating valve is not recommended.
The inlet gas connections have internal unidirectional valves which ensure a limitation to
“reverse gas flow”.
CAUTION:
Use of a high pressure inlet to the patient side puts the patient at risk.

Electrical Features
Power Supply 110 to 220 VAC with automatic

switching,50/60 Hz main power according
to NBR-13534/95 standard, or external
12VDC 3.0 A battery (for the Ventilator
only, it does not feed the Humidifier)
Main power Connector 3 (three) pin Nema 5-15P type, whose
round central pin is the ground.
Main power inlet fuses 20mm – 3.0 A / 250 VAC glass
Humidifier inlet fuses 20mm - 2.0 A / 250 VAC glass
Internal power supply inlet fuse 20mm - 4.0 A / 250 VAC glass
Ventilator power consumption 50 VA (maximum)
Humidifier power consumption 90 VA (maximum)
Internal battery Sealed, lead/acid, 12 VDC, 9.0 A and 2.7 A
maximum current required during charge
Internal battery runtime Approximately 120 minutes, for average
VCV ventilation condition, tidal volume =
500 ml and respiratory frequency = 12 rpm
Complete battery recharge time Approximately 20 hours,
with the ventilator turned off.
Graphic display High contrast liquid crystal with cold

cathode lamp.
Table 20 – Electrical features
NOTE
The rechargeable internal batteries can only be replaced by authorized K. TAKAOKA
Technical Service.
The hospital electric wiring must be appropriately grounded and according to ABNT NBR
13534 – “Electrical facilities in health care facilities – Safety requirements” standard.
Noncompliance with this recommendation may result in damage to the patient, operator
or equipment, and will void the ventilator warranty.
Others
Conical connections in conformity with ISO 5356 standard
Corrugated tubes in conformity with ISO 5367 standard
Table 21 – Tubes and connections

Dimensions and Weight with mobile base and components:
Height 1445 mm
Width 530 mm
Depth 500 mm
Weight 29 kgf
Table 22 – Dimensions and weight

11.3. Ventilation Monitor Specifications
ATPD Measured Parameters (room temperature and dry pressure)

Parameter Range Resolution Accuracy
Average exhalation tidal volume
100 to 2600 5 ± (15% or 20 ml)
(ml)
Average inhalation tidal volume 20 to 100 ± (50% or 10 ml)
5
(ml) 100 to 2600 ± (15% or 20 ml)
Minute Volume (l) 0.1 to 50 0.01 ± (15% ou 0.5 l/min)
Adult Respiratory Frequency
1 to 150 1 ± (1 s-1 or 10%)
(rpm)
Neonate Respiratory Frequency
1 to 180 1 ± (1 s-1 or 10%)
(rpm)
± (2 cmH2O + 4% of
Maximum inhaling pressure measure)
-30 to 120 1
(cmH2O)
± (2 cmH2O + 4% of
Plateau inhaling pressure
-30 to 120 1 measure)
(cmH2O)
± (2 cmH2O + 4% of
Exhaling end pressure (PEEP) measure)
-30 to 120 1
(cmH2O)
± (2 cmH2O + 4%of
Average inhaling pressure
(cmH2O)
Static pulmonary compliance
(Cstat) 1.00 to 100,00 0.01 ± 10%
(mL/cmH2O)
Dynamic pulmonary compliance
(Cdyn)
1.00 to 100.00 0.01 ± 10%
(mL/cmH2O)
Airway resistance (Raw)
1.0 to 100.0 0.1 ± 10%
(cmH2O/l/min)
Inhalation time (s) 0.01 to 20 0.01 ± 0.2 s
I:E Ratio I6:1to 1:10 0.1 ± 30%
FiO2 (%) 14 to 100 1 ± 5%
EtCO2 (optional) (mmHg) 0 to 100 1 ± 5%
Intrinsic exhaling end pressure
(PEEP) ± (2 cmH2O + 4% of
-30 a 120 1
measure)
(ipeep) (cmH2O)
± (2 cmH2O + 4%of
Occlusion pressure (P0.1)
(cmH2O)
Inhaling effort (WOB) (J/I) 10.00 to 50.00 0.01 ± 10%
Tobin Index (iT) 0 to 200 1 ± 5%
Table 23 - Measured Parameters (Range / resolution / accuracy)

NOTE
The COLOR Servo Ventilator monitors only exhaled tidal volumes above 100ml, due to its
flow sensor sensitivity.
The FiO2 monitor is in accordance with ISO 7767standard.
Numerical Alarms and Adjustments

Parameter Range Resolution
Apnea Time Alarm (s) 5 to 60 1
Audible alarm volume 2 to 10 1
Clock (hours) 0 to 23 1
Clock (minutes) 0 to 59 1
NCAL (don’t calibrate)
Cell calibration with 21% O2 Na
CAL (calibrate)
NCAL (don’t calibrate)
Cell calibration with 100% O2 Na
CAL (calibrate)
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 200 1
High Frequency Alarm (rpm) OFF, 1 to 200 1
Low FiO2 Alarm (%) OFF, 18 to 100 0.1
High FiO2 Alarm (%) OFF, 18 to 100 0.1
Low EtCO2 alarm (optional) (mmHg) OFF, 0 to 100 1
High EtCO2 alarm (optional) (mmHg) OFF, 0 to 100 1
Table 24 – Numeric Alarms and Adjustments (range/resolution)

NOTE
The ventilator alarms system is in compliance with ISO 9703-1, ISO 9703-2, and ISO 9703-3
standards.

11.4. Measurement Methods
NOTE
All calculations are based on flow and distal pressure measurements. The times are taken
from the flow curves, flow integral volumes, pressure curve pressures and compliances,
resistance and work of pressure and flow set.
1.16. Volumes
it
Volumeinh = ∫ Flowinh dt Where “it” is the inhaling time
0
et
Volumeexh = ∫ Flowexh dt Where “et” is the exhaling time
0
8
∑ Volume [n]
n =1
inh
Volumeavg_inh =
8
Volumeminute = Volumeexeh × Frequencyavg
1.17.
1.18. Frequency
∑ Frequency[n]
n =1
Frequencyavg =
8
It is taken from the time measurement elapsed between two inhalation cycles.

1.19. I:E Ratio

1.20.
1.21.
it
I : E = 1÷
et
1.22.
1.23. Inhaling and Exhaling Time
∑ Time [n]
n =1
inh
Timeinh_avg =
8
8
∑ Time [n]
n =1
inh
Timeexh_avg =
8
1.24. Maximum, Average, Plateau and PEEP Pressure
Pressuremax → During the inhaling cycle the largest pressure value read is searched.
Pressureplateau → During the inhaling cycle and after obtaining the largest pressure
value, a pressure stability in a value below Pmax that lasts more than 100 milliseconds
is searched.
PEEP is measured during the exhaling cycle, searching the point where the flow is
smaller than 3 l/min and there is a temporal stability above 200 milliseconds.

N
∑ Pressure [n]
n =1
Pressureavg =
N
Measure from the start of the inhaling cycle (n=1) until the start of the next inhaling
cycle (N).
1.25. Resistance
The Jonson method is used, where:
Pressureinhaling _ end
Resistance =
Flowmaximum_exhaling
1.26. Complacence
Volumeexp
Complacencestatic =
Pressure plateau − PEEP
Volumeexp
Complacence dinamic =
Pressure max − PEEP
NOTE
The static compliance value is shown in the alphanumeric window, however according to
the measurement method of the plateau pressure previously described, this can be the
same as the maximum pressure, and in this case the dynamic complacency value is
shown.
Static Complacence

Dinamic Complacence
1.27. Inhaling Effort

fv
Effort inh = ∫ Pressure_dV Where iv is the initial volume and fv is the final volume
iv
ATTENTION
Excess of noise in the flow measurement line may affect volume calculations.
The Ventilator automatically offsets thermal deviations which result in ± 5 l/min;
above this value, turn the ventilator off and then on.

Manufacturer Guidelines and Statements
12. Manufacturer Guidelines and

12 Statements
12.1 Electromagnetic Emissions
12.2 Electromagnetic Immunity
12.3 Recommended separation distances among mobile
RF communication devices and the Color Servo
Ventilator Model Ventilation System.

12.1. Electromagnetic Emissions
Manufacturer guidelines and statements - Electromagnetic Emissions

The Color Servo Ventilator Model Ventilation System is designed for use in the electromagnetic
environment described below. The client or user of Color Servo Ventilator Model Ventilation System must
ensure that it is used in such environment.
Emission Essays Electromagnetic Environment –guidelines

Conformity
RF Emissions The Color Servo Ventilator
ABNT NBR VentilationSystem uses RF energy only for
IECCISPR 11 its internal functions.
Group 1
However, its RF emissions are very low and
they are not likely to cause any interference
in close electronic equipment.
RF Emissions Class A
ABNT NBR The Color Servo Ventilator Model Ventilation
IECCISPR 11 System is appropriate for use in facilities
directly connected to the public low voltage
Harmonics Class A main power distribution.
Emission
IEC 61000-3-2
Emissions due to In conformity
voltage fluctuation/
scintillation
IEC 61000-3-3
Table 25 - Manufacturer guidelines and statements – Electromagnetic emissions

12.2. Electromagnetic Immunity
Manufacturer guidelines and statements – Electromagnetic Immunity

The Color Servo Ventilator Model Ventilation System is designed for use in the electromagnetic environment described below. The
client or user of Color Servo Ventilator Model Ventilation System must ensure that it is used in such environment.
Immunity Essay ABNT NBR IEC 60601 Conformity Level Electromagnetic

Essay Level Environment - guidelines
Electrostatic Discharge (ESD) + + 6 kV by contact + 6 kV by contact Floors should be made of

IEC 61000-4-2 + 8kV by air + 8kV by air wood, concrete or ceramic.
Should floors be covered with
synthetic material, the relative
humidity should be at least
30%.
Fast electric transients / Pulse + 2 kV in feeding lines + 2 kV in feeding lines

train (Burst) + 1 kV in inlet/outlet lines + 1 kV in inlet/outlet lines
IEC 61000-4-4 Compatibility of power supply

quality with a typical hospital
or commercial environment is
recommended.
Surges + 1 kV line to line + 1 kV line to line Power supply quality should

IEC 61000-4-5 + 2 kV line to ground + 2 kV line to ground be that one of a typical
hospital or commercial
environment.
Voltage drops, short (>95% voltage drop in UT ) by (>95% voltage drop in UT ) by

interruptions and voltage 0.5 cycle. 0.5 cycle.
fluctuations in the inlet feeding Compatibility of power supply
lines (60% voltage drop in UT ) by 5 (60% voltage drop in UT ) by 5 quality with a typical hospital
IEC 61000-4-11 cycles. cycles. or commercial environment is
recommended.
(30% voltage drop in UT ) by (30% voltage drop in UT ) by 25 Should the user of Color
25 cycles. cycles. Servo Ventilator Model
Ventilation System require
(>95% voltage drop in UT ) by (>95% voltage drop in UT ) by 5 continuous operation during a
5 seconds. seconds. power interruption, feeding
the Color Ventilation System
by an uninterrupted power
supply or battery is
recommended.
Magnetic field in the feeding 3 A /m 3 A /m

frequency (50/60 Hz)
Magnetic fields in the feeding
IEC 61000-4-8 frequency should be in levels
characteristic of a typical
location in a typical hospital
or commercial environment.
NOTE UT is the AC feeding voltage before the application of essay level.

Table 26 - Manufacturer guidelines and statements – Electromagnetic Immunity

Manufacturer guidelines and statements – Electromagnetic Immunity

The Color Servo Ventilator Model Ventilation System is designed for use in the electromagnetic environment described below.
The client or user of Color Servo Ventilator Model Ventilation System must ensure that it is used in such environment.
Immunity Essay ABNT NBR IEC 60601 Conformity Level Electromagnetic Environment -
Essay Level Guidelines
It is recommended that no portable and
mobile RF communication equipment
are used next to any part of the COLOR
Servo Ventilator Model Ventilation
system, including cables, within a
separation distance smaller than
recommended, calculated from the
equation applicable to the transmitter
frequency.
Recommended Separation Distance

Conducted RF 3 Vrms 3V
IEC 61000-4-6 150 kHz up to 80 MHz
 3 .5 
d=
 V 1  P
 3 .5 
d=
 E1  P
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 kHz up to 2.5 MHz 7
d=
 E1 P
 
Where P is the transmitter maximum
nominal output power in watts (W),
according to the transmitter
manufacturer, and d is the
recommended separation distance in
meters (m).
It is recommended that the intensity of

the field established by the RF
transmitter, as determined by a local
electromagnetic inspection a, is smaller
than the conformity level in each
frequency range.b
NOTE 1 In 80 MHZ and 800 MHZ the highest frequency range is applied.
NOTE 2 These guidelines may not apply to all situations. The electromagnetic propagation is affected by structures, objects and
people absorption and reflection.
a
The Field intensities established by fixed transmitters, such as base radio stations, telephone (cell phone/wireless) and ground
mobile radios, ham radios, AM/FM radio transmissions and TV transmissions cannot be theoretically foreseen with accuracy.
A local electromagnetic inspection is recommended in order to evaluate the electromagnetic environment due to fixed RF
transmitters. Should the field intensity measurement in the local where the COLOR Servo Ventilator Model Ventilation System is
used exceed the above conformity levels, the COLOR Servo Ventilator Ventilation System model should be checked to note
whether its operation is normal. Should an abnormal performance be noted, additional procedures may be required, such as
rearrangement or moving the COLOR Servo Ventilator Model Ventilation System.
b
Above the 150 kHz frequency range up to 80MHz, the field intensity should be less than [V1] V/m.
Table 27 – Manufacturer guidelines and statements – Electromagnetic Immunity (RF frequency
radio)

12.3. Recommended separation distances among mobile

RF communication devices and the Color Servo
Ventilator Model Ventilation System.
Recommended separation distances among mobile RF communication devices and the Color
Servo Ventilator Model Ventilation System.
The Color Servo Ventilator Model Ventilation System is designed for use in an electromagnetic environment in which radiated RF
perturbations are controlled. The client or user of Color Servo Ventilator Model Ventilation System can help prevent
electromagnetic interference by keeping a minimal distance between the portable and mobile RF communication equipment
(transmitters) and the Color Servo Ventilator Model Ventilation System as recommended below, in accordance with the maximum
output power of the communication equipment.
Transmitter nominal Separation distance according to transmitter frequency

maximum output power (m)
150 kHz up to 80 MHz up to
800 MHz up to
80 MHz 800 MHz
2.5 GHz
W
 3 .5  7
d=
 V 1  P  3 .5 
d=
 E1  P
D=
 E1 P
 
0.01 0.116 0.116 0.23
0.1 0.36 0.36 0.74
1 1.16 1.16 2.3
10 3.6 3.6 7.2
100 36 36 23
For transmitters with nominal maximum output power not listed above, the recommended separation distance d in meters (m) can
be determined by the equation applicable to the transmitter frequency, where P is the transmitter nominal maximum output power in
watts (W) according to the transmitter manufacturer.
NOTE 1 With 80 MHZ and 800 MHZ the highest frequency range is applied.
NOTE 2 These guidelines may not apply to all situations. The electromagnetic propagation is affected by structures, objects and
people absorption and reflection.
Table 28 - Recommended separation distances among mobile RF communication devices and the
Color Servo Ventilator Model Ventilation System.

Warranty Terms
13 WARRANTY TERMS
13.
1.28.
K. TAKAOKA IND. E COM. LTDA. warranties the equipments manufactured against

manufacturing defects in a one-year term from the date of purchase by the first owner.
A list of technical services authorized by K TAKAOKA IND. E COM. LTDA. in the

Brazilian territory and other countries which, in addition to the manufacturer, have
exclusive maintenance rights is provided below. The modification, violation, adjustments
or maintenance by third parties are not authorized.
The equipments manufactured or serviced by K TAKAOKA IND. E COM. LTDA. have a

warranty seal. This warranty becomes automatically voided if the seal is violated.
The inappropriate use of the equipment and/or its use in non-compliance with the
instructions described in this manual, the use of a voltage different from here specified,
and the use of parts and/or components not homologated by K TAKAOKA IND. E
COM. LTDA. result in warranty void.
Damages caused by accidents or natural agents are not part of the warranty, as well as
batteries, fuses and filters.
The items provided with the equipment are listed below, as well as some optional items
and their respective warranty coverage against “manufacturing defects”.

Warranty Terms
CODE Description Warranty

201050025 Color Servo-Ventilator 1 year
202010523 Mobile Base 1 year
446010053 Touch screen 17” graphic monitor 1 year
202011639 Articulated arm 1 year
202011182 3m O2 extension 6 months
202012068 Compressed air extension 6 months
202010614 Compressed air filter 6 months
202011665 400 mm flow sensor tube 3 months
203060031 Luer lock cover 3 months
203100149 Adult flow sensor 6 months
Not
204010146 Operation Manual Available
202011152 Exhaling Valve Diaphragm 3 months
202011669 Silicone adult respiratory circuit 3 months
202011670 Silicone pediatric respiratory circuit (optional) 3 months
202010632 Silicone neonatal respiratory circuit (optional) 3 months
201050003 6060 Heated Humidifier with chamber 1 year
202011938 O2 filter (optional) 6 months
203100150 Pediatric flow sensor (optional) 6 months
202011153 Exhaling valve block (extra) (optional) 6 months
202012085 Cell for O2 measurement with intermediary and cable 6 months
Table 29 – Color Servo Ventilator Components Warranty
The COLOR Servo Ventilator life cycle is estimated by 5 years, and it may vary
depending on how it is used and the adequate preventive maintenance.
Alexandre Rodrigues da Silva

Head Technician
CREA No. 0682082567

K. Takaoka Distributors
BRAZILIAN K.TAKAOKA DISTRIBUTORS

Takaoka International Dealers
TAKAOKA INTERNATIONAL DEALERS

SOUTH AMERICA IMPORTADORA JAEGER S/A BIOLOGIC MEDICAL SYSTEMS
12 Calle 8-53 Zona 01 Poonawala Terrace, Plo # JM711/5
BRASMED S/A – Anesthesia Line Phone: (502) 232-2285 Fax: (502) 251-4137 Offive nº6, Mezzanine Floor
Talcahuano, 958 L. 416 – CF 1013 Email: gmv@jaeger.com.gt New M. A. Jinnah Road
Phone:(54114) 814 – 3677 Fax: (54114) 814 – 3813 GUATEMALA CA – GUATEMALA Phone: (9221) 492-4029
Email: info@brasmed.com.ar Mr. Alexander Huschke Fax: (9221) 412-7459
BUENO AIRES – ARGENTINA – Ms. Ana Magalhães Email: lighting@cubexs.net.pk
KARACHI - PAKISTAN – Mr. Shahid Suri
ING. CARUSO SRL – ICU Line BP EQUIPOS MEDICOS PREMIUM INTERNATIONAL
Burela,1957 (1431) Calle Prof. Camila Henríquez Ureña 27 Nº 7. Esther Avenue
Phone: ( 54114) 522 –1317 Fax: ( 54114) 523-4919 Mirador Norte Park Road. Colombo 5
Email: ing.caruso@ciudadd.com.ar Phone : (809) 535 6112 – Fax: (809) 532 3718 Phone: +94 (0) 11 4 517 736 / 7
BUENO AIRES – ARGENTINA – Ing. Miguel Caruso Email: blas.bonilla@bpmedical.com.do Fax: +94 (0) 11 2 595 521
SANTO DOMINGO – REPÚBLICA DOMINICANA Email : prasantha@premium.lk
Mr. Blas Bonilla COLOMBO – SRI LANKA – Mr. Prasantha
IMPORTADORA FERNANDO CORPORATIVO MEDICO MIDDLE EAST
Calle Tucabaca, Esq. Burapucu Casilla 5 Renan 21/3 Col. Anzures
Phone: ( 5913) 354 – 2525 Fax: ( 5913) 354-2526 Deleg. Miguel Hidalgo WORLD MEDICAL SUPPLIES
Email: imp_fernando@cotas.com.bo Phone: (5255) 5440 3986 Jabal Amman – 3rd Circle
fernando.hurtado@importadorafernando.com.bo Email: corporativokr_medico@yahoo.com.mx Phone: (962 6) 463 5700
SANTA CRUZ – BOLIVIA – Mr. Erwin Hurtado MEXICO CITY – MEXICO – Ms. Karina Reja Rojas Fax: (962 6) 465 9902
Email : world_medical_supplies@hotmail.com
AMMAN – JORDAN – Mr. Nabeel Shannak
MEDI MARK MERCADOTECNICA MEDICA TECNOLOGIA HOSPITALARIA RYM SCORPION MEDICAL
Calle Villalobos nº 526 Avenida 12, Calle 28 Plz Aventura Azarieh Bldg. Block 3 3rd. floor
Savedra ed. Girasoles, piso 1, of. 05A Phone: (506) 223-7446 Fax: (506) 255-3165 Down town Riad El Soloh
Phone / Fax: (5912) 224-6493 Email: thrymsa@racsa.co.cr Phone: 961 – 1 – 973424
Email: medi_mark@yahoo.com SAN JOSE – COSTA RICA - Mr. Roberto Molina Email : m_scorpion@terra.net.lb
LA PAZ – BOLIVIA - Mr. Leopoldo Antezana BEIRUT – LEBANON
INGEMEDICA S.A – ICU Line SINTER S.A ABAJI CO.
Manuel Galecio,231 entre Ximena y Boyacá Rotonda del Periodista, 100mts al sur Eskandaroon Street – POBOX 11096
Phone: ( 5934) 230-3173 / 230-3185 Phone: (505) 2780177 Fax: (505) 278 0252 Phone: (963-21) 228-3216 Fax: (963-21) 224-0042
Fax: (5934) 230-1428 Email: amonge@sinter.com.ni Email: jamilia@net.sy
Email: ingemedica@gye.satnet.net MANAGUA - NICARAGUA - Mr. Alejandro Monge ALEPPO – SYRIA - Mr. Jamal Abaji
GUAYAQUIL– ECUADOR – Mr. Ernesto Rovayo
COMERCIALIZADORA DE PRODUCTOS – FCV DIST. EQUIPOS MEDICOS DIEDA CORPORATION
Calle, 155 A NR. 23-58 Floridablanca Col. Ruben Dario, 2117 P. O. Box 11325 – Sana´s
Phone: (577) 639-6767 Ext. 810 Fax: (577) 639-2595 Phone: (504) 232-3544 Fax: (504) 232-2503 Phone: (967-1) 278 208 Fax: (967-1) 283 805
Email: comercializadora@fcv.org Email: sabillonr@aol.com Email: dieda@y.net.ye
BUCARAMANGA – COLOMBIA – Ms. Geraldine TEGUCICALPA – HONDURAS - Ms. Yma de Sabillon
Gutierrez
BIOXEL S/A ASIA / ÁFRICA EUROPE / EAST EUROPE
Araucana, 1277 CP. 11400 LA BOUVET
Phone: (5982) 606-0172 Fax: (5982) 600-5435 HI-MED EGYPT Av. Bruselas, 38
Email: susanab@bioxel.com 41 El-Montaza St. Phone: (341) 726-4229 Fax: (341) 356-6101
Dra. Mariel Kuehr / Carlos Bonilla Phone: (202) 240-2591 Email: grupacer@teleline.es
MONTEVIDEO – URUGUAY – Ms. Susana Baccino Fax: (202) 635-2977 MADRID – ESPAÑA - Mr. Jorge Perez
Email: hanyhimed@hotmail.com /
service@himed.com.eg
CAIRO – EGYPT - Dr. Hany K. El-Shafei
AREAMEDICA EL BOSQUE, C.A. GR MEDI CORP PROMEI LTDA.
Av. El Carmen, Quinta Torre Lavega, Local nº1, 5, Kaveri Street CP 600073 Rua do Fetal, lote 5 Fornos
Urbanización el Bosque, Municipio Chacao Phone: (9144) 2227-5297 Phone: (3512) 3943-1198 Fax: (3512) 3943-1700
Phone: (58212) 731-3913 Fax: (58212) 731-3928 Fax: (9144) 2227-1206 Email: rcruz@promei.pt
Email: carlosgaravito@cantv.net Email: grmedi@satyam.net.in COIMBRA – PORTUGAL - Mr. Ramos da Cruz
Sr. Carlos Garavito / Abel Maestre GOMATHI NAGAR – CHENNAI - Mr. Krishna Kumar
CARACAS – VENEZUELA
A.JAIME ROJAS S/A PROGRESSIVE MEDICAL CORP. B&MC CARDIO-VOLGA
JR. Garcia Y Garcia, 870 Barranco 29 F/Antel Global Corporate Center nº 3 36, Sverdlov, Volzhsky
Phone: (511) 477-8410 Fax: (511) 477-1316 Dona Julia Vargas Avenue Phone: (7-8443) 31 2221 Fax: (7-8443) 31 2523
Email: import@ajaimerojas.com Phone: (632) 687-7788 Email: irina@bimcvol.vlz.ru
LIMA – PERU - Mr. Juan Santa Cruz Fax: (632) 687-2190 VOLGOGRAD – RUSSIA - Mrs. Irina Khorochoun
Email: hhclim@pmcgroupl.com
PASIG CITY – PHILIPPINES - Mr. Homer C. Lim
ALBUJAR MEDICA S.A.C. BETA MEDICAL ELPAK EOOD
Calle Lãs Palomas 533, Lima 34 12 Ivan Bogorov STR
Phone : (511) 222 5828 Fax : (511) 440 9576 Kompl Bumi Asri BI c/ 32, Medan, Propinsi Phone: (359-52) 602360
Email : albujar@terra.com.pe Sumatera Vtara Fax: (359-52) 699060
LIMA – PERU – Mr. Samuel Albujar Phone: (62 061) 846 5610 Email: elpak@elpak.bg
Email: betamed@cbn.net.id 9002 VARNA – BULGARIA – Mrs. Dora Ivanova
JAKARTA – INDONESIA – Dr. Amiruddin Noer
INTERSERVICE PERU HOSPITAL S.R.L MODUS INTL MESA MEDIKAL URUNLER LTD.
JR. Moquegua 628 Ofic. 301, Lima 24, Naya Paltan Yenisahra Mah. Sutcuyolu Cad. 73
Phone : (511) 423 9755 Fax : (511) 9901 1826 Phone: (880-2) 934-7240 Kat 1 – 2 Yenisahra Kadikoy
Email: interhospital@peru.com Fax: (880-2) 934-0668 Phone: 90 216 470 0564 Fax : 90 21 216 470 0560
LIMA – PERU – Mr. Eliud Sifuentes Lopez Email: modus@hrcworks.com E_mail : osmancakici@mesamedikal.com.tr
CARIBBEAN & CENTRAL AMERICA DHAKA 1000 – BANGLADESH – Mr. Rashid Abdur ISTANBUL – TURKEY – Mr. Osman Cakici
RAF S.A DE CV SIGMA STAR MED LTDA TECHNOLOGY GROUP
Edifício Raf. Km 8, Carretera a Sta Tecla, 1089/1091 Onnuch Road, Suanluang 27, Chaykovskaya str. – Zip Code 61024
Antiguo Cuscatlan, La Libertad. Apto 1940 Phone: (662) 742-1015 Fax: (662) 311-3550 Phone : + 38 057 714 0080
Phone: (503) 2213 3422 Email: starmed@ksc.th.com E_mail : sergey_kutsevlyak@yahoo.com
Email: oscar.leiva@raf.com.sv BANGKOK – THAILAND - Mrs. Kunvadee Egnukal KHARKOV – UKRAINE – Dr. Sergey V. Kutsevlyak
SAN SALVADOR – EL SALVADOR – Mr. Oscar Leiva
EUROTADE IBERICA ETHOS TRADE CONCERN
Aerocaribean, km 1 ½ EPC 7181 POBOX 8975
Phone: (537) 831-9594 Cel: 880-8982 Phone: (977-1) 477205
Email: eurotade@enet.cu Fax: (977-1) 473874 FOR MORE INFORMATION:
LA HABANA – CUBA - Mr. Ignácio Quintero Email: ethos@wlink.com.np R. General Isidoro Dias Lopes, 121
KATHMANDU – NEPAL - Mr. Diwakar Maskey São Bernardo do Campo – SP - Brazil
Phone: (5511) 4176 3560 FAX: (5511) 4176 3536
Email: eroque@takaoka.com.br /
www.takaoka.com.br

K. Takaoka Technical Services
K. TAKAOKA TECHNICAL SERVICES
K. TAKAOKA Indústria e Comércio Ltda. informs that only

its Technical Service Centers are authorized to provide
technical services to the equipment it supplies.
Services provided by third parties imply in serious risks, as

the origin of the parts used is unknown and their labor
force does not comply with the strict standards established
by K. TAKAOKA.
We cannot ensure the appropriate operation by our

equipment if it has been repaired by unauthorized people.
Any requests for technical services and preventive

maintenance services, if by means of an agreement or not,
must be forwarded directly to K. TAKAOKA or to one of its
exclusive authorized distributors.

Authorized K.Takaoka Technical Services
AUTHORIZED K. TAKAOKA TECHNICAL SERVICES

Information for Technical Services
This card is required be completed and returned with the device.
Name:
Hospital:
Address:
Phone: District:
Zip Code: City: State

-
Defect description:
Forward to Technical Assistance K. Takaoka in

agreement with authorized list of representatives K.
Takaoka attached to the manual.
Information for Technical Services

This card is required be completed and returned with the device.
Name:
Hospital:
Address:
Phone: District:
Zip Code: City: State:

-
Defect description:
Forward to Technical Assistance K. Takaoka in

agreement with authorized list of representatives K.
Takaoka attached to the manual.

Manual Operation - Takaoka Color Servo

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Manual Operation - Takaoka Color Servo

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Operation

Equipment Code: 201050025

Product Registration at the Ministry of Health:

• Technical Name: Pressure Pulmonary Ventilator

• IEC-60601-1:1988+amendment 1994– (Medical electrical equipment - Part 1: General

• EN 475:1995- (Medical Device Electrically generated alarm signals)

COLOR SERVO VENTILATOR

Product Installation Form

EQUIPMENT: ___________________________ Code: ____________ Serial Number: _________

DESCRIPTION CODE SERIAL NUMBER

INVOICE: K.Takaoka Original [ ] YES ____________ [ ] NO ______________________

Corporate Name: ____________________________________C.N.P.J*.:_____________________________

City: __________________________________________State:_________ Zip Code: ___________________

Person in charge of the information*:_______________________________Position: ____________________

Sector: ________________________Phone*.: _________________ email: __________________________

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

Installation performed by: ____________________Date ____/ ____ /_____ Signature: ______________

Send this form to Fax + 55 11 4176-3570 or by registered mail to K Takaoka

ATTENTION: THE WARRANTY WILL BECOME EFFECTIVE UPON THE CONFIRMATION OF

COLOR SERVO VENTILATOR

1. OBJETIVO ............................................................ ERRO! INDICADOR NÃO DEFINIDO.

COLOR SERVO VENTILATOR

5.5. SIMV/V – SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION WITH VOLUME

COLOR SERVO VENTILATOR

11. TECHNICAL INFORMATION.................................................................................. 145

13. WARRANTY TERMS.................................................................................................. 165

COLOR SERVO VENTILATOR

TABLE 1A – DEFINITION OF SYMBOLS .............................................................................. 9

COLOR SERVO VENTILATOR

TABLE 26 - MANUFACTURER GUIDELINES AND STATEMENTS –

COLOR SERVO VENTILATOR

FIGURE 1 – MEDICATION NEBULIZER............................................................................. 22

COLOR SERVO VENTILATOR

FIGURE 29 – INCORRECT ASSEMBLY OF THE TEMPERATURE SENSOR IN THE Y

COLOR SERVO VENTILATOR

FIGURE 60 - VSV® MODE – EXAMPLES OF CURVES: PRESSURE X TIME AND

COLOR SERVO VENTILATOR

K. TAKAOKA IND. E COM. LTDA.

The COLOR Servo-Ventilator is a medical device designed to combine the most

2.1. User and Patient Safety

2.1. User and Patient Safety

COLOR must be assembled, handled and operated by qualified and trained

The FULL READING OF THE OPERATION MANUAL is required BEFORE

2.2. Safety Resources

2.2.1. Electromagnetic Susceptibility

•This equipment is not appropriate for use in a magnetic resonance image

2.2.2. Emergency cylinders and gas feeding (not

• Interconnect O2 inlets and compressed air connections located in COLOR rear

• Establish an appropriate cleaning and sterilization procedure for the Servo

• Continuously watch the inhaling pressure gauge for adequate values.

• Carefully read this Operation Manual in order to appropriately use the

authorized K. TAKAOKA distributor immediately, as there are different warranty

• This product was manufactured according to good manufacturing practices

2.3. Definition of Symbols

SYMBOLS / PORTUGUESE SPANISH ENGLISH

Table 1A – Definition of Symbols

TERMINAL OU PONTO TERMINAL O PUNTO DE TERMINAL OR

SIN PROTECCIÓN WITHOUT PROTECTION

IPX1 PROTEGIDO CONTRA

PROTEGIDO CONTRA PROTEGIDO CONTRA

ATENÇÃO! CONSULTAR ATENCION! CONSULTAR ATTENTION! SEE

VENT VENTILADOR VENTILADOR VENTILATOR

CONTRASTE CONTRASTE CONTRAST

CONGELA CONGELA FREEZE

EQUIPMENT: ___________________ Code: Serial Number: _

INVOICE: K.Takaoka Original [ ] YES [ ] NO __________

Corporate Name: ________C.N.P.J*.:_

City: ______________________________________State:_ Zip Code: _______________

Person in charge of the information*:___________Position:

Sector: ________________Phone*.: _ email: __________________

Installation performed by: __________________Date / /_ Signature: ____________