Taema Neftis ICU Maintenance Manual Sw V1.xx Rev 0 April 2006

Taema

NEFTIS ICU

CONTENTS Preface... 5 Terminology ... 6 Typography ... 7 General safety instructions... 8 1.

operation/description... 10 1.1.

Operating Principle... 10

1.2. Functional Description ... 10 1.2.1. Block Diagram of Operation ... 10 Electronics... 11 Power supply ... 11 Front panel (indicator lights, screen, etc.) ... 11 Pneumatic Mechanism ... 12 Pneumatic Operation... 13 1.2.2. Pneumatic Cabling Diagram... 15 1.3. Description ... 16 1.3.1. Front View ... 16 1.3.2. View of the expiratory unit... 16 1.3.3. Rear View... 17 1.3.4. View from Above ... 17 1.3.5. Blower View ... 18 1.3.6. Inside View of Rear Cover ... 18 2.

Maintenance ... 19 2.1.

Special Tools... 19

2.2. Preventive Maintenance ... 20 2.2.1. Annual Maintenance ... 20 Required spare parts ... 20 2.2.2. 20,000-Hourly Maintenance*... 21 Required spare parts ... 21 Recommended additional spare parts ... 21 2.3.

Disassembly/reassembly protocol ... 22 Notes on how to avoid damaging the connections ... 22 2.3.1. Removing the Rear Cover ... 23 2.3.2. Removing the Battery ... 25 2.3.3. Removing the Top Cover ... 26 2.3.4. Removing the Metal Frame ... 28 2.3.5. Removing the Front ... 29 2.3.6. Replacing the Actuator Board ... 33 2.3.7. Replacing the Power Supply Board... 34 2.3.8. Replacing the Inspiratory Valve ... 37 2.3.9. Replacing the Solenoid Valve Assembly ... 38 2.3.10. Replacing the O2 Proportional Valve ... 39 2.3.11. Replacing the Flow Rate Sensor Assembly ... 40 2.3.12. Replacing the Mixer ... 40 2.3.13. Replacing the Touch Screen ... 41 2.3.14. Replacing the Microprocessor Board ... 44 2.3.15. Replacing the Blower Outlet Filter ... 45 2.3.16. Removing the Blower ... 46 2.3.17. Replacing the O2 Connector Filter ... 47

2.4. Corrective Maintenance ... 48 2.4.1. Alarm Messages... 48 Troubleshooting for alarms 002 and 004... 52 Troubleshooting for alarm 033 ... 52 2.5.

Operation Monitoring and Calibration Protocols ... 54 YM027300 / Revision 0 / April 2006

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2.5.1. Preface... 54 2.5.2. Operation Check ... 54 2.5.3. Additional Checks ... 56 Mixer Airtightness... 56 Inspiratory valve airtightness... 57 Blower ... 58 O2 Cell... 58 Nebulizer ... 58 2.5.4. Maintenance Mode ... 59 Accessing maintenance mode (Calibration) ... 59 Using Maintenance Mode ... 59 Calibrating the machine ... 59 Pressure sensor calibration ... 60 Calibrating the Low-Pressure Sensors (around 100 mbar) ... 60 Calibrating the High-Pressure Sensor (approx. 3.5 bar) ... 62 Calibrating the NEFTIS ICU Flow Rate Sensors... 63 Calibrating the ventilation flow rate sensors ... 64 Calibrating the actuators ... 67 Predictive Maintenance (under development) ... 68 2.5.5. Advanced Maintenance Mode... 69 Accessing Advanced maintenance mode ... 69 Using Advanced Maintenance Mode ... 69 2.5.6. Expert Mode... 72 Introduction ... 72 Access ... 72 Use ... 72 Description ... 74 3.

Bill of Material ... 75 3.1.

Main Components... 75

3.2.

Kits and Miscellaneous Parts ... 80

4.

NEFTIS ICU Recommissioning Sheet... 81

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PREFACE This document is a maintenance manual and is not intended to replace the user manual in any way. The objective of this document is to provide additional information to trained individuals who are both competent and qualified to carry out preventive and/or corrective maintenance on NEFTIS ICU KC023000 units. It contains technical information that is the property of Taema and that may not be divulged without the prior agreement of Taema.

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TERMINOLOGY Warning Notifies the user of the possibility of a minor or serious injury that could arise when handling the ventilator, whether correctly or incorrectly.

Attention Notifies the user of the possibility of a technical problem or malfunction of the ventilator that could arise when handling the ventilator, whether correctly or incorrectly.

Note Highlights a piece of information.

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TYPOGRAPHY Font Lucida Console, bold

Italic Bold, italic

Example

Function

excessive pressure

Text from the screen

See Section 3.1

Text referring to another section of the manual.

Solenoid valve

Text in the index

monitoring patient exhalation

Highlights an important point in a sentence.

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GENERAL SAFETY INSTRUCTIONS

− −

PRECAUTIONS FOR OXYGEN USE No incandescent source nearby No fatty substances.

− − − − −

PRECAUTIONS IN THE EVENT OF AN OXYGEN LEAK No smoking Avoid all sources of flame or spark Close the oxygen supply valve Air the room while there is a leak and for at least 20 minutes afterwards Air one's own clothing.

− − −

−

ELECTRICAL SUPPLY Check that the voltage in the mains plug used correctly corresponds to the electrical characteristics of NEFTIS ICU (indicated on the manufacturer's plate on the rear panel). As NEFTIS ICU has an internal battery, it is preferable to leave the unit plugged into the electrical power supply, with the On/Off switch in the On position in STANDBY mode, to keep the battery charged. If it is stored, the NEFTIS ICU should be charged regularly with the On/Off switch in On position, connected to the electrical power supply, in STANDBY mode, for at least 10 hours, to keep the battery charged. The interval between two recharges must not exceed three weeks (batteries charged), In the event of prolonged storage (more than three weeks), keep the battery disconnected. When returning the unit to service, perform a test of battery characteristics (see Section 2.5.5).

PUTTING NEFTIS ICU IN SERVICE − Before each use, check that the audible and visual alarms (red indicator on keyboard) are operative, and carry out checks as listed in the 'recommissioning' sheet. ELECTROMAGNETIC COMPATIBILITY − NEFTIS ICU conforms to the protection requirements of Directive 93/42/CEE. − NEFTIS ICU operation can be affected by the use of appliances in its immediate proximity, such as diathermic, high frequency electro-surgery units, defibrillators, cell phones or, more generally, by electromagnetic interference that exceeds the levels set by standard EN 60 6011-2. AT HIGH AMBIENT TEMPERATURE − The NEFTIS ICU ventilator heats the respiratory gas by 4 to 6°C above the ambient temperature according to the parameters selected. At ambient temperatures over 35°C, the respiratory gas temperature can exceed 40°C. In this case, the ventilator will trigger an alarm. IN THE EVENT OF OXYGEN SUPPLY FAILURE − In normal operation, the NEFTIS ICU delivers a mixture composed of ambient air and oxygen coming from the central supply or a cylinder, at ratios depending on the FiO2 setting. If the O2 supply fails, the NEFTIS ICU replaces the unavailable oxygen with ambient air. All ventilation parameters are maintained, except for the FiO2, which becomes equal to 21%. An alarm informs you of the situation.

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USING THE NEFTIS ICU In compliance with standard EN 60 601-1 (Appendix A Para. 6.8.2.b): "The manufacturer, assembler, installer or importer only consider themselves responsible for the safety, reliability and characteristics of a unit if the: Assembly, extensions, settings, changes or repairs were carried out by personnel authorized by them, − Electrical installation of the corresponding area is compliant with IEC recommendations, − Unit is used in compliance with the instructions for use. If the accessories used by a user do not conform to the manufacturer’s instructions, the manufacturer is relieved of all responsibility in the event of an incident. If spare parts used during scheduled maintenance do not conform to the manufacturer’s specification, the manufacturer is relieved of all responsibility in the event of an incident. − Ventilation must not be started immediately after storage or transportation under conditions that differ from the recommended operating conditions. − NEFTIS ICU must not be used with inflammable anaesthetic agents or explosive products. − Do not use anti-static or electrically conductive ducts or tubes. − NEFTIS ICU must not be used exposed to direct sunlight. − For correct operation of the NEFTIS ICU, maintain free circulation of air, keeping rear and underneath air inlets completely unobstructed. The manufacturer has anticipated the majority of possible malfunctioning cases for NEFTIS and these are normally covered by the internal monitoring system. It is nevertheless recommended, in case of complete patient dependence, to provide an additional system that is completely autonomous, and which can be used to check the effectiveness of the ventilation, as well as an emergency device, such as a manual IM5 insufflator. CLEANING AND MAINTENANCE OF NEFTIS − Do not use abrasive powders, alcohol, acetone or other easily flammable solvents. − NEFTIS ICU must be checked on a regular basis. To schedule and record maintenance operations, refer to the maintenance sheet in the user manual.

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1. OPERATION/DESCRIPTION 1.1. OPERATING PRINCIPLE The blower is controlled by a microprocessor and is slaved to a volume control unit or a pressure control unit according to the selected ventilation mode. NEFTIS ICU does not generate negative pressure during the expiratory phase. The mixer provides a precise and variable concentration between 21% and 100% oxygen. The O2 concentration of the insufflated mixture is measured by the FiO2 sensor. The expiratory circuit includes: • a two-way patient valve, • an expired gas flow rate sensor (hot wire); • a special trap. The expired gas flow rates are measured by the hot wire sensor whose signal is processed by the electronics to obtain spirometry data.

1.2. FUNCTIONAL DESCRIPTION 1.2.1.

BLOCK DIAGRAM OF OPERATION Mechanism (housing) O2 supply Gaseous mixture

Patient tube V. exp

Flow ctrl

Flow measurement

PEEP control

Ventilation/pneumatic unit

Pressure Flow measure measure ment ment

Mask or probe

Settings: PEEP, Vt, Freq, Alarms, etc.

Microprocessor board Electronics Ventilator µP Monitor µP

Touch screen LEDS

Front panel Mains power supply Battery

Inputs/Outputs Software: Ventilator Monitor

Patient

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Electrical connection Pneumatic connection Mechanical connection Logic connection

Taema

NEFTIS ICU

ELECTRONICS THE MICROPROCESSOR BOARD The microprocessor board consists of two identical central processor units from Motorola, split into two sub-systems: The ventilator: This sub-system is the processor dedicated to ventilation. It integrates the electronic conditioning stages associated with the sensors and the control of the electro-pneumatic components, the audible alarms, a dialog link and the exchanges with the monitor. The monitor: This sub-system is the MMI (Man Machine Interface) dedicated processor. It integrates a screen, the information exchange medium between the user and the NEFTIS ICU and the electronic stages associated with the safety and the redundancy of the controls for certain components and alarms, as a link to the ventilator. THE ACTUATOR BOARD The actuator board includes all the actuator power controls (solenoid valve, valves, blowers, etc.).

POWER SUPPLY The board power supply supplies power to the microprocessor board and to all the pneumatic actuators. This power can be supplied from the mains, from a direct current source connected to the NEFTIS ICU, known as an external DC source, or from the internal backup battery built into the device. The power supply board performs automatic switching between these different power sources and informs the microprocessor board of the power sources available. Linked to this sub-assembly, the internal battery provides a back-up power supply if the two other power sources are lost. However, the microprocessor board has a power supply cut-off command via the internal battery, in case battery protection is necessary.

FRONT PANEL (INDICATOR LIGHTS, SCREEN, ETC.) The NEFTIS ICU screen consists of an LCD colour display equipped with CCFL back-lighting controlled by the processor board. This screen is only visible thanks to its backlighting. The front panel is also equipped with LEDs indicating functions such as alarms and operational modes in NIV (Non-Invasive Ventilation). These displays are implemented on the microprocessor board. The front panel, at MMI level, has an interface with touch keys (touch-screen), a navigation coding wheel allowing the user to set and confirm parameters. Access is also possible by selecting the configuration zone from the touch-screen (dual access).

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PNEUMATIC MECHANISM MECHANICS The pcb supports all the pneumatic components (solenoid valve, valve, flow rate sensor etc.). The pcb is mechanically decoupled from the housing. The blower enclosure unit: The blower associated with an air/O2 mixer is integrated in the rear plate of the housing. The rear cover: covers the blower/mixer assembly and the internal battery unit. The NEFTIS ICU access and interface assembly is located on the rear plate (mains power, external DC, RS232, O2 inlet, etc.). THE COMPLETE PNEUMATIC CIRCUIT The complete pneumatic circuit consists of an assembly of components performing the pneumatic function of the NEFTIS ICU. This simple system is sub-divided into five sub-systems: Mixer: The principle of this sub-system is to provide a precise and variable concentration between 21% and 100% oxygen. Blower: This sub-system facilitates the supply of a gas flow at a given pressure. The inspiratory assembly: This sub-system allows the control of a flow rate or an inspiratory pressure from an assisted valve. The expiratory assembly: This sub-system facilitates the evacuation of an expiratory flow rate with control of the pressure level (PEEP). The electro-pneumatic components (sensors and actuators).

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NEFTIS ICU

PNEUMATIC OPERATION 16 : O2 CELL 17 : I/E cycle management solenoid valve 18 : Solenoid drain valve 19 : Blower outlet flow sensor 20 : Blower outlet particle filter 21 : Insp ∆P pressure sensor 22 : O2 pressure sensor 23 : Nebulizer reducer 24 : Nebulizer solenoid valve 25 : O2 connector 26 : Bacteriological filter 27 : Patient gas temperature sensor 28 : Laminar filter 29 : Blower inlet filter 30 : Ambient air connector 3/2 solenoid valve

1 : Inspiratory valve 4 : PEEP proportional solenoid valve 5 : Blower 6 : Enclosure/Mixer 7 : Expiratory valve 8 : O2 proportional solenoid valve 9 : Expiratory flow sensor (hot wire) 10 : Inspiratory flow sensor (Honeywell) 11 : O2 flow sensor 12a,12b: Pressure sensors 13 : Balloon pressure sensor 14 : Ambient air inlet/safety valve 15 : Air intake 15 b: Air inlet filter

30 15

1

15 B

5

22

29

14

20

26

6 28 11

O2

25

27 12a 12b T

AIR

8

21

4

10

13

O2

16

19 7

N.F

18

9

Patient

17 23

PEEPcircuit

24 Nebulizer circuit

The administering of ventilation cycles to a patient by NEFTIS ICU is the result of action involving three essential components: the pressure generator (the blower), the inspiratory valve (electro-pneumatic) and the PEEP solenoid valve (proportional solenoid valve).

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THE PRESSURE GENERATOR The role of blower (5) is to guarantee the pressurisation required to deliver a ventilation cycle that conforms to the settings. This blower draws the gaseous mixture from enclosure/mixer (6). Via O2 proportional solenoid valve (8) – connected to the network – this mixture can contain a variable rate of oxygen, from 21% to 100%. For the following description of the inspiratory and expiratory phases, it is assumed that blower 5a has pressurized the circuit sufficiently. INSPIRATORY PHASE PEEP proportional solenoid valve (4) is kept open and both I/O solenoid valves (17) and (18) (position open or closed) are closed. The output pressure from the blower is therefore at the level of the expiratory valve and thus seals the part of the circuit located between the patient and the expiratory valve. In other words, the gaseous flow is forced to focus on the patient only and cannot escape into the atmosphere. The inspiratory cycle delivered to the patient is a result of the setting of inspiratory valve (1). If the mode selected is barometric, the inspiratory valve regulates in relation to the pressure sensor which indicates the highest value (12b if 12a is inoperative or inversely). If the mode selected is volumetric, the inspiratory valve regulates in relation to the flow rate sensor which indicates the highest value (10) (19 if 10 is inoperative or inversely). EXPIRATORY PHASE In this phase, a PEEP level must be set. To do this, open at least one of the I/O solenoid valves (17 and 18) in order to lower the pressure applied to the expiratory valve membrane (this same pressure guarantees the leak-tightness of the inspiratory phase) and proportional solenoid valve 4 controls the PEEP level required via pressure sensor P12a. During this time, the inspiratory valve guarantees the flow rate regulation function via sensor (10). This flow rate allows rinsing of the circuit and easier detection of any inspiratory call by the patient. Note During NIV ventilation (thus leakage ventilation), the inspiratory valve can fulfil the additional role of an on-demand valve by adjusting the set pressure level if the leaks are too great. FUNCTION OF THE EXPIRATORY UNIT The expiratory valve is integrated into this unit and a hot wire flow-rate sensor is added to measure the flow-rate exhaled by the patient. The restriction allows a reduction of the sound produced by the expiratory bag in the presence of PEEP. A silicone disc is inserted in the bag to absorb vibrations. The ambient air plug valve enables the patient to breathe through the machine when it is switched off, with a resistance less than 6 hPa.

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1.2.2.

PNEUMATIC CABLING DIAGRAM Rear sheet assembly

Blower

5 25

22

PEEP unit

6 Enclosure mixer

4

18 Safety valve

30

17 4

Flow sensors Block

11

19

Reducer

23

Nebulizer output

24

10

8 13 21 12a 12b

1 Inspiratory valve

Front panel assembly

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1.3. DESCRIPTION 1.3.1.

FRONT VIEW

Touch screen

Mounting knob Milled screw spherical end

Expiratory valve trap

1.3.2.

Milled screw

VIEW OF THE EXPIRATORY UNIT

Exp valve disc

Expiratory valve assembly

Expiratory valve membrane

O-ring O-ring

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Taema 1.3.3.

NEFTIS ICU

REAR VIEW Deflector

Rear cover filter

Power supply connector fuses

1.3.4.

Sub D board RS232 connectors

VIEW FROM ABOVE

Base fan filter

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NEFTIS ICU

BLOWER VIEW Battery blade

Mixer enclosure Blower

1.3.6.

INSIDE VIEW OF REAR COVER

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mounting Battery

Taema

NEFTIS ICU

2. MAINTENANCE 2.1. SPECIAL TOOLS Type of unit

Part No.

Pressure gauge, 0 – 5 bar Class 1 O2 connector disassembly key Siemens test lung Integrator test lung Red restriction for integrator test lung Pressure connector T-fitting Syringe Digital voltmeter External oxygen meter Pressure gauge, 0 – 100 mbar Class 1 3-gas connector monitoring pressure gauge Mixer blanking plate Battery maintenance cable

YA004400 VS206103 KY000600 KY241800

BJ060900 YA017200 YA017300

Type of maintenance 4 Correctiv Annual yearly e X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

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2.2. PREVENTIVE MAINTENANCE 2.2.1.

ANNUAL MAINTENANCE

1- Internal dusting of device 2- Replace the four blue pressure sensor filters 3- Replace the blower output filter 4- Replace the blower dust filters located at the back of the unit 5- Replace the ventilator dust filter underneath the device 6- Replace the oxygen connector check valve end guide 7- Replace the O-rings of the black sleeve on the expiratory unit 8- Replace the expiratory valve membrane and disc 9- Replace the O-ring on the expiratory valve control pressure connector 10- Carry out a check on machine performance Note Whenever an internal component of the NEFTIS ICU is replaced (pressure sensor, flow rate sensors, microprocessor board, blower, etc.) the full adjustment and checking procedure should be carried out.

REQUIRED SPARE PARTS DESCRIPTION

QUANTITY

Acrodisc filters Blower outlet filter Rear cover filter Base fan filter Check valve end guide Sleeve O-ring Sleeve O-ring Exp valve membrane Exp valve disc Exp valve connector O-ring

Standard maintenance time: 3 hours. Equipment downtime: 12 hours.

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NEFTIS ICU ANNUAL MAINT. KIT KC026300

Taema 2.2.2.

NEFTIS ICU

20,000-HOURLY MAINTENANCE*

1- Internal dusting of device 2- Replace the four blue pressure sensor filters 3- Replace the blower outlet filter 4- Replace the blower dust filter located at the back of the unit 5- Replace the fan dust filter underneath the device 6- Replace the oxygen connector check valve end guide 7- Replace the O-rings of the black sleeve on the expiratory unit 8- Replace the expiratory valve membrane and disc 9- Replace the O-ring on the expiratory valve control pressure connector 10- Replace the blower 11- Carry out a check on machine performance

REQUIRED SPARE PARTS DESCRIPTION

QUANTITY

Acrodisc filters Blower outlet filter Rear cover filter Fan filter Check valve end guide Sleeve O-ring Sleeve O-ring Exp valve membrane Exp valve disc Exp valve connector Oring Blower MOLEX housing for female contact

5 1 1 1 1 1 1 1 1 1

NEFTIS ICU 20,000-HR MAINT. KIT KC026400

1 1

Standard maintenance time: 4 hours. Equipment downtime: 12 hours.

RECOMMENDED ADDITIONAL SPARE PARTS DESCRIPTION

REFERENCE

QUANTITY

INTERNAL BATTERY KY569400 LITHIUM BATTERY, 3.6V VS106125 ½ AA OXYGEN CELL YR049700 LCD CCFL KY620500 FLUORESCENT TUBE

1 1 1 1

Note Required spare parts are not include in the maintenance kit. However these parts could be replace in maintenance. Therefore it’s recommended to have them during an intervention. YM027300 / Revision 0 / April 2006

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