fabian +nCPAP Service Manual Ver 1.9

Manufacturer: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Phone: Fax: E-Mail:

+41 44 729 70 80 +41 44 729 70 81 [email protected] www.acutronic-medical.ch

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

2/81

P REFACE ... 4 FOR YOUR OWN AND YOUR PATIENTS SAFETY ... 5 READ INSTRUCTIONS FOR USE ... 5 WARNINGS ... 6 SYMBOLS AND ABBREVIATIONS ... 7

CMOS H ANDLING P RECAUTIONS ... 10 WARRANTY ... 10 MAINTENANCE ... 11 LIABILITY FOR PROPER FUNCTION AND DAMAGE... 12 INTENDED USE ... 13 CONTRAINDICATIONS ... 13 ADVISE FOR USE ... 13 SCOPE OF SUPPLY ... 14 INTERVALS FOR MAINTENANCE ... 15 FABIAN COMPONENTS ... 17 Y - PIECE / CONNECTION ... 23

R EPAIR INSTRUCTIONS ... 24 SERVICE TOOLS... 24 EXCHANGE OF FUSES ... 26 REPLACING AIR AND O2 INLET FILTERS ... 27 REPLACING OXYGEN SENSOR ... 28 REMOVING THE HOUSING ... 29 REPLACING THE MAINBOARD ... 31 REPLACING AIR / OXYGEN BLENDER ... 33 REPLACING INLET PRESSURE REGULATORS ... 36 REPLACING THE BACKUP LITHIUM BATTERY ... 37 REPLACING THE EXHALATION VALVE MEMBRANE ... 39 REPLACING THE BATTERY CONTROLLER BOARD ... 40 REPLACING THE BATTERY PACK... 41

U PDATE ... 42 SOFTWARE UPDATE... 42 FIRMWARE OVERVIEW... 44 INITIAL OPERATION WITH NEW SOFTWARE ... 47 TROUBLESHOOTING... 49 SYSTEM DIAGNOSIS... 50 TURN OFF SYSTEM ALARMS ... 52 LOAD NEW SW ON BATTERY CONTROLLER BOARD ... 53

C ALIBRATION ... 55 CALIBRATION - TOOLS... 55 USER MANUAL TESTLUNG ... 57 CALIBRATION OF THE EXHALATION VALVE ... 59 CALIBRATION PRESSURE SENSOR ... 60 CALIBRATION THE PROXIMAL SENSOR ON THE BLENDER BOARD ... 61 CALIBRATION INPUT PRESSURE REGULATORS... 63 COMPLETE DEVICE CHECK... 64 SYSTEM - CHECK ... 69 SPAREPARTS ... 70

TECHNICAL DATA ... 77

SETTINGS ... 77 MEASURED PARAMETERS ... 77 DIMENSIONS ... 79 CONNECTIONS ... 79 ENVIRONMENTAL CONDITIONS ... 79

P NEUMATIC SCHEMA ... 80 B LOCK DIAGRAM SUBSYSTEMS ... 81

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

3/81

PREFACE This service manual is intended for use by ACUTRONIC Medical Systems AG trained and authorized service personnel. ACUTRONIC Medical Systems AG does not condone or approve of service activity on its products by other than ACUTRONIC Medical Systems AG trained or authorized personnel and ACUTRONIC Medical Systems AG is not responsible for any unauthorized repairs or modifications, or any repairs or modifications made by unauthorized procedures. Use of the incorrect part, or failure to exercise due care in the installation, removal, servicing, checkout or calibration of parts and equipment or the use of unauthorized accessories, may result in damage to the equipment which may in turn result in damage in property and injury (including death) to persons. The purchaser and installer of these parts shall bear full responsibility and liability for the above. All maintenance performed within the applicable warranty period must be authorized in advance by a ACUTRONIC Medical Systems AG service representative in order to retain the warranty status of the subject unit.

Statements in the operating instructions preceded by words “Warning,” “Caution,” and “Note” carry special significance. The definitions of these words are as follows: WARNING ! Means there is a possibility of injury to oneself or others CAUTION ! Means there is a possibility of damage to the instrument or other property NOTE ! Indicates points of particular interest for more efficient and convenient operation.

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

4/81

FOR YOUR OWN AND YOUR PATIENTS SAFETY Read instructions for use Before the use of fabian neonatal and infant ventilator on a patient read the instructions for use and make sure to proper understand all functions of the equipment. fabian is intended to be used by physicians only or under their direct control or direction. Before attempting to use fabian in an actual life–supporting situation, the operating personnel must become practiced in fabians functions and all effects of the various controls. Please review this manual thoroughly and operate fabian in simulated situations before the dedicated use.

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

5/81

Warnings The use of the fabian presupposes the exact knowledge and attention of this operating instruction. The equipment is intended only for the described use. fabian shall only be used under supervision of qualified personnel to ensure, in case of a malfunction of the equipment, corrective action is taken immediately. When using the fabian in a clinical setting, an independent ventilation method, for example, manual ventilation equipment, must be available at all times. In the case of a visible malfunction of fabian, when its life supporting function is no longer guaranteed, fabian must be replaced immediately by an independent ventilation method such as for example a manual resuscitator. Never use fabian in combination with flammable anaesthetics. fabian is designed for use with air and oxygen only. Acoustic and visible alarms indicate either a patient or a system alarm and require immediate intervention of qualified medical personnel. If during the self-check or system test a failure or malfunction is recognised, under no circumstances fabian should be used on a patient. The use of fabian in conjunction with electrical or electronic equipment others than those mentioned in this manual are not permitted. Contact ACUTRONIC Medical Systems AG in case of special request. It is not allowed to cover or to set up fabian so that its operation is influenced negatively.

Disconnect power cord before open the housing.

To avoid any malfunctions of fabian based on radio frequency, do not use any cellular phone closer than 10m to it. Mobile phones may cause malfunctions to medical equipment.

It is not allowed to use antistatic or electrically conductive hoses.

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

6/81

Symbols and Abbreviations Symbol

Description Read instructions for use To consider Before opening the housing disconnect power cord General warning Warning of inflammability Warning of electrical injury Do not cover Do not use mobile phones

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

7/81

Definition

Description

Inspection

Determination of actual condition

Maintenance

Measurements to maintain working conditions

Service

Measurements to repair equipment

PEEP (Positive End Expiratory Pressure)

This has become an established therapy for patients with ARDS or with flow limitation. Pioneering studies have shown that the application of PEEP in acute lung injury patients undergoing mechanical ventilation improves oxygenation, increases functional residual capacity, and increases respiratory system compliance at moderate levels. It expands the alveoli and prevents atelectasis. PEEP is applied at the end of the expiration cycle,ensuring that the pressure in the airways never drops below a selected level, usually between 5 to 15 cm H2O of pressure. It holds small airways and alveoli open and thereby increase functional residual capacity and limits atelectasis.

DuoPAP Pressure

Pressure level used for NCPAP with intermittant positive pressure breath

MV (Minute volume)

Tidal volume multiplied by respiratory rate. Can be used as a predictor of weaning.

TV (Tidal volume)

The Tidal Volume in the lungs is the amount (volume) of air inhaled and exhaled with each normal breath.

Compliance

Compliance is the term used to describe the relationship between a change in volume and the pressure required to produce that change. It gives information about the elasticity of the lungs.

Static Compliance

The value obtained when compliance is measured at true equilibrium, i.e., in the absence of any motion.

Dynamic Compliance

The value obtained when lung compliance is estimated during breathing.Calculated by dividing the tidal volume by the difference in instantaneous transpulmonary pressures at the ends of the respiratory excursions, when flow in the airway is momentarily zero; this value deviates markedly from static compliance in patients in whom resistances and compliances are not uniform throughout the lung

Resistance

Resistance is a result of friction of gas flow against the air conducting system. It is roughly measured as the change in transpulmonary pressure divided by change in airflow, and is an indicator of airway function.

C20/C

This can be estimated by calculating: ⇒ total compliance of the lung in relation to the compliance of the last 20% of the breath (by dviding tidal volume by peak pressure). If the compliance of the last 20% is less than 80% of the total

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

8/81

compliance, it is suggestive of overdistention, and the ventilator should be adjusted to reach a C20 value higher than 80%. This may be accomplished by decreasing peak inspiratory pressure, inspiratory time and in some instances, PEEP. The C20/C ration quantifies the volume-pressure loop: ratio > 1.0 normal, < 0.8 over distended Leakage

Endotracheal tube leakage

VTe

Expiratory tidal volume

VTe avrg

Averaged exhaled tidal volume

VTi

Inspiratoy tidal volume

Base Flow

Minimum flow, which circulates during exhalation phase in the system

Oxygen

Inspiratory oxygen concentration

MV total

Minute volume of mechanical breath and spontaneous activity

P Insp

Inspiratory pressure

Peak Pressure

Peak inspiratory pressure

Mean Pressure

Mean airway pressure

Trig level

Trigger sensivity; 0 = most sensitive, 10 = least sensitive 5 – 30% of the average of last 5 breath

Trig Vol

Required volume to release mechanical breath

I time

Inspiratory time

E time

Expiratory time

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

9/81

CMOS HANDLING PRECAUTIONS The following precautions must be observed whenever a circuit board or an integrated circuit is handled. Failure to do so may result in serious damage to the fabian. Place fabian and parts on a grounded, conductive work surface Ground yourself (with a strap having about 1 MOhm resistance ) Ground the frame of any test instrument or soldering iron to be used

If any circuit boards are to be stored or transported, enclose them in conductive (anti-static) envelopes

WARRANTY We warrant that this product is free from defects in material and workmanship and, when properly used, will perform in accordance with applicable specifications. If within one year after the original shipment it is found not to meet this standard, it will be repaired, at Acutronic Medical Systems AG option, or replaced at no charge when returned to an Acutronic Medical Systems AG service facility. Any modification to the equipment or rework or repair by other than Acutronic Medical Systems AG approved personnel will render this warranty null and void. Acutronic Medical Systems AG shall not be liable for any indirect, special or consequential damages, even if notice has been given of the possibility of such damages. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. The policy of Acutronic Medical Systems AG is to maintain product repair capability for a period of ten years after the original shipment and to make this capability available at the then prevailing schedule of charge. All maintenance performed within the applicable warranty period must be authorized in advance by a ACUTRONIC Medical Systems AG service representative in order to retain the warranty status of the subject unit

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

10/81

Maintenance fabian is a Neonatal and Infant Ventilator and classified as Il b according all applicable requirements for Medical Products according 93/42 EWG council of European Union dated June 14th, 1993 for Medical Products. 1.) The apparatus must be inspected by experts at regular 6 months interval . 2.) We recommend obtaining a service contract with ACUTRONIC Medical Systems AG exclusive distributor in your country. 3.) Repairs and general overhaul on the apparatus may only be carried out by ACUTRONIC Medical Systems AG Service. 4.) Only original ACUTRONIC Medical Systems AG spare parts may be used for maintenance. 5.) Power connection: The apparatus is to be used only in rooms with mains power supply installations complying with national standards. The standards laid down in IEC-601/1 Safety for Medical Electrical Equipment, are applicable for electrically powered equipment.

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

11/81

Liability for proper function and damage The liability for proper function of the apparatus is irrevocably transferred to the owner or operator to the extent the apparatus has been serviced or repaired by personnel not employed or authorised by ACUTRONIC Medical Systems AG Service or when the apparatus was used in a manner not conforming to its intended use. ACUTRONIC Medical Systems AG cannot be held responsible for damage caused by non-compliance with the above mentioned recommendations. The warranty and liability provisions of the terms of sale and delivery of ACUTRONIC Medical Systems AG are likewise not modified by the recommendations mentioned above. ACUTRONIC Medical Systems AG

Service: measures to maintain desired condition Repair: measures to restore desired condition Maintenance: inspection, service and if applicable, repair

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

12/81

Intended use fabian neonatal and infant ventilator is an intensive care ventilator for premature babies, neonates and infants up to 30 kg bodyweight. fabian + nCPAP incorporates the following ventilation modes: -

Intermittent Positive Pressure Ventilation (IPPV) Synchronised Intermittent Mandatory Ventilation (SIMV) Assist Controlled Ventilation (ASSIST) Continuous Positive Airway Pressure Ventilation (CPAP) Pressure Support Ventilation (PSV) NasalCPAP and DuoPositveAirwayPressure none invasively with mask or prongs

Contraindications There are no contraindications known. For further product information, please contact: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel Switzerland

Advise for use In case of a visible malfunction of fabian, were its proper life support is no longer guaranteed, fabian must be replaced immediately with an independent manual ventilation equipment, such as a for example a resuscitator. During the ventilation, regular blood gas control shall be performed. Continuous supervision of SPO2 and CO2 with pulsoximetry or transcutaneous blood gas monitor is recommended.

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

13/81

Scope of supply The following items are supplied with the standard configuration: -

fabian neonatal and infant ventilator Flow sensor Flow sensor cable NIST adapter “Air” NIST adapter “Oxygen” Power cord Test lung

The following items are additionally available: -

Heated patient circuit Unheated patient circuit Humidifier and accessories Trolley for fabian Water chamber And more

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

14/81

Intervals for Maintenance fabian and accessories must be cleaned and sterilised prior any maintenance or repair work, also in case of returning fabian to ACUTRONIC Medical Systems AG. Every 6 month

Every 12 month

-

Maintenance and electrical safety check with protocol (IEC 601-1) Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Calibration

-

Maintenance and electrical safety check with protocol (IEC 601-1) Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Calibration

-

O2-Sensor O2 inlet filter Air inlet filter

( Art.No.: 7003 ) ( Art.No.: 3697 ) ( Art.No.: 3697 )

If O2-Sensor alarm is displayed, the sensor must be replaced at earliest convenience to assure a proper function of apparatus. Disposal of old sensor like battery according local rules. Every 3 years

-

Air / Oxygen blender Input pressure regulators Lithium battery (PCB ) Lithium battery ( coin ) Battery Pack

( Art.No.: 7078 ) if working hour > 10.000 h ( Art.No.: 7025 ) ( Art.No.: 7043 ) or ( Art.No.: CR2450) ( Art.No.: 7036 )

Repairs and general overhaul of FABIAN shall be carried out by ACUTRONIC Medical Systems AG trained and authorised service personnel only.

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

15/81

WARNING Hazardous voltages exist within the ventilator. Always observe appropriate safety precautions when working on the ventilator while the machine is connected to an electrical power source to prevent possible accidental injurious electrical shock. WARNING After calibration and/or replacement of any assembly(ies), always repeat the complete test procedure according the fabian checklist.

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

16/81

fabian components Rearside

1

Main power supply 100 – 240 V AC

2

Connector for external power supply 12 - 24 V DC

3

Earth connection

4

RS 232 serial port

5

Flow sensor connector

6

Oxygen gas input 2.0 – 6.5 bar

7

Input pressure regulator Oxygen

8

O2 Sensor compartment

9

Input pressure regulator Air

10

Air gas input 2.0 – 6.5 bar Manifold

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

17/81

1

Exhalation valve coil

2

Bleed valve coil

3

Connector to mainboard

4

Pneumatic pressure relief valve

5

To proximal pressure transducer

6

To pressure transducer insp. ( pmix )

7

Demand recoil nozzle

8

To inspiration limb ( with filter )

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

18/81

Connections frontpanel

Mainboard

PC / 104 board

Proximal pressure sensor Connection powermodule

Sensor board

Loudspeaker

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

19/81

PC / 104 board

System EPROM LO

System EPROM HI

S e r v i c e m a n u a l _ f a b i a n _ n C P A P - 1 . 9 - L R . d o c x i n d e x

1 . 9

20/81