fabian HFO Instructions for Use sw 2.0.0 Edition May 2013

Manufacturer: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland

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operating manual fabian HFO

1 Working with the manual The header on each page is for quick orientation  Main chapter  Sub-chapter Left side of the page

Right side of the page... the graphic representations, operating elements and displays belonging to the description and guides the user through any handling steps.

This operating manual describes equipment components and their operation. It is laid out so you may become familiar with the ventilator operation step by step.

ventilator.

Once you are familiar with the basic construction and the operation of the ventilator you may use the

The table of contents will assist you in quickly locating the respective topic. The operating manual is solely intended for customer information and will only be updated or

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Content 1

Working with the manual ... 3 1.1 Notes and Warnings... 8 1.1.1 Identify HW Revision ... 8 1.2

2

3

4

Symbols... 9

General Notices ... 12 2.1

Always Observe ... 12

2.2

Maintenance ... 14

2.3

Liability for Functionality / Damages ... 14

2.4

Intended use ... 15

2.5

Scope of Delivery ... 15

2.6

Contraindications ... 16

System overview ... 17 3.1

Front Connections ... 18

3.2

Rear Panel ( HW rev. ≤ 1.7 ) ... 19

3.3

Rear Panel ( HW rev. ≥ 1.8 ) ... 20

Operation and Display ... 21 4.1 Control options ... 21 4.1.1 Buttons ... 22 4.1.2 Rotary pulse encoder ... 22 4.2 Display concept structure ... 23 4.2.1 Display areas ... 23 4.2.2 Display screen ... 23 4.2.3 Info bar ... 24 4.2.4 Numeric field / Alarm limits... 25 4.2.5 Graphic field ... 26 4.2.6 LED display ... 27 4.3 Ventilation Menu ... 28 4.3.1 Operation General - ... 28 4.3.2 Operation Settings - ... 29 4.3.3 Ventilation parameter dependency ... 30 4.3.4 Locking ventilator parameters... 31

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4.4 Graphics Menu ... 32 4.4.1 Curves ... 33 4.4.2 Loops ... 34 4.4.3 Trend Menu ... 36 5

Preparing for Operation ... 39 5.1

Establish Power Supply ... 39

5.2

Establish Gas Supply ... 39

5.3 Connect tube set ... 40 5.3.1 HFO Tube Set ... 41 5.3.2 Patient circuit assembly ... 42 5.3.3 Recommended positioning of temperature probe of humidifier: ... 43 5.3.4 Use of reusable patient circuit: ... 45 5.4

Connect nCPAP Tubing ... 46

5.5

Switching On device ... 47

5.6

Switching Off device ... 48

6

Device Check fabian HFO ... 49

7

Configurations Menu ... 50 7.1 Calibration ... 51 7.1.1 O2 Sensor Calibration ... 51 7.1.2 Flow Sensor Calibration ... 52 7.2 Display... 53 7.2.1 Touch Screen Settings ... 54 7.2.2 Trend / Graph Display ... 55 7.3 Ventilation parameter settings ... 56 7.3.1 Hospital Settings ... 58

8

7.4

Patient Data ... 59

7.5

Language ... 59

7.6

Date / Time ... 60

7.7

Tools ... 60

7.8

Info ... 61

7.9

Service Mode ... 61

Alarm Limits Menu ... 62

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9

8.1

Automatic Alarm Limits: ... 64

8.2

Alarm Log... 64

Battery Operation ... 65 9.1

Power Failure ... 66

9.2

Operating on External Power Source... 67

10 Function Fields Ventilation Parameters ... 68 10.1

Special Parameters in HFO Mode ... 70

11 Ventilation Modes ... 71 11.1

IPPV ... 72

11.2

SIPPV... 73

11.3

SIMV ... 74

11.4

SIMV + PSV ... 75

11.5

PSV ... 76

11.6

CPAP... 77

11.7

nCPAP / duoPAP ... 78

11.8 HFO ... 79 11.8.1 Special HFO Mode Information ... 80 11.9

O2 Therapy mode (High and Low flow oxygen therapy) HFNC ... 81

11.10 Ventilation Additives... 82 11.10.1 Volume limit ... 82 11.10.2 Volume guarantee ... 83 11.11 Special Functions ... 84 11.11.1 Manual inspiration ( man. Breath ) ... 84 11.11.2 Nebulising medications (option) ... 85 11.11.3 O2 Flush / Preoxygenation ... 86 11.11.4 Standby stopping / pausing mechanical ventilation ... 87 12 Error Cause Solution Alarms ... 88 13 Replacing the Oxygen Sensor ... 91 14 Service and Maintenance Intervals ... 92 15 Sterilisation / Cleaning / Disinfection ... 93

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operating manual fabian HFO

16 Setting Ranges and Parameters ... 95 17 Accessories... 98 18 Practical guide to Neonatal Volume Guarantee Ventilation ... 101 18.1

... 101

18.2

Settings to start with: ... 102

18.3

How to start VG function:... 103

18.4

Setting up the ventilator PSV+VG ... 106

18.5

Settings to start with ... 106

19 Use of NO (Nitric Oxide) ... 108 20 Technical Specifications ... 109 20.1

Ambient Conditions... 109

20.2

Monitoring ... 110

20.3

Measuring ... 111

20.4

Resistance Values ... 112

20.5

Parameter Defaults in Configurations Menu ... 112

20.6

Dimensions / Weight ... 113

20.7

Ratings ... 113

20.8

Data storage ... 114

20.9

Gas blender function ... 114

21 Electromagnetic Compatibility Statement ... 115

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1.1

Notes and Warnings

NOTICE

Notices are supplements to instructions

DANGER

DANGER indicates a not directly imminent but latent hazard which may result in death or bodily injury unless prevented.

Danger ATTENTION

ATTENTION indicates a risk which may result in equipment damage when not avoided.

1.1.1 Identify HW Revision Serial number: xxyyxx-nnnn yy = Hardware Revision

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operating manual fabian HFO

1.2

Symbols

Symbol

Description External power supply input USB connection

Network connection RJ45

Connection for external trigger

Connection for medicine nebulizer

Data input / Data output RS232.

Nurse call signal output

information and precautions

Flow sensor connection

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Potential equalisation connection

Marking per Medical Devices Directive 93/42/EEC Manufacturer / Date of manufacture

Disposal information

Type B application part

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operating manual fabian HFO

Symbol

Description

Unplug power before opening housing

Flammability warning

Warning regarding operation in explosive areas

Dangerous voltage warning

Do not cover

Protect from moisture

Chemical burn warning

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2 General Notices 2.1

Always Observe The use of the ventilator requires detailed knowledge and the observation of this o . This device is only intended for the described use.

Only operate the ventilator with accessories recommended by Acutronic Medical Systems AG.

The ventilator must be operated by qualified technical staff or staff supervised by such to ensure immediate remedial action in the event of malfunction.

An alternate ventilation method (e.g. Resuscitator ) must be available at all times when using the ventilator.

If the life-support function is no longer warranted due to a noticeable ventilator defect, the patient must immediately be artificially ventilated using a stand-alone ventilator (e.g. Resuscitator).

The ventilator may not be used in combination with inflammable gases or narcotic agents there is otherwise an acute risk of fire and explosion!

Never use the ventilator in explosive environments!

An audible signal indicates a system or patient alarm and always requires action by a medical professional.

Never connect the ventilator to patients if an error or malfunction is detected during equipment check!

Never connect to electrical devices not mentioned in this o consulting the manufacturer or an expert.

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without first

operating manual fabian HFO

Never operate the ventilator while covered or set up in a way so as to negatively impact the operation or function.

Always unplug before opening the housing!

Never use anti-static or electrically conductive tubes.

Note: the safety and health of the users is guaranteed by the fact that the products for example do not contain any allergenic or mutagenic materials such as phthalates.

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2.2

Maintenance

This device is a ventilator classified as Class IIb according to the European directive. 



2.3

Inspection as per manufacturer specifications required every 12 months. Maintenance must be performed by Acutronic trained experts with access to



Appropriate test and measuring equipment.

We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service agreements and repairs. Only use original ACUTRONIC parts for repairs. Note chapter

.

Liability for Functionality / Damages

In the event of improper equipment maintenance or repair by any person not associated with ACUTRONIC Medical Systems AG Service or improper use, any and all liability for the functionality is transferred to the owner or operator. ACUTRONIC Medical Systems AG assumes no liability for damages caused by the non-

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observance of preceding notices. The preceding notices do not extend the warranty and liability terms of the ACUTRONIC Medical Systems AG sales terms and delivery conditions.

ACUTRONIC Medical Systems AG

operating manual fabian HFO

2.4

Intended use

Ventilator for premature infants, newborns, as well as children weighting up to 30 kg. The fabian HFO is intended for in-patient use in hospitals, medically-used rooms and intrahospital patient transport. The fabian HFO is an electronically microprocessor controlled ventilator. The fabian HFO Ventilates with excess pressure based on the continuous-flow principle. ( Time cycled, pressure / volume limited ) Oxygen is metered by the integrated Air/O2 blender. The Oxygen concentration is measured internally with a galvanic Oxygen sensor. The ventilator is intended for the following ventilation methods:   

2.5

HFO High frequency oscillation ( membrane principle ) IPPV Intermittent Positive Pressure Ventilation SIMV Synchronised Intermittent Mandatory Ventilation

   



SIPPV Synchronised Intermittent Positive Pressure Ventilation CPAP Continuous positive airway pressure PSV Pressure Support Ventilation SIMV + PSV Synchronised Intermittent Mandatory Ventilation combined with PSV NIV ventilation nCPAP/duoPAP with ®

variable flow generators (Infant Flow , ®



®,

Infant Flow LP , Inspire , Medijet HFNC O2 Therapy, (High and Low flow oxygen therapy)

The equipment is operated by a physician or at his orders by a professional with technical training in this task, whereupon any user must be trained on this equipment and familiar with the o and the use of the equipment. fabian HFO is not approved for use in a homecare environment.

Scope of Delivery

This product includes the following items:        

1 x fabian HFO ventilator ( # 7200 ) 1 x flow sensor ( reusable ) ( # 1031 ) 1 x flow sensor cable ( # 1016 ) 1 x membrane ( # 7006 ) 1 x membrane holder ( # 7007 ) 1 x test lung ( # 1116 ) 1 x Power cable ( # country specific ) 1 x Operating manual ( # country specific )

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2.6

Contraindications

No contra-indications for the use of the fabian HFO neonatal and infant ventilator in an intensive care unit are known. In the event of ventilation for more than several hours, care must be taken for optimal conditioning of the respiratory gases (warmth, moisture) to guarantee secretion mobilization and prevent damage to mucous membranes. In general, it should be noted with regard to contra-indications that ventilation of children should only be carried out by clinically trained specialists who have sufficient knowledge of ventilation at this age. Detailed studies and experience can be requested from the following address:

ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Tel: +41 44 729 70 80 Fax: +41 44 729 70 81

e-mail: [email protected] www.acutronic-medical.ch

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operating manual fabian HFO

3 System overview

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3.1

Front Connections

1

Inspiratory tube port. Centre port for connecting the nCPAP system

2

Expiratory tube port.

3

Pressure measuring tube port Prox.

4

HFO port

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operating manual fabian HFO

3.2

Rear Panel ( HW rev. ≤ 1.7 )

1

Connector for 24V DC external power supply (no charging!)

2

Network jack for data management , PDMS ( For connection to network with minimum 3 KV galvanic isolation )

3

USB port for data output and Software update

4

RS232 port for CO2 Option OR PDMS

5

Flow sensor connector

6

Nurse call connector ( max. switching Voltage 50 VDC )

7

Loudspeaker

8

Fan

9

Optional ports

10

Power Connector ( fuse 1 AT )

11

Pin for potential equalisation

12

O2 supply connector 2.0 6.5 bar / 40 l/min

13

Pressurised air connector 2.0 6.5 bar / 40 l/min

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3.3

Rear Panel ( HW rev. ≥ 1.8 )

1

Connector for 24V DC external power supply (no battery charging !)

2

Network jack for data management , PDMS ( For connection to network with minimum 3 KV galvanic isolation )

3

USB port for data output, Software update

4

RS232 port for PDMS

5

Flow sensor connector

6

Nurse call connector ( max. switching Voltage 50 VDC )

7

Video In , VGA ( option )

8

Loudspeaker

9

Fan

10

CO2 sensor ( option )

11

Nebulizer, ultrasonic ( option )

12

O2 supply connector 2.0 6.5 bar / 40 l/min

13

Pressurised air connector 2.0 6.5 bar / 40 l/min

14

Power Connector ( fuse 1.25 AT )

15

Pin for potential equalisation

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operating manual fabian HFO