fabian HFO Instructions for Use ver 2.3e sw 1.2.0.32

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

Using the operating manual Operator manual fabian HFO

1 Using the operating manual The header of each page as a quick guide… • The main chapter • The subchapters

The page… … Instructions and notices pertaining to use feature both text and pictorials, and depending on the topic also any brief instructions on the use. 1-1 Left page section… … Explanations, instructions and detailed description on the topic or procedure.

Right page section … … contains the pictorials for the description, controls and displays, and guides the user through actions.

Using the operating manual Operator manual fabian HFO

1

Using the operating manual

2

The operating manual 2.1

3

4

5.3 Ventilation 5.3.1 Patient Area 5.3.2 Manual Breath HFO 5.3.3 Tube Set 5.3.4 Pressure Unit 5.3.5 Flush Duration 5.3.6 Automatic O2 Calibration 5.3.7 I-Time Configuration 5.3.8 Settings max. time manual breath 5.3.9 Filter volume guarantee 5.3.10 Trigger Mode 5.3.11 Stop criterion PSV 5.3.12 Delay nCPAP Alarm 5.3.13 V-Limit Signal Tone 5.3.14 Hospital Settings 5.3.15 Factory defaults

Notices and Warnings

General Notices 3.1

Always Observe

3.2

Maintenance

3.3

Liability for Functionality / Damages

3.4

Purpose

3.5

Contraindications

3.6

Contents

Operation and Display 4.1 Configuration of the Controls 4.1.1 Control options 4.1.2 Touch-Screen 4.1.3 Keys 4.1.4 Rotary pulse encoder 4.2 Display Layout 4.2.1 Display areas 4.2.2 Display screen 4.2.3 Info bar 4.2.4 Numeric field / Alarm limits 4.2.5 Graphic field 4.2.6 LED display 4.3 Ventilation Menu 4.3.1 Operation – General 4.3.2 Operation – Settings 4.3.3 Ventilation parameter dependency 4.3.4 Locking ventilator parameters 4.4 Graphics Menu 4.4.1 Curves 4.4.2 Loops 4.4.3 Trend Menu

5

6

7

8

5.5

Language

5.6

Date / Time

5.7

Tools

5.8

Info

5.9

Service Mode

5.10

CO2

Alarm Limits Menu 6.1

Automatic Alarm Limits:

6.2

Alarm Log

Function Fields – Ventilation Parameters Special Parameters in HFO Mode

Preparing for Operation 8.1

Establish Power Supply

8.2

Establish Gas Supply

8.3 Connect Tubing 8.3.1 HFO Tube Set

5.1 Calibration 5.1.1 O2 Sensor Calibration 5.1.2 Flow Sensor Calibration

Operator manual fabian HFO

Patient Data

7.1

Configurations Menu

5.2 Display 5.2.1 Touch Screen Settings 5.2.2 Trend / Graph Display

5.4

9

8.4

Connect nCPAP Tubing

8.5

Powering on the Equipment

8.6

Powering Off the Equipment

Battery Operation 9.1

Power Failure

9.2

Operating on External Power Source

15

Sterilisation / Cleaning / Disinfection

10

fabian HFO Equipment Check

16

Setting Ranges and Parameters

11

Ventilation Modes

17

What’s What

11.1

IPPV Ventilation

17.1 Settings Field / Display Field 17.1.1 User options 17.1.2 Touch-Display

11.2

S IPPV Ventilation

11.3

S IMV Ventilation

11.4

SIMV + PSV Ventilation

11.5

PSV Ventilation

11.6

(N)CPAP

11.7

nCPAP / duoPAP

11.8

HFO Ventilation

11.9

Special HFO Mode Information

18

17.2

Ports

17.3

Back Panel

17.4

Symbols

Technical Specifications 18.1

18.2 Parameter Defaults in Configurations Menu

11.10 Ventilation Additives 11.10.1 Volume limit 11.10.2 Volume guarantee 11.11 Special Functions 11.11.1 Manually start inspiration 11.11.2 Nebulising medications 11.11.3 O2 Flush / Preoxygenation 11.11.4 Standby - Halt artificial ventilation 12

Error – Cause – Solution – Alarms

13

Replacing the Oxygen Sensor

14

Service and Maintenance Intervals

Resistance Values

18.3

Accuracy of Measurement Indications

18.4

Dimensions / Weight

18.5

Ratings

18.6

Data storage

18.7

Ambient Conditions

19

Accessories

20

Appendix 20.1

Electromagnetic Compatibility Statement

Using the operating manual Operator manual fabian HFO

2 The operating manual 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.

Please carefully read the operator’s manual before starting to operate the ventilator.

Once you are familiar with the basic construction and the operation of the ventilator you may use the operator’s manual for reference. The table of contents will assist you in quickly locating the respective topic. The operator’s manual is solely intended for customer information and will only be updated or exchanged at the customer’s request.

The operating manual Operator manual fabian HFO

2.1 Notices 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.

The operating manual Operator manual fabian HFO

3 General Notices Also refer to chapter 18.4 for an explanation of symbols

3.1 Always Observe The use of the ventilator requires detailed knowledge and the observation of this operator’s manual. 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. bag valve mask) 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. bag valve mask).

Never use the ventilator along with flammable gasses or anaesthetics – acute fire and explosion hazard!

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!

General Notices Operator manual fabian HFO

Never connect to electrical devices not mentioned in this operator’s manual without first consulting the manufacturer or an expert. 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 mobile phones within 10 metres of the ventilator. Mobile phones may interfere with the function of electro-medical devices.

Never use anti-static or electrically conductive tubes.

Note: to ensure user safety and well-being products e.g. do not contain allergens or genetically harmful substances such as phthalate.

General Notices Operator manual fabian HFO

3.2 Maintenance This device is a ventilator classified as Class IIb according to the European directive. •

•

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 “Maintenance Intervals”.

3.3 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-

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

General Notices Operator manual fabian HFO

3.4 Purpose Ventilator for premature infants, newborns, as well as children weighing up to 30 kg. The ventilator is intended for the following ventilation methods: • • • • •

Intermittent Positive Pressure Ventilation (IPPV) Synchronised Intermittent Mandatory Ventilation (SIMV) Synchronised Intermittent Positive Pressure Ventilation (SIPPV) Continuous positive airway pressure ((N)CPAP) Pressure Support Ventilation (PSV)

• • •

Pressure Support Ventilation (PSV) in conjunction with SIMV NIV mask ventilation nCPAP / duoPAP High frequency oscillation (HFO)

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 operator’s manual and the use of the equipment. fabian HFO is not approved for use in a homecare environment.

3.5 Contraindications There are no known contraindications. Detailed studies and experience are available 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

General Notices Operator manual fabian HFO

3.6 Contents This product includes the following items: • • • • • • • • •

1 x fabian HFO ventilator 2 x Flow sensor 1 x Flow sensor cable 2 x Membrane 2 x Membrane holder 1 x Test lung 2 x InfantFlow supply line 1 x Power cable 1 x Operating manual

General Notices Operator manual fabian HFO

4 Operation and Display 4.1 Configuration of the Controls 4.1.1 Control options The control panel features 2 key elements: 1

The display (Touch Screen)

2

The key/control panel with rotary pulse encoder (combines a key and a rotary encoder)

4-1

4.1.2 Touch-Screen The touch screen allows the direct control of the ventilator by tapping defined buttons on the graphic user interface.

Operation and Display Operator manual fabian HFO

4.1.3 Keys The key pad features 2 rows of keys with various functions. Manual breathing …used to apply a manual breath. O 2 Flush …used to administer an O2 flush. Menu / Calibration …used to access the setting and calibration menus. Pressing once will open the configuration menu; pressing again will open the calibration menu. Nebuliser …switches the optional medication nebuliser on and off. The flow sensor is switched off during medication nebulisation. Curves / Loops …switches to curve-/loop display. Home …displays the main screen for selecting the respiration mode. Alarm limits …switches to the alarm limits configuration. On/Off …used to switch the device on or off. Mute alarm …used to confirm/mute alarms for up to 120 seconds. Subsequent alarms of higher priority will cancel muting. Start/Stop …used to halt or commence respiration.

4.1.4 Rotary pulse encoder The rotary pulse encoder combines a push button with a rotary encoder for executing various settings, selections and confirmation options.

Operation and Display Operator manual fabian HFO

4.2 Display Layout 4.2.1 Display areas The information system features 2 key display areas: 1

The LED display

2

The display screen

4-2

4.2.2 Display screen The display screen shows various information, setting and display fields depending on the display settings or menu: 1

Info bar indicating battery status, time/date, status information, system and alarm information

2

Numeric field / alarm limits

3

Graphic field (single graph or multigraph with loops or curves)

4

Function field

5

Operating mode selection

4-3

Depending on the display mode selected, individual fields may be shown/hidden. Display field options will be described later.

Operation and Display Operator manual fabian HFO

4.2.3 Info bar The Info bar displays from general information to displaying alarms. It is divided into 3 sections.

4-4

The Info bar indicates the following among other things: 4-5

1

2

- Neonatal or paediatric mode - Patient data available - Manual breath in HFO mode ON/OFF - Nurse call active / inactive - Battery charge status – Ventilation mode, info and alarm display

4-6

4-7

– Mute alarm (time remaining until alarm reactivates) - Time / date Paediatric mode 4-8

Neonatal mode 4-9

The patient symbol indicates patient data associated with the current ventilator operation is saved to the device. Ventilation mode / Info / and Alarm display … indicates the current respiration mode and, if applicable, additional current information and notices. A red blinking Info bar also alerts the user to active alarms.

Operation and Display Operator manual fabian HFO

4-10

4-11 4-12

4.2.4 Numeric field / Alarm limits … in numeric mode indicates the measured data relevant in the selected Ventilation mode, as well as the configured limits (if applicable). Depending on the Ventilation mode the data is updated as average/minute or by breath. The upper and lower limits can be manually or automatically adjusted in the alarm limits menu.

4-13

Numeric field

4-14

Alarm limits

Operation and Display Operator manual fabian HFO

4.2.5 Graphic field … displays the current pressure-, volume- or flow

measurements as a diagram. Use “Curves/loops”

to access the graphics menu. Up to three parallel diagrams can be displayed here. You may also switch to loop display mode. In this mode in addition to the loops one of the three line graphs may also be displayed.

4-15

Key A: Display with 3 curves You may also switch to loop display mode. In this mode in addition to the loops one of the three line graphs may also be displayed. LOOP display: • •

Pressure / Volume Volume / Flow 4-16

Key B: Loop display

Operation and Display Operator manual fabian HFO

4.2.6 LED display The LED display

Warning LED This LED will light or blink red when a system alarm is triggered. Battery LED This LED will light yellow in battery operation and green when the battery is fully charged. The LED will blink green when the battery is charging. Mains LED This LED will light green in mains operation, and will switch off in battery operation.

When powered via the external 24 VDC connector the mains and battery LED will not light up.

Operation and Display Operator manual fabian HFO

4.3 Ventilation Menu 4.3.1 Operation – General Push buttons and their statuses are indicated by various colours: 1

light blue: Push button

2

dark blue: focused push button

3

yellow (in functions menu): parameters metered

4

green: selected push button, if the push button features a parameter for setting a value it may now be changed.

5

4-17

4-18

orange: parameter is automatically adjusted by fabian HFO. The value set by the user indicates the maximum value and will not be exceeded.

Depending on the Ventilation mode, the respiration menu indicates the configuration parameters (4) and measurements (5) relevant in the mode. Using the push buttons (2) you may also switch between the pressure-, volume- and flow curve (3). The Info bar (1) indicates current information. The Ventilation mode may be changed in the menu (6).

Operation and Display Operator manual fabian HFO

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