Acutronic Medical Systems
fabian Ventilator Systems
fabian Therapy Operators Manual Ver 1.01e Feb 2011
Operators Manual
75 Pages
Preview
Page 1
fabian therapy
Version 1.01e
Manufacturer:
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
0124
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Contents 1
For your safety and that of the patient ... 6 1.1
... 6
1.2
... 6
1.3
Symbols and abbreviations ... 7
1.4 Safety Instructions... 9 1.4.1 Always Observe ... 9 1.5
Service ... 12
1.6
Liability for operation or damages ... 13
1.7 Intended Use ... 14 1.7.1 Medical Purpose ... 14 1.7.2 Contraindications ... 14 1.7.3 Notices for use ... 15 1.7.4 Contents ... 15 2
Control Concept ... 16 2.1
User Interface ... 16
2.2 Display... 19 2.2.1 Bargraph ... 19 2.2.2 Measured Values ... 20 2.2.3 Settings ... 20 2.2.4 Menu... 20 2.2.5 Flow Display ... 20
3
2.3
Menu Structure ... 21
2.4
Respiration Types ... 22
2.5
Curve display ... 23
2.6
O2 Check Sensor / Calibration ... 24
2.7
Alarm Limits... 25
Preparing for Use ... 26 3.1
Connect power supply ... 27
3.2
Connect Gas Supply ... 28
3.3
Connect nCPAP tubing system ... 29
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4
Battery Operation ... 32 4.1 Battery Charge Indicator ... 32 4.1.1 Starting in mains mode ... 32 4.1.2 Starting in battery mode ... 33 4.1.3 Warnings at low battery levels ... 34
5
Start Up and Operation ... 35 5.1 Power on equipment ... 35 5.1.1 Basic settings ... 36 5.1.2 Oxygen sensor calibration ... 39
6
Equipment Check ... 40
7
Respiration Modes ... 41 7.1
O2 Therapy ... 41
7.2
duoPAP ... 43
7.3
nCPAP ... 45
7.4
Manual Breath ... 47
7.5
O2 Flush (Preoxygenation) ... 48
7.6
Suspend respiration (Standby) ... 49
8
Curve Display ... 50
9
Alarms ... 53 9.1
Setting alarm limits ... 53
9.2
Notification & confirming patient alarms ... 55
9.3
Alarm Volume ... 56
9.4
O2 Sensor Alarm ... 57
9.5
System Alarms ... 57
9.6
Disconnection Alarm ... 59
9.7
Alarm priorities ... 60
10 Powering off ... 61 11 Sterilising, disinfecting/cleaning ... 62 12 Error Cause - Correction ... 63 02 / 2011 Vers. 1.01e
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13 Maintenance and Service ... 64 13.1
Service intervals ... 64
13.2
Replacing the O2 sensor ... 64
13.3
Disposing materials ... 66
13.4
Accessories ... 67
14 Statement on electromagnetic compatability ... 68 15 Technical Specifications ... 73
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1 For your safety and that of the patient
1.1
manual
Use of the fabian therapy requires detailed knowledge and absolute compliance with this operating manual. The equipment is only intended for the described use.
1.2 :
Before each process description are abbreviated instructions, a shorter version of the steps to be performed by the user.
The left column below this contains the detailed description of the procedure.
The right column contains the corresponding graphics and displays for clarification.
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1.3 Symbols and abbreviations
Symbol
Description
Unplug equipment prior to opening the housing
General risk warnings
Flammability warning
Warning pertaining to operation in explosive areas
Dangerous voltage warning
Do not cover
Do not use mobile phones
Protect from moisture
Explosion risk warning
Corrosive warning
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General definitions
Description
Inspection
Determining the actual condition
Maintenance
Measures to maintain the target state
Repair
Measures for restoring the target state
Servicing
Inspection, maintenance, repair
PEEP
A PEEP refers to a positive atmospheric pressure artificially produce in the lung during ventilation, which exists in the lung after exhalation (expiration) has completed. This pressure prevents the pulmonary alveoli from collapsing, thus preventing atelectasis. In many cases this allows the oxygen saturation to be improved.
(positive end expiratory pressure)
Flow
Air flow [l/min]
O2
Oxygen concentration
P Insp
Inspiratory pressure
P max
Maximum inspiratory pressure
P mean
Mean airway pressure
I-time
Duration of inspiration
E-time
Duration of expiration
FiO2
Inspiratory oxygen concentration (Fraction of inspired oxygen)
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1.4 Safety Instructions 1.4.1 Always Observe
Use of the fabian therapy requires detailed knowledge manual. This equipment is only intended for the described use.
fabian therapy is only to be used by trained professionals or under their supervision to ensure prompt remedial action in the event of malfunction.
If the rotary encoder is not explicitly pressed by the operator the set value will automatically be accepted after a few seconds.
Always have an alternate method of ventilation accessible (e.g. bag valve mask) when using the fabian therapy.
If the life-support function is no longer warranted due to a noticeable defect in the fabian therapy, the patient must immediately be artificially ventilated using a stand-alone ventilator (e.g. bag valve mask).
Never use the fabian along with flammable gasses or anaesthetics - acute fire and explosion hazard!
Never use the fabian therapy in explosive environments!
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An audible signal indicates a system or patient alarm and always requires action by a medical professional.
An alarm message will appear when changing the power source. This message must be confirmed.
Never connect the fabian therapy to patients if an error or malfunction is detected during equipment check!
consulting the manufacturer or an expert.
Never operate the fabian therapy whilst covered or set up in a way so as to negatively impact the operation or function
Always unplug prior to opening the housing!
Never use mobile phones within 10 metres of the Fabian therapy. 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.
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1.5 Service fabian Therapy is an Equipment Class IIb ventilator per European directive.
1.) The equipment must be inspected every 6 months following the manufacturer instructions.
2.) Maintenance must be performed by trained professionals with the suitable measuring devices and testing device.
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 .
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1.6 Liability for operation or 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 nonobservance 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
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1.7 Intended Use 1.7.1 Medical Purpose fabian therapy for premature infants, newborns and children weighing up to 30 kg.
fabian therapy is intended for the following ventilation methods:
-
O2 ventilatory therapy (oxygen treatment)
-
nCPAP
-
duoPAP
-
non-invasive CPAP
The equipment is operated by a physician or at his orders by a professional with technical training in nual and the use of the equipment.
1.7.2 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
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1.7.3 Notices for use If the life-support function is no longer warranted due to a noticeable defect on the fabian therapy, the patient must immediately be artificially ventilated using a stand-alone ventilator (e.g. bag valve mask).
Routinely monitor oxygen saturation and CO 2 using a capnograph and pulse oximeter or blood gas analysis.
1.7.4 Contents The following are included with this product:
-
Ventilator fabian therapy
-
NIST air adapter
-
NIST oxygen adapter
-
Power cable
-
Trolley (optional)
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2 Control Concept 2.1 User Interface
Key description Calibration This key will open the calibration or settings menu
Curves This key switches to curve display Mode Used to select the respiration mode and home key 02 / 2011 Vers. 1.01e
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Start/Stop This key is used to switch the equipment on and off, and to suspend respiration Cursor up And for administering a manual breath
Cursor down And administering an O2 flush (preoxygenation of max. 2 minutes) Cursor left This key is used for general settings, and also for adjusting the screen contrast (reduce values) Cursor right This key is used for general settings, and also for adjusting the screen contrast (increase value) Limits This key switching to the alarm settings configuration menu MUTE Alarm This key is used to silence the acoustic alarm for 2 minutes
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Special Controls Rotary pulse encoder This rotary pulse encoder combines a push button and a rotary encoder for making various settings
Soft keys These keys feature variable key functions with the meaning for the respective menu displayed at the bottom of the screen.
Display LEDs Warning LED
Battery LED This LED will light red if the battery level is too low Alarm LED This LED will light if an alarm is triggered expires if there are no more alarms requiring confirmation
Cancel alarm LED This LED will light as long as there are still alarms requiring confirmation Start/Stop LED Mains operation LED
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2.2 Display
2.2.1 Bargraph 1: Ventilatory pressure The bargraphs displays the continuously updated current ventilatory pressure.
2: Lower alarm limit P [cmH2O] A symbol indicates the lower limit of the pressure alarm setting.
3: Upper alarm limit P [cmH2O] A symbol indicates the upper limit of the pressure alarm setting.
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2.2.2 Measured Values The measured values screen displays various current measurements according to the respiration type.
2.2.3 Settings The settings screen allows the user to configure various respiration parameters according to the respiration type.
2.2.4 Menu The menu bar indicates the configuration of the various soft keys for the different menu screens.
2.2.5 Flow Display The flow display shows the current flow supplied by the mixer.
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