Armstrong Medical AquaVENT FD140 User manual
AquaVENT®FD140
Instructions for use
CRITICAL CARE
The device operates as described in these instructions for use,
enclosed documents and on equipment labelling, provided that it
is assembled, operated, maintained and repaired according to the
enclosed documentation. The device must be inspected at regular
intervals. The device must not be used if found to be defective.
Damaged, missing, clearly worn out, warped or contaminated
parts must be replaced immediately. If a repair is necessary, the
manufacturer and distributor recommend requesting advice via
telephone or in writing from the nearest regional service centre.
Maintenance and repairs must only be carried out at the service
centre or by specialists authorised by the manufacturer. The user
of the device shall have sole responsibility for any malfunction or
damage which is due to improper use, poor maintenance,
improper service, improper repairs or modifications carried out by
unauthorised persons.
The devices are provided with serial numbers. Their code system
includes the product group code, year of manufacture and
ascending production number for unique identification.
75XX1234
XX represents a number which indicates the year of
manufacture:
15 = 2015, 16 = 2016, etc.
Instructions for Use, AquaVENT®FD140, Rev. 12 1
0 Contents
0 Contents 1
1 Introduction 5
1.1 About this manual 6
1.2 Symbols used in the instructions for use and on the device 7
1.3 Abbreviations used in the instructions for use and on the device 8
2 Safety 9
2.1 Safety precautions 10
3 General description 15
3.1 Intended use 16
3.2 Main components 17
3.3 Operation 19
3.4 Operating principle 19
3.4.1 CPAP mode 19
3.4.2 High Flow Oxygen Therapy (HFOT) mode 19
3.4.3 Helmet CPAP mode 19
3.4.4 Paed CPAP mode 20
4 Preparing the device for operation 21
4.1 General information 22
4.2 Power supply 22
4.2.1 Mains supply 22
4.2.2 Rechargeable battery 23
4.3 Gas supply 25
4.3.1 Two-gas operation 25
4.3.2 Single-gas operation 26
4.4 CPAP breathing circuit 26
4.5 CPAP or Paed CPAP with face mask, unheated 27
4.6 CPAP or Paed CPAP with face mask, heated 28
4.7 Nebulised drug delivery 30
4.8 High Flow Oxygen Therapy (HFOT) mode 30
4.9 Helmet CPAP application 32
4.10 Placement of the device 33
0 Contents
2Instructions for Use, AquaVENT®FD140, Rev. 12
5 Operation 35
5.1 Switching power on and off 36
5.2 System test 38
5.3 Mode selection 39
5.4 Standby 41
5.5 Parameter adjustment 42
5.5.1 Changing patient airway pressure during therapy 42
5.5.2 Treatment duration 43
5.5.3 FiO244
5.5.4 Flow adjustment 45
5.6 Patient menu 47
5.6.1 Alarm volume 47
5.6.2 Apnoea alarm 48
5.6.3 P max 48
5.6.4 P min 49
5.6.5 F max 49
5.7 Starting/ending therapy 50
5.8 Activating/deactivating the nebuliser 51
6 Alarms and messages 55
6.1 Alarms 56
6.2 Messages 59
6.2.1 Messages during the system test 60
6.2.2 Messages during the CPAP test 62
7 Cleaning 65
7.1 General information 66
7.2 Cleaning and disinfection 67
8 Maintenance 69
8.1 General information 70
8.1.1 Annual maintenance 70
8.1.2 Maintenance every two years 70
8.1.3 Maintenance every six years 71
8.1.4 Maintenance every 12 years 71
8.2 O2sensor calibration 72
9 Technical specifications 75
9.1 General information 76
9.2 Supply 77
9.2.1 Power supply 77
9.2.2 Gas supply 77
9.3 Technical specifications of the AquaVENT®FD140 78
9.4 Increments and intervals of parameter settings 78
9.5 Default settings 78
1 Introduction
6Instructions for Use, AquaVENT®FD140, Rev. 12
1.1 About this manual
These instructions for use describe the intended use of the following
product:
AquaVENT®FD140 with software version 1.13.0 and hardware version
1.02
For a list of the approved accessories, please refer to chapter 10.2
Accessories.
These instructions for use have been compiled with the greatest care. The
authors are grateful for any advice, suggestions and constructive criticism.
The contact details are stated on the back cover.
The manufacturer reserves all rights regarding the circuit diagrams,
methods used, name and the right to further develop the AquaVENT®
FD140 or to make changes in the interest of technical progress.
1 Introduction
Instructions for Use, AquaVENT®FD140, Rev. 12 7
1.2 Symbols used in the instructions for use and
on the device
Refers to dangerous situations which may occur when
failing to observe the present instructions for use.
Warning
Refers to a situation which may cause injuries to the user or
the patient.
Caution
Refers to a situation which may cause damage to the
equipment.
All warnings and precautions must be read and observed.
Scale for the bar graph indicating patient pressure.
Treatment duration in minutes:seconds
Respiratory rate
Applied flow (symbol below display)
Alarm pause key
Menu key
Measuring line connection (pressure)
Respiratory gas outlet (symbol above tube connection)
Nebuliser port
1 Introduction
8Instructions for Use, AquaVENT®FD140, Rev. 12
Power indicator
Three-level capacity indicator of the rechargeable battery
ON/OFF key
Serial interface
The AquaVENT® FD140 corresponds to Directive
93/42/EEC concerning medical devices, provided it is
operated according to the instructions for use. "0123" is the
identification number of the notified body.
Follow the instructions for use.
The AquaVENT® FD140 must not be disposed of with
ordinary, unsorted household waste but must be treated
separately. Please contact the manufacturer for more
information regarding the disposal of the AquaVENT®
FD140.
1.3 Abbreviations used in the instructions for
use and on the device
AIR
Medical air
O2
Medical oxygen
CPAP
Continuous Positive Airway Pressure,
measured and set CPAP value
PEEP
Positive end-expiratory pressure
FiO2
HFOT
Inspiratory oxygen concentration
High Flow Oxygen Therapy mode
HW
Hardware version
SW
Software version
Ser. No.
Serial number
2 Safety
10 Instructions for Use, AquaVENT®FD140, Rev. 12
2.1 Safety precautions
Reference:
These instructions for use describe the product:
AquaVENT®FD140
CPAP respiratory therapy device
Software version 1.13.0
Hardware version 1.02
Safe operation:
In order to guarantee the safe operation of the AquaVENT®FD140, the
device must only be used as described. Before putting the AquaVENT®
FD140 into operation, users must familiarise themselves with these
instructions for use. Only instructed staff are allowed to use the AquaVENT®
FD140. As a matter of principle, all directions in these instructions for use
and all legal provisions must be observed for the use of this respiratory
therapy device.
Classification:
The AquaVENT®FD140 is a Class IIb device according to Directive
93/42/EEC concerning medical devices, Annex IX, section 1.3, rule 3,
section 3.1, rule 9 and section 3.2, rule 11.
Classification according to EN 60601-1 Medical electrical equipment -
General requirements for basic safety and essential performance:
DEVICE OF PROTECTION CLASS I, with earth conductor for protection
against electric hazards.
CONTINUOUS OPERATION if applied in compliance with the INTENDED
USE and within the indicated temperature limits.
Service and maintenance:
To ensure its safety and proper functioning, the AquaVENT®FD140 should
be checked once every year. Repairs, service and maintenance on the
device must only be carried out by authorised service technicians. For
maintenance intervals and measures to take, please refer to chapter 8
Maintenance.
2 Safety
Instructions for Use, AquaVENT®FD140, Rev. 12 11
Safety functions:
The following safety functions were implemented in the AquaVENT®FD140
in order to warn the user if the patient is at risk:
Device alarms:
Monitoring
Monitoring for
of AIR gas supply,
of O2gas supply
loss of AIR supply,
loss of O2supply
of the sensors
FiO2, flow, pressure
of mains power supply
loss of mains power
of the rechargeable battery
sufficient battery capacity
All device alarms are evaluated during the treatment and in standby mode.
Where necessary, the alarm indication is triggered.
Patient safety:
The patient connected to the device requires surveillance by specialist staff.
If a patient is connected to the system, make sure that the alarm limits are
adapted to the patient condition and the alarms are activated.
Each time the device is turned on, a system test is automatically carried out.
The system test ensures that all safety-related functions and components
are tested before the device is used. For detailed information, please refer
to chapters 5.2 System test and 6 Alarms and messages.
Accessories:
The AquaVENT®FD140 is offered with original accessories. Do not use
accessories other than those specified in chapter 10.2 Accessories. For
details, please refer to chapter 1.1 About this manual.
2 Safety
12 Instructions for Use, AquaVENT®FD140, Rev. 12
Electrical hazard:
The AquaVENT®FD140 is exclusively designed for use in an electrical
environment according to VDE 0100 part 710 or EN 60601-1.
The AquaVENT®FD140 must not be used if there are doubts concerning
the quality and function of the protective earthing of the electrical
installation.
The housing must be dry before the device is connected to the mains
supply. It must be ensured that the supply voltage corresponds to the
ratings on the type plate on the back panel of the device.
The system must be stored and operated at the temperature and humidity
levels indicated in chapter 9. If the housing temperature is higher or lower
than the indicated operating range, wait approx. one hour prior to use to
allow the system to adjust to the room temperature.
The system must always be disconnected from mains supply before any
cleaning, repair or maintenance is carried out.
Fire hazard:
The AquaVENT®FD140 must not be used in potentially explosive
atmospheres or in the presence of flammable anaesthetics.
Risk of electromagnetic disturbance:
Devices which generate electromagnetic field strengths at levels exceeding
the limit values of EN 60601-1-2 and are installed in the vicinity of the
system can affect the safe operation of the device and endanger the
patient.
The use of mobile telephones in the vicinity of the AquaVENT®FD140 can
affect the safe operation of the device and endanger the patient.
Warning
The AquaVENT®FD140 must not be used in close
proximity to nuclear magnetic resonance equipment
(MRI, NMR devices).
Electromagnetic compatibility:
The AquaVENT®FD140 is only intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The users of
the AquaVENT®FD140 can contribute towards avoiding electromagnetic
interference by maintaining the minimum distance between portable and
mobile high frequency communications equipment (transmitter) and the
AquaVENT®FD140.
2 Safety
Instructions for Use, AquaVENT®FD140, Rev. 12 13
Warning
The use of other electrical devices, e.g., power cords,
may result in increased emissions or decreased
immunity performance of the AquaVENT®FD140. This
may put the patient at risk.
Caution
Using other electrical devices with the AquaVENT®
FD140 or in its vicinity can cause interference. The
correct performance of the device must be verified prior
to connecting the patient to the AquaVENT®FD140.
Note
Detailed information on electromagnetic compatibility
can be found in chapter 9.11 Guidance and
manufacturer's declaration.
3 General description
16 Instructions for Use, AquaVENT®FD140, Rev. 12
3.1 Intended use
The AquaVENT®FD140 is a clinical respiratory therapy device which
assists respiration with constant positive air pressure (CPAP and HFOT),
and can be used for administering aerosol medication. The connected
patient (without direct supervision by staff or monitoring equipment) must be
awake and breathe spontaneously. The AquaVENT®FD140 is not a life-
support device.
CPAP therapy can be applied in different modes and via face mask or
helmet. Furthermore, the AquaVENT®FD140 can be used as a flow
generator for High Flow Oxygen Therapy (HFOT) mode.
The AquaVENT®FD140 is designed for use with adults and children greater
than 5 kg in weight.
The AquaVENT®FD140 is equipped with a paramagnetic oxygen sensor.
This sensor continuously measures FiO2, which is displayed on the screen.
The oxygen sensor is maintenance-free and needs to be calibrated only
once a year.
It is also equipped with an internal rechargeable battery with an integrated
mains power failure alarm.
3 General description
18 Instructions for Use, AquaVENT®FD140, Rev. 12
Back:
Display:
Serial
interface
Power input
O2inlet
Type
plate
AIR inlet
Respiratory rate
Patient
airway pressure
(bar graph)
Patient
airway pressure
(set value)
FiO2
Treatment duration
Flow indication
Nebuliser
Battery capacity
indication
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