Flo Vigaro User manual

Instruction manual FLO Vigaro
Next Generation
English
Rev. 1.0 - July 2018
Vigaro from REV 4.15

Ventilation slot
Equipment handle
Breathing
hose connection
Pressure gauge
hose connection
Beaker
Filter box
Control unit
and display
Air humidifier
cover
Connection
angle
Heating plate
(Rear view of the device see back page)

Instruction manual FLO Vigaro
Next Generation
English
July 2018

Content
5
1Appropriate usage 8
81.1 Purpose
81.2 Contraindications
91.3 Side effects
91.4 Functional description
2Safety 10
102.1 Responsibility of the user / owner
112.2 Safety regulations
122.3 Instructions for use of the FLO Vigaro
3Symbols on the device 14
4Symbols on the packaging 15
5Operation 16
165.1 Display and keys
185.2 Menu sequence when starting up the device
195.3 Quick start instructions
195.4 Starting and stopping therapy
195.5 Ramp
195.6 Humidifier setting
205.7 Therapy displays
215.8 Training mode
6Start-up 22
226.1 Setting up the FLO Vigaro
236.2 Breathing air humidifier
256.3 Breathing hose
266.4 Mask
266.5 Oxygen intake
276.6 Memory card
7Shutdown 27
8Alarms 28
298.1 Medium priority alarms
29Pressure too high 8.1.1
30Pressure too low 8.1.2
31Disconnection 8.1.3
318.2 Power failure
328.3 Low priority alarms
9Help with therapy problems 34

6
Content
10 Cleaning / Disinfection / Processing 36
3610.1 General
3710.2 Summary of cleaning tasks
3910.3 Filter change
4010.4 Processing / Reuse
4010.5 Disinfection
11 Maintenance 41
12 Storage 41
13 Disposal 42
14 Clearance certificate 42
15 Travel / transport 43
4315.1 Checklist
4415.2 Emergency solutions
4515.3 Producer's declaration / Customs
16 Scope of supply 46
17 Approved accessories 46
18 Spare parts 47
19 Declarations regarding electromagnetic compatibility 48
20 Technical data 53
5320.1 Specifications
5620.2 Rate of flow / pressure accuracy
5720.3 Function diagram

The FLO Vigaro are a modular positive airway pressure generator.
The functional design means the machine is easy for patients to use.
The design primarily focused on control engineering, noise insulation and air
filtration.
Problems such as nasal irritation and drying out of the nasal mucous
membranes are prevented by the air humidifier which comes as standard.
The treatment can be smoothly monitored by the compliance memory.
All the important data for the doctor is stored on an SD card.
This instruction manual contains all the information needed to operate the
FLO Vigaro correctly and safely.
7
Introduction

Appropriate usage
8
1 Appropriate usage
1.1 Purpose
The FLO Vigaro is intended for intermittent, non-invasive ventilation of
restrictive, obstructive and neuromuscular.
The FLO Vigaro is intended for use in domestic environments and in medical
facilities / hospitals.
Caution!
The FLO Vigaro device is
unsuitable for use in life-support systems.
1.2 Contraindications
The FLO Vigaro should not be used for some medical conditions, or only with
particular caution. In these cases, therapy with FLO Vigaro remains the
particular decision of the treating doctor. This includes:
-severe skin conditions in the facial area (mask area)
-high risk of the presence of a barotrauma
-cranial or brain injuries with leakage of fluids or ventricular shunts
-pneumothorax / air embolism
-dehydration
-existing systemic myopathy
-physical or mental unsuitability
-anatomical deformity of the face (clefts)
-mask phobia
-acute severe heart failure
-trigeminal neuralgia in the face with clear hyper-sensitivity in the area
of the mask
-severe epistaxis (nosebleeds)
-Status following recent brain surgery

9
Appropriate usage
1.3 Side effects
The following undesirable side effects may occur during short or long-term use
of FLO Vigaro:
-Pressure marks on the face
-Air in stomach / bloating
-Dry nose / throat
-Nose bleeds
-Conjunctivitis/eye irritation
-Runny nose
-Blocked nose
-Fear whilst wearing the mask (claustrophobia)
-Skin irritation / allergic reaction of the skin
1.4 Functional description
Control concept:
The FLO Vigaro operates along the principle of an electric air turbine. The
linearly adjustable positive pressure level of the therapy pressure needed at
any one time is generated with great accuracy.
This is made possible by determining and evaluating pressure values. The
actual pressure is detected directly from the mask system and at the fan. A
flow curve is also calculated.
The measured and calculated parameters allow the control response to be
adjusted exactly to the needs of the patient. This guarantees optimum patient
care at all times.
Air flow concept:
A radial turbine draws ambient air in via a filter. The air is routed via an air
humidifier and through the breathing tube system to the patient's nasal mask.
The pressure gauge hose, which extends into the mask, ensures that the
airway pressure can be measured at all times. The mask pressure is
continuously recorded by the microprocessor and maintained by selective
adjustment of the turbine. Pressure fluctuations caused by respiration can thus
be quickly evened out.

Appropriate usage
10
Air humidification concept:
In the integrated air humidifier the ambient air which is drawn in is passed
across the surface of the water, warming and humidifying it, effectively
preventing the mucous membranes drying out as a result. The individual
humidity level can be adjusted by the patient by setting the heating plate
temperature accordingly.
2 Safety
2.1 Responsibility of the user / owner
The user or owner of this system shall bear sole responsibility for and be liable
for injuries to people or damage to property which can be ascribed to the
following:
- Use of the device in contravention of the operating instructions
- Structural and technical modifications to the system
- Opening of the ventilation device by unauthorised persons
If the safety advice is not followed, this can endanger the user of the device.
It is the user's responsibility to follow the instructions.
Keep the operating instructions near the device.
Caution!
This device should not be modified.

11
Safety
2.2 Safety regulations
Please read these operating instructions through carefully.
They form an integral part of the device and must be available at all times.
Use the device exclusively for the intended purpose as described.
Operating the device:
-Check that the device voltage corresponds to your voltage. The device
can be operated at voltages from 100 V to 240 V. Adjustment to the
available voltage occurs automatically.
-Position the device so that the mains connector can be easily removed
(disconnection from mains power supply).
-The device can also be operated on 12V DC or 24V DC. If so, an
appropriate adapter is required.
-Do not place the device near sources of heat or expose it to direct
sunlight. This can cause the breathing air and internal parts to heat up
further.
-Do not cover the device. The air intake must not be blocked. This may
cause therapy to fail and damage the device.
Caution!
-
Maintain a safe distance between the FLO Vigaro
and other devices that emit high frequency rays
(e.g. mobile phones).
Otherwise malfunctions may occur. For details of
the necessary Distances can be found in the
section “Declarations regarding electromagnetic
compatibility".
-
Please follow the guidance on hygienic use to
prevent infection or bacterial contamination.

Safety
12
Transport:
-Never transport the FLO Vigaro when the beaker is full. The remaining
water may damage the device.
Accessories / spare parts:
-Only use suitable accessories approved by FLO Medizintechnik GmbH.
-Accessories must be complete and undamaged.
-The use of unauthorised accessories can cause malfunctions or even
damage to the device.
Please note that in such cases any claims under the warranty are void.
Maintenance:
-Inspections, repairs and maintenance work must only be carried out by
employees of FLO Medizintechnik GmbH or persons it has authorised
to perform repairs.
2.3 Instructions for use of the FLO Vigaro
Fault-free functioning of the FLO Vigaro device requires high product quality
and correct use. For this reason please pay close attention to the following
pages of the instruction manual. The following must be observed without fail:
-Treatment should only start on medical advice.
-Use the device only when instructed by an authorised person on how
to use the device and accessories.
-Place the device on a flat surface.
-If using the air humidifier system, place the device lower than the
head. This allows condensation to flow back into the air humidifier.
-The device should not be placed near heat sources
(e.g. radiators).
-Do not operate the device in a humid atmosphere (e.g. in a
bathroom).
-Do not place other objects on top and avoid handling liquids near the
device.
-Ensure that there is a free supply of air to the device; do not cover the
ventilation slots.
-Operate the device only with an approved, properly positioned filter.
-Never touch the heating plate when it is still hot (it takes a few
minutes to cool down after the device has been turned off).

13
Safety
-Use only approved accessories, or malfunctions may occur.
-Ensure that an outlet system is always integrated.
-Ensure that the hoses are correctly secured.
-Only use a FLO Vigaro that is working properly.
-Report any faults to your dealer.
-If you do not need the device for several hours, turn it off at the main
switch.
-Clean the entire system regularly, as described in the relevant
instructions.
- Follow the instructions for using the attached accessories.
-Never open the housing.
-Always transport the device when the beaker is completely empty.
If the instructions given are not followed, the user of the device may be at risk.
It is the user's responsibility to follow the instructions. Keep the instruction
manual near the device to ensure correct operation.

Symbols on the device
14
3 Symbols on the device
Protection class II, totally insulated
Protection rating IP 30
- protected against access by a tool
- protection against solid foreign bodies starting at 2.5 mm
- no protection against water
Do not dispose of as household waste
Type B electric shock protection
Caution! Observe the warnings in the operating instructions.
Follow the instruction manual
CE-marking indicating the notified body
Serial Number
Part number and part designation
Name and address of the manufacturer
Beware of hot surface of the heating plate

15
Symbols on the packaging
4 Symbols on the packaging
Fragile, handle with care
Protect from moisture / Keep dry
Limit temperature (storage)
Limit humidity (storage)
Limit air pressure (storage)

Operation
16
5 Operation
5.1 Display and keys
- Training mode
- Previous menu item
- Increase humidifier output
- Change value (+)
Error and
standby display
(yellow / green)
- Start /
Stop key
- Next
menu item
- Ramp
- Reduce
humidifier output
- Change value (-)
- Menu key
- Confirm
alarm
indefinitely
The display shows the current operating status, parameters in the appropriate
menus, and any alarms that occur.
The backlighting of the display is always switched on during standby (no
treatment).
The backlighting stays on for about 1 minute after treatment starts. If a key is
pressed during treatment, the backlighting switches on again for 1 minute.
Additional displays:
Das FLO Vigaro features 2 additional LEDs:
-The green LED is always on when the device is in standby. Once the
motor starts, the green LED goes out.
-The yellow LED is constantly lit up or flashes when an error occurs.

17
Operation
Control panel keys:
The FLO Vigaro has 5 keys in total, with the following functions:
Status
Action
Start / Stop key
Other functions:
Next menu item
Standby
Start therapy
Start the ramp
(Start / Stop key
5 seconds)
Therapy
Stop therapy
Clinical menu
Selection of the next
menu item
Training mode (*)
Other functions:
Previous menu item
Standby
Start training mode
(Hold key down for
5 seconds)
Therapy
Stop training mode
Clinical menu
Selection of the previous
menu item
Increase humidifier
output
Other functions:
Change value (+)
Therapy
Increase humidifier output
Clinical menu
Change value
menu item (+)
Decrease humidifier
output
Other functions:
Change value (-)
Therapy
Reduce humidifier output
Clinical menu
Change value
Menu item (-)
Menu key
Other functions:
Confirm alarm
indefinitely
Therapy
Change the
therapy display
Clinical menu
Exit the
clinical menu
Therapy
Confirm alarm indefinitely
(*) Training mode cannot be activated at this time.

Operation
18
5.2 Menu sequence when starting up the device
The following menu sequence is displayed when the device is first started up, i.
e. is plugged into the mains or connected to a 24 V DC (12 V DC) supply:
Current software revisions and
device identification
Device serial number
Current time on therapy hour
meter (meter operates when
turbine is running).
Operating mode and readiness
display for device (operational
readiness)
If the device was switched off without ending the last treatment by pressing
the Start / Stop key, the next time it is switched on it will immediately start the
therapy again.
Every menu display can be "frozen" by pressing any key, i.e. the current
display will be held for as long as the key is pressed. If no key is pressed, each
menu is displayed for 3 seconds (serial number display 5 seconds).

19
Operation
5.3 Quick start instructions
To operate the FLO Vigaro immediately:
-the device should be plugged into the mains power supply,
-the beaker should be in place and filled with water as necessary,
-the breathing hose should be connected to the mask and device,
-the pressure gauge hose should be connected to the FLO Vigaro,
-and the patient should be wearing the mask.
Therapy can now be started by pressing the Start / Stop key. Adjust the
humidifier setting by pressing the appropriate keys.
Press the Start / Stop key again to stop therapy.
5.4 Starting and stopping therapy
If the device is in Standby mode, start therapy by pressing the Start / Stop
key. The turbine will immediately start up, and the display will show the
current actual pressure.
Press the Start / Stop key to stop the device during therapy Start / Stop key.
The turbine will immediately stop, and the display will revert to Standby.
5.5 Ramp
When the device is in standby mode, the ramp function can be Start / Stop key
activated using the Start / Stop key (hold key down for 5 seconds). The display
will show the current actual pressure and the remaining ramp time.
5.6 Humidifier setting
The humidifier setting can be adjusted during therapy by using the two
humidifier keys.
If one of the two keys is pressed during therapy, the display will initially only
show the current setting only. Press either of the two keys again to change the
current setting.

Operation
20
The following values are possible:
OFF The heating plate will not be heated (no heat output).
1 – 9 Level of humidifier output, where 1 is the lowest
and 9 is the highest level.
During treatment, the display of the humidifier setting disappears again after
2 sec (no key pressed) and the current therapy display is shown.
We recommend starting with a setting of 3. If further problems (e.g. with a
runny nose) occur, you can increment the setting a point at a time until you
find the optimum setting. At high humidities, problems can arise due to water
condensing in the mask and hose. In this case we recommend the use of a
heated hose system. Please contact your supplier to order this.
5.7 Therapy displays
The FLO Vigaro has 3 different therapy displays.
Therapy display 1
(default)
Current target pressure
Bar display for actual pressure / current pressure
- Current pressure display
Display of current target and actual pressure
+ bar display
Therapy display 2
Tidal volume Breathing rate
Inhalation time Breathing I/E ratio
- Tidal volume
Displays current tidal volume
-
Tidal volume not active or
could not be determined
=
current tidal volume in the range of
tidal volume Vt - tidal volume Vt + 20%