Flo Vigaro Instruction Manual

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Page 1

Instruction manual FLO Vigaro Next Generation

English Rev. 1.0 - July 2018

Vigaro from REV 4.15

Page 2

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)

Page 3

Instruction manual FLO Vigaro

Next Generation

English

July 2018

Page 4

Page 5

Content

3 4 5

7 8

Appropriate usage

Safety

Symbols on the device Symbols on the packaging Operation

Start-up

Shutdown Alarms

Help with therapy problems

81.1 Purpose

81.2 Contraindications

91.3 Side effects

91.4 Functional description

102.1 Responsibility of the user / owner

112.2 Safety regulations

122.3 Instructions for use of the FLO Vigaro

14 15 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

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

27 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

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Content

11 12 13 14 15

16 17 18 19 20

Cleaning / Disinfection / Processing

Maintenance Storage Disposal Clearance certificate Travel / transport

Scope of supply Approved accessories Spare parts Declarations regarding electromagnetic compatibility Technical data

3610.1 General

3710.2 Summary of cleaning tasks

3910.3 Filter change

4010.4 Processing / Reuse

4010.5 Disinfection

41 41 42 42 43

4315.1 Checklist

4415.2 Emergency solutions

4515.3 Producer's declaration / Customs

46 46 47 48 53

5320.1 Specifications

5620.2 Rate of flow / pressure accuracy

5720.3 Function diagram

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Introduction

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.

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Appropriate usage

Caution!

The FLO Vigaro device is unsuitable for use in life-support systems.

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.

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

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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.

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Appropriate usage

Caution!

This device should not be modified.

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.

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Safety

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.

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.

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Safety

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).

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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.

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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

3 Symbols on the device

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4 Symbols on the packaging

Fragile, handle with care

Protect from moisture / Keep dry

Limit temperature (storage)

Limit humidity (storage)

Limit air pressure (storage)

Symbols on the packaging

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Operation

- 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

5 Operation

5.1 Display and keys

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.

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Control panel keys:

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

The FLO Vigaro has 5 keys in total, with the following functions:

Operation

(*) Training mode cannot be activated at this time.

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Operation

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)

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:

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).

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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.

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Operation

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%

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.

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Operation

- Tidal volume

current tidal volume < Tidal volume Vt

current tidal volume > tidal volume Vt + 20%

- Breathing rate

Displays current breathing rate

- Inhalation time

Display of current measured Inhalation time

- Breathing I/E ratio

Displays current I/E ratio

Therapy display 3

Current leakage

Current flow

- Current leakage

Displays current leakage

- Current flow

Displays current flow

The therapy displays can be shown in succession during treatment by briefly pressing the Menu key. Therapy display 1 is always shown first whenever a treatment is started.

5.8 Training mode

Training mode cannot be activated at this time.

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Start-up

6 Start-up

6.1 Setting up the FLO Vigaro

The best position for the device is below head level when the patient is lying down. However, for hygiene reasons the therapy device should not stand on the floor. A lower position allows any condensation in the hose to simply flow back into the air humidifier. Keep the FLO Vigaro out of direct sunlight and away from heat sources and humid atmospheres. The FLO Vigaro does not need cleaning before initial use.

Mains connection 100 - 240 V

Take the mains lead supplied and plug it into the device socket. Insert the other end into a mains socket. The device will detect the mains voltage automatically.

The FLO Vigaro can now be switched on at the mains.

If the mains switch is always on, electricity is also consumed when the device is not in use. To keep power consumption as low as possible the equipment should be switched off at the mains when not in use.

Operation with 12 V DC or 24 V DC

An additional adapter, which produces the required voltage of 24 V DC, is needed when operating using 12 V DC. The corresponding plug is plugged into the equipment's socket for both voltages. In this case the equipment does not have to be switched on at the mains, it is immediately ready for use.

The humidifier lid must be fully inserted in the beaker. Before start-up also check that the two components have been placed on the heating plate and into the retaining brackets. If this is not the case, first switch the device off. The device is switched on after correct installation, and the display then reads "Standby". Connect a suitable hose system and mask to the device. Also connect the pressure gauge hose to the FLO Vigaro.

The FLO Vigaro is now ready for use.

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Start-up

To fill the beaker, first detach all hoses from the device.

The air humidifier lid and the beaker connected to it can now be lifted out of the device.

Take the humidifier lid off the beaker by twisting lightly.

The beaker can now be filled with water. Here the two limits, minimum 100 ml, maximum 300 ml should be observed. Use boiled water to avoid calcification.

6.2 Breathing air humidifier Fill with water:

The humidifier is a standard part of the FLO Vigaro. It consists of 3 parts: the heating plate, the beaker and the humidifier lid.

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Start-up

Put the humidifier lid back on the beaker. Put the beaker with the lid on back in the device. When doing so, the air humidifier lid must snap into both retaining brackets and be positioned straight on the connecting joint.

Caution!

The heating plate can become very hot.

Never transport the therapy device when the beaker is full.

Do not pour water into the connecting joint, i.e. into the therapy device.

When filling the beaker and fitting the humidifier lid with beaker, please take care that water does not spill into the device.

Minimum fill level 100 ml, maximum fill level 300 ml water

Power:

At room temperature, if the air humidifier is set to level 9 and a pressure of 10 hPa (≈ cmH2O), approx. 200 ml of water will be used for 6 hours of therapy. The humidifier unit takes about 15 minutes to warm up. The maximum air temperature of the humidifier is approx. 40°C.

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Start-up

This pressure gauge hose must be connected to the pressure gauge hose connection on the equipment.

The other end of the pressure gauge hose should extend almost as far as the mask.

Caution!

There must be no water or other particles in the pressure gauge hose.

If there is water or dirt in the pressure hose, these can be removed by blowing them out (e.g. with an air pump).

6.3 Breathing hose The FLO Vigaro will only function with breathing hoses which have an internal

pressure gauge hose.

The breathing hose must be replaced if the pressure gauge hose is too short. The breathing hose should be checked for damage before any treatment starts. The breathing hose must be replaced if it is damaged.

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Start-up

Caution!

There is a risk of fire if released oxygen gets into the device or comes into contact with hot objects.

The oxygen intake must be at the end of the hose system.

6.4 Mask

Please consult the latest instruction manual before using the mask and / or outlet system.

6.5 Oxygen intake

Oxygen should be introduced via an additional item of equipment close to the mask. The following points must be borne in mind regarding oxygen therapy:

In oxygen therapy the oxygen concentration inhaled is

dependent on:

Breathing pattern Amount of oxygen supplied Pressure setting Mask system Leakage

If oxygen is supplied, the therapy device must deliver air to prevent

oxygen from getting into the device. If using oxygen therapy, check the surrounding area for ignition

hazards.

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Start-up

6.6 Memory card

The memory card stores treatment data, which can be evaluated by the doctor. This memory card should only be removed when requested. The memory card is not suitable for other devices and may no longer function in the FLO Vigaro after being used in other devices.

If you are asked to remove the memory card, you can remove it from the

device once the device has been switched off.

To remove the card press down on it with an implement such as a ballpoint pen. It will now partially eject from the device and can be removed.

When reinserting the memory card in the device, make sure it is properly positioned (bevelled edge towards device, lettering facing outwards, away from mains connection).

The card must snap into place in the slot. You can use a ballpoint pen again, as when removing the card, to push it home.

7 Shutdown

To shut down the device safely, perform the following actions:

- Switch off the device at the mains switch

- Remove the water from the beaker

- Detach the accessories from the device (breathing hose, mask)

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Alarms

Priority

Visible display

Acoustic signal

Low

yellow LED is constantly lit up

Pulse repetition

Medium

yellow LED flashes

Pulse repetition

High

There are no high priority alarms.

8 Alarms

The device is equipped with various alarms to warn the user / patient about errors in operation or device faults. Alarm settings cannot be changed.

All alarm messages include numbers at the bottom, which are used as a code for the alarm.

Alarms are divided into three groups:

If more than one fault occurs at the same time, only the first fault will be displayed.

Should alarms persist despite the fault having been corrected, please contact your dealer.

The alarm system should be tested at regular intervals as part of a function test. Consult the service manual regarding instructions for this test.

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8.1 Medium priority alarms

Alarm

Actual pressure value too high (C30)

Display Alarm

Actual value exceeds set target value by 20%

Delay

Cause of alarm present for at least 2 seconds

Acoustic alarm

Medium priority

Visible alarm signal

Yellow LED flashes

Possible cause

Hose system blocked

Deactivate

It is not possible to deactivate the alarm.

Comment

The device switches off automatically. No further operation possible.

8.1.1 Pressure too high

Alarms

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Alarms

Alarm

Actual pressure value too low (C31)

Display Alarm

Actual value is below set target value by 20%

Delay

Cause of alarm present for at least 10 seconds

Acoustic alarm

Medium priority whilst cause of alarm present

Visible alarm signal

Yellow LED flashes

Possible cause

- Hose system not properly connected

- Major leakage occurring

Deactivate

The acoustic alarm can be confirmed indefinitely by pressing the menu key. This deactivation ceases when the therapy ends or if the cause of the alarm is no longer present.

Comment

The device does not switch off.

As soon as the fault is corrected, the alarm disappears from the display, and there is no more acoustic signal.

8.1.2 Pressure too low

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8.1.3 Disconnection

Alarm

Disconnection error (C13)

Display Alarm

No pressure build-up

Delay

Cause of alarm present for at least 10 seconds

Acoustic alarm

Medium priority whilst cause of alarm present

Visible alarm signal

Yellow LED flashes

Possible cause

- Hose system not connected properly

- Major leakage occurring

Deactivate

The acoustic alarm can be confirmed indefinitely by pressing the menu key. This deactivation ceases when the therapy ends or if the cause of the alarm is no longer present.

Comment

The device does not switch off.

As soon as the fault is corrected, the alarm disappears from the display, and there is no more acoustic signal.

Alarms

8.2 Power failure If the power supply to the device fails during therapy (e.g. due to an outage or

disconnection of the mains cable), this is indicated by an acoustic alarm (continuous tone).

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Alarms

No.

Display

Error

Continued usage

Device power

consumption

exceeds

the tol. range

Heating plate

power

consumption

exceeds the

tol. range

Yes, with

restrictions

(heating plate

not working)

Internal error

Pressure

measurement

error

8.3 Low priority alarms The corresponding fault is displayed for all alarms. The yellow LED stays lit for all faults. Device-specific alarms are triggered whenever there is a problem with the device. With the majority of possible faults, the device can no longer be used and must be checked immediately by a service engineer. Some alarms can be switched off using the alarm key (e.g. heating plate faults). This way, and for the time being, you can continue using the device subject to certain restrictions (heating plate not working). Such faults should also be promptly checked by the service team.

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Alarms

No.

Display

Error

Continued usage

Internal error

C10

Error accessing

memory card

Yes, after

resolving the

error

C15

Heating plate

sensor

indicating a

defect

Yes, with

restrictions

(heating plate

not working)

C16

Internal device

clock faulty

Yes, with

restrictions

(no data

recorded)

C17

Maintenance is

required

Yes

C18

Factory

maintenance is

required

Yes

C19

Motor control

fault

C20

Memory card not

supplied by FLO

Medizintechnik

GmbH

C22

Memory card

needs to be

reset

Yes, after

resetting the

memory card

using FLOsoft

Page 34

Alarms

No.

Display

Error

Continued usage

C25

The alarm limit

for under-

shooting the

tidal volume has

not been met

Yes

C26

The alarm limit

for exceeding

the tidal volume

has been

exceeded

Yes

C28

External voltage

is too low

No (if necessary recharge the ext.

battery)

Problem

Cause

Solution

Noise develops in the hose

Connections have become detached

Check that all connections are secure

Damage to the breathing hose

Replace the hose, contact your supplier

Noise develops in the mask

The mask connection and the breathing hose sleeve have become detached

Check that all connections are secure Mask leakage

Contact your supplier

9 Help with therapy problems

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Help with therapy problems

Problem

Cause

Solution

The Therapy device does not start or the pressure is much too high and the therapy device does not react

Pressure gauge hose not connected to the therapy device

Connect pressure gauge hose and therapy device

Water in pressure gauge hose

Dry pressure gauge hose

Pressure gauge hose kinked or blocked

Check pressure gauge hose is not blocked, replace breathing hose as necessary, contact your supplier

Pressure gauge hose is closed with stopper

Remove stopper

Hose smells unpleasant

Breathing hose smells due to manufacturing

Allow the breathing hose to air

The breathing hose is contaminated with germs

Replace breathing hose

Therapy device does not regulate itself correctly

The internal crosssection of the pressure gauge hose has been reduced, e.g. through crushing

Replace the hose, contact your supplier

Pressure gauge hose is too short (does not extend into mask connection)

Change the breathing hose or have the supplier adjust it Water on the heating plate

Possible hairline crack in the beaker

Replace the beaker, contact your supplier

Internal noise development

______

Contact your supplier or service engineer

Whatever the problem: If you are unable to resolve it yourself, please contact your supplier or the doctor in charge of the treatment.

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Cleaning / Disinfection / Processing

Disconnect the device from the mains power supply

before you start cleaning!

The FLO Vigaro is not a sterile medical device!

10 Cleaning / Disinfection / Processing

The following FLO Vigaro components form part of the breathing gas route and can be removed by the user / patient:

- Particulate filter:

- Glass

- Air humidifier lid

- Humidifier / equipment connecting joint

These components require regular cleaning and maintenance. This is described

in the following section.

10.1 General

Care and cleaning by the user / patient is limited to cleaning and visual inspection of the device and mains cable and to replacing device filters, the hose system and any accessories used. The user can also disinfect the beaker (see 10.5 Disinfection).

Do not submerge the device in water and do

not spray it with water or other liquids Only use mild cleaning products

Do not use any Solvents or abrasive cleaning products

Cleaning liquids must not be allowed to get inside the device

Replace damaged parts

After cleaning allow the device to dry off completely

Always carry out cleaning according to the instructions provided by the manufacturer of the cleaning agents. Cleaning should be carried out on the basis of applicable hygiene control procedures of the relevant facility.

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Cleaning / Disinfection / Processing

10.2 Summary of cleaning tasks

Housing / device: Wipe with damp (not wet) cloth.

Ensure that no water gets into the ventilation slits or recessed grip.

Mask: Clean the mask according to the

Instructions in the corresponding instruction manual.

Hose system Detach the breathing hose from the device and

clean the hose system with mild soap. Store it and the mask in a clean, dry place until next used.

Particulate filter: Processing not possible.

Recommendation for replacement: see table

"Overview table – regular checks / replacement"

Beaker: Clean the beaker with mild soap in the

dishwasher.

Air humidifier lid: Clean the humidifier lid using mild soap.

Connecting joint: No special cleaning required

Neither the FLO Vigaro nor any of the attached parts provided for by the manufacturer can be sterilized.

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Cleaning / Disinfection / Processing

Before use

Daily

Weekly

Monthly

Yearly

Change of patient

External Battery

Check

Test

Hose system Check

Cleaning

Replacement after 3000

therapy hours

Replace-

ment

Mask

Clean and replace according to instruction manual

Mains cable

Check

Device Filter

Check

Replace-

ment

Beaker

Cleaning

Air humidifier lid

Cleaning

Housing / device

Cleaning

Caution!

Disinfection or cleaning with products other than those described may cause damage and thus failure of the device.

Overview table – regular checks / replacement

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10.3 Filter change

To change the filter, take a coin or similar thin object. Insert the coin into the Lock for the filter box.

Turn the Lock for the filter box to a vertical position.

Then pull the lock from the opening. and lift the filter cartridge out of the device.

Caution! Only use approved filters!

Cleaning / Disinfection / Processing

Replace it with a new filter cartridge. Make sure the filter cartridge is properly inserted. Lock the filter cartridge with the lock supplied Lock for the filter box.

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Cleaning / Disinfection / Processing

Caution!

During disinfection, the device and mains cable must be disconnected from the mains power supply!

10.4 Processing / Reuse

The following steps must be carried out before passing on the system to a new user:

Replace the beaker (Art. no. 31100010)

Replace the particulate filter (Art. no. 40100111)

Replace the carrying handle (Art. no. 30100235)

Replace the humidifier lid (Art. no. 31300011)

Replace the connecting joint (Art. no. 30100245)

Replace the 90° connecting joint (Art. no. 51000040)

Replace the carrying bag (Art. no. 4080001x)

Disinfection using the Keredusy system (KR 1000)

See the service manual for detailed information.

10.5 Disinfection

You can disinfect the housing, mains cable, hose system and the humidifier if required, e.g. after infectious diseases or in the case of exceptional soiling. Refer to the instruction manual for which disinfectant to use. We recommend wearing suitable gloves during disinfection, e.g. household rubber gloves or disposable gloves. Before disinfecting the device, you should clean it as described in the cleaning overview. These recommendations do not apply if there is a change of patient!

The housing of the FLO Vigaro and its mains cable are cleaned by simply wiping with disinfectant. You can use a hydrogen peroxide solution (3% / 5%) for this.

You can also disinfect the humidifier using a hydrogen peroxide solution (3% / 5%). It is also possible to use thermal disinfection (boiling) to disinfect the beaker. To do this, place the beaker in a pot with sufficient warm water and heat it up (put a dishcloth under the beaker if necessary) Boil the beaker for 5 minutes. Let the pot and beaker cool off and then dry them.

Page 41

Cleaning / Disinfection / Processing

Caution!

Do not use cold water to cool off the beaker and do not fill the beaker with hot water from a kettle. The beaker may break, risk of injury.

To disinfect the breathing hose, please refer to the section on "Disinfection" in the relevant instruction manual.

11 Maintenance

Maintenance and a recurring STK inspection are required after 2 years and may only be carried out by a qualified professional.

Defective and damaged components should be immediately replaced and no longer used. Please see the service manual for detailed information about maintenance.

The expected duration of use of the overall system (device + humidifier) with daily use and cleaning is 6 years / 18,000 hours.

The system's internal battery is designed to last for approximately 20 years.

12 Storage

Storing the FLO Vigaro:

Store in a cool, dry place.

Do not expose to direct sunlight or UV light.

Max. storage time 10 years.

Storing the breathing hose:

Store in the original packaging in a cool, dry place.

Observe the expiry date on the packaging.

Do not expose to direct sunlight or UV light.

Hang up to dry after every use.

Storing the filter cartridge:

Store in the original packaging in a cool, dry place.

Do not expose to direct sunlight or UV light.

Page 42

Disposal

13 Disposal

FLO Vigaro:

The FLO Vigaro should not be disposed of with household rubbish. Before disposal, please check the procedure with your service provider, supplier or health insurance company. The device must be disposed of correctly via an authorised electrical waste recycler.

Disposing of the breathing hose:

At the end of its service life the breathing hose should be disposed of with household waste.

Disposing of the filter cartridge:

At the end of its service life the filter cartridge should be disposed of with household waste.

14 Clearance certificate

FLO Medizintechnik GmbH declares that the FLO Vigaro is suitable for transport in aircraft, and also for use in hospitals. The FLO Vigaro meets the following requirements:

EMC (electromagnetic compatibility) to DIN EN 60601-1-2

Radio interference suppression to DIN EN 55011

Immunity to interference as per DIN EN 61000-40

Page 43

Travel / transport

Caution!

Always transport the device when the beaker is completely empty.

15 Travel / transport

15.1 Checklist

You can use the following set of points as a checklist for planning a journey.

If you have booked a scheduled flight, inform the airline before

you set off that you are taking your breathing therapy device with you. Generally you are then allowed to take it on board along with your hand luggage. Carry the device with you as hand luggage. It is a common

occurrence for checked-in luggage to arrive at the destination late or damaged! Check with your travel agent what voltage and power points are

available at the destination. Your device will automatically recognise the incoming power source in the range 100 to 240 Volts. You can buy an adapter plug from an electrical shop or at the airport. Take an extension cable with you as a precaution in case there is no power point near the bed in the hotel room.

Even with the best preparation unpredictable faults can arise. All suggested solutions shown in the following section should be used only in absolute emergencies and only for a limited time. Please inform your service technician without delay to resolve technical problems long term.

Page 44

Travel / transport

Problem

Emergency solution

Emergency material

Leaking hose

Wrap adhesive tape several times around the breathing hose at the point where the fault is

Insulating tape

Broken forehead pads on the mask

Glue

Superglue

Broken beaker

Remove the air humidifier and connecting joint, then plug the breathing hose sleeve directly into the therapy device.

______ Leaking mask due to

porous materials

Wedge in a piece of leather or sponge as a buffer

wipe, kitchen sponge Pressure marks on the skin under the mask

Ointment (ask your doctor or pharmacist)

Ointment

15.2 Emergency solutions

The following table lists emergency solutions for solving problems in the short term.

Page 45

Travel / transport

15.3 Producer's declaration / Customs

Prevent potential problems at customs. Get confirmation from your doctor that you require the therapy. All you need is a signature from the attending clinic / doctor in the patient's health record.

Product declaration - German

Hiermit bestätigen wir, dass dieses Produkt ein Druckatmungsgenerator ist. Das System wurde für die intermittierende nicht-invasive Beatmung der restriktiven und obstruktiven Ventilationsstörung vorgesehen. Um eine erfolgreiche Therapie zu garantieren, muss der Patient das Gerät ständig bei sich führen.

Product declaration - English

We hereby confirm that this product is a continuous positive airway pressure machine. The device is intended to provide intermittent non-invasive ventilation for patients with restrictive and obstructive respiratory disorders.

To ensure successful treatment, patients must have the device with them at all times.

Product declaration - French

Nous déclarons par la présente que ce produit est un appareil à pression positive continue. Ce système a été conçu pour la ventilation intermittente non invasive en cas de troubles de la ventilation restrictifs et obstructifs.

Afin de garantir le succés de la thérapie. Le patient doit porter le systéme en permanence avec lui.

Product declaration - Spanish

Con la presente confirmamos que este producto es un generador de presión positiva para respiración. El sistema se ha concebido para la respiración artificial intermitente y no invasiva en pacientes con una enfermedad pulmonar obstructiva crónica.

Para poder garantízar una terapia efectiva el paciente deberá llevar la caja continuamente consigo.

Page 46

Scope of supply

Description

20300015

FLO Vigaro "Next Generation"

31210020

FLO Vigaro memory card

4080001x

Carrying bag

50000080

hose system 1800 mm, Ø 22 mm, grey, complete

4040004x

Mains power cable, black, 1.80 m

51000040

Hose / humidifier lid connecting joint

40000246

FLO Vigaro "Next Generation" Instructions for Use English

92900180

Oxygen adapter

Description

40400010

12/24 Volt converter for FLO devices

40400050

Cable for operating the FLO devices on 24 Volt, 2.50 m

93900010

Hose heater incl. power supply unit

16 Scope of supply

The FLO Vigaro "Next Generation" (Art. no. 20300020) is supplied with the following components. Additional accessories are optionally available.

17 Approved accessories

Any other accessories required for use are selected by the user. When doing so, check that they satisfy the requirements listed below.

Page 47

Approved accessories

Only use accessories for which evidence of

EC conformity is available.

Description

31100010

Glass beaker for FLO devices

31300011

Air humidifier lid

40100111

Particulate filter

30100255

Filter box lock

30100245

Joint for connecting air humidifier to device

Requirements for hose system:

- 22 mm connection on both sides

- maximum hose length 180 mm

- (internal) Pressure gauge hose required

Requirements on mask:

- Mask corresponds to DIN EN ISO 17510-2 requirements

- Mask must have an exhalation valve

- Air cushion (rim) for adaptation to facial contours (low leakage level)

- Male 22 mm connection or additionally a suitable adapter

18 Spare parts

The following spare parts are available for the FLO Vigaro:

Page 48

Declarations regarding electromagnetic compatibility

Guidelines and manufacturer's declaration - Electromagnetic emissions

The FLO Vigaro is intended for use in the electromagnetic environment specified below. The user of the FLO Vigaro should ensure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment Guidelines

RF emissions as per CISPR 11

Group 1

The FLO Vigaro uses RF energy only for its internal function. For this reason its RF emissions are very low and it is not likely to cause any interference in nearby electronic equipment.

RF emissions as per CISPR 11

Class B

The FLO Vigaro is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions as per IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions as per IEC 61000-3-3

Complies

Guidelines and manufacturer's declaration - Electromagnetic immunity

The FLO Vigaro is intended for use in the electromagnetic environment specified below. The user of the FLO Vigaro should ensure that it is used in such an environment.

Immunity testing

IEC 60601 test level

Compliance level

Electromagnetic environment - Guidelines

Electrostatic discharge (ESD) as per IEC 61000-4-2

± 6 kV Contact discharge

± 8 kV air discharge

± 6 kV Contact discharge

± 8 kV air discharge

Floors should be made of wood, concrete or ceramic tiles. If floors are covered with synthetic material, the relative humidity must be at least 30%.

19 Declarations regarding electromagnetic compatibility

Page 49

Declarations regarding electromagnetic compatibility

Electrical fast transients / bursts as per IEC 61000-4-4

± 2 kV for power lines

± 1 kV for input and output lines

± 2 kV for power lines

± 1 kV for input and output lines

Mains power quality should be that of a typical commercial or hospital environment.

Voltage surges as per IEC 61000-4-5

± 1 kV line-to-line

± 2 kV line-to-earth

± 1 kV line-to-line voltage

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on supply as per IEC 61000-4-11

< 5% U

for 1/2 cycle (> 95% dip)

40% U

for 5 cycles (60% dip)

70% U

for 25 cycles (30% dip)

< 5% U

for 5 s (> 95% dip)

< 5% U

for 1/2 cycle (> 95% dip)

40% U

for 5 cycles (60% dip)

70% U

for 25 cycles (30% dip)

< 5% U

for 5 s (> 95% dip)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the FLO Vigaro requires continued function during interruptions in the power supply, it is recommended that the FLO Vigaro is powered from an uninterruptible power supply or battery.

Power frequency magnetic field (50/60 Hz) according to IEC 61000-4-8

3 A/m

Power frequency magnetic fields should be characteristic of the values found in a typical commercial or hospital environment.

Note: UT is the AC supply voltage prior to application of the test levels

Page 50

Declarations regarding electromagnetic compatibility

Recommended safety distances between portable and mobile RF telecommunications equipment (e.g. mobile phone) and the FLO Vigaro:

The FLO Vigaro is intended for use in an electromagnetic environment in which RF disturbances are controlled. The customer or user of the FLO Vigaro can help avoid electromagnetic interference by maintaining minimum distances between portable and mobile RF telecommunications equipment (transmitters) and the FLO Vigaro as specified below, according to the output power of the communication equipment.

Transmitter’s

nominal output

Safety distance according to frequency of transmitter in

150 kHz - 80 MHz

d = 1.2 √P

80 MHz - 800 MHz

d = 1.2 √P

800 MHz to

2.5 GHz

d = 2.3 √P

0.01

0.12

0.23

0.1

0.38

0.7311.2

1.2

2.3103.8

3.8

7.310121223

For transmitters rated at a maximum output power not listed above, the recommended safety distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter (W) according to the transmitter manufacturer.

Page 51

Declarations regarding electromagnetic compatibility

Guidelines and manufacturer's declaration - Electromagnetic immunity

The FLO Vigaro is intended for use in the electromagnetic environment specified below. The user of the FLO Vigaro should ensure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - Guidelines

Conducted RF disturbances as per IEC 61000-4-6

Radiated RF disturbances as per IEC 61000-4-3

3 V

Effective value

150 kHz up to 80MHz

3 V/m 80 MHz up to 2.5 GHz

3 V

Effective value

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the FLO Vigaro incl. cables than the recommended safety distance calculated from the equation appropriate tothe frequency of the transmitter.

Recommended safety distance:

d = 1.2 √P

d = 1.2 √P 80 MHz to 800 MHz

d = 2.3 √P 800 MHz to 2.5 GHz

with P is the maximum output power of the transmitter in watt (W) according to the transmitter manufacturer and d is the recommended safety distance in metres (m).

Field strengths from fixed RF transmitters as determined by an electromagnetic site survey (a) should be less than the compliance level (b) in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

Page 52

Declarations regarding electromagnetic compatibility

Note 1 At 80 MHz and 800 MHz the higher value applies.

Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a Field strengths from fixed transmitters such as base stations for radio (cellular / cordless) telephones and land mobile radio, amateur stations, AM and FM radio transmitters and TV transmitters cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey is recommended. If the measured field strength at the location in which the FLO Vigaro is used exceeds the applicable compliance level above, the FLO Vigaro should be observed at each location to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the FLO Vigaro.

b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V/m.

Page 53

20 Technical data

Product class according to EC directive 93/42/EEC

IIa

Electrical safety

- Protection class

- Protection level

- Protection rating

- Complies with standard

II (totally insulated) B IP30 DIN EN 60601-1:2013

Electrical Connection

- Alternating current

- Direct current

100 - 240 V AC automatic, 50 - 60 Hz, tolerance -15 % to +10 % 12 V DC / 8 A (part number 40400010 required) 24 V DC /4A (part number 40400050 required) Tolerance in each case -15% to +25% After an interruption and restoration of the power supply, the device status on resuming operation is the same as that prior to the interruption.

Power

- Maximum power

- Power consumption in 24 V operation

125 VA / 95 W Average 1.6 Ah

Ambient conditions

- Operation Temperature Air humidity Air pressure

- Storage and transport Temperature Air humidity Air pressure

+5 to +40°C 15% RH to 95% RH 700 - 1200 hPa (≈ cmH2O)

-20 to +70 °C (beaker empty) 15% RH to 95% RH 500 - 1200 hPa (≈ cmH2O)

20.1 Specifications

Technical data

Page 54

Technical data

Warming the breathed air:

- without the humidifier

- with the humidifier

+1.8 °C +39.8 °C

Operation

Continuous operation

Operating Range

4 to 30 hPa (≈ cmH2O) The maximum pressure < 40 hPa (≈ cmH2O) is not exceeded even at the first error

Sound pressure level

19.48 dB (L

pAist,

DIN EN ISO 3744)

Sound power level

< 39 dB(A)

Sound pressure level Alarm messages

min. 70 db(A)

System resistance with air flow of 60 l/min at the patient connection opening

Minimum stable pressure limit (PLS min)

≥ 0 hPa (minimum pressure in event of fault)

Maximum stable pressure limit (PLS max)

≤ 40 hPa (maximum pressure in event of fault)

Dimensions

16.5 x 16.5 x 33.5 cm

Weight

3.9 kg, including warm air humidifier and integrated power supply

Humidification system

Meets requirements of DIN EN 60601-1, DIN EN ISO 8185, Integrated warm air humidifier

Page 55

Technical data

Filling level humidifier

- Operation without humidification

- Operation with humidification

- Consumpton

Do not add water

100 to 300 ml 200 ml for 6 hours of therapy at 10 hPa (≈ cmH2O) pressure, room temperature and max. air humidifier heating level

Air filtering

- Filter life

12–18 months, depending on air quality

Shape/dimensions:

- Gas outlet

- Hose connection

Conical 22 mm connector as per DIN EN ISO 5356-1 fits conical 22 mm connector as per DIN EN ISO 5356-1

Expected Duration of use

6 years 18,000 hours

Page 56

Technical data

Test pressures

min

Pmin +

¼(P

max-Pmin

)

Pmin +

½(P

max-Pmin

)

Pmin +

¾(P

max-Pmin

)

max

Pressure measured at the patient connector (hPa)

9.51622.5

Average flow at the patient connector (l/min)

220

200

175

148

119

Characteristic

Fraction of maximum selectable pressure

1/3 P

max

10.0

2/3 P

max

(breaths/min)

Vt 500ml

0.12

0.15

0.30

0.27150.16

0.22

0.28

0.32200.29

0.33

0.37

0.55

20.2 Rate of flow / pressure accuracy

Flow according to DIN EN ISO 17510-1:

Output of breathing therapy device for the following pressure settings:

(Measurements taken at Pmin = 4.0 hPa/Pmax = 30.0 hPa).

Pressure accuracy according to DIN EN ISO 17510-1:

(Measurements taken at Pmax = 20.0 hPa)

Page 57

Technical data

20.3 Function diagram The FLO Vigaro is equipped with a total of 2 pressure sensors, which ensure

control together with the turbine and CPU. They each use a display of 2 x 16 characters. This shows for example the current actual pressure during operation. The display is accurate to one representation unit. The device also has an RS232 interface and a USB interface. These ports are only required for servicing and changing parameters. A 24 V DC power supply can also be used as an alternative to mains AC power (100-240 V).

Page 58

Index

- A -

Actual pressure 20 Air flow 9 Air humidification 9 Alarm 48

Delay 29, 30 Disconnection 31 medium priority 29 Pressure too high 29

Pressure too low 30 Alarms 28 Alternating Current 53 Ambient conditions 53 Approved accessories 46

- B -

Bar display 20 Battery 33, 41 Breathing air humidifier 23 Breathing hose 25 Breathing rate 21

Disinfection 36, 40 Display, keys 16 Disposal 14, 42 Duration of use 41, 55

- E -

Electrical Connection 53 Electrical safety 14, 53 Electromagnetic Emissions 48 Electromagnetic Immunity 48 Emissions 48

- F -

Filling level 23 Filter change 39 Flow 21, 56 Function diagram 57 Function test 28 Functional description

Air flow concept: 9 Air humidification concept 9 Control concept 9

- H -

- C -

Change of Patient 40 Cleaning 36, 37

Summary 37 Cleaning Products 36 Connecting joint 37, 47 Contraindications 8 Control concept 9 Customs 45

- D -

Description of the device 8 Direct Current 53

Heating plate 20, 23, 32, 33 Hose system 37 Humidifier setting 19

- I -

I/E ratio 21 Immunity 48 Inhalation time 21 Instructions for use 12

- K -

Keredusy 40

Page 59

- L -

- R -

Leakage 21 LED (green) 16 LED (yellow) 28 Lighting 16 Lock 39, 47

- M -

Maintenance 41

Disposal 42

Filter change 39 Mask 26 Memory card 27 Menu sequence, starting up device

- O -

Operating Range 54 Operation 16 Oxygen intake 26

- P -

Positioning the device 11 Power 53 Power failure 31 Pressure accuracy 56 Pressure gauge hose 25 Pressure too high 29 Pressure Too Low 30 Processing 36, 40 Product class 53 Product declaration 45 Protection level 14, 53 Protection rating 14

- Q -

Quick start instructions 19

Ramp 19 Replacement 38

- S -

Safety 10 Safety distances 50 Safety regulations 12

Maintenance 12 Operating the device 11

Transport 12 Scope of supply 46 Serial Number 18 Setting up the FLO Vigaro 22

Operation with 12V DC or 24V

DC 22

Voltage 22 Shutdown 27 Side effects 9 Software revision 18 Solvents 36 Spare parts 47 Specifications 53 Start / Stop key 17 Starting and stopping therapy 19 Start-up 22 Symbols 14

- T -

Technical data 53 Therapy displays 20

Switch 21 Therapy problems 34 Therapy time 18 Tidal volume 20 Training mode 21 Transport 43

Page 60