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Content

5

1

Appropriate usage

8

8

1.1

Purpose

8

1.2

Contraindications

9

1.3

Side effects

9

1.4

Functional description

2

Safety

10

10

2.1

Responsibility of the user / owner

11

2.2

Safety regulations

12

2.3

Instructions for use of the FLO Vigaro

3

Symbols on the device

14

4

Symbols on the packaging

15

5

Operation

16

16

5.1

Display and keys

18

5.2

Menu sequence when starting up the device

19

5.3

Quick start instructions

19

5.4

Starting and stopping therapy

19

5.5

Ramp

19

5.6

Humidifier setting

20

5.7

Therapy displays

21

5.8

Training mode

6

Start-up

22

22

6.1

Setting up the FLO Vigaro

23

6.2

Breathing air humidifier

25

6.3

Breathing hose

26

6.4

Mask

26

6.5

Oxygen intake

27

6.6

Memory card

7

Shutdown

27

8

Alarms

28

29

8.1

Medium priority alarms

29

Pressure too high 

8.1.1

30

Pressure too low 

8.1.2

31

Disconnection 

8.1.3

31

8.2

Power failure

32

8.3

Low priority alarms

9

Help with therapy problems

34

Summary of Contents for Vigaro

Page 1: ...Instruction manual FLO Vigaro Next Generation English Rev 1 0 July 2018 Vigaro from REV 4 15...

Page 2: ...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 se...

Page 3: ...Instruction manual FLO Vigaro Next Generation English July 2018...

Page 4: ......

Page 5: ...quence when starting up the device 19 5 3 Quick start instructions 19 5 4 Starting and stopping therapy 19 5 5 Ramp 19 5 6 Humidifier setting 20 5 7 Therapy displays 21 5 8 Training mode 6 Start up 22...

Page 6: ...age 41 13 Disposal 42 14 Clearance certificate 42 15 Travel transport 43 43 15 1 Checklist 44 15 2 Emergency solutions 45 15 3 Producer s declaration Customs 16 Scope of supply 46 17 Approved accessor...

Page 7: ...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 th...

Page 8: ...y 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 t...

Page 9: ...ssible 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...

Page 10: ...ty 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 de...

Page 11: ...r 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 br...

Page 12: ...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 instruct...

Page 13: ...veral 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...

Page 14: ...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 instru...

Page 15: ...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...

Page 16: ...ers 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 st...

Page 17: ...old 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 Clini...

Page 18: ...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...

Page 19: ...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...

Page 20: ...etting 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 Thera...

Page 21: ...me 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...

Page 22: ...s 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 additi...

Page 23: ...umidifier lid 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...

Page 24: ...rox 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 Caution The heating plate can...

Page 25: ...ressure gauge hose should extend almost as far as the mask The breathing hose must be replaced if the pressure gauge hose is too short The breathing hose should be checked for damage before any treatm...

Page 26: ...en 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 t...

Page 27: ...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 p...

Page 28: ...rity 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 If more than one fault occur...

Page 29: ...alue 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 Deacti...

Page 30: ...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...

Page 31: ...ing 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 de...

Page 32: ...s 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 faul...

Page 33: ...fect 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...

Page 34: ...if necessary recharge the ext battery 9 Help with therapy problems Problem Cause Solution Noise develops in the hose Connections have become detached Check that all connections are secure Damage to t...

Page 35: ...ells 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 cross sect...

Page 36: ...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...

Page 37: ...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...

Page 38: ...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 hu...

Page 39: ...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 Replace it with a new filter cartridge Make sure...

Page 40: ...struction 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...

Page 41: ...se 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...

Page 42: ...vice 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...

Page 43: ...el 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 fro...

Page 44: ...ing 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 sleev...

Page 45: ...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 Pr...

Page 46: ...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 17 Approve...

Page 47: ...Air cushion rim for adaptation to facial contours low leakage level Male 22 mm connection or additionally a suitable adapter Only use accessories for which evidence of EC conformity is available 18 S...

Page 48: ...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 emissio...

Page 49: ...00 4 11 5 UT for 1 2 cycle 95 dip 40 UT for 5 cycles 60 dip 70 UT for 25 cycles 30 dip 5 UT for 5 s 95 dip 5 UT for 1 2 cycle 95 dip 40 UT for 5 cycles 60 dip 70 UT for 25 cycles 30 dip 5 UT for 5 s 9...

Page 50: ...ment transmitters and the FLO Vigaro as specified below according to the output power of the communication equipment Transmitter s nominal output W Safety distance according to frequency of transmitte...

Page 51: ...ffective 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 equatio...

Page 52: ...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 recom...

Page 53: ...C 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 ope...

Page 54: ...el 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...

Page 55: ...r 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 con...

Page 56: ...ure measured at the patient connector hPa 3 9 5 16 22 5 29 Average flow at the patient connector l min 220 200 175 148 119 Measurements taken at Pmin 4 0 hPa Pmax 30 0 hPa Pressure accuracy according...

Page 57: ...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 U...

Page 58: ...t 37 47 Contraindications 8 Control concept 9 Customs 45 D Description of the device 8 Direct Current 53 Disinfection 36 40 Display keys 16 Disposal 14 42 Duration of use 41 55 E Electrical Connection...

Page 59: ...5 Protection level 14 53 Protection rating 14 Q Quick start instructions 19 R Ramp 19 Replacement 38 S Safety 10 Safety distances 50 Safety regulations 12 Maintenance 12 Operating the device 11 Transp...

Page 60: ...60 Travel 37 43 Checklist 43 Emergency solutions 44 U User s responsibility 10 V Voltage 22 W Warning 14 water consumption 24...

Page 61: ...61 Notice...

Page 62: ...62 Notice...

Page 63: ...Front view of the device see front page Handle recess USB interface Mains switch RS232 interface Memory card slot Mains connection Filter box Operation socket 24V 12V with adapter Filter box lock...

Page 64: ...Art Nr 40000245...

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