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Instruction for Use

21

PRO-110  /  PRO-115

En

Guidance and manufacturer’s declaration - electromagnetic emissions

The PRO-110/PRO-115 is intended for use in the electromagnetic environment specified 

below. The customer or the user of the PRO-110/PRO-115 should assure that it is used in 

such an environment

Immunity Test

IEC 60601

Test level

Compliance 

level

Electromagnetic environment - guidance

Conducted RF

IEC  

61000-4-6

Radiated RF

IEC 61000-4-3

3Vrms

150KHz to 

80MHz

3 V/m

80MHz to 

2.5GHz

3V

3 V/m

Portable and mobile RF communications 

equipment should be used no closer 

to any part of the PRO-110/PRO-115, 

including cables, than the recommended 

separation distance calculated from the 

equation applicable to the frequency of the 

transmitter.

Recommended separation distance

       3,5 

d=[        ] √P 

         V

       3,5 

d=[        ] √P  80MHz to 800 MHz  
         

E

         

d=[        ] √P  80MHz to 2,5 GHz  

         

E

where p is the maximum output power 

rating of the transmitter in watts (W) 

according to the transmitter manufacturer 

and d is the recommended separation 

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 in each frequency range.b

Interference may occur in the vicinity of 

equipment marked with the following 

symbol: 

 

NOTE 1: 

 At 80 MHz and 800 MHz, the higher frequency range 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) tel-

ephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast 

cannot be predicted theoretically with accuracy. To assess the electromagnetic environment 

due to fixed RF transmitters, an electromagnetic site survey should be considered. If the 

measured field strength in the location in which the PRO-110/PRO-115 is used exceeds the ap-

plicable RF compliance level above, the PRO-110/PRO-115 should be observed to verify normal 

operation. If abnormal performance is observed, additional measures may be necessary, such 

as re-orienting or relocating the PRO-110/PRO-115. 

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

Recommended separation distances between portable and mobile RF 

communications equipment and the PRO-110/PRO-115.

The PRO-110/PRO-115 is intended for use in an electromagnetic environment in which 

radiated RF disturbances are controlled. The customer or the user of the PRO-110/PRO-

115 can help prevent electromagnetic interference by maintaining a minimum distance 

between portable and mobile RF communications equipment (transmitters) and the 

PRO-110/PRO-115 as recommended below, according to the maximum output power of 

the communications equipment.

Rated maximum 

output power of 

transmitter

Separation distance according to frequency of transmitter m

150kHz – 80MHz 

d

 = 1.2 √

P

80MHz – 800MHz 

d

 = 1.2 √

P

800MHz – 2,5GHz 

d

 = 2.3 √

P

0,01

0,12

0,12

0,23

0,1

0,37

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended 

separation 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 in watts (W) according to the transmitter manufacturer.

NOTE 1:

 At 80 MHz and 800 MHz, the separation distance for the higher frequency 

range applies.

NOTE 2:

 These guidelines may not apply in all situations. Electromagnetic propagation is 

affected by absorption and reflection from structures, objects and people.

16. LATEST REVISION: 2016-02-25

Manufacturer:

 B.Well Swiss AG, Bahnhofstrasse 24, CH-9443, Widnau, Switzerland

www.bwell-swiss.ch

IM_PRO-110_PRO-115_EN_RO_BG_2916.indd   21

21.07.2016   11:39:03

Summary of Contents for PRO-110

Page 1: ...Instruction for Use Manual de Utilizare EN RO BG COMPRESSOR NEBULIZER NEBULIZATOR U COMPRESOR PRO 110 PRO 115 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 1 21 07 2016 11 39 01...

Page 2: ...Table 1 Int 2 In 3 Co 4 Pr 5 Co C N 6 Pr N A 7 Op 8 Re 9 Cl C M 10 D 11 Tr 12 Sp 13 A 14 W 15 Sy 16 La M_PRO 110_PRO 115_EN_RO_BG_2916 indd 2 21 07 2016 11 39 01...

Page 3: ...eparation for use 9 Nebulizer kit preparation for use 10 Air tube connection 10 7 Operating 11 8 Replacement of the Air filter 12 9 Cleaning Maintenance and Storage 12 Cleaning the device and accessor...

Page 4: ...cian prescribed medi cation to the bronchial lung passages The particle size is less than 5 m that allows treating lower respiratory tracts 3 CONTRAINDICATIONS AND USE LIMITATION The following is stri...

Page 5: ...the bifurcations in the nose but only bringing them as close as possible Check in the medicine package leaflet for possible contraindications for use with com mon aerosol therapy systems Cautions Clo...

Page 6: ...lly unwound in order to prevent dangerous overheating The power cord of this device cannot be replaced by the user In case of a power cord damage address to a technical service center authorized by th...

Page 7: ...se the device any longer it is recommended to dispose of it accord ing to the current regulations Do not position the equipment so that it is difficult to operate the disconnection device 5 COMPONENTS...

Page 8: ...1 pcs 2 Nebulizer kit Basic 1 pcs 1 pcs 3 Air tube 1 pcs 1 pcs 4 Mouthpiece 1 pcs 1 pcs 5 Nosepiece 1 pcs 1 pcs 6 Adult mask 1 pcs 1 pcs 7 Child mask 1 pcs 1 pcs 8 Infant mask 1 pcs Neb Thank is tak...

Page 9: ...r to detect possible functioning anomalies and or damages due to transport and or storage During inhalation sit upright and relaxed at a table and not in an armchair in order to avoid compressing your...

Page 10: ...nebulizer 4 Close the nebulizer by turning clockwise the two parts paying attention that they are thoroughly sealed NOTICE Capacity of container for drugs is equal to 2 8 ml There is a scale on the c...

Page 11: ...and conduct inhalation of the drug Inhale and exhale through the mask Using of mask is recommended in treatment of upper respiratory tract It allows for irrigation of the whole nasal and pharynx cavi...

Page 12: ...device must be carried out by using a soft and dry cloth and non abrasive cleansers ATTENTION During cleaning operations make sure the internal parts of the unit are not in contact with liquids and t...

Page 13: ...the nebulizer need to be replaced after 6 12 months depending on the usage The nebulizer must be replaced after a long period of inactivity in case it shows deformations or breakings or when the nebu...

Page 14: ...tightly fitted to the main unit and nebulizer Verify that the nebulizer is not empty or has been filled with the proper quantity of medicine max 8 ml Verify that the nebulizer nozzle is not obstructed...

Page 15: ...eight PRO 115 1 510 Kg without accessories 1 786 in the gift box with accessories Maximum pressure 2 2 bar Size PRO 110 137 x 173 x 96mm Size PRO 115 224 x 112 x 170 mm Operation limits 30 min ON 30 m...

Page 16: ...edical Device Directive and the European Standard EN 13544 1 2007 A1 2009 Respiratory therapy equipment Part 1 Nebulizing systems and their components 14 WARRANTY Warranty period is 3 years from the d...

Page 17: ...tion before use Disposal for separate collection Type BF equipment Class II Equipment CE mark Serial number LOT number Article number Manufacturer s Name Keep dry Operating condition temperature Stora...

Page 18: ...quipment RF emissions CISPR 11 Class B The PRO 110 PRO 115 is suitable for use in all establishments other than domestic and may be used in domestic establish ments and those directly connected to the...

Page 19: ...transient burst EFT is generated by the switching of inductive loads Separation between the equipment and other loads shall be considered before installation Mains filter is required if necessary Sur...

Page 20: ...61000 4 3 3Vrms 150KHz to 80MHz 3 V m 80MHz to 2 5GHz 3V 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the PRO 110 PRO 115 including cables than the rec...

Page 21: ...tended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PRO 110 PRO 115 can help prevent electromagnetic interference by maint...

Page 22: ...M_PRO 110_PRO 115_EN_RO_BG_2916 indd 22 21 07 2016 11 39 03...

Page 23: ...rea kitului nebulizator pentru utilizare 30 Conectarea tubului de aer 31 7 Mod de utilizare 31 8 nlocuirea Filtrului de Aer 32 9 Cur area nre inerea i Depozitarea 32 Cur area dispozitivului i accesori...

Page 24: ...amentului urma i recomand rile medicului sau inhaloterapeutului dvs Acesta este un dispozitiv medical compact conceput pentru o transportare eficient a medicamentului prescris spre c ile respiratorii...

Page 25: ...t dispozitiv doar cu medica iile prescrise de medicul dvs i conform recomand rilor lui Folosi i doar accesoriile recomandate de medicul dvs n dependen de patologie Utiliza i piesa de nas pentru inhala...

Page 26: ...itivul expus factorilor climaterici nainte de orice procedur de ntre inere sau cur are deconecta i dispozitivul i decupla i techerul din priza electric La sf r itul procedurii deconecta i dispozitivul...

Page 27: ...uie efectuat n conformitate cu instruc iunile produc torului Montarea nepotrivit poate cauza daune persoanelor animalelor sau lucrurilor pentru care produc torul nu poate fi tras la r spundere Dac a i...

Page 28: ...ulizator cu compressor 1 buc 1 buc 2 Kitul nebulizator Basic 1 buc 1 buc 3 Tubul de aer 1 buc 1 buc 4 Piesa de gur 1 buc 1 buc 5 Piesa de nas 1 buc 1 buc 6 Masc pentru adul i 1 buc 1 buc 7 Masc pentru...

Page 29: ...e garan ie 1 buc 1 buc 1 buc 1 buc 13 Autocolante 2 buc Kitul nebulizator Basic Gra ie efectului Venturi aerul 2 p trunde din mediul ambiant prin deschiderea din partea de sus 1 i se combin cu aerul p...

Page 30: ...e utilizare efectua i procedurile de cur are precum este descris n sec iunea 9 Cur area ntre inerea i depozitarea A eza i aparatul pe o suprafa orizontal i stabil a a nc t n timpul inhal rii s v fie u...

Page 31: ...nul de pornire n pozi ia I Compresorul se va porni i va ncepe nebulizarea Efectua i tratamentul n conformitate cu instruc iunile medicului dvs Inhala i solu ia de aerosoli utiliz nd accesoriile prescr...

Page 32: ...med nlocui i l 1 R suci i capacul filtrului de aer n sens antiorar doar pentru PRO 115 2 Extrage i camera filtrul vechi din dispozitiv tr g ndu o n sus 3 Extrage i filtrul i nlocui i l cu unul nou de...

Page 33: ...crounde usc tor de p r sau alte aparate de uz casnic pentru uscarea componen telor Partea exterioar a componentelor poate fi tears cu o lavet curat i uscat Aten ionare Pentru a evita r sp ndirea infec...

Page 34: ...func ionat n limitele opera ionale indicate n Manualul de utilizare 30 minute pornit 30 minute oprit Asigura i v c capetele tubului de aer sunt bine fixate la nebulizator i compressor Verifica i cupa...

Page 35: ...f r accesorii Greutatea PRO 115 1 510 kg f r accesorii Presiunea maximal 2 2 bar Dimensiuni PRO 110 137 x 173 x 96 mm Dimensiuni PRO 115 224 x 112 x 170 mm Regim de func ionare 30 min pornit 30 min op...

Page 36: ...ispozitiv respect prevederile directivei EC 93 42 EEC privind Dispozitivele Medicale i Standardul European EN 13544 1 2007 A1 2009 privind echipamentul pentru terapia c ilor respiratorii Partea 1 Sist...

Page 37: ...c num rul s pt m nii celelalte dou ultimele cifre ale anului de fabricare 15 DESCIFRAREA SIMBOLURILOR DE PE AMBALAJ Citi i instruc iunile de utilizare A nu se arunca cu de eurile menagere Echipament t...

Page 38: ...trivite pentru toate dispozitivele cu excep ia celor de uz casnic dar pot fi utilizate i n dispozitivele i aparatele de uz casnic care sunt legate direct la re eaua de for de joas tensiune de alimenta...

Page 39: ...seala este acoperit cu material sintetic atunci umiditatea relativ a materialului nu trebuie s fie sub 30 Procesele electrice de trecere rapide sau flash urile de tensiune conform Standardului interna...

Page 40: ...une de re ea n decurs de 5 secunde Puterea re elei de alimentare cu energie electric trebuie s corespund nc perii comerciale sau medicale Dac utilizatorul aparatelor PRO 110 PRO 115 solicit continuare...

Page 41: ...rtabile i mobile i aparatele PRO 110 PRO 115 inclusiv cablurile de alimentare trebuie s nu dep easc valoarea recomandat calculat din ecua ia frecven ei emi torului undelor radio Distan a recomandat 3...

Page 42: ...ionat n actele produc torului Remarc 1 Pentru diapazonul de frecven 80 MHz 800 MHz distan a d se selecteaz ca pentru urm torul diapazon de frecven e Remarc 2 Aceste recomand ri nu corespund ntotdeauna...

Page 43: ...re 15 tip Hz el en a o de z ori ului 0 ca i up u 16 DATA MODIFIC RII MANUALULUI DE UTILIZARE 2016 02 25 Produc tor B Well Swiss AG Bahnhofstrasse 24 CH 9443 Widnau Elve ia www bwell swiss ch M_PRO 110...

Page 44: ...M_PRO 110_PRO 115_EN_RO_BG_2916 indd 44 21 07 2016 11 39 05...

Page 45: ...g PRO 110 PRO 115 45 PRO 110 PRO 115 1 46 2 46 3 46 4 47 5 49 50 51 6 52 52 53 7 53 8 54 9 55 55 56 10 56 11 56 12 57 13 58 14 58 15 59 16 66 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 45 21 07 2016 11 39 0...

Page 46: ...Bg PRO 110 PRO 115 46 1 PRO 110 PRO 115 B Well B Well B Well 2 5 3 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 46 21 07 2016 11 39 05...

Page 47: ...Bg PRO 110 PRO 115 47 4 B Well PRO 115 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 47 21 07 2016 11 39 05...

Page 48: ...Bg PRO 110 PRO 115 48 9 16 8 ml 45 B Well M_PRO 110_PRO 115_EN_RO_BG_2916 indd 48 21 07 2016 11 39 05...

Page 49: ...Bg PRO 110 PRO 115 49 11 5 1 2 3 4 5 6 2 6 3 1 5 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 49 21 07 2016 11 39 06...

Page 50: ...Bg PRO 110 PRO 115 50 PRO 110 PRO 115 1 1 1 2 Basic 1 1 3 1 1 4 1 1 5 1 1 4 4 6 5 2 3 1 1 Instructio M_PRO 110_PRO 115_EN_RO_BG_2916 indd 50 21 07 2016 11 39 06...

Page 51: ...Bg PRO 110 PRO 115 51 5 6 1 1 7 1 1 8 1 9 5 5 10 1 1 Instruction for Use RU EN KZ PRO 110 PRO 115 11 12 1 1 1 1 13 2 2 1 3 4 3 1 4 2 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 51 21 07 2016 11 39 07...

Page 52: ...Bg PRO 110 PRO 115 52 6 9 1 2 3 4 7 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 52 21 07 2016 11 39 07...

Page 53: ...Bg PRO 110 PRO 115 53 2 8 ml O I 7 45 45 I 16 20 C 5 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 53 21 07 2016 11 39 07...

Page 54: ...Bg PRO 110 PRO 115 54 1 5 1 9 30 30 8 60 10 12 1 PRO 115 2 3 4 5 PRO 115 B Well 9 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 54 21 07 2016 11 39 07...

Page 55: ...Bg PRO 110 PRO 115 55 9 5 10 15 B Well B Well 6 12 B Well M_PRO 110_PRO 115_EN_RO_BG_2916 indd 55 21 07 2016 11 39 07...

Page 56: ...Bg PRO 110 PRO 115 56 12 10 11 30 30 8 ml B Well 12 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 56 21 07 2016 11 39 07...

Page 57: ...10 kg 2 2 bar PRO 110 137 173 96 mm PRO 115 224 x 112 x 170 mm 30 30 10 C 40 C MIN 10 RH MAX 95 RH 700 1060 hPa MIN 25 C MAX 70 C MIN 10 RH MAX 95 RH 700 hPa 1060 hPa Cumulative Undersize Particle Siz...

Page 58: ...Bg PRO 110 PRO 115 58 2 ml 5 23 C 10 1000 1 60 II BF 30 30 13 EN 60601 1 EN 60601 1 2 IIa 93 42 93 42 EN 13544 1 2007 A1 2009 1 14 3 B Well M_PRO 110_PRO 115_EN_RO_BG_2916 indd 58 21 07 2016 11 39 07...

Page 59: ...Bg PRO 110 PRO 115 59 5 A1 LOT M_PRO 110_PRO 115_EN_RO_BG_2916 indd 59 21 07 2016 11 39 07...

Page 60: ...Bg PRO 110 PRO 115 60 15 BF II CE 0044 40 10 25 70 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 60 21 07 2016 11 39 07...

Page 61: ...Bg PRO 110 PRO 115 61 PRO 110 PRO 115 CISPR 11 1 PRO 110 PRO 115 CISPR 11 PRO 110 PRO 115 PRO 110 PRO 115 61000 3 2 A 61000 3 3 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 61 21 07 2016 11 39 07...

Page 62: ...Bg PRO 110 PRO 115 62 PRO 110 PRO 115 PRO 110 PRO 115 60601 ESD 61000 4 2 6 8 k 6 8 k 30 61000 4 4 2k 1k 2k 61000 4 5 1k 2k 1k M_PRO 110_PRO 115_EN_RO_BG_2916 indd 62 21 07 2016 11 39 07...

Page 63: ...RO 110 PRO 115 63 0 61000 4 11 5 95 40 60 70 30 25 5 95 5 5 95 0 5 40 60 70 30 25 5 95 5 PRO 110 PRO 115 50 60 61000 4 8 3 A 3 A PRO 110 PRO 115 M_PRO 110_PRO 115_EN_RO_BG_2916 indd 63 21 07 2016 11 3...

Page 64: ...RO 110 PRO 115 PRO 110 PRO 115 60601 61000 4 6 61000 4 3 3 1000 150 K 80 3 80 M 2 5 3 3 PRO 110 PRO 115 3 5 d P V1 3 5 d P 80 M to 800 M E1 7 d P 80M to 2 5 d a b M_PRO 110_PRO 115_EN_RO_BG_2916 indd...

Page 65: ...150 80 3 PRO 110 PRO 115 PRO 110 PRO 115 PRO 110 PRO 115 PRO 110 PRO 115 PRO 150k 80M d 1 2 P 80M 800M d 1 2 P 800M 2 5 d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100...

Page 66: ...Bg PRO 110 PRO 115 66 1 80 800 d 2 16 25 02 2016 B Well Swiss AG Bahnhofstrasse 24 CH 9443 Widnau Switzerland www bwell swiss ch M_PRO 110_PRO 115_EN_RO_BG_2916 indd 66 21 07 2016 11 39 08...

Page 67: ...M_PRO 110_PRO 115_EN_RO_BG_2916 indd 67 21 07 2016 11 39 08...

Page 68: ...IM_PRO 110_PRO 115_EN_RO_BG_2916 www bwell swiss ch M_PRO 110_PRO 115_EN_RO_BG_2916 indd 68 21 07 2016 11 39 08...

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