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Boscarol BSU402, Operating Instructions Manual

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Boscarol BSU402 Operating Instructions Manual Download Page 30

ED01_REV01-2021 IFU OB500_ENG

 

30- 32 

16.

 

DECLARATION OF CONFORMITY  

We, the manufacturer:     

 

 

OSCAR BOSCAROL SRL (LTD) 

Via E. Ferrari, 29 - 39100 BOLZANO - ITALY 
Tel. +39 0471 932893 - Fax. +39 0257760140 
Web: www.boscarol.it - Email: [email protected] 
Certifies EN ISO 13485:2016 
Certificate No. Q5 042208 0031 
Certifies UNI EN ISO 9001:2015 
Emission: TÜV-SÜD Product service (CE0123) 
EC Certificate N° G1 042208 0032 rev.00

 

We declare under our sole responsibility that the device 

(name): 

MEDICAL SUCTION UNIT

 

We declare under our own responsibility that the device 

(name):

 

MEDICAL SUCTION UNIT

 

 

Type: 

Type: 

 

OB500 FA - OB500 LINER - OB500 FM 

 

UMDNS code: 

GMDN code: 

15016 

63643 

Boscarol code: 

BSU402 - BSU412 - BSU414 - BSU442 - BSU462 - BSU464 - 

XAS0330 - XAS0331 - XAS0332 - XAS0333 - XAS0334 - 

XAS0335 - XAS0338 - XAS0340 - XAS0341 

Devices classification (MDD 93/42/EEC - Annex IX):

 

Class IIa

 

Meets all the provisions of the directive MDD 93/42/EEC and subsequent amendments which apply to it.

 

 

Applied harmonised standards, national standards, or 

other normative documents:

 

 

 

ISO 10079-1 

UNI EN 1789 

IEC 60601-1 

IEC 60601-1-2 

IEC 60601-1-12 

ECE-R10 

Conformity assessment procedure: 

MDD93/42/EEC, Annex II 

 

Notify body: 

 

 

TÜV SÜD PRODUCT SERVICE GmbH 

EC 0123 

Ridlerstrasse 65 - 80339 Munich - Germany 

 

 

Bolzano, 25/08/2020         

                            

                                DIR/QM - Quality Manager                                                                          CEO 

                                Dr. MARCHETTI BENEDETTA                                                             BRAZZO DANIELE  

       

 

 

 

 

             

Summary of Contents for BSU402

Page 1: ...ED01_REV01 2021 IFU OB500_ENG 1 32 BOSCAROL MEDICAL SUCTION UNIT OB500 FA FM LINER OPERATING INSTRUCTIONS OB500 type A FA OB500 WE FM OB500 ARI FA OB500 IR LINER ...

Page 2: ...rements described in Annex I of MDD 93 42 EEC Information on these operating instructions This document contains important information for the safe effective and compliant use of the medical device Use the information reported to train users and confirm their training This manual may not be altered even in part Only the manufacturer of the device may make changes where necessary These instructions...

Page 3: ...rol system 16 7 7 Silicone suction tube and sterile Fingertip conical fitting 16 7 8 Warnings concerning the re use of single use parts 17 7 9 Support bracket for suction jar wall mounting 17 8 REUSE CLEANING AND DISINFECTION 17 8 1 Re use of OB J FA suction jar 18 8 2 Cleaning disinfection and or sterilisation of OB J FA suction jar and silicone tube 18 8 3 Jar assembly and connection of the sili...

Page 4: ...ical and Electronic Equipment The suction unit complies with the European Directive 2011 65 EU RoHS Required maintenance service contact the manufacturer and or its authorised service centres 0 2 Symbols used on the device and accessories Insulation class II according to IEC 60601 1 Patient Applied Part Grade BF according to IEC 60601 1 Use the suction unit only within the specified temperature ra...

Page 5: ...ber Indicates that the suction unit is a medical device Connection patient suction tube cover for collection jar and Serres disposable liner INPUT The external mains power supply indicates the accepted input voltage range OUTPUT On the external mains power supply it indicates the output voltage value Indoor use only Continuous current Alternating current 1 INTENDED USE Device name Medical suction ...

Page 6: ...sively to remove organic fluids secretions during medical procedures For this reason it should only be used by trained personnel Never use the suction unit in the presence of flammable and or explosive liquids gases and anaesthetic mixtures as this may lead to explosions and or fires If aspiration is performed without the suction jar and or without the antibacterial filter or if it is suspected th...

Page 7: ...functionality of the suction unit and be a direct or indirect source of contamination of the operator and patient Sterilisation and or cleaning of disposable parts anti bacterial filters suction tubes Yankauer suction catheters etc can cause structural damage such that they lose their mechanical integrity 3 IMPORTANT INFORMATION TO KNOW BEFORE USE The suction unit has been designed and tested acco...

Page 8: ...y Side effects caused by vagus nerve stimulation Tachycardia caused by stress Choking nausea vomiting and coughing Respiratory tract infection typical of hospitals Convulsions by patients who tend to have cramps SIDE EFFECTS Attention To minimise side effects it is important to observe what is indicated in these operating instructions 6 OB500 MEDICAL SUCTION UNIT After receiving the device make su...

Page 9: ...module consists of a metal plate that can have different dimensions depending on the type of ambulance In the version with the plastic module all connection pipes are visible In the other models they are concealed under the wall of the vehicle All these versions are equipped with the reusable autoclavable OB J FA 1000 ml jar The jar is equipped with an overflow valve and an antibacterial filter on...

Page 10: ...hicle s power supply circuit 12 VDC The device complies with the general standard ISO 10079 1 and is not transportable OB500 is not equipped with an internal battery The OB500 is available in a number of variants that allow it to be fitted separately in various types of ambulances while maintaining performance and compliance With the exception of consumables and spare parts the OB500 has no access...

Page 11: ... sure not to damage the internal parts If necessary unscrew the four screws that block the cover and identify the free spaces for fixing Do not use adhesives or mastics to fix the suction unit to the floor Always check that the vent holes are not obstructed When removing the cover make sure that the gasket is not damaged when closing it Never install the unit near sources of excessive heat and or ...

Page 12: ...tional checks that can be completed in a maximum of 5 minutes 6 5 1 Daily periodic test of the OB500 suction unit valid for all variants DAILY TEST Stand in front of the suction control unit Switch on the suction unit with the switch provided depending on the type of installation on the rescue vehicle The suction unit should run smoothly and you should not hear any changes in the speed of the exte...

Page 13: ...bag or antibacterial filter before performing these operations Check the connection of the electrical cables to the motor block Check the operation of the internal pump by operating the vacuum The maximum vacuum value must be between a minimum of 730 mbar and 880 mbar Use a precision vacuum gauge to measure this value tolerance 2 5 or less There should be no operational anomalies such as unusual n...

Page 14: ... defective e g manual suction unit Always bear in mind what is stated in the initial warnings regarding the risks arising from the effects of magnetic fields EMC Always select the appropriate level of vacuum according to the patient and medical guidelines Do not alter or modify the medical device Serious consequences for the patient and the user may occur OB500 all variants is not a sterile device...

Page 15: ...s used on patients where the infection status is unknown always replace the filter after use on the same patient This will prevent even serious contamination of the environment in which the device is placed and therefore of operators and patients If on the other hand it is known and or there is no risk of indirect contamination it is advisable to replace the filter after each work shift or in any ...

Page 16: ...t be connected to the control unit via the silicone tube from the jar In the adjacent photos you can see the OB J FA suction jar connected to the external wall mounted module photo A and the pipe connection point in the built in version photo B A B 7 6 Sterile disposable Yankauer catheter with suction control system OB500 is sold complete with a sterile Yankauer type suction catheter and two tubes...

Page 17: ... painted metal and has two holes for vertical and horizontal adjustment The ideal position both for use and for cleaning and sterilisation is under the adjustment module The silicone tube supplied with the device can be shortened appropriately depending on the distance of the bracket from the module itself The OB500 Liner suction unit includes a special original bracket produced by the manufacture...

Page 18: ...n of OB J FA suction jar and silicone tube The suction jar and the silicone tube can be cleaned with specific non abrasive substances for cleaning medical devices Alcohol based cleaning agents can be used if diluted appropriately follow the instructions for use on the label of the disinfectants Avoid using coloured disinfectants as they may stain the plastic of the jar and the silicone tube reduci...

Page 19: ...ation The overfill valve has a float that slides on a plastic cage Ensure that it moves inside unhindered by sliding it and that the red silicone gasket is intact Assemble the jar by proceeding in the opposite direction to that seen above AFTER CLEANING Warning Check after each cleaning whether the device and its parts are functional If in doubt send the device to the manufacturer or an authorised...

Page 20: ...tubing Fingertip conical fitting and suction catheter proceed as follows Remove the disposable catheter together with the conical connection see adjacent photo Disconnect the silicone tubing from the white plastic fitting on the SERRES bag Discard the bag but keep the silicone tubing as it can be reused disinfected and or sterilised Remove the white 90 degree connector located on the SERRES bag if...

Page 21: ...rand jar Remove the white 90 degree connector located on the SERRES bag if not already done and close the inlet hole PATIENT with the cap see black arrow in the picture opposite Although seemingly trivial these operations can be dangerous due to their possible contamination of users Use your hand to operate the 90 connector on the jar and remove the silicone tube do not remove it Remove the dispos...

Page 22: ...se only disinfectants for cleaning medical devices Before applying them to the surface of the device and the container collection device check in a small area for damage If substances have been aspirated that are seriously contaminated with specific infections refer to the instructions of the healthcare professional Consult qualified personnel in hospitals and clinics Check for specific disinfecti...

Page 23: ...or this reason it is mandatory to close the suction hole with a piece of tape or plaster At the end of cleaning this tape or plaster must be removed Availability of disinfectants In order to disinfect and decontaminate the suction unit correctly it is advisable to use specific approved products These disinfectants must be free of abrasive substances Oscar Boscarol Srl Ltd can supply specific disin...

Page 24: ...ity data for OB500 all variants If the suction unit is to be used under extreme conditions check the following information Use in special conditions Operate the suction unit for the time strictly necessary Once used put the suction unit in a place with less critical operating conditions If the suction unit stops working let it acclimatise for at least 30 minutes in an area where the temperature is...

Page 25: ...ype WE control module flush mounted SPS4009 Ready to use IR control module flush mounted SPS4015 12 Vdc 2P power cable from motor block SPS4050 Spare silicone hose set 1 hose of 120 cm length 1 hose of 150 cm length 1 conical connector and fixing screws SPS6000 OB J FA vessel without lid SPS6002 Overfill valve 3 pcs SPS6004 Plastic fitting 90 for OB J FA jar 3 pcs SPS6006 Lid for OB J FA jar compl...

Page 26: ...d pump Contact the authorised service centre or the manufacturer NOTE In the event of anomalies and or malfunctions other than those listed in the table above always contact the authorised service centres and or the manufacturer of the device 14 TECHNICAL DATA AND CONFORMITY DATA FOR OB500 ALL VARIANTS Classification of the medical device in accordance with MDD93 42 EEC IIa Basic UDI number in con...

Page 27: ... The device can remain connected to the power source continuously Conditions of storage and use Operating temperature range 18 to 50 C 0 4 to 122 F Temperature range for storage and transport 40 to 70 C 40 to 158 F Relative humidity for storage transport and use 5 95 non condensing Atmospheric pressure range for storage transport 405 1070 mbar 40 5 107 kPa Maximum working altitude 5000 m above sea...

Page 28: ...ceivers mobile antennas Try to move to another location if possible or switch off all non essential equipment in the vicinity including electrical appliances and follow the instructions below 15 3 GUIDELINES AND MANUFACTURER S DECLARATIONS ELECTROMAGNETIC EMISSIONS The OB500 vacuum unit is intended for use in the electromagnetic environment specified below The customer or the operator of the OB500...

Page 29: ...000 4 5 L N 1kV at 0 90 180 270 L PE N PE 2 kV at 0 90 180 270 The quality of the mains power supply should be that of a typical environment Conducted disturbances induced by RF electromagnetic fields IEC 61000 4 6 0 15 80 MHz 1kHz AM 80 3 Vrms 6 Vrms in ISM and amateur radio band Portable and mobile RF communications equipment should not be used near any part of the device including cables than t...

Page 30: ... SUCTION UNIT Type Type OB500 FA OB500 LINER OB500 FM UMDNS code GMDN code 15016 63643 Boscarol code BSU402 BSU412 BSU414 BSU442 BSU462 BSU464 XAS0330 XAS0331 XAS0332 XAS0333 XAS0334 XAS0335 XAS0338 XAS0340 XAS0341 Devices classification MDD 93 42 EEC Annex IX Class IIa Meets all the provisions of the directive MDD 93 42 EEC and subsequent amendments which apply to it Applied harmonised standards ...

Page 31: ... the device and the date of purchase 2 confirmation by the manufacturer or a person representing the manufacturer that it is indeed a fault due to the production process or defective components since their procurement 3 absence of tampering modifications and or anything not conforming to the original product In terms of safety reliability and function of the suction unit Oscar Boscarol Srl can onl...

Page 32: ...ED01_REV01 2021 IFU OB500_ENG 32 32 SPACE DEDICATED TO USER NOTES Printed in Italy by Oscar Boscarol Srl Ltd ED01_REV01 2021 IFU OB500 ITA Language of editing Italian https www boscarol it ita eifu php ...

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