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Summary of Contents for Boscarol OB500 FA
- Page 1 ED01_REV01-2021 IFU OB500_ENG BOSCAROL MEDICAL SUCTION UNIT OB500 FA / FM / LINER OPERATING INSTRUCTIONS OB500 WE FM OB500 type A FA OB500 IR LINER OB500 ARI FA 1- 32...
- Page 2 Information on the manufacturer and the medical device: • Oscar Boscarol applies a quality management system in accordance with international standards ISO 13485 and ISO 9001. The OB500 medical device (in all its configurations) complies with MDD 93/42/EEC (and subsequent •...
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Page 3: Table Of Contents
ED01_REV01-2021 IFU OB500_ENG INDEX INDEX ..................................3 MEANING OF SYMBOLS AND PICTOGRAMS ....................... 4 0.1. Symbols used in these operating instructions to call the reader's attention ............ 4 0.2. Symbols used on the device and accessories ....................4 INTENDED USE ..............................5 WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION ................ -
Page 4: Meaning Of Symbols And Pictograms
ED01_REV01-2021 IFU OB500_ENG MEANING OF SYMBOLS AND PICTOGRAMS 0.1. Symbols used in these operating instructions to call the reader's attention Danger: Important safety information on the correct use of the suction unit to prevent injury to the operator or patient and/or damage to the suction unit. Warnings: information requiring special attention Notes or information to prevent damage to the device or others. -
Page 5: Intended Use
On the external mains power supply it indicates the output voltage value Indoor use only Continuous current Alternating current INTENDED USE Medical suction unit OB500 BOSCAROL Device name Suction unit designed to remove secretions, blood and other body fluids, solid pieces of Primary use food or tissue in the medical field... -
Page 6: Warnings, Precautions And Important Information
Phone +39 0471 93 28 93 info@boscarol.it Read these instructions carefully before using the device. Careful and correct use will ensure smooth • operation and protect both patients and operators. -
Page 7: Important Information To Know Before Use
WEEE (Waste Electrical and Electronic Equipment) directive, leading to a possible risk of infection (application of international worker protection law, where applicable). • If you have any doubts, please contact Boscarol's technical service before sending a device in for repair by sending an e-mail to info@boscarol.it... -
Page 8: Contraindications (Do Not Use For)
OB500 MEDICAL SUCTION UNIT After receiving the device, make sure that all parts are present. All Boscarol suction units are assembled and ready for use except for the antibacterial filter (in the version with reusable jar) which is not connected to the device (for transport and storage reasons). -
Page 9: Description Of Ob500 Suction Unit
1 OB500 suction unit complete with power cable 1 Vacuum control and regulating unit and jar connection with Serres® disposable bag 1 reusable 1000 ml jar of Boscarol complete with Serres® disposable bag already inserted in the jar of secretions 1 Sterile Yankauer catheter (unassembled) 1 Ready-made power cable for SELV voltage (12÷15 Vdc) -
Page 10: Controls, Operation And Control Panel
With the exception of consumables and spare parts, the OB500 has no accessories. Please consult the manufacturer in case of further clarifications by sending an email to info@boscarol.it. 6.2. Controls, operation and control panel All the controls for operating the device (except the operating switch, which is the responsibility of the installer) are located on the front side of the control block. -
Page 11: Motor Block Unit (Suction Pump)
ED01_REV01-2021 IFU OB500_ENG The flush-mounted version with metal plate has the same controls: the vacuum gauge, the vacuum regulator operated by the knob and the outlet to the suction jar. The connection to the pump-motor block is possible by connecting the hose on the rear side (see figure opposite). -
Page 12: Periodic Test Of Ob500 Suction Unit (All Variants)
ED01_REV01-2021 IFU OB500_ENG Refer to international and local standards for vehicle installations. The power supply connections for the device are shown in the figure on the next page. The cross-section of the power source wires must not be less than 1 mm² per wire. Do not connect the negative to the vehicle's housing, but to a common point provided by the vehicle's electrical system. -
Page 13: Periodic Six-Monthly/Annual Test Of Ob500 Suction Unit(Valid For All Variants)
ED01_REV01-2021 IFU OB500_ENG Test phase Test result Recommended action with negative outcome Uneven noise indicates a fault in the pump operation. A drop in Uniform engine noise, no rpm speed indicates insufficient current to operate the motor Checking pump operation drops, no abnormal vibration correctly. -
Page 14: Safety Information For The Safety Of Users, Patients And Third Parties
If you fail even a single test, please contact a service centre or the manufacturer. Do not use the device if you have not passed all tests. For further information please call +39 0471 932893 or send an e-mail to info@boscarol.it. 6.6. Safety information for the safety of users, patients and third parties To avoid unwanted effects and risks, always follow the information below: •... -
Page 15: Autoclavable Secretion Collection Jar Ob-J Fa
The filter is disposable and must be replaced after each use. In the event of contamination, discolouration and increased suction resistance, it must always be replaced. The filter is not produced by the Boscarol company. If the device is used on patients where the infection status is unknown, always replace the filter after use on the same patient. -
Page 16: Serres® Jar For Ob500 Liner
ED01_REV01-2021 IFU OB500_ENG 7.4. SERRES® jar for OB500 LINER The SERRES® suction jar is suitable for disposable bags from the same manufacturer (as for the OB-J FM version) and is made of transparent plastic (polycarbonate). It comprises a container (1), a grey movable connector for connection to the suction control module (2) and a SERRES®... -
Page 17: Warnings Concerning The Re-Use Of Single-Use Parts
7.9. Support bracket for suction jar (wall mounting) The OB500 FA and FM devices include a special metal bracket, which is required for wall mounting of the suction jar. The bracket must be installed in such a way that the jar is kept in a vertical position (maximum inclination ±20°). -
Page 18: Re-Use Of Ob-J Fa Suction Jar
ED01_REV01-2021 IFU OB500_ENG 8.1. Re-use of OB-J FA suction jar The steps required to separate the jar of secretions from the suction unit, disassemble it and assemble it after cleaning and disinfection are described below. Before starting, wear protective gloves, also covering your forearms, mouth and protecting your eyes. -
Page 19: Jar Assembly And Connection Of The Silicone Suction Tube
ED01_REV01-2021 IFU OB500_ENG • Do not spray liquids onto the device. Clean the device with the suction inlet closed. Place a piece of tape or leave the suction jar connected to the unit. • Do not use aldehyde and/or amine-based disinfectants to prevent discolouration. •... -
Page 20: Cleaning The Suction Jar(Ob-J Or Serres®) With Serres® Disposable Bags
ED01_REV01-2021 IFU OB500_ENG 8.5. Cleaning the suction jar (OB-J or SERRES®) with SERRES® disposable bags The OB-J Liner or SERRES® version of the suction jar is equipped with a specific SERRES® brand disposable bag, which is certified for this type of use. Unlike the OB-J FA version, the antibacterial filter is located inside the bag and is automatically replaced after each bag change. - Page 21 ED01_REV01-2021 IFU OB500_ENG Remove the plastic adapter from the suction jar by exerting a small amount of force. If necessary, use both hands to separate the two parts. Take care not to damage them. REUSABLE Unscrew the connector by 90° while holding the screw inside the jar. Take care not to damage the O-ring.
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Page 22: Disinfection And/Or Sterilisation Of The Ob-J Suction Jarand Silicone Tube
ED01_REV01-2021 IFU OB500_ENG The jar of secretions must be discarded after 30 sterilisation cycles or 5 years of use from the date of first use. Lifespan of suction jars Risk of infection due to spillage during cleaning process. Possible transmission of life threatening infections. -
Page 23: Disposal Of Contaminated Single-Use Parts
Always follow local regulations or hospital practices when disposing of contaminated waste. Never store contaminated parts with new or sterile parts. Boscarol markets specific identified bags for the disposal of contaminated hospital waste. 8.9. Cleaning and disinfection of the suction unit To clean the surface of the device, use a damp cloth soaked in diluted medical device disinfectant (same as used for the suction jar). -
Page 24: Suction Unit Power Supply
The suction unit is fully recyclable, please refer to the relevant legislation and all infection applicable guidelines. To clean and decontaminate the device prior to dismantling, the procedure for this process can be obtained from Boscarol (info@boscarol.it). DECONTAMINATION 24- 32... -
Page 25: Accessories, Consumables And Spare Parts
Unauthorised intervention on the suction unit may compromise its compliance with relevant laws and regulations and reduce the safety of use for operators and patients. Contact Boscarol Srl for a list of authorised service centres by sending an e-mail to info@boscarol.it. -
Page 26: Troubleshooting
ED01_REV01-2021 IFU OB500_ENG 13.1. Troubleshooting Malfunctioning Possible cause Solution Increased noise and poor suction of the Damaged pump or obstructions in Request assistance from • • unit even at maximum regulator. the internal suction circuit. authorised service centre or send the complete device to the service department. - Page 27 Silicone tube Reusable and sterilisable. Internal diameter: 6 mm. Length: 1.3 m For further technical information, please contact the manufacturer (info@boscarol.it). SERRES® products are disinfected at the factory and should be stored indoors and protected from the cold. Protect packaging from moisture, dirt and dust. Disposable products can be used for a period of 5 years after...
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Page 28: Information On Emc Electromagnetic Compatibility
ED01_REV01-2021 IFU OB500_ENG INFORMATION ON EMC ELECTROMAGNETIC COMPATIBILITY The OB500 suction unit does not create interference for other medical devices performing clinical tests and treatments in the same area. The unit does not need to be connected to other equipment for its operation and has an internal power supply. 15.1. - Page 29 ED01_REV01-2021 IFU OB500_ENG Recommended separation distance d = 1.2√P for 80 MHz at 800MHz d = 2.3√P for 800 MHz at 2.7 GHz Radiated radiofrequency 80-2700 MHz; 1kHz AM 80 %; 10 V/m RF EM field IEC 61000-4-3 where P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended...
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Page 30: Declaration Of Conformity
MEDICAL SUCTION UNIT (name): We declare under our own responsibility that the device MEDICAL SUCTION UNIT (name): Type: OB500 FA - OB500 LINER - OB500 FM Type: UMDNS code: 15016 GMDN code: 63643 BSU402 - BSU412 - BSU414 - BSU442 - BSU462 - BSU464 -... -
Page 31: Warranty
If, during the entire warranty period of 2 years, the product is found to be defective, it must be sent to Oscar Boscarol Srl (Ltd) with a note describing the defect. Oscar Boscarol Srl (Ltd) will repair or replace the defective parts and/or the whole unit at its discretion. - Page 32 ED01_REV01-2021 IFU OB500_ENG SPACE DEDICATED TO USER NOTES Printed in Italy by Oscar Boscarol Srl (Ltd) Language of editing: Italian ED01_REV01-2021 IFU OB500 ITA https://www.boscarol.it/ita/eifu.php 32- 32...
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