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Summary of Contents for Boscarol OB 1000
- Page 1 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG BOSCAROL MEDICAL SUCTION UNIT OPERATING INSTRUCTIONS OB 1000 - OB1000 AVIO type FA OB 1000 - OB1000 AVIO type FM CORMOS type LN CORMOS type FA...
- Page 2 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG 2- 36...
- Page 3 +39 02 57760140 info@boscarol.it www.boscarol.it 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 OB1000 medical device (in all its configurations) complies with MDD 93/42/EEC (and subsequent amendments) and bears the CE mark (CE 0123 notify body TÜV SUD Italia).
- Page 4 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG INDEX INDEX 4 MEANING OF SYMBOLS AND PICTOGRAMS ..................... 5 0.1. Symbols used in these operating instructions to call the reader's attention ............ 5 0.2. Symbols used on the device and accessories ....................5 0.3.
- Page 5 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-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 6 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Indicates the need for the user to consult these operating instructions for information such as warnings and precautions that cannot be displayed on the medical device in question CE mark in accordance with MDD 93/42/EEC for medical devices in class above I Manufacturer Production date OB1000 and OB1000 AVIO suction units contain electrical and/or electronic equipment that...
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Page 7: Intended Use
Follow the European recycling plan Read the operating instructions Production batch number INTENDED USE Medical suction units OB1000 and OB1000 AVIO BOSCAROL Device name Suction unit designed to remove secretions, blood and other body fluids, solid pieces of Primary use... - Page 8 Phone +39 0471 93 28 93 info@boscarol.it Read these instructions carefully before using the device. Careful and correct use of the device will ensure • smooth operation and protect both patients and operators.
- Page 9 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 before sending a device for repair, please contact Boscarol's technical service department by sending an email to info@boscarol.it...
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Page 10: Side Effects
ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Preventive maintenance and periodic safety inspection: The suction unit should be checked at least once a day (function check). The device should be checked at least once every 12 months by the authorised service centre. - Page 11 MEDICAL SUCTION UNITS OB1000 AND OB1000 AVIO 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).
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Page 12: Indicator Lights
ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG and solids, splashing water and cleaning substances. The vacuum can be adjusted by turning the knob (2). By turning the knob clockwise, the vacuum increases up to the maximum value that can be read on the analogue instrument (1) expressed in millibars (mbar) or kilo-pascals (kPa) or, on request, also in millimetres of mercury (mmHg). -
Page 13: Daily Test
ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG 6.4.1. Daily periodic testing of OB1000 and OB1000 AVIO suction units Disconnect the device from the bracket or external charging cable. • Place the device on a stable surface in an upright position so that the front is facing you. •... -
Page 14: Operation
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 0471 932893 or send an e-mail to info@boscarol.it. 14- 36... - Page 15 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG 6.5. Periodic safety maintenance Depending on the use of the device, the OB1000 and OB1000 AVIO suction units should be checked at least every 24 months, even if not in use. Some parts inside the unit, e.g. the battery and the filter, may be adversely affected by a long period of inactivity.
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Page 16: Antibacterial Filter
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. - Page 17 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG 7.4. Secrets jar connection The secretion jar is connected to the aspiration unit via a silicone tube Fig. 2 Fig.1 and a plastic connector (white for the FA version (Fig.1); red and 90° for the FM version (Fig.2)). Insert the connector into the device as shown in the adjacent image.
- Page 18 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG REUSE, CLEANING AND DISINFECTION After each use, disconnect the suction unit, disconnect the disposable parts and dispose of them. Check the integrity of the suction unit, the connection tube and check that there are no structural anomalies. Clean and disinfect the suction unit as described below.
- Page 19 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Remove the lid from the jar by pressing lightly on the jar and levering the lid flap. Empty the contents of the jar. Remove the overflow valve from the lid. Separate all the parts. Parts making up the lid: •...
- Page 20 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG • Never sterilise devices or parts that have not been previously cleaned. • Do not place any weight on the parts or devices during the sterilisation cycle. • Observe the maximum limits for temperature, pressure and sterilisation time (temperature: 121°...
- Page 21 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG A number of safety precautions should be taken before removing the disposable bag. Remove the Yankauer disposable catheter complete with rigid probe. Always remember the risks of infection and contamination If the device is equipped with silicone tubing, Fingertip conical fitting and suction catheter proceed as follows: Sterile disposable...
- Page 22 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Use your hand to operate the 90° connector on the jar and remove the silicone tube (do not remove it!). REUSABLE Remove the plastic adapter from the secretion jar by exerting a small amount of force. If necessary, use both hands to separate the two parts.
- Page 23 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 Disconnect the suction unit from any external power supply.
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Page 24: Cleaning And Disinfection Plan
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 S.r.l (Ltd) can supply specific disinfectants suitable for medical equipment, including our suction units. - Page 25 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Change the filter, Antibacterial even if it is blocked filter Device Not foreseen See chapter 8.9 surface Power Not foreseen See chapter 8.9 supply Support Not foreseen See chapter 8.9 bracket ACCESSORIES AND OPTIONS FOR OB1000 AND OB1000 AVIO In order to safely install the device in emergency vehicles, a support bracket (which also provides power to the device) is available.
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Page 26: Special Conditions Of Use
• The suction unit is fully recyclable, please refer to the relevant legislation and all 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 26- 36... -
Page 27: Accessories, Consumables And Spare Parts
Contact Boscarol Srl for a list of authorised service centres by sending an e-mail to info@boscarol.it. 14.1. Solving common problems... - Page 28 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Battery damaged Contact the authorised service centre to replace • • the battery • Faulty internal electronic circuit • Contact the authorised service centre Suction unit does not work when Bracket not connected to external 12 Connect the cable of the support bracket to the •...
- Page 29 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Compliance for use in the pre-hospital sector (EMS) IEC 60601-1-12:2014/AMD1 2020 Part applied according to IEC 60601-1 TYPE BF Protection class against electric shock CLASS II Degree of protection against ingress of liquids and solids (IEC 529): IP34d Risk assessment (technical documentation) ISO 14971:2019...
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Page 30: Risks Of Mutual Interference With Other Devices
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... - Page 31 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG for faults or failures). The following tables provide electromagnetic compatibility (EMC) information relevant to this medical electrical unit. Full functionality of the unit is considered an "essential service" for the purposes of electromagnetic immunity. The OB1000 and OB1000 AVIO suction units are CISPR 11 Group 1 electromedical units and comply with Class B requirements.
- Page 32 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG where P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). 385 MHz; Pulse modulation: 18 Hz; 27 V/m Immunity to 450 MHz, FM + 5 Hz deviation: 1 kHz sine;...
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Page 33: Declaration Of Conformity
ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG 17. DECLARATION OF CONFORMITY We, the manufacturer: OSCAR BOSCAROL SRL Il produttore: Via E. Ferrari , 29 – 39100 BOLZANO – ITALY Tel. +39 0471 932893 – Fax. +39 0257760140 Web: www.boscarol.it - Email : info@boscarol.it... -
Page 34: 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. - Page 35 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG SPACE DEDICATED TO USER NOTES 35- 36...
- Page 36 ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG Printed in Italy by Oscar Boscarol Srl (Ltd) Language of editing: English ED01_REV02-2021 IFU OB1000-OB1000 AVIO ENG https://www.boscarol.it/ita/eifu.php 36- 36...
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