Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT INDEX SYMBOLS ..................................... 4 WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION ................... 6 IMPORTANT INFORMATION ............................... 7 OB1000 SUCTION UNIT ............................... 8 □ DESCRIPTION AND INTENDED USE ........................8 □ CONTRAINDICATIONS FOR USE ..........................8 □...
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT SYMBOLS S.1 Symbols used on the suction unit and accessories, and indicated in the user manual Double insulation symbol. The suction unit has dual electrical insulation to protect user and work environment, providing two means of protection (there is no ground conductor or equipotential connection point).
Page 5
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT Authorized Representative in the European Community, if the manufacturer is not resident therein. Expiration date Do not use if the packaging is not intact Catalogue ID code Sterile device. Sterilization method: ethylene oxide Sterile device.
WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION Read carefully This User Manual has been prepared using simple, easy-to-understand language. If you have difficulty interpreting the above, contact the manufacturer for further clarification info@boscarol.it Tel.: +39 0471 932893 raq@boscarol.it • Read all instructions carefully before using the unit. Careful, proper use will ensure smooth operation and protect both patients and operators alike.
If the substances aspirated have entered the suction unit, it must be discarded. For Oscar Boscarol srl, the safety of its employees and authorized service centre staff is important. The suction units will not be demolished according to the WEEE Directive (Waste Electrical and Electronic Equipment) if the suction unit is contaminated and there is the risk of infection (application of It.
Disposable bag SERRES® Angular connector Silicone tube with joint Silicone tube with joint For accessories and options available, see the catalogue at www.boscarol.it or send an email to info@boscarol.it. □ Description and intended use The OB1000 is a portable electrical medical suction device designed to remove fluids and substances obstructing the upper airways and restore spontaneous and/or assisted respiration.
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT Fig.1 □ Indicator lights All lights are placed on the front and display the operation of the device (see Fig1): the autonomy of the battery (3-4-5) and the recharge state (7). The table below indicates the condition of the LEDs and the relative power of the battery: LEDS STATUS BATTERY POWER LEVEL LED green on (3)
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT reading on the vacuum gauge should reach maximum value (about -800 mbar, -80 kPa, -600 mmHg) in a few seconds.; • While keeping your finger over the silicone tubing, turn the vacuum regulator counter-clockwise and check the reading on the instrument to ensure that suction drops to nearly 0 (40-50 mbar);...
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT If the suction unit is used on a patient whose medical condition is not known, always replace the filter after use. This will prevent contamination, even serious contamination, of the operating environment, operator and patient. If, instead, the patient's medical condition is known and/or there is no danger of cross contamination, we recommend replacing the filter after each shift or when the filter turns dark.
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT Charging cable OB10WB wall bracket Power supply BSU855 BSU806 BSU897EU – BSU897UK – BSU897JP CAUTION Check that the external 11÷25 Vdc power supply is protected by a fuse rated at least 15A (time-delay). Request such protection from the manufacturer if necessary.
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT If proper PPE is not available, please contact your safety representative The organic secretions collected by the suction unit can cause severe operator infection. For this reason, always use suitable PPE and disinfection products as established by the competent authorities. CLEANING INSTRUCTIONS □...
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT WARNING • Do not put weight on the parts during the sterilisation cycle. • Observe the maximum limits for temperature, pressure and duration during the autoclave cycle. • Never exceed the value of 60°C for washing or disinfection operations (with the exception of sterilization in a steam autoclave).
To correctly disinfect and decontaminate the suction unit, we recommend using specific, approved products. These disinfectants must be free of alcoholic and/or abrasive substances. Oscar Boscarol srl can provide specific materials for disinfection of medical equipment, including our suction units. These disinfectants, available in different formats (wipes, spray, liquids), have been laboratory tested and guaranteed to deactivate viruses, bacteria and microorganisms.
Suction unit safety All electrical suction unit guards are set on the inside and cannot be accessed by the operator. If the above safety devices trip, if they do not reset automatically, contact your authorized service centre or Oscar Boscarol srl. □...
BSU825 Protection bag for OB1000 can be downloaded from www.boscarol.it User manual - NOTE To make technical improvements, the parts listed may be changed by the manufacturer without prior notice. Contact the manufacturer for additional information (info@boscarol.it). 17 - 28...
Unauthorized access to the suction unit can jeopardize its conformity with the applicable laws and reduce safety for both operators and patients. Contact Oscar Boscarol srl for a list of authorized service centres by sending an e-mail to info@boscarol.it.
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT NOTE In the case of anomalies or malfunctions other than those indicated above, always contact only an authorized service centre and/or the manufacturer. Technical data and references to legal requirements Classification according to European Directive 93/42/EEC The secretion suction unit is a medical device suitable for fixed and portable use.
Page 20
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT Electrical safety devices: Internal, not accessible to operator NOTE The external direct current power supply must provide at least 6A to enable correct unit operation or charging. If the suction unit is plugged into the mains or an external DC power supply, the internal battery is not used.
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT RISKS OF MUTUAL INTERFERENCE WITH OTHER DEVICES The OB1000 suction unit does not create interference for other medical devices performing tests and clinical treatments in the same area. The unit must not be connected to other equipment for its operation and has an internal power supply. RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE SOLUTIONS Electro-medical equipment requires special precautions regarding electromagnetic compatibility.
Page 22
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The OB1000 suction unit is designed for use in the electromagnetic environment specified below. The customer or operator of the OB1000 suction unit should ensure that it is used in such an environment. Test level Electromagnetic environment - IMMUNITY test...
Page 23
Rev. 04-2018 USMAN1000 2P-EN Rev. 04-2010 USMAN2012-IT GUIDELINES AND COMPLIANCE OF THE ELECTRO-MEDICAL DEVICES CONDUCTED AND RADIATED IMMUNITY TESTS For testing purposes, the tests are performed using IEC 60601 test levels, V =3 and E The OB1000 suction unit is designed for use in the electromagnetic environment specified below. The customer or operator should ensure that the suction unit is used in such an environment.
Rev. 04-2010 USMAN2012-IT WARRANTY Oscar Boscarol guarantees the OB1000 suction unit for a period of 24 months from the date of purchase by the original operator. The company guarantees that the suction unit is free of material and manufacturing defects.
Need help?
Do you have a question about the OB1000 Series and is the answer not in the manual?
Questions and answers