User Manual
Contents
1. 24 Rev 09 2013 USMAN1000 3P UK ACCESSORIES AND SPARE PARTS Index code Description Accessories OB10WB wall bracket Battery charger 100 240 Vca 50 60 Hz 3 poles and Euro plug Battery charger 100 240 Vca 50 60 Hz 3 poles and UK plug Battery charger 100 240 Vca 50 60 Hz 3 poles and Japan USA plug BSU806 BSU870 BSU872 BSU874 User parts BSU730 BSU732 BSU734 BSU705 BSU706 BSU707 BSU500 57308 BSU776 BSU750 BSU752 BSU754 11214101003 11214101104 11214101005 11214101006 11214101007 11214101008 Protection filter for OB J FA jar 5 pes Protection filter for OB J FA jar 15 pcs Protection filter for OB J FA jar 40 pcs Disposable 1000 ml Liner 6 pcs Disposable 1000 ml Liner 12 pcs Disposable 1000 ml Liner 36 pcs Autoclavable OB J FA jar without protection filter SERRES jar without disposable liner Jankauer suction tube End piece sterile disposable Finger typ 5 pcs End piece sterile disposable Finger typ 15 pcs End piece sterile disposable Finger typ 50 pcs Sterile suction catheter Ch 10 black Sterile suction catheter Ch 12 white Sterile suction catheter Ch 14 green Sterile suction catheter Ch 16 orange Sterile suction catheter Ch 18 red Sterile suction catheter Ch 20 yellow Spare parts BSU854 BSU902 SPS6000 SPS6002 SPS6004 SPS6006 SPS6014 SPS6023 BSU825 BSU826 ZMA3004 External charging cable with cigar lighter fitting and 3 poles plug Silico2. gently and twist holding the outer rim of the filter whilst supporting the collection jar by the lid Take care not to damage the filter 10 24 Rev 09 2013 USMAN1000 3P UK Replacing the protection filter Disconnect the tube from the top side of the contaminated filter Carefully remove the filter from the collection jar lid and dispose of it in accordance with local regulations or hospital practices Install a new filter ensuring that the written IN is the underside above the VACUUM port on the lid Incorrect installation of the filter will lead to immediate failure when used written IN to the jar NOTE Ensure that the protection filter is correctly fitted to the collection jar with written IN to the jar The filter may break if fitted incorrectly and there is a risk of unit contamination Reusable collection jar SERRES The suction cannister and its grey angle connector can be washed 85 C and autoclaved 121 C Before washing disconnect the angle connector Wear the protection gloves Disconnect the patient tube from the suction unit Remove the collection jar from the unit Disconnect the grey connector from lid Disconnect the white connector and close the connection with the plug provided on the lid Remove the sealed liner from the jar and replace with a new one Clean the canister and grey connector Reassembly of the jar Extract a new disposable bag fr
3. least 6A to allow correct running or charging of the unit With the mains powered battery charger when the unit is running the power is drawn from the battery 0 50 32 122 F 15 30 59 86 F 25 55 77 131 F 0 50 C 15 95 not condensed 70 106 kPa 700 1060 mbar 525 795 mmHg Be aware that if the unit is operating at an altitude over 2 500 meters the pressure value can slightly decrease This is caused by the decrease in the atmospheric pressure Although the OB1000 FA LINER is protected against water drip it should never be used in very heavy rain During either operation or storage the unit must always stand upright In the event that water gets into the side compartments remove the suction unit and dry thoroughly Rev 09 2013 USMAN1000 3P UK Protection filter technical data Antibacterial viral filter for suction devices with PTFE filter and polypropylene hermetically sealed chassis Max pressure applicable 1bar 100kPa Retention capacity e Tor water solution up to 0 9bar 90kPa e nebulized parts 0 1um 99 99 Storage of SERRES products SERRES products are factory sterile and should be stored in warm indoor locations Protect the package from humidity dirt and dust Disposable products can be used for 5 years after the date on the label excluding pre gelled suction bags that can be used for 2 years after the date on the label Battery charger technical data Input 100 240 Vac
4. min 6A Replace the cable Replace the wall bracket Check the external power source The suction unit only works if it is mounted on the wall bracket or fitted with the Faulty battery Refer to authorised service personnel external cable Check the Charging LED If it is on but the battery is not charged please refer to authorised service personnel Replace the battery charger The battery charger doesn t work properly Faulty battery charger Check that the indicator lights work if connected to the wall bracket or to the external charger cable If they work The suction unit works but the battery immediately charge the battery for at power indicator lights are off least 24 hours Faulty internal circuit Charge the battery for at least 24 Very low battery power hours Faulty battery Test the suction unit as described in page 9 of this manual or refer to authorised service personnel Internal recharging circuit failure Refer to authorised service personnel The suction unit only works for a short time Vacuum regulator set to minimum Turn the vacuum regulator clockwise and check the value of the vacuum on the gauge Protection filter blocked or damaged Replace the filter Connection tubes blocked kinked or Replace or reconnect the tubes check disconnected the jar connections The vacuum power on the patient side is Disposable liner not inserted properly Re insert the liner in the jar correctly eithe
5. normative applicate Conformity assessment procedure Procedimento di valutazione della conformit Notify body Organismo di notifica incaric della valut della conformit Bolzano 02 03 2013 DI RAQ Quality Manager PERINI LAURA 20 24 MDD93 42 EEC Annex Il Allegato Il T V SUD Product Service GmbH CE 0123 DI GM General Manager BRAZZO DANIELE lau 21 24 22 24 23 24 Rev 09 2013 USMAN1000 3P UK BOSCAROL Emergency Medical Systems Via Enzo Ferrari 29 39100 Bolzano IT Tel 39 0471932893 Fax 39 0257760140 info boscarol it www boscarol it Printed in Italy by Oscar Boscarol company Rev 09 2013 USMAN1000 3P UK 24 24
6. recommended separation distance calculated from the equation applicable to frequency of the transmitter Recommended separation distance d 1 2 P d 3 5 1 x VP 0 354 da 80MHz a 800MHz d 7 E1 x VP 0 7 P da 800MHz a 2 5GHz where lt P gt is the maximum output IEC 61000 4 3 80 MHz to 2 5 GHz power rating of the transmitter in watts W according to the transmitter manufacturer and lt d gt is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range 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 2 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones 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 suction unit OB1000 is used exceeds the applicable RF complianc
7. 1000 LINER OB J FA reusable autoclavable jar OB J FA jar Fig 3 is made of transparent plastic material polyprophilen The jar includes pot 1 cover 2 the shut off valve 3 and the 90 plastic pipe 4 The lid of the jar provides the direct inclusion of the protection filter The jar can be sterilized in an autoclave max pressure 2 bar g and maximum temperature 121 C for a maximum of 15 minutes It is strongly recommended that the collection jar is replaced after 30 autoclave cycles The jar must always be used in the upright position to avoid the intervention of shut off valve Should this occur switch the device off and disconnect the patient tube VACUUM marked on the lid Protection filter To prevent fluid overflow a special protection filter is used between the jar and the unit The filter is produced with PTFE hydrophobic material which prevents fluids entering the pneumatic circuit Working together with the shut off valve on the jar the filter isolates the pneumatic suction pump from 4 gas and fluid substances Replace the filter when you look at contamination discoloration or essed increased resistance of aspiration Warnings and precautions on the use of protection filter If the suction unit is used either in an emergency or on a patient where the risk of contamination is not known the filter must be changed after each use If instead the patient s pathology is known and or where there is no da
8. 50 60Hz 600mA Output 24 Vcc 1 A max Symbology Vac Voltage alternating current Vdc Voltage direct current C degrees C bar unit for pressure and vacuum kPa unit for pressure and vacuum mmHg unit for pressure Conversion formula 1 100kPa 750mmHg THE RISKS OF RECIPROCAL INTERFERENCE WITH OTHER DEVICES The OB1000 suction unit does not create interferences with other medical devices that are operating in the same area during the conduct of investigations and clinical treatments The unit must not be connected to other equipment for its operation and has an internal power source RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES The electro medical units required special precautions of use with regard to electromagnetic compatibility For this reason must be installed and or used in accordance with the information specified in the accompanying documents in our case the following tables Portable radio devices and mobile may affect the functioning of the medical device The electro medical units and medical systems should not be used in proximity adjacent or overlapping with other electrical apparatus or radio If such use is necessary and unavoidable special precautions must be taken to ensure that the medical device is functioning properly in its configuration of use envisaged for example checking constantly and visually the absence of anomalies or failures The following tables provide information about
9. 60142 E mail production manager boscarol it To validate the guarantee the customer shall provide the following documentation e presentation of a copy of the invoice and or declaration of purchase containing the device serial number and date of purchase e recognition by the service of a failure or defect attributable to defects in materials or workmanship e modifications changes and or anything not conforming to the original product For all legal purposes Oscar Boscarol Company is responsible for the safety and operation of the unit only if e technical operations repairs modifications and maintenance actions are carried out at the Oscar Boscarol company factory or by an authorised service centre e The device is used correctly as indicated in this user manual e The suction unit charger is only to be connected to the correct voltage supply for the Country it was supplied With reference to what was described in these guarantee conditions Oscar Boscarol Company cannot be responsible for accidental or indirect damage resulting from unauthorised modification or repair unauthorised technical interventions or when any parts of the unit are damaged in instances of accidental or incorrect use On the OB1000 suction unit are no other warranties expressed or limited of merchantability fitness or other outside those described in this manual 19 24 Rev 09 2013 USMAN1000 3P UK DECLARATION OF CONFORMITY OSCAR BOSCA
10. MAN1000 3P UK SYMBOLS Disposable part Applied part type BF Double insulation li Read the user manual Minimum and maximum Follow the instructions for use temperature use gt N 0123 CE mark perform to the MDD 93 42 EEC for Medical devices with class above The device contains electrical and or electronic equipment that must be recycled per Directive 2002 96 EC Waste Electrical and Electronic Equipment WEEE 10R 02447g Device homologated under the ECE R10 International Regulation and performed to the 95 54 EEC European Directive IMPORTANT SAFEGUARDS When using electrical products basic safety precautions should always be followed Read all instructions before using Important information is highlighted by these terms WARNING important safety information to avoid the risk of injury to the user or patient and or damage to the device NOTE information to which you should pay special attention Rev 09 2013 USMAN1000 3P UK N WARNINGS AND PRECAUTIONS READ CAREFULLY e Read carefully these instructions before using the device Careful and proper use of the device ensures smooth operation and protection of patients and users e OB1000 Suction Unit is an independent active medical device The device is to be used to remove fluids from the airway or respiratory support system in medical procedures For this reason its use should be undertaken by appropriately trained per
11. Max vacuum power Vacuum Regulation Vacuum range regulation Max flow rate Max running time with the maximum current load Approximate maximum noise energy Accuracy of the analogue gauge Accuracy of the battery power monitor Power supply Running charging Max current load Battery Max time for recharging Main safety NOTE Environmental and transport conditions Operating temperature range Recommended temperature for charging Storage and transport temperature range with original packaging Storage and transport temperature range without packaging Storage use and transport relative humidity Storage and transport atmospheric pressure NOTE Operating in the rain Ilb HIGH VACUUM HIGH FLOW TEMPORARY maximum continuous use 60 minutes SELV 12 15 Vdc complying to IEC60601 1 11 2010 TYPE BF CLASS II IP34d Complying with the 3 Edition 320 mm width x 100 mm depth x 250 mm height 12 6 in width x 3 94 in depth x 9 84 in height 3 5 Kg max complete with all accessories 5 800 mbar 80 kPa 600 mmHg 10 linear 30 800 mbar 3 80 kPa 22 5 600 mmHg gt 22 litres per minute with free air 10 Approximately 40 minutes 10 65 dBA 5 5 12 15 Vdc Direct Current 70 W max current 6 A Internally mounted rechargeable hermetically sealed acid type Capacity 3 4 Ah 15 hours Internal not accessible to the user The external power source must supply at
12. ROL srl Via E Ferrari 29 39100 BOLZANO ITALY Tel 39 0471 932893 Fax 39 0257760140 Web www boscarol it Email info boscarol it Certifies EN ISO 13485 2012 Certificate N Q1N 12 07 42208 019 Certifies UNI EN ISO 9001 2008 Emission TUV SUD Product service CE0123 EC Certificate N G2 13 01 42208 020 EC Certificate N G1 13 01 42208 021 EC Certificate N G1 13 01 42208 022 EC Certificate N G1 13 01 42208 023 We the manufacturer II produttore We declare under our sole responsibility that the device name Dichiariamo sotto nostra responsabilit che il dispositivo nome MEDICAL SUCTION UNIT ASPIRATORE MEDICALE DI SECRETI Type Tipo UMDNS code 0B1000 FA OB1000 LINER 15016 BSU210 BSU214 BSU220 BSU224 XAS0100 XAS0104 _ XAS0106 XAS0108 XAS0200 XAS0112 XAS0150 XAS0152 Boscarol code Devices classification MDD 93 42 EEC Annex IX Classificazione dispositivo MDD93 42 CEE Allegato IX Class Meets all the provisions of the directive MDD 93 42 EEC and subsequent amendments which apply to it Soddisfa tutte le disposizioni della direttiva MDD 93 42 CEE e successivi emendamenti che lo riguardano 15010079 1 2009 1 60601 1 Ed 1789 2010 el DIR95 54 EEC R 10 1 60601 1 11 2010 Applied harmonised standards national standards or other normative documents Norme armonizzate o nazionali applicate altri documenti
13. Rev 09 2013 USMAN1000 3P UK MEDICAL SUCTION UNIT OB1000 FA OB1000 LINER USER MANUAL C 0123 OR f SUC nid 200 MANUFACTURED BY BOSCAROL Emergency Medical Systems Rev 09 2013 USMAN1000 3P UK INDEX SYMBOLS AND IMPORTANT SAFEGUARDS nen eee eee WARNINGS PRECAUTIONS AND IMPORTANT INFORMATION OB1000 SUCTION UNIT MODELS DESCRIPTION AND INTENDED USE STATEMENT screen ea rio rara CONTRAINDICATIONS FOR USE CONTROLS INDICATIONS AND CHECK PANEL nennen nenne nenn nennen een INDICATOR LIGHTS DAILY CHECKLIST COLLECTION JAS atelier seriali REUSABLE AUTOCLAVABLE JAR PROTECTION FILTER SERRES REUSABLE JAR JANKAUER SUCTION TUBE POWER SUPPLY AND CHARGING OF THE BATTERY MAINTENANCE AND REUSE SAFETY paia DISPOSING OF THE SUCTION UNIT weisse Su asa res ACCESSORIES AND SPARE PARTS ee ee aio ian DERVCE FAULT FINDING TECHNICAL DATA AND CONFORMITY TO INTERNATIONAL LAW RISK OF MUTUAL INTERFERENCE WITH OTHER DEVICES i RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES GUARANTEE ee eee DECLARATION OF CONFORMITY N N O O O oO CO CO O 0 00 12 13 14 14 15 16 16 19 20 Rev 09 2013 US
14. blishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The OB1000 suction unit is intended for use in the electromagnetic environment specified below The user of the OB1000 suction unit should assure that it s used in such an environment IMMUNITY test IEC 60601 test level Compliance level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV in air 2 kV power supply 1 kV power supply IN OUT lt 5 0 295 dip Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 UT gt 95 dip in Ur for 5 sec 6 kV contact 8 kV in air 2 kV power supply 1 kV power supply IN OUT lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 UT gt 95 dip in Ur for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hosp
15. d below Replace all single use disposable parts with new components and recharge the battery Make a daily function test as described under Daily checklist on page 7 9 24 Rev 09 2013 USMAN1000 3P UK CLEANING INSTRUCTION Reusable collection jar OB J FA Wear gloves and protective clothing Disconnect patient tube Disconnect silicone tube and conical connector Carefully remove the jar from the unit Remove the lid of the bottle attention to possible contamination with the liquids contents Empty the contents of the bottle in accordance with local regulations or hospital practice Disconnect the protection filter Disassemble the shut off valve Ca po o NO Dispose of disposable parts and disassembled the jar soak the parts in cold water and rinse well Then dip the same parts in hot water at a temperature not exceeding 60 C containing a mild non alcoholic detergent After washing rinse all parts with clean hot water 30 40 C max and then dry with a lint free soft cloth Before reassembling check that all parts are clean dry and undamaged Decontamination of the collection jar The collection jar can be disinfected with any mild non abrasive detergent Do not use any alcohol or solvent based cleaning agents as these may damage the collection jar Do not use coloured disinfectant solutions as these may stain the collection jar Never use n
16. e level above the suction unit OB1000 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the suction unit OB1000 Over the frequency range 150 kHz to 80 MHz field strength should be less than 1 V m 18 24 Rev 09 2013 USMAN1000 3P UK GUARANTEE Oscar Boscarol Company supplies the OB1000 FA and OB1000 LINER with a 24 month guarantee from the date of purchase Oscar Boscarol Company guarantees that each new OB1000 FA and OB1000 LINER unit is free from defects in materials and workmanship Items excluded from this guarantee are the collection jar and or the liner the external cable for battery charging the internal battery normal wear and tear of the unit discoloration and any other aesthetic irregularities which do not affect the operation of the unit If returned to Oscar Boscarol Company the factory will at their discretion arrange for repairs or complete replacement within the terms of this guarantee The defective device should be decontaminated and returned in its original packaging with a note describing the defect All shipping costs are borne by the customer Conditions of guarantee To use the warranty it is necessary to fill in and return the product registration form below via post fax or mail to the following address OSCAR BOSCAROL COMPANY V E Ferrari 29 39100 BOLZANO ITALY Fax 39 02577
17. eat disinfectant dilute according to the manufacturer s instructions The jar is manufactured from plastic and whilst it offers good protection against water and humidity long periods of immersion in water or detergents may affect its integrity For sterilisation only use steam autoclaves at a maximum temperature of 121 C at a maximum pressure of 2 bar g for 15 minutes The jar should be placed in the autoclave upside down to assist draining At the end of the autoclave cycle place all parts on a flat sterile or clean surface and leave to cool to ambient temperature before reassembling Check that the collection jar and all parts are undamaged WARNING e Do not put weight on the parts during the sterilisation cycle e Observe the maximum limits for temperature pressure and duration during the autoclave cycle e Never exceed the value of 60 C for washing or cleaning operations with the exception of N sterilization in a steam autoclave e Cleaning disinfection and sterilisation should only be carried out by trained personnel e collection jar can be used for up to 30 sterilisation cycles after which the jar tubes and plastic connectors must be replaced e After reassembling the jar check that the lid is properly fitted to achieve a seal Place all components on a flat clean surface During the assembly phases check all parts for damage Ensure that the shut off valve moves freely inside its cage To remove the filter pull
18. gled to allow ease of entrance to the mouth and the respiratory airway A different type of suction set which includes a silicone tube length 130cm 51 2in and one Finger tip sterile joint is available at customer request Finger typ joint allows the user to control the vacuum by opening or closing a venturi hole with a finger When the venturi hole is completely open the vacuum will operate at the minimum value with the venturi hole completely closed the vacuum will operate at the value set on the unit Silicone tube is sterilizable Finger typ is disposable Power supply and charging of the battery The unit is equipped with an internal rechargeable battery non user replaceable The maximum time for charging the battery as the residual capacity is about 15 hours The times fall significantly if the device is recharged after each use A fully charged battery will provide approximately 45 60 minutes of continuous operation at zero vacuum level free flow It is considered an average life of the battery if properly loaded equal to 24 months In case of inactivity for along time run every 15 days a complete control and charging for at least 24 consecutive hours The device can be recharged via the supplied cable the wall bracket or the battery charger power supply 100 230 The charging cable must be connected to a power source between 12 and 15 Vdc To allow the use and recharge the device must be connected to an external p
19. ic equipment for disinfection of medical equipment including the suction units we produce DISINFECTANT S CODES e MED99050 Kit spray for disinfection of medical devices e MED99051 Concentrate for disinfection of medical devices 5 It e MED99052 Disinfectant wipes pack of 200 pcs e MED99055 Disinfectant wipes in sachets pack of 200 pcs e MED99060 Bactericidal disinfectant spray 500 ml e MED99100 DRY MIST device for environmental disinfection e MED99101 Active solution for DRY MIST 500 ml These disinfectants are tested in laboratory and guarantee the deactivation of viruses bacteria and microorganisms Periodically used they prevent and destroy the formation of dangerous bio films superficial layers that easily host bacteria molds viruses and microorganisms The disinfectants we commercialize do not contain alcohol chlorine phenols aldehyde and halogens Safety The suction unit OB 1000 is equipped with some electrical safety devices to protect it from any failure or by bad connection All protections are placed inside and there is no replacement by the user security automatic reset The intervention of the same and thus the failure of the device must provide for the immediate deployment of the device to the service Disposing of the suction unit The unit contains electrical and or electronic equipment that must be recycled per EC Directive 2002 96 EC mmm Waste Electrical and Electronic Equipment WEEE 12
20. imum e cover the patient tube on the collection jar with a finger or a lint free cloth e check the maximum value of the vacuum 800mbar 10 on the gauge e turn regulator knob anti clockwise and check the reading on the gauge When finished compare the results of this test with the value on the table below Test phase x Ri Remedy Switch the unit on The indicator lights for the power and the Pump failure and or battery completely a motor switch are on noise from the discharged Recharge the battery and check the indicator light goes green Check the battery power the battery is fully charged the green Recharge the unit immediately light will be on Check the maximum vacuum Value range between 700 and 800 mbar Check that the lid on the collection jar is Rev 09 2013 USMAN1000 3P UK 70 80kPa 525 600mmHg tight and that all connections are secure Change the disposable liner Check the vacuum regulation Gauge reading ranges from maximum to Check the vacuum connections and or the minimum regulator anti clockwise for minimum vacuum WARNING In the event of continued problems after taking the action outlined above send the unit to an authorised service centre for service or repair Collection jar The device is sold with two different types of jar with a capacity of 1000mI reusable autoclavable jar OB1000FA reusable jar with disposable 1000ml Liner SERRES OB
21. ital environment Mains power quality should be that of a typical commercial hospital environment If the user of the suction unit OB1000 requires continued operation during power mains interruptions it is recommended that the suction unit be powered from an uninterruptible power supply or a battery lf abnormal performance is observed on the suction unit OB1000 it may be necessary to position the suction unit OB1000 further from sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low NOTE Ur is the AC mains voltage prior to application of the test level 17 24 Rev 09 2013 USMAN1000 3P UK GUIDELINES AND DECLARATION OF CONPLIANCE FOR MEDICAL DEVICES TEST OF CONDUCTED AND RADIATED ELECTROMAGNETIC IMMUNITY For the purposes of conducting the tests using test levels IEC60601 Vi 3 and E 10 The BSU suction units are intended for use in the electromagnetic environment specified below The user of the OB1000 suction unit should assure that it s used in such an electromagnetic environment IEC 60601 Electromagnetic environment TEST LEVEL guidance IMMUNITY test Portable and mobile RF communications equipment should IEC 61000 4 6 150 kHz to 80 MHz be used no closer to any part of the OB1000 suction unit including cables than the
22. ne patient tube length 130cm 51 2inch int diam 6mm ext 12mm Canister OB J FA without lid Shut off valve 3 pcs 90 plastic joint for OB J FA jar 3 pcs Lid for OB J FA complete with shut off valve and 90 plastic joint Conical connector 5 pcs Silicone tube 15 cm with conical connector Red carrying bag for OB1000 FA Red carrying bag for OB1000 LINER User manual NOTE The parts listed in the list may be changed without prior notice from the manufacturer and or technical improvements Contact the manufacturer for more information gt 13 24 Rev 09 2013 USMAN1000 3P UK SERVICE There are no serviceable components inside the suction unit Do not open the suction unit and do not modify any electrical or mechanical parts Always contact your service center or the manufacturer Any even minimal intervention on the device voids the warranty Unauthorized intervention may compromise its conformity with the applicable laws and reduce the security to the detriment of users and patients FAULT FINDING The suction unit doesn t work when Completely discharged battery Charge the unit for at least 24 hours powered by the internal battery e Fauly battery e Refer to authorised service personnel Cable damaged The suction unit doesn t work when Damaged wall bracket and or contacts mounted on the wall bracket or with the on the suction unit external charger cable External power source failure 12 15Vdc
23. nger of cross contamination we recommend replacing the filter after each shift In case of complete inactivity of the unit is recommended to replace the filter once a month The material it is made should be damaged even under specific environmental conditions humidity heat cold Do not use the suction unit without the protection filter or jar Reusable jar with disposable Liner SERRES The suction unit OB1000 LINER is sold with a 1000 ml SERRES secretions jar equipped with a disposable bag The jar is made of a transparent plastic material polycarbonate and can hold a disposable bag equipped with antibacterial and anti contamination filter The jar is equipped with an angular junction placed laterally which allows it to be connected to the suction unit The filter integrated into the disposable bag performs the function of preventing the backflow of aspirated liquids towards the suction unit when it completely fills up and to avoid cross contamination On the top of the disposable bag there is a white plastic disposable corner joint which allows to connect standard suction catheters or cannulas Jankauer Rev 09 2013 USMAN1000 3P UK Jankauer suction tube and Finger typ end piece The suction unit is sold complete with a sterile Jankauer type suction probe which is connected to a plastic suction tube The probe and the tube are disposable and must be changed after each use To facilitate correct operation the probe is an
24. o recharge it for at least 24 consecutive hours e Keep the device under load even when not in using The persistent connection to the vehicle voltage 12 15 VDC does not damage the device but allows maximum autonomy of the battery e Failure to regularly recharge the battery will lead to a deep discharge at which time the battery will need to be replaced WARNING ON REUSE OF DISPOSABLE PARTS e Reuse of disposable materials or parts may compromise the functionality of the device and represent direct and indirect sources of contamination for users and patients e Sterilization and or cleaning of disposable parts antibacterial filters disposable bags suction tubes Jankauer etc can cause structural degradation of the material and consequent dangers arising from loss of mechanical integrity IMPORTANT INFORMATION Note The device was designed and tested according to the latest regulatory standards The electrical connection of the device to non compliant electrical systems and or otherwise not performed by professional installer can damage device and also the electrical system Please always consult a qualified staff with knowledge of the latest provisions Preventive maintenance and safety inspection The device should be checked at least once every 12 months from the authorized service center Every 24 months an inspection of safety and technical maintenance is required instead Refer to authorized service centers for
25. om the packing stretch it picture 1 and insert it into the jar picture 2 Insert the complete jar into the bag and connect the tube to the suction unit Activate the suction unit Close with a finger the connector lt PATIENT gt and at the same time press lightly the bag from the center of the lid picture 3 Make sure the bag is completely swollen Connect the patient tube Jankauer to the connector lt PATIENT gt 11 24 Rev 09 2013 USMAN1000 3P UK NOTE The collecting bag must be inserted into a rigid container of the same size It is strictly forbidden to use defective products Disposal of contaminated parts Always follow local regulations or hospital practices when dealing with contaminated materials Never store contaminated parts with new or sterile parts Cleaning the suction unit To clean the chassis of the suction unit use a damp cloth with mild detergent Rinse the chassis with a damp cloth and dry it with a soft towel WARNING e Before cleaning the suction unit ensure that all external power supplies have been disconnected e Never immerse the suction unit in water e Do not use abrasive substances alcohol or solvents to clean the chassis In order to correctly disinfect and decontaminate the device we suggest you to use specific products not harmful for people and the environment These disinfectants must be free of alcoholic and abrasive substances Oscar Boscarol srl can provide you of specif
26. ower source 12 15 Vdc that can provide at least 6A Charging cable BSU854 Battery charger OB10WB wall bracket BSU870 EU BSU872 UK BSU806 BSU874 JP WARNING Check that the external power source is correctly rated The external power source has to be protected by a security fuse with a minimum rating of T15A delayed type The battery charger is an exclusive accessory available only from the manufacturer It can only be used indoors WARNING Do not use the suction unit on a patient with the battery charger connected to the mains electricity supply The mains voltage can be deadly to humans Checking the battery To verify and monitor the autonomy of battery and or in case of suspicion of revocation of the same do the following Charge the device for at least 15 consecutive hours set the maximum value of vacuum closing the vacuum regulator clockwise let the unit run without closing the patient tube for at least 20 consecutive minutes if the unit stops working earlier than 20 minutes the battery is damaged and must be replaced MAINTENANCE AND REUSE After each reuse After each use disconnect the unit from external power source disconnect the single patient use disposable parts e g Finger tip catheters liner etc and dispose of them according to local regulations Verify the integrity of the device check the connecting tubes and structural abnormalities Clean and disinfect the unit as describe
27. planning of inspection The periodic safety inspection of the device does not fall under warranty Contamination of the device It is strictly forbidden to send contaminated devices to the manufacturer installer or service centres Each device in these conditions will be refused and health authorities will be informed about possible contamination gt P Rev 09 2013 USMAN1000 3P UK OB1000 Suction Unit Available models BSU 210 OB1000 suction unit with OB J FA reusable jar BSU 214 OB1000 suction unit with SERRES jar BSU 220 OB1000 suction unit with OB J FA reusable jar and OB 20WB wall bracket BSU 224 OB1000 suction unit with SERRES jar and OB 20WB wall bracket NOTE For other models refer to the catalog available at www boscarol it Model BSU210 Model BSU214 1 Suction unit 1 Suction unit 2 Autoclavable jar 2 Jar with disposable Liner 3 90 plastic joint 3 Silicone tube with joint 4 Protection filter 4 Charging cable 5 Silicone tube with joint 5 with suction tube 6 Charging cable 7 Jankauer with suction tube Description and intended use statement The OB1000 FA LINER is a portable battery operated medical suction unit used for remove fluids from the upper airway and restore breathing either spontaneously or with assistance High vacuum values are normally used for the suction of oropharyngeal tract whereas low values are used for tracheal suction of children or newbo
28. r very low or absent Shut off valve blocked or damaged Replace the reusable jar Empty the jar or disconnect the tube from the jar and unblock the shut off valve The unit will only work in the upright position Disposable liner full of fluid Replace the disposable liner substances protection filter blocked Pump motor damaged Refer to authorised service personnel Vacuum 15 at maximum even if the Fault on the internal pneumatic circuit Refer to authorised service personnel High noise low suction high vibration Internal pump damaged Refer to authorised service personnel NOTE In presence of anomalies or faults other than those listed in the table above contact the authorized service center or the manufacturer of the device 14 24 Rev 09 2013 USMAN1000 3P UK TECHNICAL DATA AND CONFORMITY TO INTERNATIONAL LAW Classification according to the MDD93 42 EEC The Boscarol OB1000 is an ACTIVE MEDICAL SUCTION UNIT for use in the field and for transportable use in accordance with ISO10079 1 2009 MDD Classification Vacuum degree Mode of operation Electrical requirements Use of the device in the home environment Degree of protection against electric shock IEC60601 1 With respect to protection from electric shock Degree of protection against ingress of liquids IEC529 Accordance with general IEC60601 1 Dimensions Max dimensions Weight Tolerance on all values Technical data
29. rns The device can be used in emergency health services in first aid medical services in private homes and hospitals fixed or mobile The device is complete with storage bag Contra indication for use Do not use the OB1000 for draining the thorax Controls indications and check panel All the controls of the suction unit are on the front The unit can be controlled when fitted on the wall bracket or in the carrying bag To activate the device press the switch 4 which is protected against the ingress of humidity water and other fluids The vacuum adjustment is possible by turning the knob 5 Turning the control knob clockwise will increase the vacuum The monitoring of required vacuum is possible by the analog vacuum meter 1 and is expressed in millibars mbar and kilo pascal kPa or millimeters of mercury mmHg On the back are two contacts 7 that allow the charging of the device if fitted on the wall bracket Alternatively you can use the charging cable plugged into the external 3 pin connector 6 on the side of device 6 24 Rev 09 2013 USMAN1000 3P UK IN 12VDC Indicator lights All lights are placed on the front and display the operation of the device see Fig1 the autonomy of the battery 2 and the recharge state 3 The table below indicates the condition of the LEDs and the relative power of the battery LEDS STATUS AUTONOMY VALUE LED green on gt 0 maximum autonomy LED yellow on 40 50 of
30. sonnel e Never use the device to the presence of liquids gases and flammable mixtures and or explosives that could cause an explosion or fire e The use of the device in environmental conditions different from those in the manual may seriously compromise the safety and technical parameters of the device e In instances where suction takes place when the jar or protection filter are incorrectly installed or any foreign substances penetrate the unit it s necessary contact the nearest service center e Before cleaning the unit or proceeding with any maintenance disconnect the unit from the external power source Do not submerge the unit in water e There are no user serviceable parts inside the unit The only operations allowed are those listed in this manual For any technical problem for the periodic review and repairs please contact your authorized service e Use only genuine and authorised spare parts supplied by the manufacturer Oscar Boscarol Company or their agents Using genuine spare parts will increase the reliability of the unit and ensure that the guarantee remains unaffected e Do not modify any mechanical or electrical parts on the wall bracket The replacement of parts of wall bracket and or alteration thereof can seriously affect the safety anchorage of device The device cannot be used to assist patients during investigations through NMR nuclear magnetic resonance BATTERY e Upon receipt of the device it s necessary t
31. the features of EMC electromagnetic compatibility of this electro medical unit The full functionality of this unit is considered essential services for the purposes of electromagnetic immunity POSSIBLE METHODS TO AVOID THE RISKS OF ELECTROMAGNETIC INTERFERENCE In the case that medical unit can influence or be influenced by other electrical appliances places nearby try to change the place of use remove sources that emit radio frequency cell phones two way radios mobile antennas Try to move away from where you are if possible or turn off all non essential appliances nearby places including the electro domestics and follow the directions below GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The OB1000 suction unit is intended for use in the electromagnetic environment specified below The customer or the user of the OB1000 suction unit should assure that it is used in such an environment c Emissionstests Compliance Electromagnetic environment guidance The OB1000 suction unit uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely cause any interference in nearby electronic equipment RF emissions CISPR11 16 24 Rev 09 2013 USMAN1000 3P UK RF emissions CISPR11 Harmonic Emissions Voltage fluctuations flicker emissions Class B The OB1000 suction unit is suitable for use in all establishments including domestic esta
32. the maximum autonomy LED red 10 20 low battery autonomy recharging immediately The indicator for charging ON CHG 2 placed next to the indicators of autonomy has two different colors Red indicates that charging is taking place green indicates that charging is complete The indicator lights up whenever the device is connected for recharging If the LED does not light up there could be a malfunction of internal recharge circuit lack of power 12 Vdc or lack of connection of external cable to a power source for 12 Vdc WARNING Always check the right connection of the cigarette lighter the vibration of vehicles might cause its release The continuous charging of the device does not damage the internal battery and can always enjoy maximum autonomy It s always necessary to recharge the battery after each use The use of the device when the battery is discharged will destroy the internal battery Daily checklist The operations described in this section allow the user to verify the correct functioning of the suction unit The test should be performed at least once a day and before use in the field e Disconnect the unit from the wall bracket or from the external charging cable e place the unit on a stable surface in the upright position e g on a table e switch the unit on e check the indicator lights for battery power when the battery is fully charged the green light will be on e regulator knob clockwise to max
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