ob 2012 fa ob 2012 liner user manual
Contents
1. 6433581 Fax 4822 6449359 Japan NORMECA ASIA Co LTD Tokyo Daito Shiko Blvd 17 27 1 3 11 KURAMAE TAITO KU Tel 81 3 56873899 Fax 81 3 56873911 Slovakia DARTIN S R O Masarikova 16 08001 PRESOV Tel 421517734403 Fax 421517734403 Spain EMERGENCIA 2000 Velencia De D Juan 23 E 28940 FUENLABRADA MADRID Tel 34 91 6420009 Fax 34 91 6420359 United Kingdom and Ireland MERLIN MEDICAL The Whitbread Centre RHYMNEY GWENT NP22 5XD UK Tel 44 0 1685 843676 Fax 44 0 1685 843860 New Zealand Frontier Medical North Shore Mail Centre P O Box 101 715 AUCKLANDGWENT NP22 5XD UK Tel 649 4145640 Fax 649 4145642 BOSCAROL Emergency Systems www boscarol it2. 9001 2000 Certificate N 9120 BOS1 Certifies UNI EN ISO 13485 1996 Certificate N 9124 BOS2 Emission IMQ ITALY Notify body 0051 Annex 11 for Medical Suction Unit N666 Med declare in sole responsibility the product name MEDICAL SUCTION UNIT UMDMS Code 15016 Type OB 2012 FA OB 2012 LINER SELV Code BSU 100 BSU 102 BSU 104 BSU 106 BSU 108 BSU 110 BSU 150 BSU 152 BSU 154 BSU 156 BSU 158 BSU 160 being in conformity with the Council Directive 93 42 EEC for Medical Devices and performed on the essential requirements Annex 1 93 42 EEC Devices classification MDD 93 42 EEC CLASS lib The device is also performed on the following Guidelines and or norms MDD 93 42 EEC IEC 60601 1 1988 Annexes EN ISO 10079 1 1999 Bolzano 30 09 2003 Oscar Boscarol Brazzo Daniele President of the company Chief Engineering Department Quality Management Control 2003 09 Rev E1 USMAN2012 E 8 9 Traceability of the product MDD 93 42 CEE DEVICE SERIAL NUMBER Date of purchasing from Actual property Address Post N City Town Phone Fax Date Signature MONITORING OF THE BACK INFORMATION THE PRODUCT Your observations critics suggestions help the Boscarol Emergency Systems to get better the production activities the products the service office and the business way Thank You Please fill in the form and send by fax to the number 39 0471 932331 or by E mail to the add
3. Storage and transport conditions The unit must be stored in a dry room and protected against high value of temperatures When not utilized for a long time period the unit must be checked every month and recharge the battery for not less of 24 consecutive hours The temperature range for the right storage is between 25 C and 606 degrees C and the humidity range is f rom 10 to maximum 809 relative value not condensed in order to prevent sudden discharge of the internal batteries The storage is possible only with the original package which avoid damage and discharge of the internal batteries When disassembled for cleaning operation see this manual for the right operation Atmospheric pressure range 700 1060hPa 700 1060mbar 2 5 2 Operating instructions While in operation the unit should not be exposed to extreme temperature fluctuations Normal operations should only take place between 10 and 50 The acceptable humi dity range is between 20 and 90 If the unit is operating correctly outside the displayed values these values in relation to suction pressure and charging could be distorted Never operate the unit in temperatures above 60 C Be aware that if the unit is operating at altitude over 2 500 meters above NN the pressure value can slightly decrease This is caused by the decrease in the atmospheric pressure We suggest recharging the unit with temperature range between 15 and 30 C Atmospheric pressure range 700
4. The jar has to be inserted in the autoclave upside down At the finish of the sterile cycle put the parts on a table and leave to cool at the ambient temperature Before the reassembling verify the integrity off all parts 11 19 2003 09 Rev E1 USMAN2012 E N CAUTION Do not put weight on the parts during the sterilization cycle Observe the maximum limits for temperature pressure e timing on the autoclave Never exceed the value of 60 during the wash and cleaning operations All the cleaning disinfection and sterilization operations have to be making from qualify people Every 30 sterilization cycles replace the jar with a new one All tubes joint and plastic connectors have to be replacing with the jar e At the finish of the reassembling of the jar verify the good closing of the lid on the jar 4 2 2 Replacing of the protection filter Disconnect the tube from the contemned filter extract them from the cover and dispose it refer to the local laws in force Replace the new filter and reconnect the tube Verify that the green point side on the filter have to be connected to the jar writing VACUUM on the lid of the jar The opposite connection causes the immediately break of the filter draw 6 4 3 Reusable collect container with disposable Abbott liner After the use extract the complete jar with the liner from the unit and put it security on a table Put for the operation mask glasses and gloves Leave the liner fro
5. case of not use for long time for example verify every month the good operation of the unit and recharge the internal battery for not less of 24 hours e Never forget to store the suction unit after the use without to have recharged the battery When sealed acid battery voltage fail following a deep discharge have to be replaced e The replace of the internal battery is not possible from the user and or customer Refer always to the service authorized e During the recharging time verify the light on the front side On the charging phase the colour of the light is red and switch on green colour when the battery is completely recharged Security inspection The device have to be checked form the service authorized people at less every 24 mounth from the receipt date of the suction unit 2003 09 Rev E1 USMAN2012 E 1 Caution notices 2 Introduction 2 1 Package contents 2 2 General description 2 3 Contra indication use 2 4 Technical features of the device 2 5 Special storage and operating instruction 2 5 1 Storage requirements 2 5 2 Operating instructions 2 5 3 Operating in the rain 2 6 Guarantee 3 Description of the device 3 1 Controls indications and check panel 3 1 1 Mechanical controls 3 1 2 Lighting indications 3 1 3 Test of the device 3 2 Collect container Jar 3 2 1 Reusable collect container 3 2 2 Protection filter 3 2 3 Reusable collect container with disposable liner 3 3 Suction cathe
6. during the charging is confirmed by the front bicolour light see fig 1 The connection with an external power source allows sparing the internal energy from the battery and at the same time recharges the battery at the maximum efficiency The power of the external source have to be minimum 6A working current If needed by customer it is possible to recharge the unit with a special adapter optional from the main supply 230VAC or 100VAC Boscarol Emergency Systems has a large family of this adapter with the right plug every type of market UK Japan USA Europe etc Refer to page 13 for the right codes 10 19 2003 09 Rev E1 USMAN2012 E Do not use the suction unit on the patient during the recharging phase with the adapter connected to the main supply ln ll Sterile Jankauer probe Silicone patient tube and Finger typ Note Do not connect the suction unit direct to the main supply You have to be sure of the value and type of the external power source The external power source have to be protected N with a security fuse for a minimum 10AT delayed type Never open the battery charger It will work with main supply 100VAC or 230VAC and it is very dangerous for the people DANGER The maximum time for the recharging of the internal battery is about 15 hours For reduce this time reconnect the suction unit to charging source after each use The permanent connection of the unit on the vehicle electrical system doesn t dama
7. explosive substances Do not use the suction unit on the patient during the recharging phase with the adapter connected to the main supply 14 19 2003 09 Rev E1 USMAN2012 E 8 2 Size and dimensions Max dimensions Weight Tolerance max on all measures 8 3 Technical features of the device Max vacuum power Vacuum Regulation Regulation range of the vacuum Max flow rate Max autonomy with the maximum current load Approximante max noise Precision of the analogical gauge Precision of the battery voltage monitor 8 4 Power supply Working recharging Max current load Battery capacity Max time for recharging External Fuse Internal Fuse N 350mm width x 120mm depth x 240mm height 13 77inch width x 4 72inch depth x 9 44inch height 4 6Kg max complete with all accessories 5 800mbar 80kPa 610mmHg 10 on the range linear 30 800mbar 0 80kPa 30 LPM litre pro minute on free air 10 about 40 minutes 10 7OdB 5 5 12 15Vdc Direct Current 7OW max current 6A internal hermetically sealed acid rechargeable with 4Ah 15 following hours T15A 1x F2 5A 2x 7A RAY 1x F0 5A not accessible from the user Note the external power source must supply at least 6ADC for the working and the recharging of the internal battery With the battery charger from the main supply the unit during the work uses the internal battery energy 8 5 Environmenta
8. on the draw 6 The wrong insertions break the filter with the right possibility of a unit contamination x The side with the green point have to be connected on the jar side writing VACUUM GREEN POINT to the patient fig 6 OBJ FA JAR 3 2 3 Reusable collect container with disposable liner LINER The OB2012 LINER is sold with a transparent graduated 1000cc reusable jar and with a disposable liner In the liner is integrated a special protection filter with double function protection against the fluid overflow and shut off valve In case of fluid substances go in contact with this filter the suction is blocked and the user has to change immediately the liner The clean operation and the disinfection of the tubes are descripted on the 4 Chapter AN Note Always verify before the use the right insertion of the jar into the unit The joint of the jar yellow part have to go in the special hole on the suction unit Insert completely the liner in the jar and verify the good close of the lid Otherwise the maximum depressure can not be reached 2003 09 Rev E1 USMAN2012 E The next pictures ilustrates the composition of the reusable jar with the disposable liner and the related connections 1 Reusable 1000cc OB J FM jar 2 Silicone patient tube length 130cm 51 2 3 Disposable plastic connector to the patient tube Tube and to fix on the liner 4 Disposable 1000cc ABBOTT liner with connection tube and protect
9. 1060hPa 700 1060mbar 2 5 3 Operating in the rain The OB2012 FA LINER is protected against the rain penetration Otherwise the unit should never be operated by very heavy rain Whether during operation or storage the unit must always stand upright In the event that water gets into the side compartments suction unit clear and then dry throughly 2 6 Guarantee The Boscarol Emergency Systems offers for the OB2012 FA e OB2012 LINER a 36 months guarantee from the date of the first purchase Boscarol Emergency Systems guarants that each new OB2012FA and OB2012 FM products is free of defects in material and workmanship From this guarantee are excluded the collect container and or the liner the external cable for the recharging the internal battery the normally wear and tear of the unit discoloration colour alteration and all the other aesthetical irregularity which not produced degradations the operations of the unit If returned to Boscarol Emergency Systems the factory will arrange for repairs or replacement within the terms of this guarantee The defective device should be decontamined and returned properly packaged with included writing note about the defect of the unit All costs for the shipment postal and or courier are to sender expense The guarantee shall not apply to any Boscarol product which has been repaired by otherone other than authorized Boscarol emergency Systems representative or altered in any way so as in Boscarol s judg
10. 2 Suction unit is manufactured in accordance with the laws in force and is engineered for a very easy use during the emergency situations The most benefits are these e Very strong ABS antischock chassis with special design easy to clean and protected against the penetration of fluid subsatances and water e Easy way to replace the disposable and or maintenance parts e Dual mode battery charger with the external cable with cigarette lighter socket or with the optional wall bracket e It is possible to recharge the battery from a main supply with a optional battery charger 230VAC or 100VAC e When the unit is put on the wall bracket or at the external cable the unit doesn t use the energy from the internal battery e Easy switch on of the device with a protected switch accessible also with glove e Realtime value of depressure on the double range analogic gauge mbar kPa e Vacuum regulation from minimum to maximum without step linear It is possible to set any value from a minimum of 800mbar 80kPa e Very high powerful pump motor about 30LPM e High affidable system with double piston pump e Realtime indication of battery autonomy with light indicator 4 steps e Realtime indication of recharging with green colour led e All controls are on the front side of the unit to be used also when the unit is fixed on the wall bracket 4 19 2003 09 Rev E1 USMAN2012 E 2 5 Special storage and operating instructions 2 5 1
11. 2003 09 Rev E1 USMAN2012 E MEDICAL SUCTION UNIT BOSCAROL OB 2012 FA OB 2012 LINER USER MANUAL OB 20 12 SUCTION LIN 2012 with autoclavabile jar OB2012FM with disposable jar MANUFACTURED BY BOSCAROL Emergency Systems Tel 39 0471 932893 Fax 39 0471 932331 E Ava 0c T WWW boscarol it gt IIALI 2003 09 Rev E1 USMAN2012 E 1 Caution notice PLEASE READ BEFORE THE USE e Before the use of the OB2012 Suction Unit please read this instruction manual carefully e The OB2012 Suction Unit is an independent active medical device Laws in force restricts this device to sale distribution and use by or on the order of a physician emergency medical technician or other medical practitioner e Do not use the suction unit in presence of flammable agents or anesthetics e Due to the nature of the unit s use all precautions must be taken to ensure the unit s reliability cleaning storage environmental conditions etc e In case of suction without the jar and or the protection filter or in the case of a suspicion that any substances are penetrated in the unit send immediately the suction unit to the service center for the control and the decontamination see the 6 chapter e Before cleaning the unit and or to proceed to the maintenance of the device disconnect the unit from the wall bracket or from the recharging cable Do not put the unit in
12. A e N 1 user manual OB2012 LINER Medical suction unit e N 1 Suction unit OB 2012 ready to use e N 1 1000cc reusable collect container with disposable liner complete with integrated filter e 1 external recharging cabel 4 poles e N sterile Jankauer suction catheter complete with suction tube e 1 red carrying bag e N 2 spare fuse of 15AT e N 1 user manual Optional only if needed by customers e Battery charger from the main supply 100 230Vac 50 60Hz e Set patient silicon tube with end piece Finger typ e Wall bracket with electrical connections for the recharging in the vehicle 12Vdc e Blue colour carrying bag 2 2 General description The OB 2012 FA LINER is a portable battery operated medical suction unit used to clear the upper airway and restore breathing either spontaneously or forced The unit is suitable for use in paramedic services in a doctor s office or for home medical care The OB2012 is powered by sealed acid battery capable of driving the unit at full power for about 40 minutes 10 The internal battery 12V is recharged with a special inside electronical circuit DC DC converter which is activated by the connection to the vehicle electrical system 12Vdc Upon request the unit can be fitted with a special charging retention shelf wall bracket OB20WB 2 3 Contra indication use Do not use the suction unit OB2012 for the thorax drainage 2 4 Technical features of the device The OB201
13. able Finger typ the suction catheter refer to the local law in force for the dispose of this material e Disassemble the parts of the jar lid shut off valve ribbon etc Follow the indication on the draw of page 8 for the disassembling and reassembling of all parts After the dispose of the disposable parts put the other parts in cold water and good rinse After this operation rinse the parts in hot water temperature not higher of 60 C with a soft not alco holic detergent Good wash the parts and if necessary use soft brushes At finish rinse the parts with hot water 30 40 C max and after dry the parts with a not abrasive to wel Before the reassembling control that all parts are cleaned dry and not broken 4 2 1 Decontamination of the jar The jar can be disinfected with appropriate chemical substances not aggressive and not abrasive Do not use any type of substances which contains alcohol and solvents Do not use coloured disinfection substances which may reduced the transparency of the jar Never use pure disinfectant substances only solution The jar is on special material and it offers a good protection against the water and the humidity but longer time immersion on the water may produce a lower chemical decomposition which with the time reduce the resistance of mechanical and pressure crash For the sterilization use only steam autoclaves at the maximum temperature of 121 max pressure 2bar for a max ti me of 15 minutes
14. ano Italy 2003 09 Rev E1 USMAN2012 E 3 Description of the device 3 1 Controls indications and check panel All the controls of the suction unit are on the front side of the unit The control of the unit is possible also when the unit is fitted on the wall bracket and or with the carryng bag 3 1 1 Mechanical controls On the front side the switch 4 is protected against the penetration of humidity water and fluid substances Adjustment of the negative pressure can be accomplished with the knob 5 also found on the front side Turning the knob clockwise achieves maximum depressure The double range analogic gauge 1 shows in realtime the value of the negative pressure on the patient side The range of the gauge is in millibar mbar and kilo Pascal kPa On the back side of the unit the two contacts 7 are located for the connection of the unit in the wall bracket The contacts are maintenance free The recharging is possible also with the external cable to put on the socket 6 near the switch Do not force the insertion of the connector into the socket refer to the figure 1 and 2 3 1 2 Lighting indications On the front side of the unit the lighting indicators allow the control of the switch condition the battery autonomy 3 and the recharging phasis 2 see fig 1 All lighting indicators are easy to see in presence of strong sun light The autonomy of the internal battery is displayed by four red leds The table belove indica
15. charging the battery and verify from the motor the depended light green Verify of the autonomy indicator With battery fully charged all red lights have Recharging immediately the unit to be on Verify of the maximum vacuum Value range between 750 and 800 mbar Check to be sure that the lid on the collect 75kPa and 80kPa container is tight and vacuum connections are sure Change the disposable liner Check of the regulation the vacuum Value range between minimum Check the vacuum connections and or the maximum regulator counter clockwise for minimum vacuum Note in case of negative results after the action above descripted send the unit to the authorized service center chapter 6 3 2 Collect container The OB2012 suction unit is sold with a reusable 1000cc jar code OB2012FA or with reusable jar and disposable 1000cc liner code OB2012 LINER The OB2012 FA includes an external protection filter which prevents the contamination of the pneumatic circuit 3 2 1 Reusable autoclavable collect container The OB2012FA includes a 1000cc reusable jar with integrated a mechanical shut off valve The jar is produced with a plastic material polypropilene and it is transparent with a graduated external printed range The cover of the jar allow inserting the protection filter on the VACUUM side The filter is hydrofobic PTFE which doesn t allows the flowing back from the fluid and wet gas substances The jar can be s
16. e the reusable jar Empty the jar and or disconnect the tube from the jar for unblock the shut off valve The unit can work only on the upright position Disposable liner full of fluid substances Replace the disposable liner protection filter blocked Pump motor damaged Refer to the service people It is impossible the regulation of the vacuum Fault on the internal pneumatic circuit e Refer to the service people which is always max even if the jar is extracted High noise low suction high vibration Internal pump damaged e Refer to the service people Note For others type of anomalies and not indicated on the table above refer always to the authorized service centre and or to the manufacturer 8 Technical data and conformity to the international law 8 1 Classification on the MDD 93 42 EEC ACTIVE MEDICAL SUCTION UNIT for the field use transportable use and performed on the norm 15010079 1 1999 Classification for medical device lib Type of suction HIGH VACUUM HIGH FLOW Destination of use TEMPORARELY max continue use 60 minutes Type of power supply SELV 12 15VDC type BF class II performed on the IEC601 1 1988 Protection against the water IEC529 1989 IPX32d Protected against the penetration of a solid matter with diameter over 2 5mm protected against the water splash and against the penetration of metallic wiring N Do not use the suction unit in the presence of flammable and or
17. ge the battery and or the unit A special electronic circuit controls the battery voltage and optimizes the efficiency of the battery The contacts on the back side of the unit are performed for the connection on the wall bracket The contacts are maintenance free Do not alterate these contacts Do not introduce any parts in or between the contacts In the case of alteration break or misuse the contact can be changed only by the authorized people of the service centre 4 Maintenance and reuse 4 1 After use After the use switch off the device disconnect the disposable parts finger typ catheters liner and etc and dispose it Verify always the integrity of the device the connection tubes and the controls on the front side Control the chassis and verify the possible anomalies chassis broken or alterate knob and vacuum regulator etc Proceed to the cleaning and disinfection of the unit as descript on the chapter 4 5 replace the disposable parts and recharge the device with the external cable or on the wall bracket Establish a daily checklist as descript on the 3 1 3 chapter 4 2 Reusable collect container Operations list for the clean and disinfection of the reusable jar e Put gloves and protection if needed protective glasses and or protection mask e Disconnect the jar from the unit e Disconnect all tubes from the jar and from the protection filter e Empty the jar and dispose the content if necessary the filter the dispos
18. ieces Protection filter tyoe AIR SAFETY 60mm for the OB2012 FA set 40 pieces Disposable 1000cc ABBOTT liner with tube and connector set 10 pieces Disposable 1000cc ABBOTT liner with tube and connector set 30 pieces Disposable 1000cc ABBOTT liner with tube and connector set 50 pieces Reusable 1000cc OB J FM iar without disposable liner Reusable 1000cc OB J FA autoclavable jar with connectors and protection filter Sterile rigid probe type Jankauer complete with plastic connections tube End piece sterile disposable Finger typ set 5 pieces End piece sterile disposable Finger typ set 15 pieces End piece sterile disposable Finger typ set 50 pieces 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 Multilanguage user manual in English language Silicone patient tube length 130cm 51 2inch int diam 6mm ext 12mm Connection tube between the protection filter and the suction unit with plastic joint 90 yellow plastic connector for the OB J FA jar on the cover 5pieces Complete kit shut off valve for the OB J FA jar 3 pieces Complete T connector for the OB J FM jar 3 pieces External recharging cable with cigar lighter plug Accessories and optionals Carrying bag with safety belt red colour Carrying bag with safety belt blue colou
19. ion filter integrated Disconnect the patient tube from the liner On the upright position extract the jar from the unit On the lid of the jar close the patient side with the disconnected tube Extract and dispose the liner form the jar after replace with a new one Bom For the reassembling proceed with the operation in the opposite direction 3 3 Jankauer suction tube and Finger typ end piece The device is soled with a special sterile suction probe type Jankauer connect to one plastic suction tube The probe and the tube are disposable and must be changed after every suction To facilitate the suction operation s the probe is bended and allow the entrance on the mouth and on the respiratory way Under customer request it is possible to order one suction set which include one silicone tube length 130cm 51 1in and one special sterile joint called Finger typ This joint allows the user to control the vacuum with a finger When the hole is completely open the vacuum reach the minimum value Otherwise with hole completely closed the vacuum can reach the right value set on the unit Refer to the chapter 4 for the change and replace operations 3 4 Power supply and recharging of the unit The internal battery of the OB2012 suction unit can be recharged with the external cable or when the unit is fixed on the wall bracket The range of the external power source has to be from 12VDC to 15VDC direct current The right operation
20. ixed on the Battery fuses protection broken e Replace the fuse under the front cover wall bracket or with the external cable T15A e Damaged battery e Hefer to the service people The battery charger doesn t work property Battery charger damaged Verify the front light indicator If it is on but the battery not charged refer please to the service people Heplace the battery charger The suction unit works but the indicator of Damaged internal circuit Verify the indicator work if connected to the autonomy is off the wall bracket or to the external charger cable If works recharging immediately the unit at least 24 following hours o refer to the service people Hecharge the suction unit at least 24 Very low battery voltage following hours The autonomy of the suction unit is very Damaged battery Make the test descript on the chapter short 4 7 of this manual and or refer to the service people Internal recharging circuit failure Hefer to the service people The vacuum power on the patient side is very Regulator vacuum completely open Turning clockwise the regulator and low and or absent verify the value of the vacuum on the gauge Protection filter blocked and or Replace the filter damaged Connection tubes closed and or folding Replace and or reconnect the tubes and or disconnected verify the jar connections Disposable liner not good inserted Insert the liner on the Jar Shut off valve blocked or damaged Replac
21. l Emergency Systems 2 spare fuses pro each suction unit Do not use other type of fuse Replace the fuse and verify the good closed of the head on the home fuse If after the replacing of the fuse goes again broken refer to the service people 12 19 2003 09 Rev E1 USMAN2012 E 4 9 Demolition and out of order The OB2012 suction unit contents electrical parts and one sealed acid battery In case of demolition and or for out of service do not put the unit in fire or water Refer to the local law in force 5 Accessories and spare parts 5 1 Accessoires liste and identification code Index Code BSU100 BSU102 BSU150 BSU152 ASP 72000 BSU730 BSUT732 BSU734 BSU700 BSU702 BSU704 BSU502 BSU500 BSU770 BSU750 BSU752 BSU754 BSU780 BSU782 BSU784 BSU786 BSU788 BSU790 ZC42000 UK BSU902 BSU906 SPS66000 SPS65000 SPS67000 BSU852 BSU834 BSU830 BSU800 BSU862 BSU866 BSU868 Description Medical suction unit OB2012 LINER white with reusable jar and disposable 1000cc Abbott liner Medical suction unit OB2012 LINER yellow with reusable jar and disposable 1000cc Abbott liner Medical suction unit OB2012 FA white with reusable 1000cc jar Medical suction unit OB2012 FA yellow with reusable 1000cc jar User parts Protection filter tyoe AIR SAFETY 60mm for the OB2012 FA 1 piece Protection filter tyoe AIR SAFETY 60mm for the OB2012 FA set 5 pieces Protection filter tyoe AIR SAFETY 60mm for the OB2012 FA set 15 p
22. l and transport conditions Working recharging temperatures Suggested temperature for charging Storage temperatures Humidity UR for the work and the storage Range of atmospheric pressure 8 6 Technical data of the protection filter 0 50C 15 30C 25 55 with original package 20 8096 non condensed 700 1060hPa 700 1060mbar Type AIR SAFETY 60mm with PTFE filter and polypropylene hermetical chassis Max pressure applicable Retention capacity e for water solution e nebulized parts 1bar 100kPa 0 1um 99 99 up to 0 9bar 90kPa 8 7 Simbology VCA Voltage alternate 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 1bar 100kPa 750mmHg 15 19 2003 09 Rev E1 USMAN2012 E APPLIED PART DISPOSABLE PART TYPE BF REFER TO THE CLASS II USER MANUAL DEVICE PERFORMED ON THE MDD 3 42 EEC 0000 FOR DEVICE CLASSIFIED Ila AND 023555 Device conforms to the requirements of Directive 72 245 EEC 16 19 2003 09 Rev E1 USMAN2012 E 8 8 Declaration of conformity EEC Letter of Conformity on Medical Product BOSCAROL Emergency Systems We the manufacturer BOSCAROL EMERGENCY SYSTEMS V G Di Vittorio 33 39100 BOLZANO ITALY Tel 39 0471 932893 Fax 39 0471 932331 www boscarol it Email info boscarol it Certifies UNI EN ISO
23. m the jar in the upright position and disconnect the tube to the jar Close with this tube the entrance with the writing VACUUM and dispose the liner Replace the liner with a new one and reassembling the jar proceeding in the opposite direction of the disassembling 4 4 Disposing of the disposable contemned parts Refer always to the local law and norms in force for the disposing of the contemned parts Never store the used parts near the new and sterile parts 4 5 Cleaning of the device chassis To clean the chassis of the suction unit use soft towel and or a moist sponge if need use a soft not alcoholic detergent To finish the cleaning operations rinse the chassis only with a moist sponge and dry it with a soft dry towel N CAUTION e Before to proceed on the cleaning operations put out the suction unit from the wall bracket or disconnect the external recharging cable e Never dip or immerse the suction unit into fluid substances and or water e Do not use abrasive substances alcohol and or solvents that can damage the plastic chassis of the unit and destroy the label 4 6 Recharging of the internal battery The recharging of the internal battery is possible with the external charger cable or if the unit is fixed on the wall bracket see chapter 3 4 An optional battery charger only if needed by customers permits the recharge of the battery from the main supply see code on page 13 This unit can be used only indoor and can
24. ment to affect its safety or efficacy nor which has had the serial number altered effaced or removed Neither shall this guarantee apply to any Boscarol product which has been connected or charged otherwise than in accordance with the instructions furnished by Boscarol Conditions for the validity of the guarantee For the validity of the guarantee the customer shall produce this documentation e Copy of the invoice and or the purchase declaration with the serial number of the unit and the date of the purchasing For all legal purposes Boscarol Emergency Systems is responsible for the security operation and affidability only if e All technical operations repairs modify and mainenance actions are executed from the Boscarol Emergency oystems and or from the authorized service center e The device is right used as indicated in this user manual e The electrical systems where the suction unit is connected is performed on the international norms and national law in force Refer to above descripted Boscarol Emergency Systems is not responsible for accidental or indirectal damage resulted by not authorized modify not authorized repair not authorized technical intervents or when any parts of the unit are damaged in case of incident accident bad use and or misuse On the OB2012 suction unit doesn t is it other guarantee limited etc and or other ability not descripted on the present user manual Jurisdiction for legal department is Bolz
25. not be connected when the unit is used on the patient The internal battery can not be changed from the user Refer always to the authorized people from the service centre The normal lifetime of the battery if good recharged is about 24 30 months We suggest replacing battery every 30 months The maximum time for the recharging with a completely discharged battery is about 15 following hours Never use different battery charger as indicated on page 13 4 7 Test on the battery capacity For testing and verify the real capacity of the battery and or if presumed the bad quality of the battery proceed with this operations list e Recharging the suction unit for at least 15 following hours e Set the maximum value of the vacuum e Running the suction unit on a free air cycle for at least 20 minutes e If the suction unit stops the running before this time period the battery is damaged and need to be replaced Send the unit to the service people chapter 6 4 8 Security on the device The OB2012 is performed with special electrical security for the fault conditions Any of these securities are placed inside the unit and are not accessible from the user Only the fuse for the protection of the battery circuit is accessible from the user To replace this fuse please remove with a planar screw driver the head of the fuse holder on the back side of the unit The value of this fuse is T15A delayed function The customers become from the Boscaro
26. r Charging Retention shelf mounting Wall bracket OB20WB with recharging cable for the 12Vdc Battery charger 100 240VCA 50 60Hz Euro plug Battery charger 100 240VCA 50 60Hz UK plug Battery charger 100 240VCA 50 60Hz Japan plug Note the list above can be modified from the manufacturer without notice to the customers There are no serviceable components within refer to trained service people for service Do not open the suction unit do not modify any parts and or the electronic circuit Refer always to the manufacturer for the update spare list Each intervent even if not important for the right operations on the unit declines immediately the guarantee and doesn t guarantee the technical requirements scheduled on the MDD 93 42 EEC and refer to the norm ISO 10079 1 1999 7 Trouble shooting Possible cause Corrective action The suction unit doesn t work with the internal e Completely discharged battery e Charge the unit at least 24 following energy from the battery hours e Battery damaged e Refer to the service people The suction unit doesn t work if fixed on the Cable damaged Replace the cable wall bracket or with the external charger cable Damaged wall bracket and or contacts Replace the wall bracket on the suction unit External power source failure Verify the external power source and the 12 15VDC min 6A value of the voltage 13 19 2003 09 Rev E1 USMAN2012 E The suction unit works only if f
27. ress production boscarol it All data are only used to perform the request of the MDD 93 42 EEC and norm UNI CEI EN 46001 15013485 1996 18 19 2003 09 Rev E1 USMAN2012 E Italy BOSCAROL EMERGENCY SYSTEMS SRL V G Di Vittorio 33 39100 BOLZANO Tel 39 0471 932893 Fax 39 0471 932331 Austria CHEMOMEDICA GMBH Wiipplingerstrasse 19 Postfach 80 WIEN Tel 43 1 53326660 Fax 43 1 535330658 Belgio M E D I Q EMERGENCY SYSTEMS Alexander Farneselaan 15 B 9120 MELSELE Tel 32 3 3142569 Fax 32 3 3149687 Czech Republik DARTIN SPOOL S R O Budejovicka 47 615 14000 PRAHA Tel 420241470361 420261216076 Email info dartin cz China MEDTEC INT L Co HK LTD Rm 202 2 F At Tower 180 Electric Rd North Point HONG KONG Tel 852 28875432 Fax 852 28070908 France DIRECT MEDICAL 84 Bis Route De Behobie BP 424 F 64700 HENDAYE Tel 33 5 59480557 Fax 33 5 59480263 Germany MEDITEACH GBR Frau Nauses 46 D 64823 GROSS UMSTADT Tel 49 6078 75208 Fax 49 6078 75208 Indonesia PT DYTANDO ALDA ABADI JL MERUYA ILIRRAYA 11650 JAKARTA BARAT INDONESIA Tel 62 021 5863569 70 Fax 62 21 58491102 Netherland KP MEDICAL BV Rumpsterweg 16A 3981 AK BUNNIK The Netherlands Tel 31 0 30 2439114 Fax 31 0 30 6668073 Printed in Italy by Boscarol Emergency Systems 2003 09 Rev E1 USMAN2012 E 19 19 Polonia PARAMEDICA POLSKA 02 815 WARSZAWA UL ZOLNY 11 Tel 4822 6435920
28. t forget to connect the side with the green point on the jar side Otherwise the filter doesn t function in the right operation and doesn t protect the pneumatic circuit Do not use the suction unit without the protection filter On the next drawing the sequence of the disassembling of the protection filter and of the jar Disassembling of the reusable jar and of the protection filter OB2012FA Place all components on a stable and safety table During the assemblyng phases verify always the absence of damage on the components The shut off valve includes one special floating which run on the plastic yellow rail Verify 2003 09 Rev E1 USMAN2012 E always the easy running of this floating To extract the protection filter from the cover of the jar operate to screw unscrew the filter This operation allows extracting of the filter without any damage gt z gummi n 3 2 2 1 Use s caution of the protection filter If the suction unit is used on patient and or in emergency situation where is not possible to know the real risk of a possible contamination change always the filter after every use Otherwise when the clinic pathology of the patient is known and or doesn t exist the danger of a direct possible contamination we recommende to change the filter after every duty or at most every month even if the unit is not used Note Control that the insertion of the protection filter is as illustrated
29. ter Jankauer and or Finger typ joint connector 3 4 Power and recharging of the battery 4 Maintenance and reuse 4 1 After use of the suction unit 4 2 Reusable collect container 4 2 1 Decontamination of the collect container 4 2 2 Replacing of the protection filter 4 3 Reusable collect container with disposable liner 4 4 Discharg of the contamined and or disposable parts 4 5 Cleaning of the unit 4 6 Recharging of the unit 4 7 Verify of the battery capacity 4 8 Security on the device 4 9 Demolition and out of order 5 Accessories and spare parts optionals 5 1 Code and index 6 Service T Trouble shooting 8 Technical data and report to the international law 8 1 Classification on the MDD 93 42 EEC 8 2 Size and dimensions 8 3 Technical features of the device 8 4 Power supply 8 5 Enviromental condition 8 6 Technical data of the protection filter 8 7 Simbology 8 8 Declaration of the conformity 8 9 Return traceability of the suction unit EN46001 1996 15013485 2002 2003 09 Rev E1 USMAN2012 E 2 Introduction 2 1 Package contents OB2012 FA Medical suction unit e N 1 Suction unit OB 2012 ready to use e n 1 1000cc reusable collect container with integrated overfill valve e N 1 protection filter type AIR SAFETY 60mm e N 1 external recharging cable 4 poles e N sterile Jankauer suction catheter complete with suction tube e 1 red carrying bag e N 2 spare fuse of T15
30. terilized in an autoclave max pressure 2bar and maximum temperature 121 for maximum 15 minutes T he maximum number of sterilization procedures is 30 When this limit is achieved the jar has to be replaced During the jar s use must always be used in an upright position If the vacuum during the use shuts down empty contents immediately or replace the jar with a new one To release the shut off valve switch off the unit disconnect the patien tube VACUUM writing over the lid Do not use the suction unit without the jar and or the protection filter The next pictures show the parts of the jar the tubing and the right connections 2003 09 Rev E1 USMAN2012 E a PROTECTION FILTER 90 plastic joint connection Fig 3 OB J FA inserted in the OB2012 FA suction unit Fia 4 OB 1 FA lar gt 3 2 2 Protection filters To prevent fluid overflow on the unit a special protection filter is used between the jar and the unit The filter is produced with PTFE hydrofobic material which blockes the way of fluid substances into the pneumatic circuit Working together with the shut off valve on the jar the filter isolates the pneumatic suction pump from gas and fluid contamined substances When the filter is wet it is not possible to suction and have to be changed immediately The protection filter can not be sterilzed or decontaminated In the case of possible contamination and or colour change change the filter immediately Do no
31. tes the condition of the leds and the relative value of the autonomy LED S STATUS AUTONOMY VALUE 4 LED on gt 80 maximum autonomy 3 LED on 50 75 of the maximum autonomy 2 LED on 20 4096 of the maximum autonomy 1 LED on lt 20 low battery voltage recharging immediately The use of the unit with low battery voltage damages the internal battery and reduces his lifetime is very important to reconnect the unit to charge after each use The replaced of the internal battery is always excluded from the guarantee At side of the autonomy indicator is the control light for the charging phase 2 This indicator is a red green coloured led red indicates rechargement green indicates rechargement terminated The not lighting of this led indicates a bad work condition of the internal electronic circuit and or absence of external power source and or bad connection of the external cable and or bad connection of the wall bracket Verify always the insertion of the unit on the wall bracket and or the cigar lighter plug in the power source It is possible that the noise and vibration of the vehicles disconnect the cigar lighter plug from the socket The continuos recharging of the unit doesn t make damage on the internal battery Otherwise this condition offers the maximum autonomy of the battery CHG ON LED STATUS AUTONOMY VALUE red colour on charging phase green colour on charging terminated 2003 09 Rev E1 USMAN2012 E Mechanical con
32. trols and lighting indicators fig 1 and 2 1 Double range analogical gauge 2 Charging phase indicator 3 Battery autonomy indicator 4 Switch ON OFF 5 Depressure regulator increase the value clockwise 6 Socket for the external recharging cable 7 Electrical contacts for the connection on the wall bracket 3 1 3 Testing of the unit This operation agrees the user to verify the right operation of the unit Establish a daily check list to assure good performance of the equipment Daily operations list e disconnect the unit from the wall bracket or from the external recharging cable e place the unit stabil in an upright position ex on a table e switch on the unit e control the light indicator for the autonomy on the front side with fully charged battery all red light have to be e turning the knob of the regulator depressure clockwise for the maximum value e close with a finger the patient tube on the collect container e verify the maximum value of the depressure 800mbar 10 on the analogical gauge e turning the knob of the regulator counter clockwise and verify the decrease of the depressure on the gauge At finish compare the results of this test with the value on the table belove Test phase Result Action to be taken with negative result Switch on of the unit The indication lights for the autonomy and the Pump failure and or battery completely pump motor switch in on condition noise discharged Re
33. water or fluid substances to avoid the damage of the device e Do not suction substances for disinfecting or cleaning fluid in the unit without the protection filter and or the jar These substances can damages the internal parts of the unit e There are no serviceable components in the unit refer always to trained service people e Use only original and authorized spare parts furnished from the manufacturer Boscarol Emergency Systems to have always the maximum security and efficiency of the device e Do not alter the mechanical and or electrical parts on the wall bracket unit The change and or the alteration of parts on this unit can be very dangerous for the security retention Never change release and or modify the spring on the wall bracket This part is very important for the security in the case of very high negative acceleration force up 10g negative force Internal battery e Reconnect the suction unit for charging after every use The charging switch on automatically when the unit is put on the wall bracket when it is connected with the external cable to a 12VDC source or with the optional battery charger from the main supply On receipt of the suction unit from the manufacturer recharge the unit at least for 24 hours e The correct use and recharging of the internal battery guarantees a typical lifetime of 2 3years After this time it is better to change the internal battery e lf it is impossible to recharge the battery in
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