HiVac User Manual - Clements Medical Equipment
Contents
1. After this the jar may show signs of wear and replacement is recommended Operation Disposable Jar 15 CLEMENTS Spares MUL 94004 000 Mains Power Switch Green Rocker Kit Yellow Suction Tubing 20 metre roll 2 litre Collection Jar for Suction Pumps Jar Only SUC 80404 001 Single Use Plastic Handpiece pack of 10 SUC 84100 049 Exhaust Filter Assembly for Suction Pumps SUC 84100 162 Blue Bacteria Filter Set of 12 SUC 84100 162 Filter Bacteria Pack 12 SUC 84100 405 Hydrophobic Shut Off Valve Filter Pack 5 SUC 84100 505 Footswitch Kit for Suction Pumps with Switch Pneumatic Actuator SUC 84100121 Resilient Motor Mount Pack of 4 SUC 84109 002 Motor and Pump for HiVac HiFlo SUC 84200 033 Bung Assembly with Overflow Cut Off Valve for 2 litre Collection Jar SUC 84200 501 Seal for Collection Jar Bung Set of 2 16 Spares CLEMENTS Spares SUC 84200 502 Suction Inlet Nipple for 2 litre Jar Bung Set of 4 SUC 84200 503 Kit Grey Bung Float Chamber Set of 2 SUC 84200 518 Washer for Overflow Valve Pack of 4 SUC 84200 519 Blue Male Nipple for Bacteria Filter Pack of 10 SUC 84200 520 Blue Female Nipple for Bacteria Filter Pack of 10 SUC 84500 110 Kit Mounting for 3L Disposable Jar Pack 2 SUC 84500 111 Kit Jar Connect Tubing Pack 2 SUC 84500 112 Kit Liner Connect Nipple Pack 5 SUC 84500 113 Kit Ring Bracket for Dis2. Hydrophobic Shut Off Valve Filter Internal Blue Bacteria Filter yen To Patient Overflow Cut Off Valve Suction Pump Unit Jar 1 Jar 2 NO Overflow Cut Off Valve Operation Reusable Jar 11 CLEMENTS Operation To operate the Pump follow the steps listed below 1 Place the pump on a level surface with a 15cm clearance from walls or other objects Install the Collection Jars and Suction Tubing in either the single jar or double jar arrangement as described in the Connecting The Collection Jars section on page 8 Connect the unit to the mains power supply and switch the power on at the mains supply outlet Press the Power Switch down into the ON position and the Motor will run Occlude the Suction Tubing and adjust the Regulator by turning the knob to obtain the required vacuum level as indicated on the Vacuum Gauge Check that there is no loss of vacuum in the Suction Tubing and fittings Apply the catheter to the patient Check the Collection Jars to ensure that suction is being applied correctly Please Note 12 Although the Collection Jars are fitted with Overflow Cut Off Valves the fluid levels should be monitored to prevent spill over into the pump unit The Hydrophobic Filter fitted to the inlet of the pump acts as a single use shut off valve to protect the pump It must be replaced if fluid has spilled over into the pump unit Always start the pump wi
3. Note For disposable jars only which have an antibacterial filter built in to the lid connection may be made directly to the pump inlet nipple For reusable jars connection must be made through an inline blue antibacterial filter Jar in Use Jar on Standby 14 Operation Disposable Jar CLEMENTS Operation 1 Turn on power switch 2 Occlude suction cannula and adjust vacuum control to obtain the required vacuum level 3 Check that there is no loss of vacuum in the Suction Tubing and fittings 4 Apply the catheter to the patient 5 Check the Collection Jars to ensure that suction is being applied correctly If fluid reaches the maximum level the hydrophobic filter in the lid will operate to prevent further fluid flow When this happens switch off pump Disposal 1 Switch off pump 2 Disconnect tubing from jar 3 Remove the white elbow 6 and close the inlet port with the cap 9 attached to lid 4 Using the lid handle remove the liner 1 from the support jar and dispose of liner according to hospital protocol 5 Retain support jar 2 for reuse Support Jar Cleaning The reusable support jar may be cleaned either with water and neutral detergents or autoclaved at 121 C for 15 minutes Do not use solvents or alcohol for cleaning and disinfection These may damage the support jar The mechanical integrity of the support jar is guaranteed for 30 cleaning cycles under the specified conditions
4. e motor brushes This warranty does not extend to cover corrosion due to any cause nor to any damage to painted or anodised surfaces BMDi TUTA Healthcare will give the purchaser the benefit of any manufacturer s warranty in respect of any components in the product which were not manufactured by BMDi TUTA Healthcare if such a manufacturer s warranty is available Warranty 31
5. sccccccceceseeeeensceeeeeeeseeees 6 DOSCHONON sccccsciicesciee i Suse tomate A 8 Installation and CORA OR ices ece cs ess tas tet tcettereaeerens 9 Operation Reusable Jat siceccclascessemeecesrscsscentcneseetasscestane 10 Operation Reusable Jat ccccccccececeeeeetncceeeeeeeeteeeeeaaaes 11 SPa S e E eee eee 16 MANION NGG ennunnninn nrin EEE 18 Troublesho ting esineisiin a iii 20 Diagnostic Setup 22a ee ea 22 Disassembly and REPAII 22 cccceeeeceeeteeeeenteeeeeeeeeeeeneaaes 24 Emissions Guidance Table 201 wu cccccccccccccssssteeeeeteteeesees 26 Immunity Guidance Table 202 0 ccccccccccsssccceeeeetteeeennaees 27 Immunity Guidance Table 204 00 ccccccccsessscceeeeeeteeeeetaees 28 Waray esre aa erp E A 30 Contents 3 CLEMENTS Identification SUC 84109 HiVac High Vacuum High Flow Suction Pump Intended Use To provide a continuous vacuum source within the stated operating vacuum range for the aspiration of fluids and particulate matter in medical procedures carried out by clinically trained and authorized personnel Uninterrupted Availability This equipment is mains powered If patient care requires the uninterrupted availability of a source of vacuum the clinical facility must make provision for either a backup power supply or standby suction units which are battery or manually powered Classifications GMDNS Code 36777 GMDNS Term Suction Unit High Vacuum High Flow GMDNS Synonym
6. Indoor Specifications 5 CLEMENTS Transportation and Storage Environmental conditions for transportation and storage are shown in the following table In addition for vehicular transportation the unit should be packed in its original packaging and kept upright Parameter Minimum Maximum Temperature 10 C 40 C Humidity 60 RH 95 RH Barometric Pressure 700 mBar 1060 mBar Warning Symbols Legend The warning symbols marked on the equipment and their meanings are shown as follows Attention consult accompanying documents gt F Defibrillation Proof Type BF applied part Dispose of product according to requirements of WEEE directive Do By Transportation and Storage CLEMENTS Electromagnetic Interference This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and the receiver e Connect the equipment into
7. following procedure and refer to the block diagram below 1 Place two clean jars in the holders ensuring that both jars are fitted with an Overflow Cut Off Valve Note orientation 2 Connect the SUCTION outlet of the jar to be used first to the Bacteria Filter inlet on the main unit 3 Connect the PATIENT inlet of the jar to be used first to the Suction Tube leading to the patient 4 When the first jar is full disconnect it and use steps 2 and 3 to connect the second jar Hydrophobic Blue Bacteria Shut Off Valve Filter External To Patient Filter Internal Overflow Cut Off Valves in BOTH Jars Suction Pump Unit Jar on Standby Jar in Use 10 Operation Reusable Jar CLEMENTS Double Jar Arrangement 2L Reusable Jar Pump Inlet Jar Outlet To Patient Jar Inlet Both Jars In Use Spare Patient Tubing Cut Off Valve in this Jar Only To connect the Collection Jars in a double jar arrangement use the following procedure and refer to the block diagram below 1 Place two clean jars in the holders ensuring that only one jar Jar 1 is fitted with an Overflow Cut Off Valve 2 Connect the SUCTION outlet with the Overflow Cut Off Valve of Jar 1 to the Bacteria Filter inlet on the main unit 3 Connect the PATIENT inlet of Jar 1 to the SUCTION outlet of the jar without an Overflow Cut Off Valve Jar 2 4 Connect the PATIENT inlet of Jar 2 to the Suction Tube leading to the patient
8. wool in the exhaust filter may contain biohazard wastes Handle using safe handling procedures which may include the use of rubber gloves and eye protection and dispose of according to local protocols for biohazard materials he k Recycling At the end of their service life the pump and accessories should be dismantled if necessary and disposed of according to the WEEE directive Maintenance 19 CLEMENTS Troubleshooting Fault Check Rectify No Suction But Motor is Working Tubing Blocked Clear or Replace Overflow Cut Off Valve Closed Clear Replace or Empty Jar Hydrophobic Shut Off Valve Filter Blocked Replace Hydrophobic Shut Off Valve Filter Hydrophobic filter in lid of liner blocked Replace liner Inlet Blocked Clear Vacuum Gauge Defective Replace Vacuum Gauge Regulator Blocked Clear or Replace Bung Not Sealing Adjust or Fit New Seal Regulator at Zero Adjust Setting No Suction Motor Not Working Mains Fuse Blown Replace Faulty Mains Power Lead Replace Power Not Turned On Turn On Unit Fuses Blown Replace Thermal Overload Acti vated Wait For Unit To Cool Down No Suction But Humming Can Be Heard From Motor 20 Blockage In Pump Dismantle And Clean Pump Motor Windings Troubleshooting Replace Motor Fault Check CLEMENTS Rectify Not En
9. 2m 0 3m Yellow Suction Tubing 2m 0 3m Yellow Suction Tubing Blue Antibacterial Filter and Nipple Blue Antibacterial Filter and Nipple Power lead User Manual Power lead User Manual Important Remove transportation strapping from motor before starting Ensure power is disconnected before opening unit WARNING This unit can generate high vacuums It must not be used for applications which require low vacuum Always check patient requirements before applying the Clements HiVac High Suction Pump Connecting The Collection Jars The unit is fitted with two Collection Jars and can be connected either in a single jar arrangement or a double jar cascade arrangement With the single jar arrangement only one jar is in use at a time with the second jar on standby As one jar is filled it is disconnected so that it can be emptied and the other jar is connected The double jar arrangement allows both jars to be in use at the same time thus providing longer periods between changeover However the larger volume means the vacuum pull down time is longer Performance is generally better in a single jar setup Installation and Operation 9 CLEMENTS Single Jar Arrangement 2L Reusable Jar Pump Inlet To Patient Jar Outlet Jar Inlet Overflow Cut Off Spare Patient Valves in Both Jars Tubing Jar in Use Jar on Standby To connect the Collection Jars in a single jar arrangement use the
10. CLEMENTS HiVac High Vacuum High Flow Suction Pump SUC 84109 SUC 84509 proven through performance User Manual Manual No SUC 91005 414 Issue 24 CLEMENTS Safety Thank you for purchasing this Clements HiVac High Suction Pump For your safety it is imperative that this unit only be operated by authorised personnel in accordance with the instructions as described in this manual Operated in this way the HiVac High Suction Pump will provide the standard of service specified Due to continual improvements in product design the HiVac High Suction Pump may vary in detail from the descriptions in this manual In the event of further questions please contact your local distributor or BMDi TUTA Healthcare direct User Manual HiVac High Suction Pump Manual Number SUC 91005 414 Issue 24 Copyright 2015 BMDi TUTA Healthcare Pty Ltd The information in this manual was originated by and is the exclusive property of BMDi TUTA Healthcare Pty Ltd It is furnished for customer information only and is not an authorisation or licence to make this product or to furnish this information to others Unit 4B 128 130 Frances Street Lidcombe NSW 2141 Australia Phone 61 2 9466 5300 Website www medaust com i BMDi TUTA Healthcare Pty Ltd CLEMENTS Contents Classification S rspp eea onie enoa 4 Specifications ie pseccecstuhs acc tensecenatecedeMnsiereite oesieeeeertacnces 5 Transportation And StOraQe
11. _ Aspirator Device Class Class lla Electric Shock Class Equipment Protection Additional Electric Defibrillation proof Type BF Applied Part Shock Protection Sterilisation Not supplied in sterile state Anaesthetic NOT Category AP Rating NOT Category APG Operation Mode Continuous operation Classifications CLEMENTS Specifications HiVac SUC 84109 Power Rating 220 240 V 50 60Hz 380W Vacuum Range__ 0 to 98 kPa 0 to 735 mm Hg Max Flow Rate 32 litre min free air Motor Thermally protected PSC motor Pump Oil Less twin piston Ambient Continuous operation in ambient temperatures Requirement of 5 C to 35 C Filters Inlet disposable bacteria filter Exhaust clean bleached cotton wool 5g Internal disposable hydrophobic filter Reusable 2 x 2 litre autoclavable shatter resistant poly Collection Jars carbonate jars with non static polypropylene bungs Kit SUC84109 and overflow shut off valves Disposable 2 x 3 litre disposable liner with reusable support jars Collection Jars Liner incorporates hydrophobic and antibacterial Kit SUC84509 filter Regulator Needle Valve Gauge Bourdon tube type Dual Scale mm Hg kPa Accuracy 3 FSD Gauge Range 0 to 760 mm Hg graduated at 20 mm Hg 0 to 100 kPa graduated at 5 kPa Unit Width 406mm Depth 305mm Height 800mm Dimensions Weight 16 5kg Standard 25 C Sea Level 100kPa Conditions Environment
12. an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for his or her help Changes or modifications to the equipment not expressly approved by Clements could void the user s authority to operate the equipment Electromagnetic Interference CLEMENTS Description The Clements HiVac High Suction Pump is a mobile enclosed suction pump designed for high suction and high flow The main feature of this unit is the low maintenance piston motor and pump assembly which can generate suction strengths from 0 to 735 mm Hg 98 kPa with flow rates up to 32 litres of Free Air Per Minute FAPM depending on the model and power supply The unit is mounted on large rubber wheels which make it easy to move to any part of a hospital The unit also has a storage compartment at the rear to house additional tubing handpieces and other items needed when using the pump Main Components of Unit 1 Power Switch Exhaust Filter Vacuum Gauge Handle Regulator Control Knob Tube Storage Hooks Inlet Connection Storage Compartment oo AJOIN Pump Internal Description CLEMENTS Installation and Operation Contents SUC 84109 SUC 84509 SUC 84109 HiVac Suction Pump SUC 84109 HiVac Suction Pump 2 x 2L Reusable Collection Jar 2 x 3L Disposable Liner with with Bung Assembly Reusable Support Jars and Ring Brackets
13. configuration in which it is used The following tables provide information regarding the EMC characteristics of this Medical Electrical Equipment The compliance levels of immunity referred to in tables 202 and 204 have not been arrived at by testing but by declaration on the basis that the HiVac suction pump contains no electronic components and is inherently immune to the specified levels of electromagnetic disturbance The performance of all functions of the HiVac suction pump are considered essential performance for the purpose of electromagnetic immunity Table 201 Guidance and manufacturer s declaration electromagnetic emissions all equipment and systems Guidance and manufacturer s declaration electromagnetic emissions The HiVac suction pump is intended for use in the electromagnetic environment specified below The customer or user of the HiVac suction pump should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance Harmonic Emissions Class A The HiVac suction pump is suitable for use in IEC 61000 3 2 all establishments including domestic establishments and those directly connected to the public low voltage power supply network Voltage fluctuations Complies that supplies buildings used for domestic flicker emissions purposes IEC 61000 3 3 RF emissions Complies The HiVac suction pump is not suitable for CSIPR 14 1 interconnection wi
14. ction Tubing 3 Remove the 4 screws from the base plate tabs at the rear of the unit and push the housing forward off the base plate 4 Remove the four cylinder head screws from each head Remove the cylinder heads 5 Check O ring pistons and replace if worn cracked or perished 6 Clean the inside of the cylinder head Check flapper valves and replace if worn cracked or perished 7 Reassemble pump Periodic Safety Check The following safety checks should be performed at least every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests Inspect the equipment and accessories for mechanical and functional damage Inspect the safety relevant labels for legibility Inspect the fuse to verify compliance with rated current and breaking characteristics Verify that the device functions properly as described in the instructions for use Test the protection earth resistance according IEC 60601 1 Limit 0 2 ohm Test the earth leakage current according IEC 60601 1 Limit NC 500 uA SFC 1000uA The leakage current should never exceed the limit The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired 24 Disassembly and Repair CLEMENTS Fuse Replacement The Pump is fitted with two cartridge fuses located in fuse holders that are accessible from ou
15. in internal tubing or connections 2 Occluded vacuum check Vacuum Gauge Switch on pump and occlude inlet Note maximum vacuum reading 3 Occluded gauge check Vacuum Calibrated Gauge Vacuum Gauge Connect a calibrated vacuum gauge directly to inlet and repeat maximum vacuum reading Confirm that pump gauge reads within the specified tolerance 22 Diagnostic Setup CLEMENTS Flow Check 1 Occluded leak check Jar SUC 81099 1 litre or SUC 80312 2 litre Tubing SUC 80297 8x13mm Connect pump as shown in diagram Set vacuum control knob to maximum and switch on pump Occlude jar inlet and con firm that pump achieves the same maximum vacuum as in the previous vacuum check setup Any difference indicates leaks in jar or connections 2 Unoccluded flow check Jar SUC 81099 1 litre or SUC 80312 2 litre Vacuum Tubing SUC 80297 8x13mm Gauge Calibrated Collection Flowmeter Jar Connect pump as shown in diagram Set vacuum control knob to maximum and switch on pump Connect jar inlet to calibrated flow meter and note flow reading If flow is significantly below specification check internal tubing and pump itself or internal shutoff valve if fitted Diagnostic Setup 23 CLEMENTS Disassembly and Repair Dismantling The Pump The steps for dismantling the Pump are as follows 1 Disconnect the unit from the mains power supply 2 Remove Collection Jars and Su
16. ing by BMDi TUTA Healthcare e any contamination or leakages caused or induced by the purchaser and e inadequate or improper maintenance of the product This warranty does not cover normal wear and tear BMDi TUTA Healthcare will not be responsible for damage or loss caused during shipping In Australia apart from any warranties implied by the Trade Practices Act 1974 all other warranties expressed or implied and whether arising by virtue of statute or otherwise are hereby excluded Outside Australia all other warranties expressed or implied and whether arising by virtue of statute or otherwise including any warranties implied by the Vienna Convention are hereby excluded BMDi TUTA Healthcare obligations under this warranty are limited to the repair or replacement of the product within the terms of this warranty and the total liability of BMDi TUTA Healthcare for loss or damage of every kind whether arising pursuant to the terms of the sale of the product or otherwise in connection with the product is limited to the amount paid by the purchaser to BMDi TUTA Healthcare for the product Apart from any liability imposed by Part VA of the Trade Practices Act BMDi TUTA Healthcare accepts no other liability for any loss or damage occasioned including consequential loss or damages in any way as a result of the use of the product The warranty does not extend to cover damage to the following parts as they are inherently prone to wear
17. n Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles lt 5 Uy gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles Mains power quality should be that of a typical commercial or hospital environment The unit shut off during the gt 95 dip for 5 sec disturbance If the user of the HiVac suction 70 Ur 70 Ur pump requires continued 30 dip in Ur 30 dip in Ur operation during power mains for 25 cycles for 25 cycles interruptions it is lt 5 Ur lt 5 Ur recommended that the HiVac gt 95 dip in Ur gt 95 dip in Ur suction pump be powered for 5 sec for 5 sec from an uninterruptible power supply or battery Power frequency 3 A m 3 A m Power frequency magnetic 50 60Hz magnetic field IEC 61000 4 8 Immunity Guidance Table 202 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 27 CLEMENTS Table 204 Guidance and manufacturer s declaration electromagnetic immunity for equipment and systems that are NOT life supporting Guidance and manufacturer s declaration electromagnetic immunity The HiVac suction pump is intended for use in the electromagnetic environment specified below The customer or user of the HiVac suction pump should assure that it is used in such an environment Immunity Test IEC 61000 test level Compliance level not tested Elect
18. nty period and the product is returned to the place of purchase at the purchaser s expense BMDi TUTA Healthcare will repair or replace the product free of charge If a valid warranty claim is made within 30 days from the date of shipment then BMDi TUTA Healthcare will also reimburse the purchaser for reasonable freight costs in returning the product to the place of purchase Conditions of Warranty 1 The product must be returned to the place of purchase with proof of purchase 2 This warranty is only available to the original purchaser of the product 3 The product must not have had its serial number removed defaced or changed its casing opened its power supply altered or have been tampered with in any other way 4 This warranty does not cover e inadequate or incorrect site preparation e improper installation e connection to the wrong voltage e failure of the product due to misuse e the use or operation of the product outside of the physical electrical or environmental specifications of the product e use in a manner or environment in which the product is not designed to be used e improper adjustment calibration or operation by the purchaser e the use of accessories including consumables hardware or software which were not manufactured or approved in writing by BMDi TUTA Healthcare 30 Warranty 10 11 12 13 CLEMENTS e any modifications of the product which were not authorised in writ
19. ough Suction Regulator Setting Too Adjust To Correct Leaks In Tubing or Fittings Tighten Connections Blockage In Tubing or Fittings Clear or Replace Hydrophobic ShutOff Valve Filter Blocked Replace Hydrophobic Shut Off Valve Filter Hydrophobic filter in lid of liner partially blocked Replace liner Excessive Noise Coming From Pump Pump Worn Replace Pump Pump Incorrectly Assemble Correctly Pump Runs Intermittently Thermal Overload Is Cutting In and Out Disconnect Mains Power And Wait For Unit To Cool Down Replacing the Hydrophobic Shut Off Valve Filter Transparent Filter Housing Filter Media a To Patient To ensure there is no entry of fluid into the pump the Hydrophobic Shut Off Valve Filter MUST be fitted as shown above Troubleshooting 21 CLEMENTS Setup for Diagnostic and Performance Testing Note that the following arrangements are not used for actual suctioning applications They are specified to remove unnecessary variations when diagnosing faults and as a standard setup for performance measurement Vacuum Check o 1 Unoccluded zero check Vacuum Gauge Disconnect all items from inlet and with pump switched off confirm that gauge reads zero A non zero reading indicates a faulty gauge Set vacuum control knob to maximum switch on pump and confirm that gauge reads zero A non zero reading indicates obstruction
20. posable Jar Pack 2 SUC 84500 120 Kit Support Jar for 3L Disposable Liner Pack 2 SUC 84500 123 Kit Disposable 3L Liner Pack 50 SUC 84500 130 Kit Starter 3L Disposable Jar Pack 2 SUC 84500 133 Kit Support Jar for 3L Disposable Liner Pack 2 SUC 89107 Kit for Pump Vacuum Controller Needle Valve Type SUC 89240 069 Regulator Knob Replacement Kit for Suction Pumps Regulator Knob Screw SUC 91005 414 User Manual for the HiVac High Suction Pump Spares 17 CLEMENTS Maintenance IMPORTANT There are no user serviceable components inside Maintenance must be carried out by qualified personnel only To keep your Clements HiVac High Suction Pump in good condition the following maintenance is recommended After Each Operation Blue Bacterial Filter The blue bacterial filter is an important device to help protect the pump from moisture and bacteria taken from patient airways Clements recommend that the filter be changed every month or when the unit is used on infectious patients or when damp or discoloured Housing Wipe clean with a damp soapy cloth Do not immerse or allow liquid to enter the housing Suction Tubing Suction Tubing should be sterilised with sterilants determined by local protocols and compatible with PVC tubing Suction Tubing may be autoclaved to a maximum of 121 C for 20 minutes At higher temperatures the Suction Tubing will discolou
21. r and lose shape Reusable Collection Jars Place jars upright or up side down in autoclave not on their sides Autoclave to a maximum of 136 C for 10 minutes Do not use phenolic solutions as disinfecting agents in polycarbonate jars Bung Disconnect float cage and float from Bung Place all items upright or up side down in autoclave not on their sides Autoclave all items to a maximum of 136 C for 10 minutes Note Do not use abrasive cleaning agents as this may damage plastic surfaces and reduce the expected performance of an item 18 Maintenance CLEMENTS After Every 100 Hours or 2 Months of Operation e Replace the Exhaust Filter 1 Remove the Exhaust Filter from the rear of the unit 2 Unscrew the caps and replace the cotton wool The filter takes 5 gram of bleached and teased out cotton wool e Check all Suction Tubing and replace if it is perished soft or discoloured Also check the tubing nipples e Check the seal rings on the Bungs and replace them if they are hard cracked or perished Check the fit of the Bung in the Collection Jar e Check the Overflow Cut Off Valve seals and replace them if they are perished or damaged IMPORTANT The preceding maintenance should also be carried out immediately after use with infectious patients Disposal and Recycling Waste Materials The contents of the collection jars suction tubing bacteria filter internal hydrophobic shut off filter or the cotton
22. romagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 28 3 Vrms 150 kHz to 80 MHz 3 V m 80MHz to 2 5 GHz Portable and mobile communications equipment should be used no closer to any part of the HiVac suction pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 Vi VP d 3 5 E VP 80 MHz to 800MHz d 7 E VP 800 MHz to 2 5GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metre 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 Can Immunity Guidance Table 204 Notes CLEMENTS 29 CLEMENTS Warranty BMDi TUTA Healthcare Medical Equipment Pty Limited BMDi TUTA Healthcare warrants that this product is free from defects in workmanship and materials for a period of 12 months 3 months for batteries from the date of shipment by BMDi TUTA Healthcare or its authorised agent to the purchaser Subject to the conditions of this warranty if the product fails to operate for any reason within the warra
23. th Suction Tubing unoccluded Always clear any blockages before re starting the pump The pump motor is protected by a thermal overload mechanism that will stop the pump if the temperature exceeds a pre set level The mechanism will then automatically restart the Pump after the motor has cooled to the appropriate temperature Operation Reusable Jar CLEMENTS If the motor thermal overload trips switch the power off at the mains switch This will prevent unexpected re starting of the pump when the thermal overload automatically resets upon cooling If it is suspected that fluid may have entered the pump either by an external spill or by a jar overflow the unit must be taken out of service until the fault has been fixed and its continued electrical safety has been confirmed The service department must also be notified of any potential biohazard Operation Reusable Jar 13 CLEMENTS Single Jar Arrangement 3L Disposable Liner Jar Setup 1 Insert liner bag 1 into the matching size support jar 2 Press edge of lid firmly all around edge to ensure seal Close the TANDEM inlet 3 with the attached cap 4 Fit jar assembly into ring bracket Fit blue nipple of the connector tubing to blue pump inlet nipple 8 Press yellow nipple of connector tubing firmly into matching yellow port 5 on the lid Connect patient tubing to white inlet elbow 6 Connect patient tubing to suitable suction cannula
24. th other equipment 26 Emissions Guidance Table 201 CLEMENTS Table 202 Guidance and manufacturer s declaration electromagnetic immunity for all equipment and systems Guidance and manufacturer s declaration electromagnetic immunity The HiVac suction pump is intended for use in the electromagnetic environment specified below The customer or user of the HiVac suction pump should assure that it is used in such an environment Immunity Test IEC 61000 test level Compliance level not tested Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 3 4 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip i
25. tside the unit To replace the fuses use the following procedure 1 Disconnect the unit from the mains power supply 2 Locate the two fuse holders which are mounted on the rear side of the unit at the lower right hand side Lift off the fuse holder cover Remove the old fuses and inspect them If they are blown replace them with new fuses Replace the fuse holder cover Connect the unit to the mains power supply switch the power on and ensure that the unit is operating correctly Electrical Wiring Diagram IEC INLET MAIN SWITCH LIGHT BLUE GREEN YELLOW 2 X 15 0 FUSES GREEN YELLOW PSC MOTOR Fuse Replacement 25 CLEMENTS EMC Information Tables per EN60601 1 2 2001 09 Section 6 In accordance with EN 60601 1 2 2001 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests 1 Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents the following tables 2 Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment 3 The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the
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