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Penlon A200SP, User Manual

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A200SP Absorber

User Manual

A N A E ST H E S I A   S O LU T I O N S

Summary of Contents for A200SP

Page 1: ...A200SP Absorber User Manual ANAESTHESIA SOLUTIONS ...

Page 2: ......

Page 3: ...servicing or repair of this device contact the nearest accredited Penlon agent or communicate directly with UK and ROW except USA Technical Support Penlon Limited Abingdon Science Park Abingdon OX14 3NB UK Tel 44 0 1235 547060 Fax 44 0 1235 547061 E mail tech support penlon com USA Penlon Inc 11515 K Tel Drive Minnetonka MN 55434 USA Toll Free 800 328 6216 Tel 952 933 3940 Fax 952 933 3375 E mail ...

Page 4: ...pability to deliver mixtures of gases and vapours to the patient which could cause injury or death unless controlled by a qualified anaesthetist There can be considerable variation in the effect of anaesthetic drugs on individual patients so that the setting and observation of control levels on the anaesthesia system does not in itself ensure total patient safety Anaesthesia system monitors and pa...

Page 5: ...e functions 10 3 10 2 Bag Ventilator Switch 10 3 11 Gas Flow 11 4 Specification 12 4 1 General Dimensions 12 4 2 Resistance of Breathing System 12 4 2 1 Resistance Measurement Parameters 12 4 2 2 Expiratory Resistance 12 4 2 3 Inspiratory Resistance 12 4 3 Internal Compressible Volume 13 4 4 System Leakage Rate 13 4 5 Canister Capacity and Resistance 13 4 5 1 Canister Capacity 13 4 5 2 Canister Re...

Page 6: ...erilisation 29 8 1 Sterilisation Policy 29 8 2 Bacterial Filters 29 8 3 Patient Circuit Components 29 8 4 Absorber Assembly Procedure Before Sterilisation 30 8 4 1 Absorber Canister 30 8 4 2 Manometer Oxygen Sensor APL Valve 30 8 4 3 Electrical Interface Cables Tubing 31 8 4 4 Bellows Assembly Removal and Cleaning 31 8 4 5 Dismantling and Cleaning the Absorber before Sterilisation 32 8 5 Sterilisa...

Page 7: ...h a repair become necessary it is recommended that a request for service advice be made to Penlon Limited or the nearest Penlon Service Centre This device and any of its constituent parts must be repaired only in accordance with written instructions issued by Penlon Limited and must not be altered or modified in any way without the written approval of Penlon Limited The user of this equipment shal...

Page 8: ...ee section 5 3 2 13 Anhydrous soda lime is known to react with some anaesthetic agents Do not continue to use an absorbent if it has been allowed to dry out or if you suspect it has dried out Always replace dried out absorbent with a fresh supply of soda lime 14 Do not use the absorber without ensuring that it passes all pre use checks See section 6 After servicing and cleaning procedures verify p...

Page 9: ... run into the electrical interface unit at the rear of the absorber Do not autoclave 3 Do not allow any liquid to run into the heater unit if fitted Do not autoclave 4 Autoclaving the absorber canister Discard the absorbent and drain the condensate from the canister then refit the canister to the absorber assembly before autoclaving see section 8 4 5 Autoclave temperatures maximum temperatures are...

Page 10: ...d to absorb exhaled CO2 Intended patient population This product is intended to be used for a patient population from neonatal to adult when used in conjunction with a Penlon approved ventilator Intended part of the body or type of tissue applied to or interacted with No direct interaction with any part of the human body The absorber is used to transmit ventilated gas to and from a patient whilst ...

Page 11: ...tory non return valve NRV 3 Inspiratory hose connector 4 Bag ventilator switch 5 Reservoir bag connector 6 Canister 7 5 8 6 11 1 2 3 12 9 4 10 7 Ventilator bellows housing 8 Electrical interface unit 9 Expiratory hose connector 10 Expiratory non return valve NRV 11 Manometer 12 Canister release lever ...

Page 12: ...use adequate fresh gas flow must be maintained to prevent excessive build up of CO2 2 Condensation which may collect in the bottom of the absorber canister is caustic Avoid skin contact when draining Release 1 Swivel the front of the absorber assembly away from the side of the anaesthetic machine 2 Turn the lever 2 clockwise to the unlocked position 3 to release the canister Refit and Lock 3 Refit...

Page 13: ...hrough the top cover 2 and the operation of each valve can be visually checked as the patient breathes in and out IT IS IMPORTANT THAT THE ABSORBER IS MOUNTED UPRIGHT SO THAT THE VALVE DISCS MOVE IN A TRULY VERTICAL PLANE WITH THE VALVE SEATS HORIZONTAL 3 3 Bag Ventilator Switch The switch 1 can be set to bag or ventilator positions See Appendix 3 for switch position labelling Ventilator mode In V...

Page 14: ...ode The ventilator must be equipped with a pressure relief valve 3 5 AGSS Outlet and Fresh Gas Inlet and Hose AGSS anaesthetic gas scavenging system connector Taper connector 1 at rear of absorber assembly Fresh Gas Inlet and Hose The fresh gas inlet 2 is at the rear of the absorber The absorber is supplied with a fresh gas hose assembly with an attached end fitting Do not use any other type of ho...

Page 15: ...TION Do not autoclave the heater unit or heater elements 3 7 2 Spirometer Sensor Heater The spirometer sensors are mounted inside the electrical interface unit 5 and each sensor is heated by an individual heater element to limit the build up of moisture and maintain sensor performance The heater elements operate automatically a power indicator lamp 6 is illuminated when the cable 7 is connected to...

Page 16: ...atic Mode switching on the ventilator as follows a Ventilator in Volume mode or Pressure mode Switching the absorber bag ventilator control from ventilator to bag The ventilator will change from Volume Mode or Pressure Mode to Spontaneous Mode b Ventilator in Spontaneous Mode Switching the absorber bag ventilator control from Bag to Ventilator NOTE The mode switching operation is dependant on the ...

Page 17: ...atic NOTE The schematic represents the gas path with the absorber ON i e the absorbent canister in the locked on position see section 3 1 3 1 Ventilator bellows 2 Bag ventilator switch 3 Absorbent canister 4 Fresh gas flow from anaesthetic machine 5 Inspiratory non return valve 6 Adjustable pressure limiting valve APL valve 7 Breathing bag 8 Patient 9 Expiratory non return valve 10 Manometer 11 Pr...

Page 18: ...be used in the patient breathing system to protect the oxygen sensor Use an appropriate filter that does not raise the resistance values of the whole system to above 0 6 kPa 6 cmH2O 3 The adjustable pressure limiting APL valve must be fully open 4 2 2 Expiratory Resistance Tested as detailed in section 4 2 1 with a flow of 6 L min of air through the fresh gas inlet and an induced flow of 60 L min ...

Page 19: ...ve These figures are measured with 1 An absorber fitted with 1060 mm 42 inch breathing hoses complying with BS EN ISO 5367 and a Safelock Y piece Absorber ON canister in locked on position Leakage rate less than 50 ml min at 3 kPa 30 cmH2O 2 Absorber only Absorber OFF canister detached Leakage rate less than 50 ml min at 3 kPa 30 cmH2O 4 5 Canister Capacity and Resistance 4 5 1 Canister Capacity W...

Page 20: ...T2AH 250 V 4 9 Device Classification and Labelling The Absorber and its constituent parts are classified as follows Type B Applied Part Degree of protection against electric shock This symbol denotes Type B equipment Class 1 Classification Type of protection against electric shock Class 1 IPX0 Ingress protection Classification according to the degree of protection against ingress of water IPX0 not...

Page 21: ... MRI environment Contact Penlon Limited for details of the A200SP MRI Absorber Electro magnetic compatibility The A200SP meets the requirements of EN60601 1 2 compatibility requirements and tests Storage and Transport Temperature 5 to 40 C 23 to 104 F Humidity 10 85 RH relative humidity non condensing Air Pressure 11 5 110 kPa Disposal at end of useful life risk assessment There are no risks assoc...

Page 22: ...the anaesthetic machine Mount the absorber on the bracket assembly and secure by tightening the knob 2 Height Adjustment Slacken the knob 2 and position the assembly at the required height Tighten the knob 5 2 Anaesthesia System Connection WARNING 1 Breathing system connection Do not use a patient Y piece containing non return valves Usage with the Absorber is hazardous because two sets of non ret...

Page 23: ...s supply 9 Auxiliary outlet on anaesthetic machine ventilator drive gas supply 10 Flow sensor expiratory 11 Flow sensor inspiratory 12 Connectors sensor patient pressure monitor 13 Expiratory valve absorber 14 Inspiratory valve absorber 15 Connector reservoir bag 16 Inlet absorber fresh gas supply 17 Drive gas inlet ventilator 18 Drive gas outlet ventilator control unit to bellows 19 Outlet ventil...

Page 24: ...s Scavenging AGS The outlet 6 from the adjustable pressure limiting APL valve 7 must be connected to a receiver system WARNING Do not connect a vacuum system directly to the APL valve outlet A receiving system with a positive and negative pressure control function must be interposed The receiving system must comply with the requirements of EN ISO 8835 part 2 5 2 4 Oxygen Monitor The use of an oxyg...

Page 25: ...bottom of the absorber canister 1 is caustic Avoid skin contact when draining 1 Swivel the front of the absorber assembly away from the side of the anaesthetic machine 2 Turn the lever 2 clockwise to the unlocked position 3 to release the canister 1 3 Check the level of liquid in the canister Carefully lift out the inner absorbent container 4 or pre pack unit WARNING Condensate may drip from the c...

Page 26: ...ill above this level 5 Check that the three spacers 7 are fitted and place the container in the canister 5 3 3 Refitting the canister WARNING The canister seals at the top face Maintain the position of the rim of the canister over the outer lip of the seal 5 as you rotate the lever anti clockwise to the vertical locked on position Failure to lock the canister in the fully closed position may cause...

Page 27: ...le with the safety clip The heaters operate automatically 4 Check that the indicator lamps 4 and 5 are illuminated when mains power is connected 5 When shutting down the system make sure that the indicator lamps are not illuminated and that power to the system is disconnected CAUTION Do not immerse or autoclave the heater elements 6 heater control unit 3 or electrical interface unit 7 Remove these...

Page 28: ...ed out in the order listed 3 Check that the manometer is zeroed before use 2 Visual inspection of the absorbant Inspect the absorbant replace if necessary 3 Absorber security check section 5 3 4 Before refitting the canister check that the sealing surfaces are clean and dust free Ensure that the canister seals securely when refitted 4 Breathing circuit hose installation check section 5 2 2 Check t...

Page 29: ...at pressure is maintained i e the pressure must not fall to zero in less than one minute 6 3 Adjustable Pressure Limiting APL Valve Test and Pressure Relief Test APL Valve Function 1 Open the APL valve 6 Check that gas escapes freely from the system through the valve outlet APL Valve Flow Resistance 2 Set maximum flow and check that the retained pressure is less than 0 5 kPa 5 cmH2O 3 Reduce flow ...

Page 30: ...s bag and the absorber reservoir bag 7 Turn off the gas flow Check that gas cannot be forced through the inspiratory valve by gentle squeezing of the spare bag on the valve outlet 8 Remove the bag from the inspiratory connector 1 6 5 Bag Ventilator switch test 1 Refit the breathing hose between the inspiratory 1 and expiratory 2 connectors Set the bag ventilator switch 4 to Vent 2 Set a flow of 10...

Page 31: ...1 anti clockwise to the vertical locked on position b Failure to lock the canister in the fully closed position may cause a system leak and or a reduction in CO2 absorption 6 Lift the canister upwards 6 and position the rim of the canister over the outer lip of the seal 5 7 Hold the canister in place check that there is no lateral movement 8 Turn the lever 1 anti clockwise to the vertical position...

Page 32: ...used clinically Check that at all times that the switch is free to move from one end of its travel to the other 7 1 Service Schedule Servicing and repairs must only be carried out by Penlon trained engineers 1 Six monthly inspection and function testing 2 24 month service which includes routine replacement of seals etc as preventive maintenance 7 2 Canister and Seals Cleanliness is the essential r...

Page 33: ...ute the liquid in the canister with water before disposal Follow your hospital procedure 6 Refit the container or pre pack Pre packed soda lime Check that the three spacers 5 are in place Check that the carrier 6 is in place Insert the pre pack into the carrier in the canister Bulk packed loose soda lime Check that the three spacers 5 are in place and place the container in the canister 7 Refit th...

Page 34: ...d carefully detach from the absorber CAUTION Do not sterilise the manometer 7 5 Adjustable Pressure Limiting APL Valve Autoclave the APL valve 2 as part of the absorber assembly see section 8 5 1 Check that the valve is in the open position before autoclaving Do NOT wash in an automatic cleaning washing machine 1 2 Maintenance ...

Page 35: ...to the diagram in section 5 Breathing Circuit Connections and the information on flow resistance in sections 4 2 2 and 4 2 3 Filters may be sterilisable or single use Please read the labelling supplied by their manufacturer CAUTION Replacement Disposal always follow the instructions supplied with the filter or HME Always renew components at the recommended interval NOTE If a bacterial filter has n...

Page 36: ...anaesthetic machine 2 Turn the lever 2 clockwise to the unlocked position 3 to release the canister 1 3 Remove the canister and carefully lift out the inner absorbent container 4 or pre pack unit WARNING Condensate may drip from the container or pre pack Use a cloth to prevent spillage 4 Dilute the liquid in the canister with water before disposal Follow your hospital procedure 5 Dispose of the pr...

Page 37: ...ken Do not damage the precision surface of the valve seat 4 Never use any hard object or abrasive agent to clean it use only a soft cloth If the valve seat is damaged the diaphragm valve will leak and may cause serious malfunction 5 Clean the valve seat 4 and the metal disk 5 attached to the base of the diaphragm valve thoroughly and remove all contamination from the surfaces of both components NO...

Page 38: ...four screws 4 securing the heater and the pole mount and bracket assembly 5 to the absorber 3 Models without heater At the base of the bracket assembly 6 remove the four screws 7 securing the pole mount and bracket assembly 8 to the absorber 4 Detach the pole mount with bracket and heater assembly if fitted and put to one side WARNING Do NOT immerse or autoclave the heater unit 4 5 Wash the absorb...

Page 39: ...block including non return valves and frame assembly Yes Yes Yes 255 124 Absorber canister Yes Yes Yes 255 124 Absorbent container Yes Yes Yes 255 124 Carrier for pre pack Yes Yes Yes 278 137 APL valve Yes Yes Yes 278 137 Pressure gauge No No No PEEP valve Yes Yes Yes 278 137 Electrical interface unit No No No Heater option No No No Refit the absorbent canister with inner carrier and container if ...

Page 40: ...ion 8 4 Refilling 1 Refit the container or pre pack Pre packed soda lime Check that the three spacers 1 are in place Check that the carrier 2 is in place Insert the pre pack into the carrier in the canister Bulk packed loose soda lime Check that the three spacers 1 are in place and place the container in the canister 2 Refit the absorbent canister Warning The canister seals at the top face Maintai...

Page 41: ... Part 1 General requirements BS EN ISO 1041 2008 Information supplied by the manufacturer of medical devices BS EN ISO 14971 2012 Medical devices Application of risk management to medical devices BS EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing within risk management process Fourth Edition Appendix 2 Disposal at end of useful life risk assessment Dispos...

Page 42: ...l Do not dispose of in landfill refer to an approved recycling facility Follow your hospital local state and federal regulations Bag bag ventilator switch Ventilator bag ventilator switch Gas inlet Lift Mechanism General Warning Heater fuse rating APL label Refer to the user manual Canister placement ...

Page 43: ... Penlon Limited Category Function Length m AC link Prima 450 460 to A200SP absorber Mains supply for an A200SP absorber equipped with a heater 0 6 A200SP control cable A200SP Absorber fitted to a Prima 450 460 equipped with an AV S ventilator Connects a the spirometry sensors and b the absorber bag vent switch on the A200SP absorber to the AV S ventilator 0 8 Oxygen sensor cable A200SP Absorber fi...

Page 44: ... Test level 385 MHz 27 V m 450 MHz 28 V m 710 MHz 9 V m 745 MHz 9 V m 780 MHz 9 V m 810 MHz 28 V m 870 MHz 28 V m 930 MHz 28 V m 1 72 GHz 28 V m 1 845 GHz 28 V m 1 97 GHz 28 V m 2 45 GHz 28 V m 5 24 GHz 9 V m 5 50 GHz 9 V m 5 875 GHz 9 V m Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Surge IEC 61000 4 5 0 5 1 2 kV...

Page 45: ...A200SP Absorber 39 User Manual Appendix ...

Page 46: ...A200SP Absorber 40 User Manual ...

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Page 48: ... their respective owners International Sales t 44 0 1235 547001 e international sales penlon com UK Sales t 44 0 1235 547036 e uk sales penlon com Technical Support t 44 0 1235 547060 f 44 0 1235 547061 e tech support penlon com Penlon Limited Abingdon Science Park Barton Lane Abingdon OX14 3NB UK Like us at facebook com PenlonGlobal Follow us at twitter com PenlonGlobal REF ...

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