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User Manual

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

Prima 465 Anaesthetic Machine 

Summary of Contents for Prima 465

Page 1: ...User Manual ANAESTHESIA SOLUTIONS Prima 465 Anaesthetic Machine...

Page 2: ......

Page 3: ...egarding the 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 Ab...

Page 4: ...IS ESSENTIAL THAT THESE ELEMENTS ARE MONITORED FREQUENTLY AND REGULARLY AND THAT ANY OBSERVATIONS ARE GIVEN PRECEDENCE OVER MACHINE CONTROL PARAMETERS IN JUDGING THE STATE OF A CLINICAL PROCEDURE Bef...

Page 5: ...s 21 4 5 Oxygen flush 21 4 6 Fresh gas mixture 21 4 7 Environmental 22 4 8 Electrical supply 22 4 9 Ventilator and breathing system 23 4 10 Device classification and labelling 26 5 Installation and Pr...

Page 6: ...ning and disinfection 75 7 3 Absorber and breathing system 76 7 4 Anaesthetic gas scavenging system Receiver unit 81 7 5 Breathing system sensors 81 7 5 Flowmeter zero calibration procedure 81 7 7 Oxy...

Page 7: ...ecessary 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 accord...

Page 8: ...delivery system Because breathing systems require frequent cleaning they are not a permanent part of the anaesthetic machine and therefore cannot be directly under the control of the anaesthetic mach...

Page 9: ...e auxiliary mains outlet sockets will not function Make sure that any equipment connected to the auxiliary mains outlet sockets are protected against mains failure Warnings and Cautions 34 Ventilating...

Page 10: ...Users must be aware of the risks of increased leakage currents when equipment is connected to the auxiliary power sockets 6 In the event of malfunction of any device powered by the auxiliary sockets...

Page 11: ...izers breathing hoses and patient connection fittings which comply with the relevant ISO standard or equivalent Depending upon the specification the system can be used in open or closed circuit config...

Page 12: ...LED lighting unit mounted under the top shelf 4 provides work area lighting A three position switch Off On dim light On bright light is mounted next to the light unit 3 1 5 Extractor fan outlet Cautio...

Page 13: ...ce the pressure of the compressed gas supply b A pressure relief valve factory set to 517 kPa 75 psi This prevents pressure build up under the diaphragm if a leak develops across the seat of the reduc...

Page 14: ...display 1 shows the range of default fresh gas flows available User set flow Fresh gas flow values 2 can be set using the touchscreen buttons 3 and 4 and the multifunction control knob 5 Note that a m...

Page 15: ...tlet assembly are both illuminated 2 The legend ACGO 3 is displayed on the screen 3 4 4 Alternate O2 supply control and flowmeter The system provides an alternate O2 flow into the breathing system The...

Page 16: ...continue to deliver oxygen if there is a total power failure Output is set by the control knob 2 and delivered through the outlet 3 3 4 8 Auxiliary gas outlets Caution When the auxiliary gas outlets a...

Page 17: ...patible vaporizer Two Selectatec compatible vaporizers e g the Sigma Delta may be fitted to a Prima 465 Each station is fitted with two valve capsule assemblies 2 for vaporizer connector block attachm...

Page 18: ...button is used to mute the alarm tone for 120 seconds Information on the alarms is given in section 6 12 Alarm reset button 3 The alarm reset button clears any cancelled alarms that are displayed on...

Page 19: ...leakage current from the machine does not exceed the values specified in any relevant national standards that may apply in the country where the machine is in use 2 Each socket is protected with a 2 A...

Page 20: ...Battery recharge The battery is charged automatically when the machine is connected to an AC power source Recharge time Approximately 4 hours from total discharge 3 8 4 2 Battery charge indicator Ven...

Page 21: ...m and low alarms are displayed on a yellow background All alarms displayed in the alarm message field are accompanied by an audible alarm 3 9 2 Alarm silence The alarm silence button 2 mutes the audib...

Page 22: ...litres of carbon dioxide absorbent Do not overfill Do not exceed the MAX line marked on the canister refer to section 6 17 Warning A gradual colour change of the soda lime absorbent indicates approxim...

Page 23: ...in the inspiratory circuit Pressure is displayed in cmH2O and kPa 3 10 8 Bellows housing The bellows housing 13 provides an airtight compartment for the breathing system bellows 3 10 9 Breathing bag...

Page 24: ...th so that the lowest pressure is used to deliver the set tidal volume 3 12 4 Synchronised intermittent mandatory ventilation volume control SIMV V The ventilator delivers volume controlled breaths wh...

Page 25: ...pired oxygen FiO2 Peripheral oxygen saturation SpO2 Pulse rate bpm Perfusion index PI Values 2 available with optional gas monitoring Note Paramagnetic O2 monitoring is not shown in the illustration M...

Page 26: ...x 22 cm Loading 10 kg 22 lb evenly distributed Top Shelf Size 71 x 35 cm Loading 30 kg 66 lb evenly distributed Drawers Size 12 x 54 5 x 35 cm Loading 10 kg 22 lb evenly distributed Castors Diameter...

Page 27: ...kPa 30 41 psig Fresh gas supply pressure Safety valve 90 cmH2O 90 cmH2O 4 4 Auxiliary gas outlets Oxygen Two self sealing connections on rear of machine Air Two self sealing connections on rear of mac...

Page 28: ...60 Hz 2000 2400 VA maximum Overload protection 10 A Thermal circuit breaker Power cable Permanently attached lead 3 m Stowage hooks are fitted at the rear of the machine Internal power distribution Fu...

Page 29: ...e 1 20 cmH2O increments 1 cmH2O Insp termination level Esens Range 5 80 increments 5 Monitored parameters Parameters Description Inspiratory tidal volume VTI Range 0 2500 mL Resolution 1 mL Error of 2...

Page 30: ...00 mmHg Resolution 1 mmHg Error is 0 43 of the volume percentage 8 of the gas concentration equivalent to the optional units used to monitor kPa and mmHg MAC values optional Range 0 to 10 resolution 0...

Page 31: ...etting time is 10 60 s in increments of 1 s Oxygen low pressure alarm Oxygen pressure is less than 280 28 kPa AC power failure alarm The mains breaks down or the power cord disconnects Low battery ala...

Page 32: ...inst electric shock Class 1 Ingress protection IPX0 Oxygen compatibility Not suitable for use in an Oxygen rich environment Mode of operation Continuous Patient All patient types No residual risks fro...

Page 33: ...transported a Remove all detachable devices b Empty the drawers c Remove the gas cylinders 5 MRI compatibility Prima 465 models are not MRI compatible 6 This machine must only be used with Selectatec...

Page 34: ...atch 3 to the locked position Warning Always set the locking catch to the locked position after the absorber assembly is installed Before use to prevent a serious fresh gas leak and inaccurate tidal v...

Page 35: ...absorber 2 Turn the sensor 1 clockwise to tighten 3 Fit the cable 3 to the sensor Warning Make sure that the absorber canister position sensor 4 is unobstructed by cables or tubing etc at all times Do...

Page 36: ...er types of gas supplies may contain water oil or other contaminants Check that cylinders are available as a backup in case of a central gas supply failure 1 Connect oxygen air and nitrous oxide medic...

Page 37: ...O2 concentration of less than 30 in the fresh gas flow An alarm message is displayed Before accepting this F G flow setting be aware that O2 will increase to X X X X represents the value that will be...

Page 38: ...lectrical equipment including devices powered by the auxiliary power outlets 3 5 1 9 Anaesthetic gas scavenging system AGSS WARNING 1 Read the AGS receiver instruction manual for installation instruct...

Page 39: ...AG monitoring tests Section 5 12 Preparing for system operation Section 5 13 5 3 Visual Inspection Warning 1 Additional equipment placed on the top shelf must be securely attached Do not install addi...

Page 40: ...brakes are set and function correctly 5 4 Start up test 1 Connect the machine to the mains supply 2 Set the anaesthesia system switch to the ON position 3 Check that the amber and red alarm LEDs 1 ill...

Page 41: ...e of tests that Fail or Skip Warning If the screen displays a Fail for the Pressure sensor Flow sensor or Flowmeter zero calibration tests DO NOT attempt manual calibration Contact a Penlon trained se...

Page 42: ...e in O2 flow 6 Turn the alternate O2 control clockwise and check that the flowmeter ball indicates a decrease in O2 flow 7 Turn the alternate O2 control clockwise to the minimum flow position 8 Set th...

Page 43: ...w to display O2 N2O 2 Set FG flow to 2 L min 3 Disconnect the O2 supply 4 Check that the O2 and the N2O gas flows reduce to 0 zero 5 Check that the O2 SUPPLY DOWN warning is shown 6 Reconnect the O2 s...

Page 44: ...2O cylinder pressure after one minute 5 If the cylinder pressure decreases more than 700 kPa 100 psi install a new cylinder seal see section 5 1 7 2 6 Open the N2O cylinder valve and repeat steps 1 th...

Page 45: ...zer concentration of 1 Caution Do not test the vaporizer when the vaporizer concentration control is between 0 and the first graduation 9 Check that the alternate O2 flow does not decrease more than 1...

Page 46: ...ms with an O2 sensor 1 fitted to the absorber 1 Use the Start Standby button to enter standby mode 2 Set the APL valve to the MIN position 3 Calibrate as follows a Press the SYSTEM button b Press the...

Page 47: ...vent switch to vent 3 Set the ventilation mode to SPONT PSV 4 Use the Start Standby button to start operational mode 5 Check that an APNEA warning is shown 6 Check that ventilation begins 7 Set the v...

Page 48: ...4 0 L min 3 Make sure that the breathing system is not damaged and correctly installed 4 Connect the Y piece to the absorber test lung 5 Use the manual bag to complete a series of breathing cycles 6 C...

Page 49: ...e is a flow of fresh gas from the auxiliary common gas outlet 3 4 Release the O2 Flush button and check that the flow of O2 from the outlet 3 stops 5 Turn the ACGO control to the OFF position 5 12 Pre...

Page 50: ...the pressure high limit and the gas delivery flow is kept constant expiration starts immediately after the high pressure limit is reached Set the Pressure high limit to prevent injury to the patient...

Page 51: ...olume is measured instead of preset Key A Airway pressure D PEEP B Pmax E Pressure support breath C SIMV breath F Flow 6 1 2 3 High airway pressures The system will prevent the selection of high airwa...

Page 52: ...ges in the patient s lung characteristics PRVC mode initially delivers a VCV breath Patient compliance is determined from this volume breath The inspiratory pressure level is then set for the next bre...

Page 53: ...me controlled breathing to the patient at the end of trigger window Spontaneous breathing outside of the trigger window can acquire pressure support 6 1 5 2 SIMV V waveforms Key A Within the trigger w...

Page 54: ...sensitivity Esens is expressed as a percentage of peak flow It is used to determine the end of the inspiratory phase allowing the expiratory phase to be synchronised Esens allows the clinician to adju...

Page 55: ...hing outside of the trigger window can acquire pressure support If trigger level is reached outside of the trigger window the ventilator delivers pressure supported ventilation based on the preset Psu...

Page 56: ...n PSV mode is applied alone PCV and VCV backup modes are available If within the preset time Backup Mode Active no spontaneous breathing occurs or spontaneous breathing is not strong enough to reach t...

Page 57: ...is not in use select standby to save power Monitored parameters and waveforms are not shown Ventilation stops 6 2 2 Standby mode features Parameters can be set and the system will operate based on th...

Page 58: ...status refer to section 6 11 10 Alarm message fields refer to section 6 12 11 System prompt message and icons field refer to section 6 13 Caution Confirm the new setting before adjusting another para...

Page 59: ...To set ventilator parameters in VCV mode select the desired button in the ventilator settings fields Parameters to be set are shown below VT Tidal volume I E Respiratory ratio f Respiratory rate Paus...

Page 60: ...mode select the desired button in the ventilator settings fields Pinsp Pressure control level Tinsp Inspiratory time f Respiratory rate Psupp Pressure support level Tslope Pressure rise time Psens Fs...

Page 61: ...r Flow trigger Tslope Pressure rise time PEEP Positive end expiratory pressure Esens Expiratory trigger sensitivity To set backup modes 1 Select the Modes shortcut button Backup 2 Touch Volume or Pres...

Page 62: ...o I E Airway resistance Rst Compliance Cdyn Fraction of inspired oxygen FiO2 Peripheral oxygen saturation SpO2 Pulse rate bpm Perfusion index PI Values 2 available with optional gas monitoring Note Pa...

Page 63: ...urs 2 Select the Parameter selection button Select the desired parameter 3 Use the multifunction control to adjust the position of the cursor to view the corresponding time point parameter values Caut...

Page 64: ...lly convert to Backup mode BACKUP will be displayed in the mode display fields 6 4 5 2 Limits 2 display In Limits 2 alarms are related to anaesthesia gas and CO2 monitoring if installed End tidal carb...

Page 65: ...or 100 maximum Language selection controls Units of measure selection controls CO2 mmHg or kPa Airway pressure cmH2O or mbar Height cm or inches Barometric pressure mmHg or hPa Gas supply kPa or psi W...

Page 66: ...ess to ventilator settings Ventilator setting fields are available in both standby and ventilation modes Values can be adjusted using the touch screen or the multifunction control Tidal volume VT Insp...

Page 67: ...To access the following waveforms press the waveform icon 1 Paw Airway pressure 2 Flow Flow rate 3 Volume Tidal volume 4 P V Loop Pressure volume loop 5 V F Loop Volume flow loop 6 P F Loop Pressure...

Page 68: ...op and Volume Flow loop will displayed as shown 6 7 5 Volume Flow loop 6 7 6 Pleth waveform On machines with an SpO2 module a Pleth waveform is displayed as shown 6 7 7 EtCO2 waveform On machines with...

Page 69: ...e fields are automatically configured to reflect the Anaesthetic in use and the ventilation mode in use MAC Minimum alveolar concentration FiAA Fraction of inspired anaesthetic agent EtAA End tidal an...

Page 70: ...3 When multiple alarms of different levels occur simultaneously the system will select the highest priority alarm and give visual and audible alarm indications for that alarm 4 Values for all technic...

Page 71: ...ing Decrease tidal volume or increase Paw high alarm limit value Check for blockages in the patient circuit FiO2 18 High FiO2 is lower than 18 Recalibrate the O2 cell FiHAL HIGH High FiAA is greater t...

Page 72: ...aw low alarm limit setting SpO2 LOW High SpO2 is lower than the low alarm limit setting Check patient s condition Set the alarm limits appropriately PULSE RATE LOW High Pulse rate is lower than the lo...

Page 73: ...rkstation Contact your service personnel EGM communication failure High Hardware error Restart anaesthetic workstation Contact your service personnel BDU communication failure High Breath delivery uni...

Page 74: ...LUSION Medium An error or occlusion occurred to the sampling line Check the CO2 sampling line Gas Module Inaccurate Gas Zeroing Medium Gas Module Inaccurate Gas Zeroing Calibrate the Gas Module Zero C...

Page 75: ...me field The time field 4 displays system time data 6 14 System start up procedure 1 Plug the power cord into an AC mains power outlet The mains indicator is lit when the AC power is connected The bat...

Page 76: ...s the O2 flush button to inflate the bag if necessary In manual ventilation mode you can use the APL valve to adjust the breathing system pressure limit and gas volume in the manual bag When the press...

Page 77: ...itoring Caution The tidal volume values on the bellows housing give an approximate indication and may be inconsistent with the actual measured volumes Tidal volume related parameters are shown below V...

Page 78: ...f it has been allowed to dry out or if you suspect it has dried out Always replace dried out absorbent with a fresh supply 3 Condensation which may collect in the bottom of the absorber canister is ca...

Page 79: ...1 2 Wipe the dust from the absorber canister support 3 Position the canister ensuring that the threads are engaged Make sure that the triangular marks 3 are aligned 4 Tighten counterclockwise until th...

Page 80: ...lacement of the mains lead must be carried out only by a Penlon trained engineer Ancillary Equipment Follow the instructions given in the relevant user manual for detailed information on maintenance a...

Page 81: ...machine or onto any electronic components 5 Do not soak synthetic rubber components for more than 15 minutes Swelling or faster aging can occur Anaesthetic workstation Clean all surfaces with an appro...

Page 82: ...nder the manifold block Do not lift the absorber by gripping any of the components attached to the manifold block The canister may contain condensate Before removal drain the canister and dispose of t...

Page 83: ...ckwise until the lugs are fully engaged in the slots 6 4 Align the flow sensor and tube assembly with the absorber Caution a Make sure that the arrow 8 and the word UP 9 are aligned uppermost as shown...

Page 84: ...the water is drained during a clinical procedure reinstall the drain plug immediately to prevent gas leakage The drain plug allows condensation drainage without the need to remove the soda lime 1 Wear...

Page 85: ...ith water then soak in a soap solution for 30 minutes at a temperature of 30 41 C Rinse with clean water Dry and wipe using 70 medical use alcohol Bellows assembly The relief valve assembly is not aut...

Page 86: ...of 30 41 C Rinse with clean water then wipe by using 70 medical use alcohol 7 3 13 Reassemble the absorber and breathing system 1 All components must be fully dried before assembly and installation 2...

Page 87: ...3 Pressure sensor zero calibration will start automatically Do not touch the breathing system tubing during calibration Caution If zeroing fails contact a Penlon trained engineer 7 4 2 Flow sensor zer...

Page 88: ...uminated 10 Press the start standby button 7 on the control panel 11 Reapply the original flow settings 12 After approximately two minutes check that the measured O2 is within 5 of the set value Cauti...

Page 89: ...nsor from the breathing system and expose to room air for three minutes 7 Push the Enter button to start calibration 8 After a successful calibration the screen will display Calibration Completed If C...

Page 90: ...ng or replacing batteries must be undertaken by a competent trained engineer 1 Switch the workstation off and disconnect the mains cable from the mains supply 2 Undo the screws and remove the battery...

Page 91: ...ch to another power outlet Contact a Penlon trained engineer Replace the fuse and check the circuit No power at auxiliary outlet Fuse has blown Contact a Penlon trained engineer Replace the fuse and c...

Page 92: ...Appendix 3 Optional extras and accessories WARNING Only use accessories approved by Penlon Ltd Please contact Penlon Ltd see below or your local Penlon Distributor UK Sales Tel 01235 547036 E mail uk...

Page 93: ...r supply Do not sit Rotation controls output Mute alarm Mark of conformity to European Medical Device Directive 93 42 EEC Backbar leak check Input connector Gas monitoring multi gas Appendix Fuse symb...

Page 94: ...ates the position of fuses for internal electrical circuits IEC indicates position of fuses for IEC socket Battery hatch label Input Label O2 Circuit Breaker Label Battery Label Do not dispose of in l...

Page 95: ...polarized mains plug Input applied label Input sample label Do not obstruct Bag Ventilator Bag port Unlock Lock Use by date YYYY MM DD Do not reuse IP classification indicating degree of protection a...

Page 96: ...r module 21 Absorber assembly 22 Bag ventilator switch 23 Rebreathing bag 24 Adjustable pressure limiting valve 25 Absorbent canister 26 Oxygen sensor inspiratory 27 Alternate common gas outlet switch...

Page 97: ...four weeks 5 The operator must be familiar with and strictly follow the guidelines detailed in the user manual for the Prima 465 and accessories 6 The user manual for the Prima 465 must be available a...

Page 98: ...aware of the limitations of gas measurement accuracy as shown in the specifications Anaesthetic gas module options The installed anaesthetic gas module is displayed on the Systems Settings page as il...

Page 99: ...l agent units only Primary gas At least 0 3 Vol Secondary gas At least 0 4 Vol Complied standards ISO 80601 2 55 IEC 60601 1 Operational characteristics Voltage input range 12 0 V to 32 0 V 5 10 Power...

Page 100: ...aesthetic gas module must not be placed closer than 25 cm to an ignition source 7 Do not use the anaesthetic gas module a In an environment containing greater than 25 oxygen b In an environment contai...

Page 101: ...You must replace the water trap When the water trap has been in use for a maximum of four weeks If a relevant error message is displayed and emptying the water trap does not remove the error message...

Page 102: ...inlet connector on the water trap 4 Enabling the gas module and selecting anaesthetic agent Warning Do not apply more than one anaesthetic agent 1 Select System 1 2 Select Setting 2 3 Switch AA O2 or...

Page 103: ...dule Water Trap or Sample Line Low Sample line is blocked or disconnected Remove the blockage from the sample line Reconnect the sample line Information Message Cause Action Gas Module Unspecified Acc...

Page 104: ...ult in increased emissions or decreased immunity of that equipment Cables supplied by Penlon Limited Category Function Length m AC mains supply input output ports Hospital mains supply to the input po...

Page 105: ...est 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...

Page 106: ...Prima 465 Anaesthetic Machine 100 User Manual...

Page 107: ......

Page 108: ...2020 All rights reserved 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 547...

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