Penlon Prima 465 User Manual
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Penlon Prima 465 User Manual

Anaesthetic machine
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User Manual
Prima 465 Anaesthetic Machine
A N A E S T H E S I A S O LU T I O N S

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  • Page 1 User Manual Prima 465 Anaesthetic Machine A N A E S T H E S I A S O LU T I O N S...
  • Page 3 The machine must be serviced to the schedule detailed in section 7. Details of these service operations are given in the Prima 465 service manual, available only for Penlon-trained engineers. For any enquiry regarding the servicing or repair of this device,...
  • Page 4 OBSERVATIONS ARE GIVEN PRECEDENCE OVER MACHINE CONTROL PARAMETERS IN JUDGING THE STATE OF A CLINICAL PROCEDURE. Before using any monitoring system or device, the user must check that it conforms to the relevant standards. Prima 465 Anaesthetic Machine User Manual...

  • Page 5: Table Of Contents

    Fresh gas fields ..................60 Prima 465 Anaesthetic Machine...
  • Page 6 Appendix 7. Electromagnetic compatibility (EMC) ..............98 Prima 465 Anaesthetic Machine...
  • Page 7 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 shall have the sole responsibility...

  • Page 8: Warnings And Cautions

    7.5.1, 7.5.2, and 7.6. easily accessed. DO NOT use any other procedures. If a ‘Fail’ error is still displayed, contact a Penlon-trained 4. No oil, grease or other flammable lubricant or sealant service engineer. must be used on any part of the machine in close proximity to medical gas distribution components.
  • Page 9 All gas cylinders must be removed. b) Always monitor oxygen concentrations 23. MRI compatibility - Prima 465 models are not MRI c) Always check that the monitors are functioning compatible. correctly before starting the clinical procedure.
  • Page 10 Do not apply excessive pressure to the display screens. Connect the external RS232 outlet only to approved devices using protocol provided by Penlon Ltd. Contact Technical Support Department for details. Vaporizers: Read the instruction manual supplied with the vaporizer before clinical use.

  • Page 11: Purpose

    CO2 in the patient expired gas. Contraindications The Prima 465 is not suitable for use in an MRI environment. Contact Penlon Limited for details of the Prima 451 MRI anaesthetic machine.

  • Page 12: Description

    (see section 4.2). CAUTION A malfunction of the central gas supply within your facility may cause immediate cessation of gas delivery and total anaesthesia system failure. A schematic is included in Appendix 5. Prima 465 Anaesthetic Machine User Manual...

  • Page 13: Gas Supply Safety Devices

    The supply of nitrous oxide is reinstated only when the oxygen supply pressure rises above the cut-off value. 3.3.2 Fresh gas pressure relief valve A valve is fitted to prevent fresh gas being delivered to the breathing system at pressures exceeding 90 cmH2O. Prima 465 Anaesthetic Machine User Manual...

  • Page 14: Gas Circuit Components And Controls

    See section 5.1.7.3 for settings when the user set a low oxygen FG FLOW flow. Note In Standby mode a minimum oxygen concentration of 30% must be set, and a minimum flow of 300 ml. Prima 465 Anaesthetic Machine User Manual...
  • Page 15 3.4.3)) switch is ON (see section 3.4.3), the oxygen flow is directed to the common gas outlet port (2). 2. If the ACGO switch is OFF, the oxygen flow is directed to the absorber circle system. Prima 465 Anaesthetic Machine User Manual...
  • Page 16 Auxiliary oxygen and air outlets (1) are mounted on the rear of the machine. WARNING Flow rates greater than 60 L/min could affect the fresh gas flow to the patient - see section 4.4. Prima 465 Anaesthetic Machine User Manual...

  • Page 17: Vaporizer

    3.5.2 Selectatec compatible 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 attachment. When a vaporizer is installed on a station the valves on that station open automatically to allow gas flow into and out of the vaporizer.

  • Page 18: Control Panel

    Alarm indicators (9) High priority alarm: Three red LEDs Low or medium priority alarm: Three amber LEDs All six alarm indicators also illuminate as part of the anaesthetic machine pre-use checks. Prima 465 Anaesthetic Machine User Manual...

  • Page 19: Electrical Power Supply

    A 10 A circuit breaker (5) provides protection to all the electronic devices connected to the system. NOTE The circuit breaker cannot be reset by the user. If the circuit breaker trips; contact a Penlon-trained engineer to reset and test the anaesthetic machine. 3.8.3 Auxiliary mains power supply sockets CAUTION 1.
  • Page 20 2. If the machine is in storage, charge the batteries every two months. 3.8.4.3 Battery life Battery life depends on frequency and period of use. Penlon recommends replacement every two years. 3.8.4.4 Battery replacement WARNING Battery replacement must be undertaken by a competent, trained engineer, see section 7.9.

  • Page 21: Alarm System

    The Limits display includes the Alarm Log page. The latest 100 alarms are listed, with the time and date of their appearance. The alarm log will only display the latest 100 alarms with newer alarms overwriting the oldest logged alarm. Prima 465 Anaesthetic Machine User Manual...

  • Page 22: Absorber

    The sensor cable (5) connects to an input socket (7) on the side of the machine. CAUTIONS Check the sensor calibration during the start-up tests whenever the system is switched on. Do not route the cable (5) in front of the canister sensor (4). Prima 465 Anaesthetic Machine User Manual...

  • Page 23: Anaesthetic Gas Scavenge System (Agss)

    1. Do not connect any vacuum system directly to the outlet (3). 2. The receiving system (1), with a positive and negative pressure control function, must be used. 3. Systems must comply with ISO 80601-2-13. Prima 465 Anaesthetic Machine User Manual...

  • Page 24: Ventilator

    The ventilator allows spontaneous breaths and delivers pressure support at a pre-set trigger level. In the event of an apnea condition, the ventilator enters a backup mode - either VCV or PCV, whichever the user has selected. Prima 465 Anaesthetic Machine User Manual...

  • Page 25: Patient Monitoring

    • End tidal nitrous oxide EtN2O • Fraction of inspired anaesthetic agent 1 (FiAA1) • End tidal anaesthetic agent 1 (EtAA1) • Fraction of inspired anaesthetic agent 2 (FiAA2) • End-tidal anaesthetic agent 2 (EtAA2) Prima 465 Anaesthetic Machine User Manual...

  • Page 26: Specification

    Three pipeline inlets (oxygen, air, nitrous oxide). UK and Europe: NIST USA: DISS Australia: SIS Medical gas colour codes Oxygen Green or White* Nitrous oxide Blue Medical air Yellow or Black* * to comply with relevant national standards Prima 465 Anaesthetic Machine User Manual...

  • Page 27: Gas Supply Pressure And Flow Rate

    Minimum oxygen concentration :25% +5%/-4% (of total O2 + N2O flow) - a minimum Anti-hypoxic fresh gas mixture of 21% oxygen Barometric compensation Compensated to 101.3 kPa Electronic mixer response time 500 msec (10% to 90% flow step) Prima 465 Anaesthetic Machine User Manual...

  • Page 28: Environmental

    Fuses T2AH 250 V ceramic (5 x 20 mm) high-breaking capacity (on live and neutral) Electromagnetic compatibility The Prima 465 meets the requirements of EN 60601-1-2 (electromagnetic compatibility - requirements and tests). Refer to Appendix 8. Battery Back-up battery specification NiMH, 12 V 8.4 Ah.

  • Page 29: Ventilator And Breathing System

    Resolution: 1 cmH2O. Error of ± (2% + 4% of full scale actual reading) PEEP Range: 0 ~ 100 cmH2O; Resolution: 1 cmH2O. Error of ± (2% + 4% of full scale actual reading) Prima 465 Anaesthetic Machine User Manual...
  • Page 30 Halothane, Isoflurane, Enflurane: 0.1 ~ 7.9%, OFF; Upper limit gas (optional) Sevoflurane: 0.1 ~ 9.9%; Desflurane: 0.1~ 19.9%, OFF Halothane, Isoflurane, Enflurane: 0 to 7.8%, Lower limit Sevoflurane: 0 to 9.8%; Desflurane: 0.1~ 19.8% Prima 465 Anaesthetic Machine User Manual...
  • Page 31 Expiratory breathing resistance in manual mode 0.05 0.21 0.46 Pressure and flow data (APL valve completely open) Flow rate (l/min) APL pressure (cmH2O STPD) APL pressure (cmH2O BTPS) 0.95 1.03 1.86 2.08 2.45 2.29 2.72 2.57 3.14 3.02 3.41 Prima 465 Anaesthetic Machine User Manual...

  • Page 32: Device Classification And Labelling

    Specification 4.10 Device classification and labelling The Prima 465 is classified as Medical Electrical (ME) equipment as defined in BS EN 60601-1. Labelling Refer to Appendix 4 Equipment classification Protection against electric shock Class 1 Ingress protection IPX0 Oxygen compatibility...

  • Page 33: Installation And Pre-Use Checks

    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- compatible vaporizers installed on the backbar.
  • Page 34 3. Position the canister, ensuring that the threads are engaged. Make sure that the triangular marks (3) are aligned. 4. Tighten counterclockwise until the ‘locked’ symbol (4) and the triangular mark on the canister are aligned. Prima 465 Anaesthetic Machine User Manual...
  • Page 35 1. Connect the elbow (1) to the Y-piece (2) 2. Connect the sampling tube (3) to the sample port (4) on the elbow (1) and to the inlet connector on water trap (5). Prima 465 Anaesthetic Machine User Manual...
  • Page 36 Dust and dirt presents a fire hazard in the presence of high pressure gas. Leakage of high pressure gas can cause serious injury. 5. Open the cylinder valves one at a time and check the pressure on each gauge. Prima 465 Anaesthetic Machine User Manual...
  • Page 37 Note that in Standby mode a minimum oxygen concentration of 30% must be set, and a minimum flow of 0.3 L/min. Ventilator, Bag, and ACGO modes Fresh gas flow (L/ % O2 % N2O min) 1.0-2.0 Prima 465 Anaesthetic Machine User Manual...
  • Page 38 The receiver (2) is fixed to the mounting system built into the side upright (3) of of the anaesthetic machine. A hose (4) connects the outlet port (1) to the receiver unit inlet port. The output hose (5) connects to the hospital disposal system. Prima 465 Anaesthetic Machine User Manual...

  • Page 39: Pre-Use Test Before Each Clinical Procedure

    3. Make sure that the absorber is correctly connected and locked in position, and that the breathing tubes are undamaged. 4. Make sure that the vaporizers are locked in position and contain sufficient agent. Prima 465 Anaesthetic Machine User Manual...

  • Page 40: Start Up Test

    10 seconds. 8. Check that audio and visual alarm indicators are triggered. 9. Press the on screen CONFIRM button. 10. When the CLEAR TREND DATA? dialogue box is shown, press the on-screen CANCEL button (4). Prima 465 Anaesthetic Machine User Manual...
  • Page 41 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 service engineer. 28. When the test has completed, press Finish, then Quit. Prima 465 Anaesthetic Machine...

  • Page 42: Pipeline Gas Supply Tests

    8. Connect the N2O pipeline to the main gas supply. 9. Check that the on-screen prompt is no longer shown. 10. Check that there are no new N2O SUPPLY DOWN warnings shown in the alarm log. Prima 465 Anaesthetic Machine User Manual...

  • Page 43: Oxygen Fresh Gas Supply Check

    2. Check that the O2 cylinder is installed correctly. 3. Disconnect all gas pipeline supplies. 4. Open each cylinder valve and check each cylinder pressure. 5. Replace the cylinder if necessary, refer to Section 5.1.7.2. 6. Close the N2O cylinder. Prima 465 Anaesthetic Machine User Manual...
  • Page 44 5. If the cylinder pressure decreases more than 700 kPa (100 psi), install a new cylinder seal. 6. Repeat steps 1 through 5. If the leak continues, contact a Penlon-trained engineer. Do not use the cylinder supply system. Nitrous oxide cylinder high pressure leak test 1.

  • Page 45: Vaporizers

    2. Make sure that the interlock mechanism of each vaporizer is working correctly: a) Check that only one vaporizer at a time can be turned b) Refer to the vaporizer user manual for additional pre-use checks. Prima 465 Anaesthetic Machine User Manual...

  • Page 46: Alarm Tests

    12. Check that after a period of time; a LOW FiO2 alarm is triggered. 13. Reset the FiO2 low alarm limit to 20%. Check that the alarm is cancelled. 14. Set the FiO2 high alarm limit to 50%. 15. Set the O2 concentration to 60%. Prima 465 Anaesthetic Machine User Manual...
  • Page 47 3. Disconnect the Y piece from the test lung. 4. Check that a PRESSURE LOW alarm is triggered. 5. Connect the Y piece to the test lung. 6. Press the O2 flush button 7. Check that the PRESSURE LOW alarm is cancelled. Prima 465 Anaesthetic Machine User Manual...

  • Page 48: Breathing Circuit Tests

    7. Release the O2 flush button. 8. If the bellows deflates within one minute: a) Remove the bellows - Turn the bellows housing counterclockwise, and lift from the base , and reinstall. b) Repeat the bellows test. Prima 465 Anaesthetic Machine User Manual...

  • Page 49: Oxygen Flush Test

    Retest the system. Do not use the machine if the circuit continues to leak. Contact a Penlon-trained engineer. 5. Turn the APL valve counterclockwise to the Min position. 6. Disconnect the hose from the absorber test block.

  • Page 50: Operating The Anaesthesia System

    Adult: 100 to 1600 ml 510 ml 4:1 to 1:10 1 to 100 bpm 1 bpm 15 bpm PEEP OFF, 3 to 30 cmH2O 1 cmH2O Pause 0% to 60% Sigh OFF, 50 to 150 Prima 465 Anaesthetic Machine User Manual...
  • Page 51 5 to 70 cmH2O 1 cmH2O 15 cmH2O 4:1 to 1:10 1 to 100 bpm 1 bpm 15 bpm PEEP OFF, 3 to 30 cmH2O 1 cmH2O Tslope 0 to 2 s 0.1 s 0.2 s Prima 465 Anaesthetic Machine User Manual...
  • Page 52 0 to 2 s 0.1 s 0.2 s 6.1.4 Support mode waveforms - colour codes Support mode waveforms are displayed in colour. Mandatory (inspiratory phase) Blue Expiratory phase Synchronised breath Green Spontaneous breath Yellow Prima 465 Anaesthetic Machine User Manual...
  • Page 53 0 to 2 s 0.1 s 0.2 s Fsens: 1 to 20.0 L/min Fsens: 0.1 L/min Fsens: 3 L/min Fsens/Psens Psens: 1 to 20 cmH2O Psens:1 cmH2O Psens: 2 cmH2O Esens 5% to 80% Prima 465 Anaesthetic Machine User Manual...
  • Page 54 1 cmH2O 15 cmH2O Tslope 0 to 2 s 0.1 s 0.2 s Fsens 1.0 to 20.0 L/min 0.1 L/min 3 L/min Psens 1.0 to 20 cmH2O 1 cmH2O 2 cmH2O Esens 5% to 80% Prima 465 Anaesthetic Machine User Manual...
  • Page 55 1 cmH2O 15 cmH2O Tslope 0 to 2 s 0.1 s 0.2 s Fsens 1.0 to 20.0 L/min 0.1 L/min 3 L/min Psens 1.0 to 20 cmH2O 1 cmH2O 2 cmH2O Esens 5% to 80% Prima 465 Anaesthetic Machine User Manual...
  • Page 56 1 cmH2O 15 cmH2O Tslope 0 to 2 s 0.1 s 0.2 s Fsens 1.0 to 20.0 L/min 0.1 L/min 3 L/min Psens 1.0 to 20 cmH2O 1 cmH2O 2 cmH2O Esens 5% to 80% Prima 465 Anaesthetic Machine User Manual...

  • Page 57: Standby Mode

    The standby page allows access to two page displays: System Test See section 5.4. Patient 1. New Patient a) New Adult b) New Paediatric c) New Infant (neonatal) d) Gender options: 2. Previous Patient - data displayed from previous patients. Prima 465 Anaesthetic Machine User Manual...

  • Page 58: Home Screen

    Press the control to confirm the set value. 2. A dialogue box with three circles next to the title indicates that more than one page can be accessed. Press the control to move between pages. Prima 465 Anaesthetic Machine User Manual...

  • Page 59: Function Fields

    I : E Respiratory rate 1:2.0 Tslope Pressure rise time 5 cmH O 70 0.10 s 10.00 bpm 100 Off cmH O 30 Cancel Accept PEEP Positive end-expiratory pressure Modes Controls Monitoring Trends Alarms System Prima 465 Anaesthetic Machine User Manual...
  • Page 60 5 cmH O 70 40 Off cmH 0.10 s 10.00 O 30 Psens/Fsens Pressure trigger / Flow trigger Cancel Accept PEEP Positive end expiratory pressure Modes Controls Monitoring Trends Alarms System Esens Expiratory trigger sensitivity Prima 465 Anaesthetic Machine User Manual...
  • Page 61 2. Touch [Volume] or [Pressure] to set desired backup mode. Volume selected: the following parameters are available: Tidal volume Respiratory ratio Respiratory rate Pressure selected: the following parameters are available: Pinsp Pressure control Respiratory ratio Respiratory rate Prima 465 Anaesthetic Machine User Manual...
  • Page 62 • End tidal nitrous oxide EtN2O • Fraction of inspired anaesthetic agent 1 (FiAA1) • End tidal anaesthetic agent 1 (EtAA1) • Fraction of inspired anaesthetic agent 2 (FiAA2) • End-tidal anaesthetic agent 2 (EtAA2) Prima 465 Anaesthetic Machine User Manual...
  • Page 63 When setting alarm limits, touch the button, turn the multifunction control knob to the value that you want to set, and push the knob to confirm. NOTE Alarm message fields - see section 6.12. Prima 465 Anaesthetic Machine User Manual...
  • Page 64 6.4.5.4 Alarm Log The alarm log, the system displays up to 100 events, stored in chronological order. When a new event occurs after 100 events are already stored, the new event overwrites the current earliest event. Prima 465 Anaesthetic Machine User Manual...
  • Page 65 The DATE & TIME page provides a facility to set the system 1:2.0 time and date. 100 ml 1600 1.10 Modes Controls Monitoring Trends Alarms System Date can be set using the UK or US date display systems. Prima 465 Anaesthetic Machine User Manual...

  • Page 66: Ventilator Setting Fields

    The Gas mix button allows the display of a single O2 display or a dual O2/Air or O2/N2O display. Fresh Gas flow and O2 concentration are displayed. Fresh gas 0.08 0.05 /Air Gas mix /Air 21 % 100 FG FLOW Prima 465 Anaesthetic Machine User Manual...

  • Page 67: Waveform Field Displays

    6.7.2 Flow waveform The flow waveform shows the flow of gases in the breathing circuit. 12 sec 6.7.3 Volume waveform The volume waveform shows the volume of gas in the breathing circuit. 12 sec Prima 465 Anaesthetic Machine User Manual...
  • Page 68 On machines with an SpO2 module, a Pleth waveform is displayed as shown. 6.7.7 EtCO2 waveform On machines with CO2 monitoring, an EtCO2 waveform is displayed as shown. 6.7.8 Pressure-Flow loop An example of a Pressure-Flow (P-F) loop is shown. 25 cmH Prima 465 Anaesthetic Machine User Manual...

  • Page 69: Measured Values Fields - Key Parameters

    When the countdown time period ends, the audible alarm is restored. The alarm message will be displayed continually until the Alarm Reset button (2) is pushed. In the alarm silence period, press the alarm silence button again if the system does not respond. Prima 465 Anaesthetic Machine User Manual...

  • Page 70: Alarm Message Field

    Different alarm tone patterns are used to match the alarm level: High priority: 10 note sequence, repeated every 10 seconds Medium priority: 3 note sequence, repeated every 2 seconds Low priority: 2 note sequence, does not repeat. Prima 465 Anaesthetic Machine User Manual...
  • Page 71 O!!! High Paw is less than -10 cmH2O PRESSURE < -10 cmH Check that there is high flow gas flowing through the AGSS. If yes, check the negative pressure relief valve on the receiver. Prima 465 Anaesthetic Machine User Manual...
  • Page 72 Set alarm limit appropriately. FiHAL LOW!! Check the fill level of the vaporizers. FiENF LOW!! FiISO LOW!! Medium FiAA is less than alarm limit. Set alarm limit appropriately. FiSEV LOW!! Check agent setting. FiDES LOW!! Prima 465 Anaesthetic Machine User Manual...
  • Page 73 AA ID Unreliable!!! High AA ID Unreliable Contact your service personnel. Plug in the power cable. Remaining battery power is BATTERY LOW!!! High Check that the system circuit breaker is between ten and thirty minutes. Prima 465 Anaesthetic Machine User Manual...
  • Page 74 SpO2 switch is turned off To monitor SpO2, set the SpO2 switch to Press the “Alarm Reset” O2 OFF! O2 switch is turned off To monitor O2 concentration, set the O2 switch to on. Prima 465 Anaesthetic Machine User Manual...

  • Page 75: System Prompt Message And Icons Field

    The self-test screen will be displayed and the self test will start. 5. The self-test will continue for about 10 seconds. The device will prompt the user to perform a pre-use test. Press the ACCEPT button to access the pre-use test screen. Prima 465 Anaesthetic Machine User Manual...

  • Page 76: Ventilation Mode

    If any tests failed, do not use the system. Refer the workstation to a Penlon-trained service engineer for repair. 6.15.1 Bag ventilation mode 1. Turn the APL valve control to adjust the pressure in the breathing system within the appropriate range.

  • Page 77: Monitoring Parameters

    The system provides two spirometry loops: Paw-V (Paw- volume) loop and V- Flow(volume-flow) loop. The scales of volume flow and Paw are adjusted automatically. Paw-V loop and V- Flow loop are shown in section 6.7. Prima 465 Anaesthetic Machine User Manual...

  • Page 78: Absorber

    The breathing circuit is bypassed and the patient re- breaths exhaled gases until the canister is refitted. 2. If necessary, Drain the condensate from the canister, see section 6.17.1. 3. Dispose of the absorbent in compliance with your local facility disposal procedures. Prima 465 Anaesthetic Machine User Manual...

  • Page 79: System Shut-Down Procedure

    1. Check that the vaporizer is in the OFF position. 2. Turn the anaesthesia system switch to the OFF position. 3. Disconnect electrical power. 4. Disconnect all gas pipelines. 5. Close the cylinder valves.. Prima 465 Anaesthetic Machine User Manual...

  • Page 80: Maintenance

    All other maintenance and servicing must be carried out only by Penlon-trained engineers. Servicing and Repair Prima 465 machines must only be serviced or repaired by Penlon-trained engineers, according to the schedule and procedures given in the Service Manual. WARNINGS 1.

  • Page 81: Cleaning And Disinfection

    All parts of the breathing circuit temperature of 121°C for a except O2 sensor, airway pressure Sterilisation 25 minimum minimum of 15 minutes and a gauge and relief valve assembly. maximum of 30 minutes. Prima 465 Anaesthetic Machine User Manual...

  • Page 82: Absorber And Breathing System

    2. Separate the Y-piece from the two breathing tubes. CAUTION Do not reuse the filter. Follow local regulations regarding disposal of hospital waste when the filter is discarded. 7.3.3 Remove the bag Remove the bag from the bag arm. Prima 465 Anaesthetic Machine User Manual...
  • Page 83 1. Turn the bellows housing (1) counterclockwise, and lift from the base 2. Remove the bellows (2) from the base (3). 3. Remove the bellows base (3) 4. Remove the locking tabs (4) and ring (5) from the bellows base. Prima 465 Anaesthetic Machine User Manual...
  • Page 84 2. Dilute the condensate with water before disposal. 1. Wear protective gloves, and turn clockwise to remove 7.3.10 Remove the airway pressure gauge Carefully pull the airway pressure gauge from the port on the top of the absorber. Prima 465 Anaesthetic Machine User Manual...
  • Page 85 Flush with water, then soak it in a soap solution for 30 minutes at a temperature of 30-41°C. Rinse with clean water, and wipe with 70% medical-use alcohol. Alternatively, autoclave at a maximum temperature of 121°C for a maximum of 15 minutes. Prima 465 Anaesthetic Machine User Manual...
  • Page 86 7. Reset the locking catch (3) to the locked position. WARNING Set the locking catch to the locked position after the absorber assembly is installed. Always check that the assembly is locked in position. Prima 465 Anaesthetic Machine User Manual...

  • Page 87: Anaesthetic Gas Scavenging System - Receiver Unit

    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 zeroing 1. Stop manual or mechanical ventilation. If a breathing tube is connected to the breathing system, then open the breathing tube patient connection to air.

  • Page 88: Oxygen Monitor Calibration

    11. Reapply the original flow settings. 12. After approximately two minutes check that the measured O2 is within 5% of the set value. CAUTION If the measured error is still displayed, contact a Penlon- trained engineer. Oxygen monitor calibration CAUTION Calibrate at the same ambient pressure in which it will be used to monitor oxygen delivery in the breathing system.
  • Page 89 In case of repeated calibration failures, replace the O2 sensor. Follow your hospital biohazard disposal procedure, do not incinerate the sensor. c) Repeat the calibration. If it still fails, contact a Penlon- trained service engineer. Calibration procedure at 21% O2 1.

  • Page 90: Water Trap - Sidestream Anaesthetic Gas Monitoring Module (Optional)

    Respiratory rate is set too fast and expiratory time is too Set respiratory rate to a reasonable value inflate completely short. The breathing system leaks Carry out a system leak test Flowmeter is closed Reset the flowmeter Prima 465 Anaesthetic Machine User Manual...
  • Page 91 2. Refer to section 7.6 and carry out a error (+/-5% error, Flowmeter zero calibration. compared to the set WARNING value) The instructions in section 7.6 must be followed. Do not use any other procedure. Prima 465 Anaesthetic Machine User Manual...

  • Page 92: Appendix

    Hose - Air / O2 / N2O Contact Sales Department Only use accessories approved by Penlon Ltd. Exhalation diaphragm valve 5008688 Please contact Penlon Ltd (see below), or your local Penlon Bellows - Latex free 5006441 Distributor. O2 sensor (MOX-3)

  • Page 93: Appendix 4. Labelling

    Rotation (controls output) 1. Transport conditions Mute (alarm) 2. Mass (weight) is indicated Mark of conformity to European Medical Device Directive 93/42/EEC Backbar leak check Auxiliary Gas Outlet label Input connector - Gas monitoring (multi-gas) Prima 465 Anaesthetic Machine User Manual...
  • Page 94 Input Label O2% Circuit Breaker Label Battery Label Do not dispose of in landfill, refer to an approved recycling facility. Follow your hospital, local, or state and federal regulations. Fuse: T2AH No L-N, non-polarized mains plugs Prima 465 Anaesthetic Machine User Manual...
  • Page 95 Input applied label Input sample label Do not obstruct Ventilator Bag port Unlock Lock Use by date (YYYY-MM-DD) Do not reuse IP classification indicating degree of protection against ingress of solid foreign objects and water Prima 465 Anaesthetic Machine User Manual...

  • Page 96: Appendix 5. Gas Circuit

    12. System master on/off switch DP: Flow sensor 28. Alternate common gas outlet (if 13. Ventilator module fitted) P: Pressure sensor 14. Drive valve 29. Backbar manifold 15. PEEP valve 30. Vaporizer 16. Bellows Prima 465 Anaesthetic Machine User Manual...

  • Page 97: Appendix 6. Optional Sidestream Anaesthetic Gas Monitoring Module - Single Agent

    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 at all times. 7. You must disconnect the sample line and seal the Luer lock on the patient Y-piece during cardiopulmonary bypass operations.
  • Page 98 Zeroing: Once per day (first zeroing 35 minutes after power on, then once every 24 hours) Duration: ≤20 s O2 (paramagnetic ) if fitted Range 0 to 100 Vol.% Accuracy ±(2.5 Vol.% +2.5 % rel.) Rise time (t10 ... 90) <500 ms Prima 465 Anaesthetic Machine User Manual...
  • Page 99 Ambient temperature +10 to +40 °C (50 to 104 °F) Ambient relative humidity 5 to 95% (without condensation) Atmospheric pressure 70 to 106 kPa (10.0 to 15.4 psi) Barometric compensation Compensated to 101.3 kPa Prima 465 Anaesthetic Machine User Manual...
  • Page 100 Water Trap and Sample Line 1. The sample line (1) must be positioned so that it does not interfere with the operation of the Prima 465 and the position of any switches Prima 465 Anaesthetic Machine...
  • Page 101 1. For each parameter: Check the alarm limit settings, and adjust if necessary. 2. For each parameter: To test the alarm function, simulate alarm conditions by setting upper and lower alarm limits to levels that are certain to trigger an alarm. Prima 465 Anaesthetic Machine User Manual...
  • Page 102 Check the name of the agent on the vaporizer that has been turned on. 2. Mixed anaesthetic agent in the circle breathing system will cause an incorrect agent concentration to be displayed. Prima 465 Anaesthetic Machine User Manual...
  • Page 103 1. Do not use silicon spray on the water trap O-rings. 2. The anaesthetic gas module must be clean and disinfected before maintenance or repair is carried out. Scheduled maintenance includes component replacement. Details are given in the Prima 465 Service manual, available for Penlon-trained service engineers. Cleaning WARNING 1.

  • Page 104: Appendix 7. Electromagnetic Compatibility (Emc)

    This device is suitable for use in the specified electromagnetic environment. The user should assure that it is used in an electromagnetic environment as described below. Changes or modifications to this device, not expressly approved by Penlon Limited, could result in EMC issues with this device. Contact Penlon Limited for more information.
  • Page 105 70% UT (30 % dip in UT) for 25/30 cycles 0% UT (100% dip in UT) for 250/300 cycles 0% UT (100 % dip in UT) for 250/300 cycles Power frequency (50 Hz) 30 A/m 30 A/m Magnetic field IEC 61000-4-8 Prima 465 Anaesthetic Machine User Manual...
  • Page 106 Prima 465 Anaesthetic Machine User Manual...
  • Page 108 Doc. No. 5008647-en Rev G Part of the InterMed Group © Penlon Ltd. 2020 All rights reserved Penlon and InterMed are trademarks of Penlon Limited. All other trademarks are the property of their respective owners. Penlon Limited Technical Support International Sales...

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