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Penlon Prima 465 User Manual

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

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Summary of Contents for Penlon Prima 465

  • Page 1 User Manual Prima 465 Anaesthesia Machine A N A E S T H E S I A S O LU T I O N S...
  • Page 3 1. Six monthly inspection and function testing. 2. Annual service which includes routine replacement of seals etc., as preventive maintenance. Details of these operations are in the Prima 465 Anaesthesia Machine servicemanual, which contains servicing procedures etc. Servicing should be carried out by engineers trained by Penlon Ltd.
  • Page 4 © Penlon Ltd. 2017. All rights reserved. system. IT IS ESSENTIAL THAT THESE ELEMENTS ARE MONITORED FREQUENTLY AND REGULARLY AND THAT ANY...

  • Page 5: Table Of Contents

    5.7 Pre 3.paration for the 3. alarm te 3.st ................52 Prima 465 Anaesthetic Machine...
  • Page 6 Appe 3.ndix 8 Ele 3.ctromagne 3.tic compatibility (EMC) ..............116 Prima 465 Anaesthetic Machine...

  • Page 7: User Responsibility

    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

    10. Prima 465 machines must only be used with Selectatec- breathing system, as described in Section 2 (Purpose). compatible vaporizers installed on the Selectatec-type backbar system.

  • Page 9: Cautions

    27. Accessories must be removed before the machine is transported. The 3. re 3.quire 3.me 3.nts of IEC 60601-1 apply to any de 3.vice 3. 28. MRI compatibility - Prima 465 models are not MRI conne 3.cte 3.d to the 3. auxiliary e 3.le 3.ctrical socke 3.ts. Use 3.rs compatible. must be 3. aware 3. of the 3. risks of incre 3.ase 3.d le 3.akage 3.

  • Page 10: Purpose

    2 . Purpose 2 .1 Purpose The 3. Prima 465 anae 3.sthe 3.tic machine 3. range 3. is for use 3. by a profe 3.ssional ope 3.rator in a hospital or clinical e 3.nvironme 3.nt, and must be 3. continually atte 3.nde 3.d whe 3.n in use 3.. The 3. de 3.vice 3. is inte 3.nde 3.d to provide 3. controlle 3.d conce 3.ntrations and flows of anae 3.sthe 3.sia gase 3.s into a patie 3.nt bre 3.athing syste 3.m, from...

  • Page 11: Description

    BS EN 60601-1. The Prima 465 has the components that are described as Applied parts: The Prima 465 has a single connection to a mains power supply. 3 .2 Frame The machine has a metal aluminium base, extruded aluminium uprights, and aluminium and plastic mouldings.

  • Page 12: Gas Circuit Sche 3.Matic

    Inspiratory flow sensor Selectatec manifold Outlet to AGSS system Vaporizer Patient Vaporizer Connector for anaesthetic gas scavenging system (AGSS) Regulator (250 kPa) Auxiliary oxygen supply Inspiratory flow control valve Pressure sensor Over-pressure valve (110 kPa) Prima 465 Anaesthetic Machine User Manual...

  • Page 13: Front Vie 3.W

    2. Anaesthesia system switch 3. Auxiliary oxygen outlet and flowmeter. 4. Cylinder pressure gauges 5. Alternate oxygen control 6. Display screen 7. Alternate oxygen control and flowmeter 8. Vaporizer 9. Common Gas Outlet and O2 flush button Prima 465 Anaesthetic Machine User Manual...
  • Page 14 Description 3 .10 .1 Castors The Prima 465 Anaesthetic machine has four castors (1) supporting the machine at the four corners of the base. Each castor has a pedal (2) that is used to operate the foot brake. Each brake will brake only a single castor.
  • Page 15 O2 flow to the breathing system. 3 .10 .5 Display screen The Prima 465 includes a display screen that is controlled by the onboard software and uses a touch screen and multifunction control interact with the user.
  • Page 16 Description 3 .10 .6 Vaporizer The Prima 465 has a Se 3.le 3.ctate 3.c-type 3. backbar syste 3.m that is capable 3. of supporting two compatible 3. vaporize 3.rs. The 3. backbar (1) has an inte 3.rlock syste 3.m that allows the 3. use 3. of only one 3. vaporize 3.r at any time 3.. The 3. backbar (1) has two locating spigots that locate 3. into a se 3.le 3.ctate 3.c compatible 3.

  • Page 17: Absorbe 3.R

    3 .11 .4 Oxygen sensor 3 .11 .5 Absorber canister 3 .11 .6 Inspiratory and expiratory ports 3 .11 .7 Leak test plug 3 .11 .8 Airway pressure gauge 3 .11 .9 Bellows housing Prima 465 Anaesthetic Machine User Manual...

  • Page 18: Communication Port

    Description 3 .12 Rear view 1. Cylinder yoke 2. Multiple socket outlets 3. Mains inlet 4. Communication port 5. SPO2 sensor connection 6. Battery box cover Prima 465 Anaesthetic Machine User Manual...

  • Page 19: Control Pane 3.L

    The USB interface is currently non-functional. 3 .13 .2 Calibration and software update port The calibration and software update port is designed for use by trained penlon engineers only. 3 .13 .3 RS232 interface The RS232 interface is designed for use with the Masimo mainstream gas module only.

  • Page 20: Batte 3.Ry

    We recommend replacement every 2 years. 3 .11 .1 Battery replacement Warning Replacement must be carried out by trained service personnel – see Section 8 .10 . The user must not replace the battery . Prima 465 Anaesthetic Machine User Manual...
  • Page 21 1. If a battery has been stored in a discharged state, charging may take longer than the time stated above. 2. Charge the batteries at least once in every two months if the machine is in storage. Prima 465 Anaesthetic Machine User Manual...

  • Page 22: Vaporize 3.Rs

    Removal of the vaporizer from the station closes the valves on that station. 3 .16 .3 Vaporizer interlock system Selectatec-compatible vaporizer interlock systems are described in the literature supplied with the vaporizer. Prima 465 Anaesthetic Machine User Manual...

  • Page 23: Specification

    Diameter - 12.5 cm (5 In,) Gas scavenging fixing Bracket on frame upright Loading 30 Kg (66 Lb.) 2.2 cm male taper with coaxial 1.5 cm female taper Auxiliary Common Gas Outlet connections Mass 125 Kg (275 Lb.) Prima 465 Anaesthetic Machine User Manual...

  • Page 24: Gas Supplie 3.S

    152-241 kPa (22 - 35 psig) 152-241 kPa (22 - 35 psig) 207-283 kPa (30 - 41 psig) 207-283 kPa (30 - 41 psig) Fresh gas supply pressure Safety valve 90 cmH2O 90 cmH2O Prima 465 Anaesthetic Machine User Manual...

  • Page 25: Auxiliary Gas Outle 3.Ts

    4 .5 Oxygen Failure Warning Devices 1. Gas system whistle 2. Visual indicator, direct pressure operated. 4 .6 Oxygen flush Button on the front edge of the worksurface The system supplies 25-75 L/min when the button is fully depressed. Prima 465 Anaesthetic Machine User Manual...

  • Page 26: Ahd Syste 3.M

    10 - 85 % R.H. non-condensing Transport and storage temperature Basic machine -5 to 40°C (23 to 104°F) Wipe external surfaces with dry or damp cloth. Use Cleaning mild soap, or disinfectant solution if necessary (See Section 6.1) Prima 465 Anaesthetic Machine User Manual...

  • Page 27: Ele 3.Ctrical Supply

    T3.15AH 250V ceramic (5 x 20 mm) high breaking Fuses capacity (On live and neutral on each outlet) Electromagnetic compatibility The Prima 465 meets the requirements of EN 60601-1-2 (electromagnetic compatibility - requirements and tests). Refer to Appendix 8. Replaceable battery specification 20 x GRPH-18670 8400P 12V...

  • Page 28: De 3.Vice 3. Classification And Labe 3.Lling

    Patient Class All patient types: No residual risks from phthalates that are carcinogenic, mutagenic, or toxic to reproduction. Oxygen compatibility The Prima 465 anaesthetic machine is not suitable for use in an Oxygen rich environment Prima 465 Anaesthetic Machine User Manual...

  • Page 29: Installation And Pre-Use Checks

    5. Do not use antistatic or conductive face masks. They can cause burns if used near high frequency electrosurgical equipment. 6. This equipment must be installed by a Penlon-trained engineer. 7. The anesthesia machine has waste gas exhaust ports. Check that residual breathing gas is scavenged.
  • Page 30 4. Expiratory port 10. APL valve 5. Inspiratory port 11. Bag/vent switch 6. Absorber canister 12. Bag arm 13. Absorber canister mount 14. Water container 15. Test plug 16. Absorber canister inlet 17. Absorber canister outlet Prima 465 Anaesthetic Machine User Manual...
  • Page 31 Installation and Pre-Use Checks 18. Inspiratory port 19. Expiratory port 20. Heater interface 21. Driving gas inlet 22. Flow sensors connectors (inspiratory/expiratory) Prima 465 Anaesthetic Machine User Manual...
  • Page 32 Set the locking catch to the locked position after the absorber assembly is installed . To prevent a serious fresh gas leak and inaccurate tidal volume measurement, always check that the assembly is locked in position . Prima 465 Anaesthetic Machine User Manual...
  • Page 33 The inspiratory and expiratory caheck valves are identical, the procedure that follows can be used for either check valve. 1. Install the check valve inserts. 2. Install the check valve cover. 3. Finger tighten the check valve cover. Prima 465 Anaesthetic Machine User Manual...
  • Page 34 5. Make sure that the bellows housing sits enenly on the seal. 6. Hold the bellows housing tightly and turn it clockwise until it stops. 7. Make sure that the side of the housing marked with the scale will face the user. Prima 465 Anaesthetic Machine User Manual...
  • Page 35 1. Install the bag bag support arm to the to the port on the top of the absorber. 2. Turn the locking nut clockwise. 5 .1 .6 Install the Airway pressure gauge Push-fit the 3. airway pre 3.ssure 3. gauge 3. to the 3. port on the 3. top of the 3. absorbe 3.r. Prima 465 Anaesthetic Machine User Manual...
  • Page 36 3. Install the O2 sensor cable (3). 4. Connect the plug on the O2 sensor cable (4) to the cable socket. 5. Make sure that there are no cables in front of the Canister sensor (5). Prima 465 Anaesthetic Machine User Manual...
  • Page 37 1. The absorber canister must only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. 2. Remove the soda lime when the system is not in use, to prevent the buildup of non-metabolic gases. Prima 465 Anaesthetic Machine User Manual...
  • Page 38 1. Insert the canister support into the canister outlet. 2. Tighten counterclockwise until the two vertical lines on the canister and absorber mount are aligned. CAUTION Afte 3.r installation, carry out a bre 3.athing syste 3.m le 3.ak te 3.st. Prima 465 Anaesthetic Machine User Manual...
  • Page 39 When refitting the absorber canister after changing the sodalime, make sure that the canister is installed correctly. To prevent dust and particles do not enter the breathing circuit, the filter must be put in the correct position – see Section 5.1.7. Prima 465 Anaesthetic Machine User Manual...
  • Page 40 3. Connect the smaller end of airway adapter (2) to the Y-piece connector in line withe face mask. CAUTION When Power is applied to the system, a green LED on the probe (1) indicates that the probe is ready for use. Prima 465 Anaesthetic Machine User Manual...
  • Page 41 5 .1 .14 Connecting a sidestream CO2 module 1. Connect the elbow (1) to the Y-piece (2) 2. Connect the sampling tube (3) to the elbow (1) water trap (4). 3. Connect the elbow to the breathing mask. Prima 465 Anaesthetic Machine User Manual...
  • Page 42 Damage 3. to the 3. locking faste 3.ne 3.r will re 3.sult. CAUTION To pre 3.ve 3.nt damage 3. to the 3. locking shaft (4), che 3.ck that the 3. gas conne 3.ction ports are 3. aligne 3.d with the 3. valve 3.s on the 3. manifold (1), and are 3. corre 3.ctly e 3.ngage 3.d, be 3.fore 3. tighte 3.ning the 3. locking le 3.ve 3.r. Prima 465 Anaesthetic Machine User Manual...
  • Page 43 Do not leave a gas cylinder valve open if the pipeline supply is in use. Cylinder supplies could be depleted, leaving an insufficient reserve supply in case of pipeline failure. Gas cylinders must conform with the requirements of IEC60601-1. Prima 465 Anaesthetic Machine User Manual...
  • Page 44 Do not connect any vacuum system directly to the outlet port . A receiving system with a positive and negative pressure control function must be interposed . 5 .3 .1 Read the AGSS instruction manual before clinical use . Prima 465 Anaesthetic Machine User Manual...
  • Page 45 CAUTION Before using this equipment, read this user manual, and to understand the function and operation of each component. If the system fails a test, do not use the device. Contact a Penlon-trained engineer. Prima 465 Anaesthetic Machine User Manual...

  • Page 46: Visual Inspection

    AC mains power source. Note that if the indicators are not on, the system does not have electrical power. 13. Make sure that the anesthesia machine can be switched on or off normally. Prima 465 Anaesthetic Machine User Manual...

  • Page 47: System Check

    PAW gauge pressure is between 25-35 cmH 11. Verify that bellows did not in ate (If bellows moved or in ated, contact service); 12. Click start button to perform Manual Leak Test Start Quit Prima 465 Anaesthetic Machine User Manual...

  • Page 48: Alarm Te 3.St

    7. Connect the machine to the mains electrical supply. 8. Make sure that mains indicator is illuminated 9. Make sure that the battery indicator is not illuminated while the Battery is charged. 10. Set the anaesthesia system switch to the OFF position. Prima 465 Anaesthetic Machine User Manual...

  • Page 49: Pre 3.-Use 3. Che 3.Ck - Gas Supply

    O supply is disconnected and N pressure decreases, that the condition that follow apply: • No O2 warnings are seen • The N2O SUPPLY DOWN !! alarm is triggered. 4. Set the anaesthesia system switch to the OFF position. Prima 465 Anaesthetic Machine User Manual...

  • Page 50: Gas Cylinde 3.R Supplie 3.S

    8. If the cylinder pressure decreases more than 690 kPa (100 psi), install a new cylinder seal. 9. Repeat steps 1 through 7. If the leak continues, contact a penlon-trained engineer. Do not use the cylinder supply system. 10. Set the anaesthesia system switch to the OFF position 11.
  • Page 51 7. If the cylinder pressure decreases more than 690 kPa (100 psi), install a new cylinder seal. 8. Repeat steps 1 through 6. If the leak continues, contact a penlon-trained engineer. Do not use the cylinder supply system. 9. Set the anaesthesia system switch to the OFF position 10.

  • Page 52: Vaporize 3.R

    7. If the vaporizer fails this test, install a different vaporizer and repeat operation 5. If the problem persists, the malfunction is in the anesthesia system. Do not use the system, contact trained technical personnel. 8. Test each vaporizer as above. Prima 465 Anaesthetic Machine User Manual...
  • Page 53 The expiratory check valve opens during expiration and closes at the start of inspiration. 5. Set the anaesthesia system switch to the OFF position 6. Disconnect the Y-piece connector from the test lung or manual bag. Prima 465 Anaesthetic Machine User Manual...
  • Page 54 8. Release the O2 flush button. 9. If the bellows deflates within one minute,.remove the bellows and reinstall, refer to Section 5.1.3. 10. Do the bellows test again.. 11. Set the anaesthesia system switch to the OFF position Prima 465 Anaesthetic Machine User Manual...
  • Page 55 Retest the system. Do not use the machine if the circuit continues to leak. Contact a Penlon-trained engineer. 10. Turn the APL valve counterclockwise to the Min position. 11. Set the anaesthesia system switch to the OFF position 12.
  • Page 56 12. Set the APL valve to the minimum position. 13. Set the anaesthesia system switch to the OFF position 14. Check that the reading on the airway pressure gauge is less than 5 cmH2O. Prima 465 Anaesthetic Machine User Manual...
  • Page 57 11. Make sure that the values of respiratory rate, and breathing ratio, displayed at the bottom of the screen are as set in step 5. 12. Set the anaesthesia system switch to the OFF position. Prima 465 Anaesthetic Machine User Manual...
  • Page 58 15. Check that a high FiO2 alarm is triggered. 16. Set the FiO2 high alarm limit to 100% and check that the alarm is cancelled. 17. Set the anaesthesia system switch to the OFF position Prima 465 Anaesthetic Machine User Manual...
  • Page 59 30 cmH2O. 6. After 15 seconds, check that a continuous positive airway pressure alarm is triggered. 7. Set the anaesthesia system switch to the OFF position. Prima 465 Anaesthetic Machine User Manual...
  • Page 60 4. Adjust the flow control knob and check that there is a flow of gas. 5. Push the Back-up O2 switch. 6. Adjust the flow control knob, check that the gas flow stops. 7. Set the anaesthesia system switch to the OFF position. Prima 465 Anaesthetic Machine User Manual...
  • Page 61 Before connecting a patient, flush the anesthesia machine with 5 L/min of O2 for at least one minute. This removes unwanted gas mixtures from the system. 11. Set the anaesthesia system switch to the OFF position Prima 465 Anaesthetic Machine User Manual...

  • Page 62: User Maintenance

    2. Care must be taken not to allow liquids to run into Servicing and Repair enclosed areas; serious damage may result. Prima 465 machines must only be serviced or repaired by Penlon-trained engineers, according to the schedule and CAUTION procedures given in the Service Manual, which contains circuit Do not use harsh abrasive cleaning agents.

  • Page 63: Operating The Anaesthesia System

    7 . Operating the Anaesthesia System 7 .1 Ventilation modes WARNING If the power-up self test fails, do not use the device. Contact a Penlon-trained maintenance engineer. Ventilator modes - Description The ventilator is capable of operating in one of the following seven modes: 1.
  • Page 64 100 to 1500 ml:10 ml Adult:300 to 1500 ml 4:1 to 1:10 4 to 100 bpm 1bpm 15bpm PEEP OFF, 3 to 30 cmH2O 1 cmH2O Pause 0% to 60% SIGH OFF, 50 to 150 Prima 465 Anaesthetic Machine User Manual...
  • Page 65 5 to 70 cmH2O 1 cmH2O 15 cmH2O 4:1 to 1:10 4 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 66 100 to 1500 ml:10ml 510 ml Adult:300 to 1500ml 4:1 to 1:10 4 to 100 bpm 1bpm 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 67 1 cmH2O 15 cmH2O Tslope 0 to 2 s 0.1 s 0.2 s Fsens:0.5 to 20.0 L/min Fsens:0.1 L/min Fsens:3 L/min Fsens/Psens Psens:0 to 20 cmH2O Psens:1 cmH2O Psens:2 cmH2O Esens 5% to 80% Prima 465 Anaesthetic Machine User Manual...
  • Page 68 15 cmH2O Tslope 0 to 2s 0.1s 0.2s Fsens: 0.5 to 20.0 L/min Fsens: 0.1 L/min Fsens: 3 L/min Fsens/Psens Psens: 0 to 20 cmH2O Psens: 1 cmH2O Psens: 2 cmH2O Esens 5% to 80% Prima 465 Anaesthetic Machine User Manual...
  • Page 69 15 cmH2O Tslope 3. 0 to 2s 0.1s 0.2 s Fse 3.ns: 0.5 to 20.0 L/min Fse 3.ns: 0.1 L/min Fse 3.ns: 3 L/min Fse 3.ns/Pse 3.ns Pse 3.ns: 0 to 20 cmH2O Pse 3.ns:1 cmH2O Pse 3.ns: 2 cmH2O Ese 3.ns 5% to 80% Prima 465 Anaesthetic Machine User Manual...
  • Page 70 0.1 s 0.2 s Fse 3.ns:0.5 to 20.0 L/min Fse 3.ns:0.1 L/min Fse 3.ns:3 L/min Fse 3.ns/Pse 3.ns Pse 3.ns: 0 to 20 cmH2O Pse 3.ns:1 cmH2O Pse 3.ns: 2 cmH2O Ese 3.ns 5% to 80% A backup mode 3. should be 3. se 3.le 3.cte 3.d in advance 3.. Prima 465 Anaesthetic Machine User Manual...
  • Page 71 Circuit Flow Sensor --. Skip Pressure Sensor --. Skip FG Flow Sensor --. Skip Oxygen Sensor --. Skip Circuit Compliance --. Skip Circuit Leakage --. Skip Battery --. Skip Quit Manual Leak Test Automatic System Test Prima 465 Anaesthetic Machine User Manual...

  • Page 72: Standby Mode 3.S

    - New Paediatric - New Infant • Gender options - - Male - Female Additionally patient height and age can be entered. The previous patient page will maintain the data from the previous patient. Prima 465 Anaesthetic Machine User Manual...
  • Page 73 2. A dialog box with three cirlces next to the title, indicates that that dialog box has more than one value associated with the dialog box. Pressing the multifunction control swaps between the foreground and background value. Prima 465 Anaesthetic Machine User Manual...

  • Page 74: Function Fie 3.Lds

    I : E PEEP 1:2.0 Tslope Pressure rise time 5 cmH O 70 bpm 100 Off cmH 0.10 s 10.00 O 30 PEEP Positive end-expiratory pressure Cancel Accept Modes Controls Monitoring Trends Alarms System Prima 465 Anaesthetic Machine User Manual...
  • Page 75 The figure shows the parameter settings. Pinsp Pressure control level Inspiratory time FREQ Respiratory rate Psupp Pressure support level Tslope Pressure rise time Psens/Fsens Pressure trigger / Flow trigger PEEP Positive end expiratory pressure Esens: Pressure trigger sensitivity Prima 465 Anaesthetic Machine User Manual...
  • Page 76 2. Touch [Volume] or [Pressure] to set desired backup mode. Volume selected: the following parameters are available: Tidal volume Respiratory ratio FREQ Respiratory rate Pressure selected: the following parameters are available: Pinsp Pressure control Respiratory ratio FREQ Respiratory rate Prima 465 Anaesthetic Machine User Manual...
  • Page 77 - I : E - Rst - Cdyn - FiO2 - SpO2 - Pulse - PI • Values 2 - MAC - FiCO2 - EtCO2 - FiN2O - EtN2O - FiAA1 - EtAA1 - FiAA2 - EtAA2 Prima 465 Anaesthetic Machine User Manual...
  • Page 78 When setting alarm limits, push the hotkey, turn the knob to the value that you want to set, then push the knob. Prima 465 Anaesthetic Machine User Manual...
  • Page 79 7 .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 80 » Height can be entered as Cm or Inches » Barometric pressure can be entered as mmHg or hPa » Gas supply can be entered as kPa or PSI » Weight can be entered as Kg or Lb. Prima 465 Anaesthetic Machine User Manual...
  • Page 81 Values can be adjusted using the touch screen or the multifunction control. The following values are available: • Tidal Volume (VT) • Inspiration Pressure (Pinsp) • Respiratory ratio (I : E) • Breathing frequency (f) • PEEP Prima 465 Anaesthetic Machine User Manual...
  • Page 82 7. CO2: Carbon Dioxide 8. N2O: Nitrous oxide 9. AA1: Anesthetic agent in use 10. Pleth: Pleth. NOTE The measured range corresponding to the waveform scales can be adjusted automatically. The sweep time is fixed. Prima 465 Anaesthetic Machine User Manual...
  • Page 83 7 .7 .3 Volume waveform The volume waveform shows the volume of gas in the breathing circuit. 12 sec 7 .7 .4 Pressure-Volume Loop Select [Monitoring] -> [Graphics] A Pressure-Volume Loop and Volume-Flow loop will displayed as shown. Prima 465 Anaesthetic Machine User Manual...
  • Page 84 7 .7 .7 EtCO2 waveform On machines with CO2, a CO2 waveform is displayed as shown. 7 .7 .8 Pressure-Flow Loop An example of a Pressure-Flow (P-F) loop is shown opposite. 25 cmH Prima 465 Anaesthetic Machine User Manual...
  • Page 85 If an AG module is installed, Page 1 will show the values that follow: • PEEP: Positive end-expiratory pressure • Pmean: Average pressure • EtCO2: End-tidal carbon dioxide • FiCO2: Fraction of inspired carbon dioxide Prima 465 Anaesthetic Machine User Manual...
  • Page 86 Key parameters are displayed at the top of the RH column at all times. The four values are as follows: Ppeak • Ppeak: Peak airway pressure • MV: Minute ventilation • VTE: Expiratory tidal volume • ftotal: Total respiratory rate ftotal Prima 465 Anaesthetic Machine User Manual...

  • Page 87: Alarm Sile 3.Nce 3. Icon

    7. Values for for all technical alarms and some physiological alarms are preset at the factory and can not be changed. Prima 465 Anaesthetic Machine User Manual...
  • Page 88 Paw high alarm limit setting. Ppeak is higher than the Paw high PRESSURE HIGH!!! High alarm limit setting. Check for blockages in the patient circuit Recalibrate the O cell. FiO2 < 18%!!! High FiO2 is lower than 18%. Prima 465 Anaesthetic Machine User Manual...
  • Page 89 EtCO2 HIGH!!! High appropriately. alarm limit. Check if absorbent needs to be changed. Set the alarm limits appropriately. FiCO2 is greater than alarm FiCO2 HIGH!!! High limit. Check if absorbent needs to be changed. Prima 465 Anaesthetic Machine User Manual...
  • Page 90 Set alarm limit appropriately. Check agent setting. EtENF LOW!! Medium EtISO LOW!! Medium EtSEV LOW!! Medium EtDES LOW!! Medium Set the required alarm limits. FiN2O LOW!! Medium FiN2O is less than alarm limit. Check the N2O setting Prima 465 Anaesthetic Machine User Manual...
  • Page 91 Check that the air pipeline AIR SUPPLY DOWN!! Medium than 280kPa. is properly connected. Check the N2O pipeline. N2O pipeline pressure is N2O SUPPLY DOWN!! Medium Check that the cylinder is less than 280kPa. properly connected. Prima 465 Anaesthetic Machine User Manual...
  • Page 92 SpO2 switch is turne 3.d off To monitor SpO2, se 3.t the 3. SpO2 switch to on. Pre 3.ss the 3. “Alarm Re 3.se 3.t” O2 OFF! O2 switch is turne 3.d off To monitor O2conce 3.ntration, se 3.t the 3. O2 switch to on. Prima 465 Anaesthetic Machine User Manual...

  • Page 93: Patie 3.Nt Type 3. Icon

    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. Pressing the ACCEPT button shows the pre-use test screen. Prima 465 Anaesthetic Machine User Manual...
  • Page 94 Before clinical use, check that all connections are secure and that the pre-operation tests are completed. If any tests failed, do not use the system. Refer the workstation to a Penlon-trained service engineer for repair. 7 .19 .1 Bag Ventilation Mode Inspiration Exspiration 1.

  • Page 95: Monitoring Parame 3.Te 3.Rs

    International standards require that the user must monitor tidal volume during a clinical procedure. Volume related parameters are measured as shown below. MVspn Breath rate related parameters are measured as shown below. ftotal fspn Prima 465 Anaesthetic Machine User Manual...

  • Page 96: Pulmonary Function

    If O2 gas source fails, the drive gas type can be switched to air. 1. Check the anesthesia machine in standby mode 2. Select the [System] -> [Settings] -> [Drive gas]. 3. Select [drive gas] to desired gas type. Prima 465 Anaesthetic Machine User Manual...
  • Page 97 Allow the machine to dry thoroughly before clinical use. Sterilisation Breathing system hoses and other components must be sterilised to the manufacturer’s recommended methods. An effective, new bacterial ⁄ viral breathing circuit filter should be used for every patient. Prima 465 Anaesthetic Machine User Manual...

  • Page 98: Maintenance

    O2% and unplug the other end of the cable from the machine. 11. Turn the oxygen sensor counterclockwise to remove 8 .3 .2 Remove the flow sensors Unscrew the inspiratory and expiratory connectors and then pull the adaptor out. Prima 465 Anaesthetic Machine User Manual...
  • Page 99 1. Turn the bellows housing counterclockwise, and lift from the base 2. Remove the bellows from the base. 3. Remove the bellows base 4. Remove the locking tabs and ring from the bellows base. Prima 465 Anaesthetic Machine User Manual...
  • Page 100 8 .3 .9 Remove the Water Container 1. Grip the water collection container and turn clockwise to remove WARNING Removing the water collection container will not cause gas leakage, but always reinstall as soon as possible. Prima 465 Anaesthetic Machine User Manual...
  • Page 101 Flush with water, then soak in a solution of water and detergent 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 134°C. Prima 465 Anaesthetic Machine User Manual...
  • Page 102 Soak the flow sensor in detergent for 30 minutes to clean. Flush with water and dry. 8 .3 .12 Reinstall the absorber assembly and breathing system Make 3. sure 3. that all compone 3.nts fully dry be 3.fore 3. installation Prima 465 Anaesthetic Machine User Manual...

  • Page 103: Mainte 3.Nance 3. Policy

    8. After repair, carry out a pre-use test - see section 5.2. Do not use a malfunctioning anesthesia machine. CAUTION All repairs must be undertaken by a competent, Penlon- trained engineer. Replace damaged parts with components supplied by Penlon Limited.

  • Page 104: Mainte 3.Nance 3. Sche 3.Dule 3

    2000 hours per year. If the actual annual usage exceeds 2000 hours, maintenance must be increased accordingly. 5. All repairs and servicing, and the replacement of components must be undertaken by a Penlon-trained engineer. Daily 1. Clean external surfaces.
  • Page 105 Do not touch the breathing system tubing during calibration. CAUTION If zeroing fails, contact a Penlon-trained engineer. 8 .6 .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 106: Oxyge 3.N Conce 3.Ntration Calibration

    - see section 9.2.1. 7. Push the [Enter] hotkey to start calibration. 8. After a successful calibration, the screen shows [Calibration Completed!]. If the message [Calibration Failure! ] is displayed, repeat the calibration. Prima 465 Anaesthetic Machine User Manual...
  • Page 107 2. In case of repeated calibration failures, replace the O2 sensor and repeat the 21% O2 calibration. 3. Calibrate at 100% O2 after a 21% O2 calibration is completed. If it still fails, contact a Penlon trained engineer. Calibration at 100% O2: 1.

  • Page 108: Flow Se 3.Nsor Calibration

    Contact a Penlon-trained engineer auxiliary outlet Replace the fuse No airway There is a disconnect between the pressure Reconnect. pressure sensor and the sample tube, or Check the gas supply waveform Gas source is exhausted Prima 465 Anaesthetic Machine User Manual...
  • Page 109 Undo the screws and remove the battery cover (1) at the rear of the machine. Fit the batteries into the holder. Check the polarity. Refit the cover and tighten the four screws. Prima 465 Anaesthetic Machine User Manual...
  • Page 110 6 . Appendix Appendix 1 References The Prima 465 and its Anaesthetic Breathing System complies with the requirements of ISO 80601-2-13. Appendix 2 Disposal at end of useful life: Risk assessment Do not dispose of in landfill, refer to an approved recycling facility.

  • Page 111: Appendix

    Do not push against the machine at a height greater than 1.1. metres Connection for neutral conductor Do not sit Transportation: Remove accessories. Rotation (controls output) Backbar leak check 1. General warning (yellow background) 2. Caution (plain background) Ventilator Mute (alarm) Prima 465 Anaesthetic Machine User Manual...
  • Page 112 Appendix Electrostatic device Serial Number Lock Unlock USB connector Common Gas Outlet Anaesthesia system switch Prima 465 Anaesthetic Machine User Manual...
  • Page 113 This ane 3.sthe 3.tic ve 3.ntilator is a pne 3.umatically drive 3.n, avoid sustaine 3.d airway pre 3.ssure 3.. microproce 3.ssor-controlle 3.d ane 3.sthe 3.sia de 3.live 3.ry syste 3.m. The 3. drive 3. gas come 3.s from O2/Air gas supply. Filte 3.r 6 filte 3.rs the 3. drive 3. gas again. Re 3.gulator 20 he 3.lps ke 3.e 3.p Prima 465 Anaesthetic Machine User Manual...
  • Page 114 Gases or anesthetic agents Gas concentration (volume percentage) Nitrous oxide Halothane Enflurane +10% of reading Isoflurane +10% of reading Sevoflurane +10% of reading Desflurane +14% of reading 1) The module allows normal operating conditions, the interference can be ignored. Prima 465 Anaesthetic Machine User Manual...
  • Page 115 The sampling tubes must not be bent to prevent pump overload and maintain accuracy of measurement. Repairs must be made only by Penlon-trained engineers, or by the manufacturer. The manufacturer will not be held responsible if the operator uses the unit incorrectly.
  • Page 116 It can display of real time and derived monitoring data of CO2, N2O, O2, and the Anesthesia agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. It is intended to be used by trained and authorized health care professionals only. Prima 465 Anaesthetic Machine User Manual...
  • Page 117 Primary and secondary agent. Waveforms Up to five simultaneous gas concentration waveforms. Diagnostic parameters Atmospheric pressure, software and hardware revision, serial number. Flags Breath detected, apnea, replace oxygen sensor, check adapter. Unspecified accuracy and sensor error. Prima 465 Anaesthetic Machine User Manual...
  • Page 118 0.15 vol% as long as apnea is not detected. Secondary agent threshold 0.2 vol% + 10% of total agent concentration Agent identification time < 20 seconds. (typically < 10s). Total system response time < 1 second Prima 465 Anaesthetic Machine User Manual...
  • Page 119 Placing an HME in front of the probe protects the airway adapter from secretions and effects of water vapor and eliminates the need of changing the adapter. It also allows free positioning of the probe. Prima 465 Anaesthetic Machine User Manual...
  • Page 120 2. Do not sterilize or immerse the IRMA probe in liquid. The IRMA probe can be cleaned using a cloth moistened with maximum 70% ethanol or maximum 70% isopropyl alcohol. Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA probe. Prima 465 Anaesthetic Machine User Manual...
  • Page 121 Appendix 8 Electromagnetic compatibility (EMC) The Prima 465 anaesthetic machine is suitable for use in the specified electromagnetic environment. The user of the Prima 465 anaesthetic machine should assume that it is used in an electromagnetic environment as described below.
  • Page 122 Appendix Table 2. Guidance and manufacturer’s declaration – electromagnetic immunity The Prima 465 anaesthetic machine is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment. Immunity test...
  • Page 123 fixe 3.d RF transmitte 3.rs, an e 3.le 3.ctromagne 3.tic site 3. surve 3.y should be 3. conside 3.re 3.d. If the 3. me 3.asure 3.d fie 3.ld stre 3.ngth in the 3. location in which the 3. Prima 465 anaesthetic machine is use 3.d e 3.xce 3.e 3.ds the 3. applicable 3. RF compliance 3. le 3.ve 3.l above 3., the 3. Prima 465 anaesthetic machine should be 3. obse 3.rve 3.d to ve 3.rify normal ope 3.ration.
  • Page 124 Table 4 . Recommended separation distances between portable and mobile RF communications equipment and the Prima 465 anaesthetic machine The Prima 465 anaesthetic machine is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Prima 465 anaesthetic machine, as recommended below, according to the maximum output power of the communications equipment.
  • Page 125 Prima 465 Anaesthetic Machine User Manual...
  • Page 126 Like 3. us at face 3.book.com/Pe 3.nlonGlobal Follow us at twitte 3.r.com/Pe 3.nlonGlobal Doc. No. FT0117 / April 2017. Penlon and InterMed are trademarks of Penlon Limited. All other trademarks are the property of their respective owners. Part of the InterMed Group © Penlon Ltd. 2017 All rights reserved...

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