Penlon Prima 320 Advance User Manual
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Penlon Prima 320 Advance User Manual

Anaesthetic machine
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User Manual
Prima 320 Advance Anaesthetic Machine
A N A E S T H E S I A S O LU T I O N S
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 320 Advance

  • Page 1 User Manual Prima 320 Advance Anaesthetic Machine A N A E S T H E S I A S O LU T I O N S 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 7.1. Details of these operations are in the Prima 320 Advance service manual, which contains servicing procedures etc. Servicing should be carried out by engineers trained by Penlon Ltd.
  • Page 4 FREQUENTLY AND REGULARLY AND THAT ANY 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 320 Advance User Manual...

  • Page 5: Table Of Contents

    Breathing System Test ................38 Prima 320 Advance...
  • Page 6 Appendix 6. Electromagnetic compatibility (EMC) ..............87 Prima 320 Advance...
  • 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

    Prima 320 Advance User Manual...
  • Page 9 1. Refer to Appendix 3 for labelling and symbols 24. Accessories must be removed before the machine is transported. 25. MRI compatibility - The Prima 320 Advance is not MRI compatible. 26. To prevent patient injury in the event of total anaesthesia system failure, an alternative means of ventilation must be available whenever the device is in use.

  • Page 10: Purpose

    2. Purpose Purpose The Prima 320 Advance anaesthetic machine is for use by a professional operator in a professional hospital or clinical environment, and must be continually attended when in use. The device is intended to provide controlled concentrations and flows of anaesthesia gases into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient.

  • Page 11: Description

    The ventilator is a pneumatically driven, microprocessor- controlled anaesthesia delivery system. The drive gas is supplied by the O2 or Air gas supply, see section 3.12. A gas circuit schematic is shown on the next page. Prima 320 Advance User Manual...
  • Page 12 19 Vaporizer 41 Connector - gas scavenging system 20 Regulator (250 kPa) - ventilator 42 Auxiliary oxygen supply 21 Inspiratory flow control valve - ventilator 43 Pressure sensor 22 Over-pressure valve (100 kPa) - ventilator Prima 320 Advance User Manual...

  • Page 13: Front View

    5. Vaporizer 6. Common Gas Outlet (ACGO) and O2 flush button 7. Multifunction control 8. Auxiliary oxygen supply outlet Refer to Appendix 3 for details of a Penlon O2 therapy flowmeter kit 9. Absorber assembly Rear View 1. Cylinder yoke 2.

  • Page 14: Control Panel

    The alarm silence symbol and a 120-second countdown sequence appear to the left of the Date/time display. NOTE The O2 Supply Failure alarm is not silenceable. 10. Date/time display 11. On/off switch - work surface lighting Prima 320 Advance User Manual...

  • Page 15: Electrical Power Supply

    5. If a battery has been discharged and/or has been stored for a long time, charging may take longer than 4 hours. Prima 320 Advance User Manual...
  • Page 16 See section 6.11.6. Connect the AC power immediately or use an alternative ventilation method. 3.7.5 Installing and replacing the battery WARNING Battery installation must be undertaken by a trained engineer, see section 7.11. Prima 320 Advance User Manual...

  • Page 17: Vaporizers

    Removal of the vaporizer from the station closes the valves on that station. Installation: refer to Section 5.4. Vaporizer Interlock System Selectatec-compatible vaporizer interlock systems are described in the literature supplied with the vaporizer. Prima 320 Advance User Manual...

  • Page 18: Absorber

    Check the instructions supplied with the absorbent. Canister ‘not fitted’ alarm A sensor (12) triggers an alarm when the canister is removed. CAUTION Do not obstruct the sensor - do not route any hoses or cables in front of the sensor. Prima 320 Advance User Manual...
  • Page 19 2. Do not route the cable in front of the canister sensor (14). NOTE If a sidestream gas monitoring module is installed (with optional oxygen monitoring) the oxygen sensor shown (6) is not required and the sensor port is blanked off. Prima 320 Advance User Manual...

  • Page 20: Auxiliary Common Gas Outlet (Acgo) And O2 Flush Control

    (b) into the breathing system. 3.11 Anaesthetic Gas Scavenge System (AGSS) The Penlon AGSS receiver (1) is mounted on the side of the machine (2), see section 5.1.9. All sources of expired anaesthetic gases (e.g. directed from the absorber APL valve, and the ventilator bellows patient gas exhaust), are directed internally to the outlet (3) at the right- hand-side of the rear of the machine.

  • Page 21: Ventilator

    3.12.4 Synchronised intermittent mandatory ventilation - Volume control (SIMV-V) The ventilator delivers volume controlled breaths which are synchronised with the patient’s inspiratory efforts. The ventilator also allows spontaneous breaths with pressure support. Prima 320 Advance User Manual...

  • Page 22: Patient Monitoring - Parameters

    • Fraction of inspired oxygen - FiO2 • Peripheral oxygen saturation -SpO2 (optional) • Pulse rate (bpm) • Perfusion index (PI) Values 2 • Fraction of inspired carbon dioxide - FiCO2 (optional) • End tidal carbon dioxide - FiCO2 - (optional) Prima 320 Advance User Manual...

  • Page 23: Alarm System

    Press the alarm silence key (2) to silence the audio alarm. ’Alarm silenced’ status will be set. The alarm silence symbol (3) and a 120-seconds countdown period will be displayed. NOTE The O2 Supply Failure alarm is not silenceable. Prima 320 Advance User Manual...

  • Page 24: Specification

    Two (oxygen and nitrous oxide), with pin-indexed cylinder yokes Pipeline Three pipeline inlets (oxygen, air, nitrous oxide). UK and Europe: NIST USA: DISS N2O cut-off N2O supply is cut-off when the internal O2 supply pressure is less than 90 kPa. Prima 320 Advance User Manual...

  • Page 25: Gas Supply Pressure

    Supply pressure 250 kPa Flow rate 100 L/min Refer to Appendix 3 for details of a Penlon O2 therapy flowmeter kit Auxiliary Common Gas Outlet (ACGO) Connector 22 mm male conical connector incorporating a coaxial female 15 mm conical connector.

  • Page 26: Electrical Supply

    Water collection container Can be emptied during use. Pressure and flow data (APL valve fully open) Flow rate (L/min) APL pressure (cmH2O, dry)  APL pressure (cmH2O), moist 0.95 1.03 1.86 2.10 2.08 2.45 2.29 2.72 2.57 3.14 3.02 3.41 Prima 320 Advance User Manual...

  • Page 27: Ventilator

    (Mvspont) Respiratory rate 0 ~ 100 bpm; Resolution: 1 bpm Spontaneous respiratory rate 0 ~ 100 bpm; Resolution: 1 bpm 30:1 to 1:150; resolution: 0.1 Peak airway pressure 0 ~ 100 cmH2O; Resolution: 1 cmH2O Prima 320 Advance User Manual...

  • Page 28: Alarm Settings

    Oxygen pressure less than 280 kPa AC power failure Mains supply failure or power cord disconnection Low battery More than 10 minutes remaining Battery is exhausted More than 5 minutes remaining Alarm silence ≤ 120 s Prima 320 Advance User Manual...

  • Page 29: Device Classification And Labelling

    No residual risks from phthalates that are carcinogenic, mutagenic, or toxic to reproduction. Applied parts (if fitted) Patient hoses/masks, SpO2 sensor (optional), sidestream Type B multigas sensor, sidestream CO2 sensor Accessories Refer to Appendix 3 Prima 320 Advance User Manual...

  • Page 30: 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 machine has waste gas exhaust ports. Check that residual breathing gas is scavenged.

  • Page 31: Absorber Assembly

    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 320 Advance User Manual...
  • Page 32 1. When installing the breathing hoses, hold the tube connector at both ends of the tube to prevent damage to the tube. 1. The two breathing hoses are connected to the expiratory and inspiratory connectors. 2. Connect the breathing hoses to the Y-piece. Prima 320 Advance User Manual...

  • Page 33: Connecting Gas Monitoring Modules

    4. Connect the other end of the elbow to the breathing bag, or to the patient breathing circuit 5.3.2 Connecting a NMed SpO2 sensor cable Insert the sensor cable into the connector socket labelled ‘SpO2’ on the machine frame rear panel. Prima 320 Advance User Manual...

  • Page 34: Installing The Vaporizer

    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 IEC 60601-1. Prima 320 Advance User Manual...

  • Page 35: Medical Gas Pipeline Connection

    (1) at the right- hand-side of the rear of the machine. A hose (4) connects the outlet to the receiver unit inlet port. The output hose (5) connects to the hospital disposal system. Prima 320 Advance User Manual...

  • Page 36: Pre-Use Test Before Each Clinical Procedure

    4. Make sure that the vaporizers are locked in position and contain sufficient agent. 5. Make sure that the gas supplies are connected and the pressures are correct. Prima 320 Advance User Manual...
  • Page 37 13. Make sure that all gas flowmeter controls are turned fully clockwise. 5.9.4 Power failure alarm test 1. Disconnect the machine from the mains power supply. a) Make sure that the mains indicator is extinguished b) Make sure that the battery indicator light illuminates. Prima 320 Advance User Manual...
  • Page 38 18. Check that no O2 warnings are displayed when the N2O supply pressure decreases. 19. Connect the Air pipeline. 20. Press the Alarm Reset button. 21. Make sure that no alarms are shown on the screen. Prima 320 Advance User Manual...
  • Page 39 10. If the cylinder pressure decreases more than 700 kPa (100 psi), install a new cylinder seal. 11. Repeat steps 5 through 9. If the leak continues, contact a penlon-trained engineer. Do not use the O2 cylinder supply. 12. Reconnect the Oxygen pipeline. N2O cylinder High pressure leak test 13.

  • Page 40: Vaporizer Tests

    2. Make sure that the interlock mechanism of each vaporizer is working correctly as follows: a) Make sure that only one vaporizer at a time can be turned on. b) Refer to the vaporizer user manual for additional pre- use checks. Prima 320 Advance User Manual...

  • Page 41: Alarm System Tests

    1. Set the pressure high alarm limit to 30 cmH2O. 2. Check the Ppeak reading. Adjust the tidal volume until the reading is higher than the pressure high alarm limit. 3. Check that a high pressure alarm triggered. Prima 320 Advance User Manual...
  • Page 42 9. Set the FiO2 high alarm limit to 25%. 10. Check that a FiO2 HIGH alarm is triggered. 11. Set the FiO2 high alarm limit to OFF and check that the alarm is cancelled. Prima 320 Advance User Manual...
  • Page 43 5.11.12 Airway pressure low alarm test 1. Set the bag/vent switch to the vent position. 2. Set the Pressure low alarm limit to 5 cmH2O. 3. Disconnect the test lung from the Y-piece patient connection. Prima 320 Advance User Manual...

  • Page 44: Breathing System Test

    If a leak is suspected, check the bellows, breathing tube, absorber, and connectors for correct function and security. Retest the system. Do not use the machine if the circuit continues to leak. Contact a Penlon-trained engineer. APL valve test 16. Turn the APL valve to 70 cmH2O position..

  • Page 45: Oxygen Flush Test

    If necessary, refer to Section 6. 3. Make sure that the system is in Standby. 4. Make sure that equipment for airway maintenance, manual ventilation, tracheal intubation, and applicable anaesthetic and emergency drugs are available. Prima 320 Advance User Manual...
  • Page 46 11. Before connecting a patient, flush the machine with 5 L/ min of O2 for at least one minute. This removes unwanted gas mixtures from the system. 12. Set the anaesthesia system switch to the OFF position. Prima 320 Advance User Manual...

  • Page 47: Operating The Anaesthesia System

    CAUTION Do not apply excessive pressure to the display screen. 6.1.5 System settings 1. Alarm volume a) Select [System] -> [Settings] -> Alarm volume. b) Select Alarm volume: 20%, 40%, 60%, 80%, 100% Prima 320 Advance User Manual...
  • Page 48 Select the desired driver gas type: O2 or Air. d) The drive gas icon (1) is displayed on screen, below the Alarm message field. ‘X’ will be shown as the drive gas in use. Prima 320 Advance User Manual...
  • Page 49 When the Air alarm switch is set to OFF, the Air supply pressure alarm is off. Note that air supply pressure monitoring is active. 11. Set CO2 unit a) Select [System] -> [Settings] -> [EtCO2 Unit]. b) Select: % / mmHg / kPa. Prima 320 Advance User Manual...

  • Page 50: Display Controls

    Trigger Level. 11. Multiple Alarm Icon: The icon is displayed if two or more alarms are active. The highest priority alarm is displayed in the alarm message field. The number of active alarms is shown. Prima 320 Advance User Manual...
  • Page 51 In SPONT/PSV mode, the backup mode (VCV or PVC mode) must be preselected. The parameters for the selected backup mode must also be preset. Backup Modes: 1. Select the [Modes] shortcut key-> [Backup]. 2. Touch [Volume] or [Pressure]. Prima 320 Advance User Manual...
  • Page 52 End-tidal carbon dioxide Note that the measured range corresponding to the waveform scales can be adjusted automatically. The sweep time is fixed. 6.2.5.1 Airway pressure waveform The airway pressure waveform field can be changed. 12 sec Prima 320 Advance User Manual...
  • Page 53 6.2.5.5 EtCO2 waveform On machines with CO2, a CO2 waveform is displayed as shown. 6.2.5.6 Pressure-Volume loop Select [Monitoring] -> [Graphics] A Pressure-Volume Loop and Volume-Flow loop will displayed as shown. 6.2.5.7 Volume-Flow loop Prima 320 Advance User Manual...
  • Page 54 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 320 Advance User Manual...

  • Page 55: Fresh Gas Settings

    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 machine to a Penlon-trained service engineer for repair. 6.3.1 N2O, O2, and air supply settings 1.

  • Page 56: Ventilation Mode

    APL valve, the valve opens to release excess gas. The APL valve is generally set at between 20-30 cmH2O. A: Airway pressure B: Flow C: Time: inspiration D: Time: Expiration Prima 320 Advance User Manual...
  • Page 57 In VCV mode, the flow waveform is at a constant flow during inspiration and the Paw waveform rises in the same period A: Airway pressure B: Inspiratory pressure C: Flow D: Time: inspiration E: Time: expiration Prima 320 Advance User Manual...
  • Page 58 Setting the parameters in PCV mode Parameter Range Step Pinsp 5-70 cmH2O 1 cmH2O 4:1 - 10:1 FREQ 4 -100 bpm 1 bpm PEEP Off, 3 - 30 cmH2O 1 cmH2O Tslope 0 - 1 s 0.1 s Prima 320 Advance User Manual...
  • Page 59 510 ml Adult: 100 to 1600 ml 4:1 to 1:10 FREQ 1 to 100 bpm 1 bpm 15 bpm PEEP OFF, 3 to 30 cmH2O 1 cmH2O Tslope 0 to 1 s 0.1 s 0.2 s Prima 320 Advance User Manual...
  • Page 60 1 cmH2O 15 cmH2O Tslope 0 to 1 s 0.1 s 0.2 s Fsens 1 to 20.0 L/min 0.1 L/min 3 L/min Psens 1 to 20 cmH2O 1 cmH2O 2 cmH2O Esens 5% to 80% Prima 320 Advance User Manual...
  • Page 61 1 cmH2O 15 cmH2O Tslope 0 to 1 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 320 Advance User Manual...
  • Page 62 1 cmH2O 15 cmH2O Tslope 0 to 1 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 320 Advance User Manual...
  • Page 63 1 cmH2O 15 cmH2O Tslope 0 to 1 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 320 Advance User Manual...
  • Page 64 3. Press the control knob to confirm and activate. Set inspiratory trigger In SIMV-V, SIMV-P, and PSV modes, patient-initiated triggering is permitted. Trigger sensitivity can be set in flow triggering (Fsens) or pressure (Psens) triggering. Normally, flow Prima 320 Advance User Manual...
  • Page 65 3. Press the control knob again to activate the change. 6.4.11 Starting mechanical ventilation CAUTION Check the parameters are set to appropriate values before starting ventilation. To exit Standby mode and start mechanical ventilation, press the Start/Standby key (1) . Prima 320 Advance User Manual...

  • Page 66: 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 6.2.5. Prima 320 Advance User Manual...

  • Page 67: Alarm Setup

    3. Use the multifunction control to reposition the cursor (d), to view the parameter values at the required time point. CAUTION 1. If system time is set, the trend graph is recorded again. 2. If ‘Patient type’ is reset, select save or record again. Prima 320 Advance User Manual...

  • Page 68: Replace Absorbent

    Make sure that the triangular marks (3) are aligned. 7. Tighten counter-clockwise until the ‘locked’ symbol (6) and the triangular mark (7) on the canister are aligned. 8. Check that the alarm message is cancelled. Prima 320 Advance User Manual...

  • Page 69: Auxiliary Common Gas Outlet (Acgo)

    Indicates a life threatening situation requiring immediate action. Medium level alarm Indicates that the patient’s vital signs appear abnormal and immediate action is required. Low level alarm Indicates that the patient’s vital signs appear abnormal; action may be required. Prima 320 Advance User Manual...
  • Page 70 Alarm Level Symbol High Medium 6.11.3.4 Alarm status symbols The alarm status icon appears on the screen to show different alarm status conditions, including Alarm Silence. NOTE The O2 Supply Failure alarm is not silenceable. Prima 320 Advance User Manual...
  • Page 71 Check the patient settings, and set the alarm alarm limit. limits appropriately. Check if the absorbent needs to be changed. FiCO2 HIGH!!! High FiCO2 is greater than alarm Set the alarm limits appropriately. limit. Check if the absorbent needs to be changed. Prima 320 Advance User Manual...
  • Page 72 Press ‘Alarm Reset’ to cancel this alarm. To monitor SpO2, switch SpO2 monitoring on. O2 OFF! O2 switch is turned off Press ‘Alarm Reset’ to cancel this alarm. To monitor O2, switch O2 monitoring on. Prima 320 Advance User Manual...

  • Page 73: Maintenance

    Penlon-trained engineers. Servicing and Repair The Prima 320 Advance must be only be serviced or repaired by Penlon-trained engineers, according to the schedule and procedures given in the Service Manual, which contains circuit diagrams, service kits and component lists.

  • Page 74: Cleaning And Disinfection

    Swelling or faster aging can occur. This warning applies to the silicon rubber case for the pressure relief valve in the base of the bellows (see section 7.3.1). 7. Cleaning solutions must have a pH of 7.0 to 10.5. Prima 320 Advance User Manual...
  • Page 75 Make sure that all cleaning agent residues are fully removed after cleaning. Always allow the machine to dry off thoroughly before clinical use. Sterilisation Breathing system hoses and other components must be sterilised to the manufacturer’s recommended methods. Prima 320 Advance User Manual...

  • Page 76: Absorber And Breathing System Components

    2. If a filter is fitted, do not reuse the filter. Follow local regulations regarding disposal of hospital waste when the filter is discarded. 1. Remove the inspiratory and expiratory hoses from the absorber outlets. 2. Separate the Y-piece from the two breathing hoses. Prima 320 Advance User Manual...
  • Page 77 Remove the airway pressure gauge 1. Pull out the pressure gauge from the breathing system. 7.3.6 Remove the bag support arm 1. Loosen the locking nut counterclockwise. 2. Remove the bag arm from the breathing system. Prima 320 Advance User Manual...
  • Page 78 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 pressure relief valve assembly from absorber. 5. Remove the locking tabs and ring from the bellows base. Prima 320 Advance User Manual...
  • Page 79 2. Hold the canister over a drain or collection bowl. 3. Carefully pull out the water drain plug. 4. Dilute the drained condensate before disposal. 5. Refit the plug. 6. Empty the canister. Dispose of the absorbent in line with local regulations. Prima 320 Advance User Manual...
  • Page 80 7.3.11 Remove the absorber assembly 1. Pull the locking catch on the adaptor plate up, rotate 90 degrees and pull off. 2. Remove the absorber assembly from the circuit adapter with both hands. Prima 320 Advance User Manual...

  • Page 81: Cleaning And Disinfection Methods

    Check valve discs √ √ Oxygen sensor √ Airway pressure gauge √ Bag support arm √ √ √ Bellows assembly √ √ Absorber canister √ √ √ Water container √ √ √ Absorber body √ √ √ Prima 320 Advance User Manual...
  • Page 82 Display screen CAUTION The display screen must not be cleaned with liquid. 1. Wipe with a cotton cloth soaked in soft detergent solution. 2. Wipe off the residual detergent solution with a dry, soft, lint-free cloth. Prima 320 Advance User Manual...

  • Page 83: Absorber And Breathing System

    3. Use BG87 or Fomblin grease to lightly lubricate the eight silicon inserts (1). 4. Lift and turn the locking catch (3) to the unlocked position. 5. Align the two connectors (4) on the absorber with the matching holes (5) on the circuit adapter plate. Prima 320 Advance User Manual...

  • Page 84: Pressure Sensor Zeroing

    1. Do not calibrate while the unit is connected to a patient. 2. During calibration, do not operate the pneumatic system. Do not move or compress the breathing tubes. 3. If zeroing fails, contact a Penlon-trained engineer. Procedure 1. Stop manual or mechanical ventilation. If a breathing tube is connected, open the breathing tube patient connection to air.

  • Page 85: Oxygen Concentration Calibration

    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 86: Touchscreen Calibration

    2. Remove the battery cover (illustrated in section 3.4), detach the battery (1) and disconnect the wiring. 3. Install a new battery and reconnect the wiring. 4. Refit the cover and tighten the four screws. Prima 320 Advance User Manual...

  • Page 87: Fault Diagnosis And Troubleshooting

    Refit or renew the breathing tube Check valve is not installed correctly Reinstall Manual / mechanical ventilation switch failure Contact a Penlon-trained engineer Bellows does not inflate completely The respiratory rate is set too fast and Set respiratory rate to a reasonable expiratory time is too short.

  • Page 88: Appendix

    8. Appendix Appendix 1 References The Prima 320 Advance 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 89: Appendix 4 Labelling

    Power Off Lighting USB Interface Inspiratory flow Expiratory flow Bag/manual ventilation Mechanical ventilation Lock Unlock Flow control O2 Flush button Oxygen sensor connector Bi-directional rotation Cylinder O2 supply connector N2O supply connector Air supply connector Prima 320 Advance User Manual...
  • Page 90 Hazardous waste (infectious) Standby button Components that must be disposed of as hazardous waste Drive gas identification ( “x” will be marked as SpO2 SpO2 inlet connector O2 or Air) Prima 320 Advance User Manual...

  • Page 91: Appendix 5 Sidestream Co2 Module (Optional)

    Gases or anaesthetic 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 320 Advance User Manual...
  • Page 92 5. The sampling tubes must not be bent. This will prevent pump overload and maintain accuracy of measurement. 6. Repairs must be made only by Penlon-trained engineers, or by the manufacturer. 7. The manufacturer will not be held responsible if the operator uses the unit incorrectly.

  • Page 93: Appendix 6. Electromagnetic Compatibility (Emc)

    Appendix 6. Electromagnetic compatibility (EMC) Electromagnetic environment The Prima 320 Advance 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.
  • Page 94 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 320 Advance User Manual...
  • Page 95 Appendix Prima 320 Advance User Manual...
  • Page 96 5008965-en A. Doc. No. TA 0119 UI / 2019 Part of the InterMed Group © Penlon Ltd. 2019 All rights reserved. Penlon and InterMed are trademarks of Penlon Limited. All other trademarks are the property of their respective owners. Penlon Limited...

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