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Prima 320 Advance

User Manual

Specification

4.15 Device Classification and Labelling

The device 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, with internal power supply

Ingress protection

IP21

Environment

Oxygen compatibility:

Not suitable for use in an Oxygen rich environment

Anaesthetic agent:

1. Use only non-flammable anaesthetic agents.

2. Do not use in close proximity to flammable anaesthetic

agents.

Mode of operation

Continuous

Patient type

All patient types

No residual risks from phthalates that are carcinogenic,

mutagenic, or toxic to reproduction.

Applied parts (if fitted)

Patient hoses/masks, SpO2 sensor (optional), sidestream

multigas sensor, sidestream CO2 sensor

Type B

Accessories

Refer to Appendix 3

Содержание Prima 320 Advance

Страница 1: ...Prima 320 Advance Anaesthetic Machine User Manual ANAESTHESIA SOLUTIONS ANAESTHESIA SOLUTIONS...

Страница 2: ......

Страница 3: ...ervicing should be carried out by engineers trained by Penlon Ltd For any enquiry regarding the servicing or repair of this device contact the nearest accredited Penlon agent or communicate directly w...

Страница 4: ...IAL THAT THESE ELEMENTS ARE MONITORED FREQUENTLY AND REGULARLY AND THAT ANY OBSERVATIONS ARE GIVEN PRECEDENCE OVER MACHINE CONTROL PARAMETERS IN JUDGING THE STATE OF A CLINICAL PROCEDURE Before using...

Страница 5: ...gen Supply 19 4 6 Auxiliary Common Gas Outlet ACGO 19 4 7 Oxygen Flush 19 4 8 Fresh Gas Mixture 19 4 9 Environmental 19 4 10 Electrical Supply 20 4 11 Absorber and Breathing System 20 4 12 Ventilator...

Страница 6: ...ning and Disinfection 68 7 3 Absorber and Breathing System Components 70 7 4 Cleaning and Disinfection Methods 75 7 5 Absorber and breathing system 77 7 6 Pressure Sensor Zeroing 78 7 7 Flow Sensor Ze...

Страница 7: ...ry it is recommended that a request for service advice be made to Penlon Limited or the nearest Penlon Service Centre This device and any of its constituent parts must be repaired only in accordance w...

Страница 8: ...vaporizer and may result in gross overdosage when the flush valve is operated 10 Ventilating Neonatal and Paediatric patients a IMPORTANT Use ONLY Volume Control or Pressure Control ventilation for ma...

Страница 9: ...y loaded machine particularly when negotiating ramps Check that hoses or power leads are not trailing on the floor 24 Accessories must be removed before the machine is transported 25 MRI compatibility...

Страница 10: ...th anaesthetic vaporizers breathing hoses and patient connection fittings which comply with the relevant ISO standard or equivalent Depending upon the patient circuit selected the machine can be used...

Страница 11: ...g The work surface has raised edges to retain instruments vials etc An LED lighting unit provides work area lighting The switch is located under the top shelf above the display screen Extractor Fan Ou...

Страница 12: ...Manual mechanical ventilation switch 10 Regulator 350 400 kPa 32 Expiratory non return valve 11 Non return valve 33 Absorber canister 12 Non return valve cylinder supply 34 Inspiratory non return valv...

Страница 13: ...ssembly 3 4 Rear View 1 Cylinder yoke 2 Multiple socket outlets 3 Mains inlet 4 Communication port see section 3 5 5 Battery box cover 6 Medical gas pipeline supply inlets 7 Extractor fan outlet 3 5 C...

Страница 14: ...an AC power source and the battery is being charged Green The system is operating on battery power 4 Start Standby Press the key to enter standby mode or to exit standby mode and start ventilating th...

Страница 15: ...gged into the auxiliary sockets plus the leakage current from the machine does not exceed the values specified in any relevant national standards that may apply in the country where the machine is in...

Страница 16: ...dicators On screen power status indicator AC power is being used Battery icon flashing Battery is charging Battery icon static Battery is fully charged AC power is off battery power is being used On s...

Страница 17: ...een the auxiliary common gas outlet ACGO and the breathing system unless it is specifically designed for such use If this is done the oxygen flush flow will pass through the vaporizer and severe overd...

Страница 18: ...e change to Manual ventilation Moving the switch from Bag to Ventilator position triggers a return to the previous mode 3 9 2 Adjustable pressure limiting valve The APL valve 3 provides breathing syst...

Страница 19: ...irway pressure gauge The pressure gauge 10 displays airway pressure in the inspiratory circuit Pressure is displayed in cmH2O and kPa 3 9 7 Bellows housing The bellows housing 11 provides an airtight...

Страница 20: ...sition 5 or 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 anaestheti...

Страница 21: ...tilator will automatically revert to the settings that were last used in the mode that you are about to use 3 12 1 Volume control ventilation VCV The ventilator delivers a mandatory set volume of gas...

Страница 22: ...rs pressure support at a preset trigger level In the event of an apnea condition the ventilator enters backup mode either VCV or PCV whichever the user has preselected 3 13 Patient monitoring Paramete...

Страница 23: ...alarms are triggered by 1 A device malfunction 2 Patient data Prompt messages Prompt messages are not alarm messages Physiological technical alarm messages and system status messages are also display...

Страница 24: ...wer supply AC power inlet three auxiliary output outlets Monitor VGA monitor connector 15 pin D sub socket Equipotential Equipotential ground terminal USB One standard USB connector RS232 Connector On...

Страница 25: ...ils of a Penlon O2 therapy flowmeter kit 4 6 Auxiliary Common Gas Outlet ACGO Connector 22 mm male conical connector incorporating a coaxial female 15 mm conical connector 4 7 Oxygen Flush Flow rate 2...

Страница 26: ...C power source 4 11 Absorber and Breathing System Bellows volume 1500 mL approximately Absorber canister volume 1500 mL approximately Connectors ACGO inspiratory and expiratory ports manual bag port a...

Страница 27: ...ystem pressure does not exceed 12 5 kPa Parameters Tidal volume 10 1500 mL 0 1600 ml measured in PCV Increment 10 100 mL 5 mL 100 1500 mL 10 mL Respiratory rate 1 100 bpm increment 1 bpm Tinsp inspira...

Страница 28: ...L Low 0 98 L Respiratory rate High 1 100 bpm Low 0 99 bpm FiO2 High 19 100 OFF Low 18 99 Airway pressure High 10 99 cmH2O Low 1 98 cmH2O ETCO2 optional High 0 13 3 Low 0 13 2 FiCO2 optional High 0 1 1...

Страница 29: ...IP21 Environment Oxygen compatibility Not suitable for use in an Oxygen rich environment Anaesthetic agent 1 Use only non flammable anaesthetic agents 2 Do not use in close proximity to flammable anae...

Страница 30: ...surgical equipment keep cables away from the breathing circuit oxygen sensors and flow sensors 4 Manual ventilation devices and monitoring and life support equipment must be available 5 Do not use ant...

Страница 31: ...rce 7 Reset the locking catch 3 to the locked position Warning Always set the locking catch to the locked position after the absorber assembly is installed Before use to prevent a serious fresh gas le...

Страница 32: ...1 Align the oxygen sensor 1 with the port on the side of the absorber 2 Fit the sensor and turn clockwise to tighten 3 Fit the cable 3 to the sensor Warning Make sure that the absorber canister positi...

Страница 33: ...1 to the Y piece 2 2 Connect the sampling tube 3 to the water trap 4 3 Connect the other end of the sampling tube to the elbow 4 Connect the other end of the elbow to the breathing bag or to the pati...

Страница 34: ...ly engaged before tightening the locking lever 5 5 Gas cylinder installation CAUTION Open the cylinder valves slowly to avoid damage to the pressure reducing valve and pressure gauges Ensure that valv...

Страница 35: ...on transformer 5 8 Anaesthetic Gas Scavenging System AGSS The gas scavenging outlet port 1 is located at the right rear of the machine as shown Warning 1 On new machines remove the blanking plug from...

Страница 36: ...4 Pipeline gas supplies Section 5 9 5 Cylinders gas supplies Section 5 9 6 Vaporizer Section 5 10 Alarms Section 5 11 Breathing circuit Section 5 12 O2 flush Section 5 13 Preparing for system operati...

Страница 37: ...the machine can be switched on or off normally 5 9 3 System check 1 Set the anaesthesia system switch 1 to the ON position 2 Make sure that the yellow and red alarm lamps illuminate 3 Make sure that a...

Страница 38: ...sure gauges shows 300 to 600 kPa 5 Disconnect the O2 supply 6 Make sure that the O2 SUPPLY DOWN alarm is triggered 7 Make sure that the O2 gauge shows zero kPa 8 Turn the O2 flowmeter control knob ful...

Страница 39: ...cylinder if necessary refer to section 5 5 4 Close the cylinder valve O2 cylinder high pressure leak test 5 Set the anaesthesia system switch to the OFF position 6 Open the O2 cylinder valve 7 Make a...

Страница 40: ...tration control is between 0 1 and the first graduation above 0 2 3 Adjust the vaporizer control over the full range of movement above the first graduation 4 Check that the O2 flow does not decrease m...

Страница 41: ...tting to the follows Ventilation Mode Select ventilation mode VCV Tidal volume VT 500 mL Respiratory rate FREQ 15 BPM Breathing ratio I E 1 2 PEEP OFF 6 Push the O2 flush button to fill the bellows 7...

Страница 42: ...iece port 6 Make sure the low Paw alarm is cancelled 5 11 7 Oxygen concentration monitoring and alarm test Caution This test is required if the O2 sensor 1 is fitted to the absorber 1 Use the standby...

Страница 43: ...Apnea alarm test 1 Use the standby button to start standby mode 2 Set the ventilation mode to SPONT PSV 3 Press the CONFIRM button 4 Use the standby button to start operational mode 5 Make sure that...

Страница 44: ...ellows 8 The airway pressure gauge must indicates less than 15 cmH2O 9 Release the O2 flush button 10 If the bellows deflates within one minute a Remove the bellows and reinstall refer to Section 7 3...

Страница 45: ...the ACGO control to the closed circuit position 8 Press the O2 button and hold in position 9 Check that the bellows fully inflate within 4 seconds 10 Release the O2 button Auxiliary common gas outlet...

Страница 46: ...ers 8 Turn the APL valve control counterclockwise to the MIN position 9 Set all gas flows to a minimum 10 Make sure that the breathing system is not damaged and correctly connected 11 Before connectin...

Страница 47: ...t use the device Contact a Penlon trained engineer 6 1 2 Standby mode and operating mode 1 Set the system switch 1 to ON 2 After the power up self test the system enters standby mode automatically 3 T...

Страница 48: ...ing If a CO2 AG module is fitted set the on off switch a Select System Settings CO2 AA b Set ON or OFF 7 SpO2 monitoring If a SpO2 module is fitted set the ON OFF switch a Select System Settings SpO2...

Страница 49: ...e Air alarm switch optional a Select System Settings Air b Set ON OFF Caution When the Air alarm switch is set to OFF the Air supply pressure alarm is off Note that air supply pressure monitoring is a...

Страница 50: ...he user 3 Ventilation mode display For manual ventilation Manual is displayed If Ventilator is selected by using the bag vent switch the currently selected ventilator mode is displayed 4 Alarm message...

Страница 51: ...PEEP Positive end expiratory pressure 6 2 4 3 Synchronized Intermittent mandatory ventilation Volume control SIMV V mode VT Tidal volume TI Inspiratory time FREQ Respiratory rate Psupp Pressure suppor...

Страница 52: ...e TI Inspiratory time FREQ Respiratory rate PEEP Positive end expiratory pressure Psupp Pressure support level Tslope Pressure rise time Psens Fsens Pressure Flow trigger sensitivity 6 2 5 Waveform To...

Страница 53: ...4 Pleth waveform On machines with an SpO2 module a Pleth waveform is displayed as shown 6 2 5 5 EtCO2 waveform On machines with CO2 a CO2 waveform is displayed as shown 6 2 5 6 Pressure Volume loop Se...

Страница 54: ...the machine To prevent patient injury set upper and lower limits for the following parameters When setting alarm limits push the hotkey turn the knob to the required then push to confirm 6 2 8 1 Limi...

Страница 55: ...sions running time and maintenance information 6 2 12 Calibration Calibration options are shown 6 3 Fresh Gas Settings Warning Before clinical use check that all connections are secure and that the pr...

Страница 56: ...irst and then increase to the required level 4 Use breathing circuits and filters specifically designed for neonatal paediatric use 5 Do not ventilate pre term babies with a birth weight below 2 4 kg...

Страница 57: ...or the required ventilation mode and then click confirm c The ventilation mode selected will be displayed in the mode display field NOTE If SPONT PSV mode is selected PCV or VCV backup mode must be pr...

Страница 58: ...pulmonary compliance and airway resistance Actual tidal volume is measured In PCV mode select PEEP to improve expiration of end tidal carbon dioxide and to increase oxygenation PCV mode waveforms PCV...

Страница 59: ...in the patient s lung characteristics PRVC mode initially delivers a VCV breath Patient compliance is determined from this volume breath The inspiratory pressure level is then set for the next breath...

Страница 60: ...w the ventilator delivers volume controlled breathing to the patient at the end of Trigger Window Spontaneous breathing outside of the Trigger Window can acquire pressure support SIMV V Waveforms Paw...

Страница 61: ...controlled breathing to the patient at the end of the Trigger Window Spontaneous breathing outside of the Trigger Window can acquire pressure support If the Trigger Level is reached outside of the Tr...

Страница 62: ...window Spontaneous breathing outside of the trigger window can acquire pressure support If trigger level is reached outside of the trigger window the ventilator delivers pressure supported ventilation...

Страница 63: ...ng spontaneously When PSV mode is applied alone PCV and VCV backup modes are available If within the preset time Backup Mode Active no spontaneous breathing occurs or is not strong enough to reach the...

Страница 64: ...e 3 Press the control knob to confirm and activate Set pressure limit alarm levels 1 Select Alarms Limit 1 2 Press the control knob and turn the knob to set the upper and lower limits pressure to the...

Страница 65: ...dance with the set Apnea time automatically enters the pre selected backup ventilation mode 1 Select Alarm Apnea time 2 Turn the control knob to set the required value 3 Press the button to confirm an...

Страница 66: ...bellows housing give an approximate indication and may be inconsistent with the actual measured volumes This is a normal phenomenon International standards require that the user must monitor tidal vo...

Страница 67: ...per and lower limits respectively and exit the menu 6 8 Trends A trend graph is used to review parameter values within a specific time period The trend is reflected through a curve Every point on the...

Страница 68: ...nfrared sensor monitors if bypass mode is activated A technical alarm is triggered to warn the user 6 9 2 Absorbent change procedure Warning To prevent dust and particles from entering the breathing c...

Страница 69: ...l condition within the anaesthesia machine Note 1 On start up the system self test checks if the alarm lamp and audible alarm tones function normally 2 Normal function triggers an audible beep and the...

Страница 70: ...he alarm level Priority Tone Pattern High 10 note sequence repeated every 10 seconds Medium 3 note sequence repeated every 2 seconds Low 2 note sequence does not repeat 6 11 3 3 Alarm message When an...

Страница 71: ...US PRESSURE HIGH High Airway pressure greater than PEEP 15 cmH2O for 15 s Check for blockages in the breathing circuit PRESSURE HIGH High Ppeak is higher than the Paw high alarm limit setting Decrease...

Страница 72: ...nister Reinstall the absorber canister VTE LOW Medium VTE is lower than the low alarm limit setting Increase tidal volume setting or decrease low alarm limit RATE HIGH Medium Rate is greater than high...

Страница 73: ...or other electrical components There is a possible electric shock hazard If a replacement fuse mains lead or battery is required this work must be carried out only by trained engineers If a replacemen...

Страница 74: ...ect cleaning and disinfection methods and reassembly procedures as described in this manual 6 Pre use tests see sections 5 9 to 5 14 must be performed before patient use if the anaesthetic machine has...

Страница 75: ...loved hand that has been in contact with blood or secretions should be regarded as contaminated and should be cleaned at the earliest opportunity between patients Appropriate disinfectants suitable fo...

Страница 76: ...eturn valve cover 10 Airway pressure gauge 11 Non return valve guide 12 Non return valve disc 13 Oxygen sensor 14 Inspiration connector assembly 15 Canister support 16 Absorber canister 7 3 2 Remove t...

Страница 77: ...Detach each flow sensor 4 from the tube 5 7 3 4 Remove the oxygen sensor 1 Unplug the oxygen sensor cable 1 from the sensor 2 2 Remove the other end of the cable from the machine 3 Turn the oxygen se...

Страница 78: ...components 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...

Страница 79: ...d with water If irritation continues after flushing with water seek medical assistance immediately Drain the condensation from the canister Warning If the water is drained during a clinical procedure...

Страница 80: ...clockwise to remove CAUTION Removing the water collection container will not cause gas leakage but always reinstall as soon as possible 7 3 11 Remove the absorber assembly 1 Pull the locking catch on...

Страница 81: ...uch as blood and other residues Cleaning in water at temperatures above 35 C may cause solidification of organic matter 3 Recommended cleaning and disinfection methods for the various components are d...

Страница 82: ...an or rinse with clean water 4 Use a mild detergent with a pH of less than 10 for 2 glutaraldehyde solution 5 Use clean water to rinse off the residual disinfectant 6 Dry the components assemble and o...

Страница 83: ...sensor until the lugs engage the slots 3 Turn the tubing clockwise until the lugs are fully engaged in the slots 2 4 Align the flow sensor and tube assembly with the absorber Caution a Make sure that...

Страница 84: ...trained engineer Procedure 1 Stop manual or mechanical ventilation If a breathing tube is connected open the breathing tube patient connection to air 2 Check that the bellows falls to the bottom 3 Tur...

Страница 85: ...of repeated calibration failures fit a new sensor and repeat the calibration If it still fails contact a Penlon trained service engineer Calibration procedure at 21 O2 1 Select standby mode 2 Press t...

Страница 86: ...by the condensation of exhaled gas and a chemical reaction between CO2 and the soda lime in the absorber canister 2 Lower fresh gas flows produce more condensation due to higher levels of CO2 in the...

Страница 87: ...manual position Turn the switch to mechanical ventilation Flow control valve has failed no drive gas is delivered Contact a Penlon trained engineer Bellows housing is damaged Replace the bellows hous...

Страница 88: ...oved by Penlon Ltd Please contact Penlon Ltd see below or your local Penlon Distributor UK Sales Tel 01235 547036 E mail uk sales penlon com International Sales Tel 44 1235 547001 E mail international...

Страница 89: ...tion to mains Power On Lighting Inspiratory flow Bag manual ventilation Lock Flow control Oxygen sensor connector Cylinder N2O supply connector Fuse General warning Type B equipment Equipotential Batt...

Страница 90: ...marked as O2 or Air Apnea alarm label Spont mode only Alarm parameter adjustment cap Do not touch Identifies that the user needs to perform the operation Operating instructions Manufacturer and date o...

Страница 91: ...a significant deviation from standard performance return the unit for factory recalibration 2 Specification Power requirements 5 0 V 0 2 V DC Power 80 mA in general use 300 mA in extreme circumstance...

Страница 92: ...will not be held responsible if the operator uses the unit incorrectly The module must only be used as stated in the manufacturer s instructions 8 Do not use the module for the measurement of exhaled...

Страница 93: ...sed emissions or decreased immunity of that equipment Cables supplied by Penlon Limited Category Function Length m AC mains supply input output ports Hospital mains supply to the input port cable is f...

Страница 94: ...vel 385 MHz 27 V m 450 MHz 28 V m 710 MHz 9 V m 745 MHz 9 V m 780 MHz 9 V m 810 MHz 28 V m 870 MHz 28 V m 930 MHz 28 V m 1 72 GHz 28 V m 1 845 GHz 28 V m 1 97 GHz 28 V m 2 45 GHz 28 V m 5 24 GHz 9 V m...

Страница 95: ...Prima 320 Advance 89 User Manual Appendix...

Страница 96: ...ternational Sales t 44 0 1235 547001 e international sales penlon com UK Sales t 44 0 1235 547036 e uk sales penlon com Technical Support t 44 0 1235 547060 f 44 0 1235 547061 e tech support penlon co...

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