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Foreword

Definitions

This manual contains special terms and icons that appear in the margins. Their purpose is to draw
your attention to specific or important information.

CAUTION

Explains special measures for the safe and effective use of the ventilator.

WARNING

Alerts you to possible injury.

Note:

Is an informative or helpful note.

This Clinical Manual is for the Elisée™ 350 Li-Ion ventilator with software version 2.54 NIV+. It
uses three different ISO-standard units for measuring pressure. These can easily be converted
by the user: 1 mbar = 1 hPa = 1.016 cm H

2

O.

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Содержание Elisee 350

Страница 1: ...Elis e 350 Clinical Manual English Making quality of care easy Respiratory Care solutions...

Страница 2: ...Making quality of care easy Respiratory Care solutions...

Страница 3: ...Explains special measures for the safe and effective use of the ventilator WARNING Alerts you to possible injury Note Is an informative or helpful note This Clinical Manual is for the Elis e 350 Li Io...

Страница 4: ......

Страница 5: ...entilation 50 5 6 Pre programming settings 54 5 7 Starting ventilation 55 5 8 The ventilator during ventilation 56 5 9 Optional settings 61 5 10 Using oxygen 65 5 11 Using the nebuliser 66 5 12 Stoppi...

Страница 6: ...iv...

Страница 7: ...nts It is recommended that you have a backup means of ventilation available Use the ventilator with CE marked accessories only and in compliance with the manufacturer s recommendations Using the Elis...

Страница 8: ...by the concurrent use of devices such as defibrillators or diathermy electrosurgical or radiology equipment or mobile phones The ventilator may be affected by electromagnetic fields greater than 10 V...

Страница 9: ...not be exposed to direct sunlight unless it is in its ergonomic transport bag The ventilator must not be subjected to any violent impact when it is not in its ergonomic transport bag nor allowed to fa...

Страница 10: ...4 102 NOT013281 8...

Страница 11: ...be used for continuous ventilation of ventilation dependent patients The Elis e 350 is approved for use in intensive care and for continuous operation It is used For transport by road sea or air For e...

Страница 12: ...ated from its internal battery mains power an external battery pack or a vehicle power supply These options which can also be used simultaneously provide considerable flexibility of use The Elis e 350...

Страница 13: ...ished Brightness sensor automatically adjusts the screen brightness Data exchange LED flashes green during data transfer via the serial port Touch screen for setting and viewing the various parameters...

Страница 14: ...the circuit is connected Right hand side Rear view Proximal pressure line connector Expiratory valve control connector Single circuit support Expiratory valve Clapper Cover Mains supply socket if the...

Страница 15: ...nly power supplies or power cords designed and distributed by ResMed should be connected to the ventilator Note In the event of a loss of mains power an audible and visual alarm is activated It can be...

Страница 16: ...ded by The mains power pack using the external power cord A DC power supply connected to the Elis e via the ResMed cigarette lighter connector CAUTION Only power supplies able to deliver 12 28 V 15 A...

Страница 17: ...stored for a prolonged period The external battery will be recharged when the ventilator is connected to The mains power pack via the external power cord An external DC power supply When the charge o...

Страница 18: ...oxygen port can accept an oxygen supply at a pressure of up to 400 kPa 2 8 Standard pneumatic nebuliser The nebulisation function is available only if the Elis e 350 is supplied with high pressure oxy...

Страница 19: ...www resmed com for more details see Technical specifications for accessories on page 94 for the connection path ResMed Mains power pack Transport bag Patient circuit Single circuit support Antibacter...

Страница 20: ...14 102 NOT013281 8...

Страница 21: ...Pi PEEP in the other pressure modes Positive End Expiratory Pressure PEEP cm H2O The pressure supplied by the ventilator and maintained during exhalation Continuous pressure cm H2O The pressure delive...

Страница 22: ...ce on the inspiratory time and the I E ratio It is fixed and known in volume controlled modes but variable and not controlled in pressure controlled modes Flow shape In volume based modes the flow rat...

Страница 23: ...pressure support Period of time after which if inspiration is not initiated by the patient the ventilator delivers an inspiratory cycle to the patient The apnea time begins at the point when the last...

Страница 24: ...nly Recommended for ventilation requiring a very high level of trigger sensitivity At the end of expiration when the patient starts to inhale the flow measured by the expiratory sensor becomes lower t...

Страница 25: ...r effort to trigger a cycle Auto corresponds to a value between 2 and 3 No controlled ventilation Expiratory trigger TgE The value which defines the end of an inspiratory phase It is configured as fol...

Страница 26: ...sing the Manual breath button If breaths are triggered by the ventilator alone ventilation is no longer Assisted Controlled ventilation but Controlled Ventilation CV or PCV On the screen the A of ACV...

Страница 27: ...essure if a plateau time was set Assisted Pressure Controlled Ventilation P A CV In P A CV mode cycles are pressure controlled The flow is adjusted so that the set pressure is maintained during a set...

Страница 28: ...e min and max VTI and VTE alarms The adjustable parameters are as follows PCV mode PACV mode Adjustable parameters PVC PACV Pi F Ti PEEP Rise time Inspiratory pressure and flow triggers PACV only Recr...

Страница 29: ...the respiratory effort required to overcome the resistance of his her respiratory system as well as the combined resistance of the ventilator circuit filter and water traps Note Make sure the respirat...

Страница 30: ...h with pressure support is triggered Note If the patient initiates a breath during the Wsync window the Wvs window is extended by which corresponds to the time remaining before another controlled cycl...

Страница 31: ...phase the flow is delivered and adjusted according to the patient s needs and the resistance and compliance of the patient s respiratory system In Pressure Support mode you can also set an apnea time...

Страница 32: ...patient s inspiratory effort and resistance and compliance characteristics Tidal volume and minute volume must be monitored by setting volume alarms Pressure support with minimum tidal volume PS VT Th...

Страница 33: ...volume is reached Switching to volume controlled mode means that the set pressure will be exceeded during that cycle in order for the minimum tidal volume to be delivered The pressure cannot be excee...

Страница 34: ...ure Continuous Positive Airway Pressure CPAP WARNING CPAP mode is intended to be used when there is constant monitoring by health care personnel in emergency situations or during rehabilitation Do not...

Страница 35: ...0 21 30 9 3 30 100 30 100 5 F bpm 15 2 50 2 50 1 1 Ti s 1 0 3 3 0 3 3 0 1 0 1 I E 1 2 0 1 0 4 1 9 9 1 0 4 1 9 9 1 0 1 Ti Max s 1 2 1 3 1 3 0 1 Tapnea s 15 10 60 10 60 1 1 Pi cm H2O 15 5 60 5 60 1 5 PS...

Страница 36: ...00 5 F bpm 25 2 80 2 80 1 1 Ti s 0 6 0 3 3 0 3 3 0 1 0 1 I E 1 3 0 1 0 4 1 9 9 1 0 4 1 9 9 1 0 1 Ti Max s 0 8 0 5 2 5 0 5 2 5 0 1 Tapnea s 10 5 20 5 20 1 1 Pi cm H2O 12 3 60 3 40 1 5 PS cm H2O 6 3 60...

Страница 37: ...dult Paediatric Adult Inspiratory pressure trigger cm H2O ACV PACV NO NO 0 2 0 2 5 9 NO 5 9 NO 0 1 PS PS Vt SIMV PSIMV NO NO 0 2 0 2 6 6 0 1 Inspiratory flow trigger L min ACV PACV 1 5 3 0 2 0 2 9 9 N...

Страница 38: ...mplicit parameters Te is an example of an implicit parameter obtained from a calculation based on the values set for the adjustable parameters Ti and F Te 60 F Ti These parameters are max Ti Te and I...

Страница 39: ...of settings and measurements The tables below display all of the measurements that vary if a setting is changed For ventilation in volume based modes Minimum value Maximum value Maximum flow max Adul...

Страница 40: ...8 For ventilation in pressure based modes Pi PS PEEP F Ti Inspiratory trigger Expiratory trigger Ti 9 Te 9 9 9 I E 9 9 9 F 9 VTI 9 9 9 VTE 9 9 9 e 9 9 9 9 evs 9 PEEP Ppeak 9 9 Pplat 9 9 Pmean 9 9 9 F...

Страница 41: ...Connecting the device to mains power enables you to recharge the internal battery 1 2 3 4 1 Insert the two nibs on the mains power pack into their slots 2 Press firmly on the mains power pack until t...

Страница 42: ...2 Plug the other end into the connector on the mains power pack 3 Plug the pack into a mains power outlet and switch on if necessary External power cord 1 2 1 Connect the 12 28 V DC power cord to the...

Страница 43: ...port To fit the double circuit support Connecting the patient circuit single or double To obtain good performance it is advisable to use the circuit supplied in the pack single or double or an equival...

Страница 44: ...used it may be necessary to cut off the nozzle of the proximal pressure line 3 Connect the inspiratory limb to the insufflation outlet Note Perform a manual test so that the Elis e 350 registers the...

Страница 45: ...flow regulator An oxygen concentrator Wall mounted O2 fitted with a flow regulator CAUTION Only connect oxygen once ventilation has commenced and disconnect oxygen before stopping ventilation 5 6 5 Pl...

Страница 46: ...the Elis e 350 An antibacterial filter is commonly placed At the point where the inspiratory limb connects to the ventilator or Adjacent to the Y connector in a double circuit However an HME filter o...

Страница 47: ...acturer s instructions Always ensure that the ventilator and expiratory valve are placed above the humidifier and water traps Note The water traps must be emptied periodically For further details refe...

Страница 48: ...and out of doors It provides protection against moderate impacts and moderate rain exposure For further details refer to the user guide for this accessory See also Recommendations for use during trans...

Страница 49: ...13281 8 Transport bracket system You can use this accessory to attach the ventilator in its ergonomic transport bag to a vertical pole in an emergency vehicle For further details refer to the user gui...

Страница 50: ...44 102 NOT013281 8...

Страница 51: ...parameters page 52 Setting alarm thresholds page 53 Monitoring ventilation page 56 Modifying the appearance of the curves page 56 Freezing the curves page 57 Respiratory mechanics parameters page 58 S...

Страница 52: ...he internal and external battery charge indicator will be displayed 1 Press the button on the right hand of the device The main screen is displayed 5 3 Checks before use Before the ventilator is used...

Страница 53: ...teries reach optimal performance after three full charge discharge cycles If an external DC power supply 12 28 V DC 15 A max is in use it must have enough charge to supply power for at least one hour...

Страница 54: ...es that will be used during ventilation are connected Repeat the test if an accessory is added or removed This quick test around 1 minute consists of four stages Measurement of the sensor offsets Chec...

Страница 55: ...l the O2 sensor has been replaced 4 Testing the alarms The operation of all of the visual and audible alarms must be checked regularly in particular prior to patient connection and during continuous v...

Страница 56: ...available Note In accordance with the standard EN 794 3 it is recommended that the user has a means of backup ventilation available CAUTION During transport the mains power pack must not be in the co...

Страница 57: ...2 5l 300 ml to 2 5l VALIDATE VALIDATE VALIDATE VALIDATE P PS PS PS V PS VT V CPAP CPAP Assist Control P Intermittent Spontaneous V S T A R T S T A R T V E N T I L V E N T I L 1 3 1 Press the appropri...

Страница 58: ...min Tg Exp Tg Exp 25 V max Ti max Ti max 1 2 s OK OK 1 1 On the parameters setting screen press 2 On the screen that is displayed select the parameter you wish to change use or to adjust the value the...

Страница 59: ...T A R T V E N T I L V E N T I L M od es OK OK Alarms setting Alarms setting ACV ACV 0 10 20 30 40 50 60 70 80 90 PE 0 0H2O cm info bpm ml l min l min cmH2O 35 35 1000 1000 15 0 15 0 3 0 3 0 300 300 30...

Страница 60: ...1000 1000 15 0 15 0 3 0 3 0 300 300 7 F Pmax Pmax Vti Vti Vi 0 0 l min 0 0 0 0 0 Pi Pi cmH2O 17 17 7 Pi Pi cmH2O 17 17 2 4 6 8 10 12 Pi Pi P t s Pmax 22 cm H2O PEEP 5 cm H2O O2 100 2 min HP Target Pi...

Страница 61: ...ect one of the five available programs 5 Use the alphanumeric buttons to change the program name if necessary 6 Use the left and right arrow buttons to scroll through the characters in the name 7 Pres...

Страница 62: ...ent trigger PEEP Flow curve HP alarm threshold Pressure curve 100 O2 supply Peak pressure Patient type Power supply status Ventilation type ACV ACV info HP HP 0 10 20 30 40 50 60 70 80 90 23cm H2O Ppe...

Страница 63: ...he ventilator freezes the curves 2 Touch any point on a curve to see the values at that point ACV ACV info HP HP 0 10 20 30 40 50 60 70 80 90 23cm H2O PE PE P 16 0 28 0 v O2 100 2 min Frozen curves dt...

Страница 64: ...s 5 seconds after which expiration is automatically triggered The screen displays the plateau pressure Pplat maximum pressure Ppeak and resistance R values 3 Press OK to go to the frozen curves screen...

Страница 65: ...before the end expiratory pause ACV ACV info HP HP 0 10 20 30 40 50 60 70 80 90 23cm H2O M odes P ar am PE PE P 16 0 28 0 v O2 100 2 min Freeze Touch curves 3 4 Manual Manual breath breath Measure Me...

Страница 66: ...he curves on page 57 or to return to the curves screen Note Wait for the real time curves to be displayed at the left hand side of the screen before pressing the P0 1 button Otherwise the frozen curve...

Страница 67: ...ress the button for 3 seconds until the screen shown on the left appears 2 Press the brightness scale to change the setting If set to AUTO the setting will self adjust according to the ambient light a...

Страница 68: ...40 50 60 70 80 90 PE 0 H2O cm Back Ventil Ventil stop stop ACV ACV Ventil Ventil stop stop The following screen is displayed 4 Press 5 Press or to move the cursor to the day of the week field It will...

Страница 69: ...s The results are displayed on the measurements screen for 5 minutes Low pressure oxygen input This option activates the low pressure or high pressure oxygen supply If Low pressure oxygen input is set...

Страница 70: ...ess MENU Config Config Setting Setting Parameters option ACV ACV 0 10 20 30 40 50 60 70 80 90 PE 0 0H2O cm info YES YES NO NO YES YES NO NO Ti Ti I E I E Vmax max BTPS correction RC auto calcul YES YE...

Страница 71: ...INI is triggered when the percentage of FiO2 decreases by 10 for 30 seconds FIO2 MAXI is triggered when the percentage increases by 10 for 30 seconds See the table under the heading Type 1 Ventilation...

Страница 72: ...eter is set to NO see Low pressure oxygen input on page 63 ACV ACV info HP HP 0 10 20 30 40 50 60 70 80 90 23cm H2O M odes P ar am PE PE P 16 0 28 0 v O2 100 2 min Freeze Touch curves Ppeak peak 20 3...

Страница 73: ...0 50 60 70 80 90 PE 0 0H2O cm info O K O K Cancel Cancel Ventil Ventil stop stop HP Flow Flow Duration Duration 7 min 15 min l 4 Set the nebulisation flow and duration parameters then press OK to conf...

Страница 74: ...power supply 2 Press and at the same time and hold until the ventilator switches off 10 seconds 0 10 20 30 40 50 60 70 80 90 PE AI 20 0 H2O cm back Pause stop ventilation Stop machine Locked touch sc...

Страница 75: ...ding this depends on the priority of the alarm It is produced by two buzzers and a digital sound generator Signals appearing on the screen e g for the High Pressure alarm One of the LEDs on the LED pa...

Страница 76: ...nute Volume double circuit Low Alarm setting 2 min Immediately MINI V min Minimum Inspired Minute Volume single circuit High Alarm setting 2 min 60 s MAXI V min Maximum Inspired Minute Volume single c...

Страница 77: ...O2 FAULT HP O2 missing High FiO2 21 or button pressed and HP O2 0 5 bar 2 min Immediately WRONG CIRCUIT Device configured for single circuit manual test but a double circuit is connected High VTE 10 o...

Страница 78: ...ended Ventilation interruption Low Restart ventilation If the problem persists refer to the Service Manual NiMH BATTERY Wrong Battery Type NiMH instead of Li Ion Low See Troubleshooting on page 78 FIO...

Страница 79: ...APNEA EXT MISSING MAXI LEAKS MAINS MISSING MAXI P expi EXPI resist WRONG CIRCUIT INSPI resist MINI V MIN MAXI V MIN MINI Vt MAXI F MAXI Vt ADJUST CLOCK FIO2 21 VENTIL STOPPED MAXI FIO2 REPLACE BLOWER...

Страница 80: ...gered by pressing the Alarm Silence button twice 4 Perform the following test for each power supply type mains external DC and external battery Mini Vte mL 10 300 10 NO NO 10 500 1000 10 1000 2300 100...

Страница 81: ...2 21 Alarm Action Visual alert Audible signal Time the alarm takes to trigger CIRCUIT OPEN Disconnect the patient circuit expiratory limb Flashing Sounding 2 cycles Reconnect the patient circuit expir...

Страница 82: ...hold to VTE 2000 mL and the lower alarm threshold to VTE 800 mL Flashing Sounding 5 cycles Adjust the lower alarm threshold to VTE 150 mL Steady Off Press the Alarm Silence button Off Off MAXI Vt Adju...

Страница 83: ...e outlet Steady Off Press the Alarm Silence button Off Off MINI Vt Adjust the upper alarm threshold to VTE 2000 mL and the lower alarm threshold to VTE 600 mL Flashing Sounding 5 cycles Adjust the low...

Страница 84: ...lue EXT BATT EMPTY Medium External battery charge less than 5 Connect the device to mains supply or change the external battery pack EXT BATT LOW Low External battery charge less than 15 Connect the d...

Страница 85: ...al volume is higher than the upper threshold for the Tidal Volume alarm Check the alarm threshold is correctly set and check the integrity of the patient circuit and the expiratory valve function MINI...

Страница 86: ...80 102 NOT013281 8...

Страница 87: ...of disposable components are provided by the manufacturers of those components As an indication this table provides information on the components that must be cleaned before reuse Antibacterial filte...

Страница 88: ...ld be changed as directed by the manufacturer Note ResMed recommends the use of a proximal antibacterial filter in accordance with the practices in effect in the hospital The antibacterial filter must...

Страница 89: ...a paper towel 4 Reassemble the expiratory valve using a new valve clapper Note After the twentieth cycle fine whitish lines may appear on the valve These will not affect its performance in any way CA...

Страница 90: ...1 2 58 NEW CLAPPER 1 After autoclaving or disinfecting the expiratory valve place a clapper in the holder so that the side with a number on it is visible as in the figure opposite 2 Line up the three...

Страница 91: ...0 remove the protective cap from the sensor 4 Disconnect the sensor connector 5 Unscrew the sensor using the disassembly tool supplied with the ventilator and remove the sensor from its housing Disass...

Страница 92: ...id directly onto the ventilator casing 7 3 Preventative maintenance Every 12 months the ventilator must be serviced by a qualified technician This service must include a check of all the functions cal...

Страница 93: ...a turbine Printed circuit board Controls the operation of the ventilator through the main microcontroller The main microcontroller controls Power supply switching Ventilation measurements and control...

Страница 94: ...of PEEP A sensor dedicated to triggering complements the proximal pressure sensor in detecting patient effort For safety reasons an inspiratory valve allows the patient to breathe spontaneously regard...

Страница 95: ...ure regulator O2 proportional solenoid valve Patient Expiratory valve Proximal pressure line Stepper motor Internal temperature sensor Atmospheric pressure sensor O2 pressure sensor Low pressure O2 po...

Страница 96: ...for a minimum of 6 hours Recharging The battery charge time is nearly 6 hours per battery with the device connected to the mains supply with an external power supply 20 volts the batteries will not b...

Страница 97: ...which does not comply with the specifications provided Electrical connection with remote alarm box via specific cord Binder 3 pin female Series 712 connector Note The ventilator casing is not electric...

Страница 98: ...rcuit fitted with a Maquet test lung to the ventilator Start ventilation For ventilation in volume modes Set up Adult Non invasive ACV and set the VT to 0 65 L and the Pmax alarm to 99 cm H2O Connect...

Страница 99: ...lative humidity 10 95 Atmospheric pressure 600 to 1100 hPa CAUTION The performance of the device is not guaranteed in operating conditions other than those described above Storage conditions Storage t...

Страница 100: ...h the electrical safety and electromagnetic compatibility standards IEC60601 1 IEC60601 1 2 The list of accessories is available at www resmed com click on Clinicians then go to the Products page then...

Страница 101: ...Maximum operating pressure 80 cm H2O Max flow rate 180 L min Pressure drop at 180 L min 3 cm H2O With spontaneous breathing 3 cm H2O Air loss at maximum pressure 20 mL min Average compliance 0 3 to 0...

Страница 102: ...oxygen fraction TgI Inspiratory flow trigger Ftot Total respiratory rate Ti Max Maximum inspiratory time HP High pressure ACV Assisted Volume Controlled Ventilation I E Ratio of inspiratory time to ex...

Страница 103: ...r outlet Expiratory valve control Serial link socket Remote alarm Transport and storage Store this way up Fragile Keep dry Relative humidity for transport and storage Temperature limits Atmospheric pr...

Страница 104: ...pment Conical connectors Part 1 Cones and sockets ISO 14971 Medical devices Application of risk management to medical devices CE marked device in accordance with Directive 93 42 EEC Notified body T V...

Страница 105: ...ip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commerc...

Страница 106: ...is the case ensure that it works correctly when placed in the location where it will be used Recommended separation distances between portable and mobile RF communications equipment and the Elis e 350...

Страница 107: ...tdown 68 H High pressure oxygen 65 93 HME filter 13 How the ventilator works 88 Humidifier Specifications 95 I I E ratio 16 Implicit calculated parameters 32 Inspiratory flow 16 Inspiratory trigger 18...

Страница 108: ...support 8 Storage conditions 93 T Tapnea 17 Target parameters in ACV mode 63 Tidal volume 18 Touch screen sound 61 Transport bag 50 Transport conditions 93 Trolley 42 Support plate 42 V Ventilation p...

Страница 109: ...Making quality of care easy Respiratory Care solutions...

Страница 110: ...224573 CA 2242882 CN 200480007797 2 FR 2766568 FR 2812203 FR 2852853 FR 2889812 EP 0893673 EP 1177810 JP 4060449 JP 4591443 JP 4689893 NZ 543179 NZ 566148 US 6164141 US 6722356 US 7905231 Others paten...

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