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ESO 2 ICU Ventilator 

User Manual

1. Warnings and Cautions

The following 

WARNINGS

 and 

CAUTIONS

 must be read and  

understood before using this ventilator.

WARNINGS
Important 

Delivering high fresh gas flows

1.  High fresh gas flows when using closed endotracheal 

suction. This ventilator is configured to deliver flows of 

oxygen in excess of the maximum shown on the flowmeter 

tube in order to fill the ventilator bellows during closed 

endotracheal suction.  Up to approximately 30 L/min can be 

delivered. 

Delivering O2 flows in excess of the maximum calibrated 

flow will temporarily negate the possibility of accurate 

volume delivery and measurement. Once the ventilator 

bellows is full the O2 flow should be reduced to that in range 

of the calibrated flow tube, then accurate volume delivery 

and measurement will resume.   

See section 5.3 for additional information.

General Information

2.  Users must make themselves familiar with the contents 

of this manual and the machine’s function before using 

the ventilator.

Before Using the Ventilator

3.  Before the ventilator is used clinically for the first time a 

Calibration Check and Output Check must be successfully 

completed. Checks must be  carried out by a Penlon-

trained engineer.

4.  Connect the ventilator to a mains supply with a protective 

earth. Before first clinical use, verify that the hospital 

engineering department has carried out an earth 

continuity test. If the integrity of the protective conductor 

is in doubt, do not use the ventilator.

5.  Excessive electronic noise caused by other poorly 

regulated devices, such as an electrocautery unit, may 

adversely interfere the functioning of the ventilator. 

Do not connect the ventilator’s power cord into the same 

electrical outlet as an electrocautery unit.

6.  If used with a mains extension cord, the unit may be 

subject  to electro-magnetic interference.

7.  Portable RF communications equipment (including 

peripherals such as antenna cables and external 

antennas) should be used no closer than 30 cm (12 

inches) to any part of the ventilator, including cables 

specified by the manufacturer. Otherwise, degradation of 

the performance of this equipment could result.

8.  The driving gas supply must be clean and dry to prevent 

ventilator malfunction.

9.  This ventilator is designed to be driven by medical air 

only. The drive gas is set during manufacture and the 

ventilator is calibrated for that gas. 

Before the ventilator is used clinically for the first time, 

the commissioning engineer must confirm that the air/

oxygen selection is set correctly to Air.  

The use of any other gas will cause inaccurate operation 

and may damage the ventilator, resulting in potential 

injury to the patient.

10.  The driving gas is discharged through the exhaust 

valve port at the back of the ventilator control unit. 

The discharged gas may contaminate the environment. 

Connect to an AGSS system if available.

11.  The bellows can only support approximately 1 kPa 

(10 cmH2O) differential positive pressure, above which 

it may be dislodged from the mounting ring, resulting in 

dangerous malfunction of the ventilator. Do not connect 

a positive end expiratory pressure (PEEP) valve or other 

restrictive device to the exhaust port on the bellows base. 

This would increase the pressure inside the bellows and 

the bellows could detach from the base, causing serious  

malfunction.

12.  The data output, VGA, and printer ports must only be 

connected to equipment complying with IEC safety 

standards (e.g. IEC 60950) which are then configured to 

comply with IEC 60601-1 (Medical Systems).

13.  Breathing System 

The breathing system which conveys gases from the 

ventilator to the patient, and disposes of expired gases, 

must conform  to the requirements of ISO 80601-2-13. 

Because breathing systems require frequent cleaning 

and disinfection they are not a permanent part of the  

ventilator and therefore cannot be directly under the 

control of the manufacturer. However, we strongly 

recommend that only breathing systems which have been 

approved and authorised by the manufacturer for use 

with the ventilator should be employed.

14.  Do not use conductive breathing  system hoses. 

15.  The spirometer sensors are mounted within the 

absorber. Do not fit a spirometer sensor to any other 

location. The device will not measure exhaled volumes in 

any other position.

16.  Verify the operation of each alarm function  daily. 

Periodically check the alarms at clinically suitable 

intervals. If  the  audible  alarm or the visual indicator 

of any alarm function fails to activate during any alarm 

condition or fails to reset after the alarm has been 

cleared, refer the unit to an authorised service engineer.

17.  Before using the ventilator check that all hose 

connections are correct, and verify that there are no 

leaks. Patient circuit disconnects are a hazard to the 

patient. Extreme care  should be taken to prevent such 

occurrences. 

Using the Ventilator

18.  Do not use Spontaneous (SPONT) mode.

19.  Before each clinical procedure, carry out pre-use  

function checks on the ventilator (see section 4.2.1.3).

20.  This apparatus must not be used with, or in close 

proximity to, flammable anaesthetic agents. 

There is a possible fire or explosion hazard.

Содержание ESO 2

Страница 1: ...ESO2 Emergency Ventilator User Manual VENTILATION SOLUTIONS...

Страница 2: ......

Страница 3: ...sting and component replacement Details of these operations are given in the Service Manual for this ventilator available only for engineers trained by the manufacturer For any enquiry regarding the s...

Страница 4: ...giving prior notice Personnel must make themselves familiar with the contents of this manual and the machine s function before using the apparatus The Importance of Patient Monitoring WARNING Patient...

Страница 5: ...tracheal suction in Volume or Pressure Mode 35 5 4 Oxygen monitor 36 6 Maintenance 37 6 1 Service Schedule 37 6 2 Cleaning and Disinfection 37 6 3 Sterilisation 39 6 4 Oxygen Sensor Replacement 40 6 5...

Страница 6: ...ial Filter 57 Fail Safe Mechanism 57 Reliability 57 Waveform Tests 57 Volume Tests 57 Mobility and Mounting 57 Device Classification and Labelling 58 Oxygen Monitor 59 APPENDIX 7 On screen Menus 60 AP...

Страница 7: ...e replaced immediately Should such a repair become necessary it is recommended that a request for service advice be made to Penlon Ltd This device and any of its constituent parts must be repaired onl...

Страница 8: ...ust confirm that the air oxygen selection is set correctly to Air The use of any other gas will cause inaccurate operation and may damage the ventilator resulting in potential injury to the patient 10...

Страница 9: ...s restricted to cleaning the outside surfaces of the ventilator see section 6 Other procedures detailed in this manual must be carried out by trained engineers Service and repair operations must only...

Страница 10: ...Gas Compensation is switched OFF Refer to section 3 2 OXYGEN MONITOR WARNINGS 1 We recommend a calibration check of the oxygen monitor every time the system is turned on as a safety precaution 2 Do n...

Страница 11: ...em for magnetic resonance imaging where the intensity of EM disturbances is high Indications for use of the device The device is intended to provide continuous mechanical ventilatory support The devic...

Страница 12: ...TFT screen with single dual waveform display 2 Ventilator control unit Pneumatically driven software controlled multi mode ventilator Drive gas supply Air at 280 to 600 kPa 41 to 87 psi See also sect...

Страница 13: ...of the breathing circuit Tidal Volume and Minute Volume display is provided by a dual spirometry system An integral oxygen monitor system measures oxygen concentration in the breathing circuit inspir...

Страница 14: ...power the ventilator for the period listed below if the battery has been maintained in a fully charged condition NOTE Manual Delivery of Fresh Gas is not possible Battery back up period A fully charg...

Страница 15: ...me alarms are not mutable 5 Navigator Wheel and Press Button Turn the wheel Select a function or parameter alter the value of an active parameter Press to confirm the setting Touchscreen 6 Active Tabs...

Страница 16: ...Active parameters that can be set for use in the current mode are displayed as White text on Blue 3 Inactive Parameters Inactive parameters that can be set for any non current mode are displayed as Wh...

Страница 17: ...firmed 2 A display window is active To Operate 1 Rotate the navigator wheel 2 clockwise to scroll through the menu options the cursor aligns with each parameter in turn 2 Press the wheel to enter the...

Страница 18: ...m within the Service menu SITE DEFAULTS Press to confirm the new settings for site defaults 3 Touch Screen Calibration Reconfigure the touch screen operating system Adult Defaults VT Set 600 mL VM Set...

Страница 19: ...s will maintain the value when changing between PSV PRESSURE and STANDBY modes 3 2 8 Output Compensation Functions WARNING The ventilator automatically compensates for fresh gas flow spirometry On fre...

Страница 20: ...urned OFF through the menu system or the spirometry system is malfunctioning 2 If the oxygen monitor is switched OFF a default mixture is assumed 3 2 8 3 Compliance Compensation The ventilator will ap...

Страница 21: ...SIGH TO BREATH RATIO INSP PAUSE INSP PAUSE WARNING PSV SIMV and SMMV are only available when spirometry is enabled Note that patient support specifications vary Support modes are enabled at the factor...

Страница 22: ...An alarm is triggered if the measured volume is 50 above or below the set volume This function is user adjustable Compliance Compensation Refer to section 3 2 8 2 Altitude Compensation Refer to secti...

Страница 23: ...s 1 breath with sigh then 10 breaths without sigh The extra volume will be approximately 50 above the tidal volume set by the user 1 5 x set VT b The High Volume Alarm is not triggered when Sigh is se...

Страница 24: ...reen tab PRESS The ventilator continues to ventilate in Volume Mode 2 The target pressure button flashes the display shows the previous setting of target pressure or default setting 3 The user can set...

Страница 25: ...P is not in use 5 PEEP is switched off when the ventilator is switched off 6 PEEP is switched off in Standby or Spont mode to ensure minimal patient breathing effort Selecting PEEP 1 Select by touchin...

Страница 26: ...con 2 is located at the left hand side of the top waveform 3 Second waveform The second waveform can be displayed by using the menu control or by touching the waveform on screen Select from Volume vs...

Страница 27: ...nds in spontaneous mode 15 120 s Automatic High tidal volume VT High Inspiratory spirometer sensor measured value exceeds 150 of set value 120 s User Default High minute volume VM High Inspiratory spi...

Страница 28: ...ice life The sensor is a self powered galvanic cell that generates a current proportional to oxygen concentration The cell has a highly stable output over its operating life Significant output loss is...

Страница 29: ...at area D see section 3 2 3 or through the menu system Fast access through touchscreen 1 Touch the screen at area D to access the High Low Alarm set value tab at area D 2 Turn the navigator wheel to...

Страница 30: ...conds O2 SENSOR FAULT The alarm is triggered 1 When either the oxygen sensor is disconnected or approaching the end of its life 2 If the O2 concentration exceeds 110 The message O2 SENSOR FAULT will b...

Страница 31: ...ic noise caused by other poorly regulated devices such as electrocautery may adversely interfere with the proper functioning of the ventilator Do not connect the ventilator power cord into the same el...

Страница 32: ...eter 1 Use breathing system bacterial filters CAUTION Replacement Disposal always follow the instructions supplied with the filter Always renew components at the recommended interval 2 The spirometry...

Страница 33: ...monitor tubing assembly connections 1 2 Push fit self sealing connectors 2 Push in the tube as far as possible Do not use excessive force The connector end piece X will also move inwards Pull the tub...

Страница 34: ...now drive gas into the absorber until a pressure of 30 cmH2O is obtained and then hold that pressure for approximately 25 seconds before releasing the pressure and completing the test 5 The menu will...

Страница 35: ...Function test the ventilator section 4 2 1 3 NOTE If there is any malfunction the ventilator must NOT be used If the problem cannot be rectified the ventilator must be checked by an engineer trained...

Страница 36: ...ds two tones 4 The ventilator displays the start up selection screen NOTE While machine power is ON the Ventilator can be turned OFF and ON using the ventilator On Off switch 9 4 2 1 3 Function Test 1...

Страница 37: ...appear after approximately ten seconds 16 Calibrate the touch screen 3 17 Select ADULT DEFAULTS 18 Set system switch to OFF and allow ventilator to boot down 19 Check for High flows of O2 Note that h...

Страница 38: ...ygen Calibrate with the sensor in position within the absorber 1 Turn the gas delivery switch 2 to ON 2 Remove the breathing circuit hoses from the inspiratory and expiratory connectors 3 on the breat...

Страница 39: ...cally detects when sensor life is low Replace the sensor when the message OXYGEN SENSOR LOW OUTPUT appears on screen Sensor output will fall very quickly to zero over a period of two to three weeks fr...

Страница 40: ...oxygen flow tube 10 indicates a basal flow 3 Set a minimum total gas flow of 12 L min to fill the bellows 4 Follow the start up instructions on the label on the front panel 5 Set the O2 flowmeter to 9...

Страница 41: ...de NOTE Always start in Volume mode 13 Select PRESS 13 14 Set TARGET 14 to 35 cmH2O 15 Start ventilation press the wheel 15 16 Set rate to 20 PEEP to 15 I E to 1 2 17 Check Oxygen reads 80 18 Connect...

Страница 42: ...larm value 4 cannot be set below 19 or above 105 note that in certain conditions of excess pressure the readout may show a value above 100 Set Low O2 Alarm The alarm value 5 cannot be set below 18 or...

Страница 43: ...be carried out by an engineer trained by the manufacturer The warranty for this product is void if the product is not maintained in accordance with the service schedule detailed below and the procedu...

Страница 44: ...ator control unit on the label 6 is also engraved on the patient block label 7 2 The location of the ventilator control unit label 6 varies depending on the system layout 3 After cleaning and sterilis...

Страница 45: ...ctive maximum pore size which is small enough to exclude microbial contamination All wrapping materials must comply with EN 868 Packaging Materials for Sterilization of Wrapped Goods Processing Equipm...

Страница 46: ...he sensor assembly before use Once exhausted the sensor must be disposed of according to hospital local state and federal regulations 6 4 1 Sensor Unit Remove and Refit Replacement sensor Part No 1027...

Страница 47: ...e of the valve seat 4 Never use any hard object or abrasive agent to clean it use only a soft cloth If the valve seat is damaged the diaphragm valve will leak and may cause serious malfunction 5 Clean...

Страница 48: ...es 278 137 Electrical interface unit No No No NOTE During autoclaving slight discolouration of the manifold block may occur This is not an indication of component deterioration Ventilator Bellows Item...

Страница 49: ...to 7 C 32 to 45 F 9 months 5 to 0 C 23 to 32 F 12 months Recharge duration a charging cycle of at least 12 hours to ensure that the battery is kept at full capacity It is recommended that at each cha...

Страница 50: ...tem if available Electrical Connection 4 Electrical mains input and fuse unit Interface and Parameter Inputs 5 Spirometer connection 6 Interface connector not used 7 Pressure monitor port 8 Input sock...

Страница 51: ...pressure monitor 13 Expiratory valve breathing module 14 Inspiratory valve breathing module 15 inlet from ventilator control unit 16 Inlet breathing module fresh gas supply 17 Drive gas inlet ventila...

Страница 52: ...3 closes The exhaust valve 4 opens Patient gas returns to the bellows 5 and as the bellows rises redundant drive gas is pushed out through the exhaust valve 3 End of Expiratory Phase With the bellows...

Страница 53: ...ESO 2 ICU Ventilator 47 User Manual A 1 2 3 to 7 bar 4 5 3 6 241 kPa 35 psi 0 80 cmH2 0 B 10 11 7 8 9 C 14 12 13 15 16 0 90 cmH2 0 100 cmH2 0 17 18 Pneumatic Flow Diagram Appendix...

Страница 54: ...to detect a loss or reduction of the input gas source pressure When the pressure falls below 235 kPa 35 psi 1 psi the LOW SUPPLY PRESSURE indicator will be displayed and the high priority audible ala...

Страница 55: ...Example 1 Select required volume VT 1 0 L 2 Select rate 20 bpm In this example the point of intersection X on the graph shows that an I E ratio can be set from 1 0 3 to 1 4 as these curves are all ab...

Страница 56: ...g a higher trigger value 3 Apnoea Alarm Mute Spontaneous mode only In spontaneous mode the mute button 3 acts both to silence an existing apnoea alarm and inhibit new apnoea alarms for a given period...

Страница 57: ...the inspiratory phase is terminated SIMV Settings NOTE 1 VT can be adjusted before SIMV is confirmed 2 The trigger setting is adjustable between 0 7 and 4 0 L min SIMV No breathing effort by Patient...

Страница 58: ...irmed 2 The trigger setting is adjustable between 0 7 and 4 0 L min A A B B Pmax PEEP 0 cmH2O E D C A A B B Pmax PEEP 0 cmH2O D C SMMV Spontaneously Breathing Patient A Cycle time set from BPM B Trigg...

Страница 59: ...cycle time 2 The trigger pressure is PEEP referenced 3 If the Spirometry system is disabled then PSV is not available 4 If the pressure limit and alarm are activated the inspiratory phase is terminate...

Страница 60: ...ESO 2 ICU Ventilator 54 User Manual...

Страница 61: ...to 87 psi Alarms Alarm Mute 30 or 120 seconds see 3 12 Apnoea Flow referenced no breath detected within 15 seconds High Continuous Airway Pressure PEEP 10 cmH2O for 1 cycle or PEEP 5 cmH2O for 3 cycl...

Страница 62: ...taneous includes advanced breathing modes Volume Cycle Sigh Sigh can be set from 1 n where n has a range of 10 to 100 Inspiratory Pause Inspiratory pause can be varied in the menu from 0 60 Pressure r...

Страница 63: ...in Disinfection and Sterilisation The patient block assembly can be sterilised if necessary see section 6 2 NOTE The bellows assembly oxygen monitor sensor and spirometer sensors are built into the br...

Страница 64: ...requirements of BS EN 60601 1 2 Medical electrical equipment General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests MRI compatibility The ESO 2 is no...

Страница 65: ...100 Life 1500000 O2 hours at 20 C 68 F 800000 O2 hours at 40 C 104 F Interference Gases and Vapours Interference Test Gas Mixture Interference in O2 Nitrous Oxide 80 N2O 20 O2 1 to 1 5 Carbon Dioxide...

Страница 66: ...ger VM MAX 9 L 1 25 Integer VT MIN 300 mL 10 1600 Integer VT MAX 900 mL 20 2400 Integer APNOEA ALARM LIMIT 15 secs 15 180 Integer ALARM VOLUME 100 50 100 Integer BACK LIGHT LEVEL 0 100 Integer Main Me...

Страница 67: ...ODE none ABSORBER SWITCH ON UPGRADE MENU AMBIENT PRESSURE 988 mbar DISPLAY HISTORY SERVICE PIN 0 ENGINEER MENU NOTES The values listed for site defaults are examples Sub menus for Service PIN and Engi...

Страница 68: ...recycling facility Follow your hospital local state and federal regulations Alarm mute Fuse Menu Rotation controls output Wear a face mask Wear a face shield Wear eye protection Wear protective gloves...

Страница 69: ...or 2 7 Remote screen display cable Connects the ventilator control unit to the remote display 1 5 Guidance and manufacturer s declaration electromagnetic emissions The ESO 2 ventilator is intended for...

Страница 70: ...est level 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...

Страница 71: ......

Страница 72: ...ners International 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 pe...

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