MISTRAL Instructions for Use Ver 4.0e

Manufactured by: ACUTRONIC Medical Systems AG Haldenstrasse 3 P.O. Box 2082 6342 Baar / Switzerland Tel: 0041 41 768 10 70 Fax: 0041 41 768 10 71 e-mail: [email protected] www.acutronic-medical.ch

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TABLE OF CONTENTS TABLE OF CONTENTS ... 3 DEFINITION OF TERMS ... 4 SUMMARY OF WARNINGS, CAUTIONS, AND NOTES ... 5 FOR YOUR SAFETY AND THAT OF YOUR PATIENTS ... 6 Read instructions for use... 6 Maintenance ... 6 Accessories ... 6 Liability for proper function and damage ... 7 Intended use... 8 Contraindications... 8 Indications for use ... 8 Ventilation Mode... 9 Intervals for Maintenance and Battery Exchange ... 10 Preface ... 11 Operation elements and display... 12 MISTRAL ... 13 Front Connectors... 14 Initial preparation... 15 Pause Pressure limit control... 16 OPERATION (MAIN LEVEL) ... 17 Setting and display of driving pressure ... 17 Inspiratory Oxygen Fraction setting (FIO2) ... 18 Automatic – Manual operating mode ... 19 Frequency setting... 20 Inspiratory time setting ... 21 ALARM LIMITS SETTING ... 22 PP alarm setting (Pause-Pressure)... 22 Alarms ... 23 Display contrast... 25 Time and date setting... 27 Auxiliary Gas Outlet... 31 CLINICAL APPLICATIONS ... 32 Infraglottic Catheter Jet Ventilation ... 32 Supraglottic Jet Ventilation... 33 Infraglottic Rigid Bronchoscopy... 34 Transtracheal Jet Ventilation... 35 ALARMS AND ERROR MESSAGES ... 36 Alarm functions... 36 System alarms... 37 Error functions ... 39 ACCESSORIES ... 40 SERVICING, DISINFECTION, CLEANING ... 43 ABBREVIATIONS AND SYMBOLS... 44 TECHNICAL DATA, SPECIFICATIONS ... 45 Settings and ranges ... 45 Dimensions... 45 Connections... 45 Environmental conditions ... 45 Rear panel ... 46 Exchange of battery and fuses... 47 Diposal... 48

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DEFINITION OF TERMS Statements in the operating instructions preceded by words “Warning,” “Caution,” and “Note” carry special significance. The definitions of these words are as follows: WARNING ! Means there is a possibility of injury to oneself or others CAUTION ! Means there is a possibility of damage to the instrument or other property NOTE ! Indicates points of particular interest for more efficient and convenient operation.

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SUMMARY OF WARNINGS, CAUTIONS, AND NOTES The operating instructions must be read before using the Mistral jet ventilator with particular attention given to warnings, cautions and notes. WARNING:

Risk of Fire. Replace proper fuse as indicated.

WARNING:

Possible explosion hazard. Do not use in presence of flammable anaesthetics.

WARNING:

If you are using catheters for Jet ventilation which have only one channel, we strongly recommend to use only rates above 100 CPM due to risk of Barotrauma and severe lung injury. For rates below 100 CPM, the additional airway pressure line is a must to provide continues pressure monitoring.

WARNING:

Mistral is not designed to be used as a stand-alone respiratory support equipment in ICU because there is no efficient way to measure the inhaled minute volume of the patient. We advise to use a conventional ventilator and use the Mistral superimposed to it. This way, a sufficient control of inhaled minute volume is given.

WARNING:

Always check the safety pressure alarm functions (pressure limits) with a test lung prior use of the equipment on a patient. The pressure limit shall be set as low as possible for the used operation. Never use pressure limits above 40 mbar. If the equipment is used on children, the alarm limits shall be set as low as 10 to 15 mbar to avoid overpressure in the lung.

WARNING:

Never use the Mistral, if the unit does not pass the self test and the test with the test lung.

CAUTION:

Electrical Shock Hazard. Do not remove cover. Refer servicing qualified service personnel.

CAUTION:

Grounding reliability can be achieved when the equipment is connected to equivalent receptacle marked “Hospital Only” or Hospital Grade.”

NOTE:

ACUTRONIC Medical Systems AG recognises hat sanitation practices vary widely among healthcare institutions. It is not possible for ACUTRONIC Medical Systems AG to specify or require specific practices that will meet all needs, or to be responsible for the for effectiveness of cleaning or disinfection and other practices carried out in the patient care setting. This manual can only give general guidelines for cleaning and disinfection. While the jet tube, the airway pressure measuring tube or the bypass flow tube have been laboratory tested to meet high level disinfection requirements, it is ultimately the end user’s responsibility to ensure the validity and effectiveness of the methods used.

NOTE:

If no button is pressed for 15 seconds, the monitor automatically returns to the main menu screen.

NOTE:

Do not use the Mistral with accessories, which are not approved by the manufacturer of the unit. Malfunction or damage of the equipment could result in patient harm.

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FOR YOUR SAFETY AND THAT OF YOUR PATIENTS

Read instructions for use For correct and effective use of the apparatus and to avoid hazards it is essential to read the following recommendations and to act accordingly. Any use of the apparatus requires full understanding and strict observation of these instructions. The apparatus is only to be used for purposes specified here.

Maintenance Mistral is a Universal Jet Ventilator and classified as II b according all applicable requirements for Medical Products according 93/42 EWG council of European Union dated June 14th, 1993 for Medical Products. 1.) The apparatus must be inspected and serviced by experts at regular 6 month intervals (and a record kept) 2.) We recommend obtaining a service contract with ACUTRONIC Medical Systems AG exclusive distributor of your country. 3.) Repairs and general overhaul on the apparatus may only be carried out by ACUTRONIC Medical Systems AG Service. 4.) Only original ACUTRONIC Medical Systems AG spare parts may be used for maintenance. 5.) Power connection: The apparatus is to be used only in rooms with mains power supply installations complying with national safety standards. The standards laid down in IEC601/1 Safety for Medical Electrical Equipment, are applicable for electrically powered equipment.

Accessories Use only original accessories to avoid any harm for patients and damage of equipment.

Possible explosion hazard. Do not use the MISTRAL in presence of flammable anaesthetics. Connection of MISTRAL with other electrical equipment: Electrical connections to other equipment, which is not listed in this instruction for use, should only be made following consultations with the respective manufacturers or an expert.

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Liability for proper function and damage The liability for the proper function of the apparatus is irrevocably transferred to the owner or operator to the extent the apparatus has been serviced or repaired by personnel not employed or authorised by ACUTRONIC Medical Systems AG Service or when the apparatus was used in a manner not conforming to its intended use. ACUTRONIC Medical Systems AG cannot be held responsible for damage caused by noncompliance with the above mentioned recommendations. The warranty and liability provisions of the terms of sale and delivery of ACUTRONIC Medical Systems AG are likewise not modified by the recommendations mentioned above. ACUTRONIC Medical Systems AG

Service: Repair: Maintenance:

measures to maintain desired condition measures to restore desired condition inspection, service and if applicable, repair

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Intended use Universal Jet Ventilator designed for use in OR for Bronchoscopy, Laryngoscopy for microfacial surgery and Laser surgery. In ICU for short term application (10 – 30 minutes) Bronchial lavage

Contraindications Jet Ventilation shall only be used by clinical specialists, which are well trained and experienced in use of this particular type of ventilation. There are no contraindications known. In some cases, the retention of CO2 must be observed carefully to avoid hypercapnia. For detailed studies please contact following address: ACUTRONIC Medical Systems AG Haldenstrasse 3 P.O. Box 2082 6342 Baar / Switzerland Tel: 0041 41 768 10 70 Fax: 0041 41 768 10 71 e-mail: [email protected] www.acutronic-medical.ch

Indications for use During the use of Jet Ventilation, always keep a manual resuscitator ready to allow manual ventilation in case of insufficient elimination of CO2.

Oxygen saturation and CO2 should be monitored carefully during use of Jet Ventilation.

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Ventilation Mode The Mistral has one Jet connection port at his disposal. This port allows the connection of the patient connecting tube and allows setting of the following parameters: -

Rate (Frequency of Jet Pulsation) Inspiratory Time (duration of Pulse) Driving Pressure (determines the Pulse strength)

This machine may not be used with combustible gases or anaesthetic gases Do not use mobile phones in distances closer then 10 m to the machine Establishing ventilation with independent manual ventilation device: If in the event of a recognisable fault in the ventilator, its life-supporting functions can no longer be ensured, ventilation must be started immediately by means of an independent manual ventilation device – if required with PEEP and / or increased O2 concentration.

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Intervals for Maintenance and Battery Exchange Apparatus and accessories must be cleaned and sterilised prior any maintenance or repair work, also in case of sending back the unit to manufacturer.

Every 6 month -

Preventive maintenance and electrical safety check with protocol Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Check security shut-off

Every 12 month -

Maintenance and electrical safety check with protocol: Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Calibration

Replace the following components: - O2-Sensor - Air and O2 inlet filter with O-Ring - Battery for power fail alarm If the Battery low alarm is displayed before servicing, the battery must be replaced immediately to assure a proper function of the power fail alarm. Disposal of the old battery according local rules. If the apparatus is not used for longer period of time, the battery should be removed and stored separately. → Use only Alkaline type battery. -

If the O2 sensor alarm is displayed, the sensor must be replaced at earliest convenience to assure a proper function of the apparatus. Disposal of old sensor like batteries according local rules.

Every 1000 hours Replace following components: -

BACOSOL Jet valve

Every 10 years Replace Lithium battery for Data backup on µP board (Disposal according local rules for batteries)

Repairs and general overhaul on the apparatus may only be carried out by ACUTRONIC Medical Systems AG trained service staff.

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Preface Mistral is a microprocessor controlled Universal Jet Ventilator based on the MONSOON Universal Jet Ventilator. One of the key features of the apparatus is safety and operators comfort. Thanks to extensive experience with the MONSOON, Mistral is equipped with the latest technology.

MENU

Parameter setting is done via the alpha-dial knob and two direct access knobs for FiO2 and driving pressure.

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Operation elements and display Following picture shows the function of knobs and display. LED Systemfailure / Error

Time / Date

LED Alarm

Alpha - Dial

Alarm reset button

Inspirationtime

Mode selector (autmatic / manual)

LED Automatic Mode LED Manual Mode

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LED Jetvalve active

jet ausgang

bypass

Start / Stop Button

Measured value Pause

Frequency FiO2

Driving Pressure

FiO2 - Knob

Limit Pause Pressure

Driving Pressure

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MISTRAL Air-Oxygen blending and measuring function for O2 concentration are integrated. Two independent ports allow the use of Jet pulsation and continuous gas supply at the same time. Following functions are further integrated in the apparatus:

1

•

Frequency

•

Inspiratory time

•

Driving pressure

•

Oxygen concentration

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Measurement of pause pressure1

•

Continuous gas supply

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Limit-value monitoring for pause pressure with automatic shut-off function

•

Clock with date and time

Pause pressure is a ACUTRONIC Medical Systems AG invention and defined as follows: Pause pressure is measured in the Jet line 1 ms prior application of next pulse and allows safety shut-off of ventilation in case of excessive pulmonary pressure.

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Front Connectors The following picture indicates the connection on the front panel of the MISTRAL:

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Jet tube connector Auxiliary gas outlet connector

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Initial preparation Perform following steps prior use of the apparatus. Warning: The patient must be disconnected from the ventilator during this procedure!! 1. Prior connection of the Mistral with the mains power, the power fail alarm must be tested. For this procedure, press on-off switch at rear. An acoustic alarm commences. Press mains switch again, the acoustic alarm ceases. 2. Plug in air and oxygen connector. Plug in electrical connector. Mains voltage accepted by the apparatus is 100 VAC to 240 VAC without manual change of input voltage selector. Fuses must be replaced with same value to avoid fire hazard. Fuses must be replaced by a technician. The unit performs an automatic 2-point calibration of the oxygen sensor. After approx. 2 minutes the unit is ready.

Attention: Max. driving pressure is 3.5 bar. If supply pressure is less then 3.5 bar, following formula for max. driving pressure: Max. driving pressure = lower supply pressure – 0.5 bar 3. Connect Jet tube on front panel with outlet port indicated JET 4. If needed, connect Bypass tube with port indicated with “Auxiliary Gas Outlet”. The oxygen concentration supplied by the Bypass port is the same as the JET port. This outlet can be used for emergency ventilation with a manual resuscitation bag or to nebulize medication with a Jet Nebulizer.

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Pause Pressure limit control Warning:

Prior use of the apparatus on a patient, the pause-pressure limit must be checked with the test lung supplied by ACUTRONIC Medical Systems AG to make sure that the safety limit is functioning correct.

1. Connect Jet tube with one of the Luer connectors on the test lung. 2. Set Pause Pressure limit to 20 mbar. 3. Set driving pressure to 1.5 bar. 4. Select AUTO (automatic) mode. The yellow LED aside the AUTO/MAN button must be on AUTO position. 5. Set Frequency to 150 CPM. Inspiratory time to 50 %. 6. Press Start/Stop button to start Jet pulsation. 7. Occlude side port on test lung with thumb. The test lung is inflated and at a pressure of 20 mbar, the pulsation stops. An acoustic alarm commences and in the first line of the display, PP high alarm is displayed. Release side port, the lung deflates and the pulsation commences. The acoustic alarm ceases. 8. Reset the visual alarm by pressing the alarm reset button

Warning:

The pause pressure is measured in the Jet line 10ms prior application of the next jet pulse and reflects the airway pressure. This safety feature allows a safe use of Jet ventilation without risk of Barotrauma. This function is only safe enough if frequencies above 100 CPM are used. Below 100 CPM, the individual pulse volume is big enough to risk a Barotrauma in case of an airway obstruction.

Following graphic shows the pause pressure measurement:

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OPERATION (MAIN LEVEL) Setting and display of driving pressure Change driving pressure with rotary knob (P). Rotate clockwise to increase and counterclockwise to decrease driving pressure. The driving pressure is displayed as DP. Driving Pressure

MENU

Driving Pressure Regulator

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Inspiratory Oxygen Fraction setting (FIO2) With the rotary knob for inspiratory oxygen fraction, select desired FiO2. Rotate clockwise to increase, counter clockwise to decrease oxygen fraction. The actual oxygen fraction is displayed. Range is 0.21 to 1.0. The displayed value corresponds after about 60 seconds with the set value.

FiO2

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FiO2 Regulator

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Automatic – Manual operating mode The MISTRAL has two different modes of operation, which are:

Mode Automatic This opens works the jet valve automatically with the chosen parameters like frequency, inspiration time and watches over the given limits for the pressure levels (PP). To set the MISTRAL in automatic mode the yellow LED next to the button "Auto/Man" has to be turned on. If the green LED is lighten up, press the button "Auto/Man".

Start the MISTRAL The MISTRAL starts to work the air pressure pulses as soon the "Start/Stop" button is pressed.

Stop the MISTRAL The MISTRAL stops immediately by pushing the "Start/Stop" button.

Mode Automatic This mode opens the jet valve manual, which means as long as the button "Start/Stop" is pressed and the PIP limit is not reached, the valve remains open. To set the MISTRAL in manual mode the green LED next to the "Auto/Man" button has to be turned on. If the yellow LED is lighten up, press the "Auto/Man" button.

Open the jet valve of the MISTRAL The MISTRAL opens the jet valve, as long as the "Start/Stop" button is pressed.

No limit control of the patient’s pressure conditions is available. Observe thorax movement carefully!! In the manual mode the message "No PP-Control" appears on the display. This message can't be cleared as long as the MISTRAL works in the manual mode.

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Frequency setting 1. Press Alpha-Dial knob to enter the main menu 2. Rotate Alpha-Dial knob until the cursor is on the left side of "f(CPM)" and press AlphaDial knob to confirm 3. Rotate Alpha-Dial to change frequency and press Alpha-Dial to confirm

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