MISTRAL Service Manual Version 4.0 Oct 2003

DEFINITION OF TERMS ...4 SUMMARY OF WARNINGS, CAUTIONS, AND NOTES ...5 ABBREVIATIONS AND SYMBOLS ...6 CMOS HANDLING PRECAUTIONS ...7 WARRANTY ...7 FOR YOUR SAFETY AND THAT OF YOUR PATIENTS...8 READ INSTRUCTIONS FOR USE ...8 MAINTENANCE ...8 ACCESSORIES ...8 LIABILITY FOR PROPER FUNCTION AND DAMAGE ...9 INTENDED USE ...10 CONTRAINDICATIONS ...10 INDICATIONS FOR USE ...10 VENTILATION MODE ...11 INTERVALS FOR MAINTENANCE AND BATTERY EXCHANGE ...12 USED MATERIALS ...13 PREFACE ...14 OPERATION ELEMENTS AND DISPLAY ...15

MISTRAL ...16 START-UP MENU FOR MISTRAL (SOFTWARE VERSION 4.O)...17 START - UP MENU ...17 SERVICE MENU ...18 FRONT CONNECTORS ...19 REAR PANEL ...20 MISTRAL OVERVIEW ...21 INITIAL PREPARATION ...23

ALARM & ERROR CODES...25 ALARM FUNCTIONS...25 ERROR FUNCTIONS ...28 DISINFECTION AND CLEANING...29

TECHNICAL DATA ...30 SETTINGS AND RANGES ...30 DIMENSIONS ...30 CONNECTIONS ...30 EXCHANGE OF BATTERY AND FUSES ...31

PNEUMATIC & ELECTRONIC DIAGRAM ...32 PART LIST ...33 PARAMETER AND INITIALTOOL ...36 MAIN ...36 CALIBRATION FOR MISTRAL ...39 BYPASS CALIBRATION ...39 PRESSURE REGULATOR ADJUSTMENT ...40 MAIN PRESSURE CALIBRATION ...42 PP CALIBRATION ...42 FIO2 FRONT PANEL CALIBRATION...43 OXYGEN SENSOR CALIBRATION ...43 BACKUP IN EEPROM ...44 MAINTENANCE DATE ...45 TEST PROTOCOL ...45

SERVICE TASKS ...46 CONFIGURATION...47 MESSAGES ...48 LICENSE...49 Service Manual Mistral / Version 4.0 29.10.2003

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Manufactured by: ACUTRONIC Medical Systems AG Fabrik im Schiffli CH-8816 Hirzel Switzerland Telefon 0041 44 729 70 80 Telefax 0041 44 729 70 81 [email protected] www.acutronic-medical.ch

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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:

Federal (USA) law restricts this device to the sale, distribution and use by and on the order of a physician.

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

NOTE:

NOTE: NOTE:

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ABBREVIATIONS AND SYMBOLS SYMBOL

Description Read instructions for use

Apparatus typ BF

Warning: High voltage. Disconnect from mains prior opening of the unit. Servicing only by qualified personnel.

Connector for equalisation of potential

OI

OFF / ON

O = OFF

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I = ON

CMOS HANDLING PRECAUTIONS The following precautions must be observed whenever a circuit board or an integrated circuit is handled. Failure to do so may result in serious damage to the MISTRAL. Place MISTRAL and parts on a grounded, conductive work surface Ground yourself (with a strap having about 1 MOhm resistance? Ground the frame of any test instrument or soldering iron to be used If any circuit boards are to be stored or transported, enclose them in conductive (anti-static) envelopes

WARRANTY We warrant that this product is free from defects in material and workmanship and, when properly used, will perform in accordance with applicable specifications. If within one year after the original shipment it is found not to meet this standard, it will be repaired or, at ACUTRONIC Medical Systems AG option, replaced at no charge when returned to an ACUTRONIC Medical Systems AG service facility. Any modification to the equipment or rework or repair by other than ACUTRONIC Medical Systems AG approved personnel will render this warranty null and void. ACUTRONIC Medical Systems AG shall not be liable for any indirect, special or consequential damages, even if notice has been given of the possibility of such damages. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. The policy of ACUTRONIC Medical Systems AG is to maintain product repair capability for a period of ten years after the original shipment and to make this capability available at the then prevailing schedule of charge.

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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 recommendation 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 th Medical Products according 93/42 EWG council of European Union dated June 14 , 1993 for Medical Products. 1.) The apparatus must be inspected and serviced by experts at regular 6 months interval (and a record kept). 2.) We recommend obtaining a service contract with ACUTRONIC Medical Systems AG exclusive distributor in 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 standards. The standards laid down in IEC-601/1 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 these instructions 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 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 non-compliance 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: measures to maintain desired condition Repair: measures to restore desired condition Maintenance: inspection, service and if applicable, repair

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Intended use Universal Jet Ventilator designed for use in OR for Bronchoscopy, Laryngoscopy for micro facial 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 Fabrik im Schiffli CH-8816 Hirzel / Switzerland

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 -

Maintenance and electrical safety check with protocol (IEC 601-1) Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Check security shut-off

-

Maintenance and electrical safety check with protocol (IEC 601-1) Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Calibration

Every 12 month

Replace 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 apparatus is not used for a longer period of time, the battery should be removed and stored separately. Æ Use only Alkaline type battery. If O2-Sensor alarm is displayed, the sensor must be replaced at earliest convenience to assure a proper function of apparatus. Disposal of old sensor like battery according local rules.

Every 1000 hours

Replace following components: - BACOSOL Jet valve

Every 3 years Replace following components: -

Every 10 years

Internal tube set

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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Used materials

Part

Description

Material

Jet tube Transparent, clear Bypass Flow Transparent, clear tube

Tygon S-50-HL Tygon S-50-HL

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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 are 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 LED Alarm Alarm reset button

Time / Date Alpha - Dial Inspirationtime

Mode selector (autmatic / manual)

LED Automatic Mode LED Manual Mode

MENU

LED Jetvalve active

jet ausgang

bypass

Start / Stop Button

Frequency FiO2

Driving Pressure

FiO2 - Knob

Limit Pause Pressure

Driving Pressure

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Measured value Pause

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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

•

Measurement of pause pressure

•

Continuous gas supply

•

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

•

Clock with date and time

1

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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START-UP MENU FOR MISTRAL (SOFTWARE VERSION 4.O) Start - up Menu To enter the service menu please act as follows: 1

Press the alpha-dial and switch on the MISTRAL, the message "Start-up menu" appears on the display

2

Press the "Start/Stop" button and hold it pressed until the start up menu on the display appears

3

Choose the option

Following options are available: 1

Ignore O2-Calibration Possibility to ignore the O2-Calibration during the start-up. Important: This mode should only be used for service!

2

Load Preset The unit starts with preset settings

MENU

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Service Menu To enter the service menu please act as follows: 1

Press the alpha-dial and switch on the MISTRAL, the message "Start-up menu" appears on the display

2

Press the "Start/Stop" button and hold it pressed until the service menu on the display appears

3

After the Start up menu appears on the display, press the alarm button

4

Choose the option

Following options are available: 1

Communication Unit waits on a signal at the RS-232, used for download data to the unit and calibration

2

EEPROM Upload from saved data to the unit

3

Zero Calibration Zero Calibration of the pressure sensors Important: Make sure that is no pressure on the unit and the driving pressure regulator is fully closed!

4

S-Preset Actual settings will be stored

MENU

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Front Connectors

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

MENU

Jet tube connector Auxiliary gas outlet connector

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Rear panel Picture below shows the rear panel and components placed on it. Element 4

Element 2 Element 3

Element 1

Element 12

Element 5

Element 10 Element 11

Element 6

Element 8 Element 9

Legend: Element 1: Element 2: Element 3: Element 4: Element 5: Element 6: Element 7: Element 8: Element 9: Element 10: Element 11: Element 12:

Mains switch Connector for remote control Alarm loudspeaker Knob for alarm loudness setting Battery compartment for power failure alarm RS-232 interface, for servicing purposes only ! Cooling fan Input connector for oxygen supply (NIST) Bleed for oxygen blender Input connector for air supply (NIST) Grounding connector Mains connector and fuses compartment

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Element 7