ACUTRONIC MONSOON Manuale utente

MONSOON

UNIVERSAL JET VENTILATOR

Instructions for Use

Version 5.6e

This manual only applies to:

monsoon with software Version: 1.15 or higher

Instructions for use MONSOON 5.6e

20/09/2010

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Manufactured by:

ACUTRONIC Medical Systems AG

Fabrik im Schiffli

8816 Hirzel / Switzerland

Phone: +41 44 729 70 80

Fax: +41 44 729 70 81

e-mail:[email protected]

www.acutronic-medical.ch

0124

Instructions for use MONSOON 5.6e

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TABLE OF CONTENTS

TABLE OF CONTENTS .................................................................................................................................................3

FOR YOUR SAFETY AND THAT OF YOUR PATIENTS........................................................................................................5

Read Instructions for Use...................................................................................................................................................5

Safety Notices......................................................................................................................................................................5

Maintenance.........................................................................................................................................................................7

Accessories..........................................................................................................................................................................8

Safe Use ................................................................................................................................................................................8

Liability for Proper Function and Damage .......................................................................................................................8

Medical Purpose..................................................................................................................................................................9

Contraindications.................................................................................................................................................................9

Indications for Use.............................................................................................................................................................10

Ventilation Modes..............................................................................................................................................................11

Maintenance Intervals, Batteries ...................................................................................................................................12

Contents...............................................................................................................................................................................13

USER INTERFACE .....................................................................................................................................................14

Front View / Connectors ...................................................................................................................................................14

Control Panel Overview ....................................................................................................................................................15

Main Unit Overview...........................................................................................................................................................16

Display - Single Jet............................................................................................................................................................17

Display - Double Jet ..........................................................................................................................................................18

MONSOON ..............................................................................................................................................................19

PRESSURE LIMITS ...................................................................................................................................................20

PIP Limit (Respiratory Tract Pressure)...........................................................................................................................20

PP Limit (Pause Pressure)................................................................................................................................................20

Superimposed Pressure Limit (Superimposed Ventilation)........................................................................................20

START-UP ...............................................................................................................................................................21

Apparatus Preparation......................................................................................................................................................21

Check P-Pressure and PIP Safety Limits.......................................................................................................................22

Using the MONSOON with Single Lumen Catheter......................................................................................................23

OPERATION .............................................................................................................................................................24

Parameter Settings............................................................................................................................................................24

Menu ....................................................................................................................................................................................24

Superimposed Pressure Limit (SIPL)..............................................................................................................................25

Double Jet (Optional).........................................................................................................................................................25

Bypass .................................................................................................................................................................................26

Humidification.....................................................................................................................................................................26

Preparation ...................................................................................................................................................................27

Dehumidification ..........................................................................................................................................................28

Settings................................................................................................................................................................................29

Language.............................................................................................................................................................................29

Maintenance.......................................................................................................................................................................29

Disconnection.....................................................................................................................................................................30

Laser Application...............................................................................................................................................................30

etCO2– Measurement (Optional).....................................................................................................................................31

Video Camera (Optional)...................................................................................................................................................32

Remote Control (Optional) ................................................................................................................................................33

Automatic – Manual Operating Mode............................................................................................................................34

CLINICAL APPLICATIONS .........................................................................................................................................35

Patient Data ........................................................................................................................................................................35

CPAP Ventilation Set for MONSOON .............................................................................................................................36

Infraglottic Catheter Jet Ventilation ...............................................................................................................................38

Supraglottic (Catheterless) Jet Ventilation ...................................................................................................................39

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Rigid Bronchoscopy ..........................................................................................................................................................40

Infraglottic Jet Ventilation................................................................................................................................................40

Transtracheal Jet Ventilation ..........................................................................................................................................41

ALARMS AND ERROR CODES ...................................................................................................................................42

Patient Alarms....................................................................................................................................................................43

System Alarms....................................................................................................................................................................44

Notices.................................................................................................................................................................................47

ACCESSORIES..........................................................................................................................................................49

TREATMENT,DISINFECTING /CLEANING .................................................................................................................51

ABBREVIATIONS AND SYMBOLS..............................................................................................................................52

ABOUT ELECTROMAGNETIC COMPATIBILITY.............................................................................................................53

TECHNICAL SPECIFICATION .....................................................................................................................................57

Settings and Ranges..........................................................................................................................................................57

Dimensions..........................................................................................................................................................................57

Connections / Ports ...........................................................................................................................................................57

Environmental Conditions.................................................................................................................................................58

Disposal...............................................................................................................................................................................58

Rear View / Connections ..................................................................................................................................................59

Replacing Fuses .................................................................................................................................................................60

TABLE OF FIGURES...................................................................................................................................................61

Instructions for use MONSOON 5.6e

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FOR YOUR SAFETY AND THAT OF YOUR PATIENTS

Read Instructions for Use

Any use of this apparatus requires full understanding and strict observation of these instructions for

use.

This apparatus is only to be used for purposes specified here.

Safety Notices

Always observe

Any use of the ventilator requires full understanding and strict observation of these

instructions. The apparatus is only to be used for purposes specified here.

The ventilator is only to be operated by qualified technical staff or under their su-

pervision to immediately provide assistance in the event of malfunction.

If the new value is not confirmed by the operator by pressing the rotary pulse en-

coder or the touch monitor the value will automatically be reset after a few se-

conds.

Always have an alternate ventilation system (e.g. resuscitation bag) when using the

ventilator.

If the life support function can no longer be ensured due to an obvious ventilator

defect, immediately provide artificial ventilation to the patient via a self-contained

ventilator (e.g. resuscitation bag).

Never use the ventilator together with flammable gas or

Anaesthetics – acute fire and explosion hazard!

Do not use the ventilator in explosion-risk areas!

An audible sound indicates a system or patient alert and always requires action by

medical staff.

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An audible alarm will sound in the event of power failure. Resetting the alarm re-

quires the on/off switch to be pressed.

Never use the ventilator on patients when a fault is detected during equipment

check!

Do not connect to electrical devices not specified in this manual without consulting

the manufacturers or an expert professional.

Never cover the ventilator or position in a way which will negatively impact opera-

tion or function.

Always unplug before opening the housing!

Never use mobile phones within 10 metres of the ventilator. Mobile phones may

interfere with the performance of electromedical equipment.

Never use antistatic or electroconductive tubes.

Note: the absence of e.g. allergy stimulating or genetically harmful substances, e.g.

Phthalates, in our products ensures user safety and health.

Instructions for use MONSOON 5.6e

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Maintenance1

MONSOON is a Universal Jet ventilator classified as device group IIb according to European di-

rective.

1.) The apparatus must be safety inspected and serviced at regular 6 months intervals in

compliance with the manufacturer instructions as well as §6 MPBetreibV Medical Devices Opera-

tor Ordinance dated 6/29/1998.

2.) Service must be performed by professionals trained by ACUTRONIC Medical Systems AG with the

suitable measuring and testing devices.

3.) ACUTRONIC Medical Systems AG recommends obtaining a service contract with an exclusive

representative of ACUTRONIC Medical Systems AG.

4.) Only use genuine ACUTRONIC Medical Systems AG replacement parts.

1Definition:

Inspection = Determine actual condition

Service = Measures to maintain desired condition

Repair = Measures to restore desired condition

Maintenance = Inspection, maintenance, repair

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Accessories

Use only accessories specified in the accessory list.

Safe Use

Do not use in explosion-risk areas.

This equipment is not approved for use in explosion-risk areas.

Safe connection with electrical devices

Do not connect to electrical devices not specified in this manual without consulting the manufacturers

or an expert professional.

Liability for Proper Function and Damage

Any and all liability for the proper function of the apparatus is irrevocably transferred to the owner or

operator if the apparatus has been serviced or repaired by personnel not associated with ACUTRONIC

Medical Systems AG Service or if the apparatus was used in a manner not conforming to its intended

use.

ACUTRONIC Medical Systems AG assumes no liability for damages caused by non-compliance with

preceding notices. 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

Instructions for use MONSOON 5.6e

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Medical Purpose

Universal Jet ventilator is designed for use in ICU (long term applications) and in the operating theatre

for laryngoscopy, rigid bronchoscopy, microsurgeries with or without laser. The apparatus is also suit-

able for use combined with imaging procedures to minimise organ motion due to artificial ventilation.

For ICU long-term applications we recommend performing routine blood gas analyses as the applied

minute volume cannot be accurately measured with Jet ventilation and could fluctuate greatly due to

modified pulmonary compliance.

Contraindications

With respect to contraindications please note Jet ventilation shall only be used by clinical specialists

with extensive knowledge of Jet ventilation.

There are no known contraindications in the area of laryngoscopy, bronchoscopy or laser surgery. In a

few cases CO2exhalation in heavy weight patients was associated with problems during Single Jet

ventilation. In these cases Jet ventilation was temporarily suspended and conventional ventilation

used until the CO2values returned to normal. With Double Jet CO2 exhalation is supported through the

low-frequency Jet, suspending Jet ventilation is therefore no longer required. Always monitor the CO2

values when using artificial ventilation. This may be done using a CO2 module for the MONSOON sold

separately, a capnograph or transcutaneous CO2measurement.

For detailed studies and experienced data please contact:

ACUTRONIC Medical Systems AG

Fabrik im Schiffli

8816 Hirzel / Switzerland

Tel: +41 44 72 9 70 80

Fax: +41 44 729 70 81

e-mail:[email protected]

www.acutronic-medical.ch

Instructions for use MONSOON 5.6e

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Indications for Use

Always have a manual resuscitator ready when using a Jet ventilator in the event of insufficient CO2

elimination or insufficient oxygenation in the patient.

Oxygen saturation and CO2should be routinely monitored via capnograph and pulse oximeter or

blood gas analysis.

With long-term use of the Jet apparatus routinely check the function of the mucous membranes of the

trachea for sufficient humidification to prevent desiccation. Since the MONSOON features an efficient

heating and humidification system no problems have occurred in the field.

A large number of surgical procedures of the ventilation system are performed through the use of la-

ser. This poses a risk of flammable materials (e.g. catheter, swab, residual tissue) in the operating field

igniting, which could be further promoted by an increased concentration of oxygen.

Laser procedures may therefore only be performed together with the Jet catheter “Laserjet”.

The MONSOON features a function specifically for laser procedures allowing the user to set the oxy-

gen concentration to be administered during a laser procedure. This feature is activated with the

Laser

on/off

switch, the blender as quickly as possible regulates at the set default oxygen concentration of <

40 %Vol, the concentration cannot be increased with active laser function. Once the blender reaches

an oxygen concentration of < 40 %Vol the notification “

Laser OK

”

is displayed.

Once the laser procedure is completed or the function is deactivated the blender automatically returns

to the last O2value setting.

The notification “

Laser OK

” merely refers to having reached the default oxygen concentra-

tion in the blender. An increased oxygen concentration may still be present in the respirato-

ry tracts of the patient as the ventilation parameters or constricted respiratory tracts results

in a decreased depletion of the oxygen.

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