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Armstrong Medical AquaVENT FD140 Скачать руководство пользователя страница 10

8

Instructions for Use, AquaVENT

®

FD140, Rev. 12

Power indicator

Three-level capacity indicator of the rechargeable battery

ON/OFF key

Serial interface

The AquaVENT® FD140 corresponds to Directive

93/42/EEC concerning medical devices, provided it is
operated according to the instructions for use. "0123" is the
identification number of the notified body.

Follow the instructions for use.

The  AquaVENT®  FD140  must  not  be  disposed  of  with
ordinary,  unsorted  household  waste  but  must  be  treated
separately.  Please  contact  the  manufacturer  for  more
information  regarding  the  disposal  of  the  AquaVENT®
FD140.

1.3 Abbreviations used in the instructions for
use and on the device

AIR

Medical air

O

2

Medical oxygen

CPAP

Continuous Positive Airway Pressure,
measured and set CPAP value

PEEP

Positive end-expiratory pressure

FiO

2

HFOT

Inspiratory oxygen concentration
High Flow Oxygen Therapy mode

HW

Hardware version

SW

Software version

Ser. No.

Serial number

«
...
8
9
10
11
12
...
»

Содержание AquaVENT FD140

Страница 1: ...AquaVENT FD140 Instructions for use CRITICAL CARE...

Страница 2: ...ing advice via telephone or in writing from the nearest regional service centre Maintenance and repairs must only be carried out at the service centre or by specialists authorised by the manufacturer...

Страница 3: ...19 3 4 1 CPAP mode 19 3 4 2 High Flow Oxygen Therapy HFOT mode 19 3 4 3 Helmet CPAP mode 19 3 4 4 Paed CPAP mode 20 4 Preparing the device for operation 21 4 1 General information 22 4 2 Power supply...

Страница 4: ...the nebuliser 51 6 Alarms and messages 55 6 1 Alarms 56 6 2 Messages 59 6 2 1 Messages during the system test 60 6 2 2 Messages during the CPAP test 62 7 Cleaning 65 7 1 General information 66 7 2 Cle...

Страница 5: ...Rev 12 3 9 6 Measuring functions 79 9 7 Paramagnetic oxygen sensor 79 9 8 Display 79 9 9 Alarms 79 9 10 External communication 80 9 11 Guidance and manufacturer s declaration 80 10 Navigation accesso...

Страница 6: ...0 Contents 4 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 7: ...Use AquaVENT FD140 Rev 12 5 1Introduction In this chapter 1 1 About this manual 6 1 2 Symbols used in the instructions for use and on the device 7 1 3 Abbreviations used in the instructions for use an...

Страница 8: ...roved accessories please refer to chapter 10 2 Accessories These instructions for use have been compiled with the greatest care The authors are grateful for any advice suggestions and constructive cri...

Страница 9: ...ation which may cause injuries to the user or the patient Caution Refers to a situation which may cause damage to the equipment All warnings and precautions must be read and observed Scale for the bar...

Страница 10: ...structions for use The AquaVENT FD140 must not be disposed of with ordinary unsorted household waste but must be treated separately Please contact the manufacturer for more information regarding the d...

Страница 11: ...Instructions for Use AquaVENT FD140 Rev 12 9 2Safety In this chapter 2 1 Safety precautions 10...

Страница 12: ...espiratory therapy device Classification The AquaVENT FD140 is a Class IIb device according to Directive 93 42 EEC concerning medical devices Annex IX section 1 3 rule 3 section 3 1 rule 9 and section...

Страница 13: ...indication is triggered Patient safety The patient connected to the device requires surveillance by specialist staff If a patient is connected to the system make sure that the alarm limits are adapted...

Страница 14: ...cleaning repair or maintenance is carried out Fire hazard The AquaVENT FD140 must not be used in potentially explosive atmospheres or in the presence of flammable anaesthetics Risk of electromagnetic...

Страница 15: ...AquaVENT FD140 This may put the patient at risk Caution Using other electrical devices with the AquaVENT FD140 or in its vicinity can cause interference The correct performance of the device must be v...

Страница 16: ...2 Safety 14 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 17: ...15 3 General description In this chapter 3 1 Intended use 16 3 2 Main components 17 3 3 Operation 19 3 4 Operating principle 19 3 4 1 CPAP mode 19 3 4 2 High Flow Oxygen Therapy HFOT mode 19 3 4 3 He...

Страница 18: ...not a life support device CPAP therapy can be applied in different modes and via face mask or helmet Furthermore the AquaVENT FD140 can be used as a flow generator for High Flow Oxygen Therapy HFOT m...

Страница 19: ...ption Instructions for Use AquaVENT FD140 Rev 12 17 3 2 Main components Front Pressure measuring line connection Respiratory gas outlet Nebuliser port ON OFF key Alarm pause key Menu key Touch screen...

Страница 20: ...ENT FD140 Rev 12 Back Display Serial interface Power input O2 inlet Type plate AIR inlet Respiratory rate Patient airway pressure bar graph Patient airway pressure set value FiO2 Treatment duration Fl...

Страница 21: ...and with an integrated rechargeable battery for uninterrupted operation in the event of a mains power failure A nebuliser outlet supplies the compressed air necessary for operation of a nebuliser 3 4...

Страница 22: ...eral description 20 Instructions for Use AquaVENT FD140 Rev 12 3 4 4 Paed CPAP mode The flow provided at the respiratory gas outlet is constant and user adjustable The maximum flow in this mode is 70...

Страница 23: ...ns supply 22 4 2 2 Rechargeable battery 23 4 3 Gas supply 25 4 3 1 Two gas operation 25 4 3 2 Single gas operation 26 4 4 CPAP breathing circuit 26 4 5 CPAP with face mask unheated 27 4 6 CPAP with fa...

Страница 24: ...d in chapter 10 Navigation 4 2 Power supply 4 2 1 Mains supply The AquaVENT FD140 is designed for a supply voltage ranging from 90 to 240 VAC at 50 to 60 Hz without switchover Before connecting the de...

Страница 25: ...ery The device is equipped with an internal battery which when fully charged provides power for a minimum operating time of 60 minutes When disconnected from the mains or in the event of a mains power...

Страница 26: ...en the internal battery charges automatically Note The internal battery used is a lead acid battery A fully charged battery can be stored for up to 3 months after which it requires charging Lead acid...

Страница 27: ...witches to the other gas supply If the O2 gas supply fails and the FiO2 is set to a value 21 the device will output an alarm message The same happens in the event of an AIR gas supply failure and an F...

Страница 28: ...messages the following must be observed If an AIR gas supply is not available the FiO2 must be set at 100 if an O2 gas supply is not available at 21 Please refer to chapter 6 1 Alarms for details of t...

Страница 29: ...4 Preparing the device for operation Instructions for Use AquaVENT FD140 Rev 12 27 4 5 CPAP or Paed CPAP with face mask unheated Connect the breathing circuit as shown in the following diagram...

Страница 30: ...ted CPAP breathing circuit Note To prevent water from the humidifier which collects during operation from entering the AquaVENT FD140 the active humidifier should be placed at a level below that of th...

Страница 31: ...4 Preparing the device for operation Instructions for Use AquaVENT FD140 Rev 12 29 Assemble the breathing circuit as shown in the following diagram...

Страница 32: ...AIR flow to the breathing circuit To provide the patient with the selected oxygen concentration the gas mixer settings adjust accordingly By default an AIR flow of 6 0 L min is set for the nebuliser I...

Страница 33: ...nected to the breathing circuit in close proximity to the patient The breathing circuit is basically identical with the illustration in chapter 4 6 Warning Be sure to adjust the required flow accordin...

Страница 34: ...r operation 32 Instructions for Use AquaVENT FD140 Rev 12 4 9 Helmet CPAP application The AquaVENT FD140 supports non invasive ventilation by means of a CPAP helmet Connect the CPAP helmet to the Aqua...

Страница 35: ...quired flow and to avoid CO2 rebreathing The approved CPAP helmets are specified in chapter 10 2 Accessories Please refer to chapter 1 1 About this manual for details 4 10 Placement of the device Ther...

Страница 36: ...4 Preparing the device for operation 34 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 37: ...n 39 5 4 Standby 41 5 5 Parameter adjustment 42 5 5 1 Changing patient airway pressure during therapy 42 5 5 2 Treatment duration 43 5 5 3 FiO2 44 5 5 4 Flow adjustment 45 5 6 Patient menu 47 5 6 1 Al...

Страница 38: ...on at any time if the battery charge level is sufficient When the device is not connected to the mains the ON OFF key must be pressed a bit longer You will first be asked whether you wish to continue...

Страница 39: ...erminating the therapy mode please refer to chapter 5 7 Starting ending therapy Automatic switch off due to discharged battery To avoid damage to the internal rechargeable battery by deep discharging...

Страница 40: ...e refer to chapter 5 6 1 Alarm volume Note It is possible to switch off all audible alarms If the audible alarms were switched off the last time the device was in use only a single tone will be emitte...

Страница 41: ...g message is shown on the screen Please refer to chapter 6 Alarms and messages for error message details After a successful system test the mode menu will be displayed Detailed information is given in...

Страница 42: ...er selection of a mode the screen display changes and you can adjust the flow Touch the vertical line under the numerical value flow in l min and drag it along the horizontal line until you reach the...

Страница 43: ...PEEP valve Please refer to chapter 5 5 1 Changing patient airway pressure during therapy for details 3 Nebuliser The nebuliser can be switched on and off Please refer to chapter 5 8 Activating deacti...

Страница 44: ...PAP and helmet CPAP modes the patient airway pressure field shows the measured patient airway pressure which is averaged over a longer period of time To view the instantaneous change of the patient ai...

Страница 45: ...o indicate that it has been activated Then the stopwatch shows the duration of the treatment The colon blinks while the stopwatch is timing the treatment Pressing the field again stops the timer Press...

Страница 46: ...py mode automatically resets the timer to 0 00 5 5 3 FiO2 The standby and the therapy screens show the set FiO2 The FiO2 value can be adjusted by pressing the corresponding field on the touch screen A...

Страница 47: ...en sensor must be used Note Should the concentration of the oxygen gas supply be less than 100 an additional field for input of the actual O2 supply concentration can be activated This must be done by...

Страница 48: ...ue Press OK to confirm the setting The standby or therapy screen will be displayed again this time with the new FiO2 value Due to the different maximal flows of the AIR and of the O2 gas supply see ch...

Страница 49: ...therapy is started 5 6 1 Alarm volume A menu is provided for setting the alarm volume Press the Menu key in the standby mode or therapy mode to display the menu Press Volume to enter the setting mode...

Страница 50: ...arm cannot be switched off Press the Menu key to save the selected apnoea alarm period The standby or therapy screen is displayed again 5 6 3 P max A menu is provided for setting the maximum airway pr...

Страница 51: ...Set the desired limit value by pressing the and fields You can turn off the P min value or set an absolute pressure value in the range from 2 cmH2O to 20 cmH2O as the alarm limit The default setting i...

Страница 52: ...g therapy Before starting the therapy verify that all parameters have been set For details please refer to chapter 5 5 Parameter adjustment Connect the patient to the breathing circuit For detailed in...

Страница 53: ...ssed it disappears after 5 seconds and the patient pressure bar graph is displayed again Please refer to chapter 5 4 Standby for details 5 8 Activating deactivating the nebuliser The nebuliser is acti...

Страница 54: ...e set FiO2 is applied while the nebuliser is activated Selecting certain settings will automatically clear the nebuliser icon which means that the nebuliser cannot be activated Note If during use of t...

Страница 55: ...ice will specify a minimum flow and displays an appropriate message When the message is acknowledged with OK a window opens for adjustment of the new flow value It is not possible to select a value be...

Страница 56: ...5 Operation 54 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 57: ...Instructions for Use AquaVENT FD140 Rev 12 55 6Alarms and messages In this chapter 6 1 Alarms 56 6 2 Messages 59 6 2 1 Messages during the system test 60 6 2 2 Messages during the CPAP test 62...

Страница 58: ...m message to be displayed The AquaVENT FD140 distinguishes between patient device and FiO2 alarms Patient alarms Patient alarms include all alarms triggered by the patient They can occur only during t...

Страница 59: ...gered by a malfunction of the device They can occur in standby and during therapy No Message Trigger condition Corrective measure No O2 supply O2 gas supply not connected and set FiO2 not 21 Connect O...

Страница 60: ...ty 3 min connect to mains power and charge battery Bat discharged Device switches off battery is discharged connect to mains power and charge battery Power failure no connection to mains power connect...

Страница 61: ...o the original colour The alarm message remains on the screen It can be cleared by pressing the Alarm pause key or by touching the alarm text If more than one alarm occurs they are shown alternately i...

Страница 62: ...numbered and accompanied by an audio signal 6 2 1 Messages during the system test Messages occurring during the system test are represented as follows As soon as the trigger condition for the message...

Страница 63: ...ician 1 Sensor defect Call service communication with pressure sensors not possible restart device if error message recurs contact authorised service technician 2 Check output Keep output open while s...

Страница 64: ...pressed do not press key 9 Touch screen permanently pressed touch screen is permanently pressed do not press touch screen 10 O2 sensor calibration needed Call service no or wrong O2 sensor calibration...

Страница 65: ...PAP value 3 cmH2O 11 Pressure during test above 30 cmH2O CPAP test was started with CPAP value 30 cmH2O press Return and set CPAP value 30 cmH2O restart CPAP test 12 PEEP valve not compatible an unapp...

Страница 66: ...6 Alarms and messages 64 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 67: ...Instructions for Use AquaVENT FD140 Rev 12 65 7Cleaning In this chapter 7 1 General information 66 7 2 Cleaning and disinfection 67...

Страница 68: ...ners acetone sharp or abrasive cleaning agents e g steel wool silver polish or silver cleaners Do not allow liquids to enter into the housing Keep liquids away from electronic components Contact the m...

Страница 69: ...k that the mains plug was removed Use a soft cloth and mild detergents to clean the surface of the housing mikrozid sensitive liquid by Sch lke Mayr GmbH www schuelke com is recommended for disinfecti...

Страница 70: ...7 Cleaning 68 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 71: ...0 Rev 12 69 8Maintenance In this chapter 8 1 General information 70 8 1 1 Annual maintenance 70 8 1 2 Maintenance every two years 70 8 1 3 Maintenance every six years 71 8 1 4 Maintenance every 12 yea...

Страница 72: ...red that the AquaVENT FD140 is switched off and the mains plug removed all components of the breathing circuit have been removed from the AquaVENT FD140 These conditions do not apply for the technical...

Страница 73: ...ance every six years Every six years the maintenance includes the replacement of the O2 pressure regulator 8 1 4 Maintenance every 12 years It is necessary to replace all active internal components of...

Страница 74: ...of the tolerances In this case start the calibration routine from the screen Mode selection by pressing the menu key Warning Do not perform the calibration while the device is being used to treat a pa...

Страница 75: ...ion routine requires AIR and O2 gas supply If the supply of at least one gas is missing or breaks down during calibration a message will appear Connect O2 and AIR Check and or reconnect the missing ga...

Страница 76: ...8 Maintenance 74 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 77: ...ply 77 9 2 1 Power supply 77 9 2 2 Gas supply 77 9 3 Technical specifications of the AquaVent FD140 78 9 4 Increments and intervals of parameter settings 78 9 5 Default settings 78 9 6 Measuring funct...

Страница 78: ...210 mm Minimum footprint 270 cm Weight net 4 5 to 5 2 kg depending on selected options Environmental conditions During operation Temperature 5 to 40 C Atmospheric pressure 60 to 110 kPa Relative humi...

Страница 79: ...ower supply Mains power 90 to 240 VAC 50 to 60 Hz wide range Power consumption 35 VA Battery 12V 1300 mAh Type lead acid Operating time 60 minutes with fully charged battery 9 2 2 Gas supply Oxygen su...

Страница 80: ...AP depending on PEEP valve used flow adjustment range 40 to 140 l min Safety functions Free breathing valve allows spontaneous breathing with room air upon loss of gas gas supply 9 4 Increments and in...

Страница 81: ...min 60 min 2 min Patient pressure actual value 1 cmH2O 0 cmH2O 50 cmH2O 10 Patient pressure bar graph 0 25 cmH2O 0 cmH2O 25 cmH2O 10 9 7 Paramagnetic oxygen sensor Accuracy 2 Calibration annual Servi...

Страница 82: ...sibility of the customer or user of the AquaVENT FD140 to ensure that the device is operated in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR11...

Страница 83: ...ge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3...

Страница 84: ...70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds The mains power quality should be that of a typical commercial or hospital environment If the user and or operator of the AquaVENT FD1...

Страница 85: ...150 kHz to 80 MHz 10 V P d 35 0 Radiated RF to IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 10 V m P d 35 0 for 80 MHz to 800 MHz P d 7 0 for 800 MHz to 2 5GHz where P is the maximum output power rating of...

Страница 86: ...r radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey...

Страница 87: ...t Rated maximum output power of the transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz P d 35 0 80 MHz to 800 MHz P d 35 0 800 MHz to 2 5 GHz P d 7 0 0 01 0 04...

Страница 88: ...9 Technical specifications 86 Instructions for Use AquaVENT FD140 Rev 12 This page is intentionally blank...

Страница 89: ...Instructions for Use AquaVENT FD140 Rev 12 87 10Navigation accessories In this chapter 10 1 Navigation 10 2 Accessories...

Страница 90: ...ctions for Use AquaVENT FD140 Rev 12 10 1 Navigation CPAP mode Press ON OFF key to switch the AquaVent on Start CPAP therapy Mode selection System test starts automatically Stopwatch for treatment dur...

Страница 91: ...Navigation Paed CPAP mode Press ON OFF key to switch the AquaVent on Mode selection System test starts automatically Start Paed CPAP therapy Stopwatch for treatment duration Patient airway pressure fi...

Страница 92: ...or Use AquaVENT FD140 Rev 12 High Flow Oxygen Therapy HFOT mode Press ON OFF key to switch the AquaVent on Mode selection System test starts automatically Start helmet CPAP therapy Stopwatch for treat...

Страница 93: ...se AquaVENT FD140 Rev 12 Helmet CPAP mode Press ON OFF key to switch the AquaVent on System test starts automatically Mode selection Start helmet CPAP therapy Stopwatch for treatment duration Patient...

Страница 94: ...5 T piece for safety valve 22mmF 22mmF 22mmM 15mmF PHFT7010 Bacterial viral breathing filter 22mmM 15mmF 22mmF HRFM113554 Face mask with headgear size PETITE HRFM113553 Face mask with headgear size EX...

Страница 95: ...Instructions for Use AquaVENT FD140 Rev 12 93 This page is intentionally blank...

Страница 96: ...KG Niederh chst dter Str 62 61476 Kronberg Germany Telephone 49 0 6173 9333 0 Fax 49 0 6173 9333 29 info salvia medical de www salvia medical de Instructions for Use AquaVENT FD140 Part number CM 929...

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