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Armstrong Medical 10190001, User Manual

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Armstrong Medical 10190001 User Manual Download Page 80

For  Technical Support and Customer Service, contact Armstrong Medical Ltd. 
 
Contact   
 
Armstrong Medical Ltd. 
Wa@stown Business Park 
Newbridge Road 
Coleraine  
BT52 1BS 
N.  Ireland 
 
 
Telephone: +44 (0) 28 7035 6029 
 
Email:               [email protected] 
 
Web:                 www.armstrongmedical.net 
 
 

 
Advena Ltd 
Tower Business Centre, 2nd Flr, 
Tower Street, Swatar, BKR 4013 

 

 

 

        Malta 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Most recent version of this manual is available on the Armstrong Medical Ltd website. 
 
This manual documents soGware version v1.01 

PMA_ZPFD140iUMEN_v1

 

 

Summary of Contents for 10190001

Page 1: ...User Manual English...

Page 2: ...y the manufacturer to undertake such work The user of the device shall have sole responsibility for any malfunc on or damage which is due to improper use poor maintenance improper service improper rep...

Page 3: ...AquaVENT FD140i User Manual English Issue 01 3 Contents...

Page 4: ...nec ng to gas supply 3 5 Gas supply failure 3 6 Single gas opera on 3 7 Breathing circuit set up 3 8 Using a heater humidi er 4 Using the AquaVENT FD140i 4 1 Powering on the device 4 2 Powering o the...

Page 5: ...s override 5 6 Alarm types 6 Maintenance and repair 6 1 Repair 6 2 Servicing schedule 7 Cleaning and decontamina on 7 1 Cleaning 7 2 Decontamina on 8 Technical speci ca ons 8 1 Technical speci ca ons...

Page 6: ...AquaVENT FD140i User Manual English Issue 01 6 1 Introduc on...

Page 7: ...ood The AquaVENT FD140i must only be used by quali ed healthcare professionals trained in the opera on of the device Armstrong Medical Ltd reserves all rights to further develop and alter AquaVENT FD1...

Page 8: ...for High Flow Oxygen Therapy HFOT delivered via nasal cannula face mask and tracheostomy tube With the excep on of CPAP Helmet therapy we advise that all breathing circuits in use must be set up to d...

Page 9: ...from secre ons Pulmonary inters al emphysema Pneumomedias num Pneumothorax Decreased cardiac output due to decreased venous return with excessive CPAP levels Inadequate ven la on Gastric distension or...

Page 10: ...CPAP is predisposed to CO2 rebreathing and could increase the pa ents ven lator asynchrony In addi on to the adverse e ects stated above Paediatric CPAP may result in conges on dry mouth lip bleeds o...

Page 11: ...must not be used in close proximity to nuclear magne c resonance equipment Devices in the vicinity of AquaVENT FD140i which generate electromagne c elds can a ect the safe opera on of the device and...

Page 12: ...anty condi ons correspond with Armstrong Medical s terms and condi ons at the me of purchase Warranty will be valid for 2 years from the date of delivery to the hospital and will cover defects in part...

Page 13: ...AquaVENT FD140i User Manual English Issue 01 13 2 AquaVENT FD140i Overview...

Page 14: ...tomized seCngs according to the therapy characteris cs The device is also equipped with a nebuliser outlet port which supplies a ow of medical air for driving a jet nebuliser containing liquid drug su...

Page 15: ...AquaVENT FD140i User Manual English Issue 01 15 AquaVENT FD140i Overview 10 11 9 12 14 17 15 13 16...

Page 16: ...er connec on indicator Ba ery status indicator Power on o bu on Serial plate Refer to instruc on manual booklet Mains power inlet USB connector Handle Fan outlet Fixa on claw Medical Oxygen inlet Medi...

Page 17: ...efault oxygen 30 30 30 30 30 60 Pressure measured Yes Yes Yes Yes No No Breath frequency meas ured Yes Yes Yes No No No Nebuliser ON Yes Yes No No Yes Yes Pressure alarm range cmH2O 2 25 and OFF 2 25...

Page 18: ...illuminated Running on internal ba ery when indicator light is illuminated solid green Power on or o device Alarm audio is muted when indicator light is ashing orange Pa ent pressure measurement conn...

Page 19: ...charging Device unplugged from mains power General SeCngs Menu Return to previous menu Warning alarm ac vated Alarm silenced Adjust ow seCngs Adjust alarm seCngs Select approximate value Increase valu...

Page 20: ...AquaVENT FD140i User Manual English Issue 01 20 Device setup 3 Device Setup...

Page 21: ...anufacturer for service or repair This is to prevent damage to 3 2 Moun ng AquaVENT FD140i has been designed to be mounted on a pole stand such as would commonly be used with a pa ent on a drip The de...

Page 22: ...umidi er it should be mounted approximately 600mm above the humidi ca on chamber When moving AquaVENT FD140i whilst it is mounted on a pole stand the device should be lowered down the pole in order to...

Page 23: ...e AquaVENT FD140i should be used with a mains supply voltage ranging from 90 240VAC at 50 60Hz only WARNING Before connec ng the device to mains power the device must be checked for visible damage Do...

Page 24: ...AquaVENT FD140i starts using the internal ba ery as its power source you are no ed by the ba ery status indicator on the front panel The ba ery status indicator provides the following indica ons Flash...

Page 25: ...se refer to Chapter 5 Alarms and No ca ons for details of the associated alarms Please also note extensive contraindica ons 3 6 Single gas opera on AquaVENT FD140i can be operated with a single gas su...

Page 26: ...spiratory limbs are not kinked or otherwise obstructed Failure to do so may introduce pressure build up within the device 3 8 Using a heater humidi er Ac ve humidi ca on should be used in all breathin...

Page 27: ...e PAP HFOT and POINT Breathing circuit arrangements for each mode are outlined in this chapter CPAP Con nuous Posi ve Airway Pressure CPAP therapy maintains a target posi ve airway pressure during ins...

Page 28: ...ue 01 28 Device setup CPAP Paed The CPAP Paediatric mode is in principle the same as adult CPAP but delivers gas ow within a suitable range for paediatric pa ents Assemble the CPAP breathing circuit a...

Page 29: ...RNING To prevent CO2 rebreathing adjust the required ow according to the instruc ons provided by the manufacturer of the CPAP helmet When using CPAP helmets with hypercapnic pa ents close monitoring i...

Page 30: ...respiratory support where high ow rates 20 70 L min of Oxygen Air mixture is delivered to the pa ent Assemble the HFOT breathing circuit and connect to AquaVENT FD140i as shown WARNING To avoid accid...

Page 31: ...ers humidi ed high ow nasal therapy to support the pa ent during the peri opera ve period Assemble the POINT breathing circuit and connect to AquaVENT FD140i as shown WARNING To avoid accidental press...

Page 32: ...pa ents from birth weight up to 10kg The therapy prevents airway closure and maintains func onal residual capacity Assemble the Bubble PAP breathing circuit and connect to To avoid accidental pressur...

Page 33: ...AquaVENT FD140i User Manual English Issue 01 33 4 Using the AquaVENT FD140i...

Page 34: ...screen The AquaVENT FD140i can be powered o by pressing and holding the On O bu on for approx 5 seconds NOTE AquaVENT FD140i can be powered o whilst in therapy mode Press the ON OFF icon and a Shutdow...

Page 35: ...a ery level indicator at 0 the device powers o all electric and pneuma c func ons and displays the following message for 120 seconds During this 2 minute period you can reconnect AquaVENT FD140i to ma...

Page 36: ...ues faults found during the system test the device will present the OXYGEN Sensor Calibra on menu The system tests check the integrity of the opera ng soGware and of the electronic and pneuma c module...

Page 37: ...plug during the O2 calibra on AGer star ng the calibra on the touch screen is disabled un l the calibra on procedure is complete The calibra on procedure takes 75 seconds An on screen count down mer i...

Page 38: ...le These modes are CPAP CPAP Paed CPAP Helmet BUBBLE PAP HFOT and POINT Select the desired mode by touching the relevant Therapy Mode Bu on and press OK to proceed In the example shown below CPAP has...

Page 39: ...d as an example Flow rates are selected using the pointer icon 1 and the 2 bu ons for ne adjustment The maximum and minimum values for the selected therapy are indicated with the triangular markers 3...

Page 40: ...iod If there is an apnoea event within the last 12 seconds of the se ling period then the alarm will be reported and ac vated at the 60 second mark in such cases there is no subsequent delay period Ac...

Page 41: ...ce restart alarm and touch tone volumes reverts to default value of 50 Language selec on Select language with and bu ons Available languages English French German Spanish Dutch and Italian Touch tone...

Page 42: ...itor ac ve alarms CPAP mode is used as an example Item Descrip on 1 Pa ent respiratory rate and CPAP pressure display window 2 Pa ent respiratory air trace 3 Pa ent ow seCngs bu on 4 Nebuliser func on...

Page 43: ...s press the pa ent ow seCngs bu on which will open the ow seCngs menu Make the required change and press OK to return to the therapy menu page Nebuliser gas ON OFF bu on To switch on the nebuliser air...

Page 44: ...bar menu CPAP mode is used as an example Start therapy bu on WARNING Before star ng therapy ensure that all therapy seCngs are appropriate for the pa ent Do not connect the pa ent to the breathing cir...

Page 45: ...op therapy press the Stop therapy bu on located on the side bar menu CPAP mode is used as an example Stop therapy bu on When the Stop therapy bu on is pressed the user must con rm that it is their int...

Page 46: ...fer to sec on 11 2 Appendix 2 Accessories The nebuliser delivers 6L min 2L min of compressed air The nebuliser func on can be pre selected during therapy set up or alterna vely ac vated aGer therapy h...

Page 47: ...dical air to the breathing circuit Consequently to provide the pa ent with the selected O2 concentra on the gas mixer seCngs adjust automa cally when the nebuliser func on is switched on The nebuliser...

Page 48: ...When the screen has not been touched for 30 seconds the screen will lock and the unlock bu on will appear on the side bar menu Side Bar Menu Unlock Bu on To unlock the screen press the Unlock Bu on t...

Page 49: ...AquaVENT FD140i User Manual English Issue 01 49 5 Alarms and No ca ons...

Page 50: ...nd associated indicator number for 2 seconds Low Priority Alarm Indicator Bu on Medium Priority Alarm Indicator Bu on Alarm Indicator Bu on Acknowledge Alarm 5 2 Alarm acknowledgement If the alarm con...

Page 51: ...ain 3 4 Alarm Indicator Bu on with mute ac vated Front panel Alarm Mute Bu on and Alarm Mute 5 6 5 3 Mu ng alarm audio In therapy alarm Alarm audio is muted by pressing the Alarm Audio Mute Bu on on t...

Page 52: ...omes available This is indicated by a yellow border around the ow seCngs bu on Alarms and No ca ons Yellow border Low pressure alarm If the ow seCngs bu on is pressed when the yellow border is present...

Page 53: ...ll ash Alarms and No ca ons Yellow border ashing NOTE If the increased ow removes the P Min alarm condi on the Alarm Acknowledge P Min Alarm no ca on appears at the indicator bu on To return to the or...

Page 54: ...calibrate device If recalibra on does not clear the alarm return the device to an approved service centre Calibra on O2 Flow d 5 Medium Oxygen 80 120 L min calibra on cannot be retrieved Recalibrate d...

Page 55: ...supply connected Connect AIR supply When air supply is disconnected FiO2 is automa cally set to 100 Supply O2 17 Medium No O2 supply connected Connect O2 supply When oxygen supply is disconnected FiO2...

Page 56: ...9 Medium Pa ent pressure greater than 25cmH2O for CPAP CPAP Paed and Helmet Pa ent pressure greater than 15cmH2O for BUBBLE PAP Evaluate High Pressure Alarm seCngs and reduce pressure seCng if appropr...

Page 57: ...tre Calibra on Air Flow e 39 Medium Air 120 140 L min calibra on cannot be retrieved Recalibrate device If recalibra on does not clear the alarm return the device to an approved service centre Sensor...

Page 58: ...AquaVENT FD140i User Manual English Issue 01 58 6 Maintenance and Repair...

Page 59: ...ear Armstrong Medical Replace Cone Filters in the NIST Cngs N2185 06 Every year Armstrong Medical Replace the Free Breathing Valve AEC1222 Every year Armstrong Medical Replace the O ring at the 1 8 sc...

Page 60: ...AquaVENT FD140i User Manual English Issue 01 60 7 Cleaning and Decontamina on...

Page 61: ...are are suitable detergents A list of speci c approved detergents is available upon request AGer cleaning and before powering the device on check that the external surfaces are completely dry 7 2 Deco...

Page 62: ...AquaVENT FD140i User Manual English Issue 01 62 8 Technical Speci ca ons...

Page 63: ...ng time 60 minutes with fully charged battery Environmental Condi ons Opera ng temperature 15 C 40 C Opera ng humidity 90 Opera ng atmospheric pressure 50 kPa 110kPa Storage and transport temperature...

Page 64: ...sensors Sensor Type Op on 1 Paramagne c Oxygen Sensor Accuracy 2 Service Annual Service life 10 years Sensor Type Op on 2 Oxygen fuel cell Accuracy 2 Service life Depends on gas ow and usage Safety Va...

Page 65: ...20 60 5 20 30 Default oxygen 30 30 30 30 30 60 Pressure measured Yes Yes Yes Yes No No Breath frequency meas ured Yes Yes Yes No No No Nebuliser ON Yes Yes No No Yes Yes Pressure alarm range cmH2O 2...

Page 66: ...FF 20s 5cmH2O OFF 2cmH2O OFF Max Value 100 9 59 59 hr min sec 100 60s OFF 25cmH2O OFF 22cmH2O 8 3 Parameter seCngs Increment Min value Max value Accuracy Gas Flow 1L min 0L min 140L min 10 Respiratory...

Page 67: ...0i is intended for use in the electromagne c environment detailed at 8 1 Technical Speci ca ons It is the responsibility of the user to ensure that the device is operated in such an environment BS EN...

Page 68: ...with display altering re selec on of func ons are available within 0 01 sec therapy mode is uninterrupted Surge IEC 61000 4 5 1 kV di eren al mode 2 kV common mode 1 kV di eren al mode 2 kV common mod...

Page 69: ...y range b In the vicinity of equipment marked with the following symbol interference may occur References and footnotes are explained on the following page Note 1 At 80 MHz and 800 MHz the higher freq...

Page 70: ...um output power of the communica ons equipment Rated maximum output power of the transmi er W Separa on distance according to frequency of transmi er m 150 kHz to 80 MHz d 0 35 P 0 01 0 04 0 1 0 11 1...

Page 71: ...AquaVENT FD140i User Manual English Issue 01 71 9 European Community Declara on of Conformity...

Page 72: ...VENT FD140i is a clinical respiratory therapy device that delivers an air and oxygen mixture at 21 100 The device assists spontaneous and natural patient respirations by providing continuous positive...

Page 73: ...AquaVENT FD140i User Manual English Issue 01 73 10 Disposal...

Page 74: ...s include The Waste Electrical and Electronic Equipment WEEE Regula ons 2013 The Waste Ba eries and Accumulators Regula ons 2009 All countries within the European Union must comply with EU Direc ve 20...

Page 75: ...AquaVENT FD140i User Manual English Issue 01 75 11 Appendices...

Page 76: ...AquaVENT FD140i User Manual English Issue 01 76 11 1 Appendix 1 Therapy Set up Flow Diagram For a detailed explana on of therapy set up and opera on refer to chapter 4 Using AquaVENT FD140i Appendices...

Page 77: ...athing circuits heater humidi er humidi ca on chambers PEEP valves lters face masks and nasal interfaces An extended list of compa ble accessories can be accessed at www armstrongmedical net or by con...

Page 78: ...FOT High Flow Oxygen Therapy POINT Periopera ve Insu atory Nasal Therapy PEEP Posi ve end expiratory pressure FiO2 Frac on of inspired oxygen SNP Sinonasal polyposis F Max Maximum respiratory rate CO2...

Page 79: ...AquaVENT FD140i User Manual English Issue 01 79 11 4 Appendix 4 User Manual Revision History Release Date Issue No Summary of change s 17 04 2020 01 Original Appendices...

Page 80: ...oleraine BT52 1BS N Ireland Telephone 44 0 28 7035 6029 Email info armstrongmedical net Web www armstrongmedical net Advena Ltd Tower Business Centre 2nd Flr Tower Street Swatar BKR 4013 Malta Most re...

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