AquaVENT FD140i User Manual Issue 01 April 2020

Guidance

Guidance WARNING Correct operaon of this device is described in this User Manual and on other documents or materials enclosed or provided by the manufacturer. It should only be assembled, operated, maintained and repaired according to such informaon. The device must be checked prior to each clinical use to verify that it is operable and meets the user’s requirements for delivery of therapy to paents. The device must be inspected at regular intervals by a competent person. The device must not be used if found to be defecve. A defecve device must be removed to a locaon where it is not at risk from inadvertent clinical use. If a repair is necessary, the manufacturer and distributor recommend contacng the manufacturer or their authorised representave to arrange such works. Maintenance and repairs must only be carried out by the manufacturer or by competent persons authorised by the manufacturer to undertake such work. The user of the device shall have sole responsibility for any malfuncon or damage which is due to improper use, poor maintenance, improper service, improper repairs or modificaons carried out by unauthorised persons. The device is provided with a serial number located on an idenficaon plate at the rear of the device. The idenficaon plate specifies the manufacturer and their contact details, the device product code and the device serial number. Aer set-up of a breathing system and prior to connec'on of the breathing system to the pa'ent, verify that: a. Gas flow is running in the breathing system. b. Separate inspiratory and expiratory gas paths are present and func'oning. Serial number format Example 1: 10190001 10190001 10190001 Example 2: 20200099 20200099 20200099

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10190001 First “10” represents device with paramagnec oxygen sensor opon “19” represents 2019 (year of manufacture) Last “1” represents the 1st device manufactured 20200099 First “20” represents device with oxygen fuel cell opon “20” represents 2020 (year of manufacture) Represents the 99th device manufactured

AquaVENT® FD140i, User Manual, English Issue 01

Contents

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AquaVENT® FD140i, User Manual, English Issue 01

Contents

Contents 1. Introducon Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 12 Page 12 Page 12

1.1 About this manual 1.2 Indicaons for use 1.3 Contraindicaons 1.4 Adverse effects 1.5 General safety precauons 1.6 Limitaon of liability 1.7 Copyright 1.8 Service life 1.9 Warranty

2. AquaVENT FD140i overview Page 14 Page 14-16 Page 17 Page 18-19

2.1 Principle of operaon 2.2 Device layout 2.3 Therapy modes technical specificaon 2.4 Device interface Front panel icons and indicator lights Touch screen icons 3. Device setup

Page 21 Page 21-22 Page 23-24

Page 25 Page 25 Page 25 Page 26 Page 26-32

3.1 Unpacking 3.2 Mounng 3.3 Power supply Connecng to mains supply Ba@ery powered operaon 3.4 Connecng to gas supply 3.5 Gas supply failure 3.6 Single gas operaon 3.7 Breathing circuit set-up 3.8 Using a heater humidifier 4. Using the AquaVENT FD140i

Page 34 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40

Page 41 Page 42-43 Page 44

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4.1 Powering on the device 4.2 Powering off the device 4.3 Automac switch-OFF due to discharged ba@ery 4.4 Self check 4.5 Oxygen sensor calibraon 4.6 Therapy selecon menu 4.7 Flow seCngs menu 4.8 Alarm seCngs menu Paent pressure alarm seCngs Apnoea alarm seCngs F Max alarm seCngs 4.9 General seCngs menu 4.10 Therapy menu 4.11 Starng therapy

AquaVENT® FD140i, User Manual, English Issue 01

Contents

Page 45 Page 46-47 Page 48

4.12 Stopping therapy 4.13 Use with a nebulising system 4.14 Touch screen unlock 5. Alarms and noficaons

Page 50 Page 50 Page 51 Page 51 Page 52-53 Page 54-57

5.1 Alarm indicator bu@on 5.2 Alarm acknowledgement 5.3 Mung alarm audio 5.4 Alarm volume adjustment 5.5 CPAP low pressure alarm flow seCngs override 5.6 Alarm types 6. Maintenance and repair

Page 59 Page 59

6.1 Repair 6.2 Servicing schedule 7. Cleaning and decontaminaon

Page 61 Page 61

7.1 Cleaning 7.2 Decontaminaon 8. Technical specificaons

Page 63-64 Page 65 Page 66 Page 66 Page 66 Page 67 Page 67-70

8.1 Technical specificaons 8.2 Therapy modes technical specificaon 8.3 Parameter seCngs 8.4 Measurement funcons 8.5 Paramagnec oxygen sensor 8.6 External communicaon 8.7 Electromagnec environment 9. European Community Declaraon of Conformity

Page 72

9.1 EC Declaraon of Conformity 10. Disposal

Page 74

10.1 Disposal 11. Appendices

Page 76 Page 77 Page 78 Page 79

11.1 Appendix 1 - Therapy Set-up flow diagram 11.2 Appendix 2 - Accessories 11.3 Appendix 3 - Definions 11.4 Appendix 4 - User manual revision history Back Cover 1. 2.

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Technical support and customer service details EU Authorised Representave AquaVENT® FD140i, User Manual, English Issue 01

1 Introducon

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AquaVENT® FD140i, User Manual, English Issue 01

Introducon

1.1 About this manual This User Manual describes the intended use of AquaVENT® FD140i with soGware version v1.01. AquaVENT® FD140i and accompanying User and Technical Manuals are available in English, French, German, Italian, Dutch and Spanish. To ensure safe operaon of AquaVENT® FD140i, the device must only be used as described in this manual. Before using AquaVENT® FD140i, the full contents of this manual must be read and understood. The AquaVENT® FD140i must only be used by qualified healthcare professionals trained in the operaon of the device. Armstrong Medical Ltd. reserves all rights to further develop and alter AquaVENT® FD140i in the interest of technical progress and paent safety.

AquaVENT® FD140i complies with Medical Devices Direcve, provided it is operated according to the User Manual. "1639" is the idenficaon number of the Nofied Body.

WARNING • •

Read the enre manual before using the AquaVENT FD140i AquaVENT® FD140i is for use only by trained healthcare professionals and only within a healthcare facility.

•

Use AquaVENT® FD140i only for the intended use as described in this manual.

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AquaVENT® FD140i, User Manual, English Issue 01

Introducon

1.2 Indicaons for use AquaVENT® FD140i is a gas flow driver, delivering an air and oxygen mixture at 21-100%. It is a clinical respiratory therapy device which assists respiraon using connuous posive airway pressure (CPAP) and high flow oxygen therapy (HFOT) in paents in a hospital seCng. Such paents must be medicallyindicated by a healthcare professional for the respecve therapy once assessed as conscious and breathing spontaneously and not at significant risk of condions of exacerbaon caused by the therapy or at risk of a prolonged apnoeic event. AquaVENT® FD140i is not a life-support device. Always verify that an expiratory gas path is present and func'oning BEFORE commencing therapy on a pa'ent. CPAP therapy can be applied in different modes and delivered using a suitable breathing circuit connected to a face mask, tracheal tube or tracheostomy tube or by helmet. In the case of BUBBLE-PAP mode the circuit is connected to a nasal cannula. Furthermore, AquaVENT® FD140i can be used as a gas flow driver for High Flow Oxygen Therapy (HFOT) delivered via nasal cannula, face mask and tracheostomy tube. With the excepon of CPAP Helmet therapy, we advise that all breathing circuits in use must be set-up to deliver the gas as heated and humidified. AquaVENT® FD140i is intended for use with adults, children and new-born babies should they be medically-indicated for the therapy and should the therapy be listed as suitable for that paent group. This device is not recommended for use in a domesc environment. AquaVENT® FD140i is equipped either with a paramagnec oxygen sensor or a replaceable oxygen fuel cell. These sensors connuously measure O2 delivery to the breathing circuit. This value is displayed on the screen. To ensure that hypoxemic and hyperoxic gas mixtures are not inadvertently delivered to paents, we advise that O2 delivery is monitored at all mes during therapy and that external peripheral oximetry is considered as an adjunct. The paramagnec oxygen sensor is maintenance-free. It should be calibrated once annually or when the device has been moved or transported – such that vibraon of the device as occurred. The replaceable oxygen fuel cell has a finite usable life-me based on volume of gas flow delivered to the breathing circuit.

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AquaVENT® FD140i, User Manual, English Issue 01

Introducon

1.3 Contraindicaons This secon details some, but not all condions, which make the following therapies inadvisable: CPAP • • • • • • • • •

Respiratory arrest or unstable cardiorespiratory status Reduced consciousness Apnoea Inability to protect airway Extremely anxious paent Facial trauma / burns Facial, oesophageal, or gastric surgery Low blood pressure secondary to blood loss Stomach surgery or bowel bleeding

Helmet CPAP • Claustrophobic or tetraplegic paents • Tidal volume monitoring requirement Paediatric CPAP • Obstrucon of sinonasal polyposis (SNP) from secreons • Pulmonary intersal emphysema • Pneumomediasnum • Pneumothorax • Decreased cardiac output (due to decreased venous return) with excessive CPAP levels • Inadequate venlaon • Gastric distension or feed intolerance • Increased work of breathing due to increased airway resistance (related to diameter of SNP) BUBBLE-PAP • Obstrucon of SNP • Large emphysematous bullae • Acute asthma or severe bronchospasm • Lung abscess • Severe fibroc changes • Increased work of breathing e.g. COPD or acute asthma • Intracranial pressure >20mmHg • Dialysis High Flow Oxygen Therapy (HFOT) • Pneumothorax • Acute bullous lung disease • Low blood pressure • Cerebrospinal fluid leak • Cranial surgery / trauma POINT • Any contraindicaon to CPAP • Reduced levels of consciousness • Extremely anxious paent paents • Epistaxis 9

AquaVENT® FD140i, User Manual, English Issue 01

Introducon

1.4 Adverse effects The most common adverse effects during CPAP therapies are face mask or helmet or gas flow/pressure related. Some paents may experience claustrophobia due to the mask, nasal congeson, rhinis or a runny nose. To minimise these adverse effects ensure that; • • •

Correct face mask size is used – if the mask is too small / large it may result in discomfort and air leaks. Mask is not overghtened – may result in mask discomfort and damage to the skin. Heated humidified air is used via a heater humidifier.

Helmet CPAP is predisposed to CO2 rebreathing and could increase the paents' venlator asynchrony. In addion to the adverse effects stated above, Paediatric CPAP may result in congeson, dry mouth, lip bleeds or nosebleeds. Masks may cause irritaon or redness of the skin. Using the correct mask size and padding can minimise pressure sores from ght contact with skin. BUBBLE-PAP may also cause nosebleeds; humidificaon can oGen help with these symptoms. Again, heated humidified air can help to prevent nosebleeds from occurring. Adverse effects when using HFOT can include skin irritaon, skin breakdown and nasal dryness. It is important to be aware that HFOT can lead to suppression of breathing, oxygen toxicity and is a fire hazard at high oxygen concentraons.

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AquaVENT® FD140i, User Manual, English Issue 01

Introducon

1.5 General safety precauons To ensure safe operaon of AquaVENT® FD140i , all precauons contained within this chapter must be adhered to, in addion to all other warnings, cauons and notes dispersed throughout the User Manual. WARNING

Alerts you to a situaon which may cause paent or user injury

CAUTION

Explains measures for the effecve use of the device

NOTE

Refers to important informaon which should be taken into consideraon by the user.

WARNING

•

AquaVENT® FD140i is for use only by trained healthcare professionals and only within a healthcare facility.

•

Paents receiving respiratory therapy should be closely monitored by a qualified healthcare professional, trained in the use of the device.

•

AquaVENT® FD140i is not intended to be operated by paents.

•

Electromagnec interference may occur if the device is not used in accordance with this User Manual. AquaVENT® FD140i has been tested and complies with BS EN 60601-1-2:2015. Informaon on electromagnec compability can be found under Secon 8.7.

•

AquaVENT® FD140i must not be used in close proximity to nuclear magnec resonance equipment. Devices in the vicinity of AquaVENT® FD140i, which generate electromagnec fields, can affect the safe operaon of the device and endanger the paent.

•

Mobile telephones and any portable RF communicaon equipment (including peripherals such as antenna cables and external antennas) should not be used within 30cm (12 inches) of any part of AquaVENT® FD140i. This can result in improper operaon of the device.

•

AquaVENT® FD140i must not be used in the presence of flammable substances or in potenally explosive atmospheres.

•

AquaVENT® FD140i is designed for use only within the limits of the operang environment described in Secon 8.1 Technical Specificaon. If the temperature of AquaVENT® FD140i is higher or lower than its specified operang range then wait 1-hour to allow the device to adjust to operang temperature prior to use.

•

AquaVENT® FD140i should not be posioned such that the cooling fan outlet is obstructed.

•

AquaVENT® FD140i must always be disconnected from mains power before any cleaning, maintenance or repair.

•

Use of this equipment, adjacent to, or stacked with other equipment should be avoided as it could result in improper operaon. If such use is necessary, this equipment should be observed to verify

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AquaVENT® FD140i, User Manual, English Issue 01

Introducon

CAUTION •

Use of other electrical equipment with AquaVENT® FD140i or in its vicinity should be avoided, as it can result in improper operaon. If such use is necessary, AquaVENT® FD140i and other equipment must be verified prior to connecng the paent to AquaVENT® FD140i.

NOTE •

The emissions characteriscs of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residenal environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protecon from radio-frequency communicaon services. The user might need to take migaon measures, such as relocang or reorienng the equipment.

1.6 Limitaon of liability The manufacturer shall not accept any liability for damages due to; • • • • •

Failure to adhere to this User Manual Use of device by untrained personnel Improper use / maintenance Unapproved modificaons to the device Use of unapproved spare parts

1.7 Copyright This User Manual may only be copied, photocopied, reproduced or translated in to other languages for personal use. Reproducon for disclosure to third pares is not permi@ed without prior wri@en consent from Armstrong Medical Ltd.

1.8 Service life When the device is used correctly and in-line with this User Manual, the expected service life of AquaVENT® FD140i is 10 years from the date of delivery to the hospital.

1.9 Warranty The warranty condions correspond with Armstrong Medical’s terms and condions 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 parts and labour that arise when the repaired device is used correctly and in-line with this User Manual.

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AquaVENT® FD140i, User Manual, English Issue 01

2 AquaVENT FD140i Overview

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AquaVENT® FD140i, User Manual, English Issue 01

AquaVENT® FD140i Overview

2.1 Principle of operaon AquaVENT® FD140i is an electronic gas flow driver which delivers an adjustable blend of medical air and oxygen to the paent via an a@ached breathing circuit. The device has six preset respiratory therapies; •

CPAP

•

CPAP Paed

•

CPAP Helmet

•

BUBBLE-PAP

•

HFOT

•

POINT®

For a descripon of each therapy please refer to Secon 3.7 “Breathing circuit setup”. Each mode has customized seCngs according to the therapy characteriscs. The device is also equipped with a nebuliser outlet port which supplies a flow of medical air for driving a jet nebuliser containing liquid drug suspension. AquaVENT® FD140i incorporates a user friendly touch screen interface facilitang intuive operaon. Its sophiscated alarm system and advanced oxygen sensing technology collaborate to safeguard paent care. Addionally, the device is equipped with an internal Li-Ion ba@ery for uninterrupted operaon in the event of a temporary disconnecon from the mains supply.

2.2 Device layout

4

5

6 7 8 1 14

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3 AquaVENT® FD140i, User Manual, English Issue 01

AquaVENT® FD140i Overview

9 10

11

12

13

14

15 16 17

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AquaVENT® FD140i, User Manual, English Issue 01

AquaVENT® FD140i Overview

2.2 Device layout

18

198

16

Item

Descrip'on

1

Pressure measurement port

2

Respiratory gas outlet

3

Nebuliser port

4

Touch screen

5

Alarm mute bu@on

6

Mains power connecon indicator

7

Ba@ery status indicator

8

Power on/off bu@on

9

Refer to instrucon manual/booklet

10

Mains power inlet

11

USB connector

12

Handle

13

Fan outlet

14

Fixaon claw

15

Serial plate

16

Medical Oxygen inlet

17

Medical Air inlet

18

Over pressure relief valve

19

An-asphyxiaon entrainment valve

AquaVENT® FD140i, User Manual, English Issue 01

AquaVENT® FD140i Overview

2.3 Therapy modes technical specificaon CPAP

CPAP (Paed)

Helmet CPAP

BUBBLEPAP

HFOT

POINT

Interface screen colour

Purple

Grey

Yellow

Green

Light blue

Dark blue

Flow range (L/min)

20-140

10-70

40-140

2-20

2-70

10-80

Default flow (L/min)

60

20

60

5

20

30

Oxygen range (%)

21-100

21-100

21-100

21-80

21-100

21-100

Default oxygen (%)

30

30

30

30

30

60

Pressure measured

Yes

Yes

Yes

Yes

No

No

Breath frequency measured

Yes

Yes

Yes

No

No

No

Nebuliser ON

Yes

Yes

No

No

Yes

Yes

Pressure alarm range (cmH2O)

2-25 and OFF

2-25 and OFF

2-25 and OFF

2-15 and OFF

-

-

Default pressure alarm 'Low'

2

2

2

2

-

-

Default pressure alarm 'High'

12

12

12

10

-

-

Apnoea alarm range (sec)

20-60

20-60

20-60

-

-

-

Default apnoea alarm period (sec)

20

20

20

-

-

-

Mode

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AquaVENT® FD140i, User Manual, English Issue 01

2.4 Device interface Front panel icons and indicator lights Descripon 1. Power source indicators AC mains power supply is connected when indicator light is illuminated Running on internal ba@ery when indicator light is illuminated solid green Internal ba@ery is charging when indicator light is flashing green Internal ba@ery level is ≤ 20% charged when indicator light is illuminated solid red

2. Power on or off device Power on or off device

3. Alarm mute Alarm audio is muted when indicator light is flashing orange

Alarm audio is sounding when indicator light is solid orange

4. Gas ports Respiratory gas outlet Paent pressure measurement connecon Nebuliser port

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AquaVENT® FD140i, User Manual, English Issue 01

Touch screen icons

Descripon 1. Screen lock Screen Locked

2. Power supply and ba@ery charge indicaon Device unplugged from mains power ...%

Internal ba@ery level-percentage charged (alternates between ba@ery icon and unplugged icon) Ba@ery level at 20% or below Ba@ery charging

Charging

3.

General seCngs General SeCngs Menu

Screen brightness

Return to previous menu

Language selecon

Touch tone volume Alarm volume

4. Therapy seCngs

5.

Adjust flow seCngs

Therapy mer

Adjust alarm seCngs

Start therapy

Select approximate value

Stop therapy

Increase value incrementally

Nebuliser gas supply off

Decrease value incrementally

Nebuliser gas supply on

Minimum permissible value

Respiratory gas values

Maximum permissible value

In therapy icon

Alarms Warning - alarm acvated Alarm silenced

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AquaVENT® FD140i, User Manual, English Issue 01

Device setup

3 Device Setup

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AquaVENT® FD140i, User Manual, English Issue 01