User’s Reference Manual
111 Pages
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GE Healthcare
Vayu User’s Reference Manual Software Revision 1.x
Manufacturer Wipro GE Healthcare Pvt Ltd. No. 4, Kadugodi Industrial Area Bangalore - 560067 Karnataka, India T 91 80 2845 2923/25/26 F 91 80 28452924 ALL RIGHTS RESERVED © Copyright 2011, GE Healthcare, Bangalore, Karnataka, India THIS DOCUMENTATION AND THE PRODUCT DESIGN DESCRIBED HEREIN ARE THE PROPERTY OF GE HEALTHCARE AND MAY NOT BE USED IN ANY MANNER DETRIMENTAL TO ITS INTERESTS; ALL RIGHTS ARE RESERVED. THIS DOCUMENTATION CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF GE HEALTHCARE WHICH IS PROTECTED BY COPYRIGHT, TRADE SECRET, AND TRADEMARK LAW AND MAY NOT BE PROVIDED OR OTHERWISE MADE AVAILABLE WITHOUT PRIOR WRITTEN AUTHORIZATION
Contents 1.
Introduction ... 1
1.1.
Warning! ... 1
1.2.
CAUTION! ... 1
1.3.
What is Vayu Ventilator?... 1
1.4.
Intended Use ... 2
1.5.
Contraindications ... 2
1.6.
About this Manual ... 2
1.6.1.
Audience ... 2
1.6.2.
Icons ... 2
2.
Safety information ... 4
2.1.
General user Precautions ... 4
2.2.
Electrical Safety ... 5
2.3.
Environmental conditions ... 5
2.4.
Patient Circuit Connections ... 6
2.5.
Usage of filter ... 8
2.6.
Humidification ... 9
2.7.
Cleaning and Maintenance ... 9
2.8.
Usage of Oxygen ... 10
3.
Product description ... 13
3.1.
Main components ... 13
3.2.
Optional Accessories... 13
3.3.
Vayu ventilator’s Front panel ... 13
3.4.
Vayu Ventilator’s Side Panels ... 14
3.5.
Vayu Ventilator Back Panel ... 15
3.6.
Equipment Designation and safety label ... 16
4.
Setting up Vayu Ventilator ... 19
4.1.
Installing Vayu Ventilator ... 19
4.2.
Placing Vayu Ventilator ... 19
4.2.1.
Placing Vayu Ventilator ...20 Vayu User’s Reference Manual 2052652-001-001 revC
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4.2.2.
Mounting Vayu Ventilator on Cart (Optional)...20
4.3.
Mounting Patient Circuit Arm to Cart (Optional)... 20
4.4.
Connecting Vayu Ventilator to AC Mains supply ... 21
4.5.
Connecting Patient Circuit ... 21
4.5.1.
Single limb Circuit with Leakage Port ...21
4.5.2.
Dual Limb Circuit ...22
4.6.
Connecting Oxygen Sensor* ... 22
4.7.
Setup Vayu Ventilator before use ... 23
4.7.1.
Inspection of Device ...23
4.7.2.
Inspection of Cables ...23
4.7.3.
Inspection of Placement ...23
4.7.4.
Checks before using Vayu ...23
4.7.5.
Preparing Vayu for patient use ...24
5.
How to use Vayu Ventilator ... 25
5.1.
Switch Ventilator ON, Start and Stop ventilation ... 25
5.1.1.
Turn on the ventilator ...25
5.1.2.
Stopping Ventilation and Switching Off ...26
5.2.
Using Menus ... 26
5.2.1.
Navigating with the Buttons ...26
5.2.2.
Overview of Menu ...28
5.2.3.
The Monitor Section ...29
5.2.4.
The Mode Section ...32
5.2.5.
The Setup Screen ...33
5.2.6.
The Alarm Section ...33
5.2.7.
The Other Section...34
5.3.
Calibrating Exhalation Sensor ... 35
5.4.
Functions and Parameters in Vayu Ventilator ... 36
5.5.
Modes in Vayu Ventilator ... 50
5.5.1.
PCV and PCV(A) - (Assisted) Pressure Controlled Ventilation ...50
5.5.2.
VCV and VCV(A) - (Assisted) Volume Controlled Ventilation ...50
5.5.3.
SIMV-PC ...50
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Vayu User’s Reference Manual 2052652-001-001 revC
5.5.4.
SIMV-VC ...50
5.5.5.
CPAP/PS (Continuous Positive Airway Pressure - Pressure Support) 50
5.5.6.
Standby and Operating Mode ...51
5.6.
Battery Operation ... 51
5.6.1.
Power source priority ...51
5.6.2.
Internal Battery ...52
5.6.3.
Charging the Internal Battery ...52
5.6.4.
Battery Operation Time ...52
6.
Alarms & Troubleshooting ... 53
6.1.
Alarm Function ... 53
6.1.1.
Alarm Indication ...53
6.1.2.
Audible Signal Pause and Reactivation ...53
6.1.3.
Alarm Reset ...54
6.2.
Physiological Alarms... 55
6.3.
Technical Alarm ... 70
6.4.
Alarm test ... 75
6.5.
Troubleshooting ... 76
7.
Cleaning and Maintenance ... 78
7.1.
Cleaning Vayu Ventilator ... 78
7.1.1.
Cleaning and sterilizing agents ...79
7.1.2.
Main Unit...79
7.1.3.
Patient Circuit ...79
7.1.4.
Replacing the Disposable Patient Air filter ...80
7.1.5.
Removing, cleaning and replacing the Exhalation Valve ...80
7.2.
Change of Patient ... 82
7.3.
Regular Maintenance Control ... 82
7.4.
Service and Repair ... 83
7.5.
Storage ... 83
7.6.
Disposal ... 83
8.
Theory of Operation ... 84 Vayu User’s Reference Manual 2052652-001-001 revC
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8.1.
Functional Diagram ... 85
8.2.
Basic Pneumatic Control Algorithms ... 87
8.2.1.
Pressure breath ...87
8.2.2.
Pressure support ...87
8.2.3.
Volume Breath ...87
8.2.4.
Inspiration Trigger...88
8.2.5.
Expiration Trigger ...88
9.
Technical Specification ... 89
9.1.
System Description... 89
9.2.
Data... 89
9.3.
Compliance to Standard... 94
9.4.
Default Setting ... 95
10.
Accessories and consumables ... 97
10.1.
Accessories ... 97
10.2.
Consumables ... 97
11.
Appendix... 102
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Vayu User’s Reference Manual 2052652-001-001 revC
1. Introduction 1.1.
Warning!
Vayu Ventilator must be only be used: •
For the intended treatment in accordance with this Vayu User’s Reference Manual and with the instructions given by the responsible clinical personnel.
•
In accordance with the operating conditions specified in this Vayu User’s Reference Manual.
•
In original and unmodified shape and only with accessories specified or approved by GE Healthcare.
Every other use may lead to risk of personal injury!
1.2.
CAUTION!
Read this Vayu User’s Reference Manual thoroughly so that you completely understand how Vayu Ventilator is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability.
1.3.
What is Vayu Ventilator?
Vayu Ventilator is a pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation. Vayu Ventilator can be operated in 7 different modes: •
PCV – Pressure Controlled Ventilation
•
PCV (A) – Assisted Pressure Controlled Ventilation
•
VCV – Volume Controlled Ventilation
•
VCV (A) – Assisted Volume Controlled Ventilation
•
SIMV-VC – Volume Controlled Synchronized Intermittent Mandatory Ventilation with Pressure Support
•
SIMV-PC – Pressure Controlled Synchronized Intermittent Mandatory Ventilation with Pressure Support
•
CPAP/PS – Continuous Positive Airway Pressure with Pressure Support.
Vayu Ventilator can be used with a single limb leakage circuit or with dual limb with exhalation valve. Vayu User’s Reference Manual 2052652-001-001 revC
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1.4.
Intended Use
Vayu Ventilator is a critical care ventilator capable of delivering continuous or intermittent ventilatory support to adult and pediatric (>10 kg) patients with reduced lung function, who are dependent partially or fully on ventilatory support such as acute respiratory failure, acute or chronic respiratory insufficiency and requires invasive or non-invasive mechanical ventilation. Vayu Ventilator is intended for treatment in hospitals and alternate care settings by qualified, trained personnel under the direction of a physician.
1.5.
Contraindications •
1.6.
The use of Vayu Ventilator is contraindicated on patients who need to be ventilated with oxygen concentrations (FiO2) higher than achievable when combining inlet from a low pressure oxygen source at 15 l/min with actual ventilator settings.
About this Manual Always read this manual before setting up and using Vayu Ventilator or performing maintenance on the machine, to ensure correct usage, maximum performance and serviceability. GE Healthcare reserves the right to make changes to the contents of this manual without any prior notification.
1.6.1. Audience This manual is primarily intended for care providers, clinical personnel, physicians, and others who require a working knowledge of the GE Healthcare Vayu Ventilator. The manual comprises detailed information on the settings and functions of Vayu Ventilator to be handled by trained health care personnel only. Service personnel may order Vayu Technical Reference manual that contains detailed technical information for maintenance, service and repair.
1.6.2. Icons In this manual, icons are used to highlight specific information. The meaning of each icon is explained in below table.
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Icon
Explanation Warning: Risk of death and serious personal injury. Caution: Risk of minor or moderate injury. Risk of equipment damage, loss of data, extra work, or unexpected results. Note: Information that may be valuable but is not of critical importance, tips. Reference: Reference to other manuals with additional information on a specific topic.
Vayu User’s Reference Manual 2052652-001-001 revC
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2. Safety information 2.1.
4
General user Precautions
•
It is advised that Vayu Ventilator be switched off and on at least once a week. This is necessary in order for Vayu Ventilator to perform a complete self-test.
•
Vayu Ventilator must only be used: •
For the intended treatment in accordance with this Vayu User’s Reference Manual and with the instructions given by the responsible clinical personnel;
•
In accordance with the operating conditions specified in this Vayu User’s manual;
•
In original and unmodified shape and only with accessories specified or approved by GE Healthcare.
•
Do not use Vayu Ventilator in the event of suspected damage to the device, unexplainable or sudden pressure, and performance or sound changes during operation, or if the delivered air from Vayu Ventilator is abnormally hot or emits an odour.
•
Vayu Ventilator may not work properly if any part has been dropped, damaged or submerged in water.
•
Inadequate use of device or accessories may cause loss of treatment or decreased performance.
•
Vayu Ventilator therapy settings must always be based on medical advice and must be carried out by authorized clinical personnel only. Blood gas measurement should be performed when changing settings or changing to another device.
•
Always perform the procedure in Section 4: Setting up Vayu Ventilator before Use.
•
Only use accessories recommended by GE Healthcare.
•
Clinical personnel must read Vayu User’s Reference Manual thoroughly and understand Vayu Ventilator operation before setting up and using the machine.
•
All the physiological alarms of Vayu Ventilator must be set at safe levels that will effectively warn the user of any risk. The alarm levels should be assessed considering the patient settings. Any change of settings or components may require the readjustment of the alarm levels.
•
Handle Vayu Ventilator with care. Vayu User’s Reference Manual 2052652-001-001 revC
2.2.
Electrical Safety •
Do not operate Vayu Ventilator if it has a damaged power cord or casing.
•
To avoid electrical shock, disconnect the electrical supply to Vayu Ventilator before cleaning. Do not immerse Vayu Ventilator into any fluids.
•
If a multiple portable socket-outlet is used, it shall not be placed on the floor.
•
The operator/user shall not touch accessible contacts of connectors and the patient simultaneously.
Do not connect external device on to USB port when device is ventilating a patient. The treatment may stop! Use only medical grade laptop/external device to connect to the ventilator if the patient is connected.
2.3.
Environmental conditions •
Do not use Vayu Ventilator in any toxic environment.
•
Do not use Vayu Ventilator in environments where there are explosive gases or other flammable anesthetic agents present.
•
If a room humidifier is used, place it at least 2 meters away from Vayu Ventilator.
•
The performance of Vayu Ventilator may deteriorate at ambient temperatures below -20°C (-4°F) and above 40°C (104°F). However, the treatment shall always be started in an ambient temperature warmer than 5°C (41°F).
•
Do not use Vayu Ventilator while positioned in a warm place, such as direct sunlight or close to a radiator.
•
The device complies with the EMC requirements of standards listed in Section 9.3: Compliance to Standard. Necessary measures should be taken in order to assure field levels exceeding 20 V/ m are avoided, since this may impair the safety and performance of Vayu Ventilator. Measures should include but not be limited to: •
Normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimize the build-up of electrostatic charges.
•
Avoiding the use of radio emitting devices closer than 1 m to Vayu Ventilator. Radio emitting devices are e.g. Vayu User’s Reference Manual 2052652-001-001 revC
5
cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus.
•
•
The performance of Vayu Ventilator and treatment of the patient may deteriorate if the operation conditions in Section 9: Technical Specification are not fulfilled. Do not use Vayu Ventilator immediately after storage or transport outside the recommended operating conditions.
•
The ventilator shall not be covered in such a way that fans and exhaust ports are compromised or positioned in such a way that the operation or performance is adversely affected. Do not use antistatic or electrically conductive breathing tubes or masks. Ensure that an alternate means of ventilation is available any time the ventilator is in use. Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation. Monitor operation when RF emitters are in the vicinity. Use of other electrical equipment on or near this system may cause interference. Verify normal operation of equipment in your configuration before use on patients. Do not attach a gas scavenging system or other accessories to the gas exhaust port. Occluding the gas exhaust port will prevent proper ventilation of the patient. Adding attachments or other components to the breathing system may increase the inspiratory or expiratory resistance. Ensure the inspiratory and expiratory resistances do not exceed 6 cmH2O pressure drop for the following flows: 60 l/min for adult use 30 l/min for pediatric use
• • •
• • •
• •
2.4. 1.
Vayu Ventilator, any accessories and all replaced parts must be disposed of in accordance with the Local environmental regulations regarding the disposal of used equipment and waste.
Patient Circuit Connections Connection of Single limb leakage circuit. The usage of leakage circuit is optimized for NIV and does not have Exhalation monitoring. Please select circuit type as “Leakage” under device settings-> Circuit Type for this configuration.
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2.
Dual limb with exhalation volume monitoring. It is recommended that dual limb circuit should be used for acute cases. Please select circuit type as “Exhalation” under device settings-> Circuit Type for this configuration.
For information on how to remove the exhalation housing and extract the exhalation valve for cleaning please refer Section 7.1.5: Removing, cleaning and replacing the Exhalation Valve. •
Only use Vayu Ventilator with a patient circuit, exhalation valve, leakage port and accessories recommended by GE Healthcare.
•
The pressurized air from Vayu Ventilator causes a continuous flow of air to escape from the leak ports or exhalation valve, flushing exhaled gas from the circuit. Vayu Ventilator should be turned on and the leakage port or exhalation valve should be checked for any blockage before application.
•
Do not connect patient to a patient circuit connected to Vayu Ventilator unless Vayu Ventilator is turned on and operating properly.
•
Do not use patient hoses or tubes made of static or electrically conductive material.
•
Always use a new patient circuit when Vayu Ventilator is to be used on a new patient.
•
Patient connected parts and all filters must be replaced regularly to ensure correct function of Vayu Ventilator. All replaced parts must be Vayu User’s Reference Manual 2052652-001-001 revC
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disposed of according to local environmental regulations regarding the disposal of used equipment and parts. •
Periodically check for moisture in the patient circuit. When present, remove the moisture. Before attempting to dry the circuit, disconnect it from Vayu Ventilator to ensure no water will flow back into Vayu Ventilator. The frequency at which these checks must be performed will depend on the patient's condition and the device used. You should assess this on an individual basis in accordance with the patient's needs.
•
When using Vayu Ventilator invasively the low volume alarm and the low breath rate alarm must be carefully set, to ensure safe use.
•
Endotracheal tubes, oral/nasal tubes etc. with small inner diameters increase the resistance in the breathing circuit.
•
In case of invasive application, the use of an appropriate external heated humidifier or HME (Heat and Moisture Exchanger, artificial nose)/HCH (Hygroscopic Condenser Humidifier) is recommended.
•
Make sure that the exhalation valve or the leakage port is never blocked or obstructed.
•
At low pressure, the air flow through the leakage ports may be inadequate to clear all exhaled gases. Some re-breathing may occur.
•
Do not leave long lengths of air tubing around the top of the bed. It could twist around the patient's head or neck while sleeping.
•
Always follow the instructions of the mask manufacturer.
•
For invasive applications using the leakage circuit, assure that an intentional leakage port is present in the circuit, as close as possible to the patient connection, to reduce the risk of re-breathing CO2.
•
Vayu Ventilator is equipped with a low leakage alarm. The low leakage alarm is not a substitute for operator/user vigilance in ensuring that the leakage ports remains clear at all times. Periodically check the leakage ports during therapy.
•
In general, with leakage circuits, as pressure decreases the potential of re-breathing increases. Lower pressures produce less flow through the leakage ports which may not clear all CO2 from the circuit to prevent rebreathing.
2.5.
8
Usage of filter
•
Always use Vayu Ventilator with patient air inlet filters installed. Only use filters that are specified in this manual.
•
Replace the filters regularly to ensure correct function of Vayu Ventilator, especially when changing patient. Failure to replace a dirty Vayu User’s Reference Manual 2052652-001-001 revC
filter may cause Vayu Ventilator to operate at higher temperatures than intended. •
When operating Vayu Ventilator, make sure that the air inlet and filters are not obstructed or occluded.
•
If Vayu Ventilator is used in a clinic by several patients, a low resistance bacteria filter is recommended between the air outlet and the patient circuit to prevent patient cross-contamination. Reuse of mask or bacteria filter may expose patients to contagious agents.
•
The uses of a high resistance bacteria filter on the output of the device may interfere with the operation of the patient disconnect function. It may also interfere with the device trigger function.
2.6.
Humidification
•
Humidification must only be used if this has been prescribed by a physician.
•
When using an external heated humidifier, it should be located below Vayu Ventilator and the patient to prevent injury from accidental spillage.
•
During transportation of Vayu Ventilator, the external humidifier shall be disconnected.
•
If the condensation in the patient circuit is excessive, the use of a heated humidifier may require the installation of a water trap in the circuit. The water trap prevents any condensate water in the patient circuit from running into the patient airways and causing personal injury.
•
When adding or removing a HME or HCH, always perform a patient circuit check for correct connections
•
The use of an HME (Heat and Moisture Exchanger, artificial nose) or an external humidifier may require readjustment of Vayu Ventilator low pressure alarm.
•
Certain HME's and HCH's (Hygroscopic Condenser Humidifiers) are sufficient to provide humidification when Vayu Ventilator is used invasively. Check specific suppliers recommended use.
•
Never use HME and heated humidifier simultaneously.
2.7. •
Cleaning and Maintenance Vayu Ventilator should be cleaned and maintained in accordance with this Vayu User’s Reference Manual. Refer Section 7: Cleaning and Vayu User’s Reference Manual 2052652-001-001 revC
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Maintenance : Do not attempt to autoclave or sterilize Vayu Ventilator main unit. •
Vayu Ventilator should be subjected to maintenance, service and any applicable upgrades, in accordance with GE Healthcare service instructions.
•
Vayu Ventilator shall only be repaired or modified in accordance with GE Healthcare Vayu Technical Reference Manual, technical bulletins, and any special service instructions, by service technicians authorized by GE Healthcare.
•
Do not under any circumstances attempt to open service or repair Vayu Ventilator yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of Vayu Ventilator. Furthermore, no guarantees will be valid.
2.8.
Usage of Oxygen User to use only gas supply hoses that meets ISO 5359 standards.
•
Always follow the oxygen provider's instructions.
•
The presence of oxygen can speed up combustion of inflammable materials.
•
At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure delivered, patient's breathing pattern, mask selection and leak rate. To monitor the oxygen concentration an oxygen fuel cell is recommended.
•
When oxygen is used with Vayu Ventilator, the oxygen flow must be turned off when Vayu Ventilator is not operating.
•
Ventilate the room adequately when oxygen is being used.
•
Do not smoke in a room where oxygen is being used.
•
Naked light bulbs and other sources of ignition must be kept a minimum of 2 meters away from the oxygen cylinder or any part of the patient circuit.
•
Do not use aerosols or solvents close to the oxygen supply, even when the oxygen supply is shut off.
•
When Vayu Ventilator is not in operation, and the oxygen flow is left on, oxygen delivered into the patient tubing may accumulate within the machine enclosure. Oxygen accumulated in the machine enclosure will create a risk of fire.
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Vayu User’s Reference Manual 2052652-001-001 revC
Supplemental oxygen flow may not exceed 15 l/min at maximal pressure of 50 cmH2O (mbar). Refer to Appendix for required oxygen flow. This product is suitable for maximum oxygen inlet pressure of 50 cmH20 (mbar). If subjected to pressure higher than 50 cmH20 (mbar) could cause patient injury. When using oxygen, use the oxygen sensor kit for monitoring. In the absence of the kit, the exhaled monitored volumes will be on the higher side because of the difference in the molecular weight of oxygen. The delivered tidal volume will not be affected. If integrated oxygen sensor kit is not used, it is recommended to use external oxygen gas monitoring when delivering supplemental oxygen.
Vayu User’s Reference Manual 2052652-001-001 revC
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Vayu User’s Reference Manual 2052652-001-001 revC
3. Product description 3.1.
Main components
No
Component
Function
1.
Vayu Technical reference Manual
Product Service Information (English)
2.
Vayu User’s Reference Manual
Product and Usage Information
3.
Disposable Single limb Patient Circuit w leakage valve
Patient Circuit
4.
Exhalation valve with parameter measurement
Exhalation Valve
5.
AC Power Cord
Mains AC power supply cord
6.
Patient Air inlet filter
Patient Inlet Air filtration
7.
Vayu Ventilator Main unit
3.2.
Optional Accessories
For more information on optional accessories, refer Section 10: Accessories.
3.3.
Vayu ventilator’s Front panel 18
1 2 3 4
GE Healthcare
5 6 7
17 16
i-Trig
15 14
13 8-12
No
Component
Function
1
Audio Pause/Mute Button
To mute the alarm sound
2-3
Alarm (red & yellow)
Alarm indication Vayu User’s Reference Manual 2052652-001-001 revC
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4
Audio Pause Indicator
Paused alarm sound indication
5
Trigger
Patient triggered breath indication
6
Mains
Power source: Mains
7
Internal Battery
Power source: Internal battery
8-12
Function
Select function according to display
13
Start/Stop
Start/Stop ventilation
14
Down Button
Down Navigation Button
15
Right/+ Button
Right Navigation or Increase Button
16
Left/- Button
Left Navigation or Decrease Button
17
Up Button
Up Navigation Button
18
Information
Show/Hide information
No
Component
Function
19
Exhalation Valve
Connect expiratory patient circuit limb
20
Patient Air outlet
Connect inspiratory patient circuit limb
3.4.
14
Vayu Ventilator’s Side Panels
Vayu User’s Reference Manual 2052652-001-001 revC