JYOTI DHAMAN-III Manuale utente
DHAMAN-III Ventilator System
Operators Manual Version No: V.02.02.06.2021
Page 2 of 93
Copyright Information
Copyright 2020 Jyoti CNC Automation Limited Dhaman, Dhaman with logo. The information
contained in this manual is the sole property of Jyoti and may not be reproduced or
duplicated in full or in parts, without the express consent or permission of Jyoti. This manual
may be revised or replaced by Jyoti at any time and without notice. You should ensure that
you have the most current applicable version of this manual; if in doubt, reach us on the
‘contact detail’ given in this manual. While the information set forth herein is believed to be
accurate, it is not a substitute for the exercise of professional judgement. The ventilator
should be operated and serviced only by trained professionals. Nothing in this manual shall
limit or restrict in any way Jyoti’s right to revise or otherwise change or modify the equipment
(including its software) described herein, without notice. In the absence of an express,
written agreement to the contrary, Jyoti has no obligation to furnish any such revisions,
changes, or modifications to the owner or user of the equipment (including its software)
described herein.
Page 3 of 93
Contents
Chapter 1 - Introduction .................................................................................. 5
1.1 Device Outline ..................................................................................................................... 5
1.2
Operator’s Safety Information ........................................................................................ 7
1.3 General Warnings & Cautions ........................................................................................ 8
Chapter 2 – System Overview ...................................................................... 14
2.1 User Interface .................................................................................................................... 15
2.2 Patient Unit ........................................................................................................................ 18
2.3 Symbols & Labels ............................................................................................................ 19
2.4 Transportation and Storage .......................................................................................... 20
2.5 Information/Assistance .................................................................................................. 21
Chapter 3 – Setting up the Ventilator .......................................................... 22
3.1 Installing Ventilator ......................................................................................................... 22
3.2 Connecting Electrical Supply ....................................................................................... 23
3.3 Connecting Oxygen/ Air Supply ................................................................................... 24
3.4 Connecting Patient Breathing Circuit with Flow Sensor ....................................... 25
3.5 Connecting High Flow Nasal Therapy circuit ........................................................... 27
3.6 Connecting Nebulizer...................................................................................................... 28
3.7 Communication Ports ..................................................................................................... 29
Chapter 4 – Operating Procedure ................................................................ 30
4.1 Operating Flow Summary .............................................................................................. 30
4.2 Turning On Ventilator ..................................................................................................... 30
4.3 Performing Functional Checks .................................................................................... 31
4.4 Attaching Patient Breathing Circuit ............................................................................ 31
4.5 Selecting Patients ............................................................................................................ 31
4.7 Selecting Ventilation Mode & Control Parameters .................................................. 33
4.8 Setting Alarm Limits ........................................................................................................ 35
4.9 Start Ventilation ................................................................................................................ 37
4.10 Stop Ventilation ................................................................................................................ 38
4.11 Turn Off Ventilator ........................................................................................................... 38
Chapter 5 – Ventilator Modes & Controls ................................................... 41
5.1 VCVs (Volume Control Ventilation with Assist Control) ........................................ 42
5.2 VCV-SIMV (Volume Control with Synchronized Intermittent-Mandatory
Ventilation) ..................................................................................................................................... 43
5.3 PRVC (Pressure Regulated Volume Control) ........................................................... 44
5.4 PCVs (Pressure controlled Ventilation with Assist Control) ................................ 47
5.5 PCV-SIMV (Pressure Control with Synchronized Intermittent Mandatory
Ventilation) ..................................................................................................................................... 48
5.6 CPAP-PSV (Continuous Positive Airway Pressure with Pressure Support) .... 49
Page 4 of 93
5.7 HFNT (High Flow Nasal Therapy) ................................................................................. 51
5.8 BiPAP ST (Biphasic Positive Airway Pressure – Spontaneous Time) ............... 52
5.9 Special Functions ............................................................................................................ 61
Chapter 6 – Monitoring ................................................................................. 63
6.1 Numerical Patient Data ................................................................................................... 63
6.2 Graphics ............................................................................................................................. 64
Chapter 7 – Alarm Handling ......................................................................... 66
7.1 Introduction ....................................................................................................................... 66
7.2 Alarm Setting ..................................................................................................................... 66
7.3 Alarm Messages ............................................................................................................... 68
7.4 Alarm Removal ................................................................................................................. 71
Chapter 8 –Technical Specification ............................................................. 72
8.1 System technical Specification .................................................................................... 72
8.2 Setting parameter ............................................................................................................. 73
8.3 Alarms ................................................................................................................................. 74
8.4 Service ................................................................................................................................ 75
8.5 Accessories ....................................................................................................................... 75
Chapter 9 – Maintenance .............................................................................. 78
9.1 Cleaning, disinfection, and sterilization..................................................................... 79
9.2 Disassembling & Assembling of Exhalation Valve for Disinfection and
Cleaning .......................................................................................................................................... 80
9.3 Disassembling & Disposal of Flow sensor circuit .................................................. 80
9.4 Preventive Maintenance ................................................................................................. 80
Chapter 10 – Definitions ............................................................................... 81
10.1 Definitions of Control Parameters with Range ......................................................... 81
10.2 Definitions of Alarm Parameters with Range ........................................................... 82
10.3 Definitions of Display Parameters with unit ............................................................ 83
Chapter 11 – Accessing Utility ..................................................................... 85
11.1 About Machine .................................................................................................................. 85
11.2 Calibration .......................................................................................................................... 85
11.3 System/ Alarm logs ......................................................................................................... 88
11.4 Special key ......................................................................................................................... 89
11.5 Sound .................................................................................................................................. 89
11.6 Display configuration ...................................................................................................... 90
Chapter 12 – Warranty .................................................................................. 92
12.1 Warranty details & Instructions .................................................................................... 92
12.2 Contact Details: ................................................................................................................ 93
12.3 Summary ............................................................................................................................ 93
Page 5 of 93
This Operator’s Manual contains detailed information and instructions which, when
adhered to, ensure the safe and effective set up, use and simple maintenance of the
DHAMAN-III ventilator.
This manual is designed for use by Respiratory Therapists and / or other qualified and
trained medical personnel under the direction of a physician in accordance with
applicable state laws and regulations.
1.1 Device Outline
DHAMAN-III Ventilator System is intended to provide invasive or noninvasive ventilator support
and monitoring for pediatric and adult patients with respiratory failure or respiratory
insufficiency.
It is a respiration assistant equipment with various alarm function and safety features for
safe respiration management. It should be used together with other clinical information
for patients’ safety and diagnosis.
Figure 1. Device Outline view
Chapter 1 - Introduction
Page 6 of 93
1.1.1
Device Configuration:
DHAMAN-III ventilator is composed of the following:
1) User Interface:
• Configures ventilation mode and displays patient measurement data with alarms.
2) Internal System:
• Mixes supplied gas.
• Delivers and exchange gases.
1.1.2
Who can Use the device:
DHAMAN-III ventilator must be used by the following users:
• Medical professionals familiar with Ventilators and have familiarized themselves with this
device.
• Individuals who have received training on the use of this device.
• Individuals who have experience in treatment of respiratory diseases and have gone
through the user manual of this device, under supervision.
1.1.3
Usage Environment:
DHAMAN-III ventilator must be used in the following environments:
• Hospitals
• Facilities and institutions with the purpose of providing medical services, including
respiratory related services.
• Inter and Intra Hospital transportation of patients - within hospitals or medical institutions.
1.1.4
Device Inspection and Service Guidelines:
CAUTION
Regular inspection and servicing:
Detailed Inspection and service of DHAMAN-III ventilator must be done at regular
intervals by a trained professional.
Maintenance of Inspection and Service Records:
All matters related to the inspection and servicing of DHAMAN-III ventilator sha
ll be
recorded in accordance to regulations prescribed by hospital, state government,
and central government.
Service Contract is strongly recommended:
We strongly recommend that all service on the DHAMAN-
III ventilator system be
performed as part of a service contract with Dhaman / Jyoti.
Page 7 of 93
1.1.5
Exceptions for Legal Responsibilities:
• Inappropriate environment
Our company has no responsibility for the safe operation of DHAMAN-III Ventilator System if
the ‘Intended Use Environment’ requirements specified in this manual are not followed.
• Improper use
Our company has no responsibility for the safe operation of DHAMAN-III ventilator if the
Intended Use described in this Manual is not followed.
• Improper user
Our company has no responsibility for the safe operation of DHAMAN-III ventilator if the
requirement/s of ‘Intended User’ described in this Manual is/are not met with.
• Service by a non-professional
Our company will not be responsible for the safe operation of DHAMAN-III if this product is
serviced or repaired by an individual who does not have or did not complete relevant training
required for maintenance and service of this product.
1.2
Operator’s Safety Information
All Operators should read and understand the following information about
General Warning and Caution before operating the DHAMAN-III ventilator.
Symbols are indicated on the interior and exterior of the product and in this User
Manual. The symbols represent important cautions and advice to the user.
Please read the following symbols carefully and be well informed of them for the
use and storage of the product.
ATTENTION
This Symbol represents “ATTENTION”
It is associated with safety issues that the user should give attention to and be
well informed of before using the product. The operating procedures of the
product are well described in this manual.
WARNING
This Symbol represents “WARNING”
It is associated with possible matters that may harm or cause irreversible damage
to the product or the patient.
CAUTION
This Symbol represents “CAUTION”
It is associated with possible matters that may damage the product or harm the
patient.
Page 8 of 93
1.3 General Warnings & Cautions
WARNING
DHAMAN-III ventilator is a critical care medical equipment and must be operated by
a trained medical or healthcare worker/professionals in accordance to the
guidelines given in this booklet.
Always perform Functional Check prior to connecting the ventilator to a patient.
To ensure that the internal battery remains functional, fully recharge the battery at
least every 2 months when the ventilator is not in use.
Always keep alternative means of ventilation ready for use in case of equipment
failure in order to avoid possibility of patient death or serious deterioration of health.
Breathing system filters and heat & moisture exchanger require frequent
replacements to prevent build-up of resistance and blockage.
In case of the following, stop the use of ventilator and contact service assistant:
If abnormal screen shows up
If an alarm cannot be settled
If the device creates any abnormal sound
If the device is operating abnormally or shows unexpected failure
The ventilator must always be kept in the vertical position during use.
If the ventilator is connected to a patient,
Carefully monitor the patient.
Prepare/keep a reserve ventilator for back-up, should the device fail
unexpectedly.
Do not raise or separate the expiratory part.
Always check the setting and measurement values displayed on the screen.
Do not cover the ventilator in any way. This will lead to errors in its functions.
Do not block or obstruct the vent (brass mesh filter for mixer damping - sintered
disc) on right side of ventilator as it may affect oxygen concentration delivery.
Continuously check the Expiratory part of the ventilator for contamination.
Do not use the system with worn or frayed hoses or hoses that have been
contaminated, or that may have come in contact / contaminated by combustible
materials such as grease or oil.
Oxygen enriched gas is extremely flammable: if you detect a burning odour, then
disconnect the oxygen supply to the ventilator and turn off the system.
The gases used in the system must be free from particles.
The system is not intended to be used with any anaesthetic agent.
NOTE
This Symbol represents “NOTE”
This symbol is associated with issues you should note regarding the surrounding
environment or additional references to the descriptions in this manual. It does not
pertain to possible damages to the product or the patient.
Page 9 of 93
CAUTION
Always use a humidifier or disposable humidifies for prevention of dry lung tissues.
When separating or transporting the ventilator or its parts, refer to User Manual or
contact us for any kind of assistance. Always take care while transporting the
ventilator against damages, contamination and missing of loose parts.
Be careful when handling tube, connector, and patient tube parts. Use of support
arm can reduce the weight of tube exerted on the patient and improve the comfort
for the patient.
Do not remove or renovate any part of the ventilator.
Under no circumstances should you attempt to service or repair the device
yourself, if you do so our company is not responsible for safe operation of
ventilator.
While using nebulisation breathing system, filters and heat and moisture
exchangers could require more frequent replacements to prevent build-up of
resistance and blockage.
Please turn off the power to recharge the battery when it is not used.
DHAMAN-III ventilator system is a product conforming to Class II.
Page 10 of 93
1.3.1 Warnings Regarding Storage of the Device:
WARNING
Do not store the product in a place exposed to extremely low / or extremely high
humidity.
Do not store the product in a place exposed to direct sunlight.
Do not store the product in a place near to a heating device.
Do not store the product in a place with extreme thermal variation. (Proper
Temperature range and humidity range is mentioned in chapter 8).
Do not store the product in a place with poor ventilation.
Do not install or place the product where it may fall or cause any kind of harm to
the patient.
Do not store the product in a place where the product could be exposed to extreme
impact or vibration.
Do not store the product in a place where the product could be exposed to
chemicals or explosive gases.
Do not touch accessible parts of the ventilator and patient simultaneously.
Be careful to prevent dirt, including metals and metal particles, from getting inside
the product.
If the product dysfunctions, do not disassemble the product yourself. Only
DHAMAN’s Service personnel and designated service technicians are authorized
to disassemble the product. If you disassemble the product yourself, you will not
receive any service for the product and the company will no longer be responsible
for the performance of the device including safety aspects.
Turn off the product & disconnect gas sources when not in use.
Indice
