Saadat Respina P1 User manual

1
Pooyandegan Rah Saadat Co.
User Manual
Code: O49-L01-V29
Rev.
Revision
Date
Description of Revision
Prepared by
Verified by
Verified by
0
16/8/13
Initial Release
2 pages.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
1
16/12/21
Some warnings have been added based on failed items in the
standard test report (9503-B-1) and technical specifications
have been modified.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
2
17/2/18
Some warnings and notes and also “Error code 17” (see
Alarms table) have been added. Section 7-3 has been
modified and “Base flow” value has been changed in
technical specifications. Pneumatic diagram has been
modified and the manual has been translated into English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
3
17/3/7
Some warnings have been added based on failed items in
the standard test report (9503-B-1) and technical
specifications have been modified. The manual has been
translated into English.
N.Rahmati
A. H.
Mehrnam
H. AzizZadeh
4
17/4/17
EMC declaration, CE sign, NB identification number and
EU rep information have been added to the manual and the
Technical Specifications have been modified. In addition,
the version 4 of the manual has been translated into English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
5
17/8/29
Some warnings and the Technical manual contents list have
been added, the device symbols, range of alarm limits and
the Technical specifications have been modified, the list of
accessories, troubleshooting table and alarms list have been
completed.
The version 5 of the manual has been translated into English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh

2
6
17/10/23
EMC declaration table has been modified.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
7
17/11/12
The alarm sound pressure range has been modified. A note
about Event log and a warning about oxygen alarms have
been added.
N. Rahmati
H. AzizZadeh
8
18/1/16
100% O2 maneuver, Flow Trig and some points about
nebulizer have been added.
“Nebulizer Not Available” and “100% O2 Not Available”
alarms as well as some warnings have been added to the
manual.
The symbol “Refer to Manual” has been modified.
The version 8 of the manual has been translated into English.
Z.Khalili
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
9
18/2/18
Some points about parameters and menus have been added
to the manual. Technical and General Setup menu and a
warning about Exh Flow sensor have been added.
Pneumatic diagram has been modified. This version of the
manual has been translated into English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
10
18/5/15
Suction Support maneuver, “Inverse ratio” and “Suction not
Available” alarms, Leak Compensation and NIV have been
added to the manual. The version 10 of the manual has been
translated into English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
11
18/9/25
Legal responsible has been changed to “Trionara”. “Self
Test” section and a sentence about the battery have been
added to the manual. Preventive Maintenance section and
Accessories tables have been modified. Finally, the version
11 of the manual has been translated into English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
12
18/12/24
A warning about humidifier and also NIV mask have been
added to the accessories list.
Air and Oxygen inlet pressure range has been modified.
“Ve” parameter has been changed to “MV” and “Vt” alarm
to “Vte”. Description of some alarms and also “Disinfection
and Sterilization” section have been modified.
“Continuous high pressure alarm test” has been deleted and
calibration procedures have been completed. Descriptions of
respiratory modes, leak compensation, non-invasive
ventilation and technical specification have been modified.
The size of the manual has been changed to “Envelope C5”
and translated into English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
13
19/05/20
Editing technical specifications and EMC table and
translating the document to English
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
14
19/06/18
Adding a note and a warning in alarm section, editing event
log description, adding PM form and translating the
document to English
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
15
19/07/20
Changing notify body number, completing trend section and
translating the document to English
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
16
19/09/24
Adding and editing some warnings and notes through the
document, compeliting battery section, editing alarm silence
section, editing the description of setting parameters,
updating the description of maneuvers, editing the
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh

3
description of alarms, deleting High oxygen alarm test,
editing ventilation modes, adding “Bi- level” mode, adding
the limitation of setting parameters, editing leak
compensation and NIV section, editing the description of
monitoring parameters, updating the technical specification,
updating the pneumatic diagram, editing trouble shooting
and translating the document to English
17
20/01/11
Updating technical specification, accessories list, section 7-
2, compeleting the self test section and translating the
document to English
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
18
20/02/17
Editing sections 2-7 and 7-2 and translating the document to
English
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
19
20/03/29
Adding “turning off the ventilator” section, editing some
alarms descriptions and “standby menu”, copmeleting the
effect of high inhalation pressure alarm in different
ventilation modes, updating the technical specifications,
deleting “Base flow” as a setting parameter and translating
the document to English
N. Rahamti
A. H.
Mehrnam
H. AzizZadeh
20
99/03/18
Renaming P-CMV & V-CMV respiratory modes.
Correction of Trionara Company Information
adding “Exh Not Fitted” alarm
Adding contraindications, cleaning part, compleating
calibration section and translating the document to English
Z.Khalili
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
21
99/04/13
Deleting the disinfecting procedure for exhalation valve and
translating the document to English
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
22
20/07/26
Compeleting the accessories list, updating the fronth panel
membrane information, deleting zero flow sensor calibration,
adding “flow pat.” To the setting parameters, adding the description
of “Home” key, updating the list of the alarms, updating the
technical specification and translating the document to English.
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
23
21/02/21
Completing the cleaning, disinfection and sterilization table and
translating the document to English.
N. Rahmati
24
11/04/21
Compeleting the table of the labels, editing the battery
specifications, editing the maneuvers, editing the autoset equations,
editing alarms section, updating the ventilation modes including
APRV, editing the motitoring parameters, updating the technical
specifications, adding the defaults of alarm limits and translating
the document to English.
N.Rahmati
25
1400/05/25
Chainging some details in technical specifications (Rate, Ti),
Adding Gas temp parameter, Changing some details in Gas Temp
Alarm, Completing the contraincdications, adding side effects and
translating the document to English.
Z.Khalili
N. Rahmati
A. H.
Mehrnam
H. AzizZadeh
26
1400/08/18
Updating alarm silence key description and translate the document
to English.
N. Rahmati
27
1400/11/09
Adding a comment about Air and Oxygen hoses tightening.
K. Baghestan
28
1400/12/16
Updating the accessories table, some alarm messages, Technical
specifications, Trend parameters, the range of alarm’s parameters
and oxygen sensor calibration, adding the preventive maintenance
table, compeleting the description of dual control and auto Tlow,
adding the description of Plim reached alarm in attachments and
translating the document to English.
N. Rahmati
29
1401/03/29
Adding statements about maximum input flow rate, adding a
warning about disconnection alarm and accessories packaging,
compeleting the table of accessories and translating the document to
English
N. Rahmati
A. H.
Mehrnam

4
RESPINA.P1
User Manual
Pooyandegan Rah
Saadat Co.

5
POOYANDEGAN RAH SAADAT CO.
Central Office:
No. 4, East. 1st St, Ettehad Blvd., Damavand Ave., Tehran, Iran
Post box: 1658916599
Tel: [phone]
Tel: [phone]
Fax: [phone]
Customer Services:
Tel: [phone]
Tel: [phone]
Fax: [phone]
Legal responsible:
Trionara Technologies AB
Polygonvägen 21. 18766. Täby. Sweden
Tel: [phone]
Web site: www.trionara.com
E-Mail: Inf[email protected]
Web site: http://www.saadatco.com/
Email: [e-mail]

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Manual Purpose
This manual provides the instructions necessary to operate ventilator system based on its intended
use. It also describes all adjustable and measurable parameters by the system, defined maneuvers,
alarms and briefly all capabilities of the Respina P1 ventilator.
Observance of this manual is a prerequisite for proper operation and assures patient and operator
safety. If you have any question about the ventilator, please contact our customer service
department. This manual is an essential part of and should always be kept close to the ventilator
system, so that it can be obtained conveniently when necessary.
Intended Audience
This manual is provided for healthcare professionals. The healthcare professionals are expected
to have working knowledge of medical terminology and procedures as required for operating the
ventilator.
Version Information
This manual has a version number. The version number changes whenever the manual is revised
due to software or technical specification changes. The version information of this manual is as
follows:
Release date
Software version
Version number
Jun. 2022
VH59 VA36 CZ3Rev56
O49-L01-V29

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Tabel of Contents
1-Introduction .............................................................................................................................................9
1-1 Device description and intended use...............................................................................................9
1-2 Contraindications.............................................................................................................................9
1-3 Side effects.....................................................................................................................................10
1-4 Warnings and safety information ..................................................................................................10
1-5 Device Labels and Symbols ............................................................................................................13
1-6 Guarantee and responsibilities ......................................................................................................15
1-7 Contents list of Technical Manual..................................................................................................16
2- Overview of Respina P1 Ventilator ........................................................................................................17
2-1 Front View......................................................................................................................................17
2-2 User interface.................................................................................................................................18
2-3 Accessories.....................................................................................................................................18
2-4 Note................................................................................................................................................20
2-5 Touch Screen..................................................................................................................................20
3- Ventilator preparation for use ...............................................................................................................21
3-1 AC Mains Supply.............................................................................................................................21
3-2 Battery............................................................................................................................................21
3-3 Air and Oxygen Supply ...................................................................................................................21
3-4 Patient Breathing Circuit................................................................................................................22
4- Operation ...............................................................................................................................................24
4-1 Use of the Ventilator......................................................................................................................24
4-2 Standby Key....................................................................................................................................24
4-3 100% O2 Key ..................................................................................................................................25
4-4 Manual Key.....................................................................................................................................25
4-5 Alarm Silence Key...........................................................................................................................26
4-6 Home key .......................................................................................................................................26
5- The Ventilator Setting ............................................................................................................................27
5-1 Turning on the Ventilator...............................................................................................................27
5-2 Patient Option................................................................................................................................29
5-3 Calibration......................................................................................................................................30
5-4 Settings...........................................................................................................................................30
5-5 Main Screen ...................................................................................................................................32
5-6 Monitoring .....................................................................................................................................33

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5-7 Alarms ............................................................................................................................................34
5-8 Config. ............................................................................................................................................37
5-9 General Setup.................................................................................................................................38
5-10 Graphic Settings .............................................................................................................................39
5-11 Clinical Setup..................................................................................................................................39
5-12 Technical settings...........................................................................................................................41
5-13 Maneuver.......................................................................................................................................42
5-14 Shuting down the ventilator ..........................................................................................................46
6-Alarms ....................................................................................................................................................48
6-1 Alarm Priority.................................................................................................................................48
6-2 Alarm sound...................................................................................................................................49
6-3 Alarm Silence key...........................................................................................................................49
6-4 Alarms ............................................................................................................................................50
6-5 Alarms test .....................................................................................................................................56
7- Maintenance ..........................................................................................................................................58
7-1 Calibration......................................................................................................................................58
7-2 Cleaning, Disinfection and Sterilization .........................................................................................60
7-3 Cleaning and disinfecting...............................................................................................................62
7-4 Preventative Maintenance.............................................................................................................64
8- Ventilation..............................................................................................................................................70
8-1 Ventilation modes..........................................................................................................................70
8-2 Limitations of setting parameters..................................................................................................84
8-3 Leak Compensation........................................................................................................................84
8-4 Non Invasive Ventilation (NIV).......................................................................................................85
8-5 Monitoring Data.............................................................................................................................86
8-6 Respiratory Curves.........................................................................................................................90
9- Technical Specifications .........................................................................................................................92
10-Pneumatic Diagram .............................................................................................................................101
11-Troubleshooting...................................................................................................................................102
12-Attachments ........................................................................................................................................106

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1- Introduction
1-1 Device description and intended use
The Respina P1 ventilator system is intended to be used with adult and pediatric patients
weighing more than 5 Kg in the ICU. This system is designed in such a way that can provide
invasive and non-invasive mechanical ventilation for patients. The ventilator is a high risk
medical device (class III according to Health Ministry of Iran and class II b according to
European Union) intended for use by qualified, trained personnel at the discretion of a
physician.
Some features of the Respina P1 ventilator are:
Mandatory and supportive ventilation modes
Volume- controlled, pressure- controlled and volume targeted pressure-controlled
breath types
Detecting respiratory effort of sensitive patient to flow or pressure
Detecting Apnea
Backup ventilation in case of Apnea occurrence (Apnea Backup)
User-selected oxygen concentration
Numeric parameters display
Respiratory curves display
72 hours Trending time
Nebulizer functions
Smart alarm system
Ideal Body Weight (IBW) calculator
1-2 Contraindications
There are no absolute contraindications for ventilator. However, in some specific diseases,
special measures must be taken to prevent possible injury to the patient. Additionally, Non-
invasive ventilation (NIV) should not be used in the following cases:
Inability to trigger breath
Intolerance of interface
Facial or brain injury
Partial or complete airway obstruction
Haemodynamic instability
It is strongly NOT recommended to use the ventilator in the following situations:
Starting and operating the ventilator in the absence of competent medical
professionals supervising the procedure.

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If there is no alternative ventilation method and equipment that can be used as a
backup.
Connected the device to an inadequate electric mains power (e.g. without earth
connection).
With gas supply which do not meet medical grade specifications.
It is NOT possible to use the ventilator when any of the following events occurs:
Never use it in the presence of flammable anesthetic gases.
Do not use nitric oxide, helium or mixtures containing helium as input gas supply.
The ventilator is located in the vicinity of MRI equipment or significant sources of
electromagnetic radiation.
During the inter hospital transfer of patients (mobilization outside the assigned
institution).
Failure to strictly comply with the instructions for use, user and intended use
environment for this ventilator.
If the ventilator is located in a hyperbaric chamber.
It is the responsibility of the user to select the appropriate ventilation mode for the underlying
disease of the patient. For all ventilator settings, the user needs to consider the respiratory
status and the general state of health of the patient in order to optimally adapt the ventilation
settings to the patient's condition.
1-3 Side effects
The instructions for use do not discuss about risks that are obvious to users, consequences of
obvious improper use of the ventilator and potentially negative effects on patients with one or
more illnesses.
Generally, mechanical ventilation may lead to negative effects, such as barotrauma or strain
on the circulatory system. Proper selection of ventilation mode and suitable adjustment of
setting parameters could decrease potential occurrence of such effects.
Side effects of NIV ventilation includes: ear discomfort, conjunctivitis, skin abrasions due to
mask/patient interface, and gastric distention (aerophagia).
1-4 Warnings and safety information
Warning
Read User manual carefully before operating the ventilator system.
The system function can be affected by using unapproved accessories.
The ventilator should only be operated and maintained by trained personnel. In
addition all patients requiring ventilation must be monitored appropriately by
qualified medical personnel.
The guidelines for the use of approved accessories, checking the device function and
the use of the device in appropriate environmental conditions should be followed by
healthcare center.