Introduction; Device Description And Intended Use; Contraindications - Saadat Respina P1 User Manual

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:

nability to trigger breath
I
 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.
9