Unitra Breath


Emergency use resuscitator system


Breath is a CE certified medical device intended to be used for invasive/noninvasive ventilation with a user powered resuscitator set. The device is intended to be used for adult ventilator dependent patients due to respiratory failure.


- Easy to use “ambu bag squeezer”

- Repetitive and reliable

- Poratble and easy to move only 8kg of total weight

- Equipped with internal power suply

- Oxygen cylinder not requied

Design inputs refering to international standards and regulations


AAMI CR503:2020

IEC 60601-1:2005+AMD1:2012

IEC 60601-1-2:2014

IEC 60601-1-6:2010

IEC 62366-1:2015

EN ISO 13485:2016

EN ISO 14971:2019

(EU) 2017/745 – MDR

Product specification

Basic information

Name

Breath

Model

BR-01

Dimensions and weight

Width

380 mm (14.96 in)

Height

93 mm (11.54 in)

Depth

253 mm (9.96 in)

Weight

7,2 kg (15,87 lb)

Classification

Protection / insulation class

Class I

Overvoltage category

II

Pollution degree

2

Degree of protection against the risk of electric shock

BF

Ingress Protection Code

IP20

Power supply

Power input

100 - 240 V AC // 50Hz / 60Hz

Maximum current

400 – 650 mA

Fuse (L and N)

T 1.0 A H 250 V

Backup battery

VRLA-AGM, 12 VDC, 5 Ah,

Mode of operation

Continuous

Back-up battery operating time

2 hours – fully charged (depending on temperature)

Operating information

Respiratory Rate

10 to 20 cycles per minute

I:E

1:2.0 (+/-0.15)

Airway pressure monitoring accuracy

+/-5%

Alarm volume level

90 dB

Operating conditions

Temperature

+0°C to +40°C (32° F to 104° F)

Humidity

20% to 75%

Pressure

70 kPa to 106 kPa

Storage conditions

Temperature

-10°C to 50°C (14° F to 140° F)

Humidity

10% to 95%

Pressure

50 kPa to 106 kPa

User Support


User manual