The self testing product is transformed from the professional testing product
CLUNGENE COVID 19 Antigen Rapid Test manufactured by Clongene
The BfArM has granted the first special approvals according to 11 paragraph 1
of the German Medical Devices Act ( of antigen tests for self administration by laypersons (self tests) for the detection of SARS CoV 2 Our self testing product can be sold and
used in Germany Overview of CLUNGENE COVID 1
Real-time waveforms: Paw, Flow, Volume, EtCO2, SPO2
Optional: CO2, SPO2 (related parameters)
Loops: P-V, V-Flow, Flow- P
Trends: 1s, 5s,1min,10min, 30min, 60min
Tidal volume: 5 to 2000mL
PEEP/CPAP: 0 to 30 cmH2O
Oxygen: 21 to 100%
I:E ratio: 1:10 to 4:1
Inspiratory time (TI): 0.2 to 5 s
Flow trigger: 0.2 to 15 l/min
Pressure trigger: -0.5 to -20cmH2O
Pressure control: 5 to 90 cmH2O, added to PEEP/CPAP
Pressure support: 0 to 90 cmH2O, added to PEEP/CPAP
Pressure ramp: 0 to 2s
Expiratory trigger sensitivity (ETS): OFF, 5 to 90 % of inspiratory peak flow
Peak flow Spontaneous: > 210 L/min
Input voltage: 100 to 240V ~ �?�±10 %, 50 / 60 Hz AC or 24 VDC�?�±10 %
Power consumption: 50 W typical
Protection class: Class I
Backup battery: batteries(5200mAh each)/ hot swappable
Oxygen supply: 280 to 600 kPa (41 to 87 psi), 120 L / min
Low pressure: oxygen �¢?�¤15 L / min, max. 600 hPa for low pressure
Operator-adjustable: Low/high minute volume, low/high pressure, low/high tidal volume, low/high rate, apnea time, low/high oxygen
Optional: low/high CO2, low/high SPO2
Special alarms: Oxygen concentration, disconnection, loss of PEEP, exhalation obstruction, flow sensor, power supply batteries, gas supply
Loudness Adjustable: 1 to 9
Event log: Storage and display of up to 1000 events with date and time stamp
Weight: < 45.3 kg
Dimensions(WxHxD): Approx. 600x402x415mm
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Multiple Ways to use
-It comes with two flow-meters having flow from 0-5 liter and 0-10 liter per minute, it can deliver
SLPM oxygen with two persons at the same time, and can deliver lOL PM with one person.
-It also has atomization function Safety
-The machine has audiovisual alarm for power failure, low oxygen level, low pressure
General Characteristics
Single-use
Sterile
Including a mechanism to prevent reuse
The syringe and needle shall be passively and automatically rendered unusable by the delivery of the intended fixed dose. And/ Or
The auto-disable feature is automatically activated and remains effective from the time that the injection is commenced. And / Or
The auto-disable feature is automatically activated on completion of the delivery of the intended fixed dose.
Type and application
Non-pre-filled, disposable.
To administer DTP, DT, tetanus toxoid and diluted freeze dried measles etc for intramuscular and sub-cutaneous injection.
Syringes with permanently attached needle
Material
Polypropylene with or without stainless steel
Syringe size with pre-set volume and single marking
0.5ml for immunization (+20% to allow for removal of air)
Graduation and accuracy
Two markings only: 0 and 0.5ml.
The difference between the maximum graduated volume and the expelled volume of distilled water shall not be greater than �± 25 micro-liters.
Needle for Immunization
· Diameter : 23G
Length : 25mm (1)
Stainless steel needle tubing for the manufacture of medical devices
Needle shall confirm to IS 10654 of 2002 (third revision) equivalent ISO 7864 of 1993
Needle fixing
Fixed capped, needle (23 G X 25 mm). Fixed needles should withstand an axial pulling force of 34N without separating from the syringe. If accidental needle stick protection devices are included in the design of the syringes or needle, they should not compromise the ease of use or the performance of the syringe.
Leakage :
Leakage of distilled water at a pressure of 0.3 mPa (3 atmospheres) for six minutes shall not be greater that 50 micro-liters.
Dead space
The maximum dead-space shall be 50 micro-liters.
Self destruction
The syringe shall be automatically rendered unusable when it has delivered a 0.5 ml dose of vaccine or distilled water.
Filling
The syringe is filled by inserting the needle through the septum of a sealed vaccine vial.
