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English
INTENDED USE
Medical device used to connect a breathing circuit or resuscitator to an Endotrachealtube or Face Mask, to enhance mobility at the patient end.
INDICATIONS
•
To enhance mobility of the breathing circuit at the patient end during anaesthesia or ventilation.
CONTRAINDICATIONS
•
Relative contraindication: ventilation of children and infants.
Further contraindications are not known.
SAFETY INFORMATION
•
Read and follow the instructions for use carefully before using the product.
•
The product must only be used by trained medical personnel.
•
When using connecting tubing with a length of 30 or 45 cm, the silicone ring must be removed before application.
•
Ensure correct and tight connection.
•
For disconnection of stuck connectors, the manufacturer offers an appropriate uncoupling wedge.
•
The product is suitable for conveyance of oxygen, air, anaesthetic gases and their gas mixtures. Anaesthetic gases used must not interact
with the product materials (see chapter “Material Data“).
•
Due to a possibility to cause static charge, the product must not be used with or in striking distance of flammable anaesthetic gases.
•
The user must pay attention for efficient ventilation during application.
•
Prior to use, the products must be inspected visually for damages (cracks, breakage, etc.) and a functional check must be performed (see
chapter “Functional check”).
•
The product is for single use and must not be reprocessed. Reprocessing influences the function of the product. Any reuse involves the
potential risk for cross contamination.
•
The product must not be used if the packaging is damaged or the shelf life has elapsed.
TECHNICAL DATA
Patient Group
Tube length
Intended delivered
volume
Compliance
(ml/cmH
2
O)
Flow resistance
(cmH
2
O/
l
/min)
Adult
15 cm
≥ 300 ml
C@60hPa: 0,20 ml/hPa
R@30
l
/min: 0,0085 hPa/
l
/min
30 cm
≥ 300 ml
C@60hPa: 0,30 ml/hPa
R@30
l
/min: 0,0092 hPa/
l
/min
45 cm
≥ 300 ml
C@60hPa: 0,28 ml/hPa
R@30
l
/min: 0,0103 hPa/
l
/min
FUNCTION CONTROL
Prior to use check the products for foreign bodies and patency. All connectors must be connected to the tubing.
Check the system for leaks as follows:
Connect the Catheter Mount Tubing to the breathing system and seal the patient end. Use a pressure of 60 cmH
2
O and check if the pressure drops or
if air escapes within one minute.
Damaged products must not be used.
MATERIAL DATA
Tube
Polyethylene (PE)
Connector
Polycarbonate (PC)
Bronchoscope / Suction cap
Silicone
SHELF LIFE
Expiry date: see product label.
STORAGE AND TRANSPORT CONDITIONS
CAUTION
•
Protect from heat and store in a dry place.
•
Keep away from sunlight and light sources.
•
Store and transport in the original packaging.
DISPOSAL
Used or damaged products must be disposed acc. to applicable national and international legal directives.
Conversion of pressure units:
1 hPa = 1,01973 cmH
2
O = 0,75006 mmHg
