Consumables, CPAP,6mos,MTTS

General Description
Consumables bundle for the MTTS CPD-10000 Dolphin bubble CPAP device. Bundle is for one CPAP device for an estimated 6 months of use, assuming a 5-day patient stay. This bundle contains nasal cannulas to support neonatal CPAP patients with weights ranging from less than 1,500 grams to greater than 2,500 grams.

TECHNICAL SPECIFICATIONS
11 x MTTS nasal cannula – Size 0 (ID 532) for newborns less than 1,500g
14 x MTTS nasal cannula – Size 1 (ID 533) for newborns between 1,500 – 2 ,500g
11 x MTTS nasal cannula – Size 2 (ID 534) for newborns greater than 2 ,500g
2 x Baby Bonnet – Size 1 (ID 1836)
2 x Baby Bonnet – Size 2 (ID 1837)
2 x Baby Bonnet – Size 3 (ID 1838)
1 x Silicon tube set (ID 1008)
1 x Humidifier (ID 1006)
1 x PEEP chamber (ID 1007)
1 x Inlet gas filter (ID 1219)
2 x Heater wire draw line (ID 991)
5 x Cleaning brush (ID 1000)
3 x Foam wrap, multisite, assembly – Pack of 12 (ID 1602)

STORAGE CONDITIONS
Temperature: 0°C to 50°C.
Relative Humidity: 5% to 90% RH non-condensing.

WARRANTY
Includes 2-year standard warranty, dated from the completion of the terms of delivery.

SHELF LIFE
3 years

WEIGHT/VOLUME
Weight: 4kg
Volume: 0.04m³
 
QUALITY MANAGEMENT SYSTEM 
- Manufacturer is certified for ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.
 
REGULATION & CONFORMITY REQUIREMENTS
Medical consumables have CE certificate under EU MDD 93/42/ECC or EU MDR 2017/745.