Technical Description - EMS AIRFLOW Prophylaxis Master Instructions For Use Manual

9. TECHNICAL DESCRIPTION

Manufacturer
Models
Classification IEC 60601-1
Classification EU MDD
93/42/EEC
Essential Performance
Operating mode
Power supply
Power consumption
Ultrasonic module
Fuse
Wireless communication
module
Weight
Dimensions
Operating conditions
(device)
Storage conditions
(application box)
Storage conditions
Transport conditions
Input fluids
Output fluids
Shelf life / lifetime
Expected service life
ENGLISH
EMS ELECTRO MEDICAL SYSTEMS SA, CH-1260 Nyon, Switzerland
AIRFLOW Prophylaxis Master, product code FT-229
Electrical Insulation Class-I
Applied part Type B
IP20 Control unit
IP21 Foot pedal
Medical Device Class IIa
This medical device, in the meaning of the EU MDD 93/42 has no Essential Performance
Continuous operation
100-240Vac, 50-60Hz, 4A max.
OFF-mode / Stand-by: 0.5W max.
Max: 700VA
Max Output Power: 8W under fully-loaded mechanical condition.
Frequency: 24-32kHz.
Primary tip vibration excursion: 200um max.
5A, T (slow), 250Vac, H type (=T5H250V)
Max 8 dBm EIRP, 2.4GHz band, Bluetooth
Control Unit 5kg max. (full operating condition)
Foot pedal: 0.35kg max. (wireless pedal)
Control Unit: Height: 245 mm, Width: 260 mm, Length: 290 mm
Wireless pedal: Diameter 135 mm, Height 35 mm
Temperature: 10°C to 35°C
Humidity: 30% to 75%
Altitude: Max 2000m
Temperature: up to 40°C
Temperature: -10°C to 30°C, no water inside
Humidity: 10% to 95% not condensed
Pressure: 500hPa to 1060hPa
Temperature: -29°C to 38°C, no water inside
Humidity: 10% to 95% not condensed
Pressure: 500hPa to 1060hPa
Water: pressure 2-5bar, temperature 10-30°C, salinity 0.2% max., hardness from 8 to
12°dH, minimum flow-rate 100ml/min, RECTUS 20KA connector type. EN-1717 compliant
water network/inlet is required.
Air: pressure 4.5-7bar, dry-only (humidity 1.032g/m3 max.), oil filtered 0.1mg/m3 max.,
minimum flow-rate 20 Nl/min at 4.5bar, RECTUS 21KA connector type
Water: min. 40ml/min. for AIRFLOW
Air: max pressure 5bar for Airflow
PIEZON and NIGHT CLEANER bottles: 5 years
®
Handpieces (main bodies): 1000 sterilization cycles
CombiTorque ® : 1000 sterilization cycles
Device: 7 years, having regular yearly preventive maintenance
FB-618/AU – rev.E – ed.2019/08
radio module
®
® , min. 30ml/min. for PIEZON ®
42/48