EMS AIRFLOW Prophylaxis Master - Technical Description

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