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mectron Piezosurgery II - 05.4 - Safety Requirements during Use

mectron Piezosurgery II
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30
Piezosurgery // - manual of use and maintenance
31
Piezosurgery // - manual of use and maintenance
13.0 Technical data
Device in accordance with Directive 93/42/EEC: Class II a.
Class according to EN 60601-1: I
Type B
IP 20 (device)
IP X8 (footswitch)
Device for intermittent operation: 60” ON 30” OFF.
Power-supply voltage: 230 VAC ± 10 % 50/60 Hz.
115 VAC ± 10 % 50/60 Hz (optional).
100 VAC ± 10 % 50/60 Hz (optional).
Max. power absorbed: 70 VA.
Fuses: Type 5 X 20 mm 230 VAC 2 X 500 mA T.
Type 5 X 20 mm 115 VAC 2 X 1 A T.
Type 5 X 20 mm 100 VAC 2 X 1,2 A T.
Working frequency: Automatic scan.
From 24 to 29.5 KHz.
Average power applied to the handpiece: Adjustable to 6 power levels:
ROOT mode Power: ENDO: 2,8 W
Power: PERIO: 4,6 W
BONE mode Power: QUALITY1: 16 W
Power: QUALITY2: 16 W
Power: QUALITY3: 16 W
Power: SPECIAL: 4,6 W
Delivery rate of the peristaltic pump: Adjustable via the keypad.
In the ROOT power mode: 6 delivery rates:
From 0 to approx. 100 ml / min.
In the BONE power mode: 5 delivery rates:
From 15 to approx. 100 ml / min circa.
Protection systems and tripping time of the APC:
- No handpiece connected
Tripping time 20 ms.
- Cord interrupted
Maximum tripping time 80 ms.
- Insert broken or not correctly tightened
Three scans, 150 ms each.
- Protection by discharge to earth
Tripping time 20 ms.
Alarms: The display on the front panel indicates error (see
point “Problem-solving”).
Operating conditions: From +10°C to +40°C.
Relative humidity from 30% to 75%.
Transport and storage conditions: From -10°C to +70°C.
Relative humidity from 10% to 90%.
Air pressure P: 500hPa/1060hPa
Cord: It is recommended not to exceed 100 sterilisation
cycles
Tube of peristaltic pump: It is recommended not to exceed 8 sterilisation
cycles
Weight and size: 3.5 Kg
L - W - H 340 X 210 X 150 mm.
13.1 Electromagnetic compatibility EN 60601-1-2
Guidance and manufacturer’s declaration - Electromagnetic emissions
The PIEZOSURGERY // is intended for use in the electromagnetic environment specied below.
The customer or the user of the PIEZOSURGERY // should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - Guidance
RF emissions
CISPR 11
Group 1 The PIEZOSURGERY // uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The PIEZOSURGERY // is suitable for use in all establishments,
including domestic establishments and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations / icker
emissions
IEC 61000-3-3
Complies

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