Bien Air CHIROPRO, Инструкция по эксплуатации

Страница: 9 / 240

ENG
7

CAUTION
Do not use Chiropro 3
rd
Gen outside the range of operating
temperature.
Classification
Class IIa in accordance with European Directive 93/42/EEC
concerning medical devices.
Electric insulation class
Class I per IEC 60601-1 (apparatus protected against electric shocks).

CAUTION
The device must be only used by the operator.
Applied parts (per IEC 60601-1):
MX-i LED 3
rd
Gen micromotor .............. REF 1601008-001
Straight handpiece 1:1 ........................... REF 1600052-001
CA 20:1 L..................................................... REF 1600598-001
CA 20:1 L Micro-Series ........................... REF 1600692-001
CA 20:1 L KM.............................................. REF 1600785-001
CA 20:1 L KM Micro-Series.................... REF 1600786-001
Irrigation lines........................................... REF 1500984-010
KM Irrigation lines.................................... REF 1501635-010
Degree of ingress protection
IP 41 (protection against insertion of objects larger than 1 mm
and dripping water (vertically falling drops)).
Memory
Memory storage of 5 steps settings including adjustment of
speed, torque, rotation direction, irrigation, and contra-angle ratio
for each step.
Languages
English.
Bracket for physiological liquid flask
Stainless steel.
Peristaltic pump
Pump delivery ........................................... From 30 to 150 ml/min.
(5 levels)
Hose for pump .......................................... External Ø 5.60 mm
....................................................................... Internal Ø 2.40 mm
Wall thickness ........................................... 1.60 mm
Intended for use with: See instructions for use
MX-i LED 3
rd
Gen micromotor .............. REF 2100245
Cable MX-i LED 3
rd
Gen .......................... REF 2100163
Contra-angle CA 20:1 L, light................ REF 2100209
Contra-angle CA 20:1 L
Micro-Series, light.................................... REF 2100209
Contra-angle CA 20:1 L KM, light......... REF 2100209
Contra-angle CA 20:1 L KM
Micro-Series, light.................................... REF 2100209
Straight Handpiece 1:1 ........................... REF 2100046

CAUTION
The use of the system with other handpieces, motors
or cables has not been validated/certified (speed and torque
values are not guaranteed in this case).
List of errors & Troubleshooting
See chapter “10 List of errors & Troubleshooting” on page 20.
4.5 Environmental protection and
information for disposal
The disposal and/or recycling of materials must be performed in
accordance with the legislation in force.
Separate collection of electric and electronic equipment and
accessories in view of recycling.
Electrical and electronic equipment may contain dangerous
substances which constitute health and environmental hazards.
The user must return the device to its dealer or establish direct
contact with an approved body for treatment and recovery of this
type of equipment (European Directive 2002/96/EC).
4.6 Electromagnetic compatibility
(technical description)
4.6.1 Precautions of use
This electronic control is in compliance with electrical safety
standards in line with standard IEC 60601-1, edition 3.1, and
those governing electromagnetic compatibility in line with
standard IEC 60601-1-2, fourth edition.

CAUTION
The device must be used by a competent person, in particular in
compliance with the legal provisions in force regarding
occupational safety, health and accident prevention measures,
and the current instruction for use. According to these measures,
the user has the following obligations:
• to only use devices that are in perfect working order
• to make sure that the device is used solely for the purpose
for which it is intended
• avoid contact with liquids.
4.6.2 Electromagnetic compatibility
warnings

CAUTION
The Chiropro 3
rd
Gen complies with the EMC requirements
according to IEC 60601-1-2. Radio transmitting equipment,
cellular phones, etc., should not be used in the immediate vicinity
of the device, since this could affect its operation. The device is
not suitable for being used close to high-frequency surgical
equipment, magnetic resonance imaging (MRI) and other similar
devices where the intensity of electromagnetic disturbances is
high. In any case, ensure that no high frequency cables are routed
above or near the device. If in doubt, contact a qualified technician
or Bien-Air Dental SA.
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the Chiropro 3
rd
Gen,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.

CAUTION
The use of accessories, transducers and cables other than those
specified, with the exception of transducers and cables sold by
Bien-Air Dental SA as spare parts for internal components, may
result in increased emissions or decreased immunity.
Relative humidity
(including
condensation)
30% to 80% 10% to 100%
Atmospheric
pressure 700 hPa to
1060 hPa
500 hPa to 1060 hPa
Environmental
conditions Operating Transport and storage
(max. 15 weeks)