DJO Global ARTROMOT-SP3 Mode D'emploi page 37

Accuracy of measured values:
goniometer in the measuring range: from -50° to +40°
in plantar flexion / dorsal extension
accuracy: +/- 5°
11 kg
weight:
ABS, POM, PUR, PA, FR4, aluminum, stainless steel,
materials used:
brass
MDD: class IIa
Standards compliance: 93/42/EEC (2007/47/EG)
IEC 60601-1:1988 +A1:1991 +A2:1995 (S# <20,000)
IEC 60601-1:2005 (S# >20,000)
IEC 60601-1-6:2006
IEC 60601-1-9:2007
IEC 60601-1-11:2010 (S# >20,000)
IEC 62366:2007
IEC 62304:2006
EN ISO 14971:2007
ANSI/UL 60601-1 (S# <20,000)
CAN/CSA C22.2 No. 601.1-M
ANSI AAMI ES 60601-1 1st Edition (S# >20,000)
CAN CSA 22.2 No. 60601-1-08 (S# >20,000)
IEC 60601-1-2:2001 (S# <20,000)
EMC
(electromagnetic compatibility)
IEC 60601-1-2:2007 (S# >20,000)
EN ISO 13485:2003+AC:2009
Manufactured in compliance with:
Ambient conditions (storage, transport)
temperature: -25 °C to +70 °C
relative humidity: at 70 °C up to 93 % no condensation
atmospheric pressure: 500 hPa to 1060 hPa
Ambient conditions (operation)
temperature: +5 °C to +40 °C
relative humidity: 15 % to 93 %
atmospheric pressure: 700 hPa to 1060 hPa
______________________________
Subject to change without notice (10/2011)
(S# <20,000)
. IEC : and IEC
The ARTROMOT®-SP device is sub-
ject to particular precautions regarding
electromagnetic compatibility (EMC).
The device must be installed and put into
service strictly in compliance with the EMC
directives set forth in the accompanying
documents.
Portable and mobile RF communication
systems may a ect the ARTROMOT®-SP .
The ARTROMOT®-SP should not be
used adjacent to or stacked with other
equipment. If adjacent or stacked use is
necessary, ARTROMOT®-SP should be
observed to verify normal operation in the
configuration in which it will be used.
If you detect damage or malfunctions that
may impair the safety of the patient or
of the operator, have the device repaired
before using it.
. Electromagnetic emissions
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
ARTROMOT®-SP is intended for use in the electromagnetic environment specified below.
It is the responsibility of the customer or user to ensure that the ARTROMOT®-SP unit is
used in such an environment.
Emissions test Compliance
RF emissions to CISPR 11 Group 1
RF emissions to CISPR 11 Class B
Harmonic emissions to
complies with class
IEC 61000-3-2 A requirements
Voltage fluctuations/flicker complies
emissions to IEC 61 000-3-3
:
If it is necessary to replace assemblies or
cables, only the manufacturer's original
parts must be used to ensure continued
compliance with EMC requirements after
repair. This requirement applies to the po-
wer supply unit, cables and cable lengths,
drive unit consisting of the motor and the
control system, the programming unit incl.
the coiled cable and the connector.
The product designation ARTROMOT®-SP
used in the text below includes all product
variants.
Electromagnetic environment
– guidance
ARTROMOT®-SP 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.
ARTROMOT®-SP is suitable for use
in all establishments, including do-
mestic and those directly connected
to the public low-voltage power
supply network that supplies buil-
dings used for domestic purposes.