Orthofix AccelStim Manual De Instrucciones página 2

Symbol
ISO 15223-1
REF
5.1.6
ISO 15223-1
SN
5.1.7
IEC 60601-1
ISO 7010-M002
IEC 60417
Read Instructions for Use
5333
ISO 15223-1
1
5.4.12
IEC 60417
5172
ISO 15223-1
5.1.1
ISO 15223-1
5.1.3
Directive
2012/19/EU
ISO 15223-1
40 C
5.3.7
10 C
ISO 15223-1
1060 hPa
5.3.9
700 hPa
75%
ISO 15223-1
5.3.8
30%
ISO 15223-1
5.3.4
IP22
21 CFR 801.109
ONLY
ASTM F2503
MR
ISO 15223-1
5.1.4
ISO 15223-1
5.2.7
MEDICAL-ULTRASOUND EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARD ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-1(2005) + AMD 1 (2012)
E522288
CAN/CSA-C22.2 N0.60601-1:14
Meaning
Catalogue number: This symbol specifies the catalogue number so that
the medical device can be identified.
Serial number: This symbol specifies the medical device serial number.
Read instructions for use: Failure to read the instructions may result in
a hazard.
Type BF applied part: Applied part (ultrasound transducer) isolated from
the rest of the appliance with a specific degree of protection against
electrical hazards, specifically regards admissible leakage current.
Single patient multiple use: Indicates a medical device that may be used
multiple times (multiple procedures) on a single patient
Class II equipment: Appliance in which protection against electric shock
does not rely on basic insulation only, but includes additional safety
precautions such as double insulation.
Manufacturer: Name and address of the manufacturer.
Date of Manufacture
Not for general waste: This symbol indicates that the AccelStim device
should not be disposed of with ordinary household waste at the end
of its life. For details on how to dispose of this device correctly, contact
your local government waste disposal agency or your local sales
representative.
Temperature limits
Atmospheric pressure limitation
Humidity limitation
Keep dry
IP22: Degrees of protection provided by enclosures, see page 24.
Prescription only
MR Unsafe: Device must not be subjected to MRI scans.
Use-by Date
Non Sterile