Spirobank II
Rev.1.6
Page 10 of 35
User manual
1.4
Labels and symbols
1.4.1
Identification label
The symbols are described in the table below:
SYMBOL
DESCRIPTION
Model
Product name
SN
Device serial number
Manufacturer's name and address
0476
CE mark for medical devices: this product is a Class IIa medical device that is certified and in compliance with the
requirements of Council Directive 93/42/EEC
Electrical safety symbol: as per IEC60601-1, the product and its component parts are type BF and therefore offer
protection against electrical shocks
WEEE symbol is mandatory to European Directive 2012/19/EEC on Waste Electrical and Electronic Equipment.
On completion of its useful life, this appliance must not be disposed of as urban waste but must be sent to an
authorised WEEE waste disposal centre. The device can also be sent back to the original supplier free of charge
when a new equivalent model is bought.
Due to the materials used in its manufacture, disposal of the device as urban waste could harm the environment
and/or health.
There are legal penalties in place for those who fail to observe the legal requirements mentioned here
IPX1
Information on protection against ingress of liquids. The label indicates the degree of protection against ingress of
liquids (IPX1). The device is protected against vertically falling drops of water
Antenna symbol for devices that include RF transmitters
FCC ID
FCC Identification code indicating traceability to FCC compliance
Rx ONLY
Reference to US FDA regulations: use the device on prescription
Instruction for use symbol. Refer to instruction manual. Read this manual carefully before using the medical device
Production date of the device
USB port warning label. For connecting the device to a PC. Only use cables supplied by the manufacturer and
observe the IEC 60601-1 safety standards
SpO2
SpO2 oximetry port warning label
Electrostatic discharge symbol. This symbol is used near every connector that has been excluded from the
electrostatic discharge test. In this device the electrostatic discharge tests have been performed.
Temperature limits: indicates the temperature limits to which the medical device can be safely exposed
Humidity limitation: indicates the range of humidity to which the medical device can be safely exposed
Pressure limitation: indicates the range of pressure to which the medical device can be safely exposed
1.4.2
FDA and FCC Warnings
Spirobank II
complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions:
(1) this device must not cause harmful interference
(2) this device must accept any interference received, including interference that may cause undesired operation.
Any modifications not expressly approved by this company could void the user's authority to operate the equipment.
