MIR SPIRODOC Manual De Usuario página 58

SYMBOL DESCRIPTION
Manufacturer symbol
This product is certified CE to conform to the Class IIa requirements of the by European Regulation (EU)
2017/745.
0476
In accordance with the IEC 60601-1 Standard, this product and its component parts are of type BF and therefore
protected against the dangers of direct and indirect contact with electricity.
To connect to other devices such as PC or printer.
Use only the USB cable supplied by the manufacturer and observe the safety regulations of IEC 60601-1-1.
SpO2
Warning symbol for the SpO2 port for oximetry (Oximetry function is on request)
Warning symbol for the WEEE
As laid down in the European Directive 2012/19/EEC requirements regarding the disposal of electrical and
electronic devices (WEEE), at the end of its useful life this device must not be thrown away together with normal
domestic waste as it contains materials which would cause damage to the environment and/or represent a health risk.
Instead it must be delivered to a WEEE authorised collection center, where the device will then be disposed of
correctly.
An alternative is to return the device without charge to the dealer or distributor, when a new equivalent device is
purchased. Due to the materials used in the manufacturing of the device, disposing it as a normal waste product
could cause harm to the environment and/or health. Failure to observe these regulations can lead to prosecution.
The (ESD) symbol required by the international standard is used in the vicinity of any connector which has not
undergone electrostatic discharge testing. In this device the electrostatic discharge tests have been performed
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.
FCC ID Identification showing traceability to FCC compliance
Rx ONLY Symbol for FDA regulation: use the device under the prescription of the physician
Symbol for devices that include RF transmitters. The symbol is applied for products that include RF transmitters
Instruction for use symbol. Refer to instruction manual. Read this manual carefully before using the medical device.
Manufacturing date of the device
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
The symbol indicates that the product is a medical device
The symbol indicates the Unique Device Identification
The symbol indicates that the device must not be exposed to direct sunlight
The symbol indicates that the device must be kept dry
1.5.3 FDA and FCC Warnings
Spirodoc 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.
NOTE: This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC
Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications.
SPIRODOC cod. 980156 Rev 4.2.1
spirodoc
User manual
EN 12/48