spirodoc
SPIRODOC
cod. 980156
Rev 2.4
EN 8/46
User manual
The battery pack can be charged within a temperature range between 0°C and approximately 40°C
The battery pack may be used within a temperature range between -20°C and approximately 60°C.
The battery pack may be stored within a temperature range between -20°C and approximately 60°C.
1.4
Unforessen errors
In case device internal memory data are damaged, when the device is switched on, the following message appears:
ERROR IN MEMORY
In this case switch off the device and contact a technical service center.
1.5
Labels and symbols
1.5.1
Identification label
The label shows:
Serial number of the device
Product name
Name and address of the manufacturer
Electrical safety symbol
Antenna symbol for devices whom include RF transmission
CE mark in compliance with the Directive 93/42 EEC.
WEEE symbol
ID code for FCC regulation
Symbol for FDA regulation (Rx ONLY)
Ingress Protection rating (IPX1)
1.5.2
CE mark for medical devices
0476
This product is certified to conform to the Class II requirements of the 93/42/EEC medical device directive.
1.5.3
Electrical safety symbol
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.
1.5.4
Warning symbol for the USB
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.
1.5.5
Warning symbol for the SpO2 port for oximetry
SpO2
1.5.6
Warning symbol for the WEEE
As laid down in the European Directive 2002/96/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.
1.5.7
FDA and FCC Warnings
SPIRODOC
complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions:
