3
1.
MODELS
The standard following models can undergo change, revision and implementation without any notice.
Spencer 190 Electronic lung ventilator
Please contact the manufacturer for more informations about Kompak and Portavent versions.
The connection standard of the device is the one determined by the customer on the order.
2.
INTENDED USE
Spencer 190 is a breathing control/assistance volumetric device, with electronic control of the respiratory function, capable of delivering two
different concentrations of medical gas with a single gas supply, equipped with mechanical and electronic safety systems able to monitor
some of the main breathing parameters. The range of volumes, respiratoy frequencies and monitoring systems for the safety of the patient,
allow its use in both adults and children.
Is not indicated for use with newborns
. The device is designed to provide temporary non-invasive
ventilation support for patients having a minimal essential breathing capacity. The device is designed for permanent installation inside
ambulances. If the device needs to be transported, is necessary to use an adequate transport bag.
3.
REFERENCE STANDARDS
As Distributor or final User of the products manufactured and/or sold by Spencer Italia S.r.l., it’s strictly required to know the law
dispositions applied in the Country of destination of the goods, applicable to the supplied devices (including the regulations about
technical specifications and/or safety requirements.).
RIFERIMENTO
TITOLO DEL DOCUMENTO
EN 794-3
Lung ventilators. Part 3: Particular requirements for emergency and transport ventilators.
CEI EN 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
EN 60601-1-2
Medical electrical equipment - part 1: general requirements for safety 2. Collateral standard:
electromagnetic compatibility - requirements and tests
Regulation 10
Uniform provisions concerning the approval of vehicles with regard to electromagnetic
compatibility
4.
INTRODUCTION
4.1
Use of the manual
This manual is intended to provide the health care operator with the all the necessary information for its safe and appropriate use as well
as adequate maintenance of the device
Note:
The manual is an integral part of the device. It must be kept for the duration of the device and must accompany the device in case of
change of ownership or destination. If the operating instructions received relate to products not received, you must immediately contact the
manufacturer before use
.
The Spencer product manuals can be downloaded from the website or can be requested by http://support.spencer.it or by contacting the
manufacturer. Exceptions are items whose essentiality for reasonable and predictable use is such as to make it unnecessary to prepare
instructions in addition to the following warnings and directions on the label.
Regardless of the level of experience gained in the past with similar devices, it is recommended that you carefully read this manual before
installing, operating or using the product or any maintenance
4.2
Labelling and tracking control of the device
Each device has got an identification label positioned on the device itself and/or on its box, which includes identification data about the
manufacturer, the product, the CE mark, the serial number (SN) or lot number (LOT).
It must never be removed or covered.
In case of damage or loss, request a duplicate from the manufacturer. Failure to do so will interrupt the validity of the guarantee as the
device can no longer be traced.
The Directive 93/42/EEC requires manufacturers and distributors of medical devices to keep track of the device location. If the device
was in a different location to the address where it was sent or to where it had been sold, donated, lost, stolen, exported, or destroyed,
permanently removed from use, or if the device had not been delivered directly from Spencer Italia S.r.l., register your device at
or inform the customer (see § 4.4).