General Information - Spencer SKID-E Bedienungs- Und Wartungshandbuch

1. GENERAL INFORMATION

1.1 AIM AND CONTENTS
The aim of this manual is to supply all the information necessary so that the client, will not only attain adequate use of the appliance, he will also be capable of using the instru-
ment in the most autonomous and secure way possible. This includes information regarding technical aspects, functioning, maintenance, spare parts and safety.
1.2 CONSERVATION OF THE INSTRUCTION MANUAL
The instruction and maintenance manual must be kept together with the product, for the whole life of the device, inside the specially provided container and above all, away
from any substances or liquids which could compromise perfect legibility.
1.3 SYMBOLS USED
Symbo Meaning
The device is in compliance with the Regulation UE 2017/745
Medical Device
Manufacturer
Date of manufacture
UDI
Unique Device Identification
1.4 SERVICING REQUEST
For any information regarding the use, maintenance and installation, please contact the Spencer Customer Care Service on tel. 0039 0521 541111, fax 0039 0521 541222,
e-mail info@spencer.it or write to Spencer Italia S.r.l. – Via Provinciale, 12 - 43038 Sala Baganza (Parma) - ITALY.
In order to facilitate the assistance service, please always indicate or communicate the serial number (SN) shown on the label applied on the box or on the device.
1.5 DEMOLITION
When the devices are no more suitable for being used, if they haven't been contaminated by any particular agents, they can be disposed of as normal solid waste, otherwise
follow the current regulations about demolition.
1.6 LABELLING
Each device has got an identifying label, positioned on the device itself and/or on the box. This label includes information about the Manufacturer, the product, CE mark, lot
number (LOT). It must never be removed or covered.
2. WARNINGS
2.1 GENERAL WARNINGS
• The product must be used by trained personnel only, having attended specific training for this device and not for similar products.
• Training routines must be registered on a special register in which the names of those trained, of the trainers, date and place are indicated. This register which will certify the
eligibility of the operators to use the Spencer device has to be kept for a period of 10 years after the disposal of the device itself. This register will be made available to the
Competent Authorities and/or Manufacturer if requested.
• Spencer Italia S.r.l. is always available for conducting training courses.
• Before carrying out any kind of operation on the appliance (training, installation, use), the operator must carefully read the enclosed instructions, paying particular attention
to the correct safety precautions and to the procedures to be followed for installation and for correct use.
• If the instructions belong to another device and not the device received, inform the Manufacturer immediately and avoid use of the device.
• In the case of any doubts as to the correct interpretation of the instructions, please contact Spencer Italia S.r.l. for any necessary clarifications.
• Do not allow untrained personnel to help when using the device as they may cause injury to the patient or themselves.
• Perform the required maintenance and to respect the life span of the device, as indicated by the Manufacturer in the User's Manual.
• Before each use of device the perfect operating state of the device must be checked as specified in the Instruction manual. If any damage or abnormalities which could in
any way influence the correct functioning and the safety of the device, of the patient and or of the user are detected, the device must be immediately removed from service
and the Manufacturer must be contacted.
• If any failure or incorrect functioning of the device is detected, it must be immediately substituted with a similar item so that the rescue procedures are guaranteed without
any interruption.
• Use of the device in anyway other than described in this manual is forbidden.
• Do not alter or modify in any way the appliance; any such interference could cause malfunctions and injury to the patient and/or rescuer.
• The appliance must not in any way be tampered with (modification, adjustment, addition, replacement). In such cases all responsibility will be denied for any malfunctions or
injuries caused by the appliance itself; moreover CE certification and product warranty will be considered void.
• Those who modify or have modified, prepare or have prepared medical appliances in such a way that they no longer serve the purpose for which they were intended, or no
longer supply the intended service, must satisfy the valid conditions for the introduction onto the market.
• Handle with care.
• Ensure that all the necessary precautions are taken in order to avoid the hazards that can arise as the result of contact with blood or body fluids.
• Register and store with these instructions: lot number, place and date of purchase, first date of use, date of checks, name of users, any comments.
• When the device is being used, the assistance of qualified staff must be guaranteed.
• Never leave an unassisted patient. The presence of at least one operator is essential at all times when the medical device is in use.
• Do not store the device underneath any heavy objects which could cause structural damage.
• Store in a cool, dry, dark place and do not expose to direct sun.
• Store and transport device in its original packaging.
• The device not be exposed to or come into contact with any source of combustion or inflammable agents.
• Position and adjust the device taking care not to cause any obstruction to rescuers and or any other rescue equipment.
• Attention: laboratory testing, post production tests, instruction manuals cannot always consider every possible scenario for use. This means that in some cases the perfor-
mance of the product could be notable different from results to date obtained. Instructions are continually being updated and are under tight surveillance of fully qualified
staffs with adequate technical formation.
• Avoid contact with the skin by placing a surgical cloth between the patient and the device.
With reference to the Regulation UE 2017/745, we remind both public and private operators that they are obliged to report any accident that involves any medical device
to the Ministry of Health and to the Manufacture as specified and within time given by the European regulations.
In addition, both public and private operators are obliged to inform the Manufacturer of any measures that should be adopted to make the steps necessary to guarantee
the safety and the health of the patients and the users o any medical device.
Symbo Meaning
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner
Warning
Read user manual
Serial number
Product code
IT
EN
DE
13