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General warnings

Training

  • 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.
  • 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. a socio unico is always at your disposal to plan trainings on products.
  • In the case of any doubts as to the correct interpretation of the instructions, please contact Spencer Italia s.r.l. a socio unico for any necessary clarifications.
  • Do not allow untrained persons to help during the use of the device, because they could cause damage to the patient or to themselves.

Functioning of device

  • Use of the device in anyway other than described in its manual is forbidden.
  • Each time before use of device the perfect operating state 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.
  • Do not use the device if any abnormalities which could in any way influence the correct functioning are detected.
  • Do not alter or modify in any way the appliance; any such interference could cause malfunctions and injury to the user and/or other persons.
  • 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 (when required by the law) 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.
  • Register and store with these instructions: lot number (LOT) or serial number (SN) if present, place and date of purchase, first date of use, date of checks, name of users, any comments.
  • During use, position and adjust the device taking care not to cause any obstruction to operators and or any other equipment.
  • 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, if applicable.
  • For devices intended for patient/corpse transport; always respect the maximum load capacity indicated in the User's Manual. Maximum load capacity means the total weight distributed according to the human anatomy. In determining the total weight load on the product, the operator must consider the weight of the patient/corpse, of the equipment and the accessories. Moreover, the operator must consider that the overall dimensions of the patient/corpse does not reduce the functionality of the product.
  • For devices intended for patient/corpse transport, check, before lifting, that the operators have the required physical conditions, as indicated on the User's Manual.
  • The maximum weight taken by each operator must comply with requirements prescribed by the current laws of the Country concerning Health and Safety at Work.
  • The warranty seals, if present on the products, must not be removed; in such case the Manufacturer will consider the warranty void and will decline any responsibility for the product and for its correct functioning and for any consequent damage that may occur to the device.
  • Avoid contact with sharp objects.
  • The device must not be exposed to or come into contact with any source of combustion or inflammable agents.
  • 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, otherwise warranty will be considered void.

Cleaning/Maintenance

  • Carry out the prescribed maintenance and respect the average life span of the product, as indicated by the Manufacturer in the User's Manual.
  • Establish a maintenance program and periodic testing, if required by the Manufacturer in the User's Manual, identifying an reference employee. The person to whom the ordinary maintenance of the device is entrusted must ensure the basic requirements foreseen by the Manufacturer in the User's Manual.
  • The inspection frequency is determined by factors such as legal requirements, the type of use, frequency of use, environmental conditions during use and storage.
  • The repair of the products produced by Spencer Italia s.r.l. a socio unico must necessarily be done at service centres authorized by Spencer, that, using original spare parts, provide a quality repair service in strict accordance with the specifications given by the Manufacturer. Spencer Italia s.r.l. a socio unico, therefore, disclaims any liability for any damages, direct or indirect, that is the result of improper handling of spare parts and/or of any repairs made by person other than service centres authorized by Spencer.
  • For any operations that are not carried out directly by the Manufacturer but by an authorised centre, we have to underline that a report regarding all operations carried out must be requested. This will permit both Spencer Italia s.r.l. a socio unico and the end user to keep a log book regarding the operations carried out on the device.
  • Spare parts will be available for 5 years since the last purchase date.
  • The cleaning of the product must be made respecting the Manufacturer's indications on the User's Manual.
  • During all checking, maintenance and cleaning procedures, the operator must wear adequate personal protection such as gloves, mask, glasses etc.
  • Failure to carry out the correct cleaning routine could increase the risk of cross infection, due to the presence of secretions and/or residuals.
  • The product and all its components, if washed, must be allowed to dry thoroughly before storing.
  • If the product requires lubrication, it must be made after cleaning and complete drying.
  • All maintenance and revision activities must be traced and documented with their reports on technical intervention. The documentation must be kept for at least 10 years from the end of life of the product and must be made available to the competent authorities and/or the Manufacturer, when required.
  • Only use components/replacement parts and/or accessories that are either original or approved by Spencer Italia s.r.l. a socio unico, in such a way that each operation causes no alteration or modification to the product.
  • Spencer Italia s.r.l. a socio unico disclaims any liability for any damages, direct or indirect, that is the result of improper handling of spare parts and/or of any repairs made by person other than the service centre Spencer authorized by Spencer, moreover, the warranty is considered void.

Regulation requirements

  • The distributor or end user of the products manufactured and/or marketed by Spencer Italia s.r.l. a socio unico, are strictly required to know the laws in force in the Country of destination of goods, applicable to devices to be supplied (including regulations about technical specifications and/or safety requirements) and, therefore, to know the steps necessary to ensure compliancy of those products to all requirements of the law of the Country.
  • Inform promptly Spencer Italia s.r.l. a socio unico (at time of enquiries) with details regarding any formalities required by the Manufacturer for the conformity of products to the specific requirements of the law of the Country (including those arising from regulations and/or other regulatory provisions).
  • Act with due care and diligence, to help ensure compliance with general safety requirements of the devices on the market, providing end users with all the information necessary to carry out periodical testing to the devices, as indicated in the User's Manual.
  • Participate in monitoring the safety of products placed on the market, passing on information on the risks of the product to the Manufacturer and the Competent Authority for the actions of their respective competence.
  • In addition to what is written here, the distributor or end user, assumes from now on more extended liability related to the failure to fulfil the above obligations with a requirement to hold non responsable and/or indemnify Spencer Italia s.r.l. a socio unico, from any prejudicial effect.
  • Attention: despite all efforts, laboratory tests, testing, operating instructions, norms cannot always represent the practice, so the results obtained under real conditions of use of the product in the natural environment may differ in a manner sometimes also relevant. The best instructions are the continual practice of use under the supervision of competent and prepared professionals.

Specific warning for medical devices

  • If in possession of a medical device, the user should read in addition to the general warnings, also the specifications listed below.
  • When the device is being used, the assistance of qualified staff must be guaranteed.
  • When the device is being used, never leave the patient unassisted. He must be assisted by at least one operator.
  • In case of use of medical devices, follow the procedures and protocols approved by your organization.
  • If the product is disposable, use it only once and for one patient only. Failure to do so can cause cross-infections.
  • The activities of disinfection and sterilization must be performed according to the validated cycle parameters, reported in the specific technical standards. Autoclave sterilization may decrease the life span of the device.
  • Do not use after expiry date stamped on the box, if present.
  • With reference to the D. Lgs. 24th February 1997, n. 46 emended by D. Lgs. 25/01/2010, n. 37 – Acknowledgement of Directive 93/42/CEE and 2007/47/CE, 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 specified 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 of any medical device.