Models; Intended Use; Intended Use And Clinical Benefits; Target Patients - Spencer WIV Instrucciones De Uso

1.

MODELS

The following basic models may be subject to implementation or change without notice. .
• WIV
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

The infusion subministration bag is a device that allows pressure to be applied to the infusion bag in order to empty the bag inside.

2.2 TARGET PATIENTS

There are no particular indications related to the patient group.

2.3 PATIENT SELECTION CRITERIA

The intended patients are those requiring pressure infusion treatment.

2.4 CONTRAINDICATIONS AND UNWANTED SIDE EFFECTS

There are no known contraindications or side effects arising from use of the device, but typical side effects arising from infusion treatment should be considered.

2.5 USERS AND INSTALLERS

The intended users are doctors or nurses competent in infusion practices.
These devices are not intended for lay people.
Operators must be able to provide the necessary patient care.
The product must be used only by personnel trained in the use of this product and not on other similar products.
3.

REFERENCE STANDARDS

REFERENCE
EU Regulation 2017/745
4.

INTRODUCTION

4.1 DEVICE LABELLING AND TRACEABILITY

Each device is provided with a label, placed on the device itself and/or on the packaging, which contains the Manufacturer's identification data, product, CE marking, serial
number (SN) or lot number (LOT). This must never be removed or covered.

4.2 SYMBOLS

Symbol Meaning
Device in compliance with EU Regulation 2017/745
Medical device
Manufacturer
Date of manufacture
Unique Device Identifier

4.3 WARRANTY AND SERVICE

Spencer Italia S.r.l. guarantees that products are free from defects for a period of one year from the date of purchase.
Spencer Customer Service tel. +39 0521 541154, fax +39 0521 541222, e-mail
Warranty and service conditions are available on the website
5.

WARNINGS/DANGERS

Product features
Use of the product for any purpose other than that described in the User Manual is prohibited.
• The product must not be tampered with or modified without the manufacturer's authorisation.
• Avoid contact with sharp or abrasive objects.
• Operating temperature: from -5°C to + 50°C.
• Storage temperature: -10°C to +60°C.
General warnings for medical devices
• Do not use if the device or parts of it are punctured, torn, frayed, or excessively worn.
• Do not alter or modify the device arbitrarily, as doing so could result in unpredictable operation and damage to the patient or rescuers and shall void the manufacturer's
warranty and release the manufacturer from all liability.
• Participate in safety checks on products placed on the market, transmitting information regarding product risks to the Manufacturer as well as to the Competent Authorities
for their respective actions.
• With reference to EU Regulation 2017/745, please note that public or private operators who, when exercising their activity, detect an incident involving a medical product
are required to notify the Ministry of Health, within the terms and in the manner established by one or more ministerial decrees, and notify the Manufacturer. Public or
private health care professionals are required to notify the Manufacturer of any other incident that may allow the adoption of measures to ensure the protection and health
of patients and users.
6.

SPECIFIC WARNINGS

To use the device, you must also have read, understood and carefully follow all the instructions in the instructions for use.
- Use only 500 and 1000 ml venous infusion bags.
- Before each use, check that the pointer on the pressure gauge reads zero.
- At the end of each use, open the vent valve on the bulb to bring the pressure gauge pointer to zero.
DO NOT PRESSURISE ABOVE 250 mmHg AS THE DEVICE MAY BECOME DAMAGED.
• To preserve the life of the device, protect it as much as possible from UV rays and adverse weather conditions.
• If the product is found to be malfunctioning, immediately use a similar device to ensure continuity of ongoing operations. Non-compliant devices must be taken out of
DOCUMENT TITLE
EU Regulation on Medical Devices
Symbol Meaning
See the instructions for use
Lot number
Product code
Danger – Indicates a hazardous situation that may result in a situation
directly related to serious injury or death.
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