CooperSurgical NEO-Prep 44-8000 Manual De Instrucciones

NEO-prep™ Neonatal Skin Prep Tabs • Instructions for Use (English)
NEO-prep™ neonatale Hautvorbereitungsstreifen • Verwendungsanleitung (Deutsch / German)
Protectores de preparación de la piel para neonatos NEO-prep™ • Instrucciones de uso (Español / Spanish)
Protections cutanées pour nouveau-né NEO-prep™ • Mode d'emploi (Français / French)
Striscette neonatali NEO-prep™ per la protezione della cute • Istruzioni per l'Uso (Italiano / Italian)
44-8000 • 44-8001
Instructions for Use (English)
44-8000 NEO-prep™ Neonatal Skin Prep Tabs Small • 44-8000 NEO-prep™ Neonatal Skin Prep Tabs Large
DEVICE DESCRIPTION
Hypoallergenic skin barrier tabs pre-cut to small and large sizes for use during nasal cannulae procedures. Non-sterile. Not made with natural rubber latex.
WARNINGS
• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause
patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to
injury, illness or death of the patient. Dispose of in accordance with all applicable Federal, State, and local Medical/Hazardous waste practices.
• NEO-prep should not be used if infant has skin irritation.
• Discontinue use if NEO-prep interferes with the administration of oxygen or other therapies.
PLEASE NOTE: If a serious incident is suspected from using the NEO-prep, report the details of the incident to CooperSurgical via phone number +1 203-601-5200 Ext 3100 or
by email at [email protected] and to the local Health Authority in your country. A serious incident may have caused or contributed to a death, a delay in
a procedure which resulted in death or serious injury, or a malfunction that could have caused an adverse event.
INTENDED USERS
The Neo-prep is intended to be used by medical professionals only (including physicians, respiratory therapists, nurses, and emergency medical staff); they may be used in
both emergency situations or under controlled conditions where quick and simple stabilization and support are necessary.
PATIENT POPULATION
The Neo-prep is intended to be used on patients in both emergency situations or under controlled conditions where quick and simple stabilization and support are necessary,
including but not limited to the hospital, ER, ICU, or point of care. The specific patient population is relative to the product in use; the Neo-prep devices are designed for neonate,
infant, or pediatric patient use.
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician.
INTENDED USE / INDICATIONS
To act as a skin barrier between nasal cannulae and the skin of the upper lip and nasal septum to minimize skin irritation or damage.
CONTRAINDICATIONS
Do not use on irritated or compromised skin.
PRECAUTIONS
For proper adhesion insure that the skin is clean, dry and free of grease or oil prior to application.
Not intended to be used to secure nasal cannulae. Use only as a protective skin barrier.
INSTRUCTIONS FOR USE
1. Remove the NEO-prep tab from the backing strip.
2. Position the NEO-prep tab on the upper lip with the narrow portion aligned on the septum of the nose. See figure.
Note: The NEO-prep tab may be trimmed according to the patient's anatomy.
GLOSSARY OF SYMBOLS
Ref # Symbol
Catalogue number
5.1.6
Batch code
5.1.5
Date of manufacture
5.1.4
Use-by date
5.1.3
5.4.5,
Not made with natural rubber latex
Annex
B.2
Do not re-use
5.4.2
Caution
5.4.4
Consult instructions for use
5.4.3
Non-sterile
5.2.7
Authorized representative in the
5.1.2
European Community
Manufacturer
5.1.1
Prescription device
n.a.
Product conforms to the Medical
n.a.
Device Directive 93/42/EEC
Title
Indicates the manufacturer's catalogue number so that the medical device can be identified.
Indicates the manufacturer's batch code so that the batch or lot can be identified.
Indicates the date when the medical device was manufactured.
Indicates the date after which the medical device is not to be used.
Indicates that natural rubber latex was not used in the manufacturing of the product, its container, or its
packaging.
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
Indicates the need for the user to consult the instructions for use for important cautionary information such as
warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
Indicates the need for the user to consult the instructions for use.
Indicates a medical device that has not been subjected to a sterilization process.
Indicates the authorized representative in the European Community.
Indicates the medical device manufacturer, as defined in EU Directive 90/385/EEC, 93/42/EEC and 98/79/EC.
Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.
Signifies European technical conformity.
NEO-prep Tab
NEO-prep™ is a trademark of CooperSurgical, Inc.
CooperSurgical is a registered trademark of CooperSurgical, Inc.
Description
Standard
Development
Organization
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
21 CFR 801.109
n.a.