Ecolab EFW5L - 1 Introduction; Intended Use; Indications for Use; Contraindications; Important Labels and Indicators

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EFW5L_IFU REV NEW
1 Introduction
1.1 Intended Use / Indications for Use
The Ecolab Fluid Warmer (EFW5L) is designed to warm and maintain the temperature of
surgical solutions prior to their use. The Ecolab Pillow Drape (EPD400/EPD400N) is a
single-use equipment cover intended for use where warm irrigation is required.
1.2 Contraindications
No direct patient contact. Not intended as a blood warmer, tissue bath, or patient bath.
1.3 Important Labels and Indicators
• Power: When lit, indicates the EFW5L fluid warming machine is on.
• Temperature Control
o Upper indicator (PV – Present Value) indicates present temperature of solution.
o Lower indicator (SV – Set Value) indicates the temperature to which the solution
is set to warm.
o AL lights when Present Value is 2°C (4°F) greater than Set Value.
o SP1 lights when heating element is active.
o SP2 is not applicable.
o Used to increase/decrease temperature setting (SV).
o “Drape Unit” indicates the correct Ecolab drape is not installed or that the Ecolab
drape has reached its 24h expiration.
Explanation of Labels/Symbols:
Symbol
Symbol Title
(Symbol Description)
Standard Title
Reference
Authorized representative in the European
Community
Indicates the authorized representative in the
European Community.
Medical devices -
Symbols to be used
with medical device
labels, labelling and
information to be
supplied - Part 1:
General requirements
ISO 15223-1
Reference #5.4.4
FDA Recognition
#5-112
Disposal of Electrical and Electronic
Equipment (EEE)
Indicates that this product shall not be treated
as household waste and instead shall be
handed over to the applicable collection point
for the recycling of electrical and electronic
equipment.
B i hi d i di d f
N/A
N/A
CE Mark European Conformity
Indicates the medical device is in conformance
with the applicable European Union Directives.
N/A N/A