CareFusion GreenLight 4559GSP Instructions For Use Manual

GreenLight Fiber Optic
TM
Laryngoscope Handle
Instructions for Use
Catalogue number
Lot Number
X
Quantity
Follow Instructions For Use
Consult instructions for use
Caution
U.S. Federal law restricts this
device to sales by or on the
order of a physician
Conforms To:
RECOGNIZED
COMPONENT
AAMI STD ES60601-1
CENELEC STD EN60601-1
IEC STD 60601-1
IEC STD 60601-1 CB Scheme
IEC STD 60601-1-2
IEC STD 60601-1-6
UL STD 60601-1
5001720
Certified To:
CAN/CSA STD C22.2 No. 60601-1
CAN/CSA STD C22.2 No. 601-1
en
INTENDED USE:
The GreenLight Fiber Optic Laryngoscope Handle is to be used for tracheal tube
intubations during anesthesia, intensive care, or emergency medical airway management.
Safety Information
Only trained personnel shall use a laryngoscope for intubation.
BLADES: Compatible with all Green Standard laryngoscope handles.
For best results, use GreenLight single-patient-use blades from CareFusion.
Laryngoscope handles should be tested prior to use, after replacing batteries, and after
cleaning/disinfecting.
Medical Electrical Equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided in the
Accompanying Documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment.
Caution: Do not use this instrument in the presence of intense magnetic fields.
WARNING: No modification of this equipment is allowed.
Storage Transport and Use Environment
Ambient Storage Temperature range: 0ºC–30ºC
Relative Storage Humidity range: 30%–95%
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, CA 92887 USA
CareFusion France 309 S.A.S.
8 bis rue de la Renaissance
44110 Châteaubriant, France
©2015 CareFusion Corporation or one of its affiliates. All rights reserved.
GreenLight, Vital Signs, CareFusion and the CareFusion logo are trademarks
or registered trademarks of CareFusion Corporation or one of its affiliates.
All other trademarks are the property of their respective owners.
Manufacturer
Date of Manufacture
Authorized Representative
in the European Community
Do Not Place In Trash
30 ˚C
Storage Temperature
0 ˚C
95%
Storage Humidity Limitation
30%
Battery Size
English
Care and Maintenance
Warning: Batteries should be removed from handles being stored for more than 7 days to
avoid possible leakage of materials from the batteries
Warning: Do not mix old and new batteries, do not mix battery brands and do not mix
Lithium and Alkaline batteries.
TEST PROCEDURE
1. Connect a Green Standard laryngoscope blade to the handle.
2. Pull blade to operating position.
3. Ensure that the light shines brightly. If the light appears dim, replace batteries
immediately.
DISASSEMBLY AND REASSEMBLY
Disassembly:
1. Grasp handle so that the bottom is facing up.
2. Turn battery cap counterclockwise (CCW) to remove.
3. Invert handle slightly and allow the Light/Battery Cartridge to slide into other hand.
Reassembly:
1. Insert Light/Battery Cartridge into main handle and screw cap back on.
2. Perform TEST PROCEDURE.
INSTALLATION AND REPLACEMENT OF BATTERIES
To install batteries:
1. Disassemble handle.
2. Install new batteries with the negative (-) end in first.
3. Reassemble handle.
4. Perform TEST PROCEDURE.
To remove batteries:
1. Disassemble handle.
2. Insert finger or suitable object into the hole in the back of the Light/battery cartridge.
3. Grasp battery and remove.
CLEANING PROCEDURE
PRE-PROCESSING INSTRUCTIONS
1. Ensure all pre-processing instructions are followed prior to cleaning and disinfecting.
2. Initiate cleaning and disinfection of device as soon as possible after use
(recommended within 1 hour).
3. Transport devices via the institution's established transport procedure.
4. Remove excess gross soil as soon as possible after use by rinsing or wiping the device.
5. Device shall be cleaned and disinfected utilizing a minimum of one (1) cleaning method
and one (1) disinfection method outlined below.
LIGHT/BATTERY CARTRIDGE CLEANING INSTRUCTIONS
Warning: Light/Battery Cartridge must be removed from Main Handle prior to executing
the "Light/Battery Cartridge" cleaning and disinfection process.
Warning: Do not use bleach (sodium hypochlorite), betadine, or peroxide solutions.
The instrument may be damaged by these solutions.
Caution: Do not soak or sterilize the Light/Battery Cartridge. Do not allow cleaning
solution to enter cartridge.
LIGHT/BATTERY CARTRIDGE MANUAL CLEANING (OPTION 1)
1. Using an unfolded Cavicide (Isopropanol = 17.2%, Ethylene Glycol Monobutyl Ether
®
(2-Butoxyethanol) = 1-5%, Diisobutylphenoxyethoxyethyldimethylbenzylammonium
chloride = 0.28%) branded wipe (or equivalent), remove heavy soil as needed.
2. Using an additional fresh wipe that has been unfolded, wipe the device to wet all
surfaces.
3. Use additional wipes as needed ensuring the surfaces remain wet for a minimum
of 2 minutes.
4. Rinse the device by wiping with disposable, lint-free cloths dampened with reverse
osmosis/deionized (RO/DI) water. Repeat two (2) additional times for a total of
three (3) rinse cycles, utilizing fresh RO/DI water each time.
5. Allow the device to dry.
6. Visually examine each device for cleanliness.
7. If visible soil remains, repeat cleaning procedure until the device is thoroughly clean.
LIGHT/BATTERY CARTRIDGE DISINFECTION INSTRUCTIONS
Warning: Light/Battery Cartridge must be removed from Main Handle prior to executing
the "Light/Battery Cartridge" cleaning and disinfection process.
Warning: Do not use bleach (sodium hypochlorite), betadine, or peroxide solutions.
The instrument may be damaged by these solutions.
Caution: Do not soak or sterilize the Light/Battery Cartridge. Do not allow disinfection
solution to enter cartridge.
LIGHT/BATTERY CARTRIDGE MANUAL LOW-LEVEL DISINFECTION
1. Using an unfolded Cavicide (Isopropanol = 17.2%, Ethylene Glycol Monobutyl Ether
®
(2-Butoxyethanol) = 1-5%, Diisobutylphenoxyethoxyethyldimethylbenzylammonium
chloride = 0.28%) branded wipe (or equivalent), remove heavy soil as needed.
2. Using an additional fresh wipe that has been unfolded, wipe the entire device to wet all
surfaces.
3. Use additional wipes as needed ensuring the surfaces remain wet for a minimum of 2
minutes.
36-10822 2015-07