endoled_instructions_aug_2012.pdf
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INSTRUCTIONS
LIGHT SOURCE
EndoLED
WA91500A, WA91502A
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
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Contents
General Information..........................4
Upon Delivery .....................................5
Terminology ......................................7
Symbols and Labels ...........................8
Technical Data.................................11
Compatible Components ...............13
Before Use.......................................15
Inspection .........................................16
Connection to an Endoscope............16
Testing ..............................................18
Use ...................................................21
Procedure .........................................22
After Use...........................................23
Reprocessing..................................27
Cleaning ...........................................30
Sterilization .......................................31
Maintenance .....................................32
Replace Batteries .............................32
End of Product Life ...........................35
Troubleshooting..............................37
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General Information
Intended use.
Light source for exclusive use with an
endoscope for the illumination of the
observed area in ENT and intubation
for diagnostic and therapeutic
purposes.
Do not use it for any other purpose.
Medical use.
This product is to be used only in a
medical facility by trained medical
personnel.
NOTE!
Instruction manual set.
The complete instruction manual set for
this product consists of this productspecific instruction manual (delivered
together with this product) and the
system-related instruction manual,
entitled “Olympus Endoscopy System
Guide” (supplied with Olympus
telescopes).
Immediately contact an Olympus
representative if either manual is
missing or lost.
Keep the instruction manual set in a
safe, accessible location.
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WARNING!
Read all instruction manuals
thoroughly.
Before use, read this manual, the
Olympus Endoscopy System Guide,
and the manuals for all other
equipment which will be used during
the procedure.
An insufficient understanding of the
dangers, warnings, cautions, and
information in these manuals can result
in death, serious injury, or equipment
damage.
Medical Device Directive (Europe).
This product complies with the
requirements of Directive 93/42/EEC
concerning medical devices.
Upon Delivery
Inspect immediately.
• Make sure that the shipping case
contains all of the items listed below.
• Contact your Olympus representative
or an authorized service center if any
items are missing or damaged.
Contents WA91500A.
• Light source
• 2 adapters O0332
• Instruction manual
• Accessory sheet “EndoLED:
Compatible Batteries”
2x
Contents WA91502A.
• Light source
• Instruction manual
• Accessory sheet “EndoLED:
Compatible Batteries”
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Unpacking.
• Remove the product from the
packaging. Do not use the packaging
for routine storage.
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Terminology
Light source WA91500A.
1) Socket (with light admission surface)
2) Release button
3) Distal part
4) Main body
5) Battery indicator
6) Power switch
7) Battery compartment lid
8) Buckle
9) Lever
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Light source WA91502A.
1) Socket (with light admission surface)
2) Distal part
3) Locking screw
4) Main body
5) Battery indicator
6) Power switch
7) Battery compartment lid
8) Buckle
9) Lever
Symbols and Labels
O\I
Power switch
Refer to the accompanying instruction
manual.
Power supply by battery
+ –
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Battery polarity
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Must not be disposed of as unsorted
municipal waste.
WARNING!
Risk of injury to the patient and/or
user (light-emitting diode (LED)
radiation).
• Use the light source only when
connected to a compatible
endoscope.
• Do not point in the patient’s eye with
the distal end of the endoscope or the
light source’s socket.
• Do not look directly into the distal end
of the endoscope or the light source’s
socket.
Type BF applied part
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Technical Data
Operating environment.
Ambient Temperature ............10–30 °C
...............................................50–95 °F
Relative humidity ....................30–85 %
Air pressure ...................700–1060 hPa
Dimensions.
Weight (without batteries)
WA91500A...................................125 g
WA91502A...................................119 g
Maximal dimensions
(length x width x depth)
WA91500A ...............112 x 34 x 39 mm
WA91502A .................90 x 70 x 35 mm
Outer diameter (distal part)
WA91500A.................................28 mm
WA91502A.................................27 mm
Inner diameter of socket
WA91500A...................................9 mm
WA91502A................................5.5 mm
LED.
Color temperature .....5500 K (± 500 K)
Wave length ......................400–800 nm
Laser class according to
EN 60825-1:1994 + A1:2002
+ A2: 2002 .......................................2M
Power supply.
Battery........................................2 x AA
Input voltage of light source ..1.9–2.5 V
See separate accessory sheet
“EndoLED: Compatible Batteries”.
Safety.
Protection class according to
IEC 60601-1:2005............................BF
Protection against foreign bodies
and dripping water.........................IP47
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IP classification according to
IEC/EN 60529:1991 + A1:2000
(degree of protection by enclosure).
IP 47 No ingress of solid objects of
≥ 1.0 mm diameter.
The equipment is suitable for
temporary immersion in water.
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Compatible
Components
WARNING!
Risk of injury to the patient and/or
user.
Use only compatible equipment as
listed in this section.
If other combinations are used, the full
responsibility is assumed by the user.
Future products may also be
compatible. For further details contact
an Olympus representative.
CAUTION!
Risk of damaging the instrument.
• Only use the batteries listed in
accessory sheet “EndoLED:
Compatible Batteries”. The use of
other batteries may damage the
instrument during reprocessing.
NOTE!
For flexible endoscopes, Olympus
recommends light-guide adapters
MAJ-900 and MAJ-1413. Use lightguide adapter MAJ-900 when possible.
This light-guide adapter provides a
better illumination of the endoscopic
image.
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ENF-GP
MAJ-900
WA91502A
MAJ-1413
LF-GP, LF-DP
LF-TP, CYF-5
O0332
WA96100A
WA96105A
WA91500A
See separate accessory sheet
“EndoLED: Compatible Batteries”.
Siehe separates Beilageblatt
„EndoLED: Kompatible Batterien“.
Sprache 3
Sprache 3
WA96200A
WA96201A
WA96202A
WA96203A
WA96204A
WA96205A
WA96206A
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Before Use
WARNING!
Infection control risk.
Properly reprocess the product before
first and each subsequent use following
the instructions in this manual and in
the Olympus Endoscopy System Guide.
Improper and/or incomplete
reprocessing can cause infection of the
patient and/or medical personnel.
WARNING!
Risk of patient injury.
Always have a spare light source
available in order to replace the light
source in case of a malfunction or when
the batteries are not charged
sufficiently.
WARNING!
Risk of injury to the patient and/or
user (light-emitting diode (LED)
radiation).
• Use the light source only when
connected to a compatible
endoscope.
• Do not point in the patient’s eye with
the distal end of the endoscope or the
light source’s socket.
• Do not look directly into the distal end
of the endoscope or the light source’s
socket.
NOTE!
When the light source is not used over
an extended period:
- Remove the batteries.
- Before use, make sure that the
batteries are loaded to full capacity.
Refer to the chapter titled
“Troubleshooting”.
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Inspection
Inspecting the product.
Visually inspect the product. Make sure
that:
- The mechanical condition of the
product does not impair safe use.
- The text and labels are legible.
- Make sure that no visible debris is on
the product. If visible debris is
present, reprocess the product before
next use.
Check sealing ring.
• Check the sealing ring for damage.
• Replace the sealing ring, if necessary.
Connection to an Endoscope
WARNING!
Risk of injury to the patient and/or
user.
Do not switch on the light source before
connecting the endoscope.
Connect the light source WA91500A
to a rigid telescope.
• Select a compatible telescope.
• Attach light-guide adapter O0332
tightly to the telescope’s light-guide
connector.
• Press and hold the light source’s
release button.
• Insert the telescope’s light-guide
connector (with light-guide adapter) in
the light source’s socket until it clicks
into position.
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Connect the light source WA91500A
to a flexible endoscope.
• Select a compatible endoscope.
• Attach light-guide adapter MAJ-900 or
MAJ-1413 tightly to the endoscope’s
light-guide connector (see section
“Compatible Components”).
• Make sure that no additonal adapter
is on light-guide adapter MAJ-900 or
MAJ-1413.
• Attach light-guide adapter O0332
tightly to the additional light-guide
adapter.
• Press and hold the light source’s
release button.
• Insert the endoscope’s light-guide
connector (with light-guide adapter) in
the light source’s socket until it clicks
into position.
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Connect the light source WA91502A
to the endoscope.
• Select a compatible endoscope.
• Align the black dot in the light
source’s distal part with the red dot on
the endoscope’s light-guide
connector.
• Slide the light source’s distal part onto
the endoscope’s light-guide
connector.
• Rotate the light source back and forth
on the endoscope’s light-guide
connector until it clicks into position.
• Secure the light source by turning the
locking screw.
NOTE!
Light source WA91502A can be rotated
about 75° in both directions when it is
connected to an endoscope.
Testing
Check the endoscopic image.
• Turn the light source on.
• Check the quality of the endoscopic
image according to each component’s
instruction manual.
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Damaged product.
If the product is damaged or does not
function properly, do not use it.
Contact an Olympus representative or
an authorized service center.
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Use
WARNING!
Infection control risk.
Do not open the battery compartment
until the procedure has been
completed. The light source will become
unsterile.
• Before use, sterilize the light source
with inserted batteries.
• Do not replace the batteries during
the procedure.
• Always have a spare light source
available in order to replace the light
source in case of malfunction.
Before use.
Make sure that the product has been
properly reprocessed, inspected, and
tested.
BF
DANGER!
Serious effect on cardiac function.
The endoscope, the video equipment,
and the light source are classified as
type BF instruments according to
IEC 60601-1. Therefore, never touch
the endoscope, or any of the
instruments used in this procedure, to
the heart or an area near the heart.
This can seriously affect the cardiac
function of the patient (ventricular
fibrillation, etc.).
Switching on.
• Switch on the light source.
The battery indicator glows green.
The LED illuminates.
NOTE!
The light source can be switched on
again immediately after use. No waiting
time is required.
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WARNING!
Risk of eye injury to the patient and/
or user (light-emitting diode (LED)
radiation).
• Use the light source only when
connected to a compatible
endoscope.
• Do not point towards the patient’s eye
with the distal end of the endoscope
or the light source’s socket.
• Do not look directly into the distal end
of the endoscope or the light source’s
socket.
Procedure
Procedure.
• Perform the procedure.
Battery indicator.
The battery indicator displays
information on the status of the light
source’s batteries.
When the light source has been
switched on, the battery indicator
displays one of the following three
statuses:
- Continuous green:
The batteries are charged.
- Continuous yellow:
The batteries are almost completely
discharged and must be replaced or
recharged soon.
- Flashing yellow:
The batteries are discharged and
must be replaced or recharged
immediately.
NOTE!
When the batteries must be replaced,
stop using the light source.
• To replace or recharge the batteries,
refer to section “Replace Batteries”.
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CAUTION!
Risk of damaging the instrument.
• Only use the batteries listed in the
accessory sheet titled “EndoLED:
Compatible Batteries”. The use of
other batteries may damage the
instrument during reprocessing.
After Use
Switching off.
• Switch off the light source.
Detach the light source WA91500A
from a rigid endoscope.
• Press and hold the light source’s
release button.
• Remove the endoscope’s light-guide
connector from the light source’s
socket.
• Remove the light-guide adapter(s)
from the endoscope’s light-guide
connector.
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Detach the light source WA91500A
from a flexible endoscope.
• Press and hold the light source’s
release button.
• Remove the light source and lightguide adapter O0332 from the
endoscope.
• Remove the light-guide adapter(s)
from the endoscope’s light-guide
connector.
Detach the light source WA91502A
from the endoscope.
• Loosen the locking screw.
• Remove the endoscope’s light-guide
connector from the light source’s
socket.
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Preparation for reprocessing at the
point of use.
• Wipe the product with a soft, lint-free
cloth that has been moistened.
• Immediately bring the product to the
reprocessing area.
• Reprocess the product following the
instructions in this manual and in the
Olympus Endoscopy System Guide.
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