OLYMPUS Compact Cystoscope Instructions WS1588-1 Aug 2012.pdf
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INSTRUCTIONS
COMPACT CYSTOSCOPE, OP TELESCOPE
A37025A, A37026A, A37027A, WA37025B, WS1588/1
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
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General
Information
A37025A
A37026A, A37027A, WS1588/1
WA37025B
Intended use.
OP telescope for use in percutaneous
nephroscopy and pediatric cystoscopy.
Compact cystoscopes for use in cystoscopy in pediatric applications.
Adapter for use as a meatus stopper
in cystoscopy in pediatric applications.
Do not use these products for any
purpose other than their intended use.
Medical use. These products are to
be used only in a medical facility by
trained medical personnel.
✓
+
NOTE!
Instruction manual set.
The complete instruction manual set
for these products consists of this
product-specific instruction manual
(delivered together with the product)
and the system-related instruction
manual, entitled “Olympus Endoscopy
System Guide” (supplied separately).
Immediately contact an Olympus
representative if either manual is
missing or lost.
Keep the instruction manual set in a
safe, accessible location.
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.
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0197
A37025A
A37026A
A37027A
WS1588/1
WA37025B
Medical Device Directive (Europe).
These products comply 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 A37025A.
• OP telescope A37025A
• Instrument tray A05961A
• Sealing caps A0387
• Instruction manual
Contents WA37025B.
• Adapter
• Instruction manual
Contents A37026A.
• Compact cystoscope A37026A
• Instrument tray A05961A
• Sealing caps A0387
• Instruction manual
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Contents WS1588/1.
• Compact cystoscope WS1588/1
• Instruction manual
Contents A37027A.
• Compact cystoscope A37027A
• Instrument tray A05961A
• Sealing caps A0387
• Instruction manual
Unpacking (not for WS1588/1).
• Remove the instrument from the
packaging. Do not use the packaging for routine storage.
• Open the instrument tray.
• Remove the transport safeguard
from the telescope’s proximal end.
• Remove the telescope from the
instrument tray.
Unpacking (only for WS1588/1).
• Remove the instrument from the
packaging. Do not use the packaging for routine storage.
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Terminology
➀
➁
➂
OP telescope A37025A.
➀ Distal end
➁ Locking cone
➂ Light-guide connector
➃ Finger rest
➄ Irrigation port
➅ Instrument port
➃
➃
➀
➁
➅
➄
Compact cystoscope A37026A,
WS1588/1.
➀ Distal end
➁ Light-guide connector
➂ Finger rest
➃ Irrigation port
➄ Instrument port
➂
➄
➃
➂
➀
➁
Compact cystoscope A37027A.
➀ Distal end
➁ Light-guide connector
➂ Finger rest
➃ Irrigation port
➄ Instrument port
➂
➂
➄
➃
➃
➄
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Technical Data
Cat.No.
Size Length Working
[Fr.] [mm] channel
[Fr.]
A37025A 9.5/10.7
A37026A 6.4/7.9
A37027A 6.4/7.9
WS1588/1 8.0/9.8
6
220
160
160
160
7.5
4.2
4.2
5.5
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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.
A03200A
A3290
WA03200A
A37025A
A37026A
A37027A
WS1588/1
MH-999E
AR-T10
A0460
O0332
A0387
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A37022A
(S-1419/1)
A37025A
6 Fr.
A37025A
A37025A
WA37025B
3.5 Fr.
A37026A
A37027A
5.5 Fr.
WS1588/1
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Before Use
WARNING!
Infection control risk. Properly reprocess the product before the 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.
CAUTION!
Risk of damaging the instrument.
This product is a precision optical
device. Make sure that this product is
handled with extreme care.
Inspection and
Testing
Inspecting the product. Visually inspect the product:
• Make sure that it has no corrosion,
dents or scratches.
• Check all stopcocks for easy
operability.
• Make sure that the sealing caps
are not damaged.
Test image quality.
• Place the OP telescope’s or compact cystoscope's distal end in a
glass filled with sterile water.
• Observe an object approximately
10 - 40 mm from the objective
lens. The object must be clearly
visible through the OP telescope/
compact cystoscope.
®
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Damaged product. If the product is
damaged or does not function properly, contact an Olympus representative
or an authorized service center.
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CAUTION!
Wear (for sealing caps). When used
as intended, this product is subject to
wear, depending on the intensity of
use.
If a product has externally visible defects, contact the responsible
Olympus representative at once.
Later guarantee claims are forfeited.
Any guarantee claims are void by
previous use.
Replace if necessary. If the instrument is damaged or does not function
properly, replace it.
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Use
Before use. Make sure that the
product has been properly reprocessed, inspected and tested.
Preparation
Light-guide cable.
• Only when using A03200A: Remove
the light-guide adapters.
• Connect the telescope’s light-guide
connector to a compatible Olympus
light-guide cable.
• Connect the light-guide cable to a
compatible Olympus light source.
Adapters on the light-guide connector. The nested light-guide
adapters allow the telescope to be
connected to light-guide cables of
various manufacturers. When using a
non-Olympus light-guide cable, remove any inappropriate adapters.
Olympus recommends the use of an
Olympus light-guide cable and an
Olympus light source.
Only this combination will guarantee
optimum illumination of the endoscopic image and color reproduction.
A0460
O0332
Connect the irrigation tubing.
• Connect the irrigation tubing to the
Luer-lock connectors.
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Connect the adapter to the
A37025A OP-telescope (only for
cystoscopic applications).
• If desired, connect the adapter
WA37025B to the OP-telescope.
Procedure
Light source.
• Turn on the light source.
Cystoscopy.
• Apply a medical-grade, water-soluble lubricant to the OP telescope or
compact cystoscope.
• Carefully introduce the OP telescope or compact cystoscope
under visual control into the
urethra, advancing it into the urinary bladder.
Percutaneous nephroscopy.
• Insert the OP telescope into the
outer sheath.
• Make sure that the outer sheath’s
release button is aligned with the
red dot on the OP telescope’s locking cone.
• Press the OP telescope's locking
cone into the outer sheath’s automatic locking ring.
• Insert the outer sheath and OP
telescope into the patient.
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WARNING!
Injury and damage from thermal
exposure. Light sources emit large
amounts of energy. As a result:
- The light-guide connector and the
telescope’s distal end become
extremely hot.
- The light energy is concentrated in
a relatively small area.
Risks:
- Thermal injury to the patient’s tissue (e.g. from prolonged exposure
to the intense illumination in cavities with small lumens, or if the
telescope’s distal end is placed into
close proximity with the tissue).
- Burns to the patient’s or user’s
skin.
- Burns or thermal damage to surgical equipment (e.g. surgical
drapes, plastic materials, etc.).
Countermeasures:
- Avoid prolonged exposure to intense illumination.
- Use the minimum level of illumination necessary to satisfactorily
illuminate the target area.
- Do not place the telescope’s distal
end or the light-guide connector on
the patient’s skin, on flammable
materials, or on heat-sensitive
materials.
- Do not touch the telescope’s distal
end or the light-guide connector.
- Turn the light source off when detaching the telescope from the
light-guide cable.
- Allow the telescope and the lightguide cable to cool down after use.
Introduce a surgical instrument.
• Select a compatible flexible surgical instrument.
• When using a surgical instrument
with jaws, close the jaws.
• Introduce the distal end of the surgical instrument through the
sealing cap into the instrument
port.
• Open the instrument stopcock.
• Advance the surgical instrument
until its distal end becomes visible
in the endoscopic image.
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CAUTION!
Risk of damaging the instrument.
Do not close the instrument stopcock
when a surgical instrument is
inserted.
CAUTION!
Reduced irrigation capacity. With
the surgical instrument introduced,
the irrigation capacity is reduced. If
this reduction prevents the visual field
from being cleared, we recommend
using pressure systems (pressure
cuff, roller pump, syringes).
Procedure.
• Perform the procedure.
After Use
Remove the surgical instrument.
• When using a surgical instrument
with jaws, close the jaws.
• Remove the surgical instrument.
Light source.
• Turn off the light source.
• Detach the light-guide cable from
the OP telescope or compact cystoscope.
Reprocessing.
• 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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Reprocessing
WARNING!
Infection control risk. Properly reprocess the product before the 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.
Observe the following instrumentspecific instructions.
Information in this section. The following reprocessing information supplements that in the Olympus Endoscopy System Guide.
However, if the information given in
this section differs from that in the
Olympus Endoscopy System Guide,
use the information given here.
➀
➁
➂
➃
➄
A37025A, A37026A
A37027A,
WA37025B,
WS1588/1
Manual or automatic cleaning
+
Ultrasonic cleaning
Disinfection or high-level disinfection
+
Gas sterilization (ETO)
+
Steam sterilization (autoclaving)
+
Compatible reprocessing methods.
This product is compatible with the
reprocessing methods listed in the table. For details of the procedures, refer to the Olympus Endoscopy System
Guide.
+ compatible
- incompatible
CAUTION!
Risk of damaging the instrument.
Do not use incompatible reprocessing
methods for this instrument. Instrument damage may occur.
Cleaning
CAUTION!
Risk of damaging the telescope.
Always clean each telescope
separately. Do not clean with other
telescopes or other instruments.
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Sterilization
Instrument tray A05961A.
• Open the instrument tray.
• Insert the instrument into the instrument tray as shown in the
loading charts below.
• When loading the instrument tray,
press the instrument into the
notches of the silicone bars as
shown in the illustration at left.
• Close the instrument tray.
• Before sterilization, seal the instrument tray in packaging appropriate
for sterilization according to your
hospital’s protocol.
Instrument tray A05961A, loading
charts.
A37025A, A37026A, WS1588/1: top
chart
A37027A: bottom chart
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Repair
®
Policy. Contact your Olympus representative or an authorized service
center for repair and warranty information.
Repair guidelines. Follow the general
repair guidelines in the Olympus
Endoscopy System Guide.
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Phone: +49 40 669 66-0
7.049.776 7.0_12/08
© Copyright 2008 Olympus Winter & Ibe GmbH
Printed in Germany