Pentax 9106 User manual

D04-IFU-0001400 Revision: B
Instructions for Use
Operating Manual
Rigid Laryngostroboscope,
Models 9106 and 9108
PENTAX of America, Inc.
3 Paragon Drive
Montvale, NJ 07645-5297 USA
Toll-Free Telephone: [phone] (In USA and Canada only
Tel: [phone]
Service: [phone]
email: [e-mail]
Web: www.pentaxmedical.com/us

Revision: B 2 D04-IFU-0001400
© PENTAX of America, Inc. All rights reserved.
The information in this publication may be changed at any time, without prior
notice. While technical inaccuracies, typographical errors, and editorial omissions
may occur, PENTAX of America, Inc. disclaims all direct, indirect or consequential
damages that may result from such errors. PENTAX of America, Inc. will make
every effort to correct the deficiencies in new editions and updates.
Distributed by:
PENTAX of America, Inc.
3 Paragon Drive
Montvale, NJ 07645-1725 USA
Tel: [phone]
Toll Free: [phone]
Fax: [phone]
STERRAD®is a registered trademark of Advanced Sterilization Products. All other
trademarks are the property of their respective owners.

D04-IFU-0001400 3 Revision: B
Table of Contents
1Introduction ............................................................................ 4
1-1 Intended Use............................................................................ 4
1-2 Warnings and Precautions ....................................................... 4
1-3 Using this Manual .................................................................... 5
2Specifications ......................................................................... 5
2-1 Components ............................................................................ 5
2-2 Appearance .............................................................................. 6
2-3 Specifications ........................................................................... 6
2-4 Environmental and Storage Conditions .................................... 7
2-5 Prolonging the Life of the Rigid Laryngostroboscope .............. 7
3Preparation and Use................................................................ 8
3-1 Assembly ................................................................................. 8
3-2 Cleaning, High Level Disinfection, and Sterilization.................. 9
3-2-1 Cleaning ......................................................................... 9
3-2-2 High Level Disinfection ................................................ 10
3-2-3 Sterilization................................................................... 10
3-3 Use......................................................................................... 11
4Disposal................................................................................ 12
5Warranty ............................................................................... 12

Revision: B 4 D04-IFU-0001400
1Introduction
The PENTAX Medical Rigid Laryngostroboscopes, Model 9106 (9106)
and Model 9108 (9108), provide optimal viewing of the vocal folds with a
maximum transmission of light. The fiberoptic cable of the rigid
Laryngostroboscope is continuous from the distal end of the cable to the
tip of the rigid Laryngostroboscope (i.e., there is no detachment where
the cable inserts into the rigid Laryngostroboscope). This provides the
user with bright, clear, high-quality imaging capabilities. This instrument
is intended to observe glottic action with the use of a stroboscopic light
source.
1-1 Intended Use
The Rigid Laryngostroboscopes, Models 9106 and 9108, are intended to
observe glottic action with the use of a stroboscopic light source. The
instrument is inserted perorally when indications consistent with the
need for observation are observed. Never use these
Laryngostroboscopes for any purpose other than that for which they
have been designed.
1-2 Warnings and Precautions
Warning
You should read and understand the instructions in this manual
before you perform any procedures using the
9106 or 9108.
Failure to do so may result in injury to the patient or damage to
the instrument.
Caution
Failure to follow the enclosed maintenance instructions could
render the
9106 or 9108 non-usable and void any effective
warranty.

D04-IFU-0001400 5 Revision: B
Warning and Caution messages appear throughout this manual in the
following formats:
Warning
Warning messages tell you about conditions that could result in
death or serious injury.
Caution
Caution messages tell you about problems that might result in
minor
or moderate injury, or property damage.
1-3 Using this Manual
This manual uses the following conventions:
Convention
Definition
Note Important information about a subject or the use of the
device. Failure to follow a note can result in
configuration or installation issues.
Italics
Reference to other sections in this manual or to other
documents.
2Specifications
2-1 Components
The 9106 and 9108 include the following components:
•Rigid Laryngostroboscope
•PENTAX Medical Laryngeal Stroboscope Adaptor, Model 7175-4200

Revision: B 6 D04-IFU-0001400
2-2 Appearance
Figure 1. Rigid Laryngostroboscope
2-3 Specifications
9106
Specifications
Total Length 252 mm
Working Length 189 mm
Outer Diameter 9.5 mm
Actual Visual Field Angle 35 degree
Angled View 70 degree
Depth of Field 2 mm-40 mm
Integral Light Cable Yes
Light Guide Length 1727 mm
9108
Specifications
Total Length 226 mm
Working Length 186 mm
Outer Diameter 6 mm
Actual Visual Field Angle 35 degree
Angled View 70 degree
Depth of Field 2 mm-40 mm
Integral Light Cable Yes
Light Guide Length 1750 mm

D04-IFU-0001400 7 Revision: B
2-4 Environmental and Storage Conditions
The 9106 and 9108 require the following conditions:
Operating Conditions:
•
Temperature: 10ºC to 40ºC (50ºF to 104ºF)
•
Relative humidity: 20% to 80%
(non-condensing)
•
Atmospheric pressure: 700mb to 1060mb
(0.69atm to 1.05atm)
Storage/Transportation
Conditions
•
Temperature: –10ºC to 60ºC (14ºF to
140ºF)
•
Relative humidity: 20% to 80%
(non-condensing)
•
Atmosphere pressure: 700mb to 1060mb
(0.69atm to 1.05atm)
2-5 Prolonging the Life of the Rigid
Laryngostroboscope
The 9106 and 9108 provide high-quality performance over many
examinations. The following precautions are essential to guarantee their
longevity:
•Bend the fiberoptic cable as little as possible. Never kink the cable.
Excessive bending causes fiberoptic bundles to break and results in
diminished transmission of light.
•If the quality of the rigid Laryngostroboscope becomes significantly
degraded as a result of broken fibers, the entire rigid
Laryngostroboscope must be replaced. You cannot replace the
cable.
•Do not scratch the lenses of the rigid Laryngostroboscope.

Revision: B 8 D04-IFU-0001400
3Preparation and Use
3-1 Assembly
You can connect the 9106 and 9108 with several light sources.
To use without a camera:
1. Insert the cable into a light source and look through the eyepiece
(an adaptor may be required). When using the PENTAX Medical
Laryngeal Stroboscope, Model 9400, the 7175-4200 adaptor
provided with the rigid Laryngostroboscope should be used.
2. Use the brightness adjustment on the front panel of the PENTAX
Medical Laryngeal Stroboscope, Model 9400, to control the amount
of light to the rigid Laryngostroboscope.
To use with a C-mount camera and attachment lens (e.g., with
PENTAX Medical’s 3-CCD HD Camera, Model 9214HD, and Lens
Coupler, such as Model 9118B):
Figure 2. Rigid Laryngostroboscope
1. Screw the attachment lens into the C-mount of the camera.
2. Insert the rigid Laryngostroboscope eyecup into the lens coupler.
3. Align the eyecup and adaptor, and lock them into place using the
screw.
Caution
You must loosen the screw prior to removing the adaptor from
the eyecup in order to avoid dama
ge to the rigid
Laryngostroboscope
.
Note
To use the 9106 or 9108 with other light sources, adaptors
may be required. Please
contact your local representative for
information
.

D04-IFU-0001400 9 Revision: B
3-2 Cleaning, High Level Disinfection, and
Sterilization
Warning
The 9106
and 9108 are provided in a non-sterilized condition. Do
not use until you clean, disinfect and sterilize the
rigid
Laryngostroboscope
, as this could result in bodily harm to the
patient
.
3-2-1 Cleaning
Caution
Meticulous and thorough cleaning of the device is required in
order to achieve high level
disinfection or sterilization. Failure to
properly clean the device will result in ineffective or incomplete
high level disinfection or sterilization.
Caution
Do not immerse
the rigid Laryngostroboscope longer than
required
in disinfectant solution. This can cause damage,
including
clouding of the lenses and loosening of gluing agents.
Note
Avoid any harsh materials that can scratch or mar optical
and outer surfaces of the device.
Note
Remove any detachable items or components and
process these in
a similar manner.
After every use, wash and clean each device, removing all tissue,
materials, and debris.
1. Prepare an enzymatic detergent solution as recommended by the
manufacturer. Add a sufficient volume of the prepared solution to a
basin to cover the devices. (Note: The cleaning validation study was
performed using KlenzymeTM from Steris Corporation.)
2. Leave the devices to soak for two minutes at the temperature
recommended by the detergent manufacturer. This will remove
proteinaceous material from the devices.

Revision: B 10 D04-IFU-0001400
3. After completing the soaking procedure, remove the devices from
the basin of detergent solution and rinse them thoroughly under
lukewarm, running tap water for a minimum of one minute.
4. Clean the devices with a general purpose detergent for healthcare
facilities, prepared in accordance with the manufacturer’s
recommendations. (Note: The cleaning validation study was
performed using Manu-Klenz® from Steris Corporation.)
5. Use a soft-bristled brush to manually clean the device while it is
immersed in the general purpose detergent solution, concentrating
on any crevices, seams, or other surface discontinuities.
6. Rinse the device thoroughly under lukewarm, running tap water for
a minimum of one minute.
7. Dry the device with a clean, soft cloth.
3-2-2 High Level Disinfection
There are two options for high level disinfection:
•Totally immerse the device in a 2.4% Glutaraldehyde prepared as
recommended by the manufacturer, for 45 minutes at 25ºC.
•Totally immerse the device in a CIDEX® OPA, prepared as
recommended by the manufacturer, for 12 minutes at 20ºC.
3-2-3 Sterilization
Caution
Do not
autoclave. Exposure to temperatures greater than 60˚C
(140˚F)
can damage the device and render it unusable.
There are three options for sterilization:
•Totally immerse the device in a 2.4% Glutaraldehyde solution for
the time and at the temperature recommended by the manufacturer
to achieve liquid chemical sterilization.
•Use Ethylene Oxide (EtO) according to the following parameters:
•EtO concentration: 600 ±30 mg/L
•Humidity: 70% ±5%
•Exposure: 240 minutes
•Degas at standard cycle: 12 hours at 55ºC ±2ºC

D04-IFU-0001400 11 Revision: B
•This device is compatible with STERRAD®100S when following the
sterilant manufacturer’s procedures and guidelines.
3-3 Use
Caution
Thoroughly inspect the device before each use.
Check the
function of the device and
visually inspect optics for moisture or
contamination. Do not drop
the device or subject it to sudden
impact.
Refer to section 5, Warranty for information about
damage to the device.
Caution
Never insert the
rigid Laryngostroboscope in water or any other
substance or agent with a temperature greater than 150 ºF (65
ºC). Hot beads can damage the
rigid Laryngostroboscope and
should not be used for anti
-fogging.
Note
The optimal working distance from the distal window for
vi
sual use of this rigid Laryngostroboscope is 5 to 50 mm.
Note
The angle of entry with the 70-degree rigid
Laryngostroboscope
is markedly different from the 90-degree
rigid
Laryngostroboscope to which you may be accustomed.
Instead of the
rigid Laryngostroboscope pointing upward in the
patient’s mouth, the 70
-degree rigid Laryngostroboscope angles
downward to allow a closer view
of the vocal fold.
Warning
Although complications resulting from use of a rigid
Laryngostroboscope
for viewing the larynx are extremely rare,
the following risks are possible:
•
Laryngospasm.
•
Blood pressure elevation during procedure.
•
Bleeding as a result of injury caused by improper scoping
procedure.
•
Adverse reaction to anesthetic (if used to prevent gagging).

Revision: B 12 D04-IFU-0001400
To use the 9106 or 9108:
1. Follow cleaning and high level disinfection or sterilization procedures
in section 3-2,
Cleaning, High Level Disinfection, and Sterilization .
2. To avoid fogging:
Note
You can apply various anti-fogging solutions to the
lens of the
rigid Laryngostroboscope to help prevent fogging;
inquire at medical or dental supply houses.
a. Dip the working end of the rigid Laryngostroboscope into a
container with hot tap water for 10-20 seconds.
b. Blot with a soft tissue prior to insertion into patient’s mouth.
You may have to repeat this during the scoping procedure.
4Disposal
This product is a medical device. In accordance with
European D
irective 2002/96/EC on Waste Electrical and
Electronic Equipment, this symbol indicates tha
t the
product must not be disposed of as unsorted waste, but
should be collected separately. Contact your local PENTAX
distributor for correct disposal and recycling
. By disposing
of this product correctly you will help
ensure that the
waste undergoes the necessary treatment, recovery and
recycling and thus prevent potential negative effects on
the environment and human health which could otherwise
arise due to inappr
opriate waste handling.
Note
Follow local, state, and federal guidelines for the proper
disposal of waste products.
5Warranty
All devices are guaranteed against defective materials and workmanship
for one (1) year. This is a sealed unit and all repairs must be made by
factory-trained personnel only. Improperly treated, misused, mishandled
or out-of-warranty products will be repaired or replaced for a fee.