1288_hd_urology_camera_head_user_guide_aug_2010.pdf
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1288 HD Urology
Camera Head
User Guide
1288310130
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Contents
User Guide. ........................................................................................ 1
Guide de l’utilisateur................................................................. 23
Benutzerhandbuch...................................................................... 45
Manuale d’uso................................................................................ 67
Manual do Utilizador.................................................................. 89
Guía del usuario.......................................................................... 113
Gebruikershandleiding. .......................................................... 135
Brugervejledning........................................................................ 157
Käyttöohje...................................................................................... 179
Brukerhåndbok............................................................................ 201
Användarhandbok...................................................................... 223
Podręcznik użytkownika. ........................................................ 245
Οδηγός χρήσης............................................................................ 267
用户指南. ............................................................................................. 289
ユーザーガイド. ................................................................................. 311
사용 설명서. ....................................................................................... 333
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Contents
Warnings and Cautions. .......................................................3
Symbol Definitions..................................................................5
Product Description and Intended Use. .....................6
Indications/Contraindications.......................................................6
Product Features..........................................................................6
Setup...............................................................................................8
Operation....................................................................................10
Using the Urology Camera Head Buttons..................................10
Adjusting the Focus....................................................................13
Cleaning, Reprocessing, and Maintenance............14
Reprocessing the Urology Camera Head...................................14
Using Sterile Drapes...................................................................20
Technical Specifications....................................................21
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Warnings and Cautions
Please read this manual and follow its instructions carefully.
IMPORTANT SAFETY NOTICE: Before operating this device, please read
this operating manual thoroughly and carefully. When using this device
with a light source, fire and/or severe injury may result to the patient, user,
or inanimate objects if the instructions in this manual are not followed.
All light sources can generate significant amounts of heat at the scope
tip, the scope light post, the light cable tip, and/ or near the light cable
adapter. Higher levels of brightness from the light source result in higher
levels of heat. Always adjust the brightness level of the camera and the
monitor before adjusting the brightness level of the light source. Adjust the
brightness level of the light source to the minimum brightness necessary
to adequately illuminate the surgical site. In addition, adjust the internal
shutter of the camera higher in order to run the light source at a lower
intensity. Avoid touching the scope tip or the light cable tip to the patient,
and never place them on top of the patient, as doing so may result in burns
to the patient or user. In addition, never place the scope tip, the scope light
post, the light cable adapter, or the light cable tip on the surgical drapes or
other flammable material, as doing so may result in fire. Always place the
light source in standby mode whenever the scope is removed from the light
cable or the device is unattended. The scope tip, scope light post, light cable
adapter, and light cable tip will take several minutes to cool off after being
placed in standby mode, and therefore may still result in fire or burns to the
patient, user, or inanimate objects.
Warnings and Cautions
To avoid potential serious injury to the user and the patient and/or damage
to this device, please note the following warnings:
1. Be a qualified physician, having complete knowledge of the use of this device.
2. Carefully unpack this device and check if any damage occurred during
shipment. If damage is detected, refer to the standard warranty.
3. Read this operating manual thoroughly, especially the warnings, and be
familiar with its contents before connecting and using this device.
4. Read the entire instruction section of the manual before assembling
or connecting the camera.
5. Pay close attention to the care, cleaning, disinfection, and sterilization
instructions in this manual. Any deviation may cause damage.
6. Test this device prior to a surgical procedure. This device was fully tested
at the factory before shipment. Never use this device in the presence of
flammable or explosive gases.
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7. Avoid disassembling any part of the camera head, as doing so may break the
seals, causing leakage and/or electric shock. This device has been factory
sealed to prevent moisture from entering electronic components. If the
camera head or cable seal is intentionally broken, the warranty will be void.
8. Before each use, check the outer surface of the camera and endoscope to
ensure that there are no rough surfaces, sharp edges, or protrusions.
9. Using the camera head with broken connector tabs may damage the CCU. If
any tab is missing or damaged, please refer to the Stryker Standard Warranty.
10. Ensure that readjustments, modifications, and/or repairs are carried out by
persons authorized by Stryker Endoscopy. Attempt no internal repairs or
adjustments not specifically detailed in this operating manual. Doing so may
result in unintended performance or product damage.
11. Always treat the urology camera with care. The camera system contains
sensitive parts that are precisely aligned and may suffer damage if dropped
or mistreated.
12. Repeated sterilization via Ethylene Oxide may result in degradation in image
quality.
The warranty is void if any of these warnings are disregarded.
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Symbol Definitions
In addition to the cautionary symbols already listed, other symbols found on the
1288 HD Urology Camera Head and in this manual have specific meanings that
clarify the proper use and storage of the 1288 HD Urology Camera Head. The
following list defines the symbols associated with this product:
Warns of presence of important operating and maintenance
instructions in the manual
Date of manufacture
Legal manufacturer
SN
Serial number
Catalogue number
Operating humidity ratings
Operating pressure ratings
Operating temperature ratings
Denotes compliance to CAN/CSA C22.2 No 601.1- M90
UL60601-1.
Type BF applied part
This symbol indicates that the waste of electrical and electronic
equipment must not be disposed as unsorted municipal waste
and must be collected separately. Please contact the manufacturer
or other authorized disposal company to decommission your
equipment.
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Product Description and Intended Use
The 1288 HD Urology Camera Head is a high-definition camera used to capture
still and video images of endoscopic urology procedures. It is designed with a 90°
angle between the camera head and the scope to allow for easier access during
urology procedures.
The urology camera head is used in conjunction with the 1288 HD Camera
Console (REF 1288010000; REF 1288010001).
Indications/Contraindications
The 1288 HD Urology Camera is indicated for use in general laparoscopy,
nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever
a laparoscope/endoscope/arthroscope is indicated for use. A few examples
of the more common endoscopic surgeries are laparoscopic cholecystectomy,
laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic
lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic
and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction,
knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression
fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy,
pleurodesis, internal mammary artery dissection for coronary artery bypass,
coronary artery bypass grafting where endoscopic visualization is indicated
and examination of the evacuated cardiac chamber during performance of
valve replacement. The users of the camera are general surgeons, gynecologists,
cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT
surgeons and urologists.
There are no known contraindications.
Product Features
The urology camera head connects to the camera console and captures video
and photographic images, which it relays to the camera console. It features several
controls that are accessible through a button keypad located on the top of the
urology camera head (see the “Operation Instructions” section of this manual).
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1
2
3
4
5
8
6
7
1. Endoscope
—
2. Endobody clamp
Secures the scope to the camera head
3. Endobody brake
Prevents rotation of scope
4. Focusing knob
Adjusts the focus of the camera head
5. 1288 HD Urology Captures photographic and video images and provides
camera head
camera controls
6. Urology camera
cable
—
7. Cable connector
Connects the camera head to the camera console
8. Soaking cap
Protects the cable connector during cleaning and
sterilization
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Setup
1. Set up the 1288 HD Camera Console according to the instructions provided
in its user manual.
2. Connect the urology camera head to the console.
•
Unscrew the soaking cap from the cable connector if necessary.
• Align the blue arrow on the cable connector with the blue arrow
on the urology camera-connector port on the front console panel.
• Push in the connector until it locks in place.
• (To unplug the urology camera from the control unit, grasp the
knobbed portion of the connector and pull straight out.)
3. Attach an endoscope to the urology camera head.
• Remove the red dust cap if it is present.
• Lock the endobody brake by pushing it to the right.
•
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Twist the endobody clamp and hold it open.
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•
Insert the endoscope into the endobody clamp.
•
Twist the endobody brake in the reverse direction to secure the
endoscope.
4. Attach a light cable from the light source to the light post on the endoscope.
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Operation
Warning: Before using the 1288 HD Urology Camera in a
surgical procedure, test all components to ensure proper
function. Ensure that a video image appears on all video
monitors before beginning any procedure.
The 1288 HD Urology Camera can be controlled using buttons on the camera
head or the touchscreen interface on the console.
Using the Urology Camera Head Buttons
The urology camera head features an oval, two-button keypad for controlling the
1288 urology camera. These buttons are labeled P and W.
P (Picture) Button
The P button controls up to two remote video accessories.
• Press the P button for less than two seconds to select Remote 1. One beep
will sound.
• Press the P button for more than two seconds to select Remote 2. Two beeps
will sound.
W (White Balance) Button
The W button activates the white-balance function or the light/zoom function.
The white balance function is used to correct slight color differences that exist
between different light sources or endoscopes.
• Press the W button for more than two seconds to activate the white balance
function.
• Press the W button for less than two seconds to increase the zoom one of
eight levels. (The zoom will cycle to the lowest level after completing the
cycle.)
Perform the white balance procedure before every surgical procedure.
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Note: Ensure that a scope and light source are attached to the camera, and that
the camera, light source and monitor are powered on before adjusting the white
balance.
1. Point the scope at several stacked 4 × 4 white gauze pads, a white laparoscopic
sponge, or any clean white surface.
2. Look at the monitor and make sure that no glare is visible off of the white
surface.
3. Press and hold the W button until “WHITE BALANCE IN PROGRESS”
begins flashing on the video monitor.
4. Continue pointing the scope at the white surface until the video monitor
indicates that white balance is “WHITE BALANCE COMPLETE.” The video
picture may change color. If you cannot achieve an acceptable white balance,
refer to the 1288 HD Camera Console user guide.
Using the Touchscreen Interface
The touchscreen interface on the console provides controls for operating the
camera and selecting system settings. From the touchscreen, you can:
• choose camera settings for urology procedures
• capture photos
• capture video
• activate white balance
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Scroll through preset camera settings designed for
surgical specialties. Choose from:
•
•
•
•
•
Arthroscopy
Cystoscopy
ENT
Flexi-Scope
Hysteroscopy
•
•
•
•
Laparoscopy
Laser
Microscope
Standard
Capture photo.
Press and hold button for two seconds before
it activates.
Capture video.
Press and hold button for two seconds before
it begins recording. Press again to stop.
Activate white balance.
Press and hold button for two seconds before
it activates.
•
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Press once to proceed to the Menu screen.
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Adjusting the Focus
Slide the focusing knob to the left or right to adjust the focus.
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Cleaning, Reprocessing, and
Maintenance
Reprocessing the Urology Camera Head
These reprocessing instructions are provided in accordance with ISO 17664,
AAMI TIR12, AAMI ST79, and AAMI ST81. While they have been validated
by Stryker as being capable of preparing the device for re-use, it remains the
responsibility of the processor to ensure that the reprocessing as actually
performed, using equipment, materials, and personnel in the reprocessing
facility, achieves the desired result. This normally requires validation and
routine monitoring of the process. Stryker recommends users observe these
standards when reprocessing medical devices.
Warnings
•
•
•
•
This device must be cleaned and sterilized prior to the first use and after
every subsequent use.
Use only the sterilization cycles outlined in this document. Using
unspecified sterilization cycles may damage the device or result in
incomplete sterilization.
Separate the urology camera head and scope prior to cleaning,
disinfection, or sterilization.
Wear appropriate protective equipment: gloves, eye protection, etc.
Cautions
•
•
•
•
•
•
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Always install the soaking cap prior to processing the urology camera.
Failure to properly tighten the soaking cap will corrode the connector
pins and void the warranty.
Inspect the camera cable for cuts and breaks before soaking in any fluid.
Return any damaged camera to Stryker for service.
Do not use brushes or pads with metal or abrasive tips during manual
cleaning, as permanent scoring or damage could result.
To minimize galvanic corrosion, avoid soaking dissimilar metals in close
proximity.
Never soak the camera in the same tray with sharp instruments.
Repeated sterilization via Ethylene Oxide may result in degradation
in image quality.
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Limitations on Reprocessing
•
•
•
•
Do not cross-sterilize the device. Using multiple sterilization methods
may significantly reduce the performance of the device.
Do not leave the device in solutions longer than necessary. This may
accelerate normal product aging.
Proper processing has a minimal effect on this device. End of life is
normally determined by wear and damage due to use.
Damage incurred by improper processing will not be covered by the
warranty.
Instructions
Point of Use
•
•
Wipe excess soil from the device using disposable paper towels.
If an automated reprocessing method will be used, rinse any channels
in the device with 50mL of sterile distilled water immediately after use.
Containment and Transportation
•
•
1
Reprocess the device as soon as reasonably practical following use1.
Transport the device in a tray to avoid damage.
A 30 minute wait time was used during cleaning validation.
Preparation for Cleaning
1. Disassemble the coupler from the scope and camera head.
2. Prepare an enzymatic detergent according to the manufacturer’s
recommendations (one ounce per gallon of tap water at 35 - 40°C)2.
3. Wipe the entire device with the detergent, using a clean cloth.
4. Immerse the device in the detergent. Using a syringe, inject any inside
regions of the device with 50mL of the detergent to ensure all parts of the
device are reached.
5. Soak the device in the detergent for a minimum of 15 minutes.
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Cleaning: Manual
1. Brush
• Prepare a fresh solution of enzymatic detergent according to the
manufacturer’s recommendations (one ounce per gallon of tap water
at 35 - 40°C)2.
• Thoroughly brush the exterior of the device with a soft-bristled brush,
focusing on any mated or rough surfaces.
• Using a syringe, inject any lumen or mated surface a minimum of
5 times with 50mL of the detergent.
• Brush any lumens a minimum of 5 times from each end, using an
appropriate bottle brush.
• Brush any movable parts in all extreme positions.
2. Rinse
• Rinse the device with reverse osmosis/de-ionized (RO/DI) water at
ambient temperature until all detergent residue is removed. Flush any
lumens or mated surfaces a minimum of 5 times. Once all detergent
residue is removed, continue to rinse for a minimum of 30 seconds.
• Drain excess water from the device and dry it using a clean cloth or
pressurized air.
• Visually inspect the device for cleanliness, paying close attention to
hard-to-reach areas. If visible soil remains, repeat steps 1 and 2.
3. Soak
• Prepare a non-enzymatic detergent according to the manufacturer’s
recommendations (0.25 ounces per gallon of tap water at 35 - 40°C)3.
• Fully immerse the device and use a syringe to inject any lumens and
mated surfaces with 50mL of the detergent.
• Soak the device for a minimum of 15 minutes.
4. Brush
• Thoroughly brush the exterior of the device using a soft-bristled brush.
• Using a syringe, inject 50mL of the detergent into any cannulae, lumens,
or mated surfaces a minimum of 5 times.
• Brush any lumens a minimum of 5 times from each end, using an
appropriate bottle brush.
• Actuate the device, brushing around any movable parts in all extreme
positions.
5. Rinse
• Thoroughly rinse the device with RO/DI water until all detergent
residue is removed. Flush any lumens or crevices a minimum of 5 times.
Once all detergent residue is removed, continue to rinse for a minimum
of 30 seconds.
• Drain the excess water from the device and dry it using a clean cloth or
pressurized air.
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Cleaning: Automated
1. Brush
• Using a syringe, inject 50mL of the enzymatic detergent (from the
“Preparation for Cleaning” section) into any lumen and mated surface
a minimum of one time.
• Brush from both ends of any lumens a minimum of 1 time, using an
appropriate bottle brush.
2. Rinse
• Rinse the device with RO/DI water at ambient temperature until there
is no visible detergent residue. Continue to rinse for a minimum of
30 seconds after all detergent residue has been removed.
• Place the device in the washer on an incline to facilitate drainage.
3. Automated wash
• Program the washer using the following parameters:
Phase
Recirculation
Time
Water
Temperature
Detergent Type and
Concentration
(if applicable)
Pre Wash
2 minutes
Cold tap
water
N/A
Enzyme
Wash
2 minutes
Hot tap water
Enzymatic Detergent2
Wash 1
2 minutes
Set point
(66°C)
Non-enzymatic Detergent3
Rinse 1
2 minutes
Hot tap water
N/A
Dry Phase
7 minutes
115°C
N/A
•
•
•
2
3
Upon completion of the draining phase after Rinse 1, stop the cycle and
open the washer door.
Remove the device from the washer during the thermal phase and place
the device back into the washer for the dry phase.
If necessary, use pressurized air to aid in drying. Visually inspect each
device for cleanliness.
ENZOL® Enzymatic Detergent is validated for cleaning efficacy.
Renu-Klenz® is validated for cleaning efficacy.
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Low Level Disinfection (optional)
1. Disinfect the device in a disinfecting solution that has one of the following
active Ingredients:
• ≥ 2.4% glutaraldehyde4 with a minimum soaking time
of 45 minutes at 25 °C
or
• ≥ 3.4% glutaraldehyde5 with a minimum soaking time
of 20 minutes at 25 °C
or
• ≥ 0.55% ortho-phthalaldehyde6 with a minimum soaking time
of 12 minutes at 25 °C.
2. Prepare the disinfecting solution according to the manufacturer’s
instructions.
3. Per manufacturer’s recommendations, immerse the device, filling all
lumens, in the disinfecting solution for the required time at the appropriate
temperature.
4. Thoroughly rinse and flush all parts and lumens with running,
demineralized water to remove the disinfectant.
5. Dry all parts with a lint-free towel immediately after rinsing.
CIDEX Activated® is validated for disinfection efficacy.
CIDEX Plus® is validated for disinfection efficacy.
6
CIDEX® OPA is validated for disinfection efficacy.
4
5
Drying
•
•
•
For automated drying, use the drying cycle provided with the washer/
disinfector.
For manual drying, use a lint-free cloth.
Dry any lumens with compressed air.
Maintenance, Inspection, and Testing
•
•
•
Inspect the device on a continual basis. If a problem is observed
or suspected, the device should be returned for repair.
Inspect all components for cleanliness. If fluid or tissue buildup
is present, repeat the above cleaning and disinfection procedures.
Inspect the camera cable for cuts and breaks. Return any damaged
urology camera to Stryker for service.
Packaging
N/A
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Sterilization
After performing the cleaning instructions specified above, perform one of the
following sterilization cycles.
Ethylene Oxide (EtO)
•
Double wrap camera head and cable prior to sterilization.
Preconditioning parameters
Temperature
55°C (131°F)
Chamber Humidity
70% RH
Vacuum Set Points
1.3 psia
Time
30 minutes
Exposure
Concentration (100% EtO)
725 mg/L
Temperature
55 ± 2°C (131 ± 5°F)
Time
1 hour
Chamber Humidity
70 ± 5% RH
Aeration parameters
Aeration Time
12 hours
Temperature
35 – 54°C (95 – 129°F)
Steris® System 1
1. Clean and prepare the urology camera head and cable as recommended in
the Cleaning section.
2. Sterilize the urology camera head and cable using Steris® System 1 with
Steris® Sterilant 20.
3. Allow the urology camera head, cable, and scope to completely dry before
reassembly. Any moisture may cause the camera window to fog during use.
Sterrad®
1. Clean and prepare the urology camera head and cable as recommended
in the Cleaning section.
2. Sterilize the urology camera head and cable using the Sterrad™ NX or
100S Sterilization System.
Storage
Never store the device in a non-ventilated, humid environment such
as a carrying case. This may present an infection control risk.
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Using Sterile Drapes
Using sterile drapes will ensure maximum longevity of your 1288 HD
Camera Head. For best results, follow the instructions provided by the drape
manufacturer.
Disposal
This product contains electrical waste or electronic equipment.
It must not be disposed of as unsorted municipal waste and
must be collected separately in accordance with applicable
national or institutional related policies relating to obsolete
electronic equipment.
The 1288 HD must be disposed of according to local laws and
hospital practices.
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Technical Specifications
60Hz settings are displayed first. (50Hz settings follow in parentheses.)
Imaging System
1/3” Progressive Scan CCDs
High Definition
Operating Conditions
Temperature: 5 – 40°C
Relative Humidity: 30 – 95%
Transport and Storage
Conditions
Temperature: -20 – 60°C
Relative Humidity: 10 – 95%
Atmospheric Pressure: 700 – 1060 hPa
Total Shipping Weight
1.5 lbs. (0.680 kg) Urology Camera head
Dimensions
Camera Head Cable to Camera Console:
10 ft (3.0 m) sealed cable
20 ft (6.1 m) cable extension available
Enhancement
8 levels (switchable)
Classification
Type BF Applied Part
Water Ingress Protection, IPX7—protected
against the effects of temporary immersion
in water
Complies with Medical
Safety Standards
IEC 60601-1:1988 + A1:1991 + A2:1995
IEC 60601-2-18:1996 + A1:2000
CAN/CSA C22.2 No 601.1-M90
UL 60601-1:2003
AS/NZS 3200.1.0:1998
CSA 22.2.601.1.1:2002
CAN/CSA C22.2 No. 601.2.18:1990
Please contact your local Stryker Endoscopy sales representative for information
on changes and new products.
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Table des matières
Avertissements et précautions d’emploi.................25
Définition des symboles....................................................27
Description et utilisation du produit..........................28
Indications/Contre-indications....................................................28
Caractéristiques du produit........................................................28
Montage.......................................................................................30
Utilisation. ..................................................................................32
Utilisation des boutons de la tête de caméra urologique...........32
Mise au point..............................................................................35
Nettoyage, retraitement et entretien.........................36
Retraitement de la tête de caméra urologique...........................36
Utilisation de housses stériles....................................................42
Caractéristiques techniques...........................................43
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Avertissements et précautions
d’emploi
Il convient de lire intégralement ce manuel et d’en suivre attentivement
les instructions.
AVIS DE SÉCURITÉ IMPORTANT : Lire attentivement ce manuel
d’utilisation avant d’actionner ce matériel. Lors de l’utilisation de ce matériel
avec une source de lumière, le non-respect des instructions contenues dans
ce manuel peut entraîner un incendie, des dommages aux objets inanimés
et/ou des blessures graves au patient ou à l’utilisateur. Toutes les sources
de lumière peuvent générer des volumes importants de chaleur à l’extrémité
de l’endoscope, au port d’éclairage de l’endoscope, à l’extrémité du câble
d’éclairage et/ou à proximité de l’adaptateur de câble d’éclairage. Des niveaux
plus élevés de luminosité de la source de lumière génèrent des niveaux
supérieurs de chaleur. Toujours régler le niveau de luminosité de la caméra
et du moniteur avant de régler le niveau de luminosité de la source de
lumière. Régler le niveau de luminosité de la source de lumière sur la
luminosité minimum nécessaire à l’éclairage adéquat du site chirurgical.
En outre, régler l’obturateur interne de la caméra à un niveau plus élevé
afin de faire fonctionner la source de lumière à une intensité inférieure.
Éviter que l’extrémité de l’endoscope ou du câble d’éclairage touche le patient
et ne jamais les placer sur le patient, sous risque d’entraîner des brûlures pour
le patient ou l’utilisateur. De plus, ne jamais placer l’extrémité de l’endoscope,
le port d’éclairage de l’endoscope, l’adaptateur du câble d’éclairage ou
l’extrémité du câble d’éclairage sur les champs opératoires ou tout autre
matériau inflammable. En effet, cela pourrait entraîner un incendie.
Toujours placer la source de lumière en mode de veille si l’endoscope
est retiré du câble d’éclairage ou si l’équipement est laissé sans surveillance.
Une fois que la source est placée en mode de veille, le refroidissement de
l’extrémité de l’endoscope, du port d’éclairage de l’endoscope, de l’adaptateur
de câble d’éclairage et de l’extrémité du câble d’éclairage prend plusieurs
minutes. Ces parties pourraient dès lors toujours entraîner un incendie
ou des brûlures pour le patient, l’utilisateur ou des objets inanimés.
Avertissements et précautions d’emploi
Pour éviter des blessures graves à l’utilisateur et au patient et/ou des dommages
à cet équipement, il convient de tenir compte des avertissements suivants :
1. L’utilisateur doit être un praticien qualifié, possédant une parfaite connaissance
du fonctionnement de l’équipement.
2. Déballer l’équipement avec précaution et vérifier qu’il n’a pas été endommagé
pendant le transport. Le cas échéant, consulter les termes de la garantie
standard.
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3. Lire intégralement le présent manuel d’utilisation, en particulier les
avertissements, et se familiariser avec son contenu avant de connecter
et d’utiliser l’équipement.
4. Lire intégralement les instructions du manuel avant d’assembler
et de connecter la caméra.
5. Il convient de prêter une grande attention aux recommandations d’entretien,
de nettoyage, de désinfection et de stérilisation présentées dans ce manuel.
Tout manquement dans ce domaine peut entraîner des dommages.
6. Tester l’équipement préalablement à toute procédure chirurgicale.
Cet équipement a été intégralement contrôlé en usine avant son transport.
Ne jamais utiliser cet équipement en présence de gaz inflammables
ou explosifs.
7. Éviter de démonter les composants de la tête de caméra afin de ne pas rompre
les joints et de provoquer des fuites ou d’éviter tout risque d’électrocution.
Cet équipement a été scellé en usine afin d’éviter toute infiltration d’humidité
au niveau des composants électroniques. Si les scellés de la tête de caméra
ou du câble viennent à être rompus intentionnellement, la garantie est annulée.
8. Avant chaque utilisation, vérifier que la surface externe de la caméra et
de l’endoscope ne présente aucune rugosité, arête aiguë ou protubérance.
9. L’utilisation de la tête de caméra avec des broches cassées peut endommager
la console. Si la moindre broche est manquante ou endommagée,
consulter les termes de la garantie standard de Stryker.
10. S’assurer que les réajustements, modifications et/ou réparations sont
effectués par des personnes autorisées par la société Stryker Endoscopy.
N’effectuer aucun réglage ou réparation interne qui ne soit pas spécifiquement
détaillé dans le manuel d’utilisation, sous peine d’altérer les performances
ou d’endommager l’instrument.
11. Toujours manipuler délicatement la caméra urologique. Le système de caméra
comporte des pièces sensibles qui sont alignées avec précision et peuvent
être endommagées en cas de chute ou de mauvaise manipulation.
12. L’emploi répété de la méthode de stérilisation à l’oxyde d’éthylène peut entraîner
une dégradation de la qualité d’image.
La garantie sera nulle et non avenue si ces avertissements ne sont pas respectés.
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