Pure Processing PureClear User manual

Digital Inspection Scope
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PureClear Digital Inspection
Scope
Models:
Inspection Control Modules
Inspection Borescope
CD-USB
CB2-60
CD-HDMI
CB2-110
CB2-200
CB1-110
Instructions For Use (IFU)

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Table of Contents
Symbol Descriptions...........................................3
GENERAL WARNINGS.........................................3
Intended Use.......................................................4
Indications for Use..............................................4
Contraindications for Use ...................................4
Complete Inspection Scope Workstation ..........4
Contents: Inspection Control Module (USB and
HDMI Models).....................................................4
Inspection Borescope..........................................5
Digital Inspection Scope Features...........5
Digital Inspection Scope Accessories .................6
Unpacking the Device ........................................7
Unpacking Inspection.........................................7
Routine Maintenance ........................................7
Startup Procedure..............................................8
Connecting or Switching aNInspection
Borescope with the Control Module...................8
Medical Scope Viewer Software *CD-USB ONLY
9
Installing Medical Scope Viewer Software
............................................................................9
Using Medical Scope Viewer Software ....9
Selecting the Video Device or Camera..............10
Capturing Still Pictures......................................10
Capturing Video Images....................................10
Setting File Name..............................................11
Setting Location for Saved Files ........................11
Creating New Folder Location for Saved Files..12
Renaming Saved Files .......................................12
Deleting Saved Files..........................................12
Performing Inspection..................................... 13
Verifying Operation ..........................................14
Compatible Cleaning, Disinfecting and Sterilization
Methods 15
Cleaning............................................................15
Manual Cleaning...............................................16
Cleaning Between Uses ....................................16
High-Level Disinfecting (Inspection Borescope
ONLY)..............................................................16
Disposal of Waste Products............................. 17
Troubleshooting and Servicing........................ 17
Warranty 18
Specifications18
Power Source Requirements............................18
Illumination Source...........................................18
Physical Properties ...........................................19
Optical...............................................................19
Connectors and Cables.....................................19
Environmental Conditions................................19
Waterproof Rating / Ingress Protection Rating 19
Manufacturer ...................................................19

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Symbol Descriptions
Read this operating manual for additional warnings and instructions for use
WARNING
Date of manufacture
Manufactured by
Reference Number
Serial Number
European Authorized Representative
GENERAL WARNINGS
1. Follow the instructions for cleaning, disinfecting and sterilizing provided in this document.
2. Do not autoclave the Digital Inspection Scope.
3. Do not attempt to service any part of this product.
4. To ensure operator safety, read and understand this manual before using the Digital Inspection Scope.
5. The Digital Inspection Scope emits visible light energy from its distal end when powered on. Avoid looking
directly at this emitted light or directing it toward others.
6. Carefully inspect the external surfaces of the Digital Inspection Scope and any accessories to ensure they are
smooth and free of any protrusions or sharp edges.
7. Light leaks may be common and possibly noticeable when inspecting the flexible portion of the Inspection
Borescope. This does not have an effect on its function, but it should be monitored for light output. If the image
on your monitor is too dark to visualize, this may be caused by damaged light fibers and may require repair or
replacement of the Inspection Borescope
8. Do not bend the Inspection Borescope to a radius less than 0.50” (12.7 mm). This may cause damage.
9. Do not apply excessive force to the Inspection Borescope. If you feel resistance, or an obstruction hinders its
path, you may gently attempt to manipulate or rotate the device to avoid the obstacle. You may also slowly
withdraw it a short distance and try advancing again. Applying excessive force to the Inspection Borescope can
result in damage.
10. Avoid rubbing the Inspection Borescope against sharp edges. This can cause damage.

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Intended Use
The Digital Inspection Scope is used for visual inspection of medical devices.
Indications for Use
Visual Inspection of channels, lumens and inner components, during reprocessing of medical devices and
endoscopes, to visually verify that they are free of damage, debris or moisture.
Contraindications for Use
The Digital Inspection Scope is notintended for human use.
Product Description
The Digital Inspection Scope allows for enhanced visual inspection by providing light, vision, magnification, and
the option for documentation in hard-to-see crevices, channels, and lumens in medical devices.
Complete Inspection Scope Workstation
Inspection Dual Control Module, USB Output Inspection Dual Control Module, HDMI Output
Contents: Inspection Control Module (USB and HDMI Models)
CD-USB: Dual Control Module, USB Output
CD-HDMI: Dual Control Module, HDMI Output
Control
Module
•Inspection Control Module houses Camera processor and LED illumination.

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Features
1. Digital Inspection Scope Connection
2. Illumination Control
3. Power Cycle
4. USB(Type C) Out
5. N/A
6. N/A
7. N/A
1. Digital Inspection Scope Connection
2. Illumination Control
3. Power Cycle
4. N/A
5. HDMI Out
6. Power Input
7. System Power Button
Cables
USB A to USB C Cable
•HDMI to HDMI Cable
•Power Cable
Software
USB Flash Drive (Containing Medical Scope
Viewer Software & Instructions for Use)
N / A
Inspection Borescope
All Digital Inspection Borescope models work in both USB and HDMI Inspection Control Module
•CB2-60: 1.83mm O.D. and 60cm Working Length
•CB2-110: 1.83mm O.D. and 110cm Working Length
•CB2-200: 1.83mm O.D. and 200cm Working Length
•CB1-110: 1.06mm O.D. and 110cm Working Length
Digital Inspection Scope Features
The user features of the Digital Inspection Scope (FIGURE 1) and Accessories (FIGURE 2) are shown in the
following illustrations.
•Light / Illumination settings:5 light settings
oLight on Control Module indicates setting
level
o5th setting is OFF
•Press Light button to advance to next setting
•5th setting turns the light OFF
Power Cycle Button
•Press button to RESET camera

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Digital Inspection Scope Accessories
Accessory
Image
Description
USB Camera
Cable
Plugs into USB port on computer.
*(USB Control Module ONLY)
HDMI Cable
Plugs into HDMI Port on monitor.
*(HDMI Control Module ONLY)
Power Adapter
Cable
Power source
*(HDMI Control Module ONLY)
USB Flash Drive
Plugs into a Computer USB Port
(contains)
•Medical Scope Viewer
Software
•Instructions for Use
1. Inspection Borescope Connector
•Contains camera video connection as well as
LED Light for illumination
2. Flexible Working Length
•The portion of the Inspection Borescope that is
inserted into a device during visual inspection.
The measuring scale markings on the Flexible
Working Length are in centimeters (accuracy = ±
0.5cm). Each dot represents 1cm, each dash
represents 5cm.
3. Distal Camera
•Distal portion of Inspection Borescope that
contains the digital camera.

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Rubber Cord
Holders
Rubber cord holders may be
attached to Control Module to
manage the working length of the
inspection borescope
Flexible Mount
(Sold Separately)
Connects the Inspection Control
Module to external surface (Shelf,
Pole, etc)
Unpacking the Device
The Digital Inspection Scope has been thoroughly inspected and carefully packaged before shipping. Once the
device is removed from its container, it should be carefully inspected for shipping damage. If there is any damage,
contact the shipping carrier and Pure Processing immediately.
WARNING: Do not attempt to use the Digital Inspection Borescope if it appears to be damaged.
WARNING: The Digital Inspection Scope is NOT STERILE as supplied from Pure Processing. The
user must follow the protocol for cleaning and disinfecting or sterilizing described in the Instructions
for Cleaning and Disinfecting or Sterilizing section.
Unpacking Inspection
Prior to use, inspect the Inspection Borescope for signs of wear or damage. Operation can be verified by following
the steps in the Verifying Operation section of this manual.
WARNING: Carefully inspect the external surfaces of the Inspection Borescope and any
accessories to assure they are smooth and free of any protrusions or sharp edges.
Routine Maintenance
There are no user serviceable parts within the Digital Inspection Scope. No user maintenance beyond cleaning is
required. Refer all service or replacement needs to Pure Processing. The contact information is listed at the end of
this document.

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Startup Procedure
CD-USB
CD-HDMI
1. Open the Windows PC viewer software
1. Plug the Control Module into a source of AC power
using Power Adapter.
2. Connect the Control Module to PC using USB
Cable
2. Connect Control Module to ANY HDMI Monitor
using HDMI cable
3. Plug the Inspection Borescope into Control
Module
3. IF NEEDED-Select correct monitor input on
monitor
4. In the viewer software, click “Settings” and Select
“USB Video Device”
4. Power button set to ON (Green Light Present)
5. Press the Power Cycle Button
5. Plug Inspection Borescope into the Control
Module
6. Press Power Cycle Button
Connecting or Switching a Inspection Borescope with the Control Module
1. Unplug the Inspection Borescope
from the Control Module
2. Connect a new or different size
Digital Inspection Borescope
3. Press Power Cycle Button

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Medical Scope Viewer Software *CD-USB ONLY
Installing Medical Scope Viewer Software
•System Requirements: MS Windows version 10.
•Install the Scope Viewer Software from the USB flash drive on a computer
Using Medical Scope Viewer Software

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Selecting the Video Device or Camera
Follow the directions below to select the video device or camera used to capture images using the Medical Scope
Viewer Software.
1. Click the ‘Settings’
Button in the lower left of
the Medical Scope Viewer
Software to display a list of
video devices or cameras
that are being detected by
your computer.
2. Select a device for
capturing images using the
Medical Scope Viewer.
a. The example below
shows an Integrated
Webcam and USB
Video Device on the
computer. Select the
USB Video Device for
the Digital Inspection
Borescope.
3. Click ‘OK’ to view the
selected Video Device.
Capturing Still Pictures
Follow the instructions below for capturing still pictures from the Main Image Window.
1. Select the ‘Picture’ Button on the software
2. Use any of the following options to capture an image:
a. Click ‘Capture’ on the Medical Scope Viewer Software (FIGURE above).
b. Press the space bar on your computer keyboard.
3. Note: When an image is captured, “Picture Captured” in red text will flash on the lower portion of the
screen and a new file will appear in the Files Box.
Capturing Video Images
Follow the instructions below for capturing video from the Main Image Window.
1. Select the ‘Video’ Button on the software
2. Use any of the following options to start and stop the video:
a. Click the ‘Capture’ Button on the Medical Scope Viewer Software (FIGURE above).
b. Press the space bar on your computer keyboard.
3. When the video is recording, ‘”Recording” in red text will appear toward the bottom of the software window.

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4. To stop recording, use any method as described in Step 2 above for starting the video.
Note: The Image Capture Button will now read ‘Stop Video’ while recording.
Setting File Name
Following the steps below allows you to create a file name that will appear after the underscore when
capturing images using the Medical Scope Viewer Software.
1. Click ‘Set File Name’ Button.
2. Enter the characters that you would like to be included in file name.
3. Click the ‘OK’ Button to set as default name.
Setting Location for Saved Files
Following the steps below allows you to set the file location of saved images using the Medical Scope Viewer
Software.
1. Click the Ellipse Button
2. Select the file location where you would like to save captured images.
3. Click ‘OK’ to set the File Loc for saved files.

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Creating New Folder Location for Saved Files
Following the steps below allows you create a new file location for saved images using the Medical Scope
Viewer Software.
1. Click the Ellipse Button
2. Click the ‘Make New Folder’ Button.
3. Create a name for the new folder.
4. Click the ‘OK’ Button to create the new file in File Loc.
Renaming Saved Files
1. Right Click on file name within Viewing Software and select “Rename”
Deleting Saved Files
The Files Window in the Medical Scope Viewer displays image files that are being stored in the File Loc. To delete
files, either:
1. Right Click on file name within Viewing Software and select “Delete”
2. Navigate to the location (shown in the File Loc) on your computer, outside of the Medical Scope Viewer
software.
Displaying Reference Image
There are two ways to display a still image in the Reference Image Window on the Medical Scope Viewer
Software.
•To display an image currently being displayed in the Main Image Window, click ‘Capture Reference Image’
Button. NOTE: The images will be saved in a file folder titled “Reference Images” in the designated File Loc.

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•To display a saved image in the Reference Image Window from your File Loc:
a. Click the ‘Open’ Button
b. Click on the Reference Images Folder.
c. Select the file that you would like to display.
d. Click the ‘Open’ Button, to display the image in the Reference Image Window.
Performing Inspection
Following the steps listed below will ensure the proper use and best performance of the Inspection Borescope.
Follow these steps prior to inspection.
1. Secure the Inspection Scope into an arm fixture (optional).
2. Grasp the Inspection Borescope near its distal end and gently insert the Flexible Working Length into the
intended device as shown in.
3. Adjust light with the Illumination button for ideal lighting.
4. Use short advancements while keeping your fingers close to the device’s opening. View the monitor while
inserting into the device. If an obstruction hinders the path of the Inspection Borescope, gently attempt to
manipulate or rotate it to avoid the obstacle.

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Inserting Borescope in Device
Rotating Device to Avoid Obstacle
WARNING: The minimum bend radius of the Digital Inspection Scope is 0.50” (12.7 mm). Do
not bend the Inspection Borescope into sharper bend or damage could occur.
WARNING: Do not apply excessive force to the Inspection Borescope. If you feel resistance, or an
obstruction hinders the path of the Inspection Borescope, gently attempt to manipulate or rotate the
device to avoid the obstacle. You may also slowly withdraw a short distance and try advancing
again. Applying excessive force to the Inspection Borescope past an obstacle could result in damage
to the device.
Once the device has reached the end of the area you are inspecting, retract the scope slowly while looking for debris
or damage.
Verifying Operation
Following the steps listed below will ensure the proper use and performance of the Inspection Borescope. The
Inspection Borescope can be checked for normal operation by connecting it as described in the Startup section of
this manual.
Normal operation includes:
•An image appearing on your computer monitor or HDMI Monitor.
•A blinking light on Control Module near the ‘Power Cycle” button indicates the image feed is transmitting.
•White light will emit from the distal end of the Inspection Borescope.
•An LED light on the Control Module front panel will indicate the light intensity setting of the device.

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Compatible Cleaning, Disinfecting and Sterilization Methods
WARNING: The Digital Inspection Scope system is provided non-sterile. Before initial use and after
each use, the external surfaces of the Inspection Borescope should be cleaned.
WARNING: The Control Modules provided for the Digital Inspection Scope system are not waterproof.
The Control Modules are to be wiped only. Do not soak or submerge the Control Modules.
WARNING: Cleaning does not disinfect or sterilize the Inspection Borescope. Be sure to follow your
institution’s specific cleaning and disinfecting or sterilizing procedures in consultation with this
manual. The user is responsible to ensure that their procedures result in disinfection or sterilization,
whichever is required.
WARNING: Do not clean, disinfect, or sterilize theDigital Inspection Scope system or its accessories
using an ultrasonic cleaner, washer sanitizer, washer pasteurizer, washer sterilizer, steam autoclave,
or any method with a processing temperature above 60°C (140°F). Use of these processes will result
in damage to the instrument and void its warranty.
WARNING: Follow the disinfectant manufacturer’s instructions for disinfecting.
WARNING: High level disinfecting does not result in terminal sterilization. Bacterial endospores may
still remain viable after high level disinfecting.
Cleaning
The Inspection Borescope has fluid ingress protection rating of IPX7 (Waterproof) and can withstand immersion in
fluid up to 1 meter in depth for up to 30 minutes.
The Inspection Borescope is made of the same material as other common endoscopes. Any wipe, solution or low-
temperature (≤ 60°C (140°F)) method intended for the reprocessing of endoscopes is likely compatible with the
Inspection Borescopes if used according to the product labeling. See below chart for details.
The Inspection Borescope is manufactured with materials known to be compatible with the STERRAD®Systems
listed below in the table.
The Control Module has a fluid ingress protection rating of:
•USB: IPX5 (Water resistant) and can withstand a sustained, low pressure water jet spray for up to three minutes.
•HDMI: IPX4 (Water resistant) can withstand splashing water from any direction. See below chart for details.
The Control Module and cables are not waterproof and should not be immersed. It may be cleaned with wipes
containing solutions in the table below. Do not soak the Control Modules or cable accessories.
Compatible agents to clean, disinfect or sterilize the are listed in the below charts. Follow the cleaning agent
manufacturer’s Instructions for Use.
Wipes and Solutions Containing (Inspection Borescope AND Control Module):
Hydrogen Peroxide
Isopropyl Alcohol (IPA)
Sodium Hypochlorite (bleach)
Ortho-Phenylphenol
Quaternary Ammonium
Low Temperature Sterilization Systems (Inspection Borescope ONLY):
Ethylene Oxide (EtO)
STERRAD® 100S System (Standard)
STERRAD® NX System (Standard, Advanced)
STERRAD® 100NX System (Standard)
STERIS® Liquid Chemical Sterilization Systems
STERIS V-PRO® Low Temperature Sterilization Systems
(Non-Lumen Cycle)
Solutions Containing (Inspection Borescope ONLY):

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Alcohol Ethoxylates
Neutral or Near-Neutral pH Detergents
Enzymatic Cleaning Solutions
Enzymatic Detergents
Glutaraldehyde
Hydrogen Peroxide (7.35%) with Peracetic Acid (0.23%)
Accelerated Hydrogen Peroxide (AHP)
Ortho-phthalaldehyde (OPA)
Peracetic Acid
Sodium Borate, Decahydrate
Sodium Xylene Sulfonate
Tetrapotassium Pyrophosphate
Trisodium Nitrilotriacetate
Manual Cleaning
•Follow the cleaning agent manufacturer’s Instructions for Use and precautions regarding health hazards,
dispensing, measuring and storage of cleaning agents.
Cleaning Between Uses
•Wipe down the Inspection Borescope system
with a compatible wipe. Follow the wipe
manufacturer’s Instructions for Use.
High-Level Disinfecting (Inspection Borescope ONLY)
•Select only the disinfecting solutions listed in the compatible disinfecting methods section.
•Follow all recommendations regarding health hazards, dispensing, measuring and storage from the manufacturer
of the cleaning and disinfecting agents.
•Soak the Inspection Borescope in the selected disinfecting solution per the solution manufacturer’s Instructions
for Use
•Rinse the Inspection Borescope with critical (sterile) water, again, following the instructions of the disinfecting
solutions manufacturer.
•Dry with a sterile, soft, lint-free cloth or sponge. Ensure that the distal tip and proximal end are dried. Air drying
could leave deposits on the optical surfaces which could result in a degraded image.

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Disposal of Waste Products
The Digital Inspection Scope System does not produce any waste materials. At the end of the device’s life, the Digital
Inspection Scope System components may be disposed of with standard electrical products. Follow local regulations
for proper disposal of electrical products.
Troubleshooting and Servicing
Condition
Appearance
Cause
Correction
No image
Main Image Window is black.
The Inspection Borescope
System was not connected to
computer when the software
was opened.
Unplug USB Connection on
Camera Cable and plug in again.
No image
Main Image Window is black.
•USB Video Device not
selected, or without the
borescope connected.
•Check HDMI Monitor “Input”
Selection
If no image, go to the ‘Settings’ Tab
and select USB Video Device.
No light
No light when borescope pointed
at surface.
No power to light source or
power connections are not
secure.
•Check the Camera Cable
connections and make sure the
computer is powered on.
•HDMI-Make sure System Power
Button is “ON”
Low light
No image or very dark image.
Weak light pattern when
borescope pointed at surface.
Light setting too low.
Cycle through light intensity
levels/settings until a clear image is
obtained
Low light
No image or very dark image.
Weak or light pattern when
borescope pointed at surface.
Broken light fibers in
borescope.
Replace Inspection Borescope (The
user must judge when the
Inspection Borescope is no longer
adequate for use, but as a guide,
when 10% of the image or
illumination has been degraded or
lost it is recommended that a
replacement be acquired).
No image or
distorted
image
No image or heavily distorted,
cracked appearance.
Broken image sensor and/or
internal cables.
•Press Power Cycle button
•Replace Inspection
Borescope.*
Overly bright
image
White-out type reflection.
Light Intensity is too bright.
Cycle through light intensity
levels/settings until a clear image is
obtained
Blurry image
or overly
bright image
Distorted image. Light often
reflective and image appears
brightly colored.
Debris or film on lens.
Wipe off end of Inspection
Borescope with soft cloth.
Image does
not capture
When you click the Capture
Button, the still image or video is
not captured.
The File Loc path may have
changed or the folder name
does not exist.
Set up a new Windows File Loc
folder.

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Warranty
The Digital Inspection Scope System is warranted, when new, to be free of defects in material and workmanship and
to perform in accordance with the manufacturer’s specifications when subject to normal use service for a period of 1
year from the date of purchase. Pure Processing at its option, will either repair or replace any components found to
be defective or at variance from manufacturer's specifications within this time at no cost to the purchaser. It shall be
the purchaser's responsibility to return the device directly to Pure Processing after receiving a Returned Material
Authorization Number from Pure Processing Customer Service Department. Prior to returning the device, it shall be
the purchaser's responsibility to clean and disinfect the device and to package it in a manner that minimizes the
possibility of shipping damage.
EXCEPT TO THE EXTENT PROVIDED ABOVE, PUREPROCESSING MAKES NO REPRESENTATION OR
WARRANTY TO THE PURCHASER OR TO ANY THIRD PARTY, WHETHER WRITTEN, ORAL, STATUTORY,
EXPRESS OR IMPLIED, CONCERNING THE DEVICE, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL PURE PROCESSING
BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER FOR
BREACH OF ANY WARRANTY, FOR BREACH OR REPUDIATION OF ANY OTHER TERM OR CONDITION OF
SALE, OR FOR LIABILITY ON THE BASIS OF NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF
PURE PROCESSING SHALL HAVE BEEN ADVISED IN ADVANCE OF THE LIKELIHOOD THEREOF.
REPAIR OR REPLACEMENT OF THE DEVICE AS PROVIDED ABOVE SHALL BE THE SOLE AND EXCLUSIVE
REMEDY FOR ANY BREACH OF THE WARRANTY GIVEN ABOVE.
Specifications
Power Source Requirements
•USB Control Module: Electrical Power for the Digital Inspection Scope System is supplied by a
USB port on a computer.
•HDMI Control Module: Medical grade power supply
oINPUT 100-240VAC, ~1A, 47-63Hz (from wall outlet)
oOUTPUT 5V, 2A (to enclosure)
Illumination Source
LED within the Inspection Control Module

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Physical Properties
Control Modules
Inspection Borescopes
USB
HDMI
CB2-60
CB2-110
CB2-200
CB1-110
Borescope Working
Length (cm)
N/A
N/A
60cm
110cm
200cm
110cm
Borescope Overall
Length
N/A
N/A
78cm
128cm
218cm
128cm
Borescope Diameter
(at Distal Camera)
N/A
N/A
1.83mm
1.83mm
1.83mm
1.06mm
Control Module
Dimensions (LxWxH)
5.25” x 3.90” x 1.85”
5.25” x 3.90” x 1.85”
N/A
N/A
N/A
N/A
Control Module
Weight
1.20 lbs
1.20 lbs
N/A
N/A
N/A
N/A
Optical
Field of View
120° in air
Angle of View
0°
Resolution
CB2-200, CB2-110, CB2-60: 160,000 Pixel or 400 Pixel x 400 Pixel format
CB1-110:40,000 Pixel or 200 Pixel x 200 Pixel format
Connectors and Cables
USB Control Module: USB Type A Male Connector
HDMI Control Module: HDMI Camera Cable: HDMI type A male to HDMI type A Male
Environmental Conditions
Storage and transport
Humidity: 10 to 100% (condensing)
Temperature: -20°C to +60°C
Pressure: 600 hPA to 900 hPA
Normal Operation
Humidity: 0-100% (condensing)
Temperature: +5°C to +40°C
Waterproof Rating / Ingress Protection Rating
•CD-USB: IPX5 (Water Resistant)
•CD-HDMI: IPX4 (Water Resistant)
•Borescope (ALL CB): IPX7 (Waterproof)
Manufacturer
Clarus Medical, LLC
13355 10th Ave., Ste 110
Plymouth, MN 55441 USA
www.clarus-medical.com
[email protected]
Tel [phone]