Pure Processing PureClear CD2-1100 User manual

PureClear Digital Inspection Scope
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PureClear™Digital Inspection Scope
Model CD2-1100
Model CD2-1100P
Instructions For Use (IFU)
Pure Processing
470 Mission Street
Unit 2
Carol Stream, IL 60188
www.pure-processing.com
[phone]

PureClear Digital Inspection Scope
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Table of Contents
Symbol Descriptions
General Warnings
Intended Use, Indications and Contraindications
Product Description
Digital Inspection Scope Features
Digital Inspection Scope Accessories
Unpacking, Inspecting, and Maintaining
PureClear Medical Scope Viewer Software
Connecting Digital Inspection Scope
Using PureClear Medical Scope Viewer Software 6
Selecting the Video Device or Camera 7
Capturing Still Pictures 7
Capturing Video Images 8
Displaying Reference Image 8
Setting File Name 9
Setting Location for Saved Files 10
Creating New Folder Location for Saved Files 10
Deleting Saved Files 10
Performing Inspection 11
Verifying Operation 11
Instructions for Cleaning, Disinfecting and Sterilizing 11
Disposal of Waste 14
Troubleshooting and Servicing 15
Advanced Settings
Disabling Video Devices 16
Enabling Video Devices 17
Warranty 18
Specification 19
Contact Information:
Manufacturer:
PureClear Medical, LLC
13355 10th Ave N #110
Minneapolis, MN55441 USA
www.clarus-medical.com Tel
[phone]

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Symbol Descriptions
Read this operating manual for additional warnings and instructions for use.
WARNING
Date of manufacture
GENERAL WARNINGS
1. Follow the instructions for cleaning, disinfecting and sterilizing provided in this document.
2. Do not autoclave the PureClear 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 PureClear Digital Inspection Scope.
5. The PureClear Digital Inspection Scope emits visible light energy from its distal end when powered on. Avoid
looking directly at this emitted light or directing ittoward others.
6. Carefully inspect the external surfaces of the PureClear Digital Inspection Scope and any accessories to assure
they are smooth and free of any protrusions or sharp edges.
7. Do not bend device below a 0.85” (21.6 mm) radius; this may cause damage to the device.
8. Do not apply excessive force to the PureClear Digital Inspection Scope.Ifyou feel resistance, or an obstruction
hinders the path of the PureClear Digital Inspection Scope, you may 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 PureClear Digital Inspection Scope canresult in damage to the device.
9. Avoid rubbing the PureClear Digital Inspection Scope against sharp edges. This can cause damage to the device.
10. Place the Soaking Cap on the Camera Connector prior to soaking the Digital Inspection Scope. Repeated
exposure to fluids may corrode the contacts of the Camera Connector.
Intended Use
The PureClear 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 arefree of damage and debris.
Contraindications for Use
Not for human use.

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Product Description
The PureClear 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 – areas as small as
2 mm and not visible to the un-aided eye.
The PureClear Digital Inspection Scope can be used with a PC running MS Windows versions 7 or 10.
PureClear Digital Inspection Scope (CD2-1100 or CD2-1100P) Product Contents:
Digital Inspection Scope
Camera Cable
Soaking Cap
USB Flash Drive (Containing PureClear Medical Scope Viewer Software &Instructions for
Use)
PureClear Digital Inspection Scope Features
The user features of the PureClear Inspection Scope (FIGURE 1)and Accessories (FIGURE 2)are shown in the
following illustrations. FIGURE 1: Digital Inspection Scope Features and Connections
# Name Function
1 Distal Camera Distal portion of PureClear Digital Inspection Scope that contains the camera lens.
2 Flexible Working Length The portion of the PureClear Digital Inspection Scope that isinserted into a device during visual inspection. Measuring scale markings on the Flexible Working
Length are in centimeters and available on CD2-1100 only.
3 Brightness Increase (+) Button Press button to increase illumination intensity.
4 Brightness Decrease (-) Button Press button to decrease illumination intensity.
5 Handpiece Capture Image Button Press button to capture video or image.
6 White Balance Button Press to white balance the image.
7
Camera Cable Connection
Connects the Controller Handpiece to USB on computer.

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FIGURE 2: Digital Inspection Scope Accessories
Camera Cable Soaking Cap USB Flash Drive
Digtial Inspection Scope Flexible Device Mount Accessory Components (sold separately)
The following components are optional:
•Flexible Arm, Manfrotto, 520 mm, Model 237HD
•Nano Clamp, Manfrotto, Model 386BC-1
•Super Clamp, Manfrotto, Model 635
Unpacking the Device
The PureClear Digital Inspection Scope has been thoroughly inspected and carefully packaged before shipping. Once
the unit is removed from its container, itshould be carefully inspected for shipping damage. If there is any damage,
contact the shipping carrier and Pure Processing immediately.
WARNING: Do not attempt touse the PureClear Digital Inspection Scope if itappears to be damaged.
WARNING: The PureClear Digital Inspection Scope is NOT STERILE as supplied from Pure Processing. The
user must follow theprotocol for cleaning and disinfecting or sterilizing described in the Instructions for
Cleaning and Disinfecting or Sterilizing section.
Inspection
Prior to use, inspect the PureClear Digital Inspection Scope for signs ofwear 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 PureClear Digital Inspection Scope 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 PureClear 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.
# Name Function
1 USB (Type-A Male) Connector Plugs into USB port on computer.
2 Camera Connector Plugs into Digital Inspection Scope.
3 Soaking Cap
Covers and seals the camera cable connection prior to soaking the Digital Inspection
Scope in fluid.
4 USB Flash Drive Plugs into USB Port on computer for downloading PureClear Medical Scope
Viewer Software and Instruction for Use.

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PureClear Medical Scope Viewer Software
IMPORTANT: Before connecting the PureClear Digital Inspection Scope, install the PureClear Medical Scope Viewer
Software from the USB Flash drive on a computer.
System Requirements: MS Windows versions 7 or 10.
Connecting PureClear Digital Inspection Scope
1. Connect the Camera Cable to the Digital Inspection Scope.
2. Plug in the USB Connector to the USB port in your computer.
3. Open Scope Viewer Software (FIGURE 3)
Using PureClear Medical Scope Viewer Software
FIGURE 3: Scope Viewer Software
#
Name
Function
1
Date & Time
Date and time display.
2
Reference Image Window Displays a Reference Image.
3
Capture Reference Image
Button
Captures still image being displayed in the Main Image Window.
4 Open Button
Opens the file location (File Loc) where images are being saved and allows you to
select image that is displayed in Reference Image Window.
5 Set File Name Button Click to set a file name that will appear when capturing images.
6
File Name Box
Text box for creating a File Name.
7
Files Box
Displays captured images that are stored in the in File Loc folder.
8
Settings Button
Click to select the video camera settings.
9
Main Image Window
Displays the image from the camera.
10
Picture Button
Click to select the picture option when capturing still images.
11
Video Button
Click to select the video option when capturing video images.
12
File Loc Box
Location where captured images are being saved.
13
Capture Button
Option to click for capturing images. Also used to start/stop video images.
14
Ellipse Button
Opens window for browsing file locations to save images

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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 PureClear Medical
Scope Viewer Software.
1. Click the ‘Settings’ Button in the lower left of the PureClear Medical Scope Viewer Software to display video
devices or cameras that are being detected by your computer. (FIGURE 4)
2. Select a device for capturing images using the PureClear 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 PureClear Digital Inspection Scope.
3. Click ‘OK’ to view the selected Video Device.
FIGURE 4: Selecting USB 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 (FIGURE 5).
FIGURE 5: Capturing Still Pictures
2. Use any of the following options to capture an image:
a. Click ‘Capture’ on the PureClear Medical Scope Viewer Software (FIGURE 5 above).
b. Press the Handpiece Capture Image Button on the Digital Inspection Scope.
c. Press the space bar on your computer keyboard.
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.

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Capturing Video Images
Follow the instructions below for capturing video from the Main Image Window.
1. Select the ‘Video’ Button on the software (FIGURE 6).
FIGURE 6: Capturing Video
2. Use any of the following options to start and stop the video:
a. Click the ‘Capture’ Button on the PureClear Medical Scope Viewer Software (FIGURE 6 above).
b. Press the Handpiece Capture Button on the Digital Inspection Scope.
c. Press the space bar on your computer keyboard.
3. When the video is recording, ‘”Recording” in red text (FIGURE 7) will appear toward the bottom of the software
window (FIGURE X).
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’ (FIGURE 7) while recording.
FIGURE 7: Video Recording
Displaying Reference Image
There are two ways to display a still image in the Reference Image Window on the PureClear Medical Scope
Viewer Software.
1. To display an image currently being displayed in the Main Image Window, click ‘Capture Reference Image’
Button (FIGURE 8).
NOTE: The images will be saved in a file folder titled “Reference Images” in the designated File Loc.
FIGURE 8: Capturing Reference Image

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2. To display a saved image in the Reference Image Window from your File Loc:
a. Click the ‘Open’ Button (FIGURE 9).
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.
FIGURE 9: Displaying Saved Reference Image
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 PureClear Medical Scope Viewer Software. (FIGURE 10)
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.
FIGURE 10: Setting File Name

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Setting Location for Saved Files
Following the steps below allows you to set the file location of saved images using the PureClear Medical Scope
Viewer Software.
1. Click the Ellipse Button (FIGURE 11).
2. Select the file location where you would like to save captured images.
3. Click ‘OK’ to set the File Loc for saved files.
FIGURE 11: Setting Saved File Location
Creating New Folder Location for Saved Files
Following the steps below allows you create a new file location for saved images using the PureClear Medical Scope
Viewer Software.
1. Click the Ellipse Button (FIGURE 12).
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.
5. FIGURE 12: Creating New Saved File Location
Deleting Saved Files
The Files Window in the PureClear Medical Scope Viewer displays image files that arebeing stored in the File Loc
(FIGURE 13). To delete files, go the location (shown in the File Loc) on your computer, outside of the PureClear Medical
Scope Viewer software. FIGURE 13: Deleting Saved Files