GlobalMed TotalExam Lite User manual

TotalExam® Lite
Exam Camera and
Otoscope Kit
User Guide

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MAN-600480 Rev. 1 © 2002-2020 GlobalMedia Group, LLC. D.B.A. GlobalMed® All rights reserved. All trademarks are the property of their respective holder. Reproduction
or distribution of this document electronically or in print, is strictly prohibited without prior written permission from GlobalMed
Legal
While GlobalMedia Group, LLC. (GlobalMed®) and its divisions make every
effort to ensure that the information contained on our website and product
literature is accurate, GlobalMed takes no responsibility for incorrect,
outdated, or otherwise inaccurate information. GlobalMed is not responsible
for typographical errors or omissions and shall not be liable for any incidental
or consequential damages caused directly or indirectly from anything on any
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No license to any intellectual property rights is granted by this document,
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One or more GlobalMed products are covered under U.S. Patent(s) with other
patents pending. Any testimonials contained within any GlobalMed website
or document are individual cases and do not guarantee that you will get the
same results. TE Lite: GMR17041010 and TE Oto: GMR17042020.
©2002-2021 GlobalMedia Group, LLC. (DBA GlobalMed). All Rights Reserved.
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Warranty and Return Policy
All GlobalMedia Group, LLC (DBA GlobalMed®) products are warranted under
the following terms:
Products that become defective during the first year after the order is shipped
will be repaired or replaced by GlobalMed free of charge. This limited
warranty is contingent upon proper use of the product and does not cover
products that have been damaged (scratches, bent metal, broken
components) misused, modified, or subject to unusual physical or electrical
stress. All returns for any other reason must be made within the first 30 days
from time of shipment and will be subject to a 25% restocking charge. Buyer
must include all original components, literature, and packaging in the same
salable condition received to avoid any additional charges.
All returned materials must have a GlobalMed return materials authorization
(RMA) number. Authorized returns must be shipped freight prepaid to
GlobalMed. GlobalMed reserves the right to refuse any return that is sent
COD or without an RMA number visible on the exterior of the package.
Unauthorized returns, refused shipments, and authorized returns of non-
defective merchandise after the above stated return periods are subject to
additional charges.
Limited Liability Agreement
No claim made by the buyer shall be for an amount greater than the
purchase price of the goods in respect of which the claim was made,
regardless of whether the claim pertains to damage incurred in shipping,
failure to ship, or inherent defects. GlobalMed will in no way be liable for
incidental or consequential charges. In all events, GlobalMed reserves the
option of repair or replacement at its discretion. GlobalMed takes no
responsibility for incorrect, outdated, or otherwise inaccurate information,
including pricing and product specifications. GlobalMed is not responsible for
typographical errors or omissions and shall not be liable for any incidental or
consequential damages caused directly or indirectly from any GlobalMed
product. In addition, GlobalMed reserves the right to change prices,
specifications or discontinue products at any time without prior notice while
reserving the right to refuse or conduct a cancellation on its transaction
activities due to price inconsistency from its suppliers.
©2002-2021 GlobalMedia Group, LLC All Rights Reserved.
GlobalMed TotalExam® Lite Exam Camera and Otoscope

GlobalMed TotalExam® Lite Exam Camera and Otoscope
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MAN-600480 Rev. 1 © 2002-2020 GlobalMedia Group, LLC. D.B.A. GlobalMed® All rights reserved. All trademarks are the property of their respective holder. Reproduction
or distribution of this document electronically or in print, is strictly prohibited without prior written permission from GlobalMed
About GlobalMed®
GlobalMed, located in Scottsdale, Arizona, designs and manufactures a
complete best-in-class ecosystem of hardware and software products for the
healthcare industry. Our products are superior in quality, versatility, and
simplicity, and enhance the patient care experience for both providers and
patients alike. Our camera, image management, store-and forward, video
conferencing and video streaming technologies efficiently enhance managing
patient information. Our products include CAS Lite™, our newest
configurable medical station; and eNcounter®, our store-and-forward
imaging and image management software, which provides automated work
flow capabilities for seamless integration into a provider's network. Contact
GlobalMed today to find out how we can simplify your work flow and help
you give your patients the access to quality care they deserve.
Contact info:
Help Desk: 1.800.886.3692
GlobalMed
15023 North 73rd Street
Scottsdale, AZ 85260
+1.480.922.0044 phone
+1.480.922.1090 fax
[email protected]
www.globalmed.com

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Revision History
Revision Changes Date
A Initial Release 03-18-2021
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MAN-XXXX Rev. 1 © 2002-2020 GlobalMedia Group, LLC. D.B.A. GlobalMed® All rights reserved. All trademarks are the property of their respective holder. Reproduction
or distribution of this document electronically or in print, is strictly prohibited without prior written permission from GlobalMed
Chapter 1: About the TotalExam Lite Camera
1.1 About the TotalExam Lite Camera
The TotalExam Lite camera is a hand-held examination video camera with
multiple functions. The kit includes One Autofocus and One Otoscope
camera. The TotalExam Lite camera allows viewing high definition freeze
frame images and live video. Light settings allow for varying levels and
intensities of natural white lighting. Buttons on the unit provide controls for
freeze frame, light control, and white balance.
USB 2.0 connectivity allows the TotalExam Lite camera to be easily used with
laptops, tablet PCs, as well as GlobalMed Exam Stations.
The TotalExam Lite camera kit is intended for indoor use only
Prior to use of the equipment, the operator must possess fundamental
understanding of the operational processes outlined in this manual.
Following the instructions provided in this manual will enable the operator to
safely utilize the camera.
The TotalExam Lite cameras are not intended to be serviced or maintained
while in use. Any repair or replacement of components will be performed by
GlobalMed personnel and are not to be replaced by clinical personnel.
1.2 What’s Included
Items in the TotalExam Lite camera kit include the following:
•Polarizing Hood Attachment - Qty 1
•Derm Hood Attachment - Qty 1
•Standard 6.0” Tongue Depressor sample - Qty 5
•One Touch Collar sample - Qty 5
•Disposable GlobalMed 4.2 mm Adult Specula - Qty 5
•Disposable GlobalMed 3.0 mm Child Specula - Qty 5
•USB-C Cable - Qty 2
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1.3 Precautions
Please thoroughly review these safety instructions before operating
the equipment. Clinical and technical personnel should adhere to
warnings and precautions at all times. Equipment should be used
according to operating instructions outlined throughout this
manual. Only use manufacturer recommended or approved
accessories to ensure compatibility.
1.4 Warnings
Warning: This Camera is an electrical device; do not attempt to submerge
into any kind of liquid. Doing so could result in electrical shock or
other hazardous conditions.
The TotalExam Lite camera has been tested and found to comply
with the limits for a Class B digital device, pursuant to part 15 of the
FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can
radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful
interference to radio communications.
Table 1: TotalExam Lite camera precautions
Precaution Type Description
Liquid and Moisture - Avoid direct contact with liquids on all electrical components of the device
- Do not store or operate equipment in areas with excessive moisture
Electrical - Warning: To avoid the risk of electric shock, this equipment must only be connected to a
supply main with protective earth
- Do not use if cable is damaged
Cerfications - The TotalExam Lite Camera complies to FCC, EMC, and EMI requirement according to:
FCC Part 15, Class B
NFPA99
EMC EN60601-1-2
IEC 60601-1
Bio Compatibility 10993-1,10993-5,10993-11
RoHS 2002/95/EC
CE MDR Class I
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MAN-XXXX Rev. 1 © 2002-2020 GlobalMedia Group, LLC. D.B.A. GlobalMed® All rights reserved. All trademarks are the property of their respective holder. Reproduction
or distribution of this document electronically or in print, is strictly prohibited without prior written permission from GlobalMed
Any dismantling of the camera will void the warranty and could
damage the device or cause electrical shock. If it is necessary to
clean the camera refer to the cleaning procedures sections for
instructions on how to maintain cleanliness and thereby prevent
contamination. This device alone is not intended to be used to
diagnose, treat, cure or prevent any disease and should not be used
as substitute for a health professional's advice.
GlobalMed does not accept any liability for injury, loss or damage by
use of or reliance on the information gathered by our product.
1.5 Specifications
1.6 Features
Specifically designed with the clinician and medical professional in
mind, the TotalExam® Lite is our most feature complete imaging
solution for telemedicine kit:
•High resolution sensor for precise exam imaging
•Extended Field of View Eliminates Need for Multiple
Exam Images
•Superior Operation in Low Lighting
•Variable Illumination Levels
Table 2: TotalExam Lite Camera specifications
Component Lite Camera Oto Camera
Dimensions 192mm x 30mm 170mm x 30mm
Weight of Camera Body 88.4 grams/3.11 oz 80.2 grams/2.83 oz
Focus Type Autofocus Fixed Focus
Snapshot Size 1 Megapixel 1 Megapixel
Captured Video Resolution 1280 x 720 1280 x 720
Captured Frame Rate 30 fps 30 fps
Output USB 2.0 USB 2.0
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•Optimized Color for Truer Images
•Advanced Auto-Focus and Intelligent Frame Capture for
Clearer Images
•Patent-Pending USB Cable Lock, Ergonomic Grip and
Easy to Clean Surfaces
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MAN-XXXX Rev. 1 © 2002-2020 GlobalMedia Group, LLC. D.B.A. GlobalMed® All rights reserved. All trademarks are the property of their respective holder. Reproduction
or distribution of this document electronically or in print, is strictly prohibited without prior written permission from GlobalMed
Chapter 2: Using the TotalExam Lite Camera
2.1 Overview
This chapter provides information on the use of the TotalExam Lite Camera,
and the TotalExam Otoscope Camera.
2.2 Installing the TotalExam Lite Camera
The TotalExam Lite and Otoscope Cameras do not have any drivers or
software to install or download. The Cameras do not require any additional
power and should be recognized automatically, making it ready for use.
2.3 TotalExam Lite Camera and Otoscope Controls
Figure 1: TotalExam Lite Camera Control Locations
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Figure 2: TotalExam Otoscope Control Locations
2.3.1 LED Light Control (LED Button)
The camera contains a light carousel for illuminating the viewing
area. There are multiple levels of LED light intensity that can be
accessed and controlled via the LED button.
1. Press the LED button to turn on the TotalExam Lite LED ring. The light
intensity level is at the lowest level.
2. Press the button again to increase the light intensity until it reaches
the highest level.
3. Press the button after the highest intensity level is reached to shut off
the LED ring.
2.3.2 White Balance Button
The Auto Focus Camera is equipped with a white balance
feature that helps ensure the overall color quality of the image.
Use this feature every time the light settings are changed.
Tip: Select the LED light level prior to selecting the WB option.
1. Point the Camera at the included White Label (or other pure white
color surface).
2. Double Click White Balance Button (WB button will flicker).
3. Press the White Balance Button once more and the image should
appear warm (WB button will stop flickering).
Note: The Otoscope has automatic white balance.
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or distribution of this document electronically or in print, is strictly prohibited without prior written permission from GlobalMed
2.3.3 Capture Image Button
Use the Capture Image button to capture an image.
1. Push the Capture Button on the Camera.
2. Adjust the Camera until the image is in focus.
3. Release capture image button, image is frozen upon release.
4. To store the image, click on the capture icon in eNcounter.
5. To resume live video stream, press the capture button on the Camera
again.
Note: Unplugging the camera from the computer while displaying a still
image will cause the camera to lose power and the image to be lost.
2.4 TotalExam Lite Camera Accessories
2.4.1 Polarizing Hood Attachment - Qty 1
The Polarizing Hood helps eliminate unwanted glare from examination
surfaces. It attaches to the end of the TotalExam Lite autofocus camera and
allows the user to reduce the amount of light reflecting off the area of
interest. Use a One Touch Collar on the Polarizing Hood when closely
examining a patient’s skin. The One Touch Collar acts as a barrier to protect
the derm hood and camera from contact with breached or broken skin. After
each use, dispose of the touch collar as medical/biohazard waste.
1. Attach the Polarizing Hood by firmly pressing onto the TotalExam Lite.
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2.4.2 Derm Hood Attachment - Qty 1
The derm hood focuses the camera’s LEDs on the examination surface and
helps stabilize the image. It is designed to fit onto the TotalExam Lite
autofocus camera for close proximity examinations. Use a One Touch Collar
on the derm hood when closely examining a patient’s skin. The One Touch
Collar acts as a barrier to protect the derm hood and camera from contact
with breached or broken skin. After each use, dispose of the touch collar as
medical/biohazard waste.
1. Attach the Derm Hood by firmly pressing onto the TotalExam Lite.
2.4.3 Standard 6.0” Tongue Depressor sample - Qty 5
The TotalExam Lite camera comes with an integrated tongue depressor
adapter that holds a standard 6.0” tongue depressor for oral examinations or
stabilization during close proximity examinations. The adapter will not work
with either the polarizing or derm hood installed.
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or distribution of this document electronically or in print, is strictly prohibited without prior written permission from GlobalMed
2.4.4 One Touch Collar sample - Qty 5
2.4.5 Disposable GlobalMed Specula
2.4.5.1
2.4.5.2
4.25mm Specula sample - Qty 5
3.0mm Specula sample - Qty 5
The TotalExam Oto camera is compatible with the GlobalMed’s
single use, child and adult size, disposable specula. After each use,
dispose of the specula as medical/biohazard waste.
2.4.6 USB-C Cable - Qty 2
2.5 Cleaning Procedures
The TotalExam Lite camera and otoscope are an FDA registered
Class I non-sterile medical device. The camera is used in conjunction
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with three accessories: the Derm Hood, Tongue Depressor, and the
Disposable Touch Collar.
The Polarizing derm hood and the tongue depressor are not
intended to be patient contact components and as such are
designed to be cleaned and reused multiple times. The touch
collars, tongue depressors, and specula are intended for patient
contact and are a one-time use components.
Table 3: Cleaning Procedures for the TotalExam Lite camera kits
Component Procedure Frequency
TotalExam Lite camera and cord Gently Wipe all parts of the outer
surfaces of the equipment and
cord with a disinfecting wipe and/
or soft cloth moistened with a
facility or CDC approved cleaning
solution
At least weekly or
when contaminated.
TotalExam Lite Otoscope
Gently wipe down with cotton
swabs and Isopropyl alcohol (90%
or higher ) .
Clean after every exam of the ear or
nose.
TotalExam Lite Camera body Use a lens cloth or soft cotton
swab with a CDC approved lens
cleaning solution.
Clean at least weekly or
when contaminated.
TotalExam Lite Camera
polarizing derm hood
Derm hood can be gently wiped
down or soaked in a facility or
CDC approved cleaning solution.
After each use.
TotalExam Lite Camera touch collar
and specula
N/A Dispose after each use.
TotalExam Lite Camera
tongue depressor
N/A Dispose after each use.
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GlobalMed TotalExam® Lite Exam Camera and Otoscope