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RealPresence
®
Practitioner Cart
®
8000
Manufactured by: Rubbermaid Healthcare • 16905 Northcross Drive • Suite 200 • Huntersville NC 28078
Polycom RealPresence® Practitioner Cart® 8000 User Manual p/n 1793149 Rev C 03/13
18
STATEMENT OF USE
The Polycom Practitioner Cart Telemedicine system
is intended for operation by a professional
healthcare provider. The Practitioner Cart may be
used to achieve the following:
(a)
Enable a remote clinician to consult
with patients and make a diagnosis
(b)
Enable a professional healthcare
provider to have real-time images
and audio sent and received from
medical devices to allow a remote
clinician to review the images,
diagnose and provide care from a
distance
(c)
Transport real-time images of
patients, images and sounds from
medical devices for educational
purposes
Indications for Use
The Polycom Practitioner Cart is indicated for use in
real-time video consultation for acquisition,
communication, and display of medical images. The
system transfers synchronous real-time video and
sounds between the clinician and the patient.
Medical devices approved by governance of the
local authority can be used to provide real-time
medical images and sounds to the system to enable
remote clinicians to offer high level assessment and
diagnosis. Clinicians can also contact patients
directly through the video conference connection.
The communication connectivity is via a standard
public
telecommunications utility to the Internet. Decisions
concerning diagnosis and treatment are solely
performed by the remote clinician. Depending on
medical devices being used, a trained and qualified
medical professional healthcare provider working
within the scope of their license should facilitate and
assist patients with use of the Polycom Practitioner
Cart and medical devices.
Contraindications
This product is not intended for use in life
sustaining or life saving applications
The Polycom Practitioner Cart does not provide an
alternative to contacting emergency services if a
patient has a health problem that requires
immediate attention.
Compliance/Classification
This product is a Class 1 Medical Device Data
System (MDDS)
ANSI/AAMI ES60601-1 2005(R2012): Medical
electrical equipment, Part 1: General
requirements for basic safety and essential
performance; Amendment No.2: 2010/05/30
CAN/CSA-C22.2 No. 60601-1: 2008: Medical
electrical equipment, Part 1: General
requirements for basic safety and essential
performanceIEC 60601-1-2 Collateral Standard:
Electromagnetic Compatibility – Requirements and
tests
All configurations of the cart shall comply with the
requirements of UL 60601-1:2003. Anybody
connecting Medical Equipment to this cart is
responsible that the system complies with the
requirements for Medical Electrical Systems.
Attention is drawn to the fact that local laws take
priority over the above mentioned requirements. If in
doubt, consult your local representative or the
technical service department
Class A, Group 1 ISM Equipment
Internally powered device with no applied parts.
This equipment is designed for continuous operation.
This device is classified IPXO for water ingress
Input 120 VAC, 60 Hz, 5.1A for North America use 16
AWG minimum power cord type SJT with Hospital
Grade or Hospital Only mains power plug.
Contact Us
Polycom Inc.
6001 America Center Drive
San Jose, CA 95164
1-888-248-4143