8176-L
Contrast Monitoring Display: Select
Power Down
from the main menu.
Contrast Monitoring System FCC Information
Smart Monitor FCC ID: BCG A1538
Contrast Monitoring Display contains FCC ID: Z64-WL18SBMOD
Smart Syringe FCC ID: 2AHUPSS
Pressure Module FCC ID: 2AHUPPM
Classifications per IEC 60601-1 / UL 60601-1:
Degree of Protection:
Type CF-Applied Part
Mode of Operation:
Noncontinuous
Contrast Monitoring Display
Enclosure Degree of Ingress Protection:
IP31
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
WARNING
: Changes or modifications to the Monitor, Smart Syringe or Pressure
Module not expressly approved by Osprey Medical could void the user’s authority
to operate the equipment.
ELECTROMAGNETIC INTERFERENCE PRECAUTIONS
This equipment has been tested and found to comply with the limits for a Group
1 Class B device, pursuant to IEC/EN 60601-1-2, 4
th
edition. These limits are
designed to provide reasonable protection against harmful interference. This
equipment, if not installed and used in accordance with the instructions, may
cause harmful interference to other equipment. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does
cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•
Reorient or relocate the other equipment.
•
Increase the separation between the Monitor and the other equipment.
•
Connect the other equipment into an outlet on a circuit different from that to
which display is connected.
•
Consult Osprey Medical for help.
WARNING
: Portable and mobile RF communications equipment may affect the
devices. The Monitor should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Display should be
observed to verify normal operation.
WARNING
: Use of accessories, transducers and cables other than those
specified or provided by Osprey Medical could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
WARNING
: Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the Monitor or disposables, including cables specified
by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
If performance of the system is lost or degraded due to electromagnetic
interference, the procedure may continue without contrast monitoring.
The Monitor and disposables have Bluetooth transceivers using short-
wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz. The
Pressure Module and Smart Syringe transmit a maximum signal strength of
0.063 mW (-12 dBm ERP) using GSFM modulation as per IEEE 802.15.1
Bluetooth standard and the Bluetooth SIG Working Group specification Version
4.0+.
WARNING
: Refer to the Smart Monitor or Contrast Monitoring Display
Instructions for Use for the electromagnetic compliance information of this
system.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY
THERE IS NO WARRANTY EXPRESSED OR IMPLIED, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR OF FITNESS FOR A PARTICULAR PURPOSE, ON THE OSPREY
MEDICAL PRODUCT(S) DESCRIBED IN THIS PUBLICATION. IN THE
EVENT OF ANY DEFECT OR NONCONFORMITY OF OR TO THIS
PRODUCT(S), OSPREY MEDICAL’S LIABILITY SHALL NOT BE IN EXCESS
OF THE PURCHASE PRICE OF THE PRODUCT(S) TO BUYER. UNDER NO
CIRCUMSTANCES SHALL OSPREY MEDICAL BE LIABLE FOR ANY
DIRECT, INDIRECT OR CONSEQUENTIAL DAMAGES BASED UPON
BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE,
STRICT TORT OR ANY OTHER THEORY ARISING OUT OF THE
PURCHASE, USE OR REUSE OF THIS PRODUCT(S). OSPREY MEDICAL
NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME FOR
IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN
CONNECTION WITH OSPREY MEDICAL PRODUCT(S). Descriptions or
specifications in Osprey Medical printed matter, including this publication, are
meant solely to generally describe the product at the time of manufacture and
do not constitute any express warranties.
Packaging Symbol Definitions
Expiration Date
YYYY-MM-DD.
Use by last day
of month (MM).
Manufacturer
STERILE
│EO
Sterilized by
ethylene oxide
Consult
electronic
Instructions for
Use
Keep Dry
REF
Model number
Single Use
European
Conformity
LOT
Lot Number
RxOnly
Prescription
Only
Do Not Use if
Package is
Damaged
EN IEC 60601-1
applied part Type
CF Defibrillation-
proof
MR Unsafe
EU authorized
representative
Australian Communications and Media Authority mark
Osprey Medical, Inc.
5600 Rowland Road, Suite 250
Minnetonka, MN 55343
USA
Customer Service Toll-Free:
1-855-860-7584 Fax: 1-855-883-4365
www.ospreymed.com
Osprey & DyeTect are trademarks of Osprey Medical Inc.
©Osprey Medical Inc. 2019. All Rights Reserved.
NOTE : Translations will be provided upon approval of english content.
MedPass SAS
95 bis Bd Pereire, 75017 Paris, France
Australian Sponsor
Osprey Medical, Pty
Level 13, 41 Exhibition Street
Melbourne, Victoria 3000 Australia
2797
