Directions For Use - Osprey Medical R-Rrl Gebrauchsanweisung

DIRECTIONS FOR USE

The Smart Syringe is to be used with the DyeVert Plus, DyeVert Plus EZ
Contrast Reduction Systems or the DyeTect Contrast Monitoring System. This
includes the Contrast Monitoring Display or Smart Monitor and a disposable
Module (DyeVert Plus Module, DyeVert Plus EZ Module or Pressure Module).
Refer to the DyeVert Plus Contrast Reduction System, DyeVert Plus EZ Contrast
Reduction System or the DyeTect Contrast Monitoring System Instructions for
Use for additional information, prior to use.
The Smart Syringe has two LEDs to provide user feedback.
1. Solid green (active for 10 seconds) indicates injections will be counted
towards cumulative volume
2. Flashing Yellow indicates system is paused and injections will not be counted
towards cumulative volume
Wirelessly Connect the Smart Syringe to the Contrast Monitoring Display
1. Remove orange battery pull tab from the Smart Syringe.
2. Select New Case. Following scanning, the LEDs on the Smart Syringe will
flash in the same pattern as shown on the Display for proper identification.
Confirm wireless connection
a) Select Yes or move the plunger of the Smart Syringe > 2 mL to confirm
Syringe flashing.
Note: Selecting No will result in further scanning.
Note: The green LED on the device will remain on for 10 seconds once the
device is connected to the Display.
ENSURE ALL PRIMING IS COMPLETED BEFORE PRESSING Start Case.
ENSURE to wirelessly connect a DyeVert Plus Module or a Pressure Module
to the Display.
b) Select Start Case to begin contrast accounting.
c) Perform procedure
Caution: Ending case will permanently disable communication between the
Display and Smart Syringe.
Smart Syringe FCC Information
Smart Syringe FCC ID: 2AHUPSS
Classifications per IEC 60601-1 / UL 60601-1:
Degree of Protection:
Mode of Operation:
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 Smart Syringe not expressly
approved by Osprey Medical could void the user's authority to operate the
equipment.
SYSTEM 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
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:
1. Reorient or relocate the other equipment.
2. Increase the separation between the display and the other equipment.
3. Connect the other equipment into an outlet on a circuit different from that to
which display is connected.
4. Consult Osprey Medical for help.
WARNING: Portable and mobile RF communications equipment may affect the
devices. The Display 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 Display or disposables, including cables specified
Type CF-Applied Part
Noncontinuous
th edition. These limits are
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 Display 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 EXPRESS 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. Use
Manufacturer
by last day of
month (MM).
Consult
electronic
Keep Dry
Instructions for
Use
EN IEC 60601-1
applied part Type
Single Use
CF Defibrillation-
proof
Do Not Use if
Prescription
RxOnly Package is
Only
Damaged
Consult instructions
for use for
Medical Device
important
information
Temperature
Syringe
Limit
European EU Authorized
Conformity Representative
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
customerservice@ospreymed.com
www.ospreymed.com
Osprey, DyeVert and DyeTect are trademarks of Osprey Medical Inc.
©Osprey Medical Inc. 2020. All Rights Reserved.
Sterilized by
STERILE │EO
ethylene oxide
REF
Model number
LOT
Lot Number
MR Unsafe
Identification of
Sterile Barrier
2797
MedPass SAS
95 bis Boulevard Pereire
75017 Paris - France
Australian Sponsor
Osprey Medical, Pty
Level 13, 41 Exhibition Street
Melbourne, Victoria 3000 Australia
8259-F Jan 2020