Osprey Medical DyeTect RRL User manual

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DyeTect™Contrast Monitoring Disposable Kit
INSTRUCTIONS FOR USE
CAUTION: Federal (USA) Law restricts this device to sale by or on
the order of a physician.
DEVICE DESCRIPTION
The DyeTect™Contrast Monitoring Disposable Kit consists of a Smart Syringe
and Pressure Module to be used with the Monitor during controlled infusion for
procedures requiring injection of contrast media. The DyeTect Contrast
Monitoring System allows for monitoring and display of contrast volumes
manually injected.
The Pressure Module has been designed for use with manifolds with Luer fittings
that have been demonstrated to comply with ISO 594 “Conical fittings with a 6%
luer taper for syringes, needles and certain other medical equipment”.
MODEL NUMBER SELECTION - Disposables
Model Number
Syringe Description
RRL
Locking Luer, Ring Plunger – Ring Grip
PRL
Locking Luer, Palm Plunger – Ring Grip
PWL
Locking Luer, Palm Plunger – Wing Grip
RRS
Swivel Luer, Ring Plunger – Ring Grip
PRS
Swivel Luer, Palm Plunger – Ring Grip
PWS
Swivel Luer, Palm Plunger – Wing Grip
CMS CLASSIFICATION
• The DyeTect Contrast Monitoring System disposables are internally powered
• The Smart Monitor is class II or Internally Powered
• The Contrast Monitoring Display is Class 1 type of protection against electric
shock.
• Degree of protection against electric shock: Type CF applied part
• Equipment not suitable for use in the presence of flammable mixtures
APPLIED PARTS
Smart Syringe and a Pressure Module. All parts are single use, disposables.
INTENDED USE
The Contrast Monitoring Disposable Kit consists of a Smart Syringe and a
Pressure Module to be used with the Monitor during controlled infusion for
procedures requiring injection of contrast media. The Osprey Medical DyeTect
Contrast Monitoring System allows for real-time monitoring and display of
contrast volumes manually injected.
INDICATION FOR USE
The DyeTect™Contrast Monitoring Disposable Kit consists of a Smart Syringe
and Pressure Module to be used with the Monitor during angiographic or CT
procedures requiring controlled infusion of radiopaque contrast media.
CONTRAINDICATIONS
Not for use with power injectors.
WARNINGS
Disposables are for single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocess or resterilization may create a risk of patient infection which
could lead to injury, illness or death.
The DyeTect Contrast Monitoring Disposable Kit should be connected to single-
use contrast source devices only. The Pressure Module does not prevent nor
protect against contamination or microbial ingress to or from a single-use
contrast source. The DyeTect Contrast Monitoring Disposable Kit and single-use
contrast source, including anyremaining contrast solution in the single-use
contrast source, should be disposed of following the procedure.
Do not use if product packaging appears compromised or damaged.
Refer to the specific Monitor Instructions for Use and ensure all labeling and
Instructions for Use are followed:
• Smart Monitor Instructions for Use and labeling, or
• Contrast Monitoring Display Instructions for Use and labeling
Please refer to the contrast agent Labeling for dosage recommendations,
warnings, contraindications, detail of reported adverse event types and detailed
directions for use associated with contrast administration.
For accurate Smart Syringe % contrast concentration values, ensure Smart
Syringe is initially primed with 100% contrast media and the contrast source is
100% contrast.
PRECAUTIONS
As with any device used for injecting contrast media into a patient, care should
be taken to assure all air has been removed from the lines, prior to injection, to
avoid air embolization.
Use only light tapping if necessary to remove air while priming the system.
Do not use tools (hemostats or other instruments).
Be cautious to not over-tighten on luer connections when connecting the Smart
Syringe and/or Pressure Module to a manifold.
The Smart Syringe or Pressure Module should not be immersed in contrast or
saline.
Osprey Medical recommends users follow hospital policy/procedure and
physician recommendation on the appropriate total cumulative volume of contrast
media used in a patient. The device is not intended to prevent manual injection of
contrast media.
User should ensure the Smart Syringe plunger is idle for a minimum of 1/2
second (Dwell Time) prior to switching between contrast & saline when
aspirating. If needed, contact Osprey Medical to adjust Smart Syringe plunger
dwell time to align with user preference. Inaccurate cumulative volume may be
displayed if dwell time is not reached prior to switching between aspirating
contrast & aspirating saline.
POTENTIAL PATIENT ADVERSE EVENTS
Possible adverse effects include but are not limited to: air embolism, infection.
HOW SUPPLIED
Disposable, sterile system components have been sterilized with ethylene
oxide (EO).
STORAGE
For optimal battery life, store the DyeVert Plus Disposable Kit between 10°C and
25°C (50°F and 77°F) and do not exceed 30°C (86°F).
MAINTENANCE and REPAIR
Maintenance is not required.
DISPOSAL
Discard Smart Syringe, Pressure Module and single-use contrast source
according to hospital procedures.
OPERATING CONDITIONS
The system is intended to be used in a standard hospital Cath lab environment
under the following conditions:
Temperature: 10°C to 27°C (50°F to 80°F)
Relative humidity 0% to 85%, noncondensing
The system is not intended be used near active high frequency surgical
equipment where the intensity of electromagnetic disturbances is high.
MRI SAFTEY INFORMATION
The Smart Syringe and DyeTect Pressure Module are MR UNSAFE. Keep them outside the
MRI Scanner room.
MASS of DEVICES
Smart Monitor with Clamp 831g
Contrast Monitoring Display with Clamp 1483g
Smart Syringe 44g
Pressure Module 38g
PHYSICIAN TRAINING INFORMATION
Qualified physicians should be knowledgeable with Cath lab procedures,
techniques and contrast media usage.
No additional special skills or training are required to operate the system but
physicians should be thoroughly familiar with the DyeTect Contrast Monitoring
System supporting material including all product labeling. Physicians may contact
Osprey Medical to request training.
DIRECTIONS FOR USE
Note: For Detailed instructions for the Monitor, refer to the Contrast Monitoring
Display Instructions for Use or the Smart Monitor Instructions for Use as
applicable.
System Overview
The DyeTect Contrast Monitoring Disposable Kit is for use with the Monitor
through wireless communication. The system allows user input and monitoring
per specific individual case; as well as monitoring of total attempted injection
volume and % contrast concentration in Smart Syringe. Input parameters include
cumulative contrast injection volume and contrast volume threshold.

8176-L
Or
The Pressure Module connects wirelessly to the
Monitor. It includes a module with a pause button and
a pressure transducer.
The Smart Syringe and Pressure Module have two LEDs to
provide user feedback.
•Solid green (active for 10 seconds) indicates injections will be
counted towards cumulative volume
•Flashing Yellow indicates system is paused and injections will
not be counted towards cumulative volume
Assemble and Prime
Note: It is recommended to leave all battery pull tabs in the disposable devices
until all priming is complete and the case is ready to begin. This will
ensure maximum battery life and performance
throughout the case.
1) Introduce disposables into sterile field per
normal procedure.
2) Attach contrast source line to the female luer located in the
pressure transducer of the Pressure Module.
3) Attach the male luer of the pressure
transducer to the Manifold, and the Manifold
to the Smart Syringe.
4) Prime manifold and all lines per normal procedure.
Wirelessly Connect Disposables to Monitor
Note: Assemble and prime system prior to wirelessly connecting disposables
1) Remove pull tabsfrom the Smart Syringe and the Pressure.
2) Select New Case. Wirelessly connect Smart Syringe & Pressure Module to
the Monitor by selecting the device to connect on the display. Following
scanning, the LEDs on the Smart Syringe & Pressure Module will flash in the
same pattern as shown on the Monitor for proper identification.
3) Confirm wireless connection
a) Select Yes on the display or move the plunger of the Smart Syringe > 2
mL to confirm Syringe flashing.
b) Select Yes or press Pause Button on DyeVert Plus Module to confirm
Module flashing.
Note: Selecting No will result in further scanning and will not allow connection
of the rejected device to the Monitor.
Note: The green LED on the syringe and Module, respectively, will remain on
for 10 seconds when each device is connected to the Display.
Start Case
1) Enter the physician specified threshold. If no threshold is desired, enter “0”.
ENSURE ALL PRIMING IS COMPLETED BEFORE PRESSING Start Case
ON THE MONITOR .
For Detailed instructions, refer to the Contrast Monitoring Displayor Smart
Monitor Instructions for Use.
2) Select Start Case on Monitor to begin contrast accounting.
3) Perform procedure
Pause/Resume
The DyeTect Pressure Module has a Pause button which allows the user to
manually pause/resume contrast accounting.
When the system is in “Pause” mode, cumulative contrast accounting is
suspended. “Resume” mode allows contrast accounting
1) To Pause select Pause on Monitor or press DyeTect Module pause button.
LED’s on Smart Syringe & Module will blink yellow and background on
Display will change to yellow.
2) To Resume
Pause Lock Disabled
Aspirate contrast into Smart Syringe (resumes automatically) or select
Resume on Monitor or press Module pause button. LED’s on Smart Syringe
and Module will be green for 10 seconds and the Monitor will return to normal
background.
Pause Lock Enabled
Select Resume on Monitor or press Module pause button. LED’s on Smart
Syringe and Module will be green for 10 seconds and the Monitor will return to
normal background.
If contrast is injected back to the source, the system does NOT need to be
paused. The system will automatically recognize this as not being administered
to the patient. To maintain system accuracy, the user should ensure that only
100% contrast is injected back to the source.
Contrast Accounting Accuracy Tips:
• Ensure system is Paused if contrast is not being injected to patient.
• Ensure system is Active (unpaused) when contrast is being injected to
patient.
•Ensure the minimum dwell time (1/2 second) is achieved between aspirations
of contrast and saline.
End Case
1) Press End Case button
2) When prompted, confirm that you want to end the case
Caution: Ending case will permanently disable communication between the
Monitor and disposables.
Caution: End Case must be selected prior to powering down the Monitor or
starting a new case. Powering down the Monitor before ending case or starting a
new case without ending the previous case, may lead to inaccurate accounting
on next patient’s case. If the Monitor is powered down prior to ending the case
and it has been less than 2 hours the Monitor will ask if the user would like to
continue the case that was in progress prior to powering down.
Case summaryscreen appears showing cumulative volume of contrast
administered to patient and the percentage of physician specified threshold.
The Smart Syringe and Pressure Module contain batteries. Discard the Smart
Syringe and Pressure Module and single-use contrast source according to
hospital procedures.
Follow local governing ordinances regarding disposal. Do not incinerate as the
enclosed batteries may explode at excessive temperatures
Note: To view summaries for previous cases, from Main Menu select Settings,
User Settings, Case History.
Select Main Menu to return to the main menu and start a new case.
System Discontinuation
Smart Monitor: Select Power Down by pressing and holding the power button
on the end of the Monitor, then swiping the screen as indicated.
Total
Volume
Last Injection
Volume
Contrast
% Mix or % Saved
Selected
Threshold
Volume Remaining
Until Selected
Threshold Reached
Monitor Case Status
Note: graphical rangeindicator is not representative of a recommended
contrast dosage
Pause
Button
Pressure
Transducer
Female Luer
(Contrast
Source)
Male Luer
(Manifold)

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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 maynot cause harmful interference, and
(2) this device must accept anyinterference 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, 4th 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
bythe 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: [phone]
customerserv[email protected]
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