8176-L
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 any remaining 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.
