9
Sensor Specifications
2F
Catheter
Type of Sensor
Diffused Semiconductor, piezoresistive
Pressure Range
-50 to + 300 mmHg (-6.7 to 40 kPa)
Overpressure
+4000 mmHg (+530 kPa), -760 mmHg (100 kPa)
Rated Excitation*
2.5-7.5 V
DC
or V
AC
rms
Sensitivity
5 µV/V/mmHg, nominal (37.6
µ
V/V/kPa)
Temperature Error Band
at Zero Pressure
±3 mmHg (
±
0.4 kPa) BSL, 23 - 38 ºC
Linearity and Hysteresis
±1%, BSL of full scale
Drift**
<6 mmHg (0.8 kPa) in 12 hours
Natural Frequency
≥
10 kHz
Bridge Resistance
1000 ohms, nominal
Reference Pressure
Atmosphere
Electrical Leakage
< 10 µA at 180 V
DC
10 µA at 120 V
AC
Zero Offset
< ±50 mmHg (
±
6.7 kPa)
* Performance specifications are for 5 V
DC
. Transient voltages up to 20 volts will not damage the
transducer.
** Based on 30 minute presoak.
2
Contraindications
The device should not be used if:
•
in the opinion of the physician, the risk of use clearly outweighs the benefits.
•
the product has not been cleaned and sterilized.
•
there is a probability of tissue or organ damage.
•
passing electric current through a vascular obstruction.
•
the product has passed expiration date.
Complications
Possible complications include, but are not limited to, the following:
•
Air embolism
•
Hematoma at the puncture site
•
Infection
•
Cardiac perforation
•
Thrombus formation
•
Vasospasm
•
Myocardial infarction
•
Serious arrhythmia
•
Vascular injury
•
Protamine reaction
•
Congestive heart failure
•
Death
Warnings
CAUTION:
Mikro-Tip catheters must be cleaned and sterilized prior to clinical use.
•
Use only with CE-approved monitoring equipment that has patient isolated input circuitry,
type CF patient applied part per EN 60601-1. The monitoring equipment used should be
compliant to relevant harmonized standards.
•
Patient isolated input is not required if used with Millar PCU-2000.
•
The recommended duration of each diagnostic procedure is under four hours.
•
Observe appropriate anticoagulation procedures to prevent thrombus formation.
•
Mikro-Tip catheters are shipped with a plastic dome fitting over the pressure sensor(s).
The dome should be in place during handling.
•
Do not allow any body fluids to collect under protective covering on catheter connector;
otherwise, sterilization cannot be assured.
•
Risk of infection may result if device is not discarded using proper procedures relating to
Biological Hazards.
•
No modification of this equipment is allowed.
•
This pressure transducer is not protected against defibrillation discharges. It must be used
only with monitors labeled as having an isolated defibrillator-protected patient connection
or shall be disconnected.
•
Disconnect the Mikro-Tip catheter from the Millar Control Unit prior to defibrillation or
electrosurgery.
•
DO NOT use the Mikro-Tip catheter in close proximity to high electrical noise-generating
equipment, as this may cause interference with the signal.
