Tabla de contenido
Publicidad
Monitoring Life
™
Critikit™ Model SP4500 / SP4572 In-Line Ice / Room
Temperature Injection Set
Model SP5045 Disposable In-Line Injectate
Sensor Housing
INSTRUCTIONS FOR USE
DESCRIPTION
Critikit™ is a closed injectate delivery system. It connects to the CVP lumen of a thermodilution catheter to
perform iced or room temperature injections to compute cardiac output.
The In-line Injectate Sensor Housing, Model SP5045 is a sensor housing designed for use with Merit or other
cardiac output computers or modules, when used in conjunction with a Merit or comparable injectate sensor
cable.
The Critikit™ and SP5045 when used with a Merit cardiac computer and connection cable provide
measurement of injectate temperatures from 0°C to 27°C at the catheter entry entry site.
INTENDED USE
CRITIKIT INLINE INJECTATE DELIVERY SYSTEM
The CRITIKIT™ In-ine Injectate delivery system is a closed injectate system intended for room or ice injectate
temperature injection at the CVP lumen of a thermodilution catheter for computing the cardiac output.
IN-LINE SENSOR HOUSING
The in-line Sensor Housings are intended for in-line injectate temperature sensing at the catheter injection
site when used with the appropriate in-line injectate sensor cables.
USER / PATIENT / CLINICAL
User: Qualified nurses, clinicians and physicians
Patient: Pediatric and adult applications
Clinical: Hospitals or appropriate clinical environments
COMPONENTS
1 ea. SP5045 In-Line Injectate Sensor Housing
1 ea. 2-way check valve assembly
1 ea. control syringe, 10mL
1 ea. IV administration spike
2 ea. Luer-Lok™ protective covers
1 ea. 3-way stopcock assembly (optional)
ADDITIONAL ITEMS FOR SETUP (SEE FIG.1)
•
SP1445 Hemopro1 Hemodynamic Profile Computer or other cardiac output computer or module for 14KΩ
resistance thermodilution catheter
•
SP4045 Cable or other compatible injectate sensor cable provided by Merit
•
SP5555 Ice Container Bracket (Optional)
•
Crushed Ice or Iced Water (Optional)
SETUP PROCEDURE
1.
Use aseptic technique when handling the device.
2.
Connect syringe to two-way valve assembly (Figure 3) or three-way stopcock. (Figure 2)
3.
Prepare injectate solution as prescribed by a physician in a non-vented solution bag.
4.
Evacuate air from injectate and IV solution bags.
NOTE: Eliminating air from IV bag will prevent air from entering the system when the solution is
exhausted or when bag is inverted.
5.
Close clamp on IV tubing.
6.
Insert IV spike into injectate solution container.
NOTE: If a non-vented glass bottle is used, an airway needle is required to vent bottle.
7.
Attach IV set to the 2-way valve assembly or three-way stopcock.
8.
Verify that all components are securely connected. Hang injectate bag on IV pole. Separate small coil
of tubing by gently peeling tubing apart for desired length and attachment to catheter. Place large coil
in ice container.
WARNING: Unraveling the large coil may tear tubing. Tears in tubing may allow air or melted ice solution
to enter the system which could be injected into the patient.
9.
Open fluid control clamp on IV set.
10. Prime system by aspirating and discarding solution with syringe (see Figure 3) until entire system is
free of air.
NOTE: Special care must be taken when debubbling to ensure no air is injected into patient.
11. Close fluid control clamp(and optional 3-way stopcock). Ensure that catheter CVP lumen is filled.
NOTE: A 3-way stopcock may be attached between catheter connection hub and in-line injectate sensor
housing in order to add an IV solution bag for continuous flush or pressure monitoring.
WARNING: Stopcock lever must be positioned 90° for "OFF" position. Do not position stopcock
at 45° to achieve an "OFF" position. 45° positioning of stopcock is imprecise and may result in
contamination, bleed back or air embolism.
12. Connect injectate sensor housing and Critikit™ assembly to the prefilled CVP lumen on the PA catheter
(see Figure 1). Secure injectate system to ensure minimum movement of connections.
PREPARE COOLING BATH
(Steps 13-18 are not applicable for room-temperature injectate sets)
13. Place a layer of crushed ice at bottom of container.
14. Place large coil in ice container with outlet tubing at the bottom and cover completely with ice.
15. Place unused tubing in ice container and secure tubing with slots provided at top of ice container.
16. Add ice water till full and close container lid.
17. Mount container on SP5555 Bracket and then on IV pole.
18. After proper setup and filling, injectate should be ready for use in about five minutes. Periodically check
ice during use. Drain excess water into separate vessel before adding more ice.
IN-LINE SENSOR CABLE CONNECTION
19. Connect the in-line sensor cable (Model SP4045 or other compatible cable) to injectate sensor housing
by pushing spring assembly into housing and tightening (see Figure 1).
English
20. Connect cable to Merit Hemodynamic Profile Computer, Cardiac Index Computer, Cardiac Index
Module or other cardiac output computer.
NOTE: For detailed instructions refer to suppliers' instruction Manual.
CARDIAC OUTPUT MEASUREMENT
CAUTION: Catheter use must always conform to hospital policies, standards, and procedures.
21. Open roller clamp on IV set. Turn stopcock OFF to patient.
CAUTION: Use of 3mL injectate is not recommended in adults.
22. Pull back on syringe barrel to fluid-fill tubing and syringe to desired volume. Turn stopcock OFF to
injectate solution.
23. Press START button on computer.
24. When you hear the tone, or when indicated by the computer, inject syringe contents rapidly into
patient.
25. Read cardiac output value on computer.
26. For subsequent measurements, repeat Steps 21 through 25.
27. At conclusion of measurements, turn stopcock off to syringe and close fluid control on injectate tubing
only.
WARNING
RF communicating equipment shall be maintained away from the device at a distance of 30cm (12 inches).
The device shall not stack or be placed close to other communicating equipment. Electrical cables and other
electronic devices may negatively affect the EMC performance.
The EMISSION characteristics of the device make it suitable for use in industrial areas and hospitals (CISPR 11
class A). Not to use in residential environment
COMPLICATIONS
Risks associated with the use of this product include: sepsis/infection, air emboli, clotted catheter and bleed-
back, over infusion, and abnormal pressure readings.
For further information regarding complications, contact your Merit representative.
CAUTION: Tighten all connections before use. Do not overtighten connections as this may crack the
connection leading to leaks, air embolism, bleed backs or loss of pressure waveforms.
CLINICAL BENEFITS
•
Facilitate cardiac output measurement
STORAGE CONDITIONS
Store in cool dry place away from direct sunlight.
STERILE and non-pyrogenic in unopened, undamaged package. For single use only. Check integrity of the
individual package before use. After use, dispose of device in a manner consistent with standard protocols for
waste disposal. Do not resterilize.
Device lifetime is 72 - 96 hours base on CDC & Joint Commission Intl (JCI) recommendation.
Re-use may lead to infection or other illness/ injury.
This product contains a phthalate which may cause a risk to {children (male), pregnant or nursing women} in
conjunction with prolonged duration of use.
In the EU, any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the applicable Member State.
For reordering information or assistance please contact local representative.
1.
Injectate solution
2.
Ice Container
3.
SP4500 Small Loop
4.
500 NS in a Pressure Bag
5.
In-line Sensor Cable SP4045
6.
Critikit™ Ice Tempkit
SP4500 (Shown)
SP4572 (Not Shown)
7.
Proximal extension
8.
Medication Extension
9.
T.D. Criticath™ Catheter to Patient
10. Distal Extension
11. Inflation Extension
12. Volume Restricted Syringe
13. SP4035 Cathether Connector Cable
14. SP1445 Hemopro 1
2/40
Figure 1. Closed Loop System Setup
Publicidad
Tabla de contenido
