Argon Criticath SP5105 Gebrauchsanleitung

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Criticath™ Flow-Directed Thermodilution
Catheters Models - SP5105, SP5107, SP5127, SP5507,
SP5527
Instructions
Models with Suffix :
"H" are heparin complex coated.
"L" are longer (110 cm) in SP5105.
"S" are softer, more flexible catheters.
"U" are polyurethane (body only).
"P" are polyurethane (entire catheter except balloon).
"13", "14", "23" and "24" have pre-attached protection sheaths; "23" &
"24" have SP5045 also.
"M" have port locations for smaller anatomies.
CONTRAINDICATIONS
Use of a heparin complex coated catheter is contraindicated in
patients with known sensitivity to heparin or benzalkonium
chloride.
General Description
The Criticath™ Flow-Directed Catheters are 14kΩ thermodilution
catheters designed for use as a diagnostic tool. Model SP5105 is
designed for use in pediatric patients while Models SP5105L, SP5107,
SP5127, SP5507 and SP5527 are for adult patients. These catheters
allow physicians to measure intracardiac pressures and cardiac output
when used with Argon Critical Care Systems (Formerly known as BD
Critical Care Systems) or other similar Cardiac Output Computers and
appropriate pressure monitoring equipment. The catheters are
intended for use at bedside, in cardiac catheterization laboratory,
surgery suite, post anesthesia recovery unit, and other specialized
critical care units. In addition to measuring cardiac output
(thermodilution method) these catheters may be used to measure right
atrial (RAP), pulmonary artery (PAP) and pulmonary capillary wedge
pressures (PCWP), to continuously monitor PA temperature, to
withdraw blood samples from the RA and PA, and to administer drugs
and I.V. solutions.
The catheter body material is Polyvinyl Chloride unless indicated by U
or P which indicates polyurethane.
These catheters are designed for diagnostic procedures and do not
require the use of fluoroscopy for insertion. However, they are
radiopaque so that fluoroscopy can be used to guide insertion and to
verify position following insertion. The catheters are marked every 10
cm to indicate distance from the distal tip. Narrow bands represent 10
cm markings and wide bands represent 50 cm markings.
SP5105, SP5107 and SP5127 has 4 lumens :
• 'PA DISTAL' [Distal (PA) Lumen]: Terminates at catheter tip and
is used for measurement of PA, PCWP, mixed venous pressure
and for blood sampling.
• 'CVP PROXIMAL' [Proximal (CVP) Lumen]: Terminates at 15
cm (for SP5105), 29 cm (for SP5105L, SP5107, SP5507, SP5127,
SP5527) and 25 cm (for "M" version models) proximal to catheter
tip and is used for injecting thermal bolus into the RA, for measuring
RAP or CVP and for blood sampling.
• 'BALLOON .75 mL CAP'/'BALLOON 1.5 mL CAP' [Balloon
Lumen]: Terminates in 0.75mL balloon (for SP5105 models) and
1.5mL balloon (for the other models) near catheter tip and allows
inflation and deflation of the balloon during catheter insertion and
measurement of PCWP.
091032-600-033 REV. 3
• Thermistor Lumen: Terminates in a thermistor bead 1.5 cm and
3.5 cm proximal to the tip for pediatric & adult respectively. Allows
cardiac output computation and PA blood temperature
measurement.
SP5127 is designed for femoral insertion (Use in cardiac
catheterization laboratory.)
SP5507 and SP5527contains five lumens. Lumen design is as
indicated above with an additional lumen:
• 'CVP MEDICATION' [Medication (CVP) Lumen]: Terminates
31cm (27cm for "M" version catheters) from catheter tip. May be
used for solution infusion, cardiac output injections, blood sampling,
fluid and drug administration and monitoring of RAP.
• Ventricular Lumen: Terminate 17cm from catheter tip. Used
mainly for monitoring of right ventricular pressure (RVP) for
SP5527 only.
SP5527 is a ventricular catheter.
NOTE: Administration of blood through the 5-lumen catheter is not
recommended.
A damaged catheter cannot be repaired. The packages are designed
to prevent catheter kinking and to protect the fragile balloon and
heparin complex coated surface.
Catheter Testing
1. Use aseptic method to remove catheter.
2. (Models "13", "14", "23", and "24" Only) Tighten the Tuohy-Borst
adaptor on the protection sheath securely to the catheter.
NOTE: Do not overtighten the adaptor as this may occlude catheter
lumens and result in inaccurate pressure readings.
3. Test thermistor by connecting catheter to Cardiac Output
Computer. If computer's display indicates appropriate room
temperature, the thermistor is operating properly.
CAUTION: Do not use a standard continuity checker or
ohmmeter when the catheter is in the vascular system. The
relatively high current in the meter can cause electric shock to the
patient in the event of insulation breakdown. Excessive
manipulation of catheter tip may damage thermistor and result in
intermittent or no output readings.
4. Test balloon by placing it in sterile water and injecting 0.75mL of air
for SP5105 and SP5105L (1.5mL for SP5107, SP5127, SP5507,
SP5527). If air bubbles appear around balloon, do not use the catheter.
Deflate balloon by removing syringe.
CAUTION
• Never use liquid for balloon inflation.
• Always deflate the balloon by removing syringe; balloon may be
damaged by aspirating air with syringe.
NOTE: Liquids within balloon lumen may cause balloon to remain
inflated. Special care must be taken to prevent moisture from entering
balloon lumen.
5. Evacuate air from injectate and IV solution bags.
NOTE: Eliminating air from solution will prevent air from entering the
system when solution is exhausted or bag inverted.
6. Connect stopcocks to the ends of the CVP proximal and PA distal
lumens. Flush and fill the CVP proximal and PA lumens with sterile
solution.
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.
Catheter Insertion
Catheter Insertion should follow the basic procedure recommended
below. However, catheter use must always conform to your hospital
policies and procedures. Thorough understanding of listed "Cautions"
is helpful before use of these catheters.
1. Monitor ECG continuously during catheter insertion.
2. Test catheter as outlined in "Catheter Testing." Connect stopcocks
to the CVP and PA lumens. When using an In-Line Injectate
Temperature Sensor, connect it directly to CVP lumen, and then add
the stopcock. Fill both lumens with sterile solution, to remove air
bubbles. Connect PA distal lumen to a pressure-monitoring system.
3. Insert catheter percutaneously or via a cutdown. Typical insertion
sites include the median basilic, jugular, femoral and subclavian veins.
4. Advance catheter into vena cava and partially inflate the balloon to
0.5 mL (for SP5105 & SP5105L) and 1 mL (for SP5107, SP5127,
SP5507 & SP5527 ). Filtered CO is recommended for inflation
2
because of its rapid absorption into blood in case of balloon rupture.
However, room air is frequently used if there is no right-to-left shunt or
pulmonary arteriovenous fistula. Introduction of an air embolus into the
arterial system can cause serious complications. The risk of balloon
rupture and likelihood of air entering the arterial system must be
considered when selecting air as the inflation medium. Determine
catheter length inserted by referring to 10 cm interval markings on
catheter. Follow the pressure waveforms as the catheter is advanced
(reference Figure 1).
5. When RAP waveform is seen (Figure 1-A), inflate balloon to full
capacity (0.75 mL for SP5105 & SP5105L and 1.5 mL for SP5107,
SP5127, SP5507 & SP5527).
6. Advance catheter through RA and into RV (Figure 1-B). If RVP
tracing is not recorded after the catheter has been advanced beyond
RA, deflate balloon by removing syringe, pull catheter back slowly,
reinflate and advance catheter (Figure 1-C). Observe a RVP waveform.
Advance into PA. If the catheter does not pass into PA, deflate balloon
and withdraw the catheter until tip is in RA. Then reinflate balloon and
repeat steps 4, 5 and 6.
A B C D
Figure 1A-E Pressure Waveforms During Catheter Insertion and
Positioning. (Chart Speed: 25 mm/sec.)
NOTE: If balloon has been inflated for more than 4 or 5 minutes during
insertion, the inflated balloon volume may decreased due to air
diffusion through latex balloon. Remove syringe and reinflate balloon if
necessary.
1/28
7. Continue advancing the catheter slowly through PA until a PCWP
is seen. (Figure 1-D).
8. Check proper positioning of catheter in PA by deflating balloon
completely (removing syringe) and observing the change from a
PCWP tracing to PAP tracing (Figure 1-E). Gradually, reinflate balloon
until a PCWP is obtained and record the volume of air required. It
should take 0.5 to 0.75mL (for SP5105 & SP5105L) and 1.25 to 1.5mL
(for SP5107, SP5127, SP5507, SP5527). If less than 0.5mL (for
SP5105 & SP5105) or 1.25mL (for SP5107, SP5127, SP5507&
SP5527 ) is required, the catheter may be advanced too far, increasing
the likelihood of distal migration and spontaneous wedging. Pull
catheter back 2 or 3 cm and recheck inflation volume.
9. (Models "13", "14", "23", and "24" Only) Extend the protection
sheath over catheter body and fasten to hub of introducer.
Cardiac Output Measurements
For cardiac output measurement instructions, refer to operating manual
provided with your cardiac output computer. Suggested introducer
sizes for catheters :
Catheter Introducer / With Sideport Flow
5F 6F
7F 7.5F
7.5F 8F
Model SP5105 is specifically designed to operate with the following
computation constants :
Volume
Injected mL
• Indicator at Ice
Temperature, In-Line
• Indicator at Ice Bath
Temperature (0-5°C)
• Indicator at Room
Temperature (23 to 25°C)
(the same for 18 to 22°C)
Models SP5107, SP5127, SP5507 and SP5527 uses the following
computation constants:
Volume
Injected mL
• Indicator at Ice
Temperature, In-Line
• Indicator at Ice
Bath Temperature (0-5°C)
• Indicator at Room
Temperature
(23 to 25°C)
(the same for 18 to 22°C)
Cautions
1. To avoid damage to catheter or balloon when inserting the catheter
by the cutdown procedure, it is recommended that a vessel dilator or
disposable vein guide introducer be used. NEVER use forceps on the
catheter.
2. (For Heparin Complex Coated Catheters only) If catheter
surface is treated with heparin complex coating, do not wipe the
catheter. The percutaneous method of insertion can minimize the
possibility of bleeding at the entry site. If wound closure is prolonged,
an appropriate topical hemostatic agent should be used to neutralize
the effect of any heparin complex that may have wiped off at the edge
of the wound.
3. It is generally recommended that the catheter not be left in the
patient for longer than 72 hours.
4. Catheters should not be advanced after properly positioned as the
portion of catheter left outside the body may not be sterile. If a catheter
protective sheath is used, catheter may be repositioned as needed.
5. Never make a cardiac output measurement with the balloon
inflated.
6. Determine PCWP by inflating balloon slowly, stop when PAP
waveform changes to PCWP waveform. Deflate balloon after
completing measurement.
7. To minimize ventricular irritation, always inflate the balloon before
the catheter reaches RV.
8. Do not exceed the recommended 0.75mL (for SP5105 & SP5105L)
and 1.5mL (for SP5107, SP5127, SP5507 & SP5527) balloon volume.
9. Initial placement of catheter in PA should always be made with the
maximum recommended balloon inflation volume. An under inflated
balloon will be smaller, thus allowing catheter to be positioned in a
narrower portion of PA, increasing the likelihood of spontaneous
wedging or the risk of PA rupture.
10. A slow heparin drip may be used to maintain catheter patency
and should be implemented before catheter insertion and maintained
thereafter. Be sure to backflush lumen after drawing blood. Care must
be taken not to damage the balloon when advancing catheter through
hemostasis valves, catheter/sheath adapters and introducers. Best
results are obtained by dilating valves, rubber seals and moistening
surfaces of balloon seals and valves with a sterile, injectable fluid. A
flow-directed catheter may migrate into the distal PA and cause
spontaneous wedging. To detect wedging, PA pressure waveform
should be monitored continuously or at short intervals.
Complications
It is important for physicians to be familiar with the catheter insertion
procedures, its advantages and associated risks in order to reduce the
incidence of complications. Risks associated with the use of this device
include: Dysrhythmias, Pneumothorax, Cardiac Tamponade, Balloon
Rupture, Thrombus/ Pulmonary Infarct, Perforation of the Pulmonary
E
Artery, Knotting, Sepsis/Infection, and other complications including
right bundle branch block (RBBB)
For further information regarding complications, contact your local
representative.
8F
8.5F
Computation
Constant
5 .291
3 .170
5 .279
3 .160
5 .316
3 .188
Computation
Constant
10 .579
5 .281
3 .160
10 .566
5 .270
3 .151
10 .628
5 .309
3 .181