Idiomas disponibles
Idiomas disponibles
en
Adapters
Venous blood inlet port adapter
Cardioplegia adapter
Other adapters
Materials
Housing parts (reservoir and lid)
Filtering media (venous and cardiotomies)
Defoamer (venous and cardiotomies)
Seals
Caps and adapters
Biocompatible coating
Technical data
available on request
1
The data include the applicable tolerances.
1
C. INTENDED USE AND INDICATIONS FOR
USE
HORIZON CVR hard-shell cardiotomy/venous
reservoir is intended to be used in an extracorporeal
perfusion circuit to collect, store and filter venous
and cardiotomy suctioned blood during routine
cardiopulmonary bypass procedures up to 6 hours
in surgery. The hard-shell cardiotomy/venous
reservoir is also intended for use during vacuum-
assisted venous drainage (VAVD) procedures.
HORIZON CVR is indicated for use on adult patients
undergoing extracorporeal circulation during
cardiopulmonary bypass procedures. HORIZON
CVR should not be used for more than 6 hours.
Contact with blood for longer periods is not advised.
HORIZON CVR should be used in combination with
the medical devices listed in section N (Medical
devices for use with HORIZON CVR).
D. CONTRAINDICATIONS
Do not use the device for any purpose other than
indicated.
Do not use if air leaks are observed during priming
or ECC, this may result in air embolism to the
patient and/or fluid/blood loss.
E. RISKS AND SIDE EFFECTS
The possible risks and side effects of the HORIZON
1 x 1/2" (12.7mm) / 3/8" (9.53 mm)
1 x POS lock male (ISO 8837) with 1/4" (6.35 mm) connector
1 x 3/8" (9.53 mm) / 1/4" (6.35 mm)
1 x 1/4" (6.35 mm) / female luer lock
1 x 3/8" (9.53 mm) / female luer lock
Polycarbonate (PC)
Polyester (PET), Polypropylene (PP)
Silicone treated Polyurethane (PU)
Thermoplastic Elastomer - Stirene - Butilene - Etilene -
Stirene (SEBS)
Polycarbonate (PC), Polypropylene (PP), Thermoplastic
Elastomer - Stirene - Butilene - Etilene-Stirene (SEBS)
Phosphorylcholine (PC)
Blood cell damage
Air-handling capability
Antifoam characteristics
Break-through volume
CVR include:
• haemolysis,
• adverse blood / tissues reaction,
• coagulation/complement activation, platelet
dysfunction,
• thrombosis,
• gaseous embolism,
• thromboembolism,
• blood loss,
• haemodilution,
• infection.
F. SAFETY INFORMATION
Information to draw the user's attention to
potentially dangerous situations and to ensure
correct and safe use of the device is indicated in the
text as follows:
WARNING
Indicates serious adverse reactions and potential
safety hazards for the practitioner and/or the
patient, which may occur during proper use or
misuse of the device and also the limitations of use
and the measures to be adopted in such cases.
CAUTIONS
Indicates that the user must take every possibly
precaution for safe and effective use of the device.
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