Spectrum Quantum PureFlow Instrucciones De Uso página 6

B. CONTRAINDICATIONS AND ADVERSE REACTIONS
The device may not be used for any purpose other than its intended use. The user is responsible for any use diff erent from that intended.
The following adverse reac� ons are possible: allergic reac� on, haemorrhage, blood toxicity, embolism, excessive ac� va� on of blood
components, bleeding, fever, hemolysis, hypercapnia and acidosis, hypotension, hypovolemia, hypoxia, compromised pa� ent
temperature control, infec� on, neurological dysfunc� on and stroke, organ dysfunc� on, renal failure, reproduc� ve harm in male neonatal
and paediatric pa� ents, respiratory and pulmonary problems, sepsis, sterility, thrombosis, toxaemia, carcinogenicity, mutagenicity,
sensi� za� on, cytotoxicity, vascular damage, death.
C. DESCRIPTION
The device (Fig. 1) has been designed to heat/cool cardioplegic solu� on during extracorporeal circula� on. The device is equipped with
an integrated bubble trap fi lter (ref. 7 in Fig.1). The device is available in the versions listed in Table 1 – sec� on D.
The device is sold sterile in a blister pack in a mul� ple box of 4 units. All the device surfaces in contact with blood are treated with
a phosphorylcholine-based biocompa� ble coa� ng. Contact with cardioplegic solu� on for a period of more than 6 hours is not permi� ed.
The device has been designed to be powered by heaters coolers that use a glycol-based heat transfer fl uid (HTF).
The device must be used in combina� on with the medical devices listed in sec� on J in these instruc� ons for use.
2
Fig. 1
References:
1. HTF inlet connector
2. HTF outlet connector
3. Cardioplegic solu� on inlet connector
4. Cardioplegic solu� on outlet connector
Instruc� ons for use
5. Purge Luer-lock connector
6. Overpressure valve
7. Bubble trap fi lter
8. Temperature probe
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