Technical Characteristics; Intended Use; Device Preparation And Set-Up - Spectrum Quantum PureFlow Instrucciones De Uso

D.

TECHNICAL CHARACTERISTICS

Characteris� cs
Blood contact materials
Maximum opera� ng pressure - cardioplegic
solu� on side
Overpressure valve opening
Maximum opera� ng pressure - HTF side
Maximum HTF compartment supply temperature
Sta� c priming volume (ml)
Exchange surface area (m
Maximum cardioplegic solu� on fl ow rate (l/min)
Filter cutoff (µm)
Temperature probe
Connec� ons - cardioplegic solu� on side
Connec� ons - HTF side (inlet/outlet)
E.

INTENDED USE

The Cardioplegia Heat Exchanger has been designed to heat/cool cardioplegic solu� on and physiological fl uids, remove air and monitor
the temperature during surgical procedures that require extracorporeal circula� on and cardiopulmonary bypass for periods of maximum
6 hours. Any blood to be treated must contain an� coagulant. Contact with cardioplegic solu� on for longer than this period is not permi� ed.
F.

DEVICE PREPARATION AND SET-UP

CAUTION
- A spare device must always be available during extracorporeal circula� on.
- Check that the O-Ring is present on the HTF connectors (ref. 3c and 3d in Fig.2).
- The device has been designed to be used only with the dedicated holder provided by Spectrum Medical.
- During circuit set-up and before star� ng extracorporeal circula� on, check that the spare medical devices and accessories indicated
in the manual of the medical devices listed in sec� on J are available.
- Be careful not to damage the connectors when connec� ng the tubes.
- Follow a suitable blood an� coagula� on protocol before and during the procedure.
- The ACT (ac� vated coagula� on � me) value must always be such as to guarantee an� coagula� on suited to the procedure.
F.1. PREPARING THE HEATER COOLER
CAUTION
- The pressure of the HTF solu� on inside the device must not exceed the value indicated in Table 1 - sec� on D.
- The heat exchanger temperature must not exceed the value indicated in Table 1 - sec� on D.
1. Prepare the quick-coupling tubes provided with the Spectrum Medical Quantum Heater-Cooler System.
F.2. INSTALLING THE HEAT EXCHANGER
1. Remove the device from the sterile packaging.
2. Fit the device on the dedicated holder provided by Spectrum Medical. For more details, refer to the user manual of the Spectrum
Medical Quantum HLM heart-lung machine (Quantum Pump Console User Guide).
3. Make sure the device is firmly attached to the holder.
4. Remove the protective caps from the connectors on the HTF side of the device (ref. 3c and 3d in Fig.2).
5. Connect the tubes of the Spectrum Medical Quantum Heater-Cooler System (ref. 4 in Fig. 2) to the device (ref. 3c and 3d in Fig. 2) using
the female quick-coupling connectors.
F.3. CHECKING THE INTEGRITY OF THE DEVICE
1. Start priming of the HTF circuit following the instructions given in the user manual of the Spectrum Medical Quantum Heater-Cooler
System.
2. The integrity of the device is guaranteed if:
HX32V-C0
High Flow
Polycarbonate
Polyethylene
Polyester
AISI 304 stainless steel sheet
Epoxy resin
Silicone
Coa� ng: phosphorylcholine
750 mmHg / 100 kPa / 1 bar / 14.5 psi
500-750 mmHg / 66-100 KPa / 0.6-1 bar / 9.7-14.5 psi
1500 mmHg / 200 kPa / 2 bar / 29 psi
42°C
32
) 0.055
2
1
120
YSI 400
IN
1/4'' (6.35 mm)
1/4'' (6.35 mm)
OUT
CPC HFC
profi le
CODE
HX22V-C0 HX22V-C1
Low Flow Low Flow
22 22
0.028 0.028
0.5 0.5
3/16'' (4.76 mm) 1/4'' (6.35 mm) 1/4'' (6.35 mm)
3/16'' (4.76 mm) 1/4'' (6.35 mm)
CPC APC CPC APC
profi le profi le
Table 1
Instruc� ons for use
HX32V-C4 HX22V-C4 HX22V-C5
High Flow Low Flow Low Flow
32 22
0.055 0.028
1 0.5
3/16'' (4.76 mm) 1/4'' (6.35 mm)
Pos Lock Pos Lock Pos Lock
CPC HFC CPC APC CPC APC
profi le profi le
22
0.028
0.5
profi le
3
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