Hemoconcentrators

Hemoconcentrators with a high permeability microporous hollow fiber membrane

DHF Hemoconcentrator

The DHF hemoconcentrator is composed of a high permeability microporous hollow fiber membrane. The device is available in the following versions:

DHF 02
DHF 06

	DHF 02	DHF 06
Active Surface Area	0.25 m²	0.68 m²
Hollow fibre (type) Internal diameter Wall thickness	Polyethersulphone 200 μm 30 μm
Static priming volume (blood compartment)	30 ml (+/-10 ml)	60 ml (+/-10 ml)
Min–Max blood flow rate (Qb)	100-500 ml/min
Min–Max transmembrane pressure (TMP)	0-66 kPa (0-0.7 bar / 0-9.6 psi / 0-500 mmHg)
Min–Max pressure drop (parameter to monitor when blood flow rate in the hemoconcentrator is not known)	6.6-20 kPa (0.066-0.2 bar / 0.95-2.7 psi / 50-150 mmHg)	1.3-4.6 kPa (0.013-0.046 bar / 0.91-0.67 psi / 10-35 mmHg)
Blood contact materials	Polyethersulfone; Polycarbonate; Polyurethane
Length	145 mm
Diameter	55 mm
Weight	98 g (0.22 lb)	105 g (0.23 lb)
Connectors: Blood compartment inlet Blood compartment outlet Filtrate outlet (UFT)	Male Pos-Lock Male Pos-Lock ¼’’ (6.35 mm)

Safety Information

Important Safety Information for Hemoconcentrators

1. INDICATIONS FOR USE / INTENDED PURPOSE
The device is intended for use in cardiopulmonary pypass circuit for hemoconcentration and consequent restoring of patient physiological hematrocrit. The blood to be treated should contain anticoagulant.

The choice of hemoconcentrator depends on the protocol being used and required filtration speed The transmembrane (TMP) pressure of the hemoconcentrator must always be lower than 66 Kpa ( 0.7 bar / 9.6 psi / 500 mm Hg).

All devices must be used up to 6 hours or less.

2. CONTRAINDICATIONS

The device is recommended only for use for the above-mentioned purpose. Not recommended for use in diseased or abnormal cannulation sites.

3. WARNINGS

The device must be used in accordance with the instructions for use. For a complete listing of warnings, please refer to the Instructions for Use which accompany each product.

4. PRECAUTIONS

For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product.

5. PERFORMANCE INFORMATION

The device is composed by an high permeability microporous hollow fiber membrane.

The devices are single use, non-toxic, non-pyrogenic, supplied STERILE and individually packaged. Sterilised by ethylene oxide. The level of ethylene oxide residuals in the device is within the limits established by national regulations in the country of use.

The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer. Please contact us through our website ( www.sorinmanuals.com) to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events The information contained in this summary represents partial excerpts taken from the product labeling. The information is not intended to serve as a substitute for a complete and through understanding of the device nor does this information represent full disclosure of all pertinent information concerning the use of this product.

Not approved in all geographies. Please consult your labeling.

Legal Manufacturer:
Sorin Group Italia S.r.l.
Via Statale 12 Nord, 86
41037 Mirandola (MO) ITALY

SH 14 Hemoconcentrator

The SH 14 hemoconcentrator is composed of a high permeability microporous hollow fiber membrane.

	SH 14
Active Surface Area	1.35 m²
Hollow fibre (type) Internal diameter Wall thickness	Polyethersulphone 200 μm 30 μm
Static priming volume (blood compartment)	80 ml (+/-10%)
Min-Max blood flow rate (Qb)	100-500 ml/min
Max transmembrane pressure (TMP)	66 kPa (0.7 bar / 9.6 psi / 500 mmHg)
Blood contact materials	Polyethersulfone; Polycarbonate; Polyurethane
Length	305 mm
Diameter	39 mm
Weight	191 g (0.42 lb)
Connectors: Blood compartment inlet Blood compartment outlet Filtrate outlet (UFT)	Male Pos-Lock Male Pos-Lock Hansen connector

Safety Information

Important Safety Information for Hemoconcentrators

All devices must be used up to 6 hours or less.

2. CONTRAINDICATIONS

The device is recommended only for use for the above-mentioned purpose. Not recommended for use in diseased or abnormal cannulation sites.

3. WARNINGS

The device must be used in accordance with the instructions for use. For a complete listing of warnings, please refer to the Instructions for Use which accompany each product.

4. PRECAUTIONS

For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product.

5. PERFORMANCE INFORMATION

The device is composed by an high permeability microporous hollow fiber membrane.

Not approved in all geographies. Please consult your labeling.

Legal Manufacturer:
Sorin Group Italia S.r.l.
Via Statale 12 Nord, 86
41037 Mirandola (MO) ITALY

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