Table Des Matières; Description; Technical Features; Intended Use - sorin SH 14 Mode D'emploi

GB - ENGLISH
I. CONTENTS
I. Contents
A. Description
B. Technical features
C. Intended use
D. Safety information
E. Set up
F. Priming procedure
G. Initiating hemoconcentration
H. Terminating hemoconcentration
I. Medical devices for use with SH 14
J. Return of used products
K. Limited Warranty
A. DESCRIPTION
The SH 14 Hemoconcentrator is composed of a high
permeability microporous hollow fiber membrane. Figure 4
indicates membrane permeability
molecular weight (Sieving coefficient) and Figure 5 indicates
blood filtration performance.
The device is single use, non-toxic, non pyrogenic, supplied
STERILE and packaged singly. 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.
B. TECHNICAL FEATURES
Membrane surface area
Hollow fibre (type)
- internal diameter
- wall thickness
Static priming volume (blood
compartment)
Blood Path Resistance
(Q B =300 ml/min, Hct=25%)
Max transmembrane pressure
(TMP)
Materials
Dimensions
- length
- diameter
Weight
Connectors:
- Blood compartment inlet
- Blood compartment outlet
- Ultrafiltrate outlet (UFT)
C. INTENDED USE
SH 14 is intended for use in cardiopulmonary by-pass circuits
for haemoconcentration and consequent restoring of patient's
physiological haematocrit. The blood to be treated should
contain anticoagulant.
The choice of Hemoconcentrator depends on the protocol
being used and required
transmembrane pressure (TMP) of the Hemoconcentrator
must always be lower than 66 Kpa (0.7 bar / 9.6 psi). The SH
14 should not be used longer than 6 hours. Contact with blood
for longer periods is not advisable. The device should be used
in combination with medical devices described in paragraph I

(Medical devices for use with SH 14).

GB - ENGLISH - DIRECTION FOR USE
according to solute
1.35 m
polyethersulphone
200 m
30 m
80 ml (±10%)
< 9 KPa
(0.09 bar / 1.3 psi)
66 kPa (0.7 bar / 9.6
Polyethersulphone
polycarbonate
polyurethane
polyethylene
silicone rubber
305 mm
39 mm
191 g (0.42 lb)
Male Pos-Lock
Male Pos-Lock
Hansen Connector
ultrafiltration rate.
D. SAFETY INFORMATION
Information intended to attract the attention of the user to
potentially dangerous situations and to ensure correct and
safe use of the device is indicated in the text in the following
way:
WARNING indicates serious adverse reactions and
potential safety hazards for practitioner and/or patient
that can occur in the proper use or misuse of the device
and also the limitations of use and the measures to be
adopted in such cases.
CAUTION indicates any special care to be exercised by a
practitioner for the safe and effective use of the device.
EXPLANATION OF THE SYMBOLS USED ON THE
LABELS
2
psi)
The following is general safety information with the aim of
The
advising the operator in preparing to use the device.
Also, specific safety information is given in the instructions for
use at locations in the text where that information is relevant
for correct operation.
GB - ENGLISH
For single use only (Do not reuse)
Batch code (number)
(reference for product traceability)
Use by (Expiry date)
Date of manufacture
Sterile - Ethylene oxide sterilised
Non Pyrogenic
Contains PHTHALATE
Latex free
Warning: Do not resterilize.
Contents sterile only if package is not
opened, damaged or broken
Non sterile
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Keep away from heat
Keep dry
5