SORIN GROUP D 632 Instrucciones De Uso página 3

GB - ENGLISH
I. CONTENTS
I. Contents
A. Description
B. Functional features
C. Intended use
D. Safety information
E. Set-up
F. Removal of oxygenator from the holder at the end of bypass
G. Maintenance
H. Limited Warranty
A. DESCRIPTION
The D632 holder consists of:
a) A clamp (ref. 1) with a knob (ref. 2).
b) A fixed arm (ref. 3).
c) A height-adjustable vertical pole (ref. 4).
d) Rigid reserve fasten-up system (ref. 5) with its height-
adjustable telescopic pole (ref. 6).
e) Water distributor with Hansen connectors (ref.7).
B. FUNCTIONAL FEATURES
The D632 holder functions are as follows:
a) Holds the oxygenator in the right and safe position.
b) Easily adjusts to any circuit configuration.
c) Hermetically connects to the thermocirculator.
d) Allows rotating oxygenating module by 360° to reduce tube
length.
C. INTENDED USE
The D632 holder must exclusively be used in conjunction with
the D903 Avant, D905 Eos, Compactflo Evo, PrimO
Synthesis oxygenator.
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:
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.
Indicates any special care to be exercised by a practitioner
for the safe and effective use of the device.
EXPLANATION OF SYMBOLS USED ON THE LABELS
Lot number (reference for product
traceability)
Code number
The following is general safety information with the aim of
advising the operator in preparing to use the device.
Also, specific safety information is given in the instructions for
GB – ENGLISH - INSTRUCTIONS FOR USE
use at locations in the text where that information is relevant for
correct operation.
The device must be used in accordance with the
–
instructions for use provided in this manual.
The device is intended to be used by professionally
–
trained personnel.
SORIN GROUP ITALIA is not responsible for problems
–
arising from inexperience or improper use.
FRAGILE, handle with care.
–
Do not expose to temperatures below 0°C (32°F) or
–
above 60°C (140°F).
Provided that all the conditions mentioned at paragraph
–
G are respected, the product can be endlessly reused.
Do not dispose of it after use. Before reusing the
product, if necessary, clean and disinfect it with alcohol.
For further information and/or in case of complaint
–
contact SORIN GROUP ITALIA or the authorised local
representative.
E. SET-UP
Remove product from packaging.
Visually inspect and carefully check the product before
use. Improper transportation an/or storage may have
damaged the product.
a) Secure the D632 holder to the pump pole at a suitable
height by using the knob (ref. 2).
b) Position the telescopic pole (ref. 6) at the top stop if using a
Compactflo Evo, PrimO
X,
2
using D903 AVANT ; and at the bottom stop for a D905
EOS.
c) Properly place the fixed arm (ref. 3)and the vertical pole
(ref. 4) of the holder.
d) Turn the lever (ref. 8) to the "OPEN" position.
e) Insert the rigid reserve in the fasten-up system (ref. 5)
taking care not to occlude the tap drain line, and hook the
oxygenating module to the water distributor (ref. 7).
f) Turn the lever (ref. 8) to the "CLOSE" position to seal the
water side of the heat exchanger.
Do not force the lever if
reposition the oxygenator and retry turning the lever.
g) Connect the holder D632 to the thermocirculator by means
of two SORIN GROUP ITALIA female Hansen connectors
code 09028, or alternatively, using two 1/2" tubes as short
as possible. The water distributor (ref. 9) connectors may
be used indifferently as inlet or outlet.
If tubings are used, secure the water connections with ties.
Connection with SORIN GROUP ITALIA female Hansen
connectors code 9028 enables quick holder replacement.
The same connection with tubings takes longer.
GB - ENGLISH
X, Synthesis; middle position if
2
it does not turn easily;
3