Priming Procedure - sorin SH 14 Mode D'emploi

- The User should carefully check the device during set-
up and priming for leaks. Do not use if any leak is
detected.
- The device must be used in accordance with the
instructions for use provided in this manual.
- For use by professionally trained personnel only.
- SORIN GROUP ITALIA is not responsible for problems
arising from inexperience or improper use.
- FRAGILE, handle with care.
- Keep dry. Store at room temperature.
- Always apply and maintain a correct dose and accurate
monitoring of the anticoagulant before, during and after
the bypass.
- For single use and for single-patient use only. During
use the device is in contact with human blood, body
fluids, liquids or gases for the purpose of eventual
infusion, administration or introduction into the body,
and due to its specific design it cannot be fully cleaned
and disinfected after use. Therefore, reuse on other
patients might cause cross-contamination, infection and
sepsis. In addition, the reuse increases the probability
of product failure (integrity, functionality and clinical
effectiveness).
- The device must not undergo any further processing.
- Do not resterilize.
- After use, dispose of the device in accordance with
applicable regulations in force in the country of use.
- The device must only be used if STERILE.
- For further information and/or in case of complaint
contact SORIN GROUP ITALIA or the authorised local
representative.
- Federal law (U.S.A.) restricts this device to sale by or on
the order of a physician.
E. SET-UP (FIG. 2 AND FIG. 3)
- Do not use if sterile packaging is damaged,
unsealed, or has been exposed to moisture or
other conditions that would compromise the
sterility of the device.
- Check the expiry date on the label attached. Do
not use the device after the date shown.
- The device must be used immediately after
opening the sterile packaging.
- The device must be handled aseptically.
1. Remove the device from the sterile packaging.
- Carry out a visual inspection and carefully check
the device before use. Transport and/or storage
conditions other than those prescribed may have
caused damage to the device.
- Do not use solvents such as alcohol, ether,
acetone, etc.: as contact may cause damage to
the device.
- Do not allow halogenated liquids such as
Halothane and Fluothane to come into contact
with the polycarbonate housing of the device.
This could
compromise the integrity and proper functioning
of the device.
2. Remove protective caps from blood inlet (ref. 1, Fig.
1), blood outlet (ref. 2, Fig. 1) and ultrafiltrate outlet
(ref. 3, Fig. 1). Close the connector (ref. 4, Fig. 1) by
a 1/2" sealing cap.
6
cause damage which
3. Insert Hemoconcentrator on the SORIN GROUP
ITALIA holder (code # 09017) with blood inlet
downwards.
4. Connect inlet blood line to connector (ref. 1, Fig. 1),
outlet blood line to connector (ref. 2, Fig. 1) and
ultrafiltrate line with collection bag to ultrafiltrate
outlet (ref. 3, Fig. 1).
F. PRIMING PROCEDURE
The Hemoconcentrator SH14 requires preparation of
the surfaces that come into contact with blood.
Therefore, prime the device with saline solution
before use in order to optimise functioning.
1. When the saline solution starts flowing from the
Hemoconcentrator, clamp and release outlet line
alternately to facilitate the removal of microbubbles
contained in the hollow fibers.
2. SH 14 is ready for use when all microbubbles have
been evacuated.
G. INITIATING
HEMOCONCENTRATION
Ultrafiltrate collection bag must be placed below the
filter during use.
1. Clamp the ultrafiltrate line (ref. 3, Fig. 1) before
priming with blood.
2. Let
respecting TMP maximum value prescribed in
paragraph B (TECHNICAL FEATURES).
3. Open ultrafiltrate line (ref. 3, Fig. 1) and start
Hemoconcentration.
- Continuously check for blood leaks in the
ultrafiltrate line. If blood leaks appear, return the
blood contained in the Hemoconcentrator to
patient.
- In order to continue the treatment, use a new
device and completely repeat the previously
described set-up and priming procedures.
H. TERMINATING
HEMOCONCENTRATION
It should be performed according to the patient's state.
1. Clamp blood inlet line (ref. 1 in Fig. 1).
2. Reverse Hemoconcentrator (blood inlet upwards).
3. Disconnect inlet line from Hemoconcentrator.
4. On the basis of the type of circuit used, return the residual
blood contained in the device to extracorporeal circulation
system.
I. MEDICAL DEVICES TO BE USED
WITH SH 14
There are
Hemoconcentrator SH 14 with any oxygenation system and
cardiopulmonary bypass set-up if the following conditions
apply (ref. paragraph B - TECHNICAL FEATURES):
- use Pos lock female connectors for connections to
may
Hemoconcentrator (blood inlet and outlet);
- respect maximum TMP value prescribed during perfusion.
Moreover, use a ultrafiltrate line connected to a collection bag
with a tubing diameter suitable for the connector placed on the
device (Standard
Hemoconcentration Kits).
Currently SORIN GROUP ITALIA is not aware of any
contraindications to the use of the device with occlusive or
GB – ENGLISH
blood slowly flow into
no contraindications
KH SORIN
Hemoconcentrator,
for the use of
GROUP ITALIA