SORIN GROUP revolution Mode D'emploi page 4

E. SET-UP
- 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.
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 the pump if it is cracked or if it has been dropped.
- Do not let organic solvents such as alcohol, or anesthetic
agents, such as isofluorane, or acetone and ether come into
direct contact with the pump. These agents may jeopardize its
structural integrity.
1) CIRCUIT CONNECTION
With accepted aseptic technique, attach the appropriate tubing to
the inlet and outlet of the pump.
- All connections downstream of the pump must be secured
by means of ties.
- Do not operate the pump with its inlet clamped. A negative
pressure would be generated in the pump and air bubbles
could form.
- To aid in the prevention of gas or particulate embolization,
SORIN GROUP ITALIA recommends the use of safety
devices, including bubble detectors for all extracorporeal
circulation procedures.
F. SUGGESTED PRIMING PROCEDURE
- Do not operate the pump unprimed. Doing so may damage
the pump.
- While not required, flushing the circuit with CO
in priming.
1) WITH THE PUMP OUTLET PORT AT THE TOP,
SLOWLY GRAVITY FILL THE PUMP WITH
PRIMING SOLUTION
Allow the priming solution to slowly flow beyond the outlet port.
2) GENTLY TAP TO REMOVE ANY REMAINING
BUBBLES
Do not strike the pump. Shock may cause damage to the
device, which may cause device malfunctioning.
3) PLACE THE PUMP IN THE MOTOR DRIVE
RECEPTACLE
Slowly increase the pump speed and check the pump for
leaks and other anomalies.
Do not use the pump if leaks or other anomalies are noticed.
4) PRIME THE REST OF THE CIRCUIT IN YOUR
USUAL MANNER
5) CONNECT THE FLOW
CIRCUIT TUBING WHERE DESIRED
G. PROCEDURE
- Adequate cannulation should be performed in order to
avoid air emboli to enter the ECC system and the pump.
Entry of massive air into the pump will cause the pump to
deprime and the blood flow to stop.
- Ensure that the pump and circuit have been properly
debubbled prior to going on bypass.
- The pump must not be run unattended.
- Do not operate the pump for long periods of time with its
outlet clamped.
4
H. BLOOD PUMP CHANGE-OUT
A spare blood pump must always be available during bypass in the
unlikely event that the pump in use requires change-out. Procedures
lasting longer than 6 hours or if particular situations where the safety of
the patient may be compromised, could require change-out. Follow the
steps below to change-out the blood pump.
Use sterile technique during all replacement procedure.
gas will aid
2
1) Clamp the REVOLUTION inlet and outlet lines and immediately
2) Remove the pump from the circuit and from the motor drive
3) Prepare the REVOLUTION to be used as replacement.
4) Connect the replacement pump to the circuit and conveniently
5) Position the blood pump into the motor drive receptacle.
6) Remove the clamps and resume blood flow.
I. MEDICAL DEVICES FOR USE WITH THE
The centrifugal pump is intended for use only with Sorin Group
Deutschland Stöckert Centrifugal Pump (SCP) or Stöckert Centrifugal
Pump Consoles (SCPC). Refer to the console operator's manual for
console operating procedures.
All tubing used to make the circuit connections must be of a diameter
that is compatible with the dimensions of the connectors on the device
(3/8").
J. RETURN OF USED PRODUCTS
Should the User be dissatisfied with anything related to the quality of
the product, he may notify the distributor or the local representative
authorised by SORIN GROUP ITALIA. All notifications considered
PROBE TO THE
critical by the User must be reported with particular care and urgency.
In order to manage notifications, it is indispensable to provide at least
the following information:
•
•
•
•
•
SORIN GROUP ITALIA reserves the right to authorise, if necessary,
recall of the product involved in the notification for assessments. If the
product to be returned is contamined, it must be treated, packed and
GB - ENGLISH
- Carefully monitor for pump correct functioning during the
all procedure. The temperature within the pump may rise
and increase cellular damage.
- Do not unclamp the pump outlet at the start of circulation
until an adequate outlet pressure has been reached to
prevent back-flow. The pump must be operated to provide
a pressure greater than the patient's systemic pressure
and circuit head pressure. Monitor pump flow, rpm and
systemic pressure as indices of potential back-flow.
- Monitor carefully for signs of occlusion throughout the
circuit.
- It is intended that systemic anticoagulation be utilized
while the pump is in use. Anticoagulation levels should be
determined by the physician based on risks and benefits to
the patient and monitored throughout the case.
1) CONTROL THE BLOOD FLOW BY ADJUSTING
THE PUMP SPEED
Partially clamping the outlet of the pump to control the blood
flow may increase cellular damage.
2) WHEN STOPPING CIRCULATION, BE SURE TO
CLAMP THE OUTLET OF THE PUMP, THEN STOP
PUMP ROTATION IMMEDIATELY
3) MONITOR UPSTREAM
PUMP OPERATING PRESSURE
Do not exceed -50 mmHg (-6,66 kPa / -0,07 bar / -0,97 psi)
negative upstream pressure in order to avoid cavitation, gas
emboli formation, tissue collapsing, haemolysis and blood
trauma.
stop the centrifugal pump.
receptacle.
debubble it.
REVOLUTION
exhaustive description of the event and, if pertinent, the condition of
the patient;
identification of the product involved;
lot number of the product involved;
availability of the product involved;
all the indications the User considers useful in order to understand
the origin of the elements of dissatisfaction.
AND DOWNSTREAM