Terminating Bypass; Blood Recovery After Bypass; Use Of Active Venous Drainage With Vacuum; Oxygenator Change-Out - SORIN GROUP D 905 E0S Instrucciones De Uso

The purging/recirculation stopcock in "PURGE" position features the continuous
purge of blood and any incidental air from the gas exchange module during
bypass.
In this condition and at full arterial blood flow, the continuous purge diverts only
few mls/min of blood from the patient.
I. TERMINATING BYPASS
Bypass should only be terminated after consideration of each individual patient's
condition as follows:
1) Turn the gas flow off.
2) Turn the heater-cooler off.
3) Slowly decrease the arterial flow to zero while clamping the venous line.
4) Clamp the arterial line.
- If extracorporeal circulation has to be subsequently reinitiated, a minimum
blood flow inside the oxygenator must be maintained (maximum 1500 ml/min).
- Verify that the cardioplegia circuit connected to the coronary outlet port is
clamped.
J. BLOOD RECOVERY AFTER BYPASS
Drain as much blood as possible from the venous line into the venous reservoir, as
1)
soon as the surgeon has removed the venous cannulae from the patient.
Slowly return the residual blood to the patient through the aortic cannulae as
2)
required by the patient's condition
If desired, blood in the oxygenator may also be returned by adding clear prime to
3)
the venous reservoir when the blood in the reservoir as reached minimum volume.
Pump the prime slowly through the oxygenator ensuring that the reservoir never is
emptied.
When the reservoir is nearly empty stop the arterial pump and clamp the arterial
4)
line.
K. USE OF ACTIVE VENOUS DRAINAGE WITH
VACUUM
This method may be applied at any time during extra-corporeal circulation, provided
that the steps below are followed. Using the kit code 086000, or equivalent supplied
separately, and a vacuum regulation device, D 905 EOS can be used for active venous
drainage using vacuum. This technique constitutes an alternative to venous drainage by
gravity and allows the use of shorter venous lines with reduced diameter and smaller-
gauged cannulas.
1 Open active venous drainage system kit. Maintain sterility of the system
2 Connect the end with the blue cap to the vent connector of the venous reservoir,
marked "VENT/VACUUM PORT" (fig. 2, ref. 7), and the end with the red cap to
the vacuum line of vacuum regulating device.
3 Close the clamp and the green cap on the line connected to the reservoir
4 If considered necessary to interrupt or suspend this method, remove the yellow
cap and open the clamp on the line.
- A controlled vacuum regulating device is required.
- Always suspend vacuum when the main pump is stopped.
- Do not exceed -50 mmHg (-6,66 kPa / -0,07 bar / -0,97 psi) negative pressure in
venous reservoir. Pressure greater than -50 mmHg (-6,66 kPa / -0,07 bar / -0,97
psi) increase the risk of hemolysis.
- Periodically check functioning of the vacuum regulating device and the degree
of vacuum.
L. USE OF VENOUS RESERVOIR FOR POST-
OPERATIVE AUTOTRANSFUSION
If desired the Venous Reservoir may be used for post-operative autotransfusion as
follows:
1. Disconnect the purging/recirculation line.
2. Separate the venous reservoir from the oxygenator by opening the latch and twist
the reservoir clockwise while holding oxygenator stationary.
3. Attach the venous reservoir on the "Post Operative Chest Drainage Holder", code
050119, and use the device, by referring to its respective instructions for use:
- D 540 AUTOTRANSFUSION CONVERSION KIT code 05053.
M. OXYGENATOR CHANGE-OUT
A spare oxygenator must always be available during bypass in the unlikely event that
the oxygenator in use requires change-out. Procedures lasting longer than 6 hours or if
particular situations where the safety of the patient may be compromised, (insufficient
oxygenator performance, leaks, abnormal blood parameters etc.), could require change
out. Follow the steps below to change out the oxygenator.
Use sterile technique during all replacement procedure.
1) Turn the gas flow off.
2) Double clamp, the venous line (5 centimetres apart).
3) Turn the arterial pump off and double clamp the arterial line (5 centimeters apart)
next to the arterial outlet port.
4) Turn the heater-cooler off, clamp and remove the water lines.
5) Disconnect the gas line, all monitoring and sampling lines.
8
6) Cut the venous return and the arterial lines in the section between the two clamps,
leaving a sufficient length of tubing to allow connection to the new oxygenator.
7) Remove the oxygenator from the holder.
8) Place a new oxygenator on the holder. Connect all lines (i.e. venous line to the
Venous Reservoir inlet port, arterial and gas to the oxygenator, pump line to
Venous Reservoir outlet and oxygenator inlet port).
In this phase, keep the venous and arterial lines clamped.
9) Open the water lines on the holder turn the heater-cooler on and check the integrity
of the new heat exchanger.
10) Fill the new venous reservoir with priming solution through the 1/4" or 3/8" quick
prime connectors located on the lid of the venous reservoir.
11) Prime the new oxygenator and remove the microbubbles, as described in the
priming and circulation procedure.
12) Verify all connections and secure with ties.
13) Remove clamps from the venous and the arterial line, close the
purging/recirculation line and start the bypass again.
Turn on the gas flow and adjust gas flow rate as required.
14) The blood remaining in the replaced Venous Reservoir may be recovered by
connecting its outlet port to one of the 3/8" inlet connectors of the new reservoir and
drain this blood into the new reservoir.
15) The blood contained in the oxygenator and heat exchanger may be poured into the
new Venous Reservoir by connecting the arterial line to one of the 3/8" inlet
connectors of the new reservoir.
N. MEDICAL DEVICES FOR USE WITH THE D 905 EOS
The user should observe the warnings and cautions and follow Instruction for
Use accompanying the separate device.
1) For the post-operative autotransfusion with venous reservoir use the device:
- D 540 AUTOTRANSFUSION CONVERSION KIT code 05053.
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", 1/4", 1/2").
2) Temperature monitoring must be carried out using SORIN GROUP ITALIA probes
(code 09026) or equivalent COBE CV temperature probes (ref TMPMV) compatible to
YSI Series 400.
3) Use a Sechrist air/oxygen mixer (SORIN GROUP ITALIA code 09046) or a system
with compatible technical features for control of the blood gas concentrations.
4) Any heating/cooling system may be used, provided that the water line connectors are
Hansen 3ST (SORIN GROUP ITALIA code 09028) or equivalent.
Currently SORIN GROUP ITALIA is not aware of any contraindications to the use of the
device with occlusive or non-occlusive peristaltic pumps or with centrifugal pumps. The
use of other types of pump must be agreed with SORIN GROUP ITALIA.
O. RETURN OF USED PRODUCTS
Should the user be dissatisfied with anything related to the quality of the product, the
product distributor or the authorized local SORIN GROUP ITALIA representative should be
notified.
All parameters considered critical by the user must be reported with particular care and
urgency. The following is the minimum information that should be provided:
Detailed description of the event and, if pertinent, the conditions 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.
SORIN GROUP ITALIA reserves the right to authorize, if necessary, recall of the product
involved in the notification for assessment. If the product to be returned is contaminated, it
must be treated, packed and handled in conformity with the provisions of the legislation in
force in the country where the product was used.
If for any reason the product must be returned to the manufacturer, a returned good
authorisation (RGA) number is required from COBE cardiovascular Inc. prior to shipping
.
It is the responsibility of the health care institution to adequately prepare and
identify the product for return shipment. Do not return products that have been
exposed to blood borne infectious diseases.
P. LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the Purchaser pursuant to
applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been taken in the
manufacture of this medical device, as required by the nature of the device and the use
for which the device is intended.
SORIN GROUP ITALIA warrants that the medical device is capable of functioning as
indicated in the current instructions for use when used in accordance with them by a
qualified user and before any expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the user will use the device
correctly, nor that the incorrect diagnosis or therapy and/or that the particular physical
GB – ENGLISH