Medical Devices For Use With The D100 Kids; Return Of Used Products; Limited Warranty - SORIN GROUP dideco KIDS D100 Instrucciones Para El Uso

All versions
4) Reduce arterial pump blood flow to 100 ml/min.
5) Empty the venous reservoir.
6) Turn the arterial pump off and double clamp the arterial line (5 centimetres apart) next to
the arterial outlet port.
7) Double clamp the pump line next to the venous reservoir outlet.
8) Place a double clamp next to the oxygenator venous inlet.
9) Turn the heater-cooler off, clamp and remove the water lines.
10) Disconnect the gas line, all monitoring and sampling lines.
11) Cut all connector tubes in the section between the two clamps, leaving a sufficient length
of tubing to allow connection of the new oxygenator.
12) Remove the oxygenator from the holder.
13) Place a new oxygenator on the holder. Connect all lines (i.e. venous to the venous
reservoir inlet port, arterial and gas to the oxygenator, pump line to venous reservoir
outlet and oxygenator inlet port, and, for Version [B], the cardiotomy to the soft venous
reservoir)
In this phase, keep the venous and arterial lines clamped.
14) Connect and open the water lines, turn the heater-cooler on and check the integrity of the
heat exchanger of the new D100 KIDS .
When no Arterial Filter or Bubble Trap is used, slightly open the arterial line clamp till the
arterial blood starts retro-priming the oxygenating module. In this way all the air remained
trapped in the arterial line is removed through the hollow fibres.
15) Prime the new oxygenator and remove the microbubbles, as described in the priming
and circulation procedure.
16) Verify all connections and secure with ties.
17) Remove clamps from the venous and the arterial line, close the purging/recirculation line
and start the bypass again.
18) Turn the gas flow on and adjust gas flow rate as required.
19) The blood contained in the oxygenator and heat exchanger may be poured into the new
Venous Reservoir (Version [B]: into the Cardiotomy Reservoir) by connecting the arterial
line to one of the filtered inlet connectors of the new reservoir.
Version [A] and [C] if in OPEN SYSTEM configuration:
20) The blood remaining in the replaced Venous Reservoir may be recovered by connecting
its outlet port to one of the filtered inlet connectors of the new reservoir and drain this
blood into the new reservoir.
M. MEDICAL DEVICES FOR USE WITH THE D100 KIDS
The User should observe the warnings and cautions and follow Instruction for Use
accompanying the separate device.
Version [B], CLOSED SYSTEM
The device must be used in combination with a paediatric cardiotomy.
Version [C], OXYGENATING MODULE
The oxygenating system must be used in combination with:
- a venous reservoir functioning as a paediatric cardiotomy ;
or
- a paediatric soft venous reservoir and paediatric cardiotomy.
All Versions
Temperature controls must be carried out using SORIN GROUP ITALIA probes, code 09026 or
compatible to YSI Series 400.
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.
Any heating/cooling system (thermocirculator) may be used, provided that the connectors to
the oxygenator are of the Hansen type (SORIN GROUP ITALIA code 09028).
Currently SORIN GROUP ITALIA is not aware of any contraindications to the use of the device
with occlusive or non-occlusive peristaltic pumps. The use of other types of pump must be
agreed with SORIN GROUP ITALIA.
N. 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.
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.
ONLY for US customers
If for any reason the product must be returned to the manufacturer, a returned good
authorisation (RGA) number is required from Sorin Group USA cardiovascular Inc. prior to
shipping .
If the product has been in contact with blood or blood fluids, it must be thoroughly cleaned
and disinfected before packing. It should be shipped in either the original carton or an
equivalent carton to prevent damage during shipment, and it should be properly labelled with
an RGA number and an indication of the biohazardous nature of the content in the shipment.
The shipping address for returned goods in the US is:
Sorin Group USA, Inc.
Returned CV Products
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031
O. 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 and biological
characteristics of an individual patient, do not affect the performance and effectiveness of the
device with damaging consequences for the patient, even though the specified instructions for
use have been respected.
SORIN GROUP ITALIA, whilst emphasizing the need to adhere strictly to the instructions for
use and to adopt all the precautions necessary for the correct use of the device, cannot
assume any responsibility for any loss, damage, expense, incidents or consequences arising
directly or indirectly from the improper use of this device.
SORIN GROUP ITALIA undertakes to replace the medical device in the event that it is defective
at the time of placing on the market or whilst being shipped by SORIN GROUP ITALIA up to
the time of delivery to the final user unless such defect has been caused by mishandling by
the purchaser.
The above replaces all other warranties explicit or implicit, written or verbal, including
warranties of merchantability and fitness for purpose.
representative, agent, dealer, distributor or intermediary of SORIN GROUP ITALIA or any other
industrial or commercial organization is authorized to make any representation or warranty
concerning this medical device except as expressly stated herein. SORIN GROUP ITALIA
disclaims any warranty of merchantability and any warranty of fitness for purpose with regard
to this product other than what is expressly stated herein. The purchaser undertakes to
comply with the terms of this Limited Warranty and in particular agrees, in the event of a
dispute or litigation with SORIN GROUP ITALIA, not to make claims based on alleged or
proven changes or alterations made to this Limited Warranty by any representative, agent,
dealer, distributor or other intermediary.
The existing relations between the parties to the contract (also in the case that it is not drawn
up in writing) to whom this Warranty is given as well as every dispute related to it or in any
way connected to it as well as anything related to it or any dispute concerning this Warranty,
it interpretation and execution, nothing excluded and/or reserved, are regulated exclusively by
the Italian law and jurisdiction. The court chosen is the Court of Modena (Italy).
GB - ENGLISH
.
No person, including any
11