Medical Devices For Use With The D101 Kids; Return Of Used Products; Limited Warranty - SORIN GROUP Dideco KIDS D101 Mode D'emploi

13) Connect and open the water lines, turn the heater-cooler on and check the integrity
of the heat exchanger of the new D101 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.
14) Prime the new oxygenator and remove the microbubbles, as described in the
priming and circulation procedure.
15) Verify all connections and secure with ties.
16) Remove clamps from the venous and the arterial line, close the
purging/recirculation line and start the bypass again.
17) Turn the gas flow on and adjust gas flow rate as required.
18) The blood contained in the replaced oxygenator and heat exchanger may be
transfered into the new Venous Reservoir by connecting the arterial line to one of
the filtered inlet connectors of the new oxygenator reservoir.
19) 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 draining this blood into the new reservoir.
M. MEDICAL DEVICES FOR USE WITH THE D101 KIDS
The User should observe the warnings and cautions and follow Instruction for
Use accompanying the separate device.
Version [B], OXYGENATING MODULE
The oxygenating module must be used in combination with:
- a separate venous reservoir functioning also as a paediatric cardiotomy like the
SORIN GROUP D121 Kids HVR venous reservoir PC code 050544;
or
- a separate paediatric soft venous reservoir like the SORIN GROUP Lilliput 2 bag
available as a PTS part and a separate paediatric cardiotomy like the SORIN
GROUP D121 Kids HVR venous reservoir PC code 050544.
All Versions
Temperature controls must be carried out using SORIN GROUP probes, code 09026 or
compatible to YSI Series 400.
Use a Sechrist air/oxygen mixer (SORIN GROUP code 09046) or a system with
compatible technical features for control of the blood gas concentration and flow.
Any heating/cooling system (thermocirculator) may be used, provided that the
connectors to the oxygenator are of the Hansen type (SORIN GROUP code 09028).
The device must be used with the appropriate SORIN GROUP holder D633 code
05083.
- Brackets shall be cleaned after each use and when dirty. Only hand cleaning
with a soft cloth is allowed. Do not clean with washing machines and do not
dip the bracket into washing solutions.
- To achieve adequate cleaning and avoid damages or alterations of the bracket
use water and cleaning fluids containing, in their prescribed dilution volumes,
alcohol, clorexidin gluconate,
glutaraldehide and mild soap.
- The bracket is maintenance free
All additional devices must be used in conjuction with their specific holders as
prescribed by the respective manufacturers.
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.
benzalconium chloride, formaldehide,
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. No person, including any
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
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