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Idiomas disponibles
Idiomas disponibles
GB - ENGLISH
I. CONTENTS
I.
Contents
A. Description
H. Operation during bypass
I.
Medical devices for use with the PRIMO
The PRIMO
X MODULE is a microporous hollow fibre membrane oxygenator composed
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of a gas exchange module connected with a heat exchanger.
The PRIMO
X MODULE is coated with PC coating. Devices coated with PC are used
2
when a coated blood path is desired. The PC coating improves the blood compatibility of
the device by reducing platelet adhesion on the coated surfaces.
The device is single use, non-toxic, non pyrogenic, supplied STERILE and packaged
singly. Sterilised by ethylene oxide. The level of ethylene oxide residuals in the device is
within the limits established by national regulations in the country of use.
B. TECHNICAL FEATURES
- Recommended max blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Static priming volume
(oxygenating module + heat exchanger)
- Connections:
Oxygenator venous inlet
Oxygenating module arterial outlet
C. INTENDED USE
The PRIMO
X MODULE is intended for use in adult surgical procedures requiring
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extracorporeal gas exchange support and blood temperature control for periods of up to 6
hours.
The PRIMO
X MODULE should be used in combination with medical devices listed in
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section L (Medical devices for use with the PRIMO
D. SAFETY INFORMATION
Information intended to attract the attention of the user to potentially dangerous situations
and to ensure correct and safe use of the device is indicated in the text in the following
way:
Indicates serious adverse reactions and potential safety hazards for practitioner
and/or patient that can occur in the proper use or misuse of the device, and also
the limitations of use and the measures to be adopted in such cases.
Indicates any special care to be exercised by a practitioner for the safe and
effective use of the device.
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
For single use only (Do not reuse)
Batch code (number)
(reference for product traceability)
Use by (Expiry date)
Manufactured by
Date of manufacture
Sterile - Ethylene oxide sterilised
Non Pyrogenic
Contains PHTHALATE
Latex free
GB - ENGLISH - INSTRUCTIONS FOR USE
2
8000 ml/min
Microporous Polypropylene
1.87 m
0.14 m
250 ml
3/8" (9.53 mm)
3/8" (9.53 mm)
X MODULE).
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ea
The following is general safety information with the aim of advising the operator in
preparing to use the device.
Also, specific safety information is given in the instructions for use at locations in the text
where that information is relevant for correct operation.
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- The User should carefully check the device during set-up and priming for
leaks.Do not use if any leak is detected.
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- 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.
- Do not expose to temperatures below 0°C (32°F) or above 60°C (140°F).
- Keep dry. Store at room temperature
- Always give 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 contains phthalates. Considering the nature of contact with the body,
the limited duration of contact and the number of treatments per patient, the
amount of phthalates which might be released from the device does not raise
specific concerns about residual risks. Further information is available on
request from Sorin Group Italia
- 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.
- Inner surfaces of the system are PC coated, currently Sorin Group Italia is not
aware of any contraindications to the use of this coated device
E. SET UP
1) POSITION THE HOLDER
Position the PRIMO
clamp at the upper end of the extension arm (fig.1).
2) FIX THE OXYGENATOR TO THE HOLDER
- 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.
GB - ENGLISH
Warning: Do not resterilize.
Contents sterile only if package is not opened,
damaged or broken
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Quantity
Keep away from heat
Keep dry
X MODULE holder on the pump structure by means of the
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