Medtronic CB4716R1 Instructions for Use

Tri-optic Measurement Cell
Célula trióptica de medición
Cellule de mesure tri-optique
Célula de medição trióptica

Instructions for Use • Instrucciones de uso • Mode d'emploi • Instruções de utilização

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The
following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.

Medtronic, el logotipo de Medtronic con la figura de una persona levantándose y el logotipo de Medtronic son marcas comerciales de Medtronic. Las marcas de
terceros (“TM*”) son marcas comerciales de sus respectivos propietarios. La siguiente lista incluye marcas comerciales o marcas comerciales registradas de una
entidad de Medtronic en Estados Unidos o en otros países.

Medtronic, Medtronic avec le logo de l'homme qui se relève et le logo Medtronic sont des marques commerciales de Medtronic. Les marques commerciales tierces
(“TM*”) appartiennent à leurs détenteurs respectifs. La liste suivante comprend des marques commerciales ou des marques déposées d'une entité Medtronic aux
États-Unis et/ou dans d'autres pays.

Medtronic, o logotipo da Medtronic com a figura do homem se levantando e o logotipo da Medtronic são marcas comerciais da Medtronic. As marcas comerciais
de terceiros (“TM*”) pertencem a seus respectivos proprietários. A lista a seguir inclui marcas comerciais ou marcas comerciais registradas de uma entidade da
Medtronic nos Estados Unidos e/ou em outros países.

BioTrend™, Cortiva™

Explanation of symbols on package labeling • Explicación de los símbolos que aparecen en la
documentación del envase • Explication des symboles des étiquettes sur l’emballage • Explicação dos
símbolos nas etiquetas da embalagem

Refer to the outer package label to see which symbols apply to this product. • Consulte la etiqueta del envase exterior
para comprobar qué símbolos son aplicables a este producto. • Se référer à l’étiquette sur l’emballage extérieur pour
savoir quels symboles s’appliquent à ce produit. • Consulte a etiqueta externa da embalagem para ver quais símbolos
aplicam-se a este produto.

Nonpyrogenic fluid path • Vía de líquido apirógena • Trajet des fluides apyrogène • Percurso de
líquidos não pirogênicos

Sterilized using ethylene oxide • Esterilizado mediante óxido de etileno • Stérilisé à l’oxyde
d’éthylène • Esterilizado com óxido de etileno

Do not reuse • No reutilizar • Ne pas réutiliser • Não reutilizar

Do not resterilize • No reesterilizar • Ne pas restériliser • Não reesterilizar

Use-by date • Fecha de caducidad • Date de péremption • Data de vencimento

Lot number • Número de lote • Numéro de lot • Número de lote

Quantity • Cantidad • Quantité • Quantidade

For US audiences only • Solo aplicable en EE. UU. • Ne s’applique qu’aux États-Unis • Aplicável
apenas aos EUA

Transit temperature limit • Límite de temperatura de transporte • Limite de température de transport •
Limite de temperatura de transporte

Date of manufacture • Fecha de fabricación • Date de fabrication • Data de fabricação

Catalog number • Número de catálogo • Numéro de référence • Número de catálogo

Manufacturer • Fabricante • Fabricant • Fabricante

Manufactured in • Fabricado en • Lieu de fabrication • Fabricado em

Contains phthalate DEHP • Contiene ftalato (DEHP) • Contient un phthalate, le DEHP • Contém
ftalato (DEHP)

Consult instructions for use • Consultar instrucciones de uso • Consulter le mode d’emploi •
Consultar as instruções de utilização

Do not use if package is damaged • No utilizar si el envase está dañado • Ne pas utiliser si l’emballage
est endommagé • Não utilizar se a embalagem estiver danificada

Do not use alcohol or alcohol-based fluids on any surface of this device • No utilizar alcohol ni líquidos
que contengan alcohol sobre ninguna superficie de este dispositivo • Ne pas utiliser d’alcool ou de
liquides à base d’alcool sur les surfaces de cet appareil • Não utilize álcool ou líquidos à base de
álcool em nenhuma superfície deste dispositivo

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1 Description

The device is a single-use device, which is nontoxic, nonpyrogenic, and supplied STERILE in individual packaging. It
is sterilized by ethylene oxide.

Store the product at room temperature. Maximum transit temperature 40°C (104°F)
The tri-optic measurement cell (TMC) is a single-use device used with the BioTrend™ oxygen saturation and

hematocrit system. The TMC provides a sealed interface between the blood pathway and the BioTrend sensor cable.
Models CB4714R1, CB4715R1, and CB4716R1 are coated with Cortiva™ bioactive surface and provided with a

15.2 cm (6 in) tubing extension. Additional information regarding coatings is available in Chapter 8.

2 Indications for use

Refer to the BioTrend oxygen saturation and hematocrit system operator manual for indications for use.

3 Contraindications

Refer to the operator manuals for contraindications.

4 Warnings

Before use, carefully read all warnings, precautions, and instructions for use. Failure to read and follow all instructions,
or failure to observe all stated warnings, could cause serious injury or death to the patient.

• The fluid pathway is sterile and nonpyrogenic. Inspect each package and device before use. Do not use the device
if the package is opened or damaged, the device is damaged, or the protective caps are not in place.

• Do not allow alcohol, alcohol-based fluid, anesthetic liquids (such as isoflurane), or corrosive solvents (such as
acetone) to come in contact with the devices as they may jeopardize the structural integrity of the devices.

• Do not touch the optical interface of the TMC.

5 Precautions

• These products are sterilized using ethylene oxide.

• These products are designed for single use only. Do not reuse, reprocess, or resterilize these products. Reuse,
reprocessing, or resterilization may compromise the structural integrity of the devices and create a risk of
contamination, which could result in patient injury, illness, or death.

• Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures. Adequate
anticoagulation should be maintained per the institution’s extracorporeal circulation procedure protocol.

• It is the responsibility of the user to dispose of the devices in accordance with local regulations and hospital
procedures.

• These products contain phthalates.

6 Adverse effects

The following known adverse effects are associated with the use of these products: blood loss, coagulopathy,
excessive blood component activation or thrombogenicity, hemolytic anemia, hypotension, infection, ischemia,
neurological dysfunction, and organ dysfunction.

7 Instructions for use

Refer to the BioTrend oxygen saturation and hematocrit system operator manual for instructions for use.

8 Information for products with Cortiva bioactive surface

The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface
enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive
surface contains nonleaching heparin derived from porcine intestinal mucosa1.

Caution: Product coated with Cortiva bioactive surface is intended for single use only. Resterilization may adversely
affect the Cortiva bioactive surface.

Caution: Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.

9 Additional information

The following information and data are available upon request: test methods used to determine coverage, leaching,
and bioactivity.

1

Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.

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10 Important notice — limited warranty (US customers only)

A. This LIMITED WARRANTY provides the following assurances to the patient who receives a tri-optic

measurement cell (TMC), hereafter referred to as the “Product”.

(1) Should the Product fail to function within normal tolerances due to a defect in materials or workmanship

prior to its Use-by date, Medtronic will, at its option: (a) issue a credit to the purchaser equal to the purchase
price, as defined in Subsection A(2), against the purchase of the replacement Product or (b) provide a
functionally comparable replacement Product at no charge.

(2) As used herein, purchase price shall mean the lesser of the net invoiced price of the original, or current

functionally comparable, or replacement Product.

B. To qualify for the LIMITED WARRANTY, these conditions must be met:

(1) The Product must be used prior to its Use-by date.
(2) The unused portion of the Product must be returned to Medtronic and shall be the property of Medtronic.
(3) The Product must not have been altered or subjected to misuse, abuse, or accident.
(4) The Product must be used in accordance with the labeling and instructions for use provided with the

Product.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) Except as expressly provided by this LIMITED WARRANTY, Medtronic is not responsible for any direct,

incidental, or consequential damages based on any defect, failure, or malfunction of the product, whether
the claim is based on warranty, contract, tort, or otherwise.

(2) THIS LIMITED WARRANTY IS MADE ONLY TO THE PATIENT ON WHOM THE PRODUCT WAS USED.

AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESSED OR IMPLIED, INCLUDING
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A
PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOMER, OR
OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND
THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE
REMEDY AVAILABLE TO ANY PERSON.

(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to,

contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held
to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity
of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations
shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term
held to be invalid. This LIMITED WARRANTY gives the patient specific legal rights. The patient may also
have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this

LIMITED WARRANTY.
Note: This LIMITED WARRANTY is provided by Medtronic, 710 Medtronic Parkway, Minneapolis, MN

55432. It applies only in the United States.

11 Important notice — limited warranty (for countries outside the US)

Important: This limited warranty does not apply in Australia.

A. This LIMITED WARRANTY provides assurance for the purchaser who receives a tri-optic measurement cell

(TMC), hereafter referred to as the “Product”, that, should the Product fail to function to specification, Medtronic
will issue a credit, equal to the original Product purchase price (but not to exceed the value of the replacement
Product) against the purchase of any Medtronic replacement Product used for that patient. The Warnings
contained in the product labeling are considered an integral part of this LIMITED WARRANTY. Contact your local
Medtronic representative to obtain information on how to process a claim under this LIMITED WARRANTY.

B. To qualify for the LIMITED WARRANTY, these conditions must be met:

(1) The Product must be used prior to its Use-by date.
(2) The Product must be returned to Medtronic within 60 days after use and shall be the property of Medtronic.
(3) The Product may not have been used for any other patient.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) In no event shall any replacement credit be granted where there is evidence of improper handling, improper

implantation, or material alteration of the replaced Product.

(2) Medtronic is not responsible for any incidental or consequential damages based on any use, defect, or

failure of the Product, whether the claim is based on warranty, contract, tort, or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene

mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held by any court of
competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining
portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and
enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

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