Merit-medical Meritrans Disposable Pressure Transducer User Manual download pdf

DISPOSABLE PRESSURE TRANSDUCER - INSTRUCTIONS FOR USE

DESCRIPTION

he Meritrans is a pre-calibrated, single use device for physiological pressure measurement. A

separate reusable interface cable is used with this system to connect the transducer to a pressure monitor.

he Meritrans may be used with a manifold, pole mount organizer, or attached directly to the patient via a strap.

SET-UP

CONNECTIONS

. Using aseptic technique, open the package containing the sterile transducer.

2. Set-up according to hospital protocol for pressure monitoring procedures. Connect to other

onitoring equipment (e.g. manifolds, stopcocks, flush devices, tubing administration sets, etc.)

CAUTION: Make sure that all connections are tight. To prevent stripping, do not overtighten.

. Ensure that the connectors are dry.

4. Connect the Meritrans disposable transducer cable to the reusable monitor cable.

. Extract all air from the flush solution container.

CAUTION: If air is not extracted from the solution container, air may be forced into the system when the fluid is

epleted.

FILL LINES

. Remove caps (if any) from stopcock on transducer and open the system.

2. Fill all lines with sterile flush solution until free of air bubbles.

OTE: Merit Medical recommends gravity filling the system rather than pressurizing the flush

solution to avoid generating bubbles in the solution.

AUTION: Verify that no air is trapped in any components of the fluid pathway. Air bubbles can cause serious

patient harm and will negatively impact pressure wave forms.

. Turn stopcock off.

4. Using sterile technique, replace vented caps with non-vented caps.

5. Repeat steps 1-4 for any additional stopcocks or ports.

. Pressurize the I.V. solution source to 300 mmHg.

ZEROING THE SYSTEM

1. Zeroing should be performed after the system has been filled and mounted.

2. Turn the pressure monitoring system “off” to the patient.

3. Verify that the opening of the stopcock to be used for zeroing is positioned at the patient’s

mid-axillary level.

4. Being careful not to contaminate the zeroing port, turn the stopcock handle to open the port

at the mid-axillary level to air.

5. Zero the transducer according to the monitor manufacturer’s instructions.

6. Turn the stopcock handle “off” to the open port.

7. Turn the pressure monitoring system “on” to the patient.

CAUTIONS: Before injecting, turn the manifold handle to the transducer off in order to isolate the transducer from

pressure.

CONNECTING TO THE CATHETER

1. Connect the monitoring kit pressure tubing carefully to the patient’s catheter or sheath so that

no air is introduced into the system.

CAUTIONS:

1. The Meritrans is a single use item. Contents sterile unless package is opened or damaged.

Do not reuse or resterilize.

2. Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.

3. Do not autoclave the reusable cable.

4. If the transducer is used to measure left arterial pressure, an air eliminator filter must be

installed between the solution source and the transducer.

5. Components of the pressure monitoring system in contact with the fluid path must be kept sterile.

MERITRANS SPECIFICATIONS

Excitation Voltage 1.0 to 10 Vdc-5kHz Excitation Impedance 240-350 Ω

Signal Impedance 300 Ω ±30 Ω Phase Shift <5º

Sensitivity 5 µV/V/mmHg Operating Temperature 15ºC to 40ºC

Storage Temperature -25ºC to 70ºC Maximum Half-Sine

Zero Drift 1 mmHg/8 hours Shock Acceleration 4500 G

Thermal Coefficient Offset ±0.3 mmHg/ºC Thermal Coefficient Span ±0.1%/ºC

Light Sensitivity <1 mmHg-

REUSE PRECAUTION STATEMENT

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may com-

promise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient

injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device

and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious dis-

ease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Manufacturer: Authorized Representative:

Merit Medical Systems, Inc.

Merit Medical Ireland Ltd

South Jordan, Utah 84095 U.S.A.1-801-253-1600

Parkmore Business Park West,

U.S.A. Customer Service 1-800-356-3748

Galway, Ireland

400610004/A ID 020810

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Summary of Contents

Page 1 - MERITRANS SPECIFICATIONS

DISPOSABLE PRESSURE TRANSDUCER - INSTRUCTIONS FOR USEDESCRIPTIONThe Meritrans is a pre-calibrated, single use device for physiological pressure measur

Page 2 - INSTALLATION

ΔΗΛΩΣΗ ΠΡΟΦΥΛΑΞΗΣ ΑΠΟ ΕΚ ΝΕΟΥ ΧΡΗΣΗΓια χρήση µόνο σε έναν ασθενή. Μην χρησιµοοιείτε ξανά, υοβάλλετε σε εκ νέου εεξεργασία ή εκ νέουαοστείρωση. Η ε

Page 3 - DATI TECNICI DEL MERITRANS

CAPTEUR DE PRESSION À USAGE UNIQUE - MODE D’EMPLOIDESCRIPTIONLe Meritrans est un appareil de mesure physiologique de la pression sanguine pré-calibré

Page 4 - MERITRANS SPEZIFIKATIONEN

TRASDUTTORE DI PRESSIONE MONOUSO - ISTRUZIONI PER L’USODESCRIZIONEIl Meritrans è un dispositivo monouso precalibrato per la misurazione fisiologica de

Page 5 - DESCRIPCIÓN

EINWEG-DRUCK-TRANSDUCER - GEBRAUCHSANWEISUNGBESCHREIBUNGDer Meritrans ist ein vorkalibriertes Einweggerät zur physiologischen Blutdruckmessung. Der Tr

Page 6 - DESCRIÇÃO

TRANSDUCTOR DE PRESIÓN DESECHABLE - INSTRUCCIONES DE USODESCRIPCIÓNEl Meritrans es un dispositivo pre-calibrado de un solo uso para medición fisiológi

Page 7 - MERITRANS-SPECIFICATIES

TRANSDUTOR DE PRESSÃO DESCARTÁVEL - INSTRUÇÕES PARA USODESCRIÇÃOO Meritrans é um dispositivo pré-calibrado que se destina a um único uso para medir pr

Page 8 - MERITRANS SPECIFIKATIONER

DISPOSABLE DRUKTRANSDUCER - INSTRUCTIES VOOR GEBRUIKBESCHRIJVINGDe Meritrans is een vooraf gekalibreerd instrument voor eenmalig gebruik bij het fysio

Page 9

TRANSDUCER FÖR ENGÅNGSANVÄNDNING - BRUKSANVISNINGBESKRIVNINGMeritrans är en förinställd, engångstransducer för mätning av fysiologiskt blodtryck. En s

Page 10

TRANSDUCER FÖR ENGÅNGSANVÄNDNING - BRUKSANVISNINGBESKRIVNINGMeritrans är en förinställd, engångstransducer för mätning av fysiologiskt blodtryck. En s