SORIN GROUP dideco kids d101 User Manual

Hollow Fiber Membrane Blood Oxygenator
Ossigenatore sangue a membrana a fibre cave • Oxygénateur sanguin à membrane du type à fibres creuses • Hohlfasermembran-Blutoxygenator •Oxigenador de
sangre con membrana de fibra hueca • Oxigenador de Sangue de Membrana de Fibra Oca • Οξυγονωτής μεμβράνης κοίλων ινών • Membraanoxygenator met holle
vezels • Membranoxygenator med hålfiber • Membranoxygenator med hule fibre • Onttokuitukalvoinen oksygenaattori • Kapilární oxygenátor krve s membránou
z dutých vláken • Oksygenator membranowy kapilarny (typu hollow fiber) • Oxygenátor krvi s membránou z dutých vlákien • Üreges szálmembrán véroxigenizáló •
Õõnesfiibermembraaniga vere oksügenaator • Oksigenators ar dobās šķiedras membrānu • Membranski oksigenator krvi z votlimi vlakni • Половолоконный
мембранный оксигенатор крови
GB – ENGLISH - INSTRUCTIONS FOR USE 5
IT – ITALIANO - ISTRUZIONI PER L’USO 10
FR – FRANÇAIS - MODE D’EMPLOI 15
DE – DEUTSCH - GEBRAUCHSANWEISUNG 20
ES – ESPAÑOL – INSTRUCCIONES PARA EL USO 25
PT – PORTUGUÊS - INSTRUÇÕES PARA UTILIZAÇÃO 30
GR – ΕΛΛΗΝΙΚΑ – ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ 35
NL – NEDERLANDS – GEBRUIKSAANWIJZINGEN 40
SE – SVENSKA – BRUKSANVISNING 45
DK – DANSK - BRUGSANVISNING 50
FI – SUOMI - KÄYTTÖOHJEET 55
CZ – ČEŠTINA - NÁVOD K POUŽITÍ 60
PL – POLSKI - INSTRUKCJA OBSŁUGI 65
SK – SLOVENČINA - NÁVOD NA POUŽITIE 70
SL – SLOVENSKO – NAVODILA ZA UPORABO 75
HU – MAGYAR - KEZELÉSI ÚTMUTATÓ 80
EE – EESTI - KASUTUSJUHEND 85
LV – LATVISKI - LIETOŠANAS INSTRUKCIJAS 90
РУ – РУССКИЙ - ИНСТРУКЦИИ ПО ИСПОЛЬЗОВАНИЮ 95
0011516/08- 07/2012

SORIN GROUP dideco kids d101 Specifications

General

Brand	SORIN GROUP
Model	dideco kids d101
Category	Medical Equipment
Language	English

Summary

Safety Information

Safety Warnings and Cautions

Highlights serious adverse reactions, potential hazards, and necessary precautions for device use.

Symbol Explanations

Explains the meaning of various symbols found on the device labeling for proper identification.

Product Description and Versions

Core Product Description

Details the D101 KIDS oxygenator's function, technology, and compatibility improvements.

Product Versions

Describes the D101 KIDS OPEN SYSTEM and OXYGENATING MODULE configurations.

Technical Specifications

Key Performance Metrics

Lists critical performance data including maximum flow, membrane area, and static priming volume.

Device Connections

Details the types and sizes of various connectors used on the device for system integration.

Open System Specifics

Details specific features for the Open System version, including reservoir capacity and filter pore sizes.

Device Setup Procedures

Mounting the Oxygenator

Guides on correctly positioning the holder and securely attaching the oxygenator unit.

Heater-Cooler and Heat Exchanger Setup

Instructions for connecting the heater-cooler and performing a check on the heat exchanger for leaks.

Open System Circuit Connections

Details connections for venous, arterial, pump lines, and reservoir for the Open System.

Oxygenating Module Circuit Connections

Details connections for arterial, pump, purge/recirculation, and sampling lines for the Module version.

Priming and Recirculation

Pre-Procedure Checks

Ensures gas flow is off, recirculation line closed, reservoir isolated, and heat exchanger checked.

Reservoir and Circuit Priming

Guides on priming the venous reservoir and the oxygenator/circuit, including volume calculations.

Debubbling and Flow Adjustments

Procedures for removing air bubbles, priming sampling system, and adjusting flow rates.

Initiating Bypass Operation

Bypass Start-up Sequence

Steps to initiate bypass, including opening lines, checking heat exchanger, and setting gas flow.

Blood Gas Monitoring

Procedures for monitoring blood gas content and adjusting parameters during bypass.

Operation During Bypass

Procedural Precautions and Integrity Checks

Ensures secure connections and adequate pump flow during blood sequestration procedures.

Venous Return and Anticoagulation Management

Guidance on adjusting venous return and monitoring anticoagulation levels (ACT).

Sample Collection and Drug Administration

Procedures for obtaining arterial/venous blood samples and injecting medications.

Reservoir Specifics and Recirculation

Details on reservoir volume/placement and low flow recirculation procedures.

Bypass Termination and Blood Recovery

Terminating Bypass Procedure

Detailed steps for safely terminating the bypass procedure, including turning off gas and adjusting flow.

Post-Bypass Blood Management

Instructions for recovering and returning blood from the circuit after bypass completion.

Advanced Drainage and Oxygenator Management

Vacuum-Assisted Venous Drainage

Details on using vacuum for venous drainage, including setup and safety precautions.

Oxygenator Change-Out Procedure

Step-by-step guide for replacing the oxygenator during a procedure, emphasizing sterile technique.