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Fresenius Medical Care multiFiltrate User Manual

Fresenius Medical Care multiFiltrate
282 pages
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multiFiltrate
Instructions for Use
Software version: 5.3
Edition: 15A-2015
Part no.: M56 963 1

Table of Contents

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Fresenius Medical Care multiFiltrate Specifications

General IconGeneral
BrandFresenius Medical Care
ModelmultiFiltrate
CategoryMedical Equipment
LanguageEnglish

Summary

Important information

Using the Instructions for Use

Explains document identification, text styles, and illustration usage for effective manual navigation.

Device Overview and Intended Use

Provides a brief description of the device, its intended purpose, and specifications for use.

Treatment Modes and Anticoagulation

Details various CRRT treatment modes and methods for anticoagulation of the extracorporeal blood circuit.

Safety, Contraindications, and Operator Responsibility

Covers contraindications, risks, target group, operator duties, and general safety warnings.

Design

Device Views

Provides visual representations of the device.

Front View

Shows a labeled diagram of the device's front components.

Rear View

Shows a labeled diagram of the device's rear components.

Key Components and Controls

Details major components like Monitor, Heparin Pump, Extracorporeal Module, and Ci-Ca Module.

Operation

Application Principles

Covers general principles for device application, including network connection and safety precautions.

Basic Operation Philosophy

Explains the device's operational concept, menu navigation, and parameter entry.

Basic Operation Steps

Details steps for setting UF goal, alarm limits, preparing the device, and selecting modes.

CRRT Treatments

Guides through CRRT setup, preparation, treatment execution, and disconnection procedures.

Alarm Processing

Understanding Alarms

Explains how to acknowledge messages and the hazards of ignoring alarm causes.

Alarm Schemes

Describes the 'Old' and 'New' alarm schemes and their assignment principles.

Alarm System Response

Details how the system responds to alarms, including overriding and suppressing audible alarms.

Specific Alarm Conditions

Explains message boxes, handling alarm limits, and key alarm ratios.

Cleaning and Disinfection

Surface Cleaning and Disinfection

Details the procedure for surface cleaning and disinfection after each treatment.

Approved Disinfectants and Agents

Lists disinfectants and cleaning agents tested and recommended for device use.

Functional Description

Core Device Functions

Provides an overview of the device's main functions like blood circuit, balancing, and alarms.

Types of Treatments

Describes CRRT, Paediatric CRRT, MPS, SCUF, and Haemoperfusion treatments.

Anticoagulation Techniques

Explains systemic anticoagulation and regional citrate anticoagulation methods.

Consumables, Accessories, and Equipment

Consumables

Lists multiFiltrate kits, haemofilters, solutions, syringes, and other disposables.

Accessories and Additional Equipment

Lists available accessories like plasma poles and additional equipment such as cables.

Installation

Connection Requirements

Details environmental and power supply network requirements for device installation.

Initial Start-Up Procedures

Covers battery charging and important information for initial device start-up.

Electrical Safety and Installation

Addresses electrical safety, installation, EMC, and power cable requirements.

Transport and Storage

Device Relocation and Transport

Provides guidance on safely moving, locking, and transporting the device.

Storage and Battery Maintenance

Details storage conditions, battery charging, and maintenance when the device is not in use.

Environmental Disposal

Outlines information for responsible organizations and recycling facilities regarding device disposal.

Technical Safety and Maintenance

Overview of TSC and MA

Provides important information on Technical Safety Checks (TSC) and Maintenance Procedures (MA) timing.

Technical Safety Checks (TSC)

Specifies the required timing for the first and subsequent Technical Safety Checks.

Maintenance Procedures (MA)

Recommends maintenance procedures to ensure trouble-free operation within specified intervals.

Tester Qualifications

Defines the qualification requirements for personnel performing safety checks and maintenance.

Specifications

Physical Characteristics

Details device dimensions, weight, load capacity, and identification labels.

Electrical and EMC Requirements

Covers electrical safety, supply details, and electromagnetic compatibility guidelines.

Operational and Safety Systems

Includes operating/storage conditions, connection options, and safety system specifications.

Materials Used

Lists the various plastics, metals, electrical components, and lacquers used in the device.

Definitions

Glossary of Terms

Provides definitions for various terms related to haemodialysis and device operation.

Abbreviations and Symbols

Lists common abbreviations used in the manual and explains device symbols.

Certificates

States that EC certificates can be obtained from the local service support organization.

Options

Ci-Ca Module Functionality

Details Ci-Ca module operation, anticoagulation, completion, and alarm management.

multiDataLink (mDL) and Patient/Case ID

Covers mDL requirements and procedures for entering patient and case IDs.

Appendix

Network Considerations

Addresses network operator responsibilities for device protection and data security.

Free Software Usage Instructions

Provides information on free software licenses and usage within the haemodialysis system.

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