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The 37Company Fluido Compact - User Manual

The 37Company Fluido Compact
52 pages
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User Manual / Technical Manual
Version: INT/R683-EN-3-10-17

Table of Contents

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Summary

General Information

About this manual

Explains the purpose and content of the Fluido®Compact Blood and Fluid Warming System manual.

Intended use

Describes the device's purpose for supplying warm fluids to patients, including types of fluids and target patient group (adults).

Contact

Provides contact details for The 37Company, including address, telephone, fax, email, and website.

Warranty

Directs users to the company website for detailed warranty information.

Authorisation of personnel

Emphasizes the requirement for only authorized personnel to operate the device.

Warning, caution and note

Defines the meaning of 'Warning', 'Caution', and 'Note' symbols to ensure safe and correct usage.

Disclaimer

States the manufacturer's rights regarding document reproduction, device alterations, and liability.

Safety

General safety precautions

Covers warnings, cautions, notes, and literature references for safe operation, including specific material handling and pre-operation checks.

Symbols

Explains the meaning of various symbols used in the manual and on the device, such as IPX1, IPX4, Rx Only, and safety certifications.

Description

Overview of the device

Provides a general overview of the Fluido Compact system, identifying the control module, warming module, and disposable set.

Overview of the control module [REF 650100]

Details the components of the control module, including the control panel, clamps, holders, and covers.

Overview of the warming module [REF 650200]

Illustrates and labels the components of the warming module, such as the slider, warming interface, and status indicator LED.

Overview of the disposable sets

Introduces the different types of disposable sets, including the standard set and standard set with drip chamber.

Overview of the control panel

Details the components of the control panel, including buttons and indicator LEDs.

Indicator LED behaviour

Explains the behaviour and meaning of the indicator LEDs on the control and warming modules for status and error indication.

Set point indicator

Describes the function of the set point indicator LED and its relation to fluid temperature accuracy.

Repair required indicator

Details the steps to take when the 'Repair required' indicator LED is active.

Overtemperature indicator

Explains the procedure to follow when the 'Overtemperature' indicator LED is active.

Installation

Transport and storage

Provides recommendations for storing and transporting the device and its accessories.

Install the cables

Instructions for installing the interface and power supply cables, including removing and replacing the hatch.

Install the power supply cord

Step-by-step guide for connecting the power supply cord to the device.

Place the hatch

Instructions for correctly placing and securing the device's hatch after cable installation.

Change the rotation of the universal clamps (optional)

Optional procedure to rotate the universal clamp by 90° for attachment to a bed rail.

Attach the device

Procedure for attaching the control module to an IV pole or bed rail and placing the warming module.

Operation

Safety instructions before operation

Crucial safety warnings and cautions to be observed before operating the device, including fluid handling and personnel authorization.

Preparation before operation

Outlines the necessary steps to prepare the device for operation, ensuring correct installation.

Turn the device on

Step-by-step guide to powering on the Fluido Compact device and checking indicator LEDs.

Install the disposable set

Detailed instructions for unpacking, inspecting, and correctly installing the disposable set into the warming module.

Prime the standard set

Procedure for priming the standard IV set to ensure no air is present in the system.

Prime the standard set with drip chamber

Instructions for priming the standard set that includes a drip chamber, ensuring proper fluid flow.

Deaerate standard set with drip chamber

Procedure for removing air from the standard set with a drip chamber using a syringe.

Operate the device

Steps for operating the warming module near the patient, with specific warnings about positioning and syringe use.

Stop the device

Instructions on how to properly stop the operation of the Fluido Compact device.

Remove the disposable set

Procedure for safely removing the disposable set from the warming module after use, with cleaning warnings.

Maintenance

General cleaning procedure

Provides a general cleaning procedure for the device, including warnings and cautions about cleaning agents and electrical safety.

Cleaning of the warming module

Specific instructions and cautions for cleaning the warming module, recommending appropriate solutions.

Cleaning of the control module

Specific instructions and cautions for cleaning the control module, emphasizing dryness and appropriate solutions.

After cleaning

Lists conditions under which the device should not be used after cleaning, such as damage or contamination.

Repair

Remove hatch

Step-by-step guide for removing the device's hatch using a hex key.

Place hatch

Instructions for re-installing the device's hatch after performing repairs.

Disconnect power supply cord

Procedure for safely disconnecting the power supply cord from the device.

Disconnect interface cable

Steps to disconnect the interface cable from the control module.

Connect interface cable

Instructions for connecting the interface cable to the control module, ensuring secure locking.

Connect power supply cord

Procedure for connecting the power supply cord to the device.

Remove fuse holder

Steps to remove the fuse holder from the device.

Remove fuse

Instructions for safely removing a fuse from its holder.

Place fuse

Procedure for inserting a new fuse into the fuse holder and reconnecting cables.

Place fuse holder

Instructions for re-installing the fuse holder after fuse replacement.

Remove warming module holder

Steps for removing the warming module holder parts from the device.

Place warming module holder

Instructions for re-installing the warming module holder parts after removal.

Remove front cover and control panel

Procedure for removing the front cover and control panel assembly from the device.

Place front cover and control panel

Instructions for re-connecting and re-installing the front cover and control panel.

Test the device

Electrical safety test

Procedure for performing the electrical safety test according to IEC 60601-1 standards.

System operation test

Steps for conducting the system operation test to verify device functionality and performance.

Overtemperature alarm test

Procedure for testing the overtemperature alarm functionality using hot water.

Specifications

Specifications of the device

Lists general and environmental specifications for the Fluido Compact device, including part numbers, dimensions, and operating parameters.

Specifications of the disposable sets

Details general, transport, and storage specifications for the disposable sets, including part numbers and priming volumes.

Electromagnetic compatibility

Electromagnetic immunity

Provides guidance and manufacturer's declaration regarding electromagnetic immunity of the device, including test levels.

Electromagnetic emissions

Details electromagnetic emissions characteristics and compliance for the device according to CISPR 11.

Recommended separation distances

Provides recommended separation distances for RF communications equipment to prevent electromagnetic interference.

The 37Company Fluido Compact Specifications

General IconGeneral
BrandThe 37Company
ModelFluido Compact
CategoryMedical Equipment
LanguageEnglish