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Fresenius Kabi Ambix nova User Manual

Fresenius Kabi Ambix nova
106 pages
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Ambix nova
Ambulatory Infusion Pump
Version V1.0
Instructions For Use

Table of Contents

Questions and Answers:

Fresenius Kabi Ambix nova Specifications

General IconGeneral
BrandFresenius Kabi
ModelAmbix nova
CategoryWater Pump
LanguageEnglish

Summary

Symbol Descriptions

1 Introduction

1.1 Scope

Defines the applicability of the Instructions for Use to the Ambix nova pump.

1.2 Principle of Operation

Explains the Ambix nova as a programmable electronic medical system for infusion.

1.3 Intended Purpose

States the Ambix nova is for IV administration of specific fluids.

1.4 Intended Use

Covers indications, contraindications, user profile, patient population, and use environment.

1.4.2 Contraindications

Lists situations and conditions where the Ambix nova pump should NOT be used.

1.4.3 Intended User Profile

Specifies who is qualified to use the Ambix nova pump.

1.4.4 Intended Patient Population

Defines the age groups for which the Ambix nova pump is intended.

1.4.5 Use Environment

Outlines the recommended environmental conditions for operating the Ambix nova pump.

1.5 Clinical Benefits

Highlights advantages of the Ambix nova pump in patient management.

1.6 Side-effects

States there are no direct side-effects from using the Ambix nova.

1.7 Risks for Patients

Details potential risks if instructions are not followed.

2 Ambix nova Infusion System

Pump

Describes the Ambix nova ambulatory volumetric infusion pump.

Software

Details the maintenance software for Ambix and Amika pumps.

Accessories

Lists and describes holders, cables, and other accessories.

3 Description

3.1 Packaging Content

Lists the items included in the Ambix nova pump packaging.

3.2 General Description

Provides an overview of the pump, infusion set, and holder.

3.3 Detailed Description

Provides detailed descriptions of the pump and its holder.

3.4 Display Description

Illustrates the pump's screen layouts for programming and monitoring.

4 Installation and Removal

4.1 Installation

Guides on how to install the Ambix nova pump and holder correctly.

4.2 Removal

Provides instructions for removing the pump and its accessories.

5 Operations

5.1 Power Management

Covers connecting to mains, battery operating mode, and battery precautions.

5.2 Switch On

Details the procedure for switching the Ambix nova pump on.

5.3 Preparing the Set

Provides instructions for preparing the infusion set before loading.

5.4 Loading the Set

Guides on how to connect and load the administration set into the pump.

5.5 Priming the Set with the Pump

Explains how to prime the infusion set using the pump.

5.6 Programming the Infusion Settings

Guides on how to program infusion parameters like flow rate and volume.

5.7 Start Infusion

Instructions on how to initiate the infusion process after programming.

5.8 Keypad Lock

Explains how to activate and use the keypad lock to prevent accidental changes.

5.9 Mute Alarm

Describes how to temporarily mute audible alarm sounds.

5.10 Terminate Infusion

Provides steps to stop the ongoing infusion process.

5.11 Switch Off Pump

Instructions for safely switching off the Ambix nova pump.

5.12 Removing/Changing the Set from the Pump

Guides on replacing the administration set.

6 Pump Menu

6.1 Access Menu

Explains how to access the pump's main menu interface.

6.2 Menus Description

Details the functions and settings available in the pump's menus.

6.3 Menu Navigation

Explains how to navigate through the pump's menu screens and select options.

6.4 Infusion Mode

Describes the four available infusion modes: Flow rate, Continuous, Ramp, and Intermittent.

6.5 Basic Settings Menu

Covers settings like Night mode, Date/Time, Delayed start, Sound, and Light.

6.6 Advanced Settings Menu

Includes settings for occlusion, air detection, pre-alarm, nurse lock, KVO, and flow rate.

6.7 History

Provides access to infusion history, cumulative counters, and alarm history.

6.8 Information

Displays technical information such as serial number, software version, and maintenance dates.

7 Cleaning and Disinfection

7.1 Recommended Cleaning and Disinfection Agents

Specifies approved agents for cleaning and disinfecting the pump.

7.2 Prohibited Cleaning or Disinfection Agents

Lists agents that should not be used to avoid damaging the device.

7.3 Cleaning Instructions

Provides detailed steps and prerequisites for cleaning the pump.

7.4 Disinfection Instructions

Outlines the procedure for disinfecting the pump after cleaning.

8 Quick Check Protocol

Before Use Checks

Lists checks to perform before connecting the Ambix nova to a patient.

After Use Checks

Lists checks to perform after using the Ambix nova pump.

9 Alarms and Safety Features

9.1 Introduction

Introduces the pump's alarm system and user response recommendations.

9.2 The Different Types of Information Signal or Alarm

Describes various alarm signals, their types, and required operator responses.

9.3 Alarm Description

Details specific alarms, their conditions, and recommended actions.

9.4 Reacting to Alarms

Provides guidance on how to respond to different types of alarms.

9.5 Maximum Alarm Raising Delay

Specifies the time between an alarm condition and its generation.

9.6 Alarm Settings

Covers adjustable alarm settings like sound level and occlusion pressure.

10 Troubleshooting

11 Technical Information

11.1 Performance

Details essential pump performance metrics like accuracy and ranges.

11.2 Technical Characteristics

Covers operation mode, power supply, battery, and power consumption.

12 Transport, Storage and Recycling Conditions

12.1 Storage and Transport Conditions

Specifies environmental and handling conditions for storage and transport.

12.2 Recycling and Disposal

Provides guidelines for the proper recycling and disposal of the device and its components.

13 Guidance and Manufacturer’s Declaration on EMC

13.1 Electromagnetic Compatibility and Interference Guidance

Explains EMC requirements and how to mitigate interference.

13.2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Details the manufacturer's declaration regarding electromagnetic immunity.

13.3 Recommended Separation Distances between Portable and Mobile RF Communication Equipment and Pump

Advises on minimum distances for RF devices to prevent interference.

14 Services

14.1 Warranty

Covers general, limited, and accessory warranty conditions.

14.2 Quality Control

Describes the quality control checks performed on the Ambix nova pump.

14.3 Maintenance Requirements

Outlines preventive maintenance schedule and requirements.

14.4 Service Policy and Rules

Details the procedure for sending the device for servicing.

14.5 Notification of Serious Incident

Informs on reporting serious incidents related to the device.

15 Ordering Information

15.1 Instructions for Use

States availability of translated IFU documents and how to obtain them.

15.2 Administration Sets

Lists recommended single-use administration sets for the Ambix nova pump.

15.3 Accessories

Lists recommended accessories and warnings for their use.

16 Glossary of Terms

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