Link+ Agilia Rack System Technical Manual SW Ver 3 Nov 2017

Symbols Description Device identification label General warning sign

Fragile, handle with care

Refer to the Instructions for Use

This way up

Operating Instructions

Keep away from rain

Product reference / part number

Temperature limitation

Product serial number

Humidity limitation

Input terminal - connector

Atmospheric pressure limitation

Output terminal - connector

General symbol for recyclable material

Electrical fuses

Eco packaging symbol

Alternating Current (AC)

IP22

Index of protection against solid foreign objects (> 12.5 mm) and dripping liquids

Not for use in residential areas

Other symbols

Located on the back of the device Warning: Clamps must be mounted outside this area

Located on the back of the device Warning! (refer to the Instructions For Use)

Part included in a recycling process

Located on the lock / release mechanism lever Press to lock and unlock Agilia IV pumps from the Link+ Agilia

Name and address of the manufacturing facility

Located near the power connection Power status indicator

Name and address of the manufacturer / Date of manufacture (Year-Month-Day) 0123

Packaging symbols

CE mark Protection against leakage current; type B applied part

On the back of the device, the Unique Device Identification label (UDI) is represented in AIDC (Automatic Identification and Data Capture) and readable text:  (01) Product Identifier GTIN  (21) Product Serial Number  (11) Date of Manufacturer  (240) Product Reference

Located on the right and left sides of the device. Warning:  Do not remove the Link+ Agilia from pole or rails if IV pumps are .  The Link+ Agilia is heavy when installed with IV pumps.  Remove IV pumps first, before removing the Link+ Agilia from poles or rails.  Unscrew lower pole clamp first.  Unplug the power cable before cleaning  Do not spray liquids directly on the power supply connector.

Warning: Warning of a potential hazard that could result in serious personal injury and/or product damage if the written instructions are not followed. Information: Recommendations to be followed.

12831-1_TM_Link+_Agilia_ENG

Revisions table TM Link+ Agilia ENG ref CC12831 Applicable to devices whose serial number is from 23640083

Date

Revision number

Description

Nov. 27th, 2017

0

Creation

Dec. 18th, 2017

1

Serial number added

Table of contents

1

2

INTRODUCTION 1.1

SCOPE ... 7

1.2

INTENDED USE ... 7

1.3

INTENDED USERS... 7

1.4

INTENDED PATIENTS ... 8

1.5

OPERATION MODE ... 8

1.6

OPERATION DIAGRAM ... 9

1.7

OPERATING SAFETY ... 10

1.8

CONTRA-INDICATIONS ... 10

1.9

USE ENVIRONMENT ... 10

1.10

SYMBOLS DESCRIPTION ... 11

INSTALLATION

PACKAGING CONTENT ... 12

2.2

LINK+ AGILIA PREPARATION... 12

2.3

LINK+ AGILIA INSTALLATION ... 13

2.4

2.5

Installation on a fixed pole or fixed rails. ... 14 Installation on a Rolling Stand... 14 Displacement of the Link+ Agilia ... 14 Powering ON and OFF... 14

AGILIA PUMP INSTALLATION AND REMOVAL ... 15 2.4.1 2.4.2 2.4.3

Compatible pumps ... 15 Installing an Agilia IV pump ... 16 Removing an Agilia pump when infusion is ended... 17

REMOVE THE LINK+ AGILIA FROM FIXED POLE, FIXED RAILS OR ROLLING STAND ... 17

SAFETY AND PRECAUTIONS

19

3.1

SAFETY RECOMMENDATIONS ... 19

3.2

PRECAUTIONS TO BE TAKEN ... 19

3.3

AGILIA PUMPS ALARMS REPORTING ... 20

3.4

POWER MANAGEMENT ... 20 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6

4

12

2.1

2.3.1 2.3.2 2.3.3 2.3.4

3

7

AC power supply precautions... 20 Power input ... 20 Battery precautions of use... 20 Battery operating mode ... 21 Agilia output power outlet ... 21 Hard Reset ... 21

3.5

ELECTROSTATIC DISCHARGE (ESD)... 22

3.6

USB COMMUNICATION PORTS ... 22

3.7

ETHERNET - RS232 - NURSE CALL ... 22

DESCRIPTION AND OPERATION 4.1

23

DEVICE DESCRIPTION ... 23 4.1.1 4.1.2 4.1.3 4.1.4

Switch power board... 24 Switch COM board ... 25 IrDa board ... 25 LED board ... 26

4.1.5

4.2 5

Main CPU board... 26

OPERATIONAL DESCRIPTION ... 30

DEVICE CONFIGURATION

31

5.1

OPERATING SYSTEMS COMPATIBILITY ... 31

5.2

WEB BROWSER COMPATIBILITY ... 31

5.3

DEVICE CONNECTION ... 32 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5

5.4

Data management cables ... 32 Connection to the nurse call system and removal... 32 Mains power connection... 32 Connecting and Disconnecting a Network Cable ... 33 Connect Link+ Agilia directly to a computer or a Wired Hospital Network ... 33

CONFIGURATION OF THE LINK+ AGILIA ... 33 5.4.1

Accessing the Link+ Agilia web interface ... 33

6

TROUBLESHOOTING

41

7

INTERVENTION PROCEDURES

44

8

7.1

PROCEDURE #1: FIXING NUT ... 45

7.2

PROCEDURE #2: BATTERY ... 46

7.3

PROCEDURE #3: LOWER HOUSING ... 48

7.4

PROCEDURE #4: MAIN CPU BOARD ... 56

7.5

PROCEDURE #5: CAP SUPPORT ... 62

7.6

PROCEDURE #6: LED BOARD ... 65

7.7

PROCEDURE #7: FRONT PANEL ... 68

7.8

PROCEDURE #8: SWITCH BOARDS ... 77

7.9

PROCEDURE #9: HOOK AND HOOK COVER ... 85

7.10

PROCEDURE #10: IRDA BOARD ... 94

7.11

PROCEDURE #11: CHANGING THE LABELS ... 102

CLEANING AND DISINFECTION 8.1

CLEANING AND DISINFECTION ... 103

8.2

WARNINGS PRIOR TO CLEANING AND DISINFECTION ... 103

8.3

PROHIBITED CLEANING AND DISINFECTION AGENTS ... 103

8.4

RECOMMENDED CLEANING AND DISINFECTION AGENTS ... 103

8.5

CLEANING AND DISINFECTION INSTRUCTIONS ... 103 8.5.1 8.5.2

8.6 9

103

Cleaning Instructions... 104 Disinfection Instructions ... 104

CLEANING AND DISINFECTION INSTRUCTIONS FOR ACCESSORIES ... 104

DEVICE STORAGE AND TRANSPORT

105

9.1

PRECAUTIONS FOR STORAGE ... 105

9.2

STORAGE AND TRANSPORT CONDITIONS ... 105

9.3

PREPARING THE LINK+ AGILIA FOR STORAGE ... 105

9.4

USING THE LINK+ AGILIA AFTER STORAGE ... 105

10 TECHNICAL CHARACTERISTICS

108

10.1

COMPLIANCE ... 108

10.2

Technical data ... 108

10.2.1 Approx. Dimensions and Weight ... 108 10.2.2 AC power input specifications ... 109 10.2.3 AC power supply cable... 109 10.2.4 Power output specifications... 109 10.2.5 Battery specifications ... 109 10.2.6 Central Processing Unit (CPU) specifications ... 110 10.2.7 Data communication connectors ... 110

10.3

ELECTRONIC ... 111

10.4

MATERIAL CHARACTERISTICS ... 111

11 RECYCLING AND DISPOSAL

113

12 WARRANTY

114

12.1

GENERAL CONDITIONS OF WARRANTY ... 114

12.2

LIMITED WARRANTY ... 114

12.3

WARRANTY CONDITIONS FOR ACCESSORIES ... 114

13 SERVICING

115

13.1

SERVICE POLICY AND RULES... 115

13.2

MAINTENANCE REQUIREMENTS ... 115

13.3

TRAINING ... 115

13.4

MAINTENANCE SCHEDULE ... 116 13.4.1 Preventive maintenance ... 116 13.4.2 Quality control ... 116

13.5

CONTROLS ... 116 13.5.1 External control ... 116 13.5.2 Power and Cap User Interface status LEDs control... 117 13.5.3 Pump power and battery operation control ... 117 13.5.4 Alarms and nurse call reporting control... 119 13.5.5 Pump power switches control... 120 13.5.6 Electrical safety control ... 120 13.5.7 Protective earth continuity control ... 120 13.5.8 Battery life control... 120 13.5.9 Link+ Agilia Quality Control Certificate ... 120

14 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC

122

14.1

ELECTROMAGNETIC COMPATIBILITY ... 122

14.2

ELECTROSTATIC DISCHARGE (ESD) ... 122 14.2.1 ESD Precautions to be Taken ... 122 14.2.2 Electromagnetic Compatibility and Interference Guidance ... 122

14.3

EMC AND ESSENTIAL PERFORMANCE... 124 14.3.1 Table 1 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions... 124 14.3.2 Table 2 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity ... 124 14.3.3 Table 4 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity ... 125 14.3.4 Table 6 - Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and Link+ Agilia ... 126 14.3.5 EMC test deviations and supplementary tests ... 126

15 SPARE PARTS CATALOGUE

128

16 ORDERING INFORMATION

129

16.1

LINK+ AGILIA PACKAGING ... 129

16.2

POWER CABLES ... 129

16.3

DATA MANAGEMENT CABLES ... 129

16.4

INSTRUCTIONS FOR USE ... 129

16.5

OTHER ACCESSORIES ... 129

17 GLOSSARY OF TERMS

130

1

Introduction

The Link+ Agilia rack system is intended to power 4, 6 or 8 Agilia pumps connected to it. It reduces the number of power cables and improves infusion pump organisation at bedside. The Link+ Agilia rack system is also intended to provide data communication features between the Agilia pumps and external systems and to centrally replicate infusion pump signalling. Use of the device does not replace patient observation at the bedside. In any cases, the user must react to infusion pump alarms and messages in an appropriate way. This is a reusable device that is capable of continuous operation and that can be used daily. The use of Link+ Agilia does NOT change the standalone pump behavior.

1.1

Scope

Warning

 This Technical manual is applicable to the Link+ Agilia - whose embedded software version is minimum version 3 - hereafter referred to as "device" or "Rack".

 Check that this document is applicable to the Link+ Agilia you are using. The Link+ Agilia exists in 3 types:

 Link 4+ Agilia,  Link 6+ Agilia,  Link 8+ Agilia. The user must adhere to the instructions specified in this document. Failure to adhere to these instructions may result in damages to the device, injuries to patients or injuries to users. Before using the Link+ Agilia, read all accompanying documents provided with the Link+ Agilia, the Agilia pumps and the accessories. Information within this document shall be completed by the ones of the IFU. Make sure to fully understand how to use the device in order to ensure your safety and the safety of the patient. Give a particular attention to the texts which are marked with a symbol (See Symbols description at the back of the first cover of this document).

1.2

Intended use

The Link+ Agilia Rack System is intended to:

   

power compatible Agilia pumps logically organize bedside infusion pump assembly centralize alarms information from connected pumps exchange data with external software applications.

It is intended for use by trained healthcare professionals in healthcare facilities.

1.3

Intended Users

The Link+ Agilia must only be used by qualified and trained healthcare professionals including but not limited to: nurses (primary users), physicians, nurse practitioners and physician assistants. The service and maintenance technicians as well as the biomedical engineers belong to the intended user population. The estimated duration for training is 30 minutes. It is recommended that users attend a refresher training session every year. A complete training course is mandatory each time a new version of the product is installed. For training, contact your Fresenius Kabi sales representative.

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1.4

Intended Patients

The Link+ Agilia in combination with Agilia pumps is intended to be used on the same patient population as Agilia infusion pumps. The Link+ Agilia is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime. Make sure that all Agilia pumps installed on one Link+ Agilia are connected to a single patient.

1.5

Operation mode

The Link+ Agilia is a continuous operation device.

8

1.6

Operation diagram

9

1.7

Operating safety

The electrical safety of the Link+ Agilia is ensured by:

   

Two protective fuses, A protective earth, Aluminium profile for the structure, Plastic material in front and rear panels.

The communication electronic safety is ensured by the main CPU board watchdog.

1.8

Contra-indications

Warning

 Do not modify the Link+ Agilia (except in the case of operations recommended by Fresenius Kabi). The Link+ Agilia is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, Magnetic Resonance Imaging (MRI) and high radiation environments, hyperbaric chambers, explosive or flammable environments, XRay environment, high humidity or ultrasonic environments. See Use environment, page 10. and Technical Characteristics, page 108. for additional information and requirements about the use environment.

1.9

Use environment

The Link+ Agilia is intended for use in healthcare facilities, under the supervision of trained healthcare personnel. The Link+ Agilia must be used in the specified operational and storage conditions to ensure its proper performance:

   

Temperature operating range: 5°C to 40°C Pressure operating range: 700 hPa (525 mmHg / 10.15 PSI) to 1060 hPa (795 mmHg / 15.37 PSI) Humidity operating range: 20% to 90% with no condensation Altitude: up to 3000 m above sea-level Information

 For more information on using the Link+ Agilia in specific conditions, contact your Fresenius kabi sales representative.

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1.10 Symbol

RESET

Symbols description

Localisation Cap user interface

Description Mains status

Cap user interface

Battery status

Cap user interface

System status

Connector identification label

Ethernet connector

Connector identification label

Nurse call connector

Connector identification label

Serial connector

Connector identification label

Hard reset button

Connector identification label

Universal Serial Bus connector

Connector identification label

Direct Current (DC)

Connector identification label

Electrostatic sensitive devices

Near power connector

Mains power indicator

On the back of the device

Warning: Clamps must be mounted outside this area

On the right and left sides of the device.

Warning:  Do not remove the Link+ Agilia from pole or rails if IV pumps are connected.  The Link+ Agilia is heavy when installed with IV pumps.  Remove IV pumps first, before removing the Link+ agilia from poles or rails.  Unscrew lower pole clamp first.  Unplug the power cable before cleaning  Do not spray liquids directly on the power supply connector.

On the lock / release mechanism lever

Press to lock and unlock Agilia IV pumps from the Link+ Agilia

Internal label

Protective earth protection

Internal label

Functional earth connection

11

2

Installation

2.1

Packaging content

The Link+ Agilia packaging contains the following elements:

   

1 Link+ Agilia for 4, 6 or 8 Agilia pumps. Several Instructions for Use manuals (depending on the part number of your device). Several power cords (depending on the part number of your device). 2 clamps to mount and fasten the Link+ Agilia on a pole, vertical or horizontal rails, or any recommended accessories.

 1 tool to fasten clamps on the Link+ Agilia.  1 Ethernet cross-over network cable required to perform device configuration using a computer  1 Software Licenses document. Information

 If the content in the packaging is not complete or is damaged, contact your Fresenius Kabi sales representative.

2.2

Link+ Agilia preparation

Pole clamp installation and adjustments. Warning

 Position pole clamps so they are compatible with your pole or rails mounting system.  Maintain sufficient distance between the clamps to ensure stable installation of the Link+ Agilia. Refer to the instructions below.

1. Slide the clamps on the back of the Link+ Agilia.

2. Position the clamps so that clamps are outside the black and yellow area.

3. Adjust / rotate the clamps to mount the Link+ Agilia on pole or rails.

4. Fasten the pole clamps firmly to avoid movement.

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2.3

Link+ Agilia installation

Warning

 Before use, check the height and location of the Agilia pump system. Ideally, pumps should be level with distal tip of the catheter (the site of fluid delivery); if accessing a central line the pump should be at the level of the patient’s heart. If the pump height is raised relative to the distal tip of the catheter (for example, during patient transport), the increase in height of the pump can result in a temporary increase in fluid delivery or bolus until the flow rate stabilizes. Alternatively, if the pump is lowered relative to the distal tip of the catheter, the decrease in height of the pump may result in a decrease in delivery or under-infusion until the flow rate stabilizes.

 If using multiple pumps and it is not clinically feasible to have all pumps level with the distal tip of

the catheter (or the site of fluid delivery), place the high risk or life-sustaining medications as close as possible to level with the distal tip of the catheter. When infusing multiple high risk or lifesustaining medications, consider placing the ones infusing at the lowest rates as close as possible to level with the distal tip of the catheter. Minimize the height difference between the pump and the patient and avoid changes in the height of the pump (for example, during transport of critically ill patients) to prevent unintended fluctuations in the flow rate.

 Fasten Link+ Agilia clamps firmly on the pole or rails to avoid any movement of the Link+ Agilia and to avoid patient or user injuries.

 Check the Link+ Agilia clamps are enough fastened after each installation of the Link+ Agilia on a fixed pole or fixed rails and on a rolling stand.

Information

 Do not install Link+ Agilia on a pole or rails if Agilia IV pumps are already mounted on the Link+ Agilia.

 Link+ Agilia is designed to be mounted to a fixed pole and fixed rails or any recommended accessories. Refer to Ordering Information, page 129.

 Observe recommended head height requirements. Refer to the pump Instructions for Use. It is recommended to apply the "Quick check protocol" after installation and before use of the device on a new patient. Refer to the Link+ Agilia Quick check protocol in the IFU. For sensitive patients, it is recommended to install the Link+ Agilia behind the patient’s bed or incubator, to prevent discomfort.

13

2.3.1

Installation on a fixed pole or fixed rails.

Fasten pole clamps firmly to avoid movement after installation.

Information Mechanical specifications for locking clamps:

 Pole : Diameter : from 16 to 42 mm.  Rail : Height : from 16 to 42 mm. Depth : 10 mm maximum.

2.3.2

Installation on a Rolling Stand

Warning

 The Link 8+ Agilia is only compatible with new MultiChannel Rolling Stand (Part number Z073160) and Twin Link Rolling Stand (Part number Z073170).

 Use only recommended Rolling Stands. To avoid any fall and potential harms, follow carefully the compatibility chart (refer to the Link+ Agilia IFU) to ensure that the Link+ Agilia is installed on the appropriate Rolling Stand.

 When installed on a Rolling Stand, do not tip over the system more than 5°: it may fall.  If the Link+ Agilia is not securely mounted on the pole, it can fall, creating different issues on the patient or the user.

For additional information about how to install the Link+ Agilia on a Rolling Stand, consult the related IFU.

2.3.3

Displacement of the Link+ Agilia

After all displacement or re-installation of the Link+ Agilia:

 Check all cables connectivity and functionality.  Verify integrity of power cord.  If a nurse call remote signaling is used, user must perform the nurse call test to check if alarms are effectively reported remotely on supervision system.

2.3.4

Powering ON and OFF

Warning

 ONLY use the power cable delivered with the device. It is mandatory to use a power cable compliant with North America standards and with IEC 60227 standard. The minimum diameter for the power cable conductor must be at least 0.75 mm2.

 The power cable and the power outlet must remain accessible at all times to allow emergency power supply disconnection.

Information

 Check the integrity and the functionality of the power cable before use, after any displacement or re-installation of the Link+ Agilia.

 There is no ON/OFF button on the Link+ Agilia.

14

The Link+ Agilia is intended to be powered ONLY by AC power supply from 100VAC to 240VAC - 50/60Hz. Be sure that the power supply network is insulated, protected and sized to support medical device equipment. For additional information related to power requirements, refer to Technical data, page 108. 1. Plug the power cable to the Link+ Agilia power connection (marker 12). 2. Plug the power cable into the wall power outlet. The Link+ Agilia powers ON when the power cord is plugged into AC power supply. 3. Check that the power status indicator (marker 11) light is green. If the Link+ Agilia was not operating on battery, a 'bip' sound is generated. The system status LED located on the upper side switches from yellow to green when the system is ready.

11

12

Warning

 If the power cable is not correctly plugged on the Link+ Agilia, the Agilia pumps will work on battery creating risks of a premature stop if the battery alarm is not detected.

The Link+ Agilia powers OFF automatically when:

 Power is disconnected (Link+ Agilia is operating on battery), AND

 No more pumps are powered ON or installed on the Link+ Agilia for at least 30 minutes.

2.4

Agilia pump installation and removal

Warning

 A push button disables power for empty positions.This system does not guarantee protection against electric shock in all cases, so usual caution must be applied.

 The Link+ Agilia must not be used when a pushbutton remains depressed (power ON) when no pump is present.This must be checked before each pump installation and removal.

OK

2.4.1

NO!

Compatible pumps

Do not try to connect pumps other than those recommended. The Link+ Agilia has 4, 6 or 8 outlets, to power Agilia IV pumps. These outlets are to a functional earth. The Link+ Agilia is ONLY compatible with Agilia syringe and large volume pumps from Fresenius Kabi sold in your country.

15

2.4.2

Installing an Agilia IV pump

When used with Agilia pumps, follow instructions as per the pump IFU (prefer the lowest positions for large volume pumps).  Do not force Agilia pump during installation. If you have to force excessively, do not use the device and contact Customer service.

 During installation, be sure that sets are not kinked/pinched or damaged when an Agilia pump is mounted on the Link+ Agilia.

 To avoid confusion between the Agilia pumps and the associated lines, it is recommended that the set is installed before another Agilia pump is mounted on the Link+ Agilia.  Be sure that the Agilia pump is correctly powered by AC power supply after installation.  Correct Agilia IV pump installation is important for the safety of the patient.

1. Ensure the pole clamp of the Agilia pump is folded up against the pump.

2. Position the Agilia pump in front of the Link+ Agilia and slide it carefully on the pump shelf (marker 3) slot.

3 3. Push the Agilia pump firmly so that the locking mechanism secures the Agilia pump (be sure to hear the 'click') as indicated on the auto locking mechanism.

Warning

 If the Agilia pump is incompletely plugged onto the Link+ Agilia, it can fall and cause patient injuries. 4. When the Link+ Agilia is powered by the AC power supply, check the Agilia pump display to confirm the power display light listen to the audio pump signal.

is ON and

Warning

 Regularly ensure that the Agilia IV pump slot number position on the Link+ Agilia is displayed on the pump.

16

2.4.3

Removing an Agilia pump when infusion is ended

In order to remove an Agilia pump, proceed as follows:

 Do not force the Agilia pump during removal. If you have to force excessively, do not use the device and contact Customer service.

 During removal, be sure that the sets are not kinked/pinched or damaged.  To avoid confusion between the Agilia pumps and associated lines, it is recommended that the set is removed before another Agilia pump is released from the Link+ Agilia. 1. First remove the set from the Agilia pump. 2. Hold the Agilia pump with one hand and push the release mechanism lever (marker 2) with the other hand. 3. Carefully remove the Agilia pump from the slot. 4. Store the Agilia pump according to the pump IFU.

2

2.5

Remove the Link+ Agilia from fixed pole, fixed rails or Rolling Stand

Warning

 Never remove the Link+ Agilia from the pole or rails if Agilia pumps are installed.

 If the Link+ Agilia is mounted to a pole, unscrew the lower clamp first to avoid any fall.

1. Unlock and remove all mounted Agilia pumps by pushing on the release mechanism.

2. Remove power cable and all other cables (including data communication cables).

17

3. Unscrew the lower clamp first. 4. Next unscrew the upper clamp. 5. Remove the Link+ Agilia from the pole or rails. 6. Store the Link+ Agilia in a suitable place. Refer to Device Storage and Transport, page 105.

18

3

Safety and precautions

3.1

Safety recommendations

Warning

 In case of any damage of the Link+ Agilia, it must immediately be put out of service and sent to the maintenance.

 Be attentive to any damage of the power connector.  Do not use a Link+ Agilia which shows external signs of shocks or degradation of the protecting envelope.

Fresenius Kabi will not be liable for any damages or claims, medical or otherwise, of any nature whatsoever, whether direct or consequential, caused by improper use of this device. Special attention must be paid to the stability of the device. Always fully tighten the pole clamp on the pole. The Link+ Agilia should be used with accessories listed in Ordering Information, page 129. Users must perform regular checks to ensure that:

 the Agilia IV pumps plugged on the Link+ Agilia functioning correctly.  the Link+ Agilia functioning correctly. The Link+ Agilia uses a Lithium-ion rechargeable battery. Incorrect handling of a Lithium-ion battery as well as replacement of the battery by unqualified personnel or use of a battery other than that specified by the manufacturer may cause leakage, overheating, smoke, explosion or fire, which could result in deterioration of performance, failure, damage to the equipment or injury to the user. An explosion hazard exists if the Link+ Agilia is used in the presence of flammable anesthetics. Exercise care to locate the Link+ Agilia away from the any such hazardous sources. The addition of Link+ Agilia and Agilia IV pumps produced a system whose weight can be very important: incorrect Link+ Agilia handling may cause falling or tipping system, resulting in damage to the equipment or injury to the user. Dangerous voltage: an electrical shock hazard exists if the Link+ Agilia casing is opened or removed. Disconnect and remove the power cable from AC power supply and disconnect all other cables. Refer all servicing to qualified service personnel. Electronic components and semiconductors can be destroyed by electrostatic discharge (ESD). In particular MOS components can be damaged from direct or indirect discharges. Damage caused by ESD is sometimes not immediately identifiable and malfunctions can even occur after a longer period of operation. The instructions on electrostatic sensitive components must be observed. If the Link+ Agilia is dropped, subjected to excessive moisture, fluid spillage, humidity, low temperature, high temperature, pressure, heat ignition sources, or otherwise suspected to have been damaged, remove it from service for inspection by a qualified service engineer.

3.2

Precautions to be taken

 Do not use the Link+ Agilia in the shower, bath, or high humidity environment.  To prevent electrical hazards, unplug the Link+ Agilia before accessing high voltage parts and performing cleaning.

 Only clean and disinfect the external surfaces of the Link+ Agilia, avoiding those chemicals identified as not recommended in the sections Cleaning and Disinfection, page 103.

 Only authorized service personnel should attempt to repair the Link+ Agilia.

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