Sapphire Service Manual Rev 01

Important Notice The Sapphire Infusion Pump Service Manual is delivered subject to the conditions and restrictions listed in this section. Qualified service technicians should read the entire Service Manual, in addition to the Sapphire Infusion Pump User Guide, prior to operating the pump, in order to fully understand the functionality and operating procedures of the pump and its accessories. Service technicians and healthcare professionals should not disclose to the patient the pump's security codes, Lock Levels, or any other information that may allow the patient access to all programming and operating functions. Improper programming may cause injury to the patient.

Prescription Notice Federal United States law restricts this device for sale by or on the order of a physician only {21 CFR 801.109(b) (1)}. The Sapphire infusion pump is for use at the direction of, or under the supervision of, licensed physicians and/or licensed healthcare professionals who are trained in the use of the pump and in the administration of medication and parenteral nutrition. The instructions for use presented in this guide should in no way supersede established medical protocol concerning patient care.

Draft Version: 3.7 May 31, 2011

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Sapphire Infusion Pump Service Manual

Copyright, Trademark and Patent Information © Copyright 2012, Q Core Ltd. All rights reserved. Sapphire and Q Core (with or without logos) are trademarks of Q Core Ltd. The design, pumping mechanism and other features of the Sapphire infusion pump are protected under one or more US and Foreign Patents.

Disclaimer The information in this manual has been carefully examined and is believed to be reliable. No responsibility is assumed for any inaccuracies. Q Core Medical reserves the right to make changes to any of its products in order to improve reliability, design and performance. The instructions presented in this manual should in no way supersede established medical protocol concerning patient care. The text and drawings herein are for the purposes of illustration and reference only; the specifications on which they are based are subject to change without notice.

Warning Use only Q Core supplied administration sets and accessories with the Sapphire infusion pump. Use of administration sets other than Q Core Medical supplied sets may impair the operation of the pump and the accuracy and flow rate of the infusion, and may generate hazardous fluid pressures which may activate occlusion alarms at unpredictable pressures. Q Core’s warranty on this device will be null and void and Q Core will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling.

Technical Assistance For technical questions, troubleshooting assistance and device problems, please contact your local agent/distributor. You may also contact the Q Core Medical support via email to the following address: [email protected]

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Sapphire Infusion Pump Service Manual

Contents 1. INTRODUCTION ...9 Manual Outline and Conventions ... 9 Document Conventions ...11 Warnings and Safety Precautions... 11 Default Configuration Settings of the Sapphire ... 13

2. CONFIGURING BASIC PUMP SETTINGS ...15 Managing Alarm Settings... 16 Configuring General Settings ... 18 Defining Regional Parameters... 20

3. USING TECHNICIAN OPTIONS...21 Overview ... 21 Controlling Alarms ... 22 Managing Pump Settings... 22 Setting Hard Limits ...22 Setting KVO Rate ...24 Setting Air Detector Thresholds ...24 Resetting the System ...26 Configuring General Settings ...26 Viewing General Pump Parameters ... 29 Calibrating the Screen... 29 Testing the Hard Keys ... 29

4. MANAGING AUTHORIZATION LEVELS ...31 Managing Authorization Levels... 31 Setting Authorization Lock Levels ...33 Setting Technician Lock Level ...34 Password Re-entry... 35

5. MAINTENANCE AND STORAGE ...37 Cleaning and Disinfecting the Pump ... 37 Cleaning and Disinfection: Safety Precautions...38 5

Disinfection Recommendations and Procedure...38 Preventative Maintenance... 41 Routine Inspection and Maintenance Tasks ...42 Thorough Visual Inspection ...43 Alarm Testing...48 Built-in Test ...48 Functional Tests...50 Annual Certification Kit ...51 Battery Care Information... 52 Battery Classification ...53 Battery Safety Information ...53 Charging the Battery ...54 Battery Maintenance...55 Transport and Storage... 55 Q Core Service for Sapphire Pumps ... 56 Q-Core Product Return Policy ...56

6. PERFORMING THE ANNUAL CERTIFICATION PROCESS ...59 Annual Certification Overview ... 59 Testing Rationale of the Annual Certification Process...60 The Calibration Verification Process...60 Annual Certification Kit ... 61 Kit Components ...61 Annual Certification Software... 64 Requirements ...64 Acquiring the Software...65 Logging In ...65 The Testing Screen...65 Station Setup...66 Working with the Station Pane ...67 Performing the Annual Certification Tests... 69 Getting Started ...70 Performing the Occlusion Sensor Test ...72 Performing the Air Detector Test...73 Performing the Flow Accuracy Test ...74 Viewing Results ...75 Troubleshooting Certification Testing ... 75 Occlusion Sensor Test ...76

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Sapphire Infusion Pump Service Manual

Air Detector Test ...77 Flow Accuracy Test...78

7. DOWNLOADING EVENTS LOGS ...81 Overview ... 81 Prerequisites... 82 Hardware Requirements...82 Software Requirements ...82 Download Procedure ... 83 Events Log Tables ... 85 Power-on Events ...86 Pump Idle Time Events...86 Pre-infusion and Intra-infusion Events...87 Operation-related Events...88 Settings and Options-related Events ...89 General Events ...92

8. UPGRADING SOFTWARE VERSION...93 Overview ... 93 Prerequisites... 94 Hardware Requirements...94 Software Requirements ...94 Upgrade Procedure... 95

9. CHANGING THE BATTERY ...99 Getting Started ... 99 Required Equipment ...99 Replacing the Battery... 100

10. ALARMS AND TROUBLESHOOTING ...105 Alarms Overview ... 106 Level 1 Alarms... 107 Level 2 Alarms... 108 Level 3 Alarms... 109 Messages ... 111 Guidance in Problem Solving... 113 Alarms Description List...114 Event Log Entries ... 118 7

Troubleshooting ... 128 Non-technical Troubleshooting ...128 Troubleshooting Programming Issues ...130

11. APPENDICES...133 Appendix A: Customer RMA Request... 134 Appendix B: Customer SW Update Form ... 136 Appendix C: Analysis Report ... 138

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Sapphire Infusion Pump Service Manual

Chapter 1: Introduction This Sapphire Infusion Pump Service Manual is a 1st-level support service manual. It is designed to assist certified and authorized technicians and support personnel to perform the service functions appropriate to their level of authorization. • Certified technicians - technicians trained by Q Core Medical to provide 1st level support. • Authorized technicians - technicians trained by a certified technician to provide 1st level support. The following sections describe the structure of the Service Manual, and provide a summary of safety information: Manual Outline and Conventions ... 9 Warnings and Safety Precautions ... 11 Default Configuration Settings of the Sapphire ... 13

Manual Outline and Conventions This manual describes the configuration settings available for authorized technicians working with the Sapphire pump, and explains the procedures involved in servicing the pump. The material provided in this manual supplements the material detailed in the Sapphire Infusion Pump User Manual. It assumes familiarity with the information contained in the User Manual. Before performing tasks or providing 1st-level service support to the Sapphire pump, read and become familiar with the material in both the User Manual and the Service Manual.

Introduction

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This Service Manual is organized into the following chapters: Chapter

Description

Introduction

Describes the scope of the current manual and its target audience.

Configuring Basic Pump Settings

Describes how to view and update basic pump configuration settings, using the Options menu.

Using Technician Options

Describes the configuration options available to users with a Technician level authorization code.

Managing Authorization Levels

Describes the procedures for assigning authorization levels in the Sapphire pump.

Performing Annual Certification Testing

Describes the annual certification testing process for the Sapphire pump.

Upgrading Software Version

Describes how to upgrade the software version in the Sapphire pump.

Downloading Events Logs

Describes how to download the Event log from the Sapphire to a PC.

Changing the Battery

Describes how to replace the battery in the Sapphire pump.

Maintenance and Storage

Describes the proper cleaning, preventive maintenance, and storage procedures for the pump and the battery.

Alarms and Troubleshooting

Describes the different types of alarms and messages that can be generated by the pump, and explains how to troubleshoot common programming issues.

To obtain information about features or procedures not included in this manual, contact Q Core Medical by sending an email to the following address: [email protected].

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Sapphire Infusion Pump Service Manual

Document Conventions The following messages in this manual prompt readers to pay special attention to specific points: Warnings indicate precautions and instructions which, if not followed, may result in personal injury. Cautions indicate instructions which, if not followed, may result in damage to the equipment. Cautions are also used to advise against unsafe practices. Notes provide additional information to help obtain optimal equipment performance.

Warnings and Safety Precautions The following sections contain important safety information. All warnings and safety precautions should be read carefully before servicing the Sapphire infusion pump. When working with the Sapphire pump, always adhere to the following instructions and safety guidelines: • This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. • The pump uses a Li-Ion battery, supplied by Q Core. Replace the battery only with the same type. An explosion hazard exists if the battery is replaced incorrectly. • Do not short circuit the battery terminals. Do not disassemble or modify battery packs. • Do not dispose of batteries or battery packs in fire. For disposal instructions, refer to the Sapphire Infusion Pump User Guide. • Do not use a pump that has been dropped or that is visibly damaged. The pump must be inspected and repaired by a qualified service technician prior to further use. Introduction

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• •

•

Do not use the pump if the room or pump temperature is below 15°C (60°F), or above 32°C (90°F). Use only Q Core approved administration sets. Use of any other sets will result in malfunction or inaccurate delivery. For a list of approved sets, refer to the Sapphire Infusion Pump User Guide. Authorization level codes are provided in Managing Authorization Levels on page 31. Do not leave this manual near unauthorized personnel or patients. Do not disclose the passwords of MEDIUM, HIGH and TECHNICIAN authorization Levels to unauthorized users.

When working with the pump, always adhere to the following precautionary guidelines:

• • • • •

• •

•

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Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed practitioner. Operate the pump only on the AC line voltage for which the AC Power Adaptor is marked. While the pump is in storage, recharge the battery at least every 6 months. Before servicing the pump, disconnect it from the AC power source. Routine cleaning and periodic maintenance is necessary to ensure that the pump remains safe and functional. For details, refer to Chapter 5: Maintenance and Storage on page 37. Solution spills should be wiped up as soon as possible, using a damp cloth or sponge. Dry the pump thoroughly before use. Static sensitive electronics used in the pump may be damaged by electrostatic discharge. Service technicians must follow proper ESD procedures when working on the pump. Do not use a pen or any other sharp object to press the hard keys or the buttons on the touch screen. Replace torn or punctured front panel immediately, to prevent damage to the front panel switch.

Sapphire Infusion Pump Service Manual

•

Use only Q Core supplied administration sets with the Sapphire pump. For a list of Q Core's administration sets, refer to the Sapphire Infusion pump User Manual.

Default Configuration Settings of the Sapphire Feature

Default

For Details Refer To

Occlusion Units

BAR

Configuring Basic Pump Settings

Occlusion pressure

0.8BAR

Configuring Basic Pump Settings

Pump unattended

10 minutes

Configuring Basic Pump Settings

Infusion near end

10 minutes

Configuring Basic Pump Settings

Alarm volume

High

Configuring Basic Pump Settings

Keys volume

High

Configuring Basic Pump Settings

Authorization level

High

Configuring Basic Pump Settings

Allow delayed start

Off

Configuring Basic Pump Settings

Allow PreProgram

Off

Configuring Basic Pump Settings

Set prime volume

20 ml

Configuring Basic Pump Settings

Backlight

On

Configuring Basic Pump Settings

Language

English

Configuring Basic Pump Settings

Single air detector

Off

Using Technician Options

Accumulated air detector

0.05 ml

Using Technician Options

Accumulated threshold

1 ml

Using Technician Options

New Patient

Off

Using Technician Options

US Format

Off

Using Technician Options

Continuous Bolus rate

600 ml/hr

Using Technician Options

Set secondary (continuous delivery)

Off

Using Technician Options

PCA bolus rate

600 ml/hr

User Manual (Using Special Mode Options)

Introduction

13

Feature

Default

For Details Refer To

Allow loading dose

On

User Manual (Using Special Mode Options)

Auto.P.Lockout

Off

User Manual (Using Special Mode Options)

PCA / PCEA infusion type

Continuous + Bolus

Using Technician Options

PCA / PCEA Max Bolus per

1 Hr

Using Technician Options

Password request

No

User Manual (Using Special Mode Options)

The specific parameters ranges are listed in 'Using the Infusion Modes' chapter of the Sapphire User Manual.

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Sapphire Infusion Pump Service Manual

Chapter 2: Configuring Basic Pump Settings The following sections describe how to view and update basic pump configuration settings, using the Options menu: Managing Alarm Settings ... 16 Configuring General Settings ... 18 Defining Regional Parameters ... 20 To confirm the new settings, press OK. ... 20 This chapter describes how to manage the basic pump configurations (available to users with High level authorization) that are most relevant to technicians. • For a description of all basic pump options, refer to the Sapphire User Manual. • For a description of configuration options available only to technicians, refer to Using Technician Options on page 21.

Configuring Basic Pump Settings

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Managing Alarm Settings The Alarms menu enables you to view and modify alarm-related options. > To a cc es s th e Al a r m s m en u:

•

From the toolbar of the Start Up screen, select Options. Then, select Pump configuration → Alarms. To Modify Parameter (from the Alarms screen)

Option

Descriptions/Notes

Occlusion units

The format of occlusion units (BAR or PSI).

Select Occlusion units. Then, select BAR or PSI.

Occlusion pressure

The minimum pressure that triggers an Occlusion alarm. Acceptable ranges are 0.4 to 1.2 BAR or 5.8 to 17.4 PSI. An alarm sounds when the pressure reaches the set value ± the sensor sensitivity level. If a value outside the permitted range is entered during programming, the range is displayed in red font, and the OK function key is disabled.

Select Occlusion pressure. Then, using the keypad, enter the desired value → OK.

Pump unattended

The number of consecutive minutes of no interaction with the pump after which a Pump Unattended alarm is triggered. Options are 2, 5, or 10 minutes. Note: A Pump Unattended alarm is not triggered while an infusion is running.

Select Pump unattended. Then, select 2 min, 5 min, or 10 min.

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Sapphire Infusion Pump Service Manual

To Modify Parameter (from the Alarms screen)

Option

Descriptions/Notes

Infusion near end

The number of minutes before completion of an infusion at which an Infusion Near End alarm is generated. You can disable the alarm by selecting Off.

Select Infusion near end. Then, select 1 min, 3 min, 5 min, 10 min, or Off.

Alarm volume

Sets the speaker volume for the auditory alarm signal. Options are Low, High, or Off. When the option is set to Off, an auditory alarm is not sounded when Messages appear on the Main Display. An auditory alarm continues to sound when Level 1, 2, or 3 alarms occur. For more information about messages and alarms, refer to Alarms and Troubleshooting on page 105.

Select Alarm volume. Then, select Low, High, or Off.

Configuring Basic Pump Settings

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Configuring General Settings The General settings menu enables you to view basic pump settings, and modify them according to clinical requirements. > To a cc es s th e G en er al s et t i ng s m en u:

•

From the toolbar of the Start Up screen, select Options. Then, select Pump configuration → General settings. To Modify Parameter (from the General settings screen)

Option

Descriptions/Notes

Keys volume

Sets the speaker volume for the auditory signal generated when users select functions and press keys on the pump.

Select Keys volume. Then, select Low, High, or Off.

Alarm volume

Sets the speaker volume for the auditory alarm signal. Options are Low, High, or Off. When the option is set to Off, an auditory alarm is not sounded when Messages appear on the Main Display. An auditory alarm continues to sound when Level 1, 2, or 3 alarms occur. For more information about messages and alarms, refer to Alarms and Troubleshooting on page 105.

Select Alarm volume. Then, select Low, High, or Off.

Authorization level

Sets the authorization lock level of the pump.

Select Authorization level. Then, select Low, Medium, High, or Tech.

Allow delayed start

Enables/disables programming of infusions that begin after a predefined period of time. When the feature is enabled, the Set Delay option appears on the Start screen. Note: This feature functions like a timer.

Select the Allow delayed start row, to toggle the option between On and Off.

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Sapphire Infusion Pump Service Manual

To Modify Parameter (from the General settings screen)

Option

Descriptions/Notes

Allow PreProgram

Enables/disables starting infusions using predefined infusion parameters. When the option is enabled, the PreSet Programs frame appears on the Startup screen.

Select the Allow PreProgram row, to toggle the option between On and Off.

Set prime volume

The amount of fluid used to prime the administration set when automatic priming is performed. The acceptable range is 2 to 25 ml. If a value outside the permitted range is entered during programming, the range is displayed in red font, and the OK function key is disabled.

Select Set prime volume. Then, using the keypad, enter the desired value → OK.

Backlight

Sets the degree of screen dimming while the pump is running. The Off and Partial options of this feature save power and promote longer battery life.

Select Backlight; then select On, Off or Partial.

Configuring Basic Pump Settings

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Defining Regional Parameters The Regional menu controls date, time, and language settings. > To a cc es s th e Re g i ona l me nu :

•

From the toolbar of the Start Up screen, select Options. Then, select Pump configuration → Regional. The following procedures explain how to configure settings from the Regional menu. > To s et t h e da t e:

1.

Select the Date frame.

2.

Using the keypad, enter values (2 digits each) for the day, month and year.

3.

To confirm the new settings, press OK.

> To s et t h e ti m e :

1.

Select the Time frame.

2.

Using the keyboard, enter values (2 digits each) for the hour and the minute.

3.

If necessary, switch the time units from AM to PM, or vice versa, by pressing the AM/PM function key. (This step is relevant only when US format is set to On).

4.

To confirm the new settings, press OK.

> To s et t h e l an g ua g e:

1.

Select the Language frame.

2.

Select the desired language. In some pumps, only the default language is listed.

3.

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To confirm the new settings, press OK.

Sapphire Infusion Pump Service Manual