Service Manual
145 Pages
Preview
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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 Manual, 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.
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Copyright, Trademark and Patent Information © 2014, Q Core Medical Ltd. All right reserved. Sapphire and Q Core (with or without logos) are trademarks of Q Core Medical Ltd. The design, pumping mechanism and other features of the Sapphire pump are protected under one or more US and Foreign Patents.
Warning Use only Q Core Medical Ltd. supplied administration sets and accessories with the Sapphire pump. Use of administration sets other than Q Core Medical Ltd. 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 Medical Ltd.’s warranty on this device will be null and void and Q Core Medical Ltd. 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. To locate authorized Hospira service centers near you, refer to Authorized Hospira service centers on page 143. You may also contact Q Core Medical Ltd. support via email to the following address: [email protected]
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Sapphire Infusion Pump User Manual
Content 1. INTRODUCTION ...7 Manual Outline and Conventions ... 7 Document Conventions ...9 Terms and Abbreviations ... 9 Warnings and Safety Precautions... 10 Default Configuration Settings of the Sapphire Pump...12 FTP site... 13
2. CONFIGURING BASIC PUMP SETTINGS ...15 Managing Alarm Settings... 15 Configuring General Settings ... 18 Defining Regional Parameters... 20
3. USING TECHNICIAN OPTIONS ...21 Overview ... 21 Alarms manager ... 22 Managing Pump Settings... 22 Setting Hard Limits ...22 Setting KVO Rate ...24 Setting Air Detector Settings and Thresholds...24 Resetting the System ...26 Configuring General Settings ...27 Viewing General Pump Parameters ... 30 Calibrating the Screen ... 31 Testing the Hard Keys... 31
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4. MANAGING AUTHORIZATION LEVELS ...33 Overview ... 33 Managing Authorization Lock Levels ... 35 Viewing Authorization Lock Levels ...35 Setting Authorization Lock Levels ...36 Setting Technician Lock Level...37 Password Re-entry... 38
5. MAINTENANCE AND STORAGE ...39 Cleaning and Disinfecting the Pump ... 39 Cleaning and Disinfection: Safety Precautions... 40 Disinfection Recommendations and Procedure... 41 Preventative Maintenance... 43 Routine Inspection and Maintenance Tasks ...43 Thorough Visual Inspection ...44 Alarm Testing ...48 Built-in Test...49 Testing System Function ...51 Annual Certification Kit ...52 Battery Care Information... 52 Battery Classification ...53 Battery Safety Information ...53 Charging the Battery ...54 Battery Maintenance...56 Splitter Assembly Instructions ... 56 Transport and Storage ... 57 Q Core Service for Sapphire Pumps ... 57 Q-Core Product Return Policy ...58
6. PERFORMING THE ANNUAL CERTIFICATION TEST ...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 ... 65 Requirements ...65 Acquiring the Software...66 4
Sapphire Infusion Pump Service Manual
Setup...66 Logging In ...66 Station Setup...67 The Testing Screen ...68 Working with the Station Pane ...70 Performing the Annual Certification Tests ... 72 Getting Started ...72 Performing the Occlusion Sensor Test ...75 Performing the Air Detector Test ...76 Performing the Flow Accuracy Test...77 Viewing Results ...78 Troubleshooting Certification Testing ... 79 Communication...80 Login and Kit Entry ...80 Occlusion Sensor Test ...81 Air Detector Test...82 Flow Accuracy Test ...83 General ...84
7. DOWNLOADING EVENTS LOGS ...85 Overview ... 85 Prerequisites... 86 Software Requirements ...86 Download Procedure ... 87 Events Log Tables ... 89 Power-on Events ...90 Pump Idle Time Events...90 Pre-infusion and Intra-infusion Events...90 Operation-related Events...92 Settings and Options-related Events ...94 General Events ...97
8. UPGRADING SOFTWARE VERSION ...99 Overview ... 99 Prerequisites... 100 Hardware Requirements...100 Software Requirements ...100 Upgrade Procedure... 101 5
9. REPLACING THE BATTERY ...105 Getting Started ... 105 Required Equipment ...106 Replacing the Battery... 106
10. ALARMS AND TROUBLESHOOTING ...111 Alarms Overview ... 112 Level 1 Alarms ... 113 Level 2 Alarms ... 114 Level 3 Alarms ... 115 Messages ... 117 Guidance in Problem Solving... 119 Alarms Description List...120 Event Log Entries ... 124 Troubleshooting... 136 Non-technical Troubleshooting...136 Troubleshooting Programming Issues ...138
11. APPENDIX: CUSTOMER REPLACING BATTERY FORM ..141
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Sapphire Infusion Pump Service Manual
Chapter 1: Introduction This Sapphire Infusion Pump Service Manual is a Level 1 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 ... 7 Terms and Abbreviations ... 9 Warnings and Safety Precautions ... 10 FTP site ... 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 Level 1 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
The scope of the current manual and its target audience.
Configuring Basic Pump Settings
How to view and update basic pump configuration settings, using the Options menu.
Using Technician Options
The configuration options available to users with a Technician authorization level code.
Managing Authorization Levels
The procedures for assigning authorization levels in the Sapphire pump.
Performing Annual Certification Testing
The annual certification testing process for the Sapphire pump.
Upgrading Software Version
How to upgrade the software version in the Sapphire pump.
Downloading Events Logs
How to download the Event log from the Sapphire pump to a PC.
Changing the Battery
How to replace the battery in the Sapphire pump.
Maintenance and Storage
The proper cleaning, preventive maintenance, and storage procedures for the pump and the battery.
Alarms and Troubleshooting
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], or a local distributor at Hospira service center (refer to Authorized Hospira service centers on page 143).
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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.
Terms and Abbreviations The following table defines common terms and abbreviations used in this manual. Term/Abbreviation
Meaning
Eeprom
Electrically Erasable Programmable Read-Only Memory
GUI
Graphical User Interface
LCM
Logic Control Module
PCA
Patient-Controlled Analgesia
PCEA
Patient-Controlled Epidural Analgesia
PMM
Pump Mechanism Module
PWM
Pulse-width modulation
PWM 140
Maximum power
TPN
Total Parenteral Nutrition
Introduction
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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 (Q Core issued battery). An explosion hazard exists if the battery is replaced by an incorrect type or not according to the instructions. • Do not short circuit the battery terminals. Do not disassemble or modify battery packs. • Do not dispose of batteries or battery packs in fire. • The packaging, the administration sets, the battery, and any other electronic components must not be disposed of as unsorted municipal waste, and must be collected separately in accordance with applicable environmental laws (such as the WEEE Directive for Waste Electrical and Electronic Equipment). Contact an authorized representative for information concerning the decommissioning of your equipment. • 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. • Do not test the pump if the room temperature is not in range (Room temperature: 20º C ± 2º C). • 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 Manual.
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Sapphire Infusion Pump Service Manual
Authorization level codes are provided in Managing Authorization Lock Levels on page 35. 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: • 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 39. • 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.
Introduction
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Default Configuration Settings of the Sapphire Pump Feature
Default
For Details Refer To
Occlusion Units
BAR
Configuring Basic Pump Settings
Occlusion Threshold
0.4 BAR
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/h
Using Technician Options
Set Secondary (continuous delivery)
Off
Using Technician Options
PCA Bolus Rate
600 mL/h
User Manual (Using Special Mode Options)
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
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Sapphire Infusion Pump Service Manual
Feature
Default
For Details Refer To
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.
FTP site Q Core FTP site contains the latest version of the Pump software, Pump Loader software, Annual Certificate software, Event Log Viewer software, updated forms, protocols and user manuals. The files located at the FTP Site are highly confidential. Keep your user name and password in a safe place and do not allow your browser to save them automatically. > To access Q Core FTP Site:
1.
Obtain username and password directly from Q Core Medical at [email protected], or from a local distributor at Hospira service center (refer to Authorized Hospira service centers on page 143).
2.
Type ftp://ftp.qcore.com in the browser address bar, and press Enter.
3.
Enter your username and password, and then click OK.
Introduction
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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 ... 15 Configuring General Settings ... 18 Defining Regional Parameters ... 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 Pump User Manual. • For a description of configuration options available only to technicians, refer to Chapter 3: Using Technician Options on page 21.
Managing Alarm Settings The Alarms menu enables you to view and modify alarm-related options. > T o ac c e s s th e Al a r ms me n u :
•
From the toolbar of the Start Up screen, select Options. Then, select Pump configuration Alarms.
Option
Descriptions/Notes
Occlusion units
The format of occlusion units (BAR, PSI or mmHg).
Configuring Basic Pump Settings
To Modify Parameter (from the Alarms screen) Select Occlusion units. Then, select BAR, PSI or mmHg.
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To Modify Parameter (from the Alarms screen)
Option
Descriptions/Notes
Occlusion pressure
The minimum pressure that triggers an Occlusion alarm. Acceptable ranges are 5.8 to 17.4 PSI, 0.4 to 1.2 BAR or 300 to 900 mmHg. 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 required 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.
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. Note: The Infusion Near End alarm is triggered only once during treatment.
Select Infusion near end. Then, select 1 min, 3 min, 5 min, 10 min, or Off.
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Sapphire Infusion Pump Service Manual
Option
Descriptions/Notes
Alarm volume
Sets the speaker volume for the auditory alarm signal. Options are Maximum or Minimum. When the option is set to Minimum, Messages are provided with a visual signal only. Level 1, 2, or 3 alarms are provided with visual and the lowest auditory signal permitted, according to IEC 60601-1-8. Infusion Complete message is provided with a visual and auditory alarm signal, which will not be affected by the volume changes. For more information about messages and alarms, refer to Chapter 10: Alarms and Troubleshooting on page 111
To Modify Parameter (from the Alarms screen) Select Alarm volume. Then, select Maximum or Minimum.
An Occlusion Auto-restart option exists and is available for configuration by authorized technicians only. This option enables the pump to restart the infusion automatically provided the occlusion was cleared. If the occlusion was not cleared within 40 seconds, the downstream occlusion alarm is activated. An Occlusion Auto-restart can occur up to 5 times an hour. Local configuration changes made after the Drug Library is loaded, will be valid until the pump is turned off. When Resuming an infusion after pump shutdown, local configurations will remain until the end of the current infusion. For more details regarding Drug Library, refer to the Sapphire Pump User Manual.
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. > T o ac c e s s th e G en e r a l se t t i n g s me n 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. Note: When keys volume is set to Off, the bolus handle is silenced.
Select Keys volume. Then, select Low, High, or Off.
Alarm volume
Sets the speaker volume for the auditory alarm signal. Options are Maximum or Minimum. When the option is set to Minimum, Messages are provided with a visual signal only. Level 1, 2, or 3 alarms are provided with visual and the lowest auditory signal permitted, according to IEC 60601-1-8. Infusion Complete message is provided with a visual and auditory alarm signal, which will not be affected by the volume changes. For more information about messages and alarms, refer to Chapter 10: Alarms and Troubleshooting on page 111.
Select Alarm volume. Then, select Maximum or Minimum.
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Sapphire Infusion Pump Service Manual
To Modify Parameter (from the General settings screen)
Option
Descriptions/Notes
Authorization level
Sets the authorization lock level of the pump.
Select Authorization level. Then, enter a password and select Low, Medium, High, or Tech.
Allow delayed start
Enables/disables programming of infusions that begin after a predefined period of time. When the option is enabled, the Set Delay frame 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.
Allow PreProgram
Enables/disables starting infusions using predefined infusion parameters. When the option is enabled, the PreSet Programs frame appears on the Start 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 required 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. > T o ac c e s s th e Re g i on a l me n u :
•
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 set the date:
1.
Select the Date frame.
2.
Using the keyboard, enter values (2 digits each) for the day, month, and year. (When U.S. format is set, the order is month, day, and year.)
3.
To confirm the new settings, press OK.
> To set the time:
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 U.S. format is set to On.)
4.
To confirm the new settings, press OK.
> To set the language:
1.
Select the Language frame.
2.
Select the required 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