Sapphire Service Manual Level 1 Rev 01

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 Q Core infusion pumps. 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 211. You may also contact Q Core Medical Ltd. support via email to the following address: [email protected]

3

Sapphire Infusion Pump Service Manual

1. INTRODUCTION ...9 Manual Outline and Conventions ... 9 Terms and Abbreviations ... 11 Document Conventions ... 13 Compliance and Classification ... 13 Wireless Communication ...14 FCC Information...14 Biocompatibility ...16 Sterilization ...16 Degree of Protection Against Ingress of Water and Dust...16 Warnings and Safety Precautions... 16 General Warnings and Precautions...17 Proper Use of the Pump ...21 Default Configuration Settings of the Sapphire Pump...27 FTP site... 28

2. MANAGING AUTHORIZATION LEVELS ...31 Overview ... 31 Managing Authorization Lock Levels ... 33 Viewing Authorization Lock Levels ...33 Setting Authorization Lock Levels ...34 Setting Technician Lock Level...35 Password Re-entry... 36

3. MAINTENANCE AND STORAGE ...37 Cleaning and Disinfecting the Pump ... 37 Cleaning and Disinfection: Safety Precautions... 38 Cleaning and Disinfecting Procedure ... 39 Cleaning Procedure ...39 Disinfection Procedure... 40 Reprocessing the pump when used by a single patient multiple times ...41 Preventative Maintenance... 42 Routine Inspection and Maintenance Tasks ...42 Thorough Visual Inspection ...43 Alarm Testing ...47 Built-in Test...48 Testing System Function ...50 4

Annual Certification Kit ...51 Battery Care Information... 51 Battery Classification ...52 Battery Safety Information ...52 Charging the Battery ...53 Battery Maintenance...55 Splitter Assembly Instructions ... 55 Sapphire Multi-Pump Mounting System ... 56 Mounting System safety guidelines: ...56 Overview ...57 Unpacking the Mounting System ...57 Mounting System setup instructions ...58 Transport and Storage ... 64 Q Core Service for Sapphire Pumps ... 65 Q Core Product Return Policy...66

4. PERFORMING THE ANNUAL CERTIFICATION TEST ...67 Annual Certification Overview ... 67 Certification due date counting...68 Testing Rationale of the Annual Certification Process ...69 The Calibration Verification Process ...69 Annual Certification Kit ... 70 Kit Components ...71 Annual Certification Software ... 74 Requirements ...74 Acquiring the Software...75 Logging In ...75 Station Setup...76 The Testing Screen ...77 Working with the Station Pane ...78 Performing the Annual Certification Tests ... 80 Getting Started ...80 Performing the Occlusion Sensor Test ...87 Performing the Air Detector Test ...89 Performing the Flow Accuracy Test...89 Viewing Results ...91 After the Test...92 Troubleshooting Certification Testing ... 93

5

Communication...93 Login and Kit Entry ...94 Occlusion Sensor Test ...95 Air Detector Test...96 Flow Accuracy Test ...97 General ...98

5. DOWNLOADING EVENT LOG ...101 Overview ... 101 Prerequisites... 102 Hardware Requirements...102 Software Requirements ...103 Download Procedure ... 103 Event Log Tables... 106 Power-on Events ...106 Pump Idle Time Events...107 Pre-infusion and Intra-infusion Events...107 Operation-related Events...110 Settings and Options-related Events ...112 General Events ...117

6. REPLACING THE BATTERY ...119 Getting Started ... 119 Required Equipment ...120 Replacing the Battery... 120 Customer Battery Replacement Form... 124

7. SAPPHIRE & SAPPHIREH100 ...125 Configuring Basic Pump Settings ...125 Managing Alarm Settings... 125 Configuring General Settings ... 128 Defining Regional Parameters... 130 SapphireH100 Design ... 131 SapphireH100 Infusion Pump Functions ... 132 Delivery Modes ...132 Pressure Settings...132

Using Technician Options ...132 Overview ... 133 6

Alarms manager ... 134 Managing Pump Settings... 134 Setting Hard Limits ...134 Setting KVO Rate ...136 Setting Air Detector Settings and Thresholds...137 Air In Line Alarm...138 Resetting the System ...139 Configuring General Settings ...140 Viewing General Info Parameters... 143 Calibrating the Screen ... 143 Testing the Hard Keys... 143

Alarms and Troubleshooting ...144 Alarms Overview ... 145 Level 1 Alarms ... 146 Level 2 Alarms ... 147 Level 3 Alarms ... 148 Messages ... 150 Guidance in Problem Solving... 152 Alarms Description List...152

Upgrading Software Version ...157 Overview ...157 Prerequisites...158 Upgrade Procedure ...159 Troubleshooting Software Upgrade ...162

8. SAPPHIREPLUS ...167 Configuring Basic Pump Settings ...167 Managing Alarm Settings... 167 Configuring Audio Settings... 170 Configuring General Settings ... 171 Defining Regional Parameters... 174

Using Technician Options ...175 Overview ... 175 Alarms manager ... 176 Managing Pump Settings... 176 Setting Hard Limits ...176 Setting KVO Rate ...178 Setting Air Detector Settings and Thresholds...178 7

Air In Line Alarm...180 Resetting the System ...180 Configuring General Settings ...182 Viewing General Info Parameters... 185 Configuring the WiFi Settings ... 185 View Configuration ...186 Start Configuration ...188 SxManager...188 Testing the Hard Keys... 189

Alarms and Troubleshooting ...190 Alarms Overview ... 191 Level 1 Alarms ... 192 Level 2 Alarms ... 193 Level 3 Alarms ... 194 Messages ... 196 Guidance in Problem Solving... 198 Alarms Description List...198 Troubleshooting... 202 Non-technical Troubleshooting...202 Troubleshooting Programming Issues ...205

Upgrading Software Version ...208 Upgrade Procedure ...208

9. AUTHORIZED HOSPIRA SERVICE CENTERS ...211 10. CUSTOMER SOFTWARE UPDATE FORM ...213

8

Chapter 1: Introduction This Sapphire Infusion Pump Service Manual is a Level 1 support service manual that includes the technical information of all the available Sapphire pumps: Sapphire Multi-therapy, Sapphire Epidural, SapphireH100 and SapphirePlus. It is designed to assist trained technicians and support personnel to perform the service functions appropriate to their level of authorization. A trained technician is a technician trained to complete maintenance actions according the Q Core Training Standard Operating Procedure. The following sections describe the structure of the Service Manual, and provide a summary of safety information: Manual Outline and Conventions ... 9 Compliance and Classification ... 13 Terms and Abbreviations ... 11 Warnings and Safety Precautions ... 16 FTP site ... 28

Manual Outline and Conventions This manual describes the configuration settings available for trained technicians working with the Sapphire pump, and explains the procedures involved in servicing the Sapphire Multi-therapy and Sapphire Epidural (revisions 11 and lower), SapphireH100 (revision 11) and SapphirePlus (revision 13). The material provided in this manual supplements the material detailed in the Sapphire 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

9

This Service Manual is organized into the following chapters: Chapter

Description

Common chapters for all Sapphire infusion pumps Introduction

The scope of the current manual and its target audience.

Managing Authorization Levels

The procedures for assigning authorization levels in the Sapphire pump, WiFi settings, WiFi configuration using the SXManager Software and testing the hard keys.

Maintenance and Storage

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

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 Event Log

How to download the Event Log from the Sapphire pump to a PC.

Replacing the Battery

How to replace the battery in the Sapphire pump.

Sapphire and SapphireH100 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.

Alarms and Troubleshooting

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

Event Log Tables

Lists of the events that are recorded to the Event Log.

Upgrading Software Version

How to upgrade the pump software version.

SapphirePlus Configuring Basic Pump Settings

10

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

Sapphire Infusion Pump Service Manual

Chapter

Description

Using Technician Options

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

Alarms and Troubleshooting

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

Event Log Tables

Lists of the events that are recorded to the Event Log.

Upgrading Software Version

How to upgrade the pump software version.

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 211).

Terms and Abbreviations The following table defines common terms and abbreviations used in this manual. Term/Abbreviation

Meaning

AFFV

Anti-Free-Flow-Valve

AC/DC

Alternating Current / Direct Current

BPOC

Barcode Point-Of-Care

CCA

Clinical Care Area

ECG

Electrocardiogram

eMAR

Electronic Medication Administration Record

EMC

Electromagnetic compatibility

EMI

Electromagnetic interference

FCC

Federal Communications Commission

H

Hour

Introduction

11

Term/Abbreviation

Meaning

HIS

Hospital Information System

Kg

Kilograms

KVO

Keep Vein Open

LE-LAN

License-Exempt Local Area Network

MAC

Media Access Control

mcg

Micrograms

mEq

Milliequivalents

min

Minutes

mg

Milligrams

mL

Milliliters

mmol

Millimoles

mUnits

Milliunits

M Units

Million Units

nanog

Nanograms

Occ.

Occlusion

PAV

Pressure Activated Valve

PDA

Personal Digital Assistant

PHY

Physical Layer

RF

Radio Frequency

TPN

Total Parenteral Nutrition

VI

Volume Infused

VTBI

Volume To Be Infused

Q Core

Q Core Medical Ltd.

QoS

Quality of Service

Sapphire pump

Q Core Sapphire infusion pump family

WLAN

Wireless Local Area Network

12

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.

Compliance and Classification This manual has been written in conjunction with the requirements in the International Standard, IEC 60601-2-24 for Medical Electrical Equipment Part 2-24: Particular Requirements for Safety of Infusion Pumps and Controllers. Data presented in the Technical Specification section reflect specific test conditions defined in this standard. Other external factors, such as varying back pressure, temperature, head height, set usage, fluid restrictions, solution viscosity, or combinations of these factors may result in deviations from the performance data presented. • IEC 60601-1, UL 60601-1 and CAN/CSA C22.2 601.1-M90 medical electrical equipment, which classifies the Sapphire pump as: • Class II • Type BF • Continuous operation • IP24 dust and splash proof • Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide • IEC 60601-1-2: Electromagnetic compatibility.

Introduction

13

• • • • • •

IEC 60601-2-24: Infusion pumps and controllers, which classifies the Sapphire pump as a Type 4 pump (continuous infusion flow, combined with bolus delivery). IEC 60601-1-11: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. IEC 60601-1-8: Requirements for alarm systems in medical electrical equipment and medical electrical systems. Defibrillator compliance statement: Equipment Type BF Applied Part. IEEE 802.11 a/b/g/n: Requirements for wireless local area network (WLAN) computer communication – synonymous with WiFi. FCC: The Federal Communications Commission (FCC) regulates interstate and international communications by radio, television, wire, satellite and cable. The Sapphire pump complies with Part 15B, 15C, 15E of the FCC Rules.

Wireless Communication The SapphirePlus pump contains a Connectivity Module that allows for implementing Wireless Local Area Network (WLAN) networking capabilities. This allows the application software to download drug libraries and software updates to the infusion pump and enable the auto-programming feature over a wireless connection. The pump’s WiFi abilities have been tested and approved according to United States rules and regulations. Using the pump’s WiFi abilities outside of the United States where allocations and technical parameters may be different, may result in the violation of government regulations and possibly affect the functionality of the WiFi module.

FCC Information US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT The Federal Communications Commission (FCC) regulates interstate and international communications by radio, television, wire, satellite and cable. The Sapphire pump complies with Part 15B, 15C, 15E of the FCC Rules. 14

Sapphire Infusion Pump Service Manual

Operation is subject to the following two conditions:

1.

This device may not cause interference.

2.

Pump operation must not be affected by any transmitted interference from other devices.

FCC INTERFERENCE STATEMENT This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15B, 15C, 15E of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the distance between the equipment and the receiver. • Connect the equipment to an outlet on a circuit other than the one to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. RADIO FREQUENCY EXPOSURE STATEMENT

•

•

The Wireless LAN radio device in the connectivity module peripheral board of this infusion device has been evaluated and found compliant to the requirements of the following Radio Frequency exposure standards: • Federal Communications Commission, OET Bulletin 65 (Edition 97-01), Supplement C (Edition 01-01), Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields, July 2001. • EN 50360 and EN62311 The radiated output power of this Wireless device is far below the FCC radio frequency exposure limits. The Wireless Sapphire device has been

Introduction

15

evaluated at 0.2 inches away from a human body, and found to be compliant with FCC RF exposure limits.

Biocompatibility All materials in components of the administration sets that are in the fluid pathway have been tested for biocompatibility, and are in compliance with applicable international standards ISO 10993-1 for biocompatibility.

Sterilization Administration sets that are manufactured by Q Core for the Sapphire pump, are sterilized with ethylene oxide (EO), according to the sterilization requirements of ISO 11135-1.

Degree of Protection Against Ingress of Water and Dust The Sapphire pump meets the IP24 splash/dust standard according to IEC 60601-1-11. Protects from water which is sprayed at 10L/min at a pressure of 80-100kN/m2 for 5 minutes at all angles, and protects from touch by objects greater than 12 millimeters such as fingers.

Warnings and Safety Precautions The following sections contain important safety information. All warnings and safety precautions should be read carefully before operating the Sapphire pump: • General Warnings and Precautions on page 17 • Proper Use of the Pump on page 21 Safety information specific to particular pump functions appears in the relevant sections of this manual.

16

Sapphire Infusion Pump Service Manual

General Warnings and Precautions To ensure safety and proper operation, read the User Manual and any instructions accompanying disposables or accessories before operating this device. In addition, adhere to the following safety guidelines: Avoid placing the administration set or power cord on the floor, or any other location where it can accidentally be damaged or provide a risk of strangulation, particularly due to excessive length.

• •

To avoid damage to the pump and its accessories, keep the equipment away from unattended children and pets. Do not clean, disinfect or sterilize any part of the pump by autoclaving, or with ethylene oxide gas. Doing so may damage the pump and void the warranty. Only external parts of the pump should be disinfected. If the pump is dropped or appears to be damaged, it should be taken out of service and inspected by Q Core Medical Ltd. trained, qualified personnel only.

•

Do not operate the pump with the safety door open.

Waste Disposal Make sure to dispose of the packaging, the administration sets, the battery, and any other electronic components in accordance with applicable environmental laws (such as the WEEE Directive for Waste Electrical and Electronic Equipment). Contact your local authority to determine the proper method of disposal.

Waste Disposal Safety Precautions

•

Keep used plastic reservoir container, packaging and tubing out of the reach of children.

Introduction

17

• •

Administration sets should be disposed of in a proper manner, considering the nature of residual fluid that may be contained within, in accordance with hospital disposal practices. Do not dispose of the battery in or near fire.

Explosion Hazard The equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Electric Shock Hazards To promote safety, always adhere to the warnings listed below. Electrical Safety Precautions

• • • • •

Access to any internal part of the Sapphire pump and the performance of any service procedures should be carried out only by a qualified service technician, fully trained in the operation of the infusion pump. Disconnect the power supply before servicing. Disconnect the battery prior to opening the pump casing. Voltage present on internal components may cause severe shock or death on contact. Connect AC power to the pump only via a Q Core supplied power adapter. Do not touch the pump to cradle (P2C) connection in the back on the pump.

Electromagnetic Compatibility The Sapphire pump is designed to conform with electromagnetic compatibility (EMC) standard IEC 60601-1-2 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard. To avoid electromagnetic interference that may affect the operation of the pump, do not use the pump near sources of strong electric and magnetic interference (EMI), such as large electric motors. • Manage the electromagnetic environment to permit the device to perform as intended without disturbing other equipment. 18

Sapphire Infusion Pump Service Manual

•

Separate the device from all other electronic equipment. If the device must be used near other electrical equipment, monitor the equipment to ensure there is no electromagnetic interference. • Devices should not be used adjacent to or stacked with other equipment. If the device must be used adjacent to or stacked with other equipment, monitor the device to verify normal operation. • If you suspect external RF sources or other equipment are influencing device operation, contact the biomedical engineering department for additional guidelines concerning electromagnetic immunity. • Contact the biomedical engineering department for additional information in the service manual concerning operating devices near RF sources. The EMC limits for the Medical Device Directive 93/42/EEC (EN301489-1/-17 IEC/EN 60601-1-2:2007) are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates uses and can radiate radio frequency energy, and if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving device. • Increase the separation between the equipment. • Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected. • Consult the manufacturer or field service technician for help. Portable and mobile RF communications equipment, such as cellular telephones, 2-way radios, Bluetooth™ devices, microwave ovens in close proximity to this device may affect wireless communications with the Infusion pump and/or the operation of the Infusion pump. Special precautions need to be exercised regarding EMC. These include: • Maintaining a minimum separation distance of 2 ½ ft (¾ m) between the Infusion pump system and portable/mobile RF communications equipment

Introduction

19

Electromagnetic Safety Precautions

•

•

Do not expose the pump to therapeutic levels of ionizing radiation, as permanent damage to the pump’s electronic circuitry may occur. It is preferable to remove the pump from the patient during therapeutic radiation sessions. Do not use the pump in the vicinity of magnetic resonance imaging (MRI) equipment, as magnetic fields may adversely affect the operation of the pump. Remove the pump from the patient during MRI procedures, and keep it at a safe distance from magnetic energy.

Wireless Compatibility To promote safety, always adhere to the precautions listed below. Wireless Device Precautions

• • •

The wireless 802.11a/b/g/n device usage in the 5150-5250 MHz band is limited to indoor use to reduce potential for harmful interference to co-channel mobile satellite systems. In the 5250-5350 MHz and 5650-5850 MHz frequency bands, high power radars are allocated as primary users and these radars could cause interference and/or damage to LE-LAN devices. Operation is subject to the following two conditions: (1) the wireless device may not cause interference, and (2) Pump operation must not be affected by any transmitted interference from other devices.

Data Transfer and Integrity The SapphirePlus pump wireless system is capable of operating at a full bandwidth of 802.11 a/b/g/n. For network planning purposes, each pump transfers no more than 10 KB/min (kilobyte per minute). Data integrity is achieved in two levels: • By WiFi TCP/IP protocol • By the software of the pump

20

Sapphire Infusion Pump Service Manual

Wireless Quality of Service Quality of Service is primarily the responsibility of the network and the networking equipment. It may be achieved by improving several network aspects: • Use networking devices that support QoS infrastructure. • Use a dual-band access point so that if one of the bands is too crowded, the second band can be used. This is supported by the Sapphire WiFi module. • Use roaming to ensure that the WiFi device will be assigned to the access point where the radio signal received from the pump is the strongest one. The level of cyber security is the responsibility of the network administrator and based on the network configuration.

Proper Use of the Pump Although the Sapphire pump has been designed and manufactured to exacting specifications, it is not intended to replace trained personnel in the monitoring of infusions. Home users must be trained by their medical provider before using the Sapphire pump. Clinicians are advised to verify the proper route of delivery, and the patency of the infusion site.

Introduction

21