Eitan Sapphire Multi-Therapy User Manual

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Do you have a question about the Sapphire Multi-Therapy and is the answer not in the manual?

Questions and answers

Kate Gancarczyk

January 27, 2025

Hello, I **** having difficulties switching from continuous infusion to multi-step

1 comments:

Mr. Anderson

May 14, 2025

To switch from continuous infusion to multi-step on the Eitan Multi-Therapy device:

1. Change the delivery mode to Multi-step:
- From the Indicators Bar, verify or select Multi-step mode.

2. From the Start Up screen, select "New Infusion."

3. If a warning about air detection being off appears, ensure you are using a set with an air-eliminating filter, then press OK.

4. If the Dosing method screen appears, select the appropriate method.

This starts a new Multi-step infusion.

This answer is automatically generated

Summary of Contents for Eitan Sapphire Multi-Therapy

Page 2 Important Notice The Sapphire Infusion Pump User Manual is delivered subject to the conditions and restrictions listed in this section. Clinicians, qualified hospital staff, and home users should read the entire User Manual prior to operating the Sapphire pump in order to fully understand the functionality and operating procedures of the pump and its accessories.
Page 3 Disclaimer The information in this manual has been carefully examined and is believed to be reliable. No responsibility is assumed for any inadvertent inaccuracies. Q Core Medical Ltd. reserves the right to make changes to any of its products in order to improve reliability, design and performance.
Page 4 Technical Assistance For technical questions, troubleshooting assistance and reporting of unexpected events, please contact your local agent/distributor, and refer to page 290. You may also contact Q Core Medical Ltd. support via email to the following address: support@qcore.com...
Page 5: Table Of Contents
Contents ............10 NTRODUCTION Product Overview and Indications ............. 10 Dedicated Delivery Mode Configurations........11 Features ....................11 Terms and Abbreviations..............14 Document Conventions ..............16 Safety and Compliance Information........... 16 Symbols and Labeling ................17 Compliance and Classification ............20 Biocompatibility ..................21 Sterilization ..................21 Degree of Protection Against Ingress of Water and Dust ....21 Warnings and Safety Precautions ............
Page 6 External Battery Pack ................51 Multi-Pump Mounting System ............58 Administration Sets................63 ....68 UNDAMENTAL ONCEPTS AND PERATIONS Working with the Main Display ............68 Using the Keypad................68 Overview of Toolbar Function Keys...........70 Overview of Icons................71 Selecting Delivery Mode..............74 Enabling Special Features ..............76 Setting KVO rate .................80 .............82 ETTING...
Page 7 Multi-step Mode: Mid-infusion Actions.......... 130 Total Parenteral Nutrition (TPN) Mode ..........132 Infusion Parameters: TPN Mode ............. 133 Starting a TPN Infusion ..............134 Intermittent Mode ................139 Infusion Parameters: Intermittent Mode......... 140 Starting an Intermittent Infusion ............. 140 Intermittent Mode: Mid-infusion Actions ........147 Patient Controlled Analgesia (PCA) Mode ........
Page 8 Managing Configuration Settings ............ 200 Managing Alarm Settings..............200 Configuring Audio Settings .............203 Configuring General Settings ............204 Defining Regional Parameters ............208 Testing System Function..............210 View Menu ..................211 Using Special Mode Options ............218 PCA Options Menu................218 Epidural Mode Options Menu............219 ........220 SING DVANCED EATURES...
Page 9 ......244 LARMS AND ROUBLESHOOTING Alarms Overview................244 Level 1 Alarms ................. 245 Level 2 Alarms ................. 246 Level 3 Alarms ................. 247 Messages ..................249 Troubleshooting................251 ....... 256 AINTENANCE AND TORAGE Cleaning and Disinfecting the Pump ..........256 Cleaning and Disinfection Procedure ..........
Page 10 Electromagnetic Compatibility Statement ........281 Electromagnetic Emission ..............281 Electromagnetic Immunity ...............282 ..........288 IMITED ARRANTY Sapphire Infusion Pump User Manual...
Page 11: Introduction
Chapter 1: Introduction The following sections describe the functions and features of the Sapphire Infusion Pump, and provide a summary of safety and regulatory information: ................Product Overview and Indications ..................Terms and Abbreviations ..................Document Conventions ................. Safety and Compliance Information ................
Page 12: Dedicated Delivery Mode Configurations
Dedicated Delivery Mode Configurations To promote safety and convenience of use in different environments, the Sapphire Infusion Pump can be preconfigured to support only certain delivery modes. The different types of configurations available on various pump types, are described in the following table.
Page 13 • Delayed Infusion: Allows users to program an infusion in advance, and set it to Standby for an unlimited time period, or to set it for a defined Delayed Period. • Repeat Last Infusion: Automatically saves the parameters of the last infusion, and allows a quick-start infusion using these parameters.
Page 14 the parameters already entered by the user, or by the limits defined in the Drug Library, if one is installed on the pump. • Easy alarm troubleshooting: Alarm screens display specific instructions about how to manage the alarm or resolve the problem. •...
Page 15: Terms And Abbreviations
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 Accum. Accumulated Clinical Care Area Directions for Use External Battery Pack Electrocardiogram Electromagnetic compatibility Electromagnetic interference Epi.
Page 16 Term/Abbreviation Meaning nanog Nanograms Occ. Occlusion Pressure Activated Valve Personal Computer Patient Controlled Analgesia PCEA Patient Controlled Epidural Analgesia PIEB Programmed Intermittent Epidural Bolus Prim. Primary Sec. Secondary Total Parenteral Nutrition Volume Infused VTBI Volume To Be Infused Q Core Q Core Medical Ltd.
Page 17: Document Conventions
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 or to the quality of treatment.
Page 18: Symbols And Labeling
Symbols and Labeling The following table describes the labels and symbols that appear on the Sapphire pumps and their components, and identifies their locations on the equipment. Symbol Description Location Back of the pump casing and Serial number. on the back of the mini cradle.
Page 19 Symbol Description Location EBP, on the back of the mini Consult instructions for use. cradle, and PCA Lockbox 500mL. Back of the pump casing, Follow instructions for use. PCA Lockbox 250mL, and Mounting System. The C and US indicators adjacent to the Back of the pump casing and CSA mark signify that the product has Mounting System.
Page 20 Symbol Description Location IPX2 Waterproof rating. EBP. Rx Only US federal law restricts this device to Back of the pump casing, on prescription only. the back of the mini cradle, PCA Lockboxes 100, 250, and 500mL. Waste Electrical and Electronic Equipment (WEEE) Disposal.
Page 21: Compliance And Classification
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.
Page 22: Biocompatibility
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.
Page 23: Warnings And Safety Precautions
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: • on page General Warnings and Precautions • on page Proper Use of the Pump Safety information specific to particular pump functions appears in the relevant sections of this manual.
Page 24 Waste Disposal Take care 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 •...
Page 25 • 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.
Page 26 the device, connect the device to different outlet or decrease emitting device output power (to 30 dBm). • 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.
Page 27: Proper Use Of The Pump
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.
Page 28 • Use only Q Core supplied accessories and cables. The use of accessories and cables other than those specified in this manual, with the exception of cables sold by Q Core Medical Ltd. as replacement parts for internal components, may result in increased emissions or decreased immunity of the pump.
Page 29 For infection control purposes, consider the set change interval recommended by the local Centers for Disease Control and Prevention (CDC), your facility guidelines, and the instructions provided with the administration set. Administration Sets: Safety Precautions • Do not use a damaged administration set or damaged set components or packaging.
Page 30 Basic Infusion Safety Information To obtain maximum accuracy of the pump when used in a hospital or clinical environment, verify that the infusion container is positioned at a height of 50 cm above the pump. There is no restriction on the location of the infusion container in relation to the patient’s heart.
Page 31 • Secondary Infusions: When using the Piggyback infusion feature, verify that: • The medication/solution in the Secondary infusion container is compatible with the medication/solution in the Primary infusion container. • The Secondary administration set is connected to the appropriate injection site on the primary administration set (above the administration cassette).
Page 32 • When using the Clinician Bolus function, pay close attention to the current treatment parameters, as well as to the amount of additional dosage being administered. • Do not allow the patient to access the Clinician Bolus function. Do not reveal the Clinician code to the patient.
Page 33: Administration Sets
Chapter 2: Components, Accessories, and Administration Sets The following sections present a high level overview of the Sapphire pump components and accessories: ....................Unpacking the Pump ..............Hardware and Software Components ..................Using Pump Accessories Unpacking the Pump When unpacking the Sapphire pump, inspect each item to ensure that it is undamaged. The following items should be included: •...
Page 34: Hardware And Software Components
Hardware and Software Components The pump includes both hardware (control unit) and software (touch screen) components. Hardware components are shown in the figure below. The parts of the control unit are listed and described in the table following the figure. Hardware Components Figure 2.1.
Page 35: Touch Screen
Number Component Description/Notes Power socket Enables you to charge the battery using the power adaptor, connect a communication cable or a bolus handle. Battery Houses the battery. (Located on the back of the pump.) compartment Touch Screen The touch screen is used to configure and operate the pump. The main areas of the screen are listed and described in the table following the figure.
Page 36 Number Component Description/Notes Indicators Bar Displays the following essential status information: • CCA name (appears above Screen title, across all screens when Drug Library is loaded). • Soft Limit icon (appears above Battery status icon, when Drug Library is loaded and current infusion exceeds soft limit range).
Page 37: Using Pump Accessories
Using Pump Accessories This section explains how to set up the following pump accessories: ......................Mini Cradle ...................... PCA Lockboxes ................. PCA/PCEA/PIEB Bolus Handle ......................Power Supply ..................... External Battery Pack ................Multi-Pump Mounting System ....................Administration Sets Mini Cradle The small, easy to use bedside mini cradle offers flexible positioning of the pump at any angle or height.
Page 38 Mini cradle Figure 2.3. Number Component Name Description/Notes Pump hook Located on the pump holder. Press the hook to release the pump from the mini cradle. Mini cradle knob Located on the base of the mini cradle. Twist the knob to connect or release the mini cradle from an IV pole.
Page 39 Figure 2.4. Mini-Cradle with Integrated Power Supply Number Component Description/Notes Integrated Power Located on the base of the mini cradle. Used for Supply (optional) power-supply connection. Cord retainer Located at the bottom of the integrated power supply. It holds the AC power cord in the IPS power socket. AC Power Cord Medical Grade AC Power Cord that connected the IPS to the wall socket.
Page 40 The following steps explain the workflow of attaching the mini cradle to the IV pole, attaching and releasing the pump, and releasing the mini cradle from the pole: Attach the mini cradle to the IV pole by tightening the mini cradle knob on the right side (Figure 2.3, #2).
Page 41: Pca Lockboxes
PCA Lockboxes PCA Lockboxes are designed to secure the IV bag, primarily for treatments involving narcotics or opioids, without interrupting the treatment workflow. PCA Lockbox 500mL This Lockbox can accommodate IV bags of up to 500 mL. PCA Lockbox 500mL and Mini cradle Figure 2.6.
Page 42 PCA Lockbox 500mL: Workflow Figure 2.7. Attach the pump to the mini cradle (Figure 2.7, #3). Hang the IV bag with the medication (Figure 2.7, #4) inside the PCA Lockbox. Clamp the administration set, spike the bag, and attach the administration set to the pump.
Page 43 PCA Lockbox 100mL This Lockbox can accommodate IV bags of up to 100 mL. PCA Lockbox 100mL Figure 2.8. The following steps explain the workflow of using the PCA Lockbox 100mL: Using the key supplied with the Lockbox (Figure 2.8, #1), open the box and remove the plastic cover.
Page 44 Lockbox 100mL: Workflow Figure 2.9. Connect the administration set to the pump. Close the box by sliding back the plastic cover (Figure 2.9, #3). Place the pump on the plastic cover (Figure 2.9, # ), and secure it by locking the box with the supplied key (Figure 2.9, #5).
Page 45: Pca Lockbox 250Ml
PCA Lockbox 250mL This Lockbox can accommodate IV bags of up to 250 mL. • The Lockbox is used in an upright position only; it may be attached to an IV pole, carried by the carry handle, or carried by the shoulder strap.
Page 46 Attaching the Lockbox to the Mini Cradle Figure 2.10. Unlock the Lockbox, and open the door. To lock and unlock the Lockbox the key must be first pressed inwards before turned. Insert the pump onto the bottom hooks of the Lockbox, and then click it into the top hook.
Page 47 Placing the IV Bag and Set Inside the Lockbox Figure 2.11. Attach the administration cassette to the pump. Insert the set tubing between the IV bag and the pump into the organizer (Figure 2.11, #1). Make sure this segment of the set does not contain any additional components.
Page 48 Removing the Lockbox from the IV pole: Unlock the Lockbox using the supplied key. Then, open the door. To release the Lockbox, press the top hook of the mini cradle. Secure the pump by holding it in the Lockbox while releasing the Lockbox from the mini cradle. Lock the Lockbox using the supplied key.
Page 49: Pca/Pcea/Pieb Bolus Handle
PCA/PCEA/PIEB Bolus Handle The remote bolus handle enables patients to deliver boluses on demand (under clinician's programmed limits). The bolus is requested by pressing the button on the handle, eliminating the need for patient interaction with the function keys on the pump.
Page 50: Power Supply
Power Supply The pump power supply is used to charge the battery. Specifications of the power supply include: • Input voltage: 100-240 VAC • Output voltage: 10 VDC To prevent entanglement, always secure the cable cord properly. Always detach the Sapphire pump from the EBP, before connecting it to the power supply.
Page 51 • Output voltage: 10 VDC > To c o nnec t t he A C Po wer C o rd t o t he I P S: Connect the Q Core AC Power Cord to the IPS. Connect the Cord Retainer to the IPS, using a Philips head screwdriver. The cord retainer is an integral part of the IPS, and must be connected prior to initial use.
Page 52: External Battery Pack
External Battery Pack The EBP extends the pump's operation time with no need for additional charging. Warning EBP: • Do not use the EBP if it is difficult to insert AA batteries or to attach it to the pump. • Do not use the EBP if the black O-Ring is missing or not attached all around the AA batteries compartment lid.
Page 53 General information • The duration of operation time provided by the EBP, varies according to the pump's Internal Battery power status, infusion rate, backlight settings and AA batteries power status. Operation time of the pump with the EBP is presented in the following table: Operation time duration (with fresh AA batteries of the Pump Settings...
Page 54 Getting Ready to Use the EBP The EBP requires six 1.5 V AA batteries (not included in package). The EBP Components Figure 2.14. Number Component Small hooks Large hook Latch Suspension hooks EBP LED Inserting AA Batteries into the EBP >...
Page 55 Opening EBP Lid Figure 2.15. Place the batteries in their slots by pressing the flat end (negative pole) of each battery to the flat metal plates (marked with "-"), and then fix the other end (positive pole) in place (marked with "+"). After all six batteries are in place, insert the protrusion at the bottom of the lid (Figure 2.16, #A1) to its slot in the EBP, and press the latch...
Page 56 Strapping the EBP If the pump needs to be hung, thread the strap supplied with the EBP through the suspension hooks (Figure 2.14, #4). > To s t r ap t he EBP: Thread the strap before attaching the Pump to the EBP. Place the EBP with the cover facing down.
Page 57 Attaching the Pump to the EBP > To at t ac h t he p ump to the EB P: Insert the bottom of the pump onto the two small hooks (Figure 2.14, #1) at the bottom of the EBP, and then push it to click into the large hook (Figure 2.14, #2) at the top of the EBP.
Page 58 AA batteries may deplete when pump is turned off and still attached to the EBP. If stable power supply is available, make sure to detach the Pump from the EBP before connecting the pump to a power supply. EBP storage It is recommended to remove the AA batteries from the EBP when not in use.
Page 59: Multi-Pump Mounting System
Multi-Pump Mounting System The Mounting System is designed to facilitate the use of multiple pumps while saving valuable bed-side space and providing power consolidation. The Mounting System is designed to accommodate three mini cradles, and charge three pumps via a single power outlet, all attached to an IV pole via a single clamp.
Page 60 • Use only Q Core approved AC input cord and power supply with the Mounting System. • To avoid entanglement of lines and cords, do not mount more than 4 Mounting Systems on a single IV pole. It is recommended to use additional IV bag hooks (not supplied by Q Core) when mounting more than two Mounting System on a single IV pole.
Page 61 To prevent detaching from the IV pole, the Mounting System can be locked to the pole by removing the knob cap or knob key from the clamp knob. > To at t ac h a m ini c ra dle to the Mo u nt i ng Sy s te m : Rotate the mini cradle to a vertical position with the mini cradle knob pointing downward and the top hook pointing upward.
Page 62 Placing Mini Cradle on Mounting System Figure 2.20. Plug a DC output connector to the mini cradle splitter. Fasten the DC output cables to the clips located on the bottom of the Mounting System. Plug the AC input cord to the power outlet. Verify that the Mounting System power supply LED is ON.
Page 63 > To tr a ns p o rt t he Mo unting Sy ste m, d et a c h it f ro m the I V p o l e: Unplug the AC input cord from the power outlet. Firmly hold the Mounting System and rotate the clamp knob counter-clockwise, until the Mounting System is loose.
Page 64: Administration Sets
Administration Sets The Sapphire pump should be used with a Q Core approved administration set, which includes the Q Core administration cassette.Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as manufacturer’s website, catalog or any other formally published document.
Page 65 Q Core Administration Cassette and AFFV Figure 2.22. Only administration sets that include a roller clamp and do not include pressure activated valves (PAV) can be used by gravity. For more information, refer to the Directions for Use of each set. For more information about priming the administration set and inserting it into the pump, refer to on page...
Page 66 Q Core Approved Administration Sets This section provides a list of administration sets approved by Q Core Medical Ltd. to be used with the Sapphire pump. Use Q Core standard administration sets listed here or in Q Core's approved list of products: http://www.qcore.com/ Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well.
Page 67 Name of Set Part Number 12005-000-0003 AP409-01 Primary infusion set with vented/non-vented drip chamber, back check valve and 2 needleless y-site 12003-000-0014 AP414-01 Microbore with non-vented spike, female luer lock with a back check valve 12003-000-0012 AP416-01 Microbore with 2 female luer locks and a back check valve All filters used in Q Core approved administration sets are air eliminating filters.
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Page 69: Fundamental Concepts And Operations
Chapter 3: Fundamental Concepts and Operations The following sections explain the structure and function of the Main Display and the toolbar, provide an overview of the delivery modes, and describe special features that can be enabled and disabled, according to user requirements: ................
Page 70 The acceptable range of a given parameter is displayed in the upper right corner of the Main Display. When you enter a value that is outside of a permitted range, the range values stay red, and the OK function key is disabled. The values of a range are dynamic, and change according to other parameters that have already been programmed.
Page 71: Overview Of Toolbar Function Keys
Overview of Toolbar Function Keys The function keys are located in the toolbar, and enable user actions. The function keys that appear vary according to the screen or program that is currently selected. Function keys enabling basic actions are described in the following table. Name of Key Action Notes...
Page 72: Overview Of Icons
Name of Key Action Notes Request Pause/ Pauses an infusion or a bolus For more information, refer to Pausing Pause Bolus on page 192. Infusions Request Continue/ Resumes a paused infusion Continue Bolus or a bolus View/Edit Displays a list of infusion parameters to be viewed or edited Bolus...
Page 73 Icon Meaning Notes Time remaining until the end of the infusion. Indicates that an infusion is currently running. For more information, refer to Indicates status of battery charge. Battery Care Information page 264. Indicates that the current infusion is For more information, refer to Soft above the upper soft limit range in at on page 241.
Page 74 Icon Meaning Notes Updating data. May appear when transitioning between lines. Pump connected to PC. Indicates that the pump is connected to the PC. Air detection is disabled (OFF) No Air in Line alarm is triggered when the pump air detection is disabled (OFF).
Page 75: Selecting Delivery Mode
Selecting Delivery Mode The Sapphire pump is a multi-platform device that has the ability to operate in several different delivery modes. The delivery modes availability can be set by a technician Possible delivery modes include: Mode Description/Notes Continuous Delivers an infusion at a constant, programmed rate. This mode includes the option to add a Secondary (Piggyback) line.
Page 76 Each delivery mode features its own unique options. The current mode is displayed at the right side of the Indicators Bar on some of the screens. On screens that are not mode related, such as Delivery mode selections screen below, the name "Sapphire" is displayed instead.
Page 77: Enabling Special Features
Enabling Special Features Depending on the needs of a specific clinical care area or institution, the Sapphire pump can be enabled to perform special functions. An authorization code is required to enable/disable these functions. Local configuration made after the Drug Library is loaded, will be valid until the user selects a CCA or turns the pump Off.
Page 78 Delivery Feature Mode(s) Description/Notes Repeat last Allows the users to start infusions using the same infusion infusion parameters for the same patient. When this option is enabled, the Repeat Last Infusion button appears on the pump Start Up screen. For more information, refer to Repeating Last Infusion page 188.
Page 79 Delivery Feature Mode(s) Description/Notes Bolus Reminder Enables a reminder for the user to connect the bolus Epidural handle before starting a PCA, or PCEA or PIEB infusion (PCEA and that includes patient boluses. The reminder (i) instructs Epidural to connect the bolus handle directly to the pump (ii) intermittent) Checks functionality –...
Page 80 Delivery Feature Mode(s) Description/Notes Set Secondary Continuous Allows users to program a Secondary infusion. (Piggyback) For more information about programming a Secondary infusion, refer to on page 115. Adding a Secondary Line Allow Bolus Continuous Allows users to program a bolus during a Continuous infusion.
Page 81: Setting Kvo Rate
Setting KVO rate Allows users to set the default rate of fluid that is delivered when the infusion program is completed. The permitted range for the KVO rate parameter is 0-20 mL/h (for all delivery modes). Fundamental Concepts and Operations...
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Page 83: Getting Started
Chapter 4: Getting Started The following sections explain the sequence of actions necessary to prepare the pump and the administration set for an infusion: ....................Typical Workflow ........Connecting the Infusion Container to the Administration Set ..................Opening the Safety Door ..............
Page 84 The workflow sequence is illustrated in the following figure: Recommended Workflow Figure 4.1. Sapphire Infusion Pump User Manual...
Page 85: Turning The Pump On
Turning the Pump On The pump is turned On by pressing the On/Off hard key, at the lower right corner of the pump. When a Drug Library is loaded, a message is displayed asking to accept or change the current CCA. For more information about CCA, refer to Clinical Care Area (CCA) page 235.
Page 86: Connecting The Infusion Container To The Administration Set
The pump enables resuming an infusion after pump shut down. For more information, refer to on page 191. Resuming Infusions After Pump Shutdown Connecting the Infusion Container to the Administration Set This section explains how to connect the infusion container to the administration set. Before setting up the infusion, verify that the container, administration set and administration set package are undamaged.
Page 87: Opening The Safety Door
Opening the Safety Door Opening the safety door involves pressing it down while simultaneously pulling the safety door open. > To o pe n t he sa f ety do o r : Using your thumb, press the door outwards. While maintaining pressure, swing the safety door outwards.
Page 88: Inserting The Administration Cassette
Inserting the Administration Cassette Inserting the administration cassette into the pump involves positioning the cassette in the proper direction, and ensuring that all portions of the cassette including the flange, are secured inside the administration cassette’s housing. In 4.2, the flange is Figure represented by #2, and the saddle is represented by #1.
Page 89 Insertion of Cassette Figure 4.3. Clip the upper end of the administration cassette into the metal lock (Figure 4.3, #4). Close the safety door over the administration cassette. Ensure that the safety door clicks upon closure. Getting Started...
Page 90: Removing The Administration Cassette
Removing the Administration Cassette When the infusion is complete, close the clamps, disconnect the administration set from the patient, and disconnect the administration cassette. In case of emergency, you can stop pump operation by opening the safety door, closing the clamps, removing the administration cassette from the pump and disconnecting the administration set from the patient.
Page 91: Automatic Priming Using The Pump
Automatic Priming Using the Pump Before commencing infusion setup, the administration set needs to be primed. Priming expels all the air from the administration set, and fills it with the infusion liquid. A fully primed administration set is a set filled with infusion liquid (from which all the air was removed).
Page 92 > To p r im e t he a dm in ist ra tio n using t he p u m p : Position the pump in an upright position using one of the following methods: • Attach the pump to the cradle base. •...
Page 93: Priming Manually
Priming Manually The Q Core administration set can also be used as a gravity set, and the Anti-Free-Flow Valve (AFFV) can be used manually. Before commencing infusion setup, the administration set needs to be primed. Priming expels all the air from the administration set, and fills it with the infusion liquid. A fully primed set is a set filled with infusion liquid (from which all the air was removed).
Page 94 Opening and Closing the AFFV Figure 4.4. Closed AFFV Opened AFFV Closed AFFV Although the AFFV offers automatic free flow protection, a small amount of fluid (up to 0.12 mL) may be expelled when the administration cassette is attached. In order to ensure full protection, insert the administration cassette to the pump housing before connecting the set to the patient.
Page 95: Using The Delivery Modes
Chapter 5: Using the Delivery Modes The following sections explain how to operate the pump in the different delivery modes. After setting up the pump and the infusion, always check the battery 4status to ensure it is sufficient for the desired infusion program....................
Page 96 The Sapphire pump can also be configured to support Secondary (Piggyback) infusions. The Secondary option is used when two medications are administered from two different bags; The user may either alternate between the bags or administer them sequentially. To use the Secondary option, the option must be enabled (requires Technician authorization code).
Page 97 When the Secondary option is enabled, you can set Secondary infusion parameters: • Immediately after programming the Primary infusion (Starting a Continuous Infusion on page 103). Using the Secondary Function • While a Primary infusion is already running (Adding a Secondary Line on page 115).
Page 98: Infusion Parameters: Continuous Mode
Infusion Parameters: Continuous Mode The following infusion parameters are relevant for a Continuous infusion. When programming the infusion, it is necessary to specify two of the parameters. The third parameter is then automatically calculated by the pump. Parameter Description/Notes Rate The speed at which the fluid is infused.
Page 99 From the Start Up screen, select New Infusion. If a warning that the air detection is disabled (OFF) appears, ensure that a set with an air-eliminating filter is used, and press OK. If the Dosing method screen appears, select the appropriate option: •...
Page 100 • Time: Using the keypad, enter the value  OK. The third (unprogrammed) parameter is then automatically calculated by the pump and displayed in the relevant box. If the calculated rate is beyond the pump resolution (0.1 mL/h increments), the pump decreases the rate by 0.1 mL/h during the infusion to achieve accurate delivery of the volume in the specified time.
Page 101 • Rate: Current infusion rate. For all dose units other than mL/h, the calculated rate will be displayed in mL/h, both in the View system menu and in the Running screen. • VTBI: Total volume left to be infused during the current infusion. As the infusion progresses, this value decreases.
Page 102 • When the required drug is not found in the Drug Library, press Choose General key on the toolbar: 'Choose General' will bypass specific drug limits, and the infusion will be programmed without Drug Library limits. From the Attention screen, confirm choosing General, and press OK. Proceed to Step on page 98 (To begin a new Continuous infusion without Drug...
Page 103 • Full concentration: Proceed to Step on page 98 (To begin a new Continuous infusion without Drug Library), and continue programming from there. If a list of available drug profiles does not appear, continue to Step on page 98 (To Library), and continue programming from begin a new Continuous infusion without Drug there.
Page 104 Starting a Continuous Infusion Using the Secondary Function The following procedure explains how to program a Continuous infusion using both Primary and Secondary lines. > To b eg i n a new Co ntinuo us inf us io n u si n g t h e S e c o nd a ry o pti o n w ith o u t D ru g L ib r a ry : Verify that the pump is in Continuous mode, and then enter parameters for the Primary infusion (Step...
Page 105 According to pump configuration one of the following screens will appear: • Concentration: From the Concentration screen, using the keypad, enter the Concentration  OK. Then, continue to Step 8. • Drug amount: Using the keypad, enter the Drug Amount  OK. Then, using the keypad, enter the Diluent Volume ...
Page 106 From the Start screen, select one of the following: • Start secondary: The Attention screen appears. After verifying that the clamps on the Secondary administration set are open, press OK. The Secondary screen appears, and the Secondary infusion begins. When the Secondary infusion is complete, the pump automatically continues with the Primary infusion.
Page 107 • Time left: Time remaining until the end of the current infusion. You can switch between the two infusions at any time. For more information, refer to Switching between Primary and Secondary on page 119. Infusions To view all programmed parameters of the current infusion, including the rate in mL/h, from the Running screen, press View/ Edit ...
Page 108 • Using the keypad, enter the drug name, then press Find and proceed to Step 5. Find key can be used to display all available drugs without entering any characters (letters, numbers or symbols), or filter drug names according to the characters entered. •...
Page 109 From the Attention screen, confirm the concentration and press OK. Proceed to Step on page 104 (To begin a new Continuous infusion using the Library), and continue programming from there. Secondary option without Drug • Full concentration: Proceed to Step on page 104 (To begin a new Continuous infusion using the Library), and continue programming from there.
Page 110: Continuous Mode: Mid-Infusion Actions
Continuous Mode: Mid-infusion Actions The following actions can be performed during Continuous infusions: ................Updating Infusion Parameters ..................Administering a Bolus ..................Adding a Secondary Line ..........Switching between Primary and Secondary Infusions ..............Replacing the Current Secondary Line ....................Pausing Infusions ....................
Page 111 • Clear Accum. VI: Resets the total volume infused via all infusions associated with the current patient to 0 mL. For more information, refer to Clearing on page 233. Accumulated VI • View system: Displays various system and pump parameters. (Refer to View on page 211.) Menu...
Page 112 According to configuration, one of the following screens will appear: • Edit: • Amnt (Bolus): Using the keypad, enter the Bolus Amount  OK (the acceptable range varies, according to the current VTBI). Trying to enter one of the unavailable (grayed out) boxes, triggers a message requesting to enter the Bolus amount first.
Page 113 Review the parameters displayed on the Confirm screen. Verify that the parameters reflect the correct treatment according to the prescription. Then, press OK. To start the bolus, from the Attention screen, press OK. The Bolus delivery screen is displayed, and the bolus begins. Throughout the bolus, the following information is displayed on the screen: •...
Page 114 Mid-bolus Actions The following actions can be performed during bolus delivery: ..............Updating Bolus Infusion Parameters ....................Pausing a Bolus ....................Aborting a Bolus Updating Bolus Infusion Parameters Bolus infusion parameters are updated directly from the Bolus delivery screen. > To up d a t e pa r am ete rs f ro m t he B o l us d e l i ve ry sc ree n: On the Main Display, select the relevant frame (Bolus Rate, Bolus VTBI or Time Left).
Page 115 Aborting a Bolus The following procedures involve pausing and then permanently quitting the bolus, with the option to quit the entire infusion. > To ab o r t a bo lus a nd q uit a ll infu si o n s: Press the Stop hard key.
Page 116 Adding a Secondary Line The following procedure explains how to add a Secondary line while a Primary infusion is already running. If you have already programmed the Secondary infusion, and want to start it, refer to Switching between Primary and Secondary on page 119.
Page 117 If the Patient Weight screen appears, specify whether the infusion is weight based: • Yes: Continue to Step 8. • No: Continue to Step 9. From the Patient Weight screen: If the patient weight was entered during the primary line programming, continue to Step 9.
Page 118 From the Start screen, select one of the following: • Start secondary: The Attention screen appears. After verifying that the clamps on the Secondary administration set are open, press OK. The Secondary screen appears, and the Secondary infusion begins. When the Secondary infusion is complete, the pump automatically continues with the Primary infusion.
Page 119 From the Drug List screen, select the row of the relevant drug. To display additional drugs press Next If a list of available drug profiles appears, select the appropriate drug profile and proceed according to the step directed to: • No concentration: proceed to Step on page 116 (To add a Secondary line while...
Page 120 Switching between Primary and Secondary Infusions Switching between infusions involves pausing the infusion that is currently running, and then starting or continuing the other infusion. > To s w i t c h f rom th e Pr ima r y to th e S ec o n d a r y i n fu si o n: Pause the Primary infusion: From the toolbar of the Primary screen, press Request Pause.
Page 121 Replacing the Current Secondary Line During a running secondary infusion, the secondary line can be replaced by using one of the following methods: ....Deleting the Current Secondary Line and Moving to the Primary Infusion ......Replacing the Current Secondary Line with a New Secondary Line Deleting the Current Secondary Line and Moving to the Primary Infusion The following procedure explains how to delete the running secondary line and move to the primary infusion.
Page 122 Replacing the Current Secondary Line with a New Secondary Line The following procedure explains how to replace the current secondary line with a different secondary infusion. Before programming a Secondary infusion, verify that the administration set you are using is appropriate for Secondary (Piggyback) infusions.
Page 123 > To re p la c e t he r unning sec o nd ar y l i n e wi t h a d i ffere nt sec o n da ry l i ne w i th D ru g L i b r a r y: Pause the Secondary infusion: From the toolbar of the Secondary screen, press Request Pause.
Page 124: Multi-Step Mode
Multi-step Mode The following sections will be reviewed: ..............Infusion Parameters: Multi-step Mode ................Starting a Multi-step Infusion ..............Multi-step Mode: Mid-infusion Actions This mode allows the pump to deliver a series of up to 25 consecutive infusion Steps from the same infusion container. Each Step is delivered as a Continuous infusion, at its own pre-programmed parameters.
Page 125: Infusion Parameters: Multi-Step Mode
Infusion Parameters: Multi-step Mode When programming a Multi-step infusion, the number of Steps must be specified. Infusion parameters relevant to each Step are listed in the following table. During programming, it is necessary to specify two of the three parameters. The remaining parameter is then automatically calculated by the pump.
Page 126 If a warning that the air detection is disabled (OFF) appears, ensure that a set with an air-eliminating filter is used, and press OK. If the Dosing method screen appears, select the appropriate option: • mL: Continue to Step 8. •...
Page 127 • VTBI 1: Using the keypad, enter the value  OK. • Time 1: Using the keypad, enter the value  OK. The unprogrammed parameter is then automatically calculated by the pump, and displayed in the relevant box. After reviewing the infusion parameters for the current Step (as displayed on the Indicators Bar), press OK to proceed and program the next Step.
Page 128 • Drug Concentration: Drug concentration as entered by the user (Final concentration or Drug Amount / Diluent Volume). Displayed when applicable. • Rate: Current infusion rate. For all dose units other than mL/h, the calculated rate will be displayed in mL/h, both in the View System menu and in the Running screen.
Page 129 From the Drug Name screen: • Using the keypad, enter the drug name, then press Find and proceed to Step 5. Find key can be used to display all available drugs when not entering any characters (letters, numbers or symbols), or filter drug names according to the characters entered.
Page 130 From the Attention screen, confirm the concentration and press OK. Proceed to Step on page 125 (To begin a new Multi-step infusion without Drug Library), and continue programming from there. • Full concentration: Proceed to Step on page 125 (To begin a new Multi-step infusion without Drug Library), and continue programming from there.
Page 131: Multi-Step Mode: Mid-Infusion Actions
Multi-step Mode: Mid-infusion Actions The following actions can be performed during Multi-step infusions: ..................Updating Step Parameters ....................Pausing Infusions ....................Aborting Infusions ....................Locking the Screen ..................Activating Patient Lockout Updating Step Parameters Infusion parameters for the current Step can be modified directly from the Running screen.
Page 132 > To up d a t e pa r am eters o f the c ur re nt o r ne xt Ste p usi n g the V i ew /Ed i t f un c- ti o n key : From the toolbar, press View/Edit.
Page 133: Total Parenteral Nutrition (Tpn) Mode
Total Parenteral Nutrition (TPN) Mode The following sections will be reviewed: ................Infusion Parameters: TPN Mode ..................Starting a TPN Infusion ................TPN Mode: Mid-infusion Actions Total Parenteral Nutrition, also known as Parenteral Nutrition or hyperalimentation, is used for patients who are unable to obtain adequate nutrients by oral or enteral routes. TPN solutions supply basic nutrients, including fluids, proteins, carbohydrates, electrolytes, fatty acids, vitamins, minerals, and trace elements directly to the patient's blood stream, bypassing the GI tract.
Page 134: Infusion Parameters: Tpn Mode
Infusion Parameters: TPN Mode The infusion parameters that need to be set for a TPN infusion are listed in the following table. Based on the values that are programmed, the pump automatically calculates the rate (and the gradual increase and decrease) necessary to deliver the infusion.
Page 135: Starting A Tpn Infusion
• Prior to administration, verify the identity of the patient by using at least two identifiers, as well as the parenteral nutrition container label. • The Air in Line detector working range when delivering fatty acids is 2%-20% lipids. Starting a TPN Infusion The following procedure explains how to program the pump to start a new TPN infusion.
Page 136 Using the keypad, enter the infusion period  OK. Review the parameters displayed on the Confirm screen. Verify that the parameters reflect the correct treatment according to the prescription. Then, press OK. To begin the infusion, make sure that the clamps on the administration set are open;...
Page 137 TPN Mode: Mid-infusion Actions The following actions can be performed during TPN infusions: ....................Pausing Infusions ..................Immediate Taper Down ....................Aborting Infusions ....................Locking the Screen ..................Activating Patient Lockout In TPN mode, infusion parameters cannot be updated using the View/Edit function key.
Page 138 > To p a us e a n infusio n d uring the p l a t ea u r a t e us i n g the Ta p er D o wn f un c ti o n k e y: From the toolbar, press Taper Down.
Page 139 Immediate Taper Down Immediate Taper Down can be used to end the infusion prematurely, utilizing taper down, to slow the infusion rate gradually before stopping. The option is available during the infusion's plateau period, provided there are more than 10 minutes before the infusion is complete.
Page 140: Intermittent Mode
Intermittent Mode The following sections will be reviewed: ..............Infusion Parameters: Intermittent Mode ................Starting an Intermittent Infusion ............... Intermittent Mode: Mid-infusion Actions This mode enables you to program a dose time and volume infusion to be repeated at regular intervals or cycles. The Dose Interval is the time frequency at which the dose is delivered.
Page 141: Infusion Parameters: Intermittent Mode
Infusion Parameters: Intermittent Mode The following infusion parameters need to be set for an Intermittent infusion: Parameter Description/Notes VTBI The total amount of fluid to be infused. The remaining VTBI is displayed on the screen as the infusion progresses. VTBI values can range from 0.1 to 9999 mL.
Page 142 > To b eg i n a new In ter mit tent infu s io n w i t ho u t Dru g L i b ra ry: From the Indicators Bar, verify that the pump is in Intermittent mode. For more information about changing delivery modes, refer to on page 74.
Page 143 From the Patient Weight screen, using the keypad, enter the patient weight  From the Dose Rate units screen, select the appropriate dose rate units. Using the keypad, enter the VTBI value  OK. Using the keypad, enter the Intermittent Dose  OK. Using the keypad, enter the Dose Time ...
Page 144 • VI / Total: Total volume delivered in the current infusion (including KVO if applied during a delayed start period) / the total VTBI value programmed. As the infusion progresses, the VI increases, and the Total remains constant. • Time to Dose: Time remaining before the next dose starts (until the end of the current interval;...
Page 145 • Pause During KVO The pump can be switched off or paused between intermittent doses without impacting the dose schedule. The time to dose will be displayed, and the pump will also alert when dose schedule is due and infusion not started, reminding when to resume the infusion.
Page 146 > To b eg i n a new In ter mit tent infu s io n w i t h a D ru g Li b ra ry: From the Indicators Bar, verify that the pump is in Intermittent mode. For more information about changing delivery modes, refer to on page 74.
Page 147 If a list of available drug profiles appears, select the Appropriate drug profile and proceed according to the step directed to: • No concentration: proceed to Step on page 141 (To begin a new Intermittent Library), and continue programming from there. infusion without Drug •...
Page 148: Intermittent Mode: Mid-Infusion Actions
Intermittent Mode: Mid-infusion Actions The following actions can be performed during Intermittent infusions: ................Updating Infusion Parameters ....................Pausing Infusions ....................Aborting Infusions ....................Locking the Screen ..................Activating Patient Lockout Updating Infusion Parameters Infusion parameters can be modified by using the View/Edit function key. In addition, the VTBI for the current phase (Intermittent Dose or KVO) can be modified directly from the Main Display.
Page 149 To update additional parameters, repeat Steps 2-3. In addition to parameter changes, the following actions are also available: • Clear Accum. VI: Resets the total volume infused for all infusions associated with a patient to 0 mL. • View system: Displays various system and pump parameters. (Refer to View on page 211.) Menu...
Page 150: Patient Controlled Analgesia (Pca) Mode
Patient Controlled Analgesia (PCA) Mode The following sections will be reviewed: ................Infusion Parameters: PCA Mode ..................Starting a PCA Infusion ................PCA Mode: Mid-infusion Actions The Patient Controlled Analgesia (PCA) mode allows the pump to deliver medication at a continuous rate (optional) and limited boluses activated by the patient (via screen key or bolus handle).
Page 151: Infusion Parameters: Pca Mode
Infusion Parameters: PCA Mode The following infusion parameters need to be set for a PCA infusion: Parameter Description/Notes Continuous Rate The rate of the basal infusion. Continuous Rate values can range from 0.1 to 99.9 mL/h, or be equal to zero (Bolus Only infusion). VTBI The total amount of fluid to be infused.
Page 152: Starting A Pca Infusion
Parameter Description/Notes Boluses per 1h (or 4hrs) The maximum number of boluses OR the maximum dose that can be delivered during a 1 hour (or 4 hours) period. (A user with high Total dose per 1h (or 4 authorization codes can set the 1 hour or 4 hours parameters). The hrs) Total dose limit takes into account medication delivered via: Continuous rate...
Page 153 If a warning that the air detection is disabled (OFF) appears, ensure that a set with an air-eliminating filter is used, and press OK. If the Dosing method screen appears, select the appropriate option: • mL: Continue to Step 8. •...
Page 154 From the Dose Limit Type screen, specify whether the boluses available for the patient should be limited: • Yes: Continue to Step 16. • No: Continue to Step 17. Choosing on the Dose limit screen will set patient boluses to the maximum allowed, according to the other parameters defined for the infusion, including Lockout Time and Demand Bolus.
Page 155 Throughout the infusion, the infusion phase (Loading Dose, Running, Bolus Delivery, or Clinician Bolus) is displayed on the Indicators Bar. In addition, the following information appears on the screen: • Drug Name: The name of the selected drug. Displayed on the indicators bar, when working with a Drug Library.
Page 156 > To b eg i n a new PCA inf usion w it h a D r ug L ib ra ry : From the Indicators Bar, verify that the pump is in PCA mode. For more information about changing delivery modes, refer to on page 74.
Page 157 If a list of available drug profiles appears, select the appropriate drug profile and proceed according to the step directed to: • No concentration: proceed to Step on page 152 (To begin a new PCA infusion Library), and continue programming from there. without Drug •...
Page 158: Pca Mode: Mid-Infusion Actions
PCA Mode: Mid-infusion Actions The following actions can be performed during PCA infusions: ................Updating Infusion Parameters ................Administering a Clinician Bolus ....................Pausing Infusions ....................Aborting Infusions ....................Locking the Screen ..................Activating Patient Lockout ..................Viewing Delivery History Updating Infusion Parameters In PCA mode, the infusion must be paused before parameters can be updated.
Page 159 Using the keypad, enter the new value of the parameter  OK. When modifying demand bolus limitations (volume or lockout time), the pump will prompt the user to confirm or adjust the other bolus limitations. To update additional parameters, repeat Steps 3-4. In addition to parameter changes, the following functions are also available: •...
Page 160 Administering a Clinician Bolus A bolus of any amount (within the predefined safe range) can be delivered by clinicians who have a High authorization level. A clinician bolus can be given only while the infusion is running. The lockout time is reset after delivering a clinician bolus. >...
Page 161: Epidural Mode
Epidural Mode This mode enables the pump to deliver epidural infusions. Epidural administration is limited to short term infusions (up to 96 hours), using indwelling catheters specifically identified for epidural drug delivery. In Epidural delivery mode, the pump can operate in either of the following sub-modes: •...
Page 162: Patient Controlled Epidural Analgesia (Pcea) Mode
Patient Controlled Epidural Analgesia (PCEA) Mode The following sections will be reviewed: ................Infusion Parameters: PCEA Mode ..................Starting a PCEA Infusion ................. PCEA Mode: Mid-infusion Actions The PCEA mode allows the pump to deliver medication at a continuous rate (optional) and limited boluses activated by the patient (via screen key or bolus handle).
Page 163 Infusion Parameters: PCEA Mode The following infusion parameters need to be set for a PCEA infusion: Parameter Description/Notes Continuous Rate The speed at which the fluid is infused. Continuous Rate values can range from 0.1 to 25 mL/h, or be equal to zero (Bolus Only infusion).
Page 164 Parameter Description/Notes Boluses per 1 h (or The maximum number of boluses OR the maximum dose that can 4 hrs) be delivered during a 1 hour (or 4 hours) period. (A user with high authorization codes can set the 1 hour or 4 hours parameters). The Total dose per 1 h (or Total dose limit takes into account medication delivered via: 4 hrs)
Page 165 Starting a PCEA Infusion The following procedure explains how to program the pump to start a new PCEA infusion. If relevant, you may skip programming by using the Repeat Last Infusion or PreSet programs procedures to begin the infusion. For more information, refer to Starting New Infusions: Shortcuts page 188.
Page 166 From the Attention screen, confirm the concentration and press OK. If the selected drug unit is Million Units, continue to Step 9. If the Patient Weight screen appears, specify whether the infusion is weight based: • Yes: Continue to Step 8. •...
Page 167 • Total Dose: Using the keypad, enter the maximum amount of medication that may be delivered within a one or four-hour period OK. Continue to Step 16. If Add Loading Dose screen appears, specify whether to program a loading dose: •...
Page 168 • Lockout time: Time remaining until the next bolus is available. After the lockout time elapses, this parameter changes to Bolus available. When a bolus is being given (loading dose, clinician bolus or patient bolus), this parameter does not appear. •...
Page 169 • When the required drug is not found in the Drug Library, press Choose General key on the toolbar: 'Choose General' will bypass specific drug limits, and the infusion will be programmed without Drug Library limits. From the Attention screen, confirm Choosing General and press OK. Proceed to Step on page 164 (To begin a new PCEA infusion without Drug...
Page 170 If a list of available drug profiles does not appear, continue to Step on page (To begin a new PCEA infusion without Drug Library), and continue programming from there. For more information about the Drug Library, refer to Chapter 9: Drug Library page 234.
Page 171 > To u p d a t e p a ra met ers using t he V i ew / Ed i t f u nc ti o n k ey : Pause the infusion (Pausing Infusions on page 192). From the toolbar, press View/Edit.
Page 172 Administering a Clinician Bolus A bolus of any amount (within the predefined safe range) can be delivered by clinicians who have High authorization level. A clinician bolus can be given only while the infusion is running. The lockout time is reset after delivering a clinician bolus. >...
Page 173: Epidural Intermittent Mode
Epidural Intermittent Mode The following sections will be reviewed: ........... Infusion Parameters: Epidural Intermittent Mode .............. Starting an Epidural Intermittent Infusion ..........Epidural Intermittent Mode: Mid-infusion Actions This mode enables you to program epidural doses (boluses) that are given at a rate of 125 mL/h or 200 mL/h, and are repeated at regular intervals or cycles.
Page 174 The Sapphire pump can also be configured to support PIEB (Programmed Intermittent Epidural Boluses). When enabled, the option to add PCEA is available on the Start screen. Note that in any case, an Epidural Intermittent infusion will start with an intermittent dose.
Page 175 For more information about the bolus handle, refer to PCA/PCEA/ on page 48. PIEB Bolus Handle When the PIEB option is enabled, you can set PCEA infusion parameters immediately after programming the Epidural Intermittent infusion (Starting a PIEB Infusion page 181). Infusion Parameters: Epidural Intermittent Mode The following infusion parameters need to be set for an Epidural Intermittent infusion: Parameter...
Page 176 Parameter Description/Notes Boluses per 1 h (or 4 hrs) The maximum number of boluses OR the maximum dose that can be delivered during a 1 hour (or 4 hours) period. (A user with Total dose per 1 h (or high authorization codes can set the 1 hour or 4 hours parameters).
Page 177 Starting an Epidural Intermittent Infusion The following procedure explains how to program the pump to start a new Epidural Intermittent infusion. If relevant, you may skip programming by using the Repeat Last Infusion or PreSet programs procedures to begin the infusion. For more information, refer to Starting New Infusions: Shortcuts page 188.
Page 178 If the Patient Weight screen appears, specify whether the infusion is weight based: • Yes: Continue to Step 8. • No: Continue to Step 9. From the Patient Weight screen, using the keypad, enter the patient weight  From the Dose Rate units screen, select the appropriate dose rate units. Using the keypad, enter the VTBI value ...
Page 179 Throughout the infusion, the infusion phase (Intermittent Dose or Continuous Rate) is displayed on the Indicators Bar. In addition, the following information appears on the screen: • Drug Name: The name of the selected drug. Displayed on the indicators bar, when working with a Drug Library.
Page 180 > To b eg i n a new Ep idura l Inter mitt e nt i n fus i o n wi th a D rug L i bra ry : From the Indicators Bar, verify that the pump is in Epidural mode. For more information about changing delivery modes, refer to on page 74.
Page 181 • No concentration: proceed to Step on page 177 (To begin a new Epidural Library), and continue programming from Intermittent infusion without Drug there. • Diluent only (e.g. 10 mL): proceed to Step on page 177 (To begin a new Library), and continue programming Epidural Intermittent infusion without Drug from there.
Page 182 Starting a PIEB Infusion The following procedure explains how to program an Epidural Intermittent with PCEA. > To b eg i n a new PIEB I nfusio n w it h o ut D ru g Li b ra ry: Verify that the pump is in Epidural Intermittent mode, and then program the Epidural Intermittent infusion (Step on page...
Page 183 Verify that the parameters reflect the correct treatment according to the prescription. To begin the infusion, make sure that the clamps on the administration set are open, and press Start. The Running screen appears, and the infusion begins. Throughout the infusion, the infusion phase (Intermittent dose, continuous rate or bolus) is displayed on the Indicators Bar.
Page 184 To view all programmed parameters of the current infusion, including the rate in mL/h, from the Running screen, press View/ Edit  View system  Infusion values > To b eg i n a new PIEB I nfusio n w it h a D ru g L i b r a ry: Verify that the pump is in Epidural Intermittent mode, and then program the Epidural Intermittent infusion (Step on page...
Page 185 Epidural Intermittent Mode: Mid-infusion Actions The following actions can be performed during Epidural Intermittent infusions: ................Updating Infusion Parameters ................. 186 Administering a Clinician Bolus ....................Pausing Infusions ....................Aborting Infusions ....................Locking the Screen ................... Activating Patient Lockout ..................Viewing Delivery History Updating Infusion Parameters In the Epidural Intermittent mode, the infusion must be paused before any parameter...
Page 186 Select the box of the parameter to be modified. Using the keypad, enter the new value of the parameter  OK. When changing the Intermittent Dose or Dose Rate, you will be prompted to confirm or adjust the dose interval. When modifying demand bolus limitations (volume or lockout) the pump will prompt you to confirm or adjust the other bolus limitations.
Page 187 Administering a Clinician Bolus A bolus of any amount (within the predefined range) can be delivered by clinicians who have a High authorization level code. A clinician bolus can be given only while the infusion is running. The lockout time is reset after delivering a clinician bolus. Clinician bolus is applicable only when programming Epidural Intermittent with PCEA.
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Page 189: Basic Infusion Operations
Chapter 6: Basic Infusion Operations The following sections explain procedures and actions that are commonly performed in all delivery modes to start and manage infusions: ................Starting New Infusions: Shortcuts ............. Resuming Infusions After Pump Shutdown .................... Mid-infusion Actions Starting New Infusions: Shortcuts The following shortcut operations allow you to begin an infusion without the need to enter required parameters: ..................
Page 190 Information about Secondary (Piggyback) infusions is not saved. This option is not relevant to Secondary infusions. Repeat Last Infusion is not available (grayed out) when the pump settings differ from those used for the previous infusion. These include: CCA, regional settings, and PCA/PCEA infusion type. Repeat Last Infusion does not include a loading dose, even if one was programmed for the original infusion.
Page 191: Using A Preset Program
Using a PreSet Program The PreSet Programs function allows you to select an infusion with predefined parameters. Each delivery mode can support up to 10 PreSet programs. PreSet programs are available only in the delivery mode in which they were saved. For the PreSet Programs option to appear on the Start Up screen, the PreSet programs need to be enabled on the pump.
Page 192: Resuming Infusions After Pump Shutdown
Resuming Infusions After Pump Shutdown When the pump is turned Off during an active infusion (running or paused), the option to resume the previous infusion will be displayed after the pump is turned On. This option is applicable for all delivery modes, excluding TPN: >...
Page 193: Mid-Infusion Actions
Mid-infusion Actions The following sections describe procedures that are commonly performed during an infusion: ....................Pausing Infusions ....................Aborting Infusions ....................Locking the Screen ..................Activating Patient Lockout Pausing Infusions The Pause function allows you to temporarily stop an infusion. Infusions can be paused using either the Request Pause function key, or, in an emergency, the Stop hard key.
Page 194: Aborting Infusions
> To p a us e a n infusio n using the R eq ue st Pa u se f un c ti o n k e y : From the toolbar, press Request Pause. From the toolbar of the Attention screen, press OK. The infusion is paused.
Page 195: Locking The Screen
From the toolbar of the Attention screen, press Quit Infusion. Resuming infusion after quitting will not be possible. When a Drug Library is loaded on the pump, the Clinical Care Area screen appears. The user can either accept or change the current CCA.
Page 196: Activating Patient Lockout
> To unl oc k the sc reen: From the toolbar, press Press to Unlock Screen. From the toolbar of the Attention screen, press OK. Activating Patient Lockout The Patient Lockout feature prevents unauthorized personnel from modifying pump and infusion settings. In this state, only limited features are available. A password is required to unlock the pump.
Page 197 • Rate – the rate at which the infusion was delivered • Total time – the total time of the infusion The default KVO can be set by an authorized technician. When the remaining VTBI is 0.1 mL or less, the time left displayed on the screen may deviate up to a few minutes from the actual time remaining.
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Page 199: Options Menu : Configuring
Chapter 7: Options Menu: Configuring, Viewing and Testing The following sections describe configuring settings, testing elements, and viewing system data using the Options menu: ..................Main Options: Overview ..................Setting Delivery Mode ................Managing Configuration Settings ................. Using Special Mode Options Main Options: Overview The Options screen provides access to configurable pump settings, testing modes, and system data.
Page 200: Setting Delivery Mode
Setting Delivery Mode The Sapphire pump is a multi-platform device that has the ability to operate in several different modes. Each delivery mode features its own unique options. The current mode is displayed at the right side of the Indicators Bar. Setting the delivery mode is done using the Options menu.
Page 201: Managing Configuration Settings
Managing Configuration Settings The following sections describe how to view and update pump configuration settings: ..................Managing Alarm Settings ................... Configuring Audio Settings ................. Configuring General Settings ................Defining Regional Parameters ..................Testing System Function ......................View Menu When a drug library is loaded to the pump, local configurations made on the pump remain valid until the user selects a CCA or turns the pump Off.
Page 202 To Modify Parameter (from the Alarms Option Descriptions/Notes screen) Occlusion The minimum downstream pressure that Occlusion Select pressure triggers an Occlusion alarm. Acceptable pressure . Then, using the ranges are 5.8 to 17.4 PSI, 0.4 to 1.2 BAR keypad, enter the desired or 300 to 900 mmHg.
Page 203 To Modify Parameter (from the Alarms Option Descriptions/Notes screen) Alarm volume Sets the speaker volume for the auditory Alarm volume Select Maximum alarm signal. Options are Then, select Maximum Minimum Minimum When the option is set to Minimum, messages are provided with a visual signal only.
Page 204: Configuring Audio Settings
Configuring Audio Settings The Audio settings menu allows you to view and modify audio-related pump settings. Only users with authorization levels of High or Technician have access to this menu. > To a c c es s the A udi o set ting s me n u: •...
Page 205: Configuring General Settings
To Modify Parameter (from the General Option Descriptions/Notes settings screen) Bolus Handle Sets the Bolus auditory signal, generated Bolus Handle Select when the bolus handle is pressed. Then, select Always On When the option is set to Always On, an When Bolusing auditory signal is generated each time the bolus handle is pressed.
Page 206 To Modify Parameter (from the General Option Descriptions/Notes settings screen) Authorization Sets the authorization lock level of the Authorization Select level pump. For more information, refer to level . Then, enter a on page 220. Managing Authorization Levels password and select Medium High Tech...
Page 207 To Modify Parameter (from the General Option Descriptions/Notes settings screen) Advanced Bolus Allows users to program a bolus by Advanced Select the entering rate, amount and time. When this Bolus row, to toggle the option is disabled, the bolus is option between programmed by amount only, and the rate is the default bolus rate.
Page 208 To Modify Parameter (from the General Option Descriptions/Notes settings screen) Screen Saver Enables/disables a far-view display of the Screen Saver Select the main infusion parameters during a running row, to toggle the option infusion. These include drug information, between delivery mode (color indication), infusion rate, and the phase (dose, continuous rate etc.).
Page 209: Defining Regional Parameters
Start Up Configuration Menu From the toolbar of the Start Up > To ac c e s s t he Sta rt Up Co nf ig ura t i o n m e nu : screen, select Options. Then, select Pump configuration  General settings  Start Up Config To Modify Parameter (from the General...
Page 210 > To s et t he d a te: Select the Date frame. Using the keyboard, enter values (2 digits each) for the day, month, and year. (When US format is set, the order is month, day, and year.) To confirm the new settings, press OK. >...
Page 211: Testing System Function
Testing System Function The Test system menu allows you to test basic system functionalities. Only users with authorization levels of High or Technician have access to this menu. > To ac c e s s t he Tes t syst em men u: •...
Page 212: View Menu
View Menu The View menu provides access to current pump settings and lists of events that are audited by the system. The main categories are: Category Description/Notes View system Provides a view of the current system settings, and allows updating selected settings.
Page 213 Viewing System Parameters The View system screen allows you to view current system settings and infusion parameters, and update selected settings. You can navigate through the pages of settings, by pressing the Next and the Back function keys. The following settings appear in all delivery modes: Setting Description/Notes Infusion Values...
Page 214 Setting Description/Notes Backlight Current backlight settings. For more information refer to on page 204. Configuring General Settings The setting can be modified by pressing > ; then selecting Partial Accumulated VI The cumulative volume infused (mL). The Accumulated VI can be cleared by pressing >...
Page 215 Setting Description/Notes Drug Library name The Drug Library name appears only if the pump is loaded with a Drug Library. For more information about the Drug Library, refer on page 234. Chapter 9: Drug Library Drug Library published The Drug Library published date appears only if the pump is date loaded with a Drug Library.
Page 216 Viewing the Event Log The Event log screen allows you to view a record of all events audited by the system. You can view a list of all events or only the events that occurred on a specific day. > To v iew eve nts tha t o c c urre d o n a s p e c i f i c d a y : From the Options menu, select View.
Page 217 When the row of an event is selected, the Event details frame displays the complete timestamp of the event (date and exact time), and a brief description of the event. When the pump is turned Off, or a power failure occurs, the pump shut-down is registered as an event (with a time stamp), and the event log is saved.
Page 218 Name of Value Description/Notes Patient bolus given/attempts Total number of patient boluses delivered to the patient/ number of times that the patient requested a bolus (by pushing the button on the Bolus Handle, or by pressing the Bolus function key). Patient Bolus given Total amount of infusion (in mL, mg, mcg, mUnits, million Units, gram, nanogram, mmol, or mEq) given via demand...
Page 219: Using Special Mode Options
Using Special Mode Options The following sections describe options that are available only in PCA and Epidural delivery modes: ....................PCA Options Menu ................Epidural Mode Options Menu PCA Options Menu The PCA options screen is accessed from the main Options menu, when the pump is in PCA delivery mode.
Page 220: Epidural Mode Options Menu
To save the change in the system, press OK. Epidural Mode Options Menu The PCEA options and Epi Int options screens are accessed by pressing the Options function key when the pump is in PCEA or Epidural Intermittent delivery modes, respectively.
Page 221: Using Advanced Features
Chapter 8: Using Advanced Features This chapter explains how to work with less frequently used pump features. The following options are generally reserved for more advanced pump users: ................Managing Authorization Levels ....................Password Re-entry ..............Creating and Editing PreSet Programs ..................
Page 222 Specific actions allowed in each of the authorization levels are listed in the following table. Authorization Level Allowed Actions Stop the pump, and then continue the infusion Power the pump On and Off Administer patient bolus Use the View menu Activate immediate taper-down during TPN infusion, using the taper-down period defined by the clinician Medium...
Page 223: Setting Authorization Lock Levels
When the pump is turned Off, the authorization lock level setting is saved. Therefore, the lock level set most recently is maintained when the pump is turned back On. If the pump is turned Off in Technician mode, the pump turns back On in a High authorization level.
Page 224: Password Re-Entry
The authorization level matching the entered password, as well as all levels below it, are listed on the Main Display. Select the authorization level at which you want to lock the pump. Then, from the Attention screen, press OK. To exit the Options menu, press OK. >...
Page 225: Creating And Editing Preset Programs
Creating and Editing PreSet Programs The PreSet Programs feature allows users to start infusions using predefined infusion parameters, thus eliminating the need for programming. Each delivery mode can support its own set (of up to 10) predefined infusion programs. Only the infusion programs set for the currently selected delivery mode are displayed (a preset program is available for use and edit only when the pump is set to the delivery mode in which the program was saved).
Page 226 Using the keypad, enter a relevant name for the new program. • To enter the second character that appears on a key, press the key twice. (Press 3 times to enter the third character, etc.) • To enter a space, press the 0 (zero) key once. •...
Page 227 > To e d i t a p reset p ro gr am: From the Indicators Bar, verify that the pump is in the desired delivery mode. From the Start Up screen, select PreSet Programs. From the toolbar of the PreSet Programs screen, press Edit. Using the keypad, enter the appropriate password;...
Page 228: Using The Set Delay Feature
Using the Set Delay Feature The Set Delay feature allows users to program an infusion in advance. When the option is enabled, the Set Delay option appears on the Start screen. The users can then choose to set the infusion to Standby for an unlimited time period, or to set the infusion for a defined Delayed Period, after which one of the following occurs: •...
Page 229 Throughout the Standby period, the following information appears on the screen: • Drug Name: The name of the selected drug. Displayed on the indicators bar, when working with a Drug Library. • Concentration: Drug concentration as entered by the user (Final concentration or Drug Amount / Diluent Volume).
Page 230 > To s t a r t an inf usio n fro m t he S tan d b y s t a te : Press End Standby. Review the parameters displayed on the Confirm screen. Verify that the parameters reflect the correct treatment according to the prescription.
Page 231 Specify whether or not to run the infusion in a KVO, during the delay period: If KVO rate is pre-configured to 0 mL/h for the delivery mode, from the Start screen, select Start with Delay. (Refer to Do not use KVO: below) •...
Page 232: Using The New Patient Feature
Using the New Patient Feature The Sapphire pump allows you to associate infusions to a specific patient. When the New Patient feature is enabled, and either a New Infusion or a PreSet program is selected, the pump will prompt you to indicate whether the infusion to be programmed is for a new patient or not.
Page 233: Monitoring The Accumulated Volume Infused (Shift's Total)
Monitoring the Accumulated Volume Infused (Shift's Total) The Sapphire pump calculates the Accumulated Volume Infused (Accumulated VI) for all infusions associated with a specific patient. The accumulated VI includes the volume infused to a specific patient via infusions (including primary, secondary etc.), Boluses and KVO (if applied during delayed Start or post infusion).
Page 234: Clearing Accumulated Vi
From the toolbar of the View system screen, press Next until the Accumulated VI parameter is displayed. In addition to the Accumulated VI value, when using the Continuous delivery mode, the View System screen also presents the Accumulated Volume Infused via the primary line (Accum. Prim. VI) and the Accumulated Volume Infused via the secondary line (Accu.
Page 235: Drug Library
Chapter 9: Drug Library The following sections explain about the Drug Library unique features, and describe how to operate the pump in the different delivery modes using the Drug Library: ......................Overview ..................Clinical Care Area (CCA) ..........Programming a New Infusion with the Drug Library ......................
Page 236: Clinical Care Area (Cca)
Clinical Care Area (CCA) The Drug Library accommodates of up to 40 CCAs, and up to 8,500 unique drug profiles. Each CCA can accommodate up to 1000 drug profiles, and each unique drug profile can be assigned to more than one CCA, i.e. up to a total of 40,000 medications. The CCA unique configuration is set by the Drug Library.
Page 237 • To accept the current CCA, press Accept. The Start Up screen appears. • To change the current CCA, press Change. • From the Choose CCA screen, select the relevant CCA. Next To display additional CCAs press From the Attention screen, press OK. In case the current delivery mode is unavailable in the selected CCA, the pump will prompt the user to change the delivery mode.
Page 238 The Start Up screen appears. Selecting a CCA should be conducted according to local facility procedures. The Repeat Last Infusion option will be unavailable (grayed out) after the CCA is changed. Changing a CCA during a running infusion When changing the CCA during a running infusion, the CCA will change only after the infusion has completed.
Page 239 The View/Edit screen is displayed. To view or change the Next CCA: • View System From the View/Edit screen, press • Next CCA Press • Select CCA from list. Note: To display additional CCAs press Next • From the Attention screen, press The Repeat Last Infusion option will be unavailable (grayed out) after the CCA is changed.
Page 240: Programming A New Infusion With The Drug Library
Programming a New Infusion with the Drug Library When the Sapphire pump is loaded with a Drug Library, the programming flow includes additional related steps: Drug name entry, Drug list and Drug profile. Following the drug profile selection, the user is required to enter the infusion parameters according to the delivery mode.
Page 241: Drug Profiles
Drug Profiles The pump displays the available profiles for the selected drug. The drug profile includes concentration and defines hard limits and soft limits. Each available drug is defined by the CCA and the delivery mode to which it was assigned; a drug profile may be available in more than one delivery mode.
Page 242: Soft Limit
Soft Limit The limits set in the Drug Library create a guiding range, thus reducing infusion errors. When programming values that exceed the recommended range (soft limits), an Attention screen is displayed, showing the applicable soft limit icon, with the details of the exceeded parameter.
Page 243: Update A New Drug Library Version
Update a New Drug Library Version Following a Drug Library update, when the pump is turned On, the user is prompted to specify whether or not to update the Drug Library with the new available version. Updating Drug Library should be conducted according to local facility procedures.
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Page 245: Alarms And Troubleshooting
Chapter 10: Alarms and Troubleshooting The following sections describe the different types of alarms and messages that can be generated by the pump, and explain how to troubleshoot common programming issues: ....................Alarms Overview ..................... Level 1 Alarms ..................... Level 2 Alarms .....................
Page 246: Level 1 Alarms
The following sections provide details about each alarm type. In the lists of alarms, messages and alarms related to battery issues are shaded. Alarms related to battery problems can be prevented by adhering to the recommended guidelines for battery care (Battery Care Information on page 264).
Page 247: Level 2 Alarms
Level 2 Alarms This alarm type is a high severity category. If the pump is running when a Level 2 alarm occurs, the infusion automatically stops. The pump can be reactivated by a technician (using a technician authorization code) to retrieve infusion data and/or manage a battery problem.
Page 248: Level 3 Alarms
Level 3 Alarms This alarm type is a medium severity category that requires immediate attention. If the alarm occurs during an infusion, the infusion automatically stops. However, you may continue the infusion after the problem has been resolved. Instructions for resolution of the problem are displayed on the touch screen.
Page 249 • Prime: Enables automatic priming. This key appears only during an Air in Line alarm. Alarm Title Displayed Text Air in Line Accumulated air in line is over the limit. Please prime administration set. If problem reoccurs, remove and reinsert the cassette. Please prime administration set.
Page 250: Messages
Alarm Title Displayed Text Insufficient Low battery voltage for current rate. Please connect pump to power supply. Battery Messages A Message indicates a condition of medium severity that you should attend to as soon as possible. When a Message occurs, an auditory alarm sounds, and the condition that triggered the message (and recommended actions, if relevant) is displayed on the touch screen.
Page 251 • Unmute: Returns the auditory alarm. • OK: Confirms the message, and returns the display to the previous screen. If the infusion is complete, the pump returns to the Start Up screen. This soft key is enabled after Mute is pressed. If the alarm volume is configured to minimum in the Alarms menu, the OK soft key will always be enabled.
Page 252: Troubleshooting
Troubleshooting The following table lists some common programming issues, and explains how to solve them. Problem Probable Cause Solution Programming cannot be The parameter entered is Verify the prescription, and obtain outside of the safety range a new one if necessary. Enter completed.
Page 253 Problem Probable Cause Solution A password needs to be The Password Request Disable the Password request entered to change any feature is enabled. setting (Epidural Mode Options parameter in Epidural on page 219). Authorization Menu mode. level of High is required. •...
Page 254 Problem Probable Cause Solution • • Pump is not charging. The power supply has Verify the power supply is become disconnected connected to the mini cradle from the mini cradle. splitter. • • The power supply was Disconnect and reconnect the connected to the pump power supply to the pump.
Page 255 Problem Probable Cause Solution • • Screen saver does not Screen saver option was Enable the Screen Saver option appear. not enabled. (refer to Configuring General on page 204) Settings • • Pump is not in an appli- The screen saver will not appear cable state.
Page 256 Problem Probable Cause Solution • • Pump does not show EBP was not properly Detach the EBP and re-attach it indications of attached. exactly as instructed. connection when • • AA batteries were mis- Detach the EBP, make sure the attached to the EBP.
Page 257: Maintenance And Storage
Chapter 11: Maintenance and Storage The following sections describe the proper cleaning, preventive maintenance, and storage procedures for the pump and the battery: ..............Cleaning and Disinfecting the Pump ..................Preventive Maintenance ..................Battery Care Information ..................Transport and Storage Cleaning and Disinfecting the Pump Between use on different patients, the Sapphire pump and all of its components need to be first cleaned, and then disinfected, per hospital/medical provider protocol for...
Page 258 Cleaning and Disinfection: Safety Precautions Before and during cleaning, adhere to the following safety guidelines and recommendations: • Only people who are trained in the maintenance of this type of medical device should clean the infusion pump • Before cleaning/disinfecting the pump, verify that: •...
Page 259: Cleaning And Disinfection Procedure
Cleaning and Disinfection Procedure Cleaning/Disinfecting Solution Manufacturer Dispatch® (Caltech) ready-to-use towels Caltech Virex® II 256 Diversey Klor DeTM (Chlorine tablets) Concept 70% Isopropyl alcohol Veltek Associates, Inc. Virox® AHP 5 RTU Diversey Cleaning Procedure The following procedure explains how to clean the pump using the approved agents (listed above): >...
Page 260 Wipe the pump with a clean dry cloth. The pump must be completely dried out before connecting it to a power supply. Disinfecting Procedure The following procedure explains how to disinfect the pump using the approved agents (listed in on page 258): Cleaning and Disinfection Procedure >...
Page 261: Reprocessing The Pump When Used By A Single Patient Multiple Times
Component Cleaning Recommendations Sensor Fingers Clean the finger tip of the sensor using only a damp cloth or sponge. • This part should be kept free from foreign materials and dirt. If Internal White Panel necessary, use foam swab moistened with the detergent solution •...
Page 262: Preventive Maintenance
Preventive Maintenance The following sections describe: ............Routine Inspection and Maintenance Tasks ...................... Alarm Testing ......................Certification Routine Inspection and Maintenance Tasks The following sections provide guidelines about inspecting and caring for the pump before and after use. Take care not to drop the pump. If the pump is dropped or appears to be damaged, cracked or dented, return it to your local representative for inspection.
Page 263: Alarm Testing
Alarm Testing It is recommended to perform manual testing of the following alarms at least once a year. Alarm testing can be conducted as part of the yearly certification. For the Sapphire Epidural pump manual alarm testing, refer to the testing protocols available for authorized technicians (for more information refer to the service manual).
Page 264: Certification
Certification To ensure proper fluid delivery, the pump should be checked by an authorized service provider at least once a year, to perform yearly certification. For more information on yearly maintenance procedures to be performed by technicians or certified service providers, refer to the Sapphire Infusion Pump Service Manual.
Page 265: Battery Care Information
Battery Care Information The Sapphire pump can operate on battery power, enabling operation of the pump during an electrical power failure, during patient transport or during ambulatory care. When working on battery power (disconnected from main power supply) the battery charge level icon, at the upper right corner of the indicators bar, indicates the remaining battery capacity.
Page 266: Battery Safety Information
The UL 1642 Standard for Lithium batteries classifies the Lithium-Ion battery used in the Sapphire pump as follows: • Secondary battery (rechargeable) • Technician replaceable Battery Safety Information When working with the battery, adhere to the safety precautions and recommendations listed below.
Page 267 Long Term Battery Storage When you store batteries for extended periods of time, ensure the following conditions: • Well-ventilated facility, free of a corrosive gas atmosphere • Low humidity environment • Storage temperature should be between -20ºC (-4ºF) to +35ºC (+95ºF). The recommended temperature is 23º...
Page 268: Charging The Battery
Charging the Battery Before initial use of the Sapphire pump, the battery must be charged for at least 6 hours. The battery must also be charged if it has been disconnected from the pump unit for more than 6 months. While the pump is in storage, recharge the battery at least every 12 months.
Page 269: Battery Maintenance
Battery Maintenance To promote maximum battery life, the following procedures should be performed at regular intervals. Frequency Action Following each use of the Check the status of battery charge, and recharge as pump necessary. Every 2 years or every 500 Replace batteries.
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Page 271: Technical Specifications
Chapter 12: Technical Specifications The following sections present technical specifications for the pump and its components: ....................Pump Accuracy ..................... Pump Specifications ..............Average Bolus Volume After Occlusion ................Environmental Specifications .............. Electromagnetic Compatibility Statement Pump Accuracy The following graphs and curves were derived from the pump accuracy testing procedures described in the IEC60601-2-24 standard.
Page 272 Infusion under high backpressure conditions (for example, when using catheters, or other restricting administration set components) may cause the accuracy of the pump flow delivery to deviate from the accuracy stated for normal conditions. The pump is designed to accommodate the delivery of infusions under backpressure conditions with an expected deviation in accuracy of +5% to -5% (Note: In high backpressure conditions, such as with a 26G PICC line infusing at 100mL/h, additional under delivery may occur).
Page 273: Start-Up And Trumpet Graphs
Start-up and Trumpet Graphs The start-up graphs represent startup flow versus operating time for the first two hours from the start of the infusion. They exhibit the stability of delivery due to mechanical compliance and provide a visual representation of uniformity. Start-up graphs were performed according to the IEC 60601-2-24 standard.
Page 274 Delivery Startup Graph, First 2 Hours of Test Period, Figure 12.1. 1 mL/h Trumpet Graph, Second Hour of Delivery, 1 mL/h Figure 12.2. Sapphire Infusion Pump User Manual...
Page 275 Trumpet Graph, 24th (Last) Hour of Delivery, 1 mL/h Figure 12.3. Delivery Startup Graph, First 2 Hours of Test Period, Figure 12.4. 25 mL/h Technical Specifications...
Page 276 Trumpet Graph, Second Hour of Delivery, 25 mL/h Figure 12.5. Trumpet Graph, 24th (Last) Hour of Delivery, 25 mL/h Figure 12.6. Sapphire Infusion Pump User Manual...
Page 277: Pump Specifications
Pump Specifications The following table lists and describes pump specifications. Parameter Description Dimensions 143 x 96 x 49 mm (5.63 x 3.78 x 1.93 in.) (H x W x D) Weight (excluding batteries) 418 g (14.7 oz.) Pumping mechanism Single channel volumetric, with integral pressure sensor Infusion delivery modes Continuous (with and without a Secondary line), PCA, Intermittent, Multi-step, TPN, Epidural (PCEA, Epidural...
Page 278: Average Bolus Volume After Occlusion
Parameter Description Alarms Refer to full list of alarms in Chapter 10: Alarms and on page 244. Troubleshooting Prime Manual or automatic priming (600 mL/h, or from air in line alarm 900 mL/h) • Sensors Air in line sensor: Detects both single and accumulated bubbles sized 0.02-0.5 mL.
Page 279: Environmental Specifications
The following table presents the average time to a downstream occlusion alarm at a rate of 0.1 mL/h. Parameter Pressure 0.4 bar 1.2 bar Average time to downstream 2:30 hours 12:30 hours occlusion alarm In case of an occlusion (upstream or downstream), clear the occlusion by disconnecting the set from the patient and priming the administration set.
Page 280: Environmental Conditions For Transport And Storage
Environmental Conditions for Transport and Storage When transporting or storing the pump, adhere to the following conditions: Condition Details/Range Atmospheric pressure 50 kPa to 106 kPa (500 hPa to 1060 hPa) Relative humidity 15% to 95% Temperature -40°C to +70°C (-40°F to 158°F) Sapphire Do not disassemble the portion of the pump that houses...
Page 281 • Avoid damp locations, or locations where moisture level may increase considerably. • Avoid locations with large temperature fluctuations. • Avoid locations exposed to direct sunlight. • Avoid locations near an electrical heating apparatus. • Avoid locations exposed to chemicals or explosive gases. Technical Specifications...
Page 282: Electromagnetic Compatibility Statement
Electromagnetic Compatibility Statement The following sections provide information about testing of and recommendations for: ..................Electromagnetic Emission ................... Electromagnetic Immunity ..Recommended Separation Distances from Mobile RF Communication Equipment Electromagnetic Emission The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should ensure that it is used in such an environment.
Page 283: Electromagnetic Immunity
Electromagnetic Immunity The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should ensure that it is used in such an environment. IEC 60601 Test Compliance Electromagnetic Immunity Test Level Level Environment Guidance Electrostatic...
Page 284 IEC 60601 Test Compliance Electromagnetic Immunity Test Level Level Environment Guidance Power frequency 3 A/m 3 A/m Power frequency magnetic (50/60 Hz) magnetic fields should be at levels field characteristic of a typical IEC 61000-4-8 location in a typical commercial or hospital environment.
Page 285 Electromagnetic Environment IEC 60601 Test Compliance Immunity Test Level Level Guidance where is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and is the recommended separation distance in meters (m). Radiated RF 3 V/m 10 V/m Recommended...
Page 286 Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Page 287 Rated Maximum Output Power of Separation Distance According to Frequency of Transmitter (W) Transmitter (m) 150 kHz to 150 kHz to 80 MHz to 800 MHz 80 MHz 80 MHz in 800 MHz to 2.5 outside ISM ISM bands bands 1.2 p 1.2 p 2.3 p...
Page 288 Sapphire Infusion Pump User Manual...
Page 289: Limited Warranty
Chapter 13: Limited Warranty Q Core Medical Ltd. (the "Manufacturer") warrants to the buyer who purchased the Sapphire directly from the manufacturer (Initial Buyer) that the Sapphire Infusion Pump ("Sapphire"), not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with this User Manual, for a period of two years from the actual date of sale to the Initial Buyer.
Page 290 B. Conditions of Warranty: The warranty is void if the Sapphire has been 1) repaired by someone other than the Manufacturer or its authorized agent 2) altered so its stability or reliability is affected 3) misused or 4) damaged by negligence or accident.
Page 291 Service Information While under Q Core warranty, the Sapphire pump must not be opened by unauthorized personnel. Use only an authorized Q Core service provider for service and repair. In the event that your pump needs to be returned for service, contact your local representative, or obtain a Return Authorization by filling an inquire form through the Q Core website.
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Sapphire epidural Sapphire Q core sapphire

Eitan Sapphire Multi-Therapy User Manual

Chapter 1 : Introduction

Introduction

Administration Sets

Fundamental Concepts and Operations

Getting Started

Chapter 5 USING the DELIVERY MODES

Basic Infusion Operations

Options Menu : Configuring

Viewing and Testing

Chapter 8 : Using Advanced Features

Using Advanced Features

Drug Library

Chapter 10 ALARMS and TROUBLESHOOTING

Chapter 11 MAINTENANCE and STORAGE

Chapter 12 TECHNICAL SPECIFICATIONS

Limited Warranty

Quick Links

Troubleshooting

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Questions and answers

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