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Technical Specifications

270

The following sections present technical specifications for the pump and its
components:

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Pump Specifications

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Average Bolus Volume After Occlusion

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Environmental Specifications

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Electromagnetic Compatibility Statement

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Pump Accuracy

The following graphs and curves were derived from the pump accuracy testing
procedures described in the IEC60601-2-24 standard. Testing was performed under
normal conditions (specified in IEC60601-2-24 standard) at room temperature (25°C,
72°F).
Normal conditions to ensure optimal accuracy of ±2.5%:

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Fluid level should be 50 cm above the pump

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No back pressure due to catheter size or difference in height of pump and infusion
site

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Room temperature (25°C)

•

Barometric pressure of sea level altitude (101kPa)

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IV medication with water like fluid characteristics

Chapter 12: Technical Specifications

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Summary of Contents for Q Core Sapphire

Page 1: ......

Page 2: ...rtified home healthcare provider or clinician on the proper use of this pump Prescription Notice Federal United States law restricts this device for sale by or on the order of a physician only 21 CFR 801 109 b 1 The Sapphire pump is for use at the direction of or under the supervision of licensed physicians and or licensed healthcare professionals who are trained in the use of the pump and in the ...

Page 3: ...infusion and may generate hazardous fluid pressures which may activate occlusion alarms at unpredictable pressures 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 manufactur...

Page 4: ...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: ...ocompatibility 21 Sterilization 21 Degree of Protection Against Ingress of Water and Dust 21 Warnings and Safety Precautions 22 General Warnings and Precautions 22 Proper Use of the Pump 26 2 COMPONENTS ACCESSORIES AND ADMINISTRATION SETS 32 Unpacking the Pump 32 Hardware and Software Components 33 Touch Screen 34 Using Pump Accessories 36 Mini Cradle 36 PCA Lockboxes 40 PCA Lockbox 250mL 44 PCA P...

Page 6: ...TED 82 Typical Workflow 82 Turning the Pump On 84 Turning the Pump Off 84 Connecting the Infusion Container to the Administration Set 85 Opening the Safety Door 86 Inserting the Administration Cassette 87 Removing the Administration Cassette 89 Automatic Priming Using the Pump 90 Priming Manually 92 5 USING THE DELIVERY MODES 94 Continuous Mode 94 Infusion Parameters Continuous Mode 97 Starting a ...

Page 7: ...ing a PCA Infusion 151 PCA Mode Mid infusion Actions 157 Epidural Mode 160 Patient Controlled Epidural Analgesia PCEA Mode 161 Epidural Intermittent Mode 172 6 BASIC INFUSION OPERATIONS 188 Starting New Infusions Shortcuts 188 Repeating Last Infusion 188 Using a PreSet Program 190 Resuming Infusions After Pump Shutdown 191 Mid infusion Actions 192 Pausing Infusions 192 Aborting Infusions 193 Locki...

Page 8: ...220 Managing Authorization Levels 220 Setting Authorization Lock Levels 222 Password Re entry 223 Creating and Editing PreSet Programs 224 Using the Set Delay Feature 227 Using the New Patient Feature 231 Monitoring the Accumulated Volume Infused Shift s Total 232 Viewing Accumulated VI 232 Clearing Accumulated VI 233 9 DRUG LIBRARY 234 Overview 234 Clinical Care Area CCA 235 Changing a CCA 235 Pr...

Page 9: ...Preventive Maintenance 261 Routine Inspection and Maintenance Tasks 261 Alarm Testing 262 Certification 263 Battery Care Information 264 Battery Classification 264 Battery Safety Information 265 Charging the Battery 267 Battery Maintenance 268 Transport and Storage 268 12 TECHNICAL SPECIFICATIONS 270 Pump Accuracy 270 Start up and Trumpet Graphs 272 Pump Specifications 276 Average Bolus Volume Aft...

Page 10: ...Sapphire Infusion Pump User Manual 9 Electromagnetic Compatibility Statement 281 Electromagnetic Emission 281 Electromagnetic Immunity 282 13 LIMITED WARRANTY 288 ...

Page 11: ... products The Sapphire Infusion Pump includes the following infusion modes for all intended uses Continuous Intermittent TPN PCA Multi step and Epidural The pump is intended to be used by both licensed health care professionals in a clinical environment and home users in an ambulatory environment and in pre hospital medical air and ground transportation The dedicated Q Core administration sets for...

Page 12: ...odes Figure 3 1 on page 75 Features The features of the Sapphire Infusion Pump are designed to simplify treatment and ensure patient safety Treatment Related Features Single platform device The delivery mode of the pump can be changed according to the required type of infusion Priming alternatives Both manual priming by gravity and automatic priming using the pump are available Quick infusion titr...

Page 13: ... variety of dose rate units including the following per different time units mL mg mcg units mUnits Million Units gram nanogram mmol mEq Infusion rate can be programmed as a weight based infusion patient weight can range from 0 1 500 Kg PIEB epidural infusion can support the combination of programmed intermittent doses with patient controlled boluses Safety Related Features Lock Screen Avoids inad...

Page 14: ...brary 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 Drug Library Enables safer practice according to clinical care area Programming is done with drug specific name profile hard limits and recommended soft limits ...

Page 15: ...nical Care Area DFU Directions for Use EBP External Battery Pack ECG Electrocardiogram EMC Electromagnetic compatibility EMI Electromagnetic interference Epi Int Epidural Intermittent h Hour Kg Kilograms KVO Keep Vein Open mcg Micrograms mEq Milliequivalents min Minutes mg Milligrams mL Milliliters mmol Millimoles Mounting System Sapphire Multi Pump Mounting System MRI Magnetic Resonance Imaging m...

Page 16: ...ed Epidural Analgesia PIEB Programmed Intermittent Epidural Bolus Prim Primary Sec Secondary TPN Total Parenteral Nutrition VI Volume Infused VTBI Volume To Be Infused Q Core Q Core Medical Ltd Sapphire pump Q Core Sapphire infusion pump family SapphirePlus pump Q Core SapphirePlus infusion pump SapphireH100 pump Q Core SapphireH100 infusion pump Term Abbreviation Meaning ...

Page 17: ...mportant labeling safety and compliance information Symbols and Labeling on page 17 Compliance and Classification on page 20 Biocompatibility on page 21 Sterilization on page 21 Degree of Protection Against Ingress of Water and Dust on page 21 Warnings indicate precautions and instructions which if not followed may result in personal injury Cautions indicate instructions which if not followed may ...

Page 18: ...the back of the mini cradle EBP PCA Lockboxes 100 250 and 500mL and Mounting System Batch code Inside casing of the mini cradle EBP PCA Lockboxes 100 250 and 500mL and Mounting System Caution Consult accompanying documents for safety instructions service to be performed by qualified technician consult Service Manual before removing cover Back of the pump casing cover EBP on the back of the mini cr...

Page 19: ...States Back of the pump casing and Mounting System Date of manufacture year Back of the pump casing Name of manufacturer Back of the pump casing on the back of the mini cradle EBP PCA Lockboxes 100 250 and 500mL and Mounting System Identify defibrillation proof and degree of protection against electric shock Equipment Type BF Applied Part Back of the pump casing Input 100 240 V 50 60 Hz Max 120 VA...

Page 20: ...ver EBP and on the back of the mini cradle ALARM Alarm LED when lit indicates an alarm situation in the operation of the pump Refer to Hardware and Software Components on page 33 Front casing of the pump below the red LED CHARGE Charge LED when lit indicates that the battery is charging Refer to Hardware and Software Components on page 33 Front casing of the pump below the yellow LED RUN Run LED w...

Page 21: ...pment which classifies the Sapphire pump as Class II Type BF Continuous operation IP24 dust and splash proof Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide IEC 60601 1 2 Electromagnetic compatibility IEC 60601 2 24 Infusion pumps and controllers which classifies the Sapphire pump as a Type 4 pump continuous infusion flow combined with ...

Page 22: ...dministration 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 Degree of Protection Against Ingress of Water and Dust The Sapphire pump meets the IP24 splash dust standard according to IEC 60601 1 11 Protects from water which is sprayed at 10 L min at a pressure of 80 100 kN m2 for 5 minutes at...

Page 23: ...the equipment away from unattended children and pets Do not clean disinfect or sterilize any part of the pump by autoclaving or with ethylene oxide gas Doing so may damage the pump and void the warranty Only external parts of the pump should be disinfected All service procedures including certification calibration part replacement and modification of equipment should be carried out only by a quali...

Page 24: ...in accordance with hospital disposal practices Do not dispose of the battery in or near fire Explosion Hazard The equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Electric Shock Hazards To promote safety always adhere to the warnings listed below Electrical Safety Precautions Access to any internal part of the Sapphire pump ...

Page 25: ... Special precautions need to be exercised regarding EMC These include Maintaining a minimum separation distance of 2 ft m between the Infusion pump system and portable mobile RF communications equipment Manage the electromagnetic environment to permit the device to perform as intended without disturbing other equipment Separate the device from all other electronic equipment If the device must be u...

Page 26: ...equipment does cause harmful interference with other devices which can be determined by turning the equipment Off and On the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the distance separating between the equipment parts Connect the equipment to an outlet on a circuit different from that to which ...

Page 27: ... detect infiltrations or extravasations and such conditions will not trigger an alarm Environmental Safety Precautions The pump has not been evaluated for use within magnetic resonance imaging MRI environments or with other medical equipment that emits radiation for diagnostic or therapeutic purposes The Sapphire pump has not been evaluated for compatibility with Extracorporeal Membrane Oxygenatio...

Page 28: ...sted 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 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 pu...

Page 29: ...cclude the administration set prior to removing the Q Core administration cassette from the pump Do not apply pressure or pressurized air to any outlet or tubing connected to the pump Pressure may destroy sensitive elements Do not pull or stretch the tubing in any section of the administration set when the pump is in use nor apply pressure to the infusion container The administration set and conta...

Page 30: ...dministering Infusions General Safety Precautions Occlusion Pressure Alarm Settings High pressure settings may affect the time for occlusion detection Make sure that the occlusion pressure is set according to the clinical use case When using sets with a Pressure Activated Valve PAV detection may be offset by 0 3 BAR 4 35 PSI or 225 mmHg This offset is called PAV cracking pressure Volume To Be Infu...

Page 31: ...s idle The clamp of the Secondary set is closed when Piggyback infusions are not running Do not infuse non epidural drugs in the Epidural Delivery mode Epidural drugs must be infused in the Epidural Delivery mode PCA PCEA and Epidural Intermittent Delivery Mode When using the Clinician Bolus and Patient Demand Bolus functions special safety precautions need to be followed In addition adhere to all...

Page 32: ...ed incurs the risk of potentially fatal overdose Epidural Delivery Mode Epidural administration of anesthetics is limited to short term infusion not to exceed 96 hours with indwelling catheters specifically identified for short term anesthetic epidural drug delivery Epidural Delivery Safety Warnings Epidural administration of drugs other than those indicated for epidural use could result in seriou...

Page 33: ...ed The following items should be included Sapphire pump with Li Ion Battery enclosed AC DC power adaptor for pump User Manual Mini cradle with key to lock and pin to allow open close without the key Other optional items Demand bolus handle Splitter for mini cradle Communication cable PCA Lockbox 100mL PCA Lockbox 250mL PCA Lockbox 500mL Infusion Pouch 500 mL Home Large Backpack 5 liter Travel Case...

Page 34: ... Component Description Notes 1 Safety door Covers and protects the administration set and pumping mechanism 2 Speaker Delivers auditory alarm sounds 3 Status LEDs Colored indicators providing a summary of the pump current status Red An alarm is occurring Yellow blinking The battery is charging Yellow steady on The pump is connected to main power and the battery is fully charged Green The pump is r...

Page 35: ...nd described in the table following the figure Figure 2 2 Touch Screen Areas 6 Power socket Enables you to charge the battery using the power adaptor connect a communication cable or a bolus handle N A Battery compartment Houses the battery Located on the back of the pump Sapphire without Drug Library Sapphire with Drug Library Number Component Description Notes ...

Page 36: ...ve the delivery mode header when an EBP is connected to the pump Screen title Start Up Running Paused drug name etc Drug concentration appears when applicable under screen title Running icon appears while an infusion is running Delivery mode Continuous Multi step etc Battery status icon 2 Main Display Displays infusion parameters and other pump settings and serves as a work area in which most prog...

Page 37: ...in one of the following configurations With an optional connection splitter at the base Figure 2 3 3 With an optional Integrated Power Supply IPS at the base Figure 2 4 1 The IPS is an AC to DC power supply that is assembled to the Mini Cradle and is used to charge the pump battery Without the optional connection splitter or the optional IPS at the base Identify your Mini Cradle configuration by t...

Page 38: ...release the pump from the mini cradle 2 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 To unlock the knob use the supplied key or pin 3 Connection splitter optional Located on the base of the mini cradle Used for the RS 232 communication cable optional and power supply connections ...

Page 39: ...act In the mini cradle you can also charge the pump Number Component Description Notes 1 Integrated Power Supply optional Located on the base of the mini cradle Used for power supply connection 2 Cord retainer Located at the bottom of the integrated power supply It holds the AC power cord in the IPS power socket 3 AC Power Cord Medical Grade AC Power Cord that connected the IPS to the wall socket ...

Page 40: ...e it 2 To attach the pump to the mini cradle insert the pump onto the bottom hooks of the mini cradle Figure 2 5 1 and then click it into the top hook Figure 2 5 2 Ensure that the pump is seated on both hooks 3 To release the pump press the pump hook located on the top of the pump holder Figure 2 5 2 4 To open and release the mini cradle rotate the knob Figure 2 5 Mini cradle Hooks To attach sever...

Page 41: ...terrupting the treatment workflow PCA Lockbox 500mL This Lockbox can accommodate IV bags of up to 500 mL Figure 2 6 PCA Lockbox 500mL and Mini cradle The following steps explain the workflow of using the PCA Lockbox 500mL 1 Using the mini cradle knob attach the mini cradle to the IV pole Figure 2 3 on page 37 2 To open the Lockbox swing the blue handle to the left Figure 2 7 2 ...

Page 42: ...PCA Lockbox 5 Clamp the administration set spike the bag and attach the administration set to the pump 6 Place the administration set through the hole on top of the pump Figure 2 7 5 Verify that there are no kinks in the administration set so the infusion can run smoothly 7 Unclamp the administration set Then close both locks of the Lockbox and lock it using the supplied key Figure 2 7 6 ...

Page 43: ...ockbox Figure 2 8 1 open the box and remove the plastic cover 2 Close the clamps on the administration set and spike the bag 3 Block the administration set using the AFFV for more information about the AFFV refer to Priming Manually on page 92 and then open the clamps 4 Insert the container into the box and wrap the tube around the inner walls of the box in order to allow free flow and prevent kin...

Page 44: ... Lockbox 100mL Workflow 5 Connect the administration set to the pump 6 Close the box by sliding back the plastic cover Figure 2 9 3 7 Place the pump on the plastic cover Figure 2 9 4 and secure it by locking the box with the supplied key Figure 2 9 5 ...

Page 45: ...o the top hook Figure 2 10B Make sure the Lockbox is secured to the mini cradle 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 Do not use sets with drip chamber or burette with the Lockbox Use the Lockbox with bags up to 250 mL IV that are smaller than 7 cm depth 10 cm width and 24 cm height Before setup...

Page 46: ...oor 3 Insert the pump onto the bottom hooks of the Lockbox and then click it into the top hook 4 Make sure the organizer is aligned with the inner Lockbox wall Figure 2 11 1 Hang the spiked IV bag on the hook inside the Lockbox Figure 2 11 2 A B To lock and unlock the Lockbox the key must be first pressed inwards before turned ...

Page 47: ...t 8 Close the Lockbox door and lock it using the supplied key Note not to close the Lockbox door on the set itself 9 Make sure the Lockbox is locked before removing the key Make sure this segment of the set does not contain any additional components Verify there are no kinks in the administration set Locking the Lockbox with attached mini cradle locks in the mini cradle as well as the medication T...

Page 48: ... supplied key Figure 2 12 Shoulder Strap The Lockbox can be carried using the carry handle or the optional shoulder strap Figure 2 12 The shoulder strap can be used with a pouch for storing the power supply when it is not plugged in Do not grab the Lockbox by the handle when attached to an IV pole Therapy Identification to identify the therapy the Lockbox is used for stick one of the supplied colo...

Page 49: ... more information refer to Configuring Audio Settings on page 203 Figure 2 13 Bolus Handle Connect the bolus handle by attaching it to the socket at the bottom of the pump Make sure that the white arrows on the cable connector are facing up arrows on the bolus cable towards the arrow on the pump When using a mini cradle the blue buttoned bolus handle must be connected directly to the pump When usi...

Page 50: ...e Charge LED status indicator is On blinking yellow light For more information regarding charging the battery refer to Charging the Battery on page 267 To disconnect the power supply from the pump Gently press on both sides of the power supply connector and pull it straight out of the Sapphire pump power socket without rotating the connector Integrated Power Supply The Integrated Power Supply IPS ...

Page 51: ...f the IPS verify that the Power LED status indicator is On blue light 3 Mount the pump into the mini cradle 4 On the front of the pump verify that the Charge LED status indicator is On blinking yellow light To disconnect the AC Power Cord from the IPS 1 Unplug the Q Core AC Power Cord from the main power supply source 2 Disconnect the Cord Retainer from the IPS using a Philips head screwdriver 3 R...

Page 52: ...d to the EBP Hang the EBP with the pump only on an IV pole so that there is no risk of the pump falling General Safety Precautions Begin using the EBP before the pump shuts down due to battery depletion When using the EBP with the pump do not connect the power supply to the pump AA Battery Safety Guidelines AA Batteries with signs of rust bad odor overheating and or other irregularities should not...

Page 53: ...ries power status Operation time of the pump with the EBP is presented in the following table Pump Settings Operation time duration with fresh AA batteries of the specified brands Infusion rate of 125 mL h Backlight set to Off Internal Battery depleted 15 20 hours It is recommended to turn the pump s backlight Off in order to extend its operation time For details about configuring the backlight re...

Page 54: ...n package Figure 2 14 The EBP Components Inserting AA Batteries into the EBP To insert AA batteries into the EBP 1 Make sure that the pump is detached from the EBP 2 Open the AA batteries compartment lid by pushing the latch up Figure 2 14 3 Number Component 1 Small hooks 2 Large hook 3 Latch 4 Suspension hooks 5 EBP LED ...

Page 55: ...er end positive pole in place marked with 4 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 Figure 2 14 3 downwards until it clicks Figure 2 16 Closing EBP Lid To avoid damaging the product open and close the batteries compartment lid only as instructed Avoid using excessive force as it may crack the plas...

Page 56: ...nsion hooks Figure 2 14 4 Make sure that both buckles Figure 2 17 A1 of the strap are facing up 3 Bend both ends of the strap to form a loop and thread each end through the top notch of the suspension hooks Figure 2 14 4 4 Thread each end through the buckle and stretch to adjust the length 5 Attach the pump to the EBP and hang on an IV pole Figure 2 17 C2 For attaching instructions refer to the ne...

Page 57: ...atteries are depleted or stable power supply becomes available Detach the pump from the EBP before turning the pump Off To detach the pump from the EBP 1 Hold the pump firmly when detaching it from the EBP 2 Detach the pump from the EBP by gently pulling the large hook Figure 2 14 2 until the pump is released from grip Make sure not to pull the suspension hooks Figure 2 14 4 because this prevents ...

Page 58: ...e 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 It is recommended to remove the AA batteries from the EBP when not in use Clean only exterior surfaces of the EBP ...

Page 59: ... Mounting System and that the Mounting System is securely attached to the IV pole before attaching the pumps Do not transport the Mounting System while mounted on an IV pole Detach and carry using the handle Verify that the IV pole is not moving tilting or wavering when mounted with a Mounting System Before using the Mounting System make sure that the Mounting System power supply and all cords are...

Page 60: ...lockwise Figure 2 18 Figure 2 18 Mounting System on IV Pole 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 It is recommended to...

Page 61: ...en the mini cradle knob to maximum extent by rotating it 3 Tilt the mini cradle and place the open vice on the top of the Mounting System Figure 2 20 Item A Align the cradle and tighten the knob by rotating it Figure 2 20 Item B 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 Place the mini cradles accordi...

Page 62: ... 4 Plug a DC output connector to the mini cradle splitter 5 Fasten the DC output cables to the clips located on the bottom of the Mounting System 6 Plug the AC input cord to the power outlet Verify that the Mounting System power supply LED is ON Figure 2 21 Fully Assembled Mounting System ...

Page 63: ...nting System and rotate the clamp knob counter clockwise until the Mounting System is loose 3 To carry the Mounting System always use the dedicated carry handle Always contact a certified technician in cases of Mounting System electrical and mechanical malfunctions When removing the Mounting System from the IV pole avoid applying pressure on the power cable connectors or cradles ...

Page 64: ...em 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 This cassette includes a normally closed valve three state Anti Free Flow Valve that provides automatic anti free flow protection Opening the valve allows manual priming as well as transition of ...

Page 65: ...ng the administration set and inserting it into the pump refer to Priming Manually on page 92 and Inserting the Administration Cassette on page 87 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 ...

Page 66: ... s website catalog or any other formally published document Using anything other than administration sets regulatory cleared and labeled for use with Sapphire infusion system may result in operation that is not within the constraints and parameters of the device Note The use of Administration sets manufactured by ICU Medical is approved for sale through March 2023 Name of Set Part Number AP206 01 ...

Page 67: ...sion set with vented non vented drip chamber back check valve and 2 needleless y site 12005 000 0003 AP414 01 Microbore with non vented spike female luer lock with a back check valve 12003 000 0014 AP416 01 Microbore with 2 female luer locks and a back check valve 12003 000 0012 All filters used in Q Core approved administration sets are air eliminating filters Name of Set Part Number ...

Page 68: ...Sapphire Infusion Pump User Manual 67 This page is left intentionally blank ...

Page 69: ...unning selected infusion parameters and other relevant information such as time left until completion of the infusion appear on the4 Main Display The following sections describe how to use the keypads and provide an overview of the main function keys and icons that appear on the Main Display Using the Keypad Numeric keypad The keypad is used for entering digits to specify parameters for volumes ra...

Page 70: ...p to the value of 59 Infusion time of over 59 minutes must be expressed in hours and minutes For example 90 minutes must be entered as 1 30 h min Alphanumeric keypad In some instances for example defining a new PreSet program or entering a drug name the keypad displays letters and symbols in addition to numbers The Alphanumeric keypad displays uppercase letters with numbers and lowercase letters w...

Page 71: ...nitiates priming Appears in the Attention screen after the Prime function has been selected Mute Unmute Silences unsilences the speaker Appears when any alarm is triggered The speaker unmutes automatically after 2 minutes Back Displays the previous screen Exit Returns to either the Start Up screen or to the screen displaying current infusion parameters In situations when the Back key and the Exit ...

Page 72: ...to Pausing Infusions on page 192 Request Continue Continue Bolus Resumes a paused infusion or a bolus View Edit Displays a list of infusion parameters to be viewed or edited Bolus Delivers a bolus during continuous PCA and PCEA modes Icon Meaning Notes Indicates that the parameter immediately adjacent to the icon can be viewed and updated directly from the Main Display To initiate the update touch...

Page 73: ...that the current infusion is below the lower soft limit range in at least one parameter For more information refer to Soft Limit on page 241 Indicates that the current infusion is exceeding both upper and lower soft limit ranges When more than one parameter is limited by the Drug Library one of the parameters is programmed above the upper soft limit and another parameter is programmed below the lo...

Page 74: ... in Line alarm is triggered when the pump air detection is disabled OFF A technician authorization code is required to enable or disable air detection this can only be set manually on the pump and not by the DLE If air detection is disabled OFF use a set with an air eliminating filter to prevent injury Always ensure that the administration set is primed before starting an infusion Icon Meaning Not...

Page 75: ... at a constant rate with optional tapering at the beginning and end of the infusion PCA Patient Controlled Analgesia Delivers PCA boluses either alone or in addition to a basal programmed rate Multi step Delivers the infusion in a set of 1 and up to 25 steps Epidural PCEA Patient Controlled Epidural Analgesia Delivers epidural boluses either alone or in addition to a basal programmed rate Intermit...

Page 76: ...creens that are not mode related such as Delivery mode selections screen below the name Sapphire is displayed instead Figure 3 1 Indicators Bar Delivery Mode Changing the delivery mode is done using the Options menu An authorization code of High is required to modify the delivery mode For more information about how to change the delivery mode refer to Setting Delivery Mode on page 199 ...

Page 77: ... current infusion For more information about Drug Library refer to Chapter 9 Drug Library on page 234 When no Drug Library is loaded all local changes made to any configuration will remain valid until reconfigured or until the pump is set to factory defaults Feature Delivery Mode s Description Notes Allow delayed start All Enables users to start an infusion at a later time The user may either defi...

Page 78: ...he administration set before starting an infusion For more information refer to Automatic Priming Using the Pump on page 90 Allow loading dose PCA PCEA Epidural Enables starting a PCA or PCEA infusion with a programmed initial clinician dose bolus For more information about enabling the feature refer to PCA Options Menu on page 218 or Epidural Mode Options Menu on page 219 Password request Epidura...

Page 79: ...o unlock the screen in order to make changes to the infusion parameters or to start a new infusion Activated first during a running infusion and automatically re activated throughout the infusion For more information about enabling the feature refer to Configuring General Settings on page 204 For more information about using the feature refer to Activating Patient Lockout on page 195 Screen Saver ...

Page 80: ...tart an infusion up to 5 times an hour if a downstream occlusion was detected and cleared within 40 seconds Calculate Concentration All Excluding TPN Determines if the user enters final concentration or Drug Amount and Diluent Volume mL h Only All Excluding TPN Allows users to use units other than mL h If this option is enabled programming will automatically default to mL h This feature is availab...

Page 81: ... and Operations 80 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 ...

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Page 83: ...pump and administration set for an infusion comprises the following steps 1 Turn the pump On 2 Connect the infusion container to the administration set 3 Open the safety door 4 Insert the cassette 5 Prime the administration set using the pump 6 Connect the administration set to the patient When using an administration set with a filter place the filter under the patient s IV infusion site Chapter ...

Page 84: ...Sapphire Infusion Pump User Manual 83 The workflow sequence is illustrated in the following figure Figure 4 1 Recommended Workflow ...

Page 85: ...key for 5 consecutive seconds turns the pump Off Alternatively press the On Off hard key and then from the Attention screen press Off For more information about turning the pump Off during an infusion refer to Aborting Infusions on page 193 While the pump turns On a system check is performed If you do not hear a sound from the speaker or if items on the screen do not display properly do not use th...

Page 86: ... in from the pump when possible 3 Spike the administration set into the container Connecting the Infusion Container Safety Precautions Make sure there is no leakage from the container and that the spike is firmly attached to the container Verify that the set components are positioned correctly The arrows on the administration cassette and the filter must point toward the direction of the flow from...

Page 87: ...ety Door Opening the safety door involves pressing it down while simultaneously pulling the safety door open To open the safety door 1 Using your thumb press the door outwards 2 While maintaining pressure swing the safety door outwards ...

Page 88: ... 1 Figure 4 2 Administration Cassette To insert the Q Core administration cassette 1 Open the safety door Opening the Safety Door on page 86 Then insert the administration cassette at an angle by placing the saddle Figure 4 3 1 on the round metal anchor 2 in the cassette s housing Make sure that the arrow on the cassette 3 is pointing toward the bottom of the pump and the bottom flange is inside t...

Page 89: ...igure 4 3 Insertion of Cassette 2 Clip the upper end of the administration cassette into the metal lock Figure 4 3 4 3 Close the safety door over the administration cassette Ensure that the safety door clicks upon closure ...

Page 90: ... remove the cassette from the pump To remove the Q Core administration cassette 1 Close all clamps on the administration set 2 Disconnect the patient from the administration set 3 Open the safety door Opening the Safety Door on page 86 4 Loosen the cassette by raising the metal lock that secures it to the pump 4 in Figure 4 3 5 Pull out the cassette and close the safety door Although the AFFV offe...

Page 91: ...lus Air in Line Alarm Before using the pump for priming ensure that The administration set clamp is open The safety door is closed The Q Core administration cassette is properly connected to the pump It is recommended to prime the administration set using the pump Before priming verify that the administration set is disconnected from the patient When the Prime Reminder is enabled and the set has n...

Page 92: ...e countdown displayed The default priming time is 2 minutes When using administration sets that contain less than 20 mL shorter priming times can be set For more information refer to Set prime volume on page 205 The pump automatically indicates when priming is finished If priming is completed before the default priming time has elapsed automatic priming can be discontinued To discontinue priming 1...

Page 93: ...nd down towards the center of the Q Core administration cassette 1 in Figure 4 4 3 Fill the entire administration set with fluid so that the fluid displaces all air in the administration set 4 To block free flow close the AFFV by pushing it up and away from the center of the cassette 2 in Figure 4 4 The following procedure explains how to prime the administration set manually using gravity However...

Page 94: ...s attached In order to ensure full protection insert the administration cassette to the pump housing before connecting the set to the patient To use as a gravity set fix the AFFV in an open position as described in step 2 in To prime the administration set manually on page 92 Only administration sets that include a roller clamp and do not include pressure activated valves PAV can be used by gravit...

Page 95: ...ous Mode 94 Multi step Mode 123 Total Parenteral Nutrition TPN Mode 132 Intermittent Mode 139 Patient Controlled Analgesia PCA Mode 149 Epidural Mode 160 Continuous Mode The following sections will be reviewed Infusion Parameters Continuous Mode 97 Starting a Continuous Infusion 97 Continuous Mode Mid infusion Actions 109 In this mode the pump infuses fluid at a constant programmed rate Figure 5 1...

Page 96: ... 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 Figure 5 2 Secondary Infusion Setup To use the Secondary option the option must be enabled requires Technician authorization code ...

Page 97: ...afety Precautions When working with Secondary infusions adhere to the following instructions and guidelines Use only Q Core administration sets designed for Piggyback infusions For more information refer to Q Core Approved Administration Sets on page 65 Hang the Secondary solution container at least 8 inches above the Primary solution fluid level Use the drip chamber on the set to verify that the ...

Page 98: ...fluid is infused Rate values can range from 0 1 to 999 mL h Note When selecting units that are not from the mL h family the word Rate is replaced with Dose Rate VTBI The total amount of fluid to be infused VTBI values can range from 0 1 to 9999 mL The remaining VTBI is displayed on the screen as the infusion progresses Time The period of time over which the fluid is infused The range for the Time ...

Page 99: ...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 OK then continue to Step 7 7 From the Attention screen confirm the concentration and press OK If the selected drug unit is Million Units continue to Step 10 8 If the Patient Weight screen appears specify whether the infusion is weight based ...

Page 100: ...ug concentration as entered by the user Final concentration or Drug Amount Diluent Volume Displayed when applicable 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 The rate reduction is always 0 1 mL h and is presented on the Running screen when sele...

Page 101: ...ous infusion with a Drug Library 1 From the Indicators Bar verify that the pump is in Continuous mode 2 From the Start Up screen select New Infusion 3 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 4 From the Drug Name screen Using the keypad enter the drug name then press Find and proceed to Step 5 To view all prog...

Page 102: ... without Drug Library and continue programming from there Diluent only e g 10 mL proceed to Step 8 on page 98 To begin a new Continuous infusion without Drug Library and continue programming from there Partial concentration the Drug Amount or Diluent Volume is missing The screen of the missing value will appear From the Drug Amount screen using the keypad enter the Drug Amount OK From the Diluent ...

Page 103: ...hout Drug Library and continue programming from there If a list of available drug profiles does not appear continue to Step 11 on page 98 To begin a new Continuous infusion without Drug Library and continue programming from there For more information about the Drug Library refer to Chapter 9 Drug Library on page 234 ...

Page 104: ...et Secondary 4 If the Dosing method screen appears select the appropriate option mL Continue to Step 8 Dose calculation Continue to Step 5 Weight based units are available for both Dosing methods Otherwise continue to Step 11 5 From the Concentration units screen select the appropriate drug units If the calculated rate is beyond the pump resolution 0 1 mL h increments the pump decreases the rate b...

Page 105: ...om the Patient Weight screen If the patient weight was entered during the primary line programming continue to Step 10 If the patient weight was not entered during the primary line programming using the keypad enter the Patient Weight OK 10 From the Dose Rate units screen select the appropriate dose rate units 11 Program 2 of the following 3 parameters by selecting the relevant boxes Rate Secondar...

Page 106: ... of the drug infused After the secondary infusion is completed the pump automatically switches to the primary line and beeps to notify the user The following information is displayed on the Primary Secondary screen Drug Name The name of the selected drug Displayed on the indicators bar when working with a Drug Library Drug Concentration Drug concentration as entered by the user Final concentration...

Page 107: ... Switching between Primary and Secondary Infusions on page 119 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 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 If the calculated rate is beyond the pump resolu...

Page 108: ...begin a new Continuous infusion using the Secondary option without Drug Library and continue programming from there Diluent only e g 10 mL proceed to Step 8 on page 104 To begin a new Continuous infusion using the Secondary option without Drug Library and continue programming from there Partial concentration the Drug Amount or Diluent Volume is missing The screen of the missing value will appear F...

Page 109: ...ncentration Proceed to Step 8 on page 104 To begin a new Continuous infusion using the Secondary option without Drug Library and continue programming from there If a list of available drug profiles does not appear continue to Step 11 on page 104 To begin a new Continuous infusion using the Secondary option without Drug Library and continue programming from there For more information about the Drug...

Page 110: ...In addition you can modify the rate VTBI and time left directly from the Running Primary or Secondary screen To update current parameters directly from the screen 1 On the Main Display select the relevant parameter Rate VTBI or Time left 2 Using the keypad enter the new value of the parameter OK 3 To confirm and save changes press OK To return to the original infusion screen without saving changes...

Page 111: ...ttention screen press OK Administering a Bolus The Bolus feature enables administration of a fast dose when rapid volume infusion in the Continuous mode is necessary To deliver a bolus 1 From the toolbar of the Running Primary or Secondary screen press Bolus 2 If the Patient Weight screen appears using the keypad enter the Patient Weight OK Bolus delivery allows infusion at high rates Only certifi...

Page 112: ...ing to the current VTBI Then continue to Step 5 Trying to enter one of the unavailable grayed out boxes triggers a message requesting to enter the Bolus amount first When trying to exit programming before its completion a message is displayed stating that the data entered has not been saved Bolus units used may differ from the units used by the infusion due to their pre configuration in the Drug L...

Page 113: ...on as entered by the user Final concentration or Drug Amount Diluent Volume Displayed when applicable Bolus Rate Current infusion rate Bolus VTBI Total bolus amount left to be infused As the bolus progresses this value decreases Bolus VI Total Total bolus amount that has been infused during the current infusion the total bolus amount programmed As the infusion progresses the Bolus VI increases and...

Page 114: ...Bolus VTBI or Time Left 2 Using the keypad enter the new Rate VTBI or Time left OK 3 From the Attention screen press OK Updated parameters are displayed Pausing a Bolus When necessary you can temporarily stop the bolus To pause a bolus From the toolbar of the bolus delivery screen press Pause Bolus Then from the Attention screen press OK Alternatively press the Stop hard key All volume delivery st...

Page 115: ...e infusion Secondary option not in use 1 Press the Stop hard key Alternatively press the Pause Bolus then press OK The bolus is paused 2 From the toolbar press Quit Bolus 3 From the toolbar of the Paused screen press Request Continue 4 From the Attention screen press OK To abort a bolus and continue the infusion Secondary option in use 1 Press the Stop hard key Alternatively press the Pause Bolus ...

Page 116: ...one of the following screens will appear Concentration From the Concentration screen using the keypad enter the Concentration OK Then continue to Step 7 Drug amount Using the keypad enter the Drug Amount OK Then using the keypad enter the Diluent Volume OK Then continue to Step 6 6 From the Attention screen confirm the concentration and press OK If the selected drug unit is Million Units continue ...

Page 117: ... Using the keypad enter the value OK VTBI Secondary Using the keypad enter the value OK Time Secondary Using the keypad enter the value OK The third unprogrammed parameter is then automatically calculated by the pump and displayed in the relevant box 11 Review the parameters displayed on the Confirm screen Then press OK If the calculated rate is beyond the pump resolution 0 1 mL h increments the p...

Page 118: ...ndary line while a Primary line is running with a Drug Library 1 From the toolbar press View Edit 2 Select Add Sec Line 3 From the Drug Name screen Using the keypad enter the drug name then press Find and proceed to Step 4 When the required drug is not found in the Drug Library press the Choose General key on the toolbar From the Attention screen confirm choosing General and press OK Proceed to St...

Page 119: ...ill appear From the Drug Amount screen using the keypad enter the Drug Amount OK From the Diluent Volume screen using the keypad enter the Diluent Volume OK From the Attention screen confirm the concentration and press OK Proceed to Step 7 on page 116 To add a Secondary line while a Primary line is running without Drug Library and continue programming from there Full concentration Proceed to Step ...

Page 120: ...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 To switch from the Secondary to the Primary infusion 1 Pause the Secondary infusion From the toolbar of the Secondary screen press Request Pause Then from the Attention screen press OK Alternatively press the Stop hard key...

Page 121: ...nfusion From the toolbar of the Secondary screen press Request Pause Then from the Attention screen press OK Alternatively press the Stop hard key 2 From the toolbar of the paused screen press View Edit 3 On the View Edit screen select Delete Replace Sec Line 4 On the Delete Replace screen select Delete and move to primary 5 The Attention screen appears After verifying that the clamps on the Secon...

Page 122: ...atively press the Stop hard key 2 From the toolbar of the paused screen press View Edit 3 On the View Edit screen select Delete Replace Sec Line 4 On the Delete Replace screen select Replace secondary 5 From the Attention screen press OK to delete the current secondary line and to program a different secondary infusion 6 Proceed to Step 3 on page 115 To add a Secondary line while a Primary line is...

Page 123: ...ress OK Alternatively press the Stop hard key 2 From the toolbar of the paused screen press View Edit 3 On the View Edit screen select Delete Replace Sec Line 4 On the Delete Replace screen select Replace secondary 5 From the Attention screen press OK to delete the current secondary line and to program a different secondary infusion 6 Proceed to Step 3 on page 117 To add a Secondary line while a P...

Page 124: ...Mid infusion Actions 130 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 Although the infusion rates of each Step can differ the rate within a single Step does not vary constant continuous infusion Figure 5 3 Multi step Flow Profile ...

Page 125: ...ect New Infusion Parameter Description Notes Rate The speed at which the fluid is infused Rate values can range from 0 1 to 999 mL h Note When selecting units that are not from the mL h family the word Rate is replaced with Dose Rate 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 Time T...

Page 126: ...nt Using the keypad enter the Drug Amount OK Then using the keypad enter the Diluent Volume OK Then continue to Step 7 7 From the Attention screen confirm the concentration and press OK If the selected drug unit is Million Units continue to Step 10 8 If the Patient Weight screen appears specify whether the infusion is weight based Yes Continue to Step 9 No Continue to Step 10 9 From the Patient We...

Page 127: ... steps Number of Steps making up the total infusion Review Steps details Selecting this option displays the parameters of all programmed Steps screen by screen with each step displayed in its own screen 15 Review the parameters displayed on the Confirm screen Then press OK 16 Make sure that the clamps on the administration set are open then press Start The Running screen is displayed and the infus...

Page 128: ...creases and the Total remains constant Time left Time remaining until the end of the entire infusion Step Time Time remaining until the end of the current Step To begin a new Multi step infusion with a Drug Library 1 From the Indicators Bar verify that the pump is in Multi step delivery mode 2 From the Start Up screen select New Infusion 3 If a warning that the air detection is disabled OFF appear...

Page 129: ...Step 8 on page 125 To begin a new Multi step infusion without Drug Library and continue programming from there Diluent only e g 10 mL proceed to Step 8 on page 125 To begin a new Multi step infusion without Drug Library and continue programming from there Partial concentration the Drug Amount or Diluent Volume is missing The screen for the missing value will appear From the Drug Amount screen usin...

Page 130: ... from there Full concentration Proceed to Step 8 on page 125 To begin a new Multi step infusion without Drug Library and continue programming from there If a list of available drug profiles does not appear continue to Step 8 on page 125 To begin a new Multi step infusion without Drug Library and continue programming from there For more information about the Drug Library refer to Chapter 9 Drug Lib...

Page 131: ...ng Step can be updated by using the View Edit function key To update current Step parameters from the Running screen 1 Select the frame of the parameter that you want to update Rate VTBI or Step Time 2 Using the keypad enter the new rate VTBI during the Step or time remaining until the end of the Step OK 3 To confirm and save changes press OK To return to the original infusion screen without savin...

Page 132: ...ions are also available 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 Accumulated VI on page 233 Next step Allows you to update infusion parameters of the Step following the current Step This box appears only if there is a Step following the current Step View system Displays various system and pum...

Page 133: ...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 The TPN delivery mode permits high volume delivery of solutions with optional tapering ramping When tapering is used delivery rate is gradually increased decreased tapered up tapered down at the beginning and end of the ...

Page 134: ...BI The total amount of fluid to be infused VTBI values can range from 0 1 to 9999 mL with a tolerance of 0 2 mL The remaining VTBI is displayed on the screen as the infusion progresses The pump calculates the Plateau Rate based on the VTBI the infusion period and the taper values Taper Up The length of time over which the rate increases to the Plateau Rate The Taper Up and Down period can be set t...

Page 135: ...abled OFF appears ensure that a set with an air eliminating filter is used and press OK 4 Using the keypad enter the VTBI value OK 5 Specify whether you want to use tapers Select Yes or No If you select No proceed to Step 7 6 Specify tapers a On the Taper Up screen use the keypad to enter the Taper Up time OK The Taper Up time can be set to 0 b On the Taper Down screen use the keypad to enter the ...

Page 136: ...culated 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 As the infusion progresses this value decreases 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 Tim...

Page 137: ...meters Refer to View Menu on page 211 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 A message stating that the infusion is paused appears 30 seconds after pausing the infusion audible and visual Pressing the Stop hard key stops the infusion immediately bypassin...

Page 138: ...the pump is set to the Low authorization level with no Taper Down period programmed the Request Pause key will be available without the option to Taper down To resume a paused infusion 1 From the toolbar press Request Continue 2 From the toolbar of the Attention screen press OK If the pump is set to a Low authorization level with no Taper Down period programmed the Request Pause key will be availa...

Page 139: ...r than 10 minutes The pump is set to Medium or higher authorization level in case no Taper period is programmed To immediately Taper Down an infusion 1 From the toolbar press Taper Down 2 From the Taper Down screen select Immediate Taper Down 3 From the Immediate Taper Down screen accept the preprogrammed time settings or enter the Taper Down time using the keypad OK 4 From the Attention screen pr...

Page 140: ...n Intermittent Infusion 140 Intermittent Mode Mid infusion Actions 147 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 A KVO rate can be programmed to run between intermittent dose Figure 5 5 Intermittent Flow Profile ...

Page 141: ...99 mL Dose Time The period of time over which the intermittent dose is delivered Values can range from 00 01 to 96 00 hh mm Dose Interval The frequency of intermittent dose delivery Intermittent Dose KVO Intermittent doses can be given as frequently as 5 minutes apart Therefore the minimum programmable Dose Interval is the Dose time plus 5 minutes This rule applies even when the KVO rate is set to...

Page 142: ...ntration units screen select the appropriate drug units 6 According to pump configuration one of the following screens will appear Concentration From 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 OK Then continue to Step 7 7 From the Attention screen confi...

Page 143: ...ntermittent Dose screen is displayed and the infusion begins with the first dose Throughout the infusion the infusion phase Intermittent Dose or KVO 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 Drug Concentration Drug concentration as entered by...

Page 144: ...otal 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 Dose time left KVO time Pause During Dose When the infusion is paused during Dose the time to the next Intermittent Dose Time to Dose is paused and not displayed ...

Page 145: ... started reminding when to resume the infusion When the infusion is paused during KVO the time to the next Intermittent Dose Time to Dose is displayed and continues to count Time left Time remaining until the end of the entire infusion 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 For more in...

Page 146: ...ess Choose General key on the toolbar From the Attention screen confirm Choosing General and press OK Proceed to Step 4 on page 141 To begin a new Intermittent infusion without Drug Library and continue programming from there 5 From the Drug List screen select the row of the relevant drug For more information about changing delivery modes refer to Selecting Delivery Mode on page 74 The Find key ca...

Page 147: ...appear From the Drug Amount screen using the keypad enter the Drug Amount OK From the Diluent Volume screen using the keypad enter the Diluent Volume OK From the Attention screen confirm the concentration and press OK Proceed to Step 8 on page 141 To begin a new Intermittent infusion without Drug Library and continue programming from there Full concentration Proceed to Step 8 on page 141 To begin ...

Page 148: ...dified directly from the Main Display To update parameters of the current phase from the Main Display 1 On the Main Display select the VTBI relevant frame 2 Using the keypad enter the new VTBI OK 3 Review the parameter displayed on the Attention screen OK To return to the original infusion screen without saving changes press Back Then from the VTBI screen press Back To update parameters using the ...

Page 149: ...ailable 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 Menu on page 211 5 To confirm and save changes press OK To return to the original infusion screen without saving changes press Back Then from the Attention screen press OK ...

Page 150: ...ions 157 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 Additional boluses can be provided by a clinician using the appropriate authorization code Figure 5 6 PCA Flow Profile For more information about the bolus handle refer to PCA PCEA PIEB Bolus Handle on pag...

Page 151: ...ge from 0 1 to 9999 mL Demand Bolus The amount of fluid infused in a single bolus Demand bolus values can range from 0 1 to 30 mL or be equal to zero Continuous Only infusion Bolus Lockout The minimum time that must pass between the end of one bolus to the start of the next bolus After a bolus delivery ends the next bolus becomes available following the lockout time Dose Limit The option to choose...

Page 152: ...livered via Continuous rate Yes Demand Bolus Yes Loading Dose Yes Clinician bolus Yes All doses including boluses given by clinician are taken into account When the Total dose limit is reached the patient is locked out from activating additional boluses Loading Dose An optional feature that begins the infusion with a clinician bolus Loading dose values range from 0 1 to 30 mL To use this feature i...

Page 153: ...t Using the keypad enter the Drug Amount OK Then using the keypad enter the Diluent Volume OK Then continue to Step 7 7 From the Attention screen confirm the concentration and press OK If the selected drug unit is Million Units continue to Step 10 8 If the Patient Weight screen appears specify whether the infusion is weight based Yes Continue to Step 9 No Continue to Step 10 9 From the Patient Wei...

Page 154: ...e delivered within a one or four hour period OK Continue to Step 17 17 If Add Loading Dose screen appears specify whether to program a loading dose Yes Using the keypad enter the value for the Loading Dose OK No Proceed to Step 18 Otherwise continue to Step 18 18 Review the parameters displayed on the Confirm screen Then press OK 19 To begin the infusion make sure that the clamps on the administra...

Page 155: ...infused As the infusion progresses this value decreases 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 Lockout time Time remaining until the next bolus is available After the lockout time elapses this parameter changes to Bolus a...

Page 156: ... General key on the toolbar From the Attention screen confirm Choosing General and press OK Proceed to Step 4 on page 152 To begin a new PCA infusion without Drug Library and continue programming from there 5 From the Drug List screen select the row of the relevant drug For more information about changing delivery modes refer to Selecting Delivery Mode on page 74 The Find key can be used to displa...

Page 157: ...will appear From the Drug Amount screen using the keypad enter the Drug Amount OK From the Diluent Volume screen using the keypad enter the Diluent Volume OK From the Attention screen confirm the concentration and press OK Proceed to Step 8 on page 152 To begin a new PCA infusion without Drug Library and continue programming from there Full concentration Proceed to Step 8 on page 152 To begin a ne...

Page 158: ...for the current infusion phase can be updated directly from the Main Display During a bolus delivery no parameter can be changed To update parameters for the current phase Basal Bolus from the Main Display 1 Pause the infusion Pausing Infusions on page 192 2 On the Main Display select the relevant frame Continuous Rate or VTBI 3 Using the keypad enter the new Continuous Rate or VTBI OK 4 To confir...

Page 159: ...to 0 mL View system Displays various system and pump parameters Refer to View Menu on page 211 Delivery history Displays a summary of bolus delivery events For more information refer to Viewing Delivery History on page 216 6 To confirm and save changes press OK To return to the Paused screen without saving changes press Back Then from the Attention screen press OK When modifying demand bolus limit...

Page 160: ...ering a clinician bolus To administer a clinician bolus 1 From the toolbar of the Running screen press View Edit 2 Select Clinician bolus 3 Using the keypad enter the appropriate password OK 4 On the Clinician bolus screen using the keypad enter the bolus amount OK 5 To start the bolus from the Attention screen press OK The Clinician bolus screen appears and the bolus begins The default clinician ...

Page 161: ...to accommodate the special requirements of an epidural infusion such as lower VTBI lower infusion rate and higher backpressure In Epidural intermittent mode and in PCEA mode bolus rate can be configured to 125 mL h or 200 mL h before starting infusion for more information refer to Epidural Mode Options Menu on page 219 Epidural Mode Safety Precautions When working with epidural infusions adhere to...

Page 162: ...ode Mid infusion Actions 169 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 Additional boluses can be provided by a clinician using the appropriate authorization code Figure 5 7 PCEA Flow Profile For more information about the bolus handle refer to PCA PCEA PIEB Bolus Handle on page 48 ...

Page 163: ... from 0 1 to 9999 mL Demand Bolus The amount of fluid infused in a single bolus Demand bolus values can range from 0 1 to 30 mL or be equal to zero Continuous Only infusion Bolus Lockout The minimum time that must pass between the end of one bolus to the start of the next patient bolus After a bolus delivery ends the next patient bolus becomes available following the lockout time Dose Limit The op...

Page 164: ... for the Total dose limit Loading Dose No Clinician bolus No When the Total dose limit is reached the patient is locked out from activating additional boluses Loading Dose An optional feature that begins the infusion with a clinician bolus Loading dose values range from 0 1 to 30 mL To use this feature it must be enabled For more information refer to Epidural Mode Options Menu on page 219 The bolu...

Page 165: ...the Concentration units screen select the appropriate drug units 5 According to pump configuration one of the following screens will appear Concentration From concentration screen using the keypad enter the Concentration OK Then continue to Step 7 Drug amount Using the keypad enter the Drug Amount OK Then using the keypad enter the Diluent Volume OK Then continue to Step 6 If relevant you may skip...

Page 166: ...The Continuous Rate can be set to zero 12 Using the keypad enter the value for the Demand Bolus OK 13 Using the keypad enter the value for the Bolus Lockout OK 14 From the Dose Limit Type screen specify whether the infusion is according to dose limits Yes Continue to Step 15 No Continue to Step 16 15 From the Dose Limit Type screen select the appropriate Dose Limit type and proceed to the directed...

Page 167: ...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 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 ...

Page 168: ...ame screen Using the keypad enter the drug name then press Find and proceed to Step 4 When a bolus is being given loading dose clinician bolus or patient bolus this parameter does not appear 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 For more information refer to Viewing System Parameters ...

Page 169: ... g 10 mL proceed to Step 7 on page 165 To begin a new PCEA infusion without Drug Library and continue programming from there Partial concentration the Drug Amount or Diluent Volume is missing A screen for the missing value will appear From the Drug Amount screen using the keypad enter the Drug Amount OK From the Diluent Volume screen using the keypad enter the Diluent Volume OK From the Attention ...

Page 170: ...meters In PCEA mode the infusion must be paused before any parameter can be updated Once the infusion is paused infusion parameters can be modified by using the View Edit function key In addition the continuous rate and VTBI for the current infusion phase can be modified directly from the Main Display During a bolus delivery no parameters can be changed To update parameters for the current phase B...

Page 171: ...le 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 Menu on page 211 Delivery history Displays a summary of medication delivery events For more information refer to Viewing Delivery History on page 216 6 To confirm and save changes press OK To return to the Paused screen without ...

Page 172: ...lus To administer a clinician bolus 1 From the toolbar of the Running screen press View Edit 2 Select Clinician bolus 3 Using the keypad enter the appropriate password OK 4 Using the keypad enter the bolus amount OK 5 To start the bolus from the Attention screen press OK The Clinician bolus screen appears and the bolus begins The rate of all boluses during PCEA is defined prior to programming the ...

Page 173: ...idural Intermittent Mode Mid infusion Actions 184 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 The dose interval is the frequency at which the intermittent dose is delivered A continuous rate can be programmed to run between intermittent doses Figure 5 8 Epidural Intermittent Flow Profile ...

Page 174: ...kout Time period immediately after an intermittent dose or any other bolus If the time remaining from the Patient Bolus to the next scheduled intermittent dose is shorter than the Lockout Time the next intermittent dose will be delayed to accommodate the Lockout Time Unlike the Patient Bolus the clinician will be able to administer a Clinician Bolus within the Lockout Time immediately after the in...

Page 175: ...m 0 1 to 30 mL Dose Interval The frequency of intermittent dose delivery Intermittent Dose Continuous Rate Intermittent doses can be given as frequently as 5 minutes apart Therefore the minimum programmable Dose Interval is the Intermittent Dose time plus 5 minutes This rule applies even when the continuous rate is set to 0 Continuous Rate The rate of fluids delivered between doses to prevent clot...

Page 176: ...te Yes Intermittent dose Yes Demand Bolus Yes Boluses given by a clinician are not taken into account for the Total dose limit Clinician bolus No When the Total dose limit is reached the patient is locked out from activating additional boluses Applicable only when programming Epidural Intermittent with PCEA The bolus rate applies to all boluses delivered during the infusion The bolus rate can be c...

Page 177: ...the appropriate drug units 5 According to pump configuration one of the following screens will appear Concentration From concentration screen using the keypad enter the Concentration OK Then continue to Step 7 Drug amount Using the keypad enter the Drug Amount OK Then using the keypad enter the Diluent Volume OK Then continue to Step 6 6 From the Attention screen confirm the concentration and pres...

Page 178: ...nterval OK 13 Using the keypad enter the Continuous rate OK The Continuous rate may be set to zero 14 Review the parameters displayed on the Confirm screen Then press OK 15 To begin the infusion make sure that the clamps on the administration set are open and press Start The Intermittent Dose screen is displayed and the infusion begins with the first dose Verify that the parameters reflect the cor...

Page 179: ...ning screen VTBI Total volume left to be infused As the infusion progresses this value decreases 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 Left Time remaining until the end of the current infusion This parameter remains...

Page 180: ...To begin a new Epidural Intermittent infusion without Drug Library and continue programming from there 4 From the Drug List screen select the row of the relevant drug 5 If a list of available drug profiles appears select the appropriate drug profile and proceed according to the step directed to For more information about changing delivery modes refer to Selecting Delivery Mode on page 74 The Find ...

Page 181: ...ount OK From the Diluent Volume screen using the keypad enter the Diluent Volume OK From the Attention screen confirm the concentration and press OK Proceed to Step 7 on page 177 To begin a new Epidural Intermittent infusion without Drug Library and continue programming from there Full concentration Proceed to Step 7 on page 177 To begin a new Epidural Intermittent infusion without Drug Library an...

Page 182: ... the Bolus Lockout OK 6 From the Dose Limit Type screen specify whether or not the patient boluses should be limited Yes Continue to Step 7 No Continue to Step 8 7 From the Dose Limit Type screen select the appropriate Dose Limit type and proceed to the directed step Number of Boluses Using the keypad enter the maximum number of boluses that will be available for the patient within a one or four h...

Page 183: ...alculated 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 As the infusion progresses this value decreases 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 L...

Page 184: ...ers displayed on the Confirm screen Then press OK 3 From the Start screen select Add PCEA Proceed to Step 4 on page 181 To begin a new PIEB Infusion without Drug Library and continue programming from there For more information about the Drug Library refer to Chapter 9 Drug Library on page 234 To view all programmed parameters of the current infusion including the rate in mL h from the Running scre...

Page 185: ...tinuous Rate or Dose Rate and VTBI for the Intermittent Dose phase can be modified directly from the Main Display during a bolus delivery no parameter can be changed To update parameters for the current phase intermittent dose Continuous rate the Main Display 1 Pause the infusion Pausing Infusions on page 192 2 On the Main Display select the relevant frame Dose rate Continuous rate or VTBI 3 Using...

Page 186: ...arameters Refer to View Menu on page 211 Delivery History Displays a summary of medication delivery events For more information refer to Viewing Delivery History on page 216 Applies only when Epidural Intermittent with PCEA infusion was programmed 6 To confirm and save changes press OK To return to the Paused screen without saving changes press Back Then from the Attention screen press OK When cha...

Page 187: ...ral Intermittent with PCEA To administer a clinician bolus 1 From the toolbar of the Running screen press View Edit 2 Select Clinician bolus 3 Using the keypad enter the appropriate password OK 4 Using the keypad enter the bolus amount OK 5 To start the bolus from the Attention screen press OK The Clinician bolus screen appears and the bolus begins The RATE of the Clinician Bolus as all other bolu...

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Page 189: ...he first one has been emptied or discontinued the same infusion parameters used for the same patient The pump automatically saves all the parameters programmed excluding secondary line for the last infusion performed in that delivery mode If a parameter is updated while an infusion is running the updated parameter is saved The Last Infusion settings are saved even if the last infusion was not comp...

Page 190: ...and the infusion begins 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 ...

Page 191: ...he desired program 4 Review the parameters that are displayed Then press OK 5 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 For the PreSet Programs option to appear on the Start Up screen the PreSet programs need to be enabled on the pump For more information refer to Configuring General Setting...

Page 192: ... Paused infusion screen appears Press Request continue to resume the infusion 4 On the Attention screen press OK to confirm The running screen appears To abort the previous infusion On the Attention screen press Exit The Start Up screen appears The option to resume will not be available if the pump was shut down due to a critical alarm or if the infusion was quit When a Drug Library is loaded Resu...

Page 193: ...30 seconds after pausing the infusion audible and visual To pause an infusion using the Stop hard key At the bottom of the pump press Stop The infusion is paused Pressing the Stop hard key stops the infusion immediately bypassing the need for confirmation of the Pause action In an emergency it is recommended to pause the infusion using the Stop hard key In routine situations using the Request Paus...

Page 194: ...suming the infusion after quitting is impossible Turning off the pump Turns the pump Off mid infusion using the On Off hard key When the pump is turned Off mid infusion the infusion parameters are saved When the pump is turned back On the user is prompted to indicate whether or not to continue the stopped infusion To pause and then quit an infusion 1 At the bottom of the pump press the Stop hard k...

Page 195: ... is running To lock the screen 1 From the toolbar of the Running screen press Lock 2 On the Lock options screen select Lock Screen The icons on the Main Display and the toolbar function keys disappear Only the Press to Unlock Screen function key appears on the toolbar Resuming infusion after quitting will not be possible When a Drug Library is loaded on the pump the Clinical Care Area screen appea...

Page 196: ...toolbar press Press to Unlock Patient 2 Using the keypad enter the relevant password and press OK Ending Infusion When the infusion is complete entire programmed VTBI delivered the pump automatically activates the KVO the default or the infusion rate the lower of the two and displays the infusion summary VI volume infused VI for the current completed infusion If the Accumulated VI has been cleared...

Page 197: ...ge screen press OK 2 From the toolbar of the KVO screen press Quit 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 When a Drug Library is loaded and CCA was changed during the previous running infusion an Attention screen appears asking to confirm th...

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Page 199: ...d by pressing the Options function key on the toolbar of the Start Up screen The Options screen allows access to all configurations and settings of the Sapphire pump as opposed to settings relevant to a specific infusion The screen also provides access to testing components and viewing pump as opposed to infusion parameters e g System parameters Event logs and Delivery History Chapter 7 Options Me...

Page 200: ...zation code of High or Technician is required to modify the delivery mode To change the delivery mode 1 From the toolbar press Options 2 From the Options screen select Delivery mode 3 Using the keypad enter the required password and then press OK 4 Select the relevant delivery mode The Start Up screen of the selected mode appears When you change the delivery mode the pump reverts to the default va...

Page 201: ...related options Only users with authorization levels of High or Technician have access to this menu To access the Alarms menu From the toolbar of the Start Up screen select Options Then select Pump configuration Alarms 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 For more information refer to Chapter...

Page 202: ...Pump unattended The number of consecutive minutes of no interaction with the pump after which a Pump Unattended alarm is triggered Options are 2 5 or 10 minutes Note A Pump Unattended alarm is not triggered when the pump is in Delayed start or Standby Select Pump unattended Then select 2 min 5 min or 10 min Infusion near end The number of minutes before completion of an infusion at which an Infusi...

Page 203: ... levels can impede operator recognition of alarm conditions For more information about messages and alarms refer to Chapter 10 Alarms and Troubleshooting on page 244 Select Alarm volume Then select Maximum or Minimum An Occlusion Auto restart option exists and is available for configuration by authorized technicians only This option allows the pump to restart the infusion automatically provided th...

Page 204: ...ress keys on the pump Select Keys volume Then select Low High or Off Alarm volume Sets the speaker volume for the auditory alarm signal Options are Maximum or Minimum When the option is set to Minimum messages are provided with a visual signal only Alarm levels 1 2 and 3 and the Infusion Complete message are provided with a visual signal and the lowest auditory signal permitted according to IEC 60...

Page 205: ...us handle is pressed When set to When Bolusing an auditory signal is generated when the bolus handle is pressed and bolus is available Select Bolus Handle Then select Always On or When Bolusing Option Descriptions Notes To Modify Parameter from the General settings screen Current CCA Used to select the CCA to which the pump should be set Appears only when Drug Library is loaded For more informatio...

Page 206: ...d used to prime the administration set when automatic priming is performed The acceptable range is 2 to 25 mL Select Set prime volume Then using the keypad enter the desired value OK Backlight Allows the user to set the degree of screen brightness for a running infusion Backlight can also be modified during a running infusion The Off and Partial options of this feature save power and promote longe...

Page 207: ...s a reminder for the user to connect the bolus handle before starting a PCA PCEA or PIEB infusion that includes patient boluses The reminder Instructs to connect the bolus handle directly to the pump Checks functionality bolus press is recognized by the pump Select the Bolus Reminder row to toggle the option between On and Off Auto P lockout Enables disables Patient Lockout a safety feature that r...

Page 208: ...s started and the pump has not been touched The screen saver will not appear in the following cases Delayed start end of infusion KVO or during a Bolus delivery The screen saver will disappear in the following cases Alarm screen will revert to the alarm screen Touching the screen screen will revert to the Running screen Infusion is paused screen will revert to the Paused screen Select the Screen S...

Page 209: ...onfigure settings from the Regional menu Option Descriptions Notes To Modify Parameter from the General settings screen Repeat last infusion Allows the user to start infusions using the same infusion parameters for the same patient When the option is enabled the Repeat Last Infusion button appears on the pump Start screen For more information refer to Repeating Last Infusion on page 188 Select the...

Page 210: ...h the time units from AM to PM or vice versa by pressing the AM PM function key This step is relevant only when U S format is set 4 To confirm the new settings press OK To set the language 1 Select the Language frame 2 Select the desired language 3 To confirm the new settings press OK To set the US format 1 Select the US format frame 2 Toggle the settings between On and Off 3 To confirm the new se...

Page 211: ...tem Option Descriptions Notes Speaker high On High volume auditory signal sounds Off No auditory signal Speaker low On Low volume auditory signal sounds Off No auditory signal Alarm LED On The red Alarm LED is lit Off The red Alarm LED is not lit Charge LED On The yellow Charge LED is lit Off The yellow Charge LED is not lit Running LED On The green Run LED is lit Off The green Run LED is not lit ...

Page 212: ...egory Description Notes View system Provides a view of the current system settings and allows updating selected settings For more information refer to Viewing System Parameters on page 212 Event log Provides a view of the events recorded by the system such as authorization level change programming infusion parameters activated alarms etc For more information refer to Viewing the Event Log on page ...

Page 213: ...at triggers an occlusion alarm For more information refer to Managing Alarm Settings on page 200 The setting can be modified by pressing entering a value using the keypad and then pressing OK Authorization Current authorization lock level For more information refer to Managing Authorization Levels on page 220 The setting can be modified by pressing selecting a setting and then pressing OK Password...

Page 214: ...mulated Volume Infused Shift s Total on page 232 VI cleared date The date and time in which the Accumulated VI was last cleared For more information refer to Monitoring the Accumulated Volume Infused Shift s Total on page 232 VI cleared time Delivery mode Current delivery mode Single Air detector These settings are associated with the amount of air that triggers an Air in Line alarm when the air d...

Page 215: ...ault KVO rate set for the current delivery mode The parameter is not relevant to Intermittent or Epidural Intermittent mode in which the KVO is equal to the KVO continuous rate programmed for the infusion Bolus rate The default bolus rate set for the current delivery mode The parameter is not relevant to the Intermittent TPN or Multi step modes In continuous mode when the Advanced Bolus option is ...

Page 216: ...ar 2 digits When U S format is set the order is month day and year 5 On the toolbar press OK A list of events is displayed To view all events 1 From the Options menu select View 2 On the View screen select Event log 3 On the Event log screen select All events A list of events is displayed The Event log is sorted according to time with the most recent event listed first Each event is assigned a spe...

Page 217: ...ncluding all bolus related events Delivery history information includes To access the Delivery History during PCA PCEA or PIEB infusion From the tool bar select View Edit then select Edit PCEA Delivery history When the pump is locked the Delivery History can be accessed from the toolbar without unlocking the pump Name of Value Description Notes Total Dose given The total amount of drug delivered t...

Page 218: ...ing dose Total Bolus given Total amount of infusion given to the patient via boluses loading dose clinician patient or intermittent doses PIEB Intermittent Doses given Total amount of intermittent doses in mL mg mcg mUnits million Units gram nanogram mmol or mEq Appears only when Epidural Intermittent with PCEA is programmed Intermittent doses Given Total Total number of Intermittent doses actuall...

Page 219: ...us and Loading dose is delivered Options are 125 or 200 mL h the default is 125 mL h Allow loading dose Enables the user to program a loading dose starting the infusion with a clinician bolus Select the row to toggle the option between On and Off Infusion type Defines the PCA infusion type that is available for the user Continuous only includes only a continuous rate without boluses if enabled a l...

Page 220: ... to program a loading dose starting the infusion with a clinician bolus Select the row to toggle the option between On and Off Infusion type PCEA mode only Defines the PCEA infusion type that is available for the user Continuous only includes only a continuous rate without boluses if enabled a loading dose can be programmed Bolus only includes only patient boluses and no continuous rate clinician ...

Page 221: ...ch level allows users to access a different set of pump actions and programming options Authorization levels are modular Therefore users with a given authorization level can access actions available to their level plus all actions available to users with lower authorization levels The levels are Low All programming options are disabled and no settings can be changed Medium Basic programming option...

Page 222: ... Start infusions using the PreSet Programs feature Start infusions using the Repeat Last Infusion feature Priming with the pump Edit Rate during running infusion the option must be enabled prior to the infusion by an authorized Technician View bolus rate PCA options Activate immediate taper down during TPN infusion and set the time for it Use the Set Delay feature High Start infusions using the Ne...

Page 223: ...r of the Running screen press View Edit 2 From the View Edit screen select View system The Authorization parameter is displayed Setting Authorization Lock Levels Users with an authorization level of High can reset the authorization lock level of the pump To change authorization level from a lock level of High 1 From the Options menu select Pump configuration General settings 2 Select Authorization...

Page 224: ...e pump is designed to prevent inadvertent parameter changes or actions other than those permitted by the currently set authorization level As a safety measure the pump will prompt the user to re enter the High level password before performing the following actions Changing delivery modes Changing authorization levels A password entry is also required to unlock the screen when the Auto Patient Lock...

Page 225: ...ng a PCA PreSet program while the pump is set to Continuous Bolus infusion type this program can be used only when the pump is configured to Continuous Bolus and not when the pump is configured to Continuous only or Bolus only To create a new preset program 1 From the Indicators Bar verify that the pump is in the desired delivery mode 2 From the Start Up screen select PreSet Programs 3 From the to...

Page 226: ... for more information about setting parameters in each mode 7 Review the parameters displayed on the screen Then press OK The program is saved 8 To return to the PreSet programs screen press OK Delivery Mode Refer to Continuous Starting a Continuous Infusion on page 97 Intermittent Starting an Intermittent Infusion on page 140 TPN Starting a TPN Infusion on page 134 Multi step Starting a Multi ste...

Page 227: ...screen Then press OK The program is saved To delete a preset program 1 From the Indicators Bar verify that the pump is in the desired delivery mode 2 From the Start Up screen select PreSet Programs 3 From the toolbar of the PreSet Programs screen press Edit 4 Using the keypad enter the appropriate password then press OK 5 From the list select the program that you want to delete 6 From the toolbar ...

Page 228: ...ion 1 Set the relevant infusion parameters Refer to the following table for more information about setting parameters in each mode 2 From the Start screen select Set Delay 3 From the Delayed Start screen select Standby 4 The Standby screen is displayed For the Set Delay option to appear on the Start screen the pump needs to be configured with the Allow delayed start setting enabled For more inform...

Page 229: ...ut the Standby period VI Total Total volume that has been infused in the current infusion the VTBI value programmed These parameters remain constant throughout the Standby period Time left Time remaining until the end of the current infusion This parameter remains constant throughout the Standby period During Standby Pump unattended alarm will not be active To view all of the current infusion prog...

Page 230: ...t setting parameters in each mode 2 From the Start screen select Set Delay 3 From the Delayed Start screen select Delay Period 4 Using the keypad enter the desired delay period h min then press OK Verify that the parameters reflect the correct treatment according to the prescription Delivery Mode Refer to Continuous Starting a Continuous Infusion on page 97 Intermittent Starting an Intermittent In...

Page 231: ... is over an alarm sounds 6 To begin the infusion verify that the clamps on the administration set are open and press OK then press Start 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 Pressing Start during the delay period begins the infusion immediately overriding the delay period To override the delay peri...

Page 232: ...on page 215 In addition when Repeat Last Infusion is used the pump calculates the accumulated volume infused Accumulated VI for all infusions associated with the patient and the Delivery History When a new patient is selected the Accumulated VI and Delivery History values are automatically cleared for more information refer to Monitoring the Accumulated Volume Infused Shift s Total on page 232 The...

Page 233: ...ncluding KVO if applied during a delayed start period This VI is presented on the running screen as well as in the message given at the end of the infusion Clearing the Accumulated VI automatically clears the VI Viewing Accumulated VI The Accumulated VI value can be viewed before programming an infusion via the Options menu or during a running infusion via the View Edit and View System menus To vi...

Page 234: ... The user clears the Accumulated VI During infusion via the View Edit screen This will reset the total volume infused for all infusions associated with a specific patient to 0 mL To clear the Accumulated VI value during infusion 1 From the toolbar of the Running screen press View Edit 2 From the View Edit screen press Clear Accum VI 3 From the Clear Accum VI screen press Yes to clear the Accumulat...

Page 235: ... the pump turns On The Drug Library functions as an error reduction tool thus enabling safer practice The Drug Library displays for each drug its available concentrations and allowed range hard limits of various infusion parameters such as continuous rate and bolus amount In addition it contains the recommended range soft limits of these infusion parameters The information about customized groups ...

Page 236: ...mp is turned On When the pump is idle from the General Settings menu During a running infusion the selected CCA will apply after the infusion has completed The name of the selected CCA is displayed on the Indicators Bar above the screen title Selecting a CCA when pump is turned On When a Drug Library is loaded a message is displayed asking to accept or change the current CCA To accept or change a ...

Page 237: ... configuration General Settings 2 Select the Current CCA row 3 From the Choose CCA screen press the row of the relevant CCA 4 To confirm the selected CCA press OK To display additional CCAs press Next In case the current delivery mode is unavailable in the selected CCA the pump will prompt the user to change the delivery mode CCA selection should be selected according to local facility procedures ...

Page 238: ...reen select the row of the relevant CCA 5 From the Attention screen confirm the selected CCA and press OK 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 When changing the CCA during a running infusion the CCA will change only after the infusion has completed The selected CCA name wil...

Page 239: ...n press OK To view or change the Next CCA From the View Edit screen press View System Press Next CCA Select CCA from list Note To display additional CCAs press Next From the Attention screen press OK The Repeat Last Infusion option will be unavailable grayed out after the CCA is changed ...

Page 240: ...am an infusion without a defined drug by using the Choose General key on the toolbar Drugs List The filtered drugs are displayed in the Drugs List screen The Drugs List screen displays only drugs that are available in the current CCA and delivery mode When there are more than 4 available drugs use the Next key to display additional drugs Drug name search is not sensitive to uppercase or lowercase ...

Page 241: ...g min 3 Partial concentration Without Drug Amount Only Diluent Volume is defined The user will be asked to enter Drug Amount e g __ mg 100 mL Without Diluent Volume Only the Drug Amount is defined The user will be asked to enter Diluent Volume e g 10 mg __ mL 4 Full concentration Both Drug Amount and Diluent Volume are defined For more information about programming a new infusion with Drug Library...

Page 242: ...mit Icon To acknowledge the message and continue with the entered value From the Attention screen press OK and continue programming To enter a new value instead of the entered value From the Attention screen press Back Then using the keypad enter a new value and press OK When a soft limit has been exceeded an applicable Soft Limits icon will be shown on the Sapphire pump indicators bar during infu...

Page 243: ...tive CCA is available in the new Drug Library the Clinical Care Area screen will appear Press Accept and the Start Up screen will appear If the last active CCA is not available in the new Drug Library the Choose CCA screen will appear a Select the relevant CCA b To confirm the changed CCA press OK The Start Up screen will appear Updating Drug Library should be conducted according to local facility...

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Page 245: ...rms The alarm types are categorized according to their effect on the infusion In all alarm types instructions about how to proceed and if relevant to solve the problem are displayed on the touch screen When Level 1 2 and 3 alarms occur the red Alarm LED stays On continuously and an auditory alarm sounds continuously These alarms require immediate attention Chapter 10 Alarms and Troubleshooting Ala...

Page 246: ...ops immediately and the pump automatically shuts down within 3 minutes The infusion cannot be restarted or continued The following soft keys are available during a Level 1 alarm Mute Silences the auditory alarm Shutdown Turns Off the pump immediately When a Battery Depleted alarm occurs connect the pump to an AC power supply A pump with an Internal Error alarm needs to be evaluated by an authorize...

Page 247: ...an alarm press the Mute soft key This silences the alarm sound for 2 minutes If the issue has not been cleared after 2 minutes the alarm sound will be resumed The following soft keys are available during a Level 2 alarm Mute Silences the auditory alarm for 2 minutes Unmute Returns the auditory alarm OK Displays the Paused screen This soft key is enabled after Mute is pressed Alarm Title Displayed ...

Page 248: ...y This silences the alarm sound for 2 minutes If the issue has not been cleared after 2 minutes the alarm sound will be resumed Figure 10 1 Sample Level 3 Alarm Screen The following soft keys are available during a Level 3 alarm Mute Silences the auditory alarm for 2 minutes Unmute Returns the auditory alarm OK Displays the Paused screen The infusion may then be resumed after the problem is resolv...

Page 249: ...m reoccurs please contact authorized technician Check for Occlusion Please verify clamps are open and set is not occluded Downstream Occlusion To clear occlusions verify 1 Clamps are open 2 Administration cassette is properly positioned 3 Line is not kinked 4 No occlusion at the output connection If all occlusions were cleared press OK to continue Pump Stopped Please quit and restart the infusion ...

Page 250: ...he audio sound of a message press the Mute soft key This silences the message sound for 2 minutes If the issue has not been cleared after 2 minutes the alarm sound will be resumed Figure 10 2 Sample Message Screen If a message is displayed during infusion the infusion continues and the system continues to operate The following soft keys are available Mute Silences the auditory alarm for 2 minutes ...

Page 251: ...yed Text Low Battery 30 minutes left to battery depletion Connect pump to power supply Message Battery life will expire in 2 days Please contact authorized technician The battery could not be fully charged please check power supply Door open Check administration cassette position and close the safety door Infusion complete Infusion near end The pump has been inactive for xx minutes System temperat...

Page 252: ...ed The PreSet Programs option does not appear on the Start Up screen in any mode The option is not enabled Enable the PreProgram setting Start Up Configuration Menu on page 208 High Authorization level is required The Repeat last infusion option does not appear on the Start Up screen in any mode The option is not enabled Enable Repeat Last infusion setting Start Up Configuration Menu on page 208 H...

Page 253: ...dle is not responding The handle has become disconnected from the pump or the blue buttoned bolus handle is being used and is connected to the mini cradle instead of to the pump Reconnect the bolus handle to the pump The Bolus button does not appear in the toolbar during a Continuous infusion The Allow Bolus feature is not enabled Enable the Allow Bolus setting Technician Authorization level is re...

Page 254: ...and prime flush the set manually If the issue is not resolved replace the administration set If the issue is still not resolved have a technician review and adjust the air detection settings Recurring Occlusion alarms The occlusion issue has not been properly resolved Close clamps remove adminis tration cassette from pump dis connect patient and prime flush the set manually Replace the administrat...

Page 255: ...ted to an AC outlet and currently the battery power is insufficient to support both the primary line rate and the secondary line programming Connect the pump to an AC outlet and select to continue the primary or start the secondary Fast depletion of AA batteries Power Supply is connected to the Pump and not to electricity while EBP is attached to the pump Disconnect power supply from the Pump Pump...

Page 256: ...s were mis placed in compartment AA batteries are depleted Detach the EBP and re attach it exactly as instructed Detach the EBP make sure the AA batteries inserted properly and re attach it exactly as instructed Detach the EBP and replace the AA batteries with fresh AA bat teries and re attach it exactly as instructed Problem Probable Cause Solution ...

Page 257: ...n 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 multiple patient use Cleaning and disinfecting the pump involves wiping it with Dispatch Caltech ready to use towels Additional Cleaning and Disinfection Agents Virex II 256 Virox AHP 5 RTU Diversey Klor DeTM Chlorine tablets 70 Isopropyl ...

Page 258: ...ecting the pump do not allow fluid to enter the pump housing speaker holes or battery chamber Do not steam autoclave ethylene oxide sterilize or immerse any part of the pump in fluid Do not use spray or aerosol cleaners Dispose of all cleaning disinfectant materials per laws and regulations for infectious waste disposal Do not clean or disinfect the pump using liquid household Bleach Before using ...

Page 259: ...ip 4 Wipe the exterior planes areas in back and forth motions vertically and horizontally mainly on the pump housing 5 The wiping should be applied with normal force few times on the same locations at least twice verifying complete coverage of the areas to be cleaned 6 Guidelines for cleaning specific pump components are listed in the table below 7 After the cleaning process is completed the pump ...

Page 260: ... a total of 3 cycles 3 After the disinfection process is completed the pump should be dried out for 15 minutes 4 Wipe the pump with a clean dry cloth Guidelines for cleaning disinfecting specific pump components Guidelines for cleaning disinfecting specific pump components are listed in the following table The pump must be completely dried out before connecting it to a power supply The pump must b...

Page 261: ...Fingers Clean the finger tip of the sensor using only a damp cloth or sponge Internal White Panel Bubble Detector on the internal white panel Anchor on the inter nal white panel Locking tooth on the internal white panel P to C connector Power communication connector This part should be kept free from foreign materials and dirt If necessary use foam swab moistened with the detergent solution to cle...

Page 262: ...al damage Post use Procedures The following equipment checks should be performed following each use of the pump and as required 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 Do not use the pump if you identify anything which may indicate impaired functioning of the system In such a case contact...

Page 263: ...fusion at a rate of 100 mL h An Air in Line alarm should occur Note To test the Air in Line alarm ensure that air detection is enabled ON in the Technician options If air detection has been disabled OFF the icon is displayed and a warning message stating that air detection has been disabled OFF appears when programming an infusion The Air in Line alarm will not be triggered Occlusion Alarm Start a...

Page 264: ...ry 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: ...triggered when there are 30 minutes left until battery depletion This time may depend on the delivery rate the frequency of pressing keys and whether the backlight is On When the Battery Depletion alarm sounds or following long periods of storage connect the pump to the power supply Notification messages begin appearing on the Main Display of the pump 2 weeks before battery life expiration When th...

Page 266: ...autions and recommendations listed below Battery Safety Guidelines Ensure that only Q Core Medical s rechargeable Lithium Ion Li Ion battery is used In case of rust bad odor overheating and or other irregularities when using the battery pack for the first time return it to your local representative Avoid any contact with water Do not immerse the battery pack in water Do not open the battery casing...

Page 267: ...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 3ºC 73º 5ºF Storage at low temperatures may affect initial battery performance Storage at high temperatures may degrade battery performance ...

Page 268: ... arrows facing up plug the power cord into the Sapphire pump power socket or into the splitter connector 3 On the front of the pump verify that the Charge LED status indicator is On blinking yellow light When using the pump while connected to the power supply ensure that the pump is attached securely to the power supply the mini cradle is attached securely to an IV pole and the power cord is secur...

Page 269: ...ain the battery at full charge If the pump is disconnected from the power supply or is in storage without being connected to power for several months check the battery level and recharge the battery before using the pump Charging the Battery on page 267 For any storage period make sure that the Q Core administration cassette is disconnected from the pump and that the safety door over the pump mech...

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Page 271: ... from the pump accuracy testing procedures described in the IEC60601 2 24 standard Testing was performed under normal conditions specified in IEC60601 2 24 standard at room temperature 25 C 72 F Normal conditions to ensure optimal accuracy of 2 5 Fluid level should be 50 cm above the pump No back pressure due to catheter size or difference in height of pump and infusion site Room temperature 25 C ...

Page 272: ...ems external factors may cause fluctuations in rate accuracy Conditions that can cause flow fluctuations include Position of the infusion container height any deviation from 50 cm above the pump Fluid characteristics that deviate from water like characteristics such as density viscosity and homogeneity Positive and negative pressure including back pressure Environmental temperature above or below ...

Page 273: ...y Conditions that can cause flow fluctuations include Position of the infusion container Fluid density Positive and negative pressure Environmental temperature Operation of the pump beyond the recommended operating limits Trumpet curves are named for their characteristic shape and are developed in accordance with IEC 60601 2 24 They display the percent flow rate deviation from the programmed rate ...

Page 274: ...Sapphire Infusion Pump User Manual 273 Figure 12 1 Delivery Startup Graph First 2 Hours of Test Period 1 mL h Figure 12 2 Trumpet Graph Second Hour of Delivery 1 mL h ...

Page 275: ...Technical Specifications 274 Figure 12 3 Trumpet Graph 24th Last Hour of Delivery 1 mL h Figure 12 4 Delivery Startup Graph First 2 Hours of Test Period 25 mL h ...

Page 276: ...Sapphire Infusion Pump User Manual 275 Figure 12 5 Trumpet Graph Second Hour of Delivery 25 mL h Figure 12 6 Trumpet Graph 24th Last Hour of Delivery 25 mL h ...

Page 277: ... external conditions such as tubing pressure container position relative to the pump barometric pressure humidity and temperature Defibrillation proof recovery time Max 1 sec Flow rate 0 1 99 9 mL h in increments of 0 1 mL h 100 999 mL h in increments of 1 mL h Volume VTBI 0 1 9999 mL in increments of 0 1 mL Infusion device Volumetric peristaltic External power supply 100 240V 50 60 Hz 0 6A Batter...

Page 278: ...al 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 The desired size range of each option can be selected by the technician Upstream Downstream occlusion sensor Door open sensor Temperature sensor Parameter Pressure 0 4 bar 1 2 bar Average bolus volume following downstream occlusion 0 135 mL 0 ...

Page 279: ...ns Adhere to the following operating conditions Parameter Pressure 0 4 bar 1 2 bar Average time to downstream occlusion alarm 2 30 hours 12 30 hours In case of an occlusion upstream or downstream clear the occlusion by disconnecting the set from the patient and priming the administration set When priming manually close clamps and disconnect the patient from the administration set prior to detachin...

Page 280: ...here sudden impact or vibration may occur 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 Do not disassemble the portion of the Sapphire pump that houses the pump mechanism and the electronics This should be done by authorized personnel only Q Core Medical Ltd will not be obligated to provide techn...

Page 281: ...ations 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 ...

Page 282: ...nsure that it is used in such an environment Emission Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 Group 1 The pump uses RF energy for its internal function only Therefore RF emissions are very low and are not likely to cause any interference with nearby electronic equipment RF emission CISPR 11 Class B The pump is suitable for use in all establishments including domes...

Page 283: ...s 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 1 kV at 110 230 VAC Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 ...

Page 284: ...site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the symbol Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment The pump was tested to the EMC requirements o...

Page 285: ...ransmitters in these frequency ranges where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 10 V m 80 MHz 2 5 GHz 80 AM 2 Hz 80 MHz 2 5 GHz 80 AM 1 KHz Recommended separation distances 80 MHz to 800 MHz 800 MHz to 2 5 GHz At 80 MHz ...

Page 286: ...should be less than 3 V m Recommended Separation Distances from Mobile RF Communication Equipment The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer pump user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the pump accor...

Page 287: ...tor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz This decreases the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Rated Maximum Output Power of Transmitter W Separation Distanc...

Page 288: ...Sapphire Infusion Pump User Manual 287 ...

Page 289: ... and handling any defective Sapphire provided a claim is made during such two years period The following conditions procedures and limitations apply to the Manufacturer s obligation under this warranty A Parties Covered by this Warranty This Warranty extends only to the Initial Buyer of the Sapphire Warranty Performance Procedure Notice of the claimed defect must be made by Initial Buyer in writin...

Page 290: ...the Manufacturer has authority to bind the Manufacturer to any representation or warranty expressed or implied 2 THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE SAPPHIRE FOR ANY PARTICULAR PURPOSE 3 The Sapphire can only be used under the instruction of trained medical personnel whose skill and judgment determine the suitability of the Sapphire for any particular medical treatment...

Page 291: ...ensure prompt return a Q Core authorized service representative must be notified before shipping any pump for repair When calling for service please be prepared to provide the serial number of the pump and software version details A brief written description of the problem should be attached to the pump when it is returned for service Q Core Medical Ltd will not be responsible for unauthorized ret...

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