CareFusion Alaris SE 7130 Directions For Use Manual

CareFusion Alaris SE 7130 Directions For Use Manual

Pump with guardrails safety software

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Alaris® SE Pump
(Models 7130/7131 and 7230/7231)
with Guardrails® Safety Software
s
Directions For Use
en

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Summary of Contents for CareFusion Alaris SE 7130

  • Page 1 Alaris® SE Pump Directions For Use (Models 7130/7131 and 7230/7231) with Guardrails® Safety Software...
  • Page 2: Table Of Contents

    Contents • Introduction  .................................. 2 • About this Manual  ................................ 2 • Features  ..................................3 • Controls and Indicators  ............................... 4 • Symbol Definitions  ............................... 5 • Display Features  ................................6 • Operating Precautions  ..............................7 • Getting Started  ................................10 • Initial Set Up ................................10 •...
  • Page 3: Introduction

    Introduction This document provides directions for use for the Alaris® SE pump, Models 7131 and 7231. The pump is intended for use in professional healthcare environments, including healthcare facilities, home care, and medical transport, that utilize infusion pumps for the delivery of fluids, medications, blood, and blood products. It is indicated for continuous or intermittent delivery through clinically acceptable routes of administration;...
  • Page 4: Features

    Features AC power indicator Rate Display(s) Latch POWER POWER HOLD HOLD ml/hr ml/hr KVO OPT HLD PRI SEC HLD OPT KVO OPTIONS Pumping Mechanism • Clear Enter Pressure Transducer Air-in-line Detector Lower Display Main Display Air-in-line Arm Panel Lock Keypad Flow Sensor Receptacle(s) RS232 Connector Pole Clamp...
  • Page 5: Controls And Indicators

    Controls and Indicators Controls: Symbol Description Numeric Keypad keys - Enters/changes values..Channel Select keys and indicators - Select channel A or B. Lights to indicate which channel is selected. Split Screen key - Displays information for both channels when both channels are infusing. Audio Volume key - Sets audio volume for alarms, alerts and KVO tone.
  • Page 6: Symbol Definitions

    Symbol Definitions Labelling Symbols: Symbol Description Attention (Consult accompanying document) Consult accompanying document Potential Equalisation (PE) Connector Type CF applied part. (Degree of protection against electrical shock) Defibrillation-proof Type CF applied part. (Degree of protection against electrical shock) IPX1 Protected against vertically falling drops of water Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.
  • Page 7: Display Features

    Display Features Main Display The Main Display is backlit for easy viewing. The backlight dims when operating on battery power as an energy-saving feature. Pressing any key automatically turns OPTIONS the backlight up again. Rate = 56.0 mL/h Dose= 0.8 mg/kg/h Conc= 100 mg/ 100 mL Wt= 70 kg Appearance of lines and/or dots that remain on constantly...
  • Page 8: Operating Precautions

    Operating Precautions Infusion Sets • Use only sets dedicated for use with the pump. The use of any other set may cause improper operation, resulting in an inaccurate fluid delivery or other potential hazard. • It is recommended that infusion sets are changed according to the instructions in the 'Changing the Infusion Set' section.
  • Page 9 MRI compatible pump as such. If use of the pump within an MRI environment is unavoidable, then CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the pump; or MRI image distortion.
  • Page 10 Operating Precautions (continued) Hazards • An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to locate the pump away from any such hazardous sources. • Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all servicing to qualified service personnel.
  • Page 11: Getting Started

    • AC Power Cable (as requested) • Protective Packaging Connect the pump to the AC power supply for at least 24 hours to ensure that the internal battery is charged (verify that the AC Mains indicator is lit). Maximum battery capacity, as well as gauge accuracy, is reached after several charge/discharge/ recharge cycles, in the refresh process. CareFusion recommends that the battery be fully charged/ discharged/recharged, using the refresh cycle, before placing the pump in use. The pump will automatically operate from its internal battery if the pump is switched on without being connected to the power supply. Should the pump fail to perform correctly, replace in its original protective packaging, where possible and contact a qualified service engineer for investigation.
  • Page 12: Priming An Infusion Set

    Getting Started (continued) Priming an Infusion Set When priming: Ensure patient is not connected. • Ensure air is expelled from line prior to beginning infusion (unexpelled air in line could have serious • consequences). • Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient. Prepare the primary solution container in accordance with the manufacturer’s directions for use. Use only sets dedicated for use with the Alaris® SE Pump. 1. Slide Flow Regulator thumb clamp down until an audible click verifies it is in fully closed position. 2.
  • Page 13: Loading An Infusion Set

    Getting Started (continued) Loading an Infusion Set • After set installation, verify no fluid is flowing through the infusion set’s drip chamber, to avoid free- flow. Before operating pump, verify that infusion set is free from kinks and installed correctly in pump. • • Ensure the appropriate infusion set for the fluid/drug to be infused has been selected. • Follow the instructions supplied with the individual infusion set. Use only sets dedicated for use with the pump. The use of any other set may cause improper • operation, resulting in an inaccurate fluid delivery or other potential hazard. Position the fluid container to avoid spillage onto the pump. • Thumb Clamp Slide Flow Regulator thumb clamp down until an audible click verifies it is in fully closed position. Click Using both hands, press top and bottom of Flow Regulator into pump until it snaps into place.
  • Page 14: Starting The Infusion

    Getting Started (continued) Starting the Infusion To turn channel on, press channel’s POWER key. • The pump will run a short self-test. • Check the display test pattern and ensure that no rows or pixels are missing. Confirm Profile? - Press change to change Profile, Profile selection menu displays, select profile and ok. Go to step 3. Accept will retain profile and display NEW PATIENT? screen.
  • Page 15 Getting Started (continued) Starting the Infusion (continued) Pausing and Restarting Infusion An infusion may be paused temporarily by pressing channel RUN/HOLD key. To restart infusion while on hold, press channel RUN/HOLD key. Rate LED flashes while infusion is on hold. • After 2 minutes, “Hold Time Exceeded” visual and audio prompts begin. An additional 2 minute • period may be initiated by pressing either hold soft key or channel RUN/HOLD key. Making Changes to Rate, Dose or VTBI Continuous infusion parameters (Rate, Dose or VTBI) may be changed without pausing the infusion and VI may be cleared. Select desired channel, as necessary.
  • Page 16 Getting Started (continued) Starting the Infusion (continued) Clearing Volume Infused The volume infused counter increments as fluids are infused through a given channel. All fluids infused in primary mode, including boluses, all fluids infused in secondary mode and all fluids infused in KVO mode are counted. To reset volume infused counter to 0.0ml, press VI soft key. VI field is highlighted. Press CLEAR key or press 0 (zero) key then press ENTER key.
  • Page 17: Secondary Infusion

    Secondary Infusion This mode is designed to support automatic secondary infusions (“piggybacking”) in the same channel. When the secondary VTBI reaches zero, an audio tone sounds (if enabled), Secondary Complete message displays briefly, and the primary infusion rate automatically resumes. When the pump is programmed and delivering in the secondary mode, the primary infusion is temporarily stopped and fluid is drawn from the secondary container.
  • Page 18: Options

    Options Loading Dose This feature allows an initial infusion rate to be set up for a specific volume, automatically followed by a maintenance rate (primary settings) from the same container. The primary VTBI and VI include the loading dose volumes. When the loading dose VTBI reaches zero, a transition tone sounds (if transition tone feature is enabled), Load Dose Complete message displays briefly, and the primary settings automatically take effect.
  • Page 19: Multi-Dose

    Options (continued) Multi-Dose This feature allows 1 to 24 infusions to be preprogrammed with the same rate and volume, to be delivered at equally spaced intervals, over a period of up to 24 hours. It also offers a delayed start option up to 8 hours and a Dose Complete Alert Option. These features can be turned on or off.
  • Page 20: Multi-Step

    Options (continued) Multi-Step The Multi-Step feature allows a sequential drug delivery program (up to 9 steps) to be set, delivering volumes of fluid at different rates during each step. This allows the pump parameters to be set up once and to deliver a sequence eliminating the need to change the rate and VTBI after each infusion step.
  • Page 21: Monitoring Options

    Options (continued) Monitoring Options All features and options in this section are shown enabled. Options are enabled through the hospital data set profile configuration settings, or through the pump configuration settings if the Profiles feature is not enabled (OFF). The Dynamic Monitoring System provides the ability to monitor downstream pressure or resistance, allowing rapid detection of full and partial occlusions.
  • Page 22 Options (continued) Monitoring Options (continued) Auto Restart Plus Feature The Auto Restart Plus feature provides the ability to automatically continue an infusion if downstream resistance or pressure measurements indicate that an occlusion condition has cleared within a 40-second Checking Line period (excluding High Resistance Monitoring mode). The Checking Line message and tone are presented when a resistance measurement exceeds the alarm threshold of 100%.
  • Page 23 Options (continued) Monitoring Options (continued) Adjustable Pressure Alarm In the Adjustable Pressure monitoring mode, the pressure alarm limit may be varied from 25 mmHg to the maximum configured pressure limit, in 25 mmHg increments. A default alarm level and a maximum pressure limit are set through the hospital data set profile configuration settings or through the pump confirmation settings if the Profiles feature is not enabled (OFF).
  • Page 24 Options (continued) Monitoring Options (continued) Pressure Baseline The Pressure Baseline feature, when enabled through the hospital data set profile configuration settings, provides a real-time bar graph and numeric display of line pressure. The pressure limit may be reduced if the pressure in the set is high or changing. This results in the pressure limit being lowered from the selected setting.
  • Page 25: Smartsite® Needle-Free System Instructions

    Options (continued) Monitoring Options (continued) Pressure Trend Graphs In Pressure Monitoring mode, a trend graph displays monitored pressure over time. Trend graphs of 15 minutes, 1 hour, 4 hours and 12 hours are available during normal operation when enabled through the hospital data set. Downstream Occlusions, which occur in Pressure or Resistance modes, are indicated by a tick mark (y) at the top of the trend screen.
  • Page 26: Alarms, Alerts And Prompts

    Alarms, Alerts and Prompts There are 3 types of displayed messages listed on the following pages with a probable cause and suggested remedy next to each one. Use this section in conjunction with the appropriate clinical practice of hospital procedure. ALARM: pump or channel problem. •...
  • Page 27: Alerts

    Alarms, Alerts and Prompts (continued) Alarms (continued) Alarm Meaning Response instrument malfunction Pump malfunction. For a dual Turn pump off and then on. If problem persists, do not use channel pump, neither channel pump. Contact qualified service personnel. is functional. key stuck A key is stuck or was held down Release key.
  • Page 28: Prompts

    Alarms, Alerts and Prompts (continued) Prompts Prompt Meaning Response Air In Line Air detector has detected air prior to starting Press continue soft key to allow infusion to infusion or is in poor contact with set. continue. An alarm occurs if air detector detects an air bubble larger than configured threshold. Verify set is loaded correctly.
  • Page 29 Alarms, Alerts and Prompts (continued) Prompts (continued) Prompt Meaning Response Pressure Unstable Cannot Excessive variation in pressure due to motion, flow Reduce or temporarily remove sources of Set Baseline from other pumps or blood pressure prevents variation while performing manual baseline accurate setting of pressure baseline. setting operation. Pressure Baseline feature is on.
  • Page 30: Guardrails® Event Counter

    Alarms, Alerts and Prompts (continued) Guardrails® Event Counter The pump keeps a running count of Guardrails® Events that occur that can be viewed with the Guardrails® Events counter feature. Press OPTIONS key. Press Event Counters soft key. To return to main display, press return soft key. To clear counter (reset all values to zero), press clear soft key. To view second event counter page, press page soft key.
  • Page 31: Flow Sensor Operation (Optional)

    Flow Sensor Operation (optional) The optional flow sensor notifies users of empty containers and/or upstream Flow Sensor Connectors occlusions. A handle cap accessory is available for storing the flow sensor when not in use. The flow sensor is not used for the first 25 ml delivered when changing from secondary to primary.
  • Page 32: Configurable Settings

    If the Profiles feature is not enabled (off ) or if no data set is loaded, the configurations options are set in the configuration mode by qualified service personnel. If the configuration settings need to be changed from the factory default settings, reference the Technical Service Manual or contact CareFusion Technical Support for technical, troubleshooting, and preventive maintenance information.
  • Page 33 Configurable Settings (continued) Feature Description Resistance Provides an “Occlusion Downstream” alarm when measured pressure reaches Resistance Pressure limit while Pressure Setting operating in Resistance Mode. This threshold may be set from 1 to 600 mmHg in 1 mmHg increments. In other words, while operating in Resistance mode or High Resistance mode, an “Occlusion Downstream” condition can be detected in 2 ways;...
  • Page 34: Configured Options Record

    Configured Options Record Configurable Options Enter the pump-specific information for your records on a copy of this page. Option Default Range Setting Air-in-Line Accumulator On/Off Air-in-Line threshold 100 µl 50, 100, 200 or 500 µl Air-in-Line Reset On/Off Transition Tone On/Off Audio Volume Low/Med/Hi Low/Med/Hi, Med/Hi, Hi Configuration Name...
  • Page 35: Specifications

    Specifications Infusion sets: Use only infusion sets for Alaris® SE Pump. Alarms: Accumulated Air In Line Key Stuck Set Out Air In Line Latch Open Set Up Time Exceeded Battery Depleted No Upstream Flow Detected Pump Malfunction Channel Malfunction Occlusion Downstream Hold Time Exceeded Occlusion Upstream Computer Link Failure...
  • Page 36 Specifications (continued) Environmental Operating Storage Conditions: Atmospheric Pressure 700 to 1060 hPa 500 to 1060 hPa Relative Humidity 20 to 90% (Non condensing) 5 to 95% (Non condensing) Temperature Range 5 to 40°C (41 to 104°F) -40 to 60°C (-40 to 140°F) Flow Rate Range: 0.1 to 600.0 ml/h in 0.1 ml/h increments (secondary mode) 0.1 to 999.9 ml/h in 0.1 ml/h increments (all other modes)
  • Page 37: Maintenance

    Technical Service Manual (TSM). Circuit diagrams and components parts lists and all other servicing information which will assist the qualified service engineer in performing repair of the parts designated as repairable are available upon request from CareFusion. If the pump is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of service for examination by a qualified service engineer.
  • Page 38: Cleaning And Storage

    If you wish to discard electrical and electronic equipment, please contact your CareFusion affiliate office or distributor for further information. Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling.
  • Page 39: Rs232 Computer Link

    RS232 Computer Link The optional Computer Link feature allows a hospital/facility computer to interact with the pump. The computer cannot start or stop the pump, set the rate, or make any change in status. The feature may be enabled or disabled by qualified personnel in the pump configuration settings.
  • Page 40: Trumpet And Start-Up Curves

    Trumpet and Start-Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET AND START-UP CURVES In this pump, as with all infusion systems, the action of the pumping mechanism and variations in individual administration sets cause short-term fluctuations in rate accuracy. The following graphs show typical performance of the system for both Pressure and Resistance modes in two ways: •...
  • Page 41: Pressure Mode

    Trumpet and Start-Up Curves (continued) Pressure Mode Pressure Mode Start-up at 1 mL/h (initial) -0.2 Time (min) Pressure Mode Trumpet Curve at 1 mL/h (initial) 12.2 21.2 -6.2 -12.1 Observation Interval (min) Pressure Mode Trumpet Curve at 0.1 mL/h (48 hr) 98.0 51.0 23.8 12.3 -11.9 -7.5 -21.8...
  • Page 42 Trumpet and Start-Up Curves (continued) Pressure Mode (continued) Pressure Mode Start-up at 25 mL/h (initial) Pressure Mode Start-up at 999.9 mL/h (initial) 2000 1800 1600 1400 1200 1000 -200 Time (min) Time (min) Pressure Mode Trumpet Curve at 25 mL/h (initial) Pressure Mode Trumpet Curve at 999.9 mL/h (initial) -1.2 -0.9 -1.0...
  • Page 43: Resistance Mode

    Trumpet and Start-Up Curves (continued) Resistance Mode Resistance Mode Start-up at 0.1 mL/h (initial) Resistance Mode Start-up at 1 mL/h (initial) 0.20 0.18 0.16 0.14 0.12 0.10 0.08 0.06 0.04 0.02 0.00 -0.02 -0.2 Time (min) Time (min) Resistance Mode Trumpet Curve at 0.1 mL/h (initial) Resistance Mode Trumpet Curve at 1 mL/h (initial) 13.3 153.4...
  • Page 44: High Resistance Mode

    Trumpet and Start-Up Curves (continued) Resistance Mode (continued) Resistance Mode Trumpet Curve at 25 mL/h (initial) Resistance Mode Trumpet Curve at 999.9 mL/h (initial) 15.6 -0.7 -0.3 -0.6 -0.7 -0.9 -0.2 -1.1 -1.2 -2.0 -1.5 -1.0 -1.9 -8.4 Observation Interval (min) Observation Interval (min) Resistance Mode Trumpet Curve at 25 mL/h (48 hr) Resistance Mode Trumpet Curve at 999.9 mL/h (24 hr) 13.4 -2.7...
  • Page 45: Service Contacts

    Tel: +31 (0)30 2289 711 Tel: (1) 800 854 7128 Fax: (1) 905-752-3343 Fax: (34) 902 555 661 Fax: +31 (0)30 2289 713 Fax: (1) 858 458 6179 CareFusion Switzerland 221 Sàrl CareFusion, CareFusion, CareFusion, Critical Care Parc d’affaire le Val Saint Quentin Solbråveien 10 A,...
  • Page 46: Compliance

    The authority to operate this system is conditioned by the requirement that no modifications will be made to the system unless the changes or modifications are expressly approved by CareFusion. This Class A/B digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulation.
  • Page 47 Note 3—Performed at the Minimum and Maximum Rated Input Voltage. Note 4—CareFusion recommends using signal cables of less than 3 meters in length and this requirement is applicable only if signal cables are 3 meters or more in length. (IEC/EN 60601-1-2:2002, Clause 36.202.4)
  • Page 48 Compliance (continued) Guidance and Manufacturer’s Declaration—Electromagnetic Immunity LIFE SUPPORT Equipment The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should ensure that it is used in such an environment. IEC/EN 60601-1-2 Compliance Immunity Test Electromagnetic Environment – Guidance Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 49 Compliance (continued) Recommended Separation Distances for LIFE SUPPORT Equipment between portable and mobile RF communications equipment and the Pump The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the pump as recommended below, according to the maximum output power of the communications equipment.
  • Page 50 CareFusion Corporation or one of its subsidiaries is strictly forbidden. CareFusion Switzerland 317 Sàrl, CH-1180, Rolle EC REP CareFusion U.K. 305 Ltd., RG22 4BS, UK 1000DF00480 Issue 2 carefusion.com...

This manual is also suitable for:

Alaris se 7131Alaris se 7230Alaris se 7231

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