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Cardinal Health Alaris 7130/7131 Directions For Use Manual

Supports guardrails suite mx
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Directions for Use
RUN
POWER
HOLD
ml/hr
OPT
PRI
HLD
SEC
KVO
PRI
SEC
OPTIONS
1
2
3
4
5
6
8
9
7
.
0
Clear
Enter
®
Alaris
Models 7130/7131 and 7230/7231
SE Pump
A
RUN
HOLD
KVO OPT
HLD PRI
A B
Supports Guardrails
B
RUN
POWER
POWER
HOLD
ml/hr
ml/hr
SEC
PRI
SEC HLD
OPT KVO
PRI
SEC
OPTION
1
2
3
4
5
6
7
8
9
0
•
Clear
Enter
®
Alaris
®
Suite MX
June 2006
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Summary of Contents for Cardinal Health Alaris 7130/7131

  • Page 1 Directions for Use ® Alaris SE Pump Models 7130/7131 and 7230/7231 Supports Guardrails ® Suite MX June 2006 POWER HOLD ml/hr OPTIONS Clear Enter POWER POWER HOLD HOLD ml/hr ml/hr KVO OPT HLD PRI SEC HLD OPT KVO OPTION • Clear Enter ®...
  • Page 2 Fax: (46) 8 544 43 225 China. Fax: (36) 12 01 5987 Tel: (56) 8621-63844603 Tel: (56) 8621-63844493 Fax: (56) 8621-6384-4025 ©2006 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Directions for Use ® Alaris SE Pump Models 7130/7131, 7320/7231...

  • Page 3: Table Of Contents

    Table of Contents GETTING STARTED INTRODUCTION ........................................ UNPACKING ......................................... CHECK-IN AND CONFIGURATION ................................Rate Accuracy Qualification Test ..............................Alternative Rate Accuracy Qualification Test ..........................Set Sensor Check / Pressure Calibration Verification ......................Functional Test ......................................Flow Stop Test ......................................Ground Current Leakage Test ................................
  • Page 4 PROGRAMMING (Continued) ® SECONDARY INFUSION - WITH GUARDRAILS SUITE MX PROTECTION ..............Introduction ......................................... Setup ..........................................Secondary Intermittent Infusion ................................ PRIMARY INFUSION - NO GUARDRAILS ® SUITE MX PROTECTION ................... Selecting New Patient Option-Profiles Feature Not Enabled (OFF) ................. Basic Infusion ......................................
  • Page 5 GENERAL INFORMATION WARNINGS AND CAUTIONS ..................................General ......................................... Guardrails ® Suite MX ..................................... Administration Sets ....................................Epidural Administration ..................................Electromagnetic Compatibility ................................BATTERY MANAGEMENT SYSTEM ................................ Battery Power Gauge and Indicator ..............................Battery Recharge ..................................... FLOW SENSOR ........................................ALERTS COUNTER ......................................
  • Page 6 REGULATIONS AND STANDARDS COMPLIANCE ........................................Electromagnetic Environment ................................Standards ........................................TRADEMARKS ........................................DIRECTIONS FOR USE SUPPLEMENTS SUPPLEMENTS..............................Table of Contents Directions for Use ® Alaris SE Pump Models 7130/7131, 7230/7231...

  • Page 7: Getting Started

    Getting Started Introduction This document provides directions for use for the SE Pump, WARNING Models 7130/7131 and 7230/7231. It is used in conjunction Read all instructions before using with: the SE Pump. ® Alaris product administration set instructions Drug product labeling CAUTION SE Pump Technical Service Manual Ground test equipment instructions...
  • Page 8 Introduction (Continued) ® Information about a Guardrails alert that occurs during use is stored within the SE Pump, and can be accessed using the CQI Reporter. The SE Pump may be operated with or without the Guardrails ® Suite MX protection. When an approved Data Set is transferred to the SE Pump by qualified personnel and the Profiles feature is enabled (ON) in instrument configuration, ®...

  • Page 9: Unpacking

    24 hours prior to use. Maximum battery capacity, as well as gauge accuracy, is reached after several charge/discharge/recharge cycles, in the refresh process. Cardinal Health recommends that the battery be fully charged/discharged/recharged, using the refresh cycle, before placing the instrument in use.

  • Page 10: Check-In And Configuration

    Check-In and Configuration This is a quick reference procedure for check-in and WARNING configuration of new and recently serviced instruments. Instruments returned from the service depot may be set to factory defaults and not have a hospital-defined Data Set loaded. Biomedical personnel in the facility are responsible for checking-in the instrument and ensuring the current...
  • Page 11 Check-In and Configuration (Continued) Rate Accuracy Qualification Test (Continued) Do not use the Model 80VCS Calibration Set for more than 30 rate verification runs (15 rate calibration number changes). Keep track of the number of times the set is used by recording each use on the 80VCS insert or on a separate record.
  • Page 12 Check-In and Configuration (Continued) Rate Accuracy Qualification Test (Continued) Close latch. Verify no fluid flow or drops falling in drip chamber. Plug instrument into a properly grounded AC outlet. Set stopcock to output into a class A or B burette. Press POWER key to turn channel on.
  • Page 13 • outside a range of -5.5% to +7.0% from expected volume, return instrument to Cardinal Health for repair or replace mechanism. 27. Set stopcock to drain fluid in burette to zero level, in preparation for next test. NOTES: À...

  • Page 14: Alternative Rate Accuracy Qualification Test

    Three-way stopcock and used fluid receptacle are no longer needed. Due to the dynamic monitoring feature, the rate is varied during operation. For this reason, Cardinal Health does not recommend using automatic testers to check rate accuracy. Generally, these devices collect small samples and may cause the results to be incorrect, even though the instrument is accurate.
  • Page 15 Check-In and Configuration (Continued) Alternative Rate Accuracy Qualification Test (Continued) 11. Set VTBI to 20 mL. 12. Ensure instrument (both channels if dual channel) is set to À Pressure mode. 13. Press RUN/HOLD key to start primary infusion. Infuse until tubing is fully primed (approximately 1 minute). 14.
  • Page 16 • outside a range of -5.5% to +7.0% from expected volume, return instrument to Cardinal Health for repair or replace mechanism. 27. Empty flask and reset scale to zero, in preparation for next test. NOTE: À...

  • Page 17: Set Sensor Check / Pressure Calibration Verification

    DIAGNOSTICS MODE Service Manual, “Troubleshooting” chapter, for details or À ID No. : 000000000 contact Cardinal Health Technical Support. SW Rev.: 08.XX Advance to D6 page and choose Cal Pressure (both PM Due : 52 weeks Channel A and Channel B for dual channel instruments).
  • Page 18 Check-In and Configuration (Continued) Functional Test (Continued) Perform Upstream Occlusion Test, as follows: Verify infusion rate is set to 460 mL/h. With instrument on hold, or at start-up, verify primary VTBI is set to greater than 100 mL. Press RUN/HOLD key to begin infusion. Clamp off IV line just above instrument (about 2 inches) to simulate an upstream occlusion.

  • Page 19: Flow Stop Test

    Check-In and Configuration (Continued) Flow Stop Test With an administration set primed and loaded in instrument, turn power off. With all tubing clamps open and fluid container 2 or more feet above instrument, verify no fluid flows through set. Open latch and remove set. Verify no fluid flows through set.

  • Page 20: Administration Set Information

    Administration Set Information General The SE Pump uses a wide variety of Flow Regulator administration sets. The sets dedicated for use with the SE Pump are designed for use with the instruments as well as for gravity-flow stand-alone use. The unique, patented Flow Regulator has an integral flow control device that minimizes the risk of unintended flow when the set is removed from the instrument, and provides accurate rate control during gravity...

  • Page 21: Preparing Solution Container And Set

    Administration Set Information (Continued) ® SmartSite Infusion Set (Continued) • Replace every 72 hours or 100 activations, whichever Á comes first. NOTES: À For multiple syringes, swab prior to each syringe access. Á For infusions of blood, blood products or lipid emulsions replace every 24 hours.

  • Page 22: Loading Set

    Administration Set Information (Continued) Preparing Solution Container and Set (Continued) Slide up to open Slide Flow Regulator thumb clamp to open position to slowly prime set. for priming. Close Flow Regulator clamp when priming is complete, as in Step 1. Verify no fluid is flowing. A gravity flow rate may be adjusted with Flow Regulator thumb clamp, if desired.
  • Page 23 Administration Set Information (Continued) Loading Set (Continued) Press firmly just below blue thumb clamp on Flow Regulator with one hand while using other hand to close latch fully to left. • If resistance is met while closing latch, remove set, verify Flow Regulator is fully closed and then reinstall set.

  • Page 24: Removing Set

    Administration Set Information (Continued) Removing Set Place channel on hold. Open latch. • Flow Regulator automatically closes to prevent accidental unintended flow. Press latch fully to right. • Set is ejected from instrument. WARNING Even though the instrument automatically closes the Flow Regulator, verify the Flow Regulator is closed when the set is removed from the instrument to...

  • Page 25: Programming

    Programming References throughout this procedure to specific drugs and drug doses are for illustration purposes only. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages. Programming and Navigation Tips Soft Keys Soft Keys are the keys located on the left side and the bottom of the main LCD display.

  • Page 26: Menus - With Guardrails Suite Mx Protection

    Programming and Navigation Tips (Continued) ® Menus - With Guardrails Suite MX Protection MENU screens provide access to the Profile drug libraries and to basic programming in both the primary and the secondary À mode: • MENU (Primary Main Menu) •...

  • Page 27: Menus - No Guardrails ® Suite Mx Protection

    Programming and Navigation Tips (Continued) ® Menus - NO Guardrails Suite MX Protection MENU screens for optional modes can be accessed using the CAUTION OPTIONS key: ® Guardrails Suite MX protection is • MULTI-STEP MENU not available within the MULTI-STEP, MULTI-DOSE OR DOSE-RATE •...
  • Page 28 OPTIONS revision; ID No. is instrument serial number). © 2002, 2006 Cardinal Health SW Rev. : 08.xx ID No. : - - - - - - - - - • When self test completes, if Guardrails ®...

  • Page 29: Responding To Maintenance Reminder

    Programming and Navigation Tips (Continued) Responding to Maintenance Reminder If the Preventive Maintenance Reminder option is enabled and OPTIONS the device is due for preventive maintenance a Maintenance Reminder message appears at power up. Maintenace Reminder Notify appropriate facility personnel if a Maintenance Reminder message appears.

  • Page 30: Guardrails Suite Mx Prompts

    ® Guardrails Suite MX Prompts ® Guardrails Suite MX software allows the facility to create ® Soft and/or Hard Limits for Guardrails continuous dose, Concentration, Guardrails ® Bolus Dose, Bolus Dose ® Administration Rate, Guardrails intermittent total dose, Intermittent Time, and IV Fluid Rate. Within each profile the facility may also pre-define the following Hard Limits: maximum patient weight (kg), maximum patient body surface area (m...

  • Page 31: Selecting New Patient And Profile Options

    ® Primary Infusion - With Guardrails Suite MX Protection Selecting New Patient and Profile Options Previous programming parameters may either be cleared or preserved. Cleared, if: • Profile is changed. • Profile is accepted but New Patient? - yes is selected. Preserved, only if: •...
  • Page 32 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Selecting New Patient and Profile Options (Continued) Changing Profile (Continued) To confirm Profile selection, press ok soft key. OPTIONS Confirm Profile To select another Profile, press return soft key. Adult ICU return Once confirmed: OPTIONS...

  • Page 33: Primary Infusion - With Guardrails Suite Mx Protection

    ® Primary Infusion - With Guardrails Suite MX Protection Selecting New Patient and Profile Options (Continued) Selecting New Patient Option (Continued) To confirm programming is for same patient and retain all stored patient parameters, press no soft key. • All previous patient data is maintained. •...
  • Page 34 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Continuous Infusion (Continued) To use pre-selection menu press soft key corresponding OPTIONS to first letter of desired drug. Select Drug A - F Select Drug G - M Select Drug N - S Select Drug T - Z menu Press soft key next to desired drug name to select it.
  • Page 35 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Continuous Infusion (Continued) Press soft key next to desired selection. To confirm selection and continue programming, press ok OPTIONS soft key. alteplase • If a different selection is desired, press return soft stroke 100 mg/100 mL key to return to the drug list or press menu soft key...
  • Page 36 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Continuous Infusion (Continued) • If selected drug is weight-based, Wt (patient weight in kg) needs to be entered. • If selected drug is not weight-based, Wt field does not appear. Verify that all parameters are correct and press ok soft OPTIONS key to confirm.

  • Page 37: Pausing And Restarting Infusion

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Continuous Infusion (Continued) 12. Verify that all parameters are correct, then press run soft OPTIONS key or RUN/HOLD key to start infusion Rate = 56.0 mL/h Dose = 0.8 mg/kg/h VTBI = 100.0 VI = 0.0 alteplase menu...

  • Page 38: Resuming Interrupted Infusion

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Making Changes During Continuous Infusion (Continued) Making Changes to Rate, Dose or VTBI (Continued) Make changes: To enter a new value, use numeric keypad. To reset Volume Infused to 0.0 mL, press CLEAR or 0 (zero) key.

  • Page 39: Kvo Mode

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Resuming Interrupted Infusion (Continued) Press Resume Previous Drug soft key. OPTIONS • Previous drug review screen displays. New Guardrails Drug New Guardrails Fluid Resume Previous Drug Basic Infusion MENU Press ok soft key to confirm drug, therapy, concentration and dosing units.

  • Page 40: Resuming Operation From Kvo Mode

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Resuming Operation from KVO Mode To place channel on hold, press RUN/HOLD key. Press VTBI soft key. • VTBI is highlighted. To enter desired VTBI, use numeric keys then press ENTER key.

  • Page 41: Delivering A Bolus Dose Prior To Beginning Continuous Infusion

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Delivering a Bolus Dose Prior to Beginning Continuous Infusion Set up infusion as described in “Continuous Infusion” procedure, steps 1 - 10. Do not start infusion. On VTBI and VI setup page, press Bolus soft key. OPTIONS •...

  • Page 42: Delivering A Bolus Dose During A Continuous Infusion

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Delivering a Bolus Dose Prior to Beginning Continuous Infusion (Continued) Verify that all parameters are correct, then press run soft key or RUN/HOLD key to start infusion. • When bolus dose completes, an audio tone sounds OPTIONS and “Bolus Dose Complete”...

  • Page 43: Bolus Only

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Delivering a Bolus Dose During a Continuous Infusion (Continued) An optional hospital-defined bolus dose administration rate may have been used to calculate an editable Time in minutes to deliver programmed bolus dose. To enter a value, use numeric data entry keys then press ENTER key.
  • Page 44 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Bolus Only (Continued) To enter a value, use numeric data entry keys then press ENTER key. • If bolus is weight-based and weight has already been programmed in same channel, Wt (patient weight in kg) is automatically entered.

  • Page 45: Stopping Bolus Dose

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Stopping Bolus Dose To place channel on hold, press channel RUN/HOLD key. Press menu soft key. • Bolus Menu displays. Press Quit Bolus soft key. OPTIONS BOLUS MENU To start continuous infusion, if one was programmed, Repeat Last Bolus verify parameters are correct and then press run soft key New Bolus...

  • Page 46: Intermittent Infusion

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Intermittent Infusion When using a drug listed in the Drug Library, the drug parameters are automatically calculated based on: • drug amount • weight entry or BSA entry (if required) •...
  • Page 47 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Intermittent Infusion (Continued) • If applicable, a weight-based, non-weight-based or BSA-based option for delivery of this infusion may appear. • If applicable, multiple concentration listings for delivery OPTIONS of this infusion may appear (as in illustrated example VANCOmycin which reflects use of vancomycin).
  • Page 48 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Intermittent Infusion (Continued) • If a drug with -- / -- mL was selected, Conc OPTIONS (concentration values, drug amount and diluent paclitaxel volume), need to be entered. Drug amount is total Conc = - - - - mg/ - - - - mL...

  • Page 49: Making Changes During Intermittent Infusion

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) Intermittent Infusion (Continued) 11. An optional hospital-defined and editable starting value for OPTIONS time may already be entered. Rate = 166.7 mL/h VTBI = 500.0 mL VI = 0.0 mL Time = 3 h 0 min To enter a value, use numeric data entry keys to enter paclitaxel...

  • Page 50: Iv Fluid Infusion

    ® Primary Infusion - With Guardrails Suite MX Protection (Continued) IV Fluid Infusion Press New Guardrails Fluid soft key. OPTIONS New Guardrails Drug • If 15 or less fluids are available in selected profile, a New Guardrails Fluid list of fluid names displays; otherwise, an alphabetic Basic Infusion pre-selection menu displays.
  • Page 51 ® Primary Infusion - With Guardrails Suite MX Protection (Continued) IV Fluid Infusion (Continued) If a Clinical Advisory has been defined for selected fluid, a OPTIONS message appears. To indicate that information has been noted and continue programming, press ok soft key. 0.22 micron filter Dedicated Line ADVISORY...

  • Page 52: Secondary Infusion - With Guardrails

    ® Secondary Infusion - With Guardrails Suite MX Protection Introduction This mode is designed to support automatic secondary WARNINGS infusions (“piggybacking”) in the same channel. A secondary • Secondary applications require infusion can be programmed as a Basic SEC or Guardrails the use of a check valve set on SEC drug.

  • Page 53: Setup

    ® Secondary Infusion - With Guardrails Suite MX Protection (Continued) Setup Open secondary administration set package, remove set and close clamp. Insert administration set spike into prepared fluid container and hang secondary container, following accepted hospital/facility procedure. Fill drip chamber to 2/3 full. Open secondary administration set clamp and prime set.

  • Page 54: Secondary Intermittent Infusion

    ® Secondary Infusion - With Guardrails Suite MX Protection (Continued) Secondary Intermittent Infusion When using a secondary intermittent drug listed in the Drug Library, the drug parameters are automatically calculated based on: • drug amount • weight entry or BSA entry (if required) •...
  • Page 55 ® Secondary Infusion - With Guardrails Suite MX Protection (Continued) Secondary Intermittent Infusion (Continued) • If applicable, an optional hospital-defined therapy OPTIONS or clinical indication for delivery of this infusion may VANCOmycin appear (as in illustrated example, which reflects use of Central vancomycin).
  • Page 56 ® Secondary Infusion - With Guardrails Suite MX Protection (Continued) Secondary Intermittent Infusion (Continued) Enter parameters as needed. • If a drug with a defined standard concentration was selected, Conc (concentration values, drug amount and diluent volume) are automatically entered. (Note that these values are not editable).
  • Page 57 ® Secondary Infusion - With Guardrails Suite MX Protection (Continued) Secondary Intermittent Infusion (Continued) 12. An optional hospital-defined and editable starting time for Time may already be entered. To enter a value, use numeric data entry keys to enter hours (0-99), then minutes (0-59). Press ENTER key to accept each entry.

  • Page 58: Primary Infusion - No Guardrails Suite Mx Protection

    Primary Infusion - Guardrails ® Suite MX Protection The following procedures should be used only when the drug to be infused is not listed in the Drug Library or when the Profile feature is set to OFF in the instrument system configuration.

  • Page 59: Promoting Basic Infusion To Guardrails

    Primary Infusion - Guardrails ® Suite MX Protection (Continued) Basic Infusion (Continued) If there is a VI value that needs to be cleared, press CLEAR key or press 0 (zero) key then press ENTER key. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.

  • Page 60: Promoting Basic Infusion To Guardrails

    Primary Infusion - Guardrails ® Suite MX Protection (Continued) Promoting Basic Infusion to Guardrails ® Drug Infusion (Continued) Press soft key next to desired drug name to select it. OPTIONS Alprostadil • page soft key(s) may be used to view additional Bretylium selections.

  • Page 61: Iv Fluid Infusion

    Primary Infusion - Guardrails ® Suite MX Protection (Continued) Promoting Basic Infusion to Guardrails ® Drug Infusion (Continued) • If selected drug is weight-based, Wt (patient weight in kg) needs to be entered. • If selected drug is not weight-based, Wt (patient weight) field does not appear.

  • Page 62: Dose Rate Calculation- Drug? No Dose Limit-Profiles Feature Enabled (On)

    Primary Infusion - Guardrails ® Suite MX Protection (Continued) Promoting Basic Infusion to Guardrails ® IV Fluid Infusion (Continued) If a Clinical Advisory has been defined for selected fluid, a message appears. To indicate that information has been noted and continue programming, press ok soft key. •...
  • Page 63 Primary Infusion - Guardrails ® Suite MX Protection (Continued) Dose Rate Calculation-Drug? NO DOSE LIMIT - Profiles Feature Enabled (ON) (Continued) Press 0 (zero) numeric key then press Drug? – NO DOSE OPTIONS LIMIT soft key. Drug? NO DOSE LIMIT •...

  • Page 64: Dose Rate Calculation- Drug? No Dose Limit-Profiles Feature Not Enabled (Off)

    Primary Infusion - Guardrails ® Suite MX Protection (Continued) Dose Rate Calculation-Drug? NO DOSE LIMIT - Profiles Feature Enabled (ON) (Continued) Enter parameters as needed. OPTIONS • Dose field is highlighted for first entry but soft keys can Rate = - - - - - mL/h be used to highlight other parameters for entry prior to Dose= - - - - -...
  • Page 65 Primary Infusion - Guardrails ® Suite MX Protection (Continued) Dose Rate Calculation-Profiles Feature Not Enabled (OFF) (Continued) Press OPTIONS soft key. • Options page appears. Press Dose Rate Calculator soft key. OPTIONS Resistance Trend Monitoring Options Dose Rate Calculator Set Pressure Baseline return page Press Enter New Program soft key.
  • Page 66 Primary Infusion - Guardrails ® Suite MX Protection (Continued) Dose Rate Calculation-Drug? NO DOSE LIMIT - Profiles Feature Not Enabled (OFF) (Continued) To enter desired values, use numeric keys then press ENTER key. • Dose field is highlighted for first entry, but soft keys can be used to highlight other parameters for entry prior to dose.

  • Page 67: Loading Dose

    Loading Dose This feature allows an initial infusion rate to be set up for a WARNING specific volume, automatically followed by a maintenance This mode is useful for delivering rate (primary settings) from the same container. If delivering fluid challenges. This feature is for a bolus dose of medication to load prior to the start of a delivery from primary containers ®...
  • Page 68 Loading Dose (Continued) Programming (Continued) If current value is appropriate, press ENTER key. OPTIONS Rate= 200.0 mL/h VTBI= 500.0 To enter a new infusion rate, use numeric keypad and Primary Settings press ENTER key. LOADING DOSE • Loading Dose VTBI is highlighted. If current value is appropriate, press ENTER key.

  • Page 69: Multi-Dose

    Multi-Dose This feature allows 1 to 24 infusions to be preprogrammed with CAUTION the same rate and volume, to be delivered at equally spaced Guardrails ® drug dosing limits intervals, over a period of up to 24 hours. It also offers a are available only within the delayed start option up to 8 hours and a Dose Complete Alert New Guardrails Drug or New...
  • Page 70 Multi-Dose (Continued) Programming (Continued) • Setup page appears with infusion rate highlighted. OPTIONS Rate= ----- mL/h VTBI/Dose= ----- mL No. Doses= -- Frequency= -- h menu To enter infusion rate, use numeric keypad. Press ENTER OPTIONS key. Rate=250.0 mL/h VTBI/Dose= ----- No.
  • Page 71 Multi-Dose (Continued) Programming (Continued) Verify that all parameters are correct then press ok soft OPTIONS key. Rate=250.0 mL/h VTBI/Dose=100.0 mL No. Doses= 4 Frequency= 6 h menu • If Dose Complete Alert Option is enabled, DOSE OPTIONS COMPLETE ALERT OPTION page appears. DOSE COMPLETE ALERT OPTION menu...
  • Page 72 Multi-Dose (Continued) Programming (Continued) Starting First Dose Immediately After Programming (Continued) OPTIONS To start infusion, press RUN/HOLD key or run soft key. Rate=250.0 mL/h VTBI=100.0 mL VI= 0.0 mL Dose 1 of 4 menu Delaying Start of First Dose To enter number of hours until first dose, use numeric OPTIONS keypad.
  • Page 73 Multi-Dose (Continued) Programming (Continued) Delaying Start of First Dose (Continued) • Hourglass icon flashes to indicate timer is counting OPTIONS down to start of dose. 12 min • Dose automatically starts its infusion when timer Until First Dose reaches 0 hours, 0 minutes. stop timer To briefly view Multi-Dose programmed information, press OPTIONS...

  • Page 74: Resuming An Interrupted Multi-Dose

    Multi-Dose (Continued) Resuming an Interrupted Multi-Dose Select desired channel, as necessary. À Select New Patient and Profile Options, as necessary. • Return To Multi-Dose? page appears. Press yes soft key. OPTIONS • Pressing no soft key returns screen to primary setup page.

  • Page 75: Multi-Step

    Multi-Dose (Continued) Resuming an Interrupted Multi-Dose (Continued) If Infusion Was Not in Progress When Interrupted Press ok soft key. OPTIONS Rate=250.0 mL/h VTBI/Dose=100.0 mL Frequency= 6 h DOSE 1 COMPLETE menu Edit time to delivery of next dose, as necessary. To begin timer’s countdown to delivery of next dose, press OPTIONS start timer soft key.
  • Page 76 Multi-Step (Continued) Programming (Continued) Press Multi-Step soft key. OPTIONS Multi-Step Multi-Dose Loading Dose View Curr. Settings return page Press Enter New Program soft key. OPTIONS MULTI-STEP MENU Review/Resume Enter New Program Quit Program Determine setup method: OPTIONS • Rate and Volume: Instrument calculates step PROGRAMMING OPTIONS Rate and Volume infusion time.
  • Page 77 Multi-Step (Continued) Programming (Continued) Programming by Rate and Volume (Continued) To enter a rate, use numeric keypad. Press ENTER key. OPTIONS STEP 1 Rate= 25.0 mL/h VTBI= ----- Time= -- h -- min menu To enter VTBI, use numeric keypad. Press ENTER key. •...
  • Page 78 Multi-Step (Continued) Programming (Continued) Programming by Rate and Volume (Continued) To clear VI, if desired, press CLEAR or 0 (zero) key. OPTIONS Press ENTER key. STEP TOTALS (3) VTBI= 130.0 mL Time= 1 h 42 min 25.0 menu To accept STEP TOTALS page, press ok soft key. OPTIONS STEP TOTALS (3) VTBI= 130.0 mL...
  • Page 79 Multi-Step (Continued) Programming (Continued) Programming by Volume and Time • Step 1 of infusion profile displays. OPTIONS • VTBI is highlighted. STEP 1 Rate= ----- mL/h VTBI= ----- Time= -- h -- min menu To enter VTBI, use numeric keypad. Press ENTER key. OPTIONS •...
  • Page 80 Multi-Step (Continued) Programming (Continued) Programming by Volume and Time (Continued) When all steps have been entered and accepted, press OPTIONS done soft key. STEP 4 Rate= ----- mL/h • Review page(s) display 3 profile steps at a time. VTBI= ----- mL Time= -- h -- min menu done...

  • Page 81: Making Changes During Multi-Step

    Multi-Step (Continued) Programming (Continued) Programming by Volume and Time (Continued) 11. To start Multi-Step infusion program, press RUN/HOLD OPTIONS key or run soft key. Rate= 25.0 mL/h VTBI= 5.0 mL 0.0 mL STEP 1 of 3 menu setup Making Changes During Multi-Step Select the desired channel, as necessary.
  • Page 82 Multi-Step (Continued) Making Changes During Multi-Step (Continued) Viewing Totals Remaining Press soft key. OPTIONS Rate= 50.0 mL/h VTBI= 25.0 mL 5.0 mL STEP 2 of 3 10% Resistance • Time and VTBI remaining in Multi-Step program display for OPTIONS a short interval. Rate= 50.0 mL/h VTBI= 25.0 mL Totals...
  • Page 83 Multi-Step (Continued) Making Changes During Multi-Step (Continued) Viewing or Editing (Continued) To select a step for editing, press a soft key. To select value for editing, press a soft key. To enter new value, use numeric keypad. Press ENTER OPTIONS key.

  • Page 84: Resuming An Interrupted Multi-Step

    Multi-Step (Continued) Resuming an Interrupted Multi-Step The channel retains its place in the program if the instrument is turned off. The program can be restarted from step 1 or resumed where it left off. Select desired channel, as necessary. À Select New Patient and Profile Options, as necessary.

  • Page 85: Quitting Multi-Dose And Multi-Step

    Multi-Step (Continued) Resuming an Interrupted Multi-Step (Continued) To approve review page(s) and STEP TOTALS page, OPTIONS press ok soft key. # RATE VTBI TIME 25.0 5.0 0h12m 2 25.0 25.0 1h00m 3 100.0 100.0 1h 0m menu To continue or restart program, press RUN/HOLD key or OPTIONS run soft key.

  • Page 86: Secondary Infusion - No Guardrails Suite Mx Protection

    Secondary Infusion - Guardrails ® Suite MX Protection Introduction ® See “Secondary Infusion With Guardrails Suite MX Protection, Introduction and Setup". Basic Secondary Infusion- Profiles Feature Enabled (On) Primary infusion must be on hold to program secondary infusion. Secondary mode must be set to ON in the instrument system configuration settings.

  • Page 87: Basic Secondary Infusion-Profiles Feature Not Enabled (Off)

    Secondary Infusion - Guardrails ® Suite MX Protection (Continued) Basic Secondary Infusion- Profiles Feature Enabled (On) (Continued) Verify that secondary clamp is open before proceeding, OPTIONS then press yes soft key. • Basic secondary RUN/HOLD page displays. IS SECONDARY CLAMP OPEN? Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
  • Page 88 Secondary Infusion - Guardrails ® Suite MX Protection (Continued) Basic Secondary Infusion- Profiles Feature Not Enabled (Off) (Continued) To start secondary infusion, press RUN/HOLD key. • Secondary clamp reminder message displays. Verify that secondary clamp is open before proceeding, then press yes soft key. To briefly view primary settings during secondary infusion press Primary Settings soft key.

  • Page 89: Dynamic Monitoring System

    Dynamic Monitoring System All features and options in this section are shown enabled. Options are enabled through the hospital Data Set profile WARNINGS configuration settings, or through the instrument configuration • The SE Pump is designed to settings if the Profiles feature is not enabled (OFF). stop fluid flow under alarm The Dynamic Monitoring System provides the ability to monitor conditions.

  • Page 90: Selecting Monitoring Option

    Monitoring Options - General (Continued) • Adjustable Pressure: designed to monitor IV line/ site pressure and provide user-adjustable pressure OPTIONS alarm limits. Used for Precision Flow mode or for high resistance systems; such as, infusion through transducers, Rate= 125.0 mL/h into dialysis systems and through highest resistance VTBI= 1000.0 mL À...
  • Page 91 Monitoring Options - General (Continued) Selecting Monitoring Option (Continued) Press soft key for Resistance, High Resistance or OPTIONS À Adjustable Pressure. Monitoring Options Resistance High Resistance Adjustable Pressure Press ok soft key. Display automatically returns to normal WARNING Á operating screen. Each time the instrument is turned on, verify and/or set the monitoring mode, resistance alert...

  • Page 92: Monitoring Options - Resistance Mode

    Monitoring Options - General (Continued) Selecting Monitoring Option (Continued) If Adjustable Pressure option is selected, pressure OPTIONS system accuracy can be enhanced by ensuring no Rate= 125.0 mL/h occlusion or other pressure source exists in IV line Ä Å VTBI= 1000.0 mL when activating RUN/HOLD.

  • Page 93: Auto Restart Plus Feature

    Monitoring Options - Resistance Mode (Continued) Detection of Downstream Occlusions (Continued) An OCCLUSION DOWNSTREAM condition is detected when the measured resistance reaches 100% of scale. For the Resistance mode, 100% results from a resistance producing 2 mmHg per mL/h of flow. For the High Resistance mode, 100% results from a resistance producing 6 mmHg per mL/h flow.

  • Page 94: Resistance Alert

    Monitoring Options - Resistance Mode (Continued) Auto Restart Plus Feature (Continued) If resistance measurements initiate the Checking Line OPTIONS condition, the channel continues infusing in order to Rate= 125.0 mL/h determine if the measured flow resistance has changed. If VTBI= 1000.0 mL the measured flow resistance falls to any value below 100% 0.0 mL within 40 seconds, the channel automatically resumes normal...

  • Page 95: Resistance Trend Graphs

    Monitoring Options - Resistance Mode (Continued) Resistance Alert If Flow Resistance Exceeds Alert Level Marker If flow resistance exceeds the alert level marker, a Resistance OPTIONS Alert message displays and an alert tone sounds. The Rate= 125.0 mL/h channel continues to infuse, and the message and tone VTBI= 1000.0 mL continue until one of the following resistance levels occurs: 0.0 mL...
  • Page 96 Monitoring Options - Resistance Mode (Continued) Resistance Trend Graphs (Continued) Viewing Graphs (Continued) Press Resistance Trend soft key. OPTIONS Resistance Trend Monitoring Options Guardrails ® Library Set Pressure Baseline return page To change graph time frame, press time soft key. OPTIONS •...
  • Page 97 Monitoring Options - Resistance Mode (Continued) Resistance Trend Graphs (Continued) Clearing Graphs (Continued) Press ok soft key. OPTIONS All trend data will be cleared return • All data is cleared from graphs. OPTIONS -12h RESISTANCE return clear time Returning to Normal Operating Screen Press return soft key.

  • Page 98: Monitoring Options - Pressure Mode

    Monitoring Options - Pressure Mode Detection of Downstream Occlusions When using the Adjustable Pressure monitoring mode, a OPTIONS pressure alarm limit may be selected, in 25 mmHg increments, from 25 mmHg to the maximum configured pressure limit. Rate= 125.0 mL/h When measured pressure exceeds this level, an OCCLUSION VTBI= 1000.0 mL 0.0 mL...

  • Page 99: Adjustable Pressure Alarm

    Monitoring Options - Pressure Mode (Continued) Auto Restart Plus Feature (Continued) The Checking Line message and tone occur whenever a OPTIONS pressure measurement exceeds the selected alarm threshold. If the pressure falls to less than one-third of the alarm limit OCCLUSION within 40 seconds, normal flow resumes.
  • Page 100 Monitoring Options - Pressure Mode (Continued) Adjustable Pressure Alarm Pressure Monitoring Using Automatic Baseline Calibration The auto pressure baseline calibration remains in effect until the instrument is turned off, the latch is opened, the set is reloaded, or the Set Pressure Baseline function is performed. •...

  • Page 101: Pressure Baseline

    Monitoring Options - Pressure Mode (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 line is high or changing.
  • Page 102 Monitoring Options - Pressure Mode (Continued) Pressure Baseline (Continued) Manually Setting Pressure Baseline While Operating in Adjustable Pressure Mode (Continued) À Press Set Pressure Baseline soft key. OPTIONS Pressure Trend Monitoring Options Guardrails Library Set Pressure Baseline return page • Set Pressure Baseline screen appears.

  • Page 103: Pressure Trend Graphs

    Monitoring Options - Pressure Mode (Continued) Pressure Baseline (Continued) Manually Setting Pressure Baseline While Operating in Adjustable Pressure Mode (Continued) Á Verify pressure readout is 0 (zero) mmHg. Â Ã Ä To start infusion, press RUN/HOLD key. OPTIONS Rate= 125.0 mL/h VTBI=1000.0 mL 0.0 mL Primary...
  • Page 104 Monitoring Options - Pressure Mode (Continued) Pressure Trend Graphs (Continued) Viewing Graphs Dual channel instruments: Select desired channel, as necessary. Trend graph is not available while split screen is displayed. Press OPTIONS key. OPTIONS Rate= 125.0 mL/h VTBI=1000.0 mL 0.0 mL Primary Limit = 300 mmHg Press Pressure Trend soft key.
  • Page 105 Monitoring Options - Pressure Mode (Continued) Pressure Trend Graphs (Continued) Clearing Graphs To clear graphed data, press clear soft key. OPTIONS -12h PRESSURE return clear time Press ok soft key. OPTIONS All trend data will be cleared return • All data is cleared from graphs. OPTIONS -12h PRESSURE...

  • Page 106: Upstream Occlusion Detection

    Monitoring Options - Pressure Mode (Continued) Pressure Trend Graphs (Continued) Returning to Normal Operating Screen (Continued) • Normal operating screen appears. OPTIONS Following events also turn off trend graph: Rate= 125.0 mL/h VTBI=1000.0 mL 0.0 mL • Pressing RUN/HOLD key. Primary •...
  • Page 107 Upstream Occlusions Detection (Continued) When an upstream occlusion condition is detected: • OCCLUSION UPSTREAM message appears. • Audio alarm sounds and infusion stops. • In certain conditions, upstream alarm system may briefly pause instrument and present Checking Line message for 10 seconds to confirm or rule out presence of an occlusion.
  • Page 108 THIS PAGE INTENTIONALLY LEFT BLANK Dynamic Monitoring System Directions for Use ® Alaris SE Pump Models 7130/7131, 7230/7231...

  • Page 109: General Setup And Operation

    General Set Up and Operation Audio Adjust This feature allows the audio volume to be adjusted for alarms, alerts and KVO tone to either High, Medium or Low if all audio volume levels are enabled in the Profile configuration or in the instrument configuration settings and the Profiles features is set to OFF (not enabled).
  • Page 110 Tamper Resist (Continued) Locking and Unlocking Panel Lock (Continued) Turning Panel Lock Feature On (Continued) OPTIONS For dual channel instruments, while panel lock is activated, Rate= 125.0 mL/h keys can be used to view settings. VTBI=1000.0 mL 0.0 mL Since panel lock must be inactivated to power down Panel Locked instrument, it is always off when instrument is powered on.

  • Page 111: General Information

    General Information Warnings and Cautions DANGER Explosion risk if used in the presence of flammable anesthetic agents or gases. General WARNINGS • The SE Pump is designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected.

  • Page 112: Guardrails Suite Mx

    Warnings and Cautions (Continued) General (Continued) WARNINGS • Electrical shock hazard. Do not open case. Refer to qualified service personnel. CAUTIONS • The SE Pump is not intended to replace supervision by medical personnel. The user must become thoroughly familiar with the SE Pump features, operation and accessories prior to use.

  • Page 113: Administration Sets

    Warnings and Cautions (Continued) Administration Sets WARNINGS • 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.

  • Page 114: Electromagnetic Compatibility

    Warnings and Cautions (Continued) Epidural Administration (Continued) WARNINGS • The SE Pump can be used for epidural administration of anesthetic and analgesic drugs. This application is only appropriate when using anesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use. Use only sets dedicated for use with the SE Pump, without a ‘Y’...

  • Page 115: Battery Management System

    Warnings and Cautions (Continued) Electromagnetic Compatibility (Continued) CAUTIONS • The SE pump is intended for use under the supervision of healthcare professionals only. This is a CISPR 11 Class B device without the use of the Model 180 (Flow Sensor) and CISPR 11 Class A when the Model 180 (Flow Sensor) is used.

  • Page 116: Battery Power Gauge And Indicator

    Battery Management System (Continued) Battery Power Gauge and Indicator The gauge indicates approximate battery run time remaining under current operating conditions. It is located in the lower display and is always on. To ensure a more accurate GOLD battery gauge reading, review the remaining battery run time 5 minutes after starting an infusion.
  • Page 117 Flow Sensor (Continued) If a flow sensor is not connected to the instrument, ensure Flow Sensor Connectors protective plugs are installed at the connector site to prevent entry of foreign material. Plug a Model 180 Flow Sensor into applicable channel connector on back of instrument.

  • Page 118: Alerts Counter

    Flow Sensor (Continued) Routinely clean flow sensor with warm water while CAUTION actuating slider, then dry thoroughly. Do not use solvents or cleaning agents. Damage to plastic parts of the flow sensor could occur. NOTE: À If the flow sensor option is in use, VTBI can be turned off by selecting VTBI, pressing CLEAR and then ENTER keys.

  • Page 119: Viewing Alerts Counter

    Alerts Counter (Continued) Definitions (Continued) New Patients: Total number of new patients or profiles selected. Counter increments when yes to New Patient? screen prompt or a different profile at instrument power up is selected. Overrides: Total number of Soft Limit Guardrails ®...

  • Page 120: Nurse Call (7130/7230 Only)

    Nurse Call (7130/7230 Only) If the instrument is equipped with the optional nurse call feature, alarms and some alerts from the instrument are relayed to the hospital’s existing nurse call system. No instrument operating features are changed. The instrument alarms with or without the nurse call installed. Activating Nurse Call Feature RS 232 Plug nurse call cable into...

  • Page 121: Pole Clamp

    Pole Clamp The uniquely designed pole clamp adapts to a wide variety of surfaces (such as, poles, bed rails) to provide greater À Á versatility and to simplify transports. It features: • 360º rotation in 90º increments • ergonomically designed knob •...

  • Page 122: Rs-232 Computer Link

    RS-232 Computer Link The optional Computer Link feature allows a hospital/facility computer to interact with the instrument. The computer cannot WARNINGS start or stop the instrument, set the rate, or make any change • Use of any accessory or cable in status.

  • Page 123: Disconnecting From A Computer

    RS-232 Computer Link (Continued) Disconnecting from a Computer Press OPTIONS key. To advance to next page, press page soft key. Press Computer Link soft key. Press Off soft key. Press ok soft key. RS 232 Disconnect RS-232 cable from port on instrument back panel.

  • Page 124: Features And Displays

    Features and Displays Operating Features, Controls, Indicators Models 7130/7131 Power Key: Turns instrument on and off. Power Indicator: Green = Plugged in and charging. Flashing Amber = Battery power. Infusing Indicator: Indicates instrument is infusing. Alarm Indicator: Indicates instrument is in alarm and has stopped infusing. RUN/HOLD Key: Starts and stops POWER HOLD...
  • Page 125 Features and Displays (Continued) Operating Features, Controls, Indicators (Continued) Models 7230/7231 Channel Select Keys/Indicators: Select channel A or B. Light to indicate which channel is selected. Alarm Indicators: Indicate a channel is in alarm and has stopped infusing. Infusing Indicators: Indicate a channel is infusing.
  • Page 126 Features and Displays (Continued) Operating Features, Controls, Indicators (Continued) Panel Lock Key RS-232 Connector Cover Flow Sensor Receptacle(s) RS-232 Connector Pole Clamp Rotation Lever Battery Door Potential Equalization Connector (7131/7231) POWER POWER HOLD HOLD Latch ml/hr ml/hr KVO OPT HLD PRI SEC HLD OPT KVO OPTIONS...

  • Page 127: Displays

    Features and Displays (Continued) Displays Main Display The Main Display is backlit for easy viewing. The backlight CAUTION dims when operating on battery power as an energy-saving Appearance of lines and/or dots feature. Pressing any key automatically turns the backlight up that remain on constantly when again.

  • Page 128: Feature Definitions

    Features and Displays (Continued) Displays (Continued) Lower Display The lower LCD display is backlit for easy viewing. The display dims when operating on battery power, as an energy-saving feature. Panel Lock Indicator Displayed if panel lock is on. Audio Volume Indicator Indicates audio volume for alarms and alerts.

  • Page 129: Configurable Settings

    Features and Displays (Continued) Feature Definitions (Continued) IV Fluid Allows rate and volume to be entered for an infusion that is delivered in mL/h, providing a prompt if a rate is entered that is outside facility’s best-practice guidelines. Profile A unique set of system configuration settings and best-practice guidelines for a specific patient population or patient type, and can consist of following components: •...

  • Page 130: Configurable Option Definitions-General

    Configurable Settings (Continued) (Continued) Configurable Option Definitions - General Air in Line: Air in Line Threshold (microliters) Sets upper limit for a single bolus of air to pass without alarm. In other words, it is amount of air allowed to pass through air- in-line detector before an air-in-line alarm sounds.
  • Page 131 Configurable Settings (Continued) Configurable Option Definitions - General (Continued) Dynamic Monitoring: Auto Restart Plus Part of the Dynamic Monitoring system and designed to help minimize nuisance “occlusion downstream” alarms. It allows instrument to automatically continue an infusion following detection of a downstream occlusion if downstream pressure falls to an acceptable level within a 40- second Checking Line period.
  • Page 132 Configurable Settings (Continued) Configurable Option Definitions - General (Continued) Dynamic Monitoring - Pressure: (Continued) Pressure Limit, Initial This is default pressure alarm limit that is automatically set when instrument is powered on and a new profile is selected or New Patient? - Yes is selected.
  • Page 133 Configurable Settings (Continued) Configurable Option Definitions - General (Continued) KVO Rate KVO (keep vein open) mode automatically occurs when primary VTBI has counted down to 0.0 mL. Channel switches to preset KVO rate or remains at current rate, whichever is less. KVO rate may be set to a value between 0.1 and 20 mL/h in 0.1 mL/h increments.

  • Page 134: Configurable Option Definitions-Guardrails

    Configurable Settings (Continued) Configurable Option Definitions - General (Continued) Optional Modes: (Continued) Multi-Step Allows a sequential drug delivery program (up to 9 steps) to be set delivering volumes of fluid at different rates at each step. This allows instrument parameters to be set up once and deliver a step profile, eliminating need to change rate and VTBI after each step of infusion.

  • Page 135: Configurable Options

    Configurable Settings (Continued) Configurable Options Feature Options Default Air-in-Line: Air-in-Line Accumulator On/Off Air-in-Line Threshold 50,100,200, or 500 mcL 100 mcL Air-in-Line Reset On/Off Audio: Transition Tone On/Off Volumes Low/Med/Hi Med/Hi Low/Med/Hi Configuration Name 4 alphanumeric characters GOLD BSA, Maximum* 0.05 - 3 Dynamic Monitoring: Auto Restart Plus 0 (Off) /1 to 9...

  • Page 136: System Configurable Options

    Configurable Settings (Continued) System Configurable Options The following features can be customized by qualified service personnel in the Configuration or Diagnostic Modes. Feature Options Default Computer Link: Baud Rate 300/600/1200/1800/2400/4800/9600 9600 Mode Monitor/Off, Off Parity Even/Odd/None None Instrument ID* 9 digits 000000000 Maintenance:* Maintenance Interval...
  • Page 137 Specifications (Continued) Battery: Rechargeable nickel-cadmium. A single channel instrument operates for 4 hours nominal and a dual channel instrument operates for 3 hours nominal, under following conditions: • new, fully charged battery • ambient room temperature, 73±7°F (23±4°C) • resistance monitoring modes •...
  • Page 138 Specifications (Continued) À (Continued) Downstream Occlusion: Bolus Volume Bolus Volume Released Monitoring Options Upon Correcting Pressure Resistance and Downstream Occlusion High Resistance (mL) 100% 100% Threshold Settings mmHg mmHg 25 mmHg 600 mmHg Maximum 1 mL/h Typical <0.1 <0.1 <0.1 Maximum 25 mL/h Typical...
  • Page 139 Specifications (Continued) Rate Accuracy: For rates greater than 1 mL/h, up to 999.9 mL/h: ±5%, 95% of time with 95% confidence, under conditions listed below. For rates equal to or less than 1 mL/h: ±6.5%, 95% of time with 95% confidence, under conditions listed below.

  • Page 140: Symbols And Terms

    Symbols and Terms Alarm indicator. Caution: Refer to accompanying documentation. Audio volume. Approximate battery time remaining under current infusing conditions. Battery gauge does not represent battery time remaining when instrument is turned off. Conformité Européenne [CE - Marking] notified body “0086”: British Standards Institution. À...
  • Page 141 Symbols and Terms (Continued) Green = instrument plugged into power and battery being charged. Flashing amber = instrument running on battery power and battery being depleted. RS 232 connector. RS-232 Silence mode. Split screen (dual channel instrument only). Transition Tone A brief tone during transition from one mode to another.
  • Page 142 Symbols and Terms (Continued) NOTE: À Depending on manufacturing and distribution timing, the SE Pump may bear either the CF or CF Defibrillator-Proof symbol on the main rating label. The SE Pump has been tested and complies with IEC 60601-1 Amendment 2, Clause 17 (h) for Defibrillator-Proof Equipment. centimeter day (d) gram (g)

  • Page 143: Trumpet And Start-Up Curves

    Trumpet and Start-Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET and provide a visual representation of uniformity. AND START-UP CURVES Trumpet curves are derived from the second hour of this data. In this instrument, as with all infusion systems, the action of the pumping mechanism and FLOW CHARACTERISTICS UNDER VARYING variations in individual administration sets cause DELIVERY CONDITIONS...

  • Page 144: 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...
  • Page 145 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...

  • Page 146: 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 147 Trumpet and Start-Up Curves (Continued) Resistance Mode (Continued) Resistance Mode Start-up at 999.9 mL/h (initial) Resistance Mode Start-up at 25 mL/h (initial) 2000 1800 1600 1400 1200 1000 -200 Time (min) Time (min) Resistance Mode Trumpet Curve at 25 mL/h (initial) Resistance Mode Trumpet Curve at 999.9 mL/h (initial) 15.6 -0.7...

  • Page 148: High Resistance Mode

    Trumpet and Start-Up Curves (Continued) High Resistance Mode High Resistance Mode Start-up at 999.9 mL/h (initial) 2000 1800 1600 1400 1200 1000 -200 Time (min) High Resistance Mode Trumpet Curve at 999.9 mL/h (initial) -0.1 -0.5 -0.3 -0.7 -1.1 -1.4 -0.9 -1.3 -2.3...

  • Page 149: Troubleshooting And Maintenance

    Troubleshooting and Maintenance General The SE Pump Technical Service Manual is available from Cardinal Health. It includes routine service schedules, interconnect diagrams, component parts lists and descriptions, test procedures, and other technical information, to assist qualified service personnel in repair and maintenance of the instrument’s repairable components.

  • Page 150: Single Or Accumulated Air Bubble Detection (No Reset Feature)

    Air In Line Assembly (Continued) NOTE: À Ensure that the tubing is properly inserted into the air detector to avoid false alarms. The tubing may be reshaped to ensure optimum contact with the sensors. Periodically clean the Air- in-Line Detector to ensure a clear signal can be received (see “Cleaning”).

  • Page 151: Alarms, Alerts, Prompts

    Alarms, Alerts, 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. Additional information can be found in other sections of this DFU (see "Table of Contents").

  • Page 152: Alarms

    Alarms, Alerts, Prompts (Continued) Alarms Alarm Meaning Response ACCUMULATED AIR IN LINE Air detector has detected Press hold soft key. Open multiple small bubbles. latch to remove set. Clear air per hospital protocol. Reinstall set. Press Run/Hold to resume infusion. If reset key is active and air bubbles are clinically insignificant, press reset soft...
  • Page 153 Alarms, Alerts, Prompts (Continued) Alarms (Continued) Alarm Meaning Response CHANNEL MALFUNCTION Channel malfunction. Turn channel off and then on. If problem persists, do not use Dual channel instrument channel. Contact qualified only. service personnel. COMPUTER LINK FAILURE RS-232 connection to computer Check RS-232 connections.
  • Page 154 Alarms, Alerts, Prompts (Continued) Alarms (Continued) Alarm Meaning Response NO UPSTREAM FLOW Flow has been obstructed Check to see if container DETECTED between container and is empty, flow sensor is instrument when using a flow mispositioned or clouded, tubing sensor. is kinked or air vent is closed.
  • Page 155 Alarms, Alerts, Prompts (Continued) Alarms (Continued) Alarm Meaning Response PRIMARY FLOW DETECTED Instrument detected flow Verify that flow sensor is on DURING SECONDARY from primary container Primary line and that set up is during secondary infusion. correct. NOTE: Alarm can only occur when using optional flow sensor.

  • Page 156: Alerts

    Alarms, Alerts, Prompts (Continued) Alerts Alert Meaning Response Battery Low Battery has 30 minutes or less Plug power cord into an AC of charge remaining. outlet as soon as possible. Checking Line Flow has been obstructed. Auto Restart Plus feature must be on for downstream occlusion Auto Restart Plus feature is on.

  • Page 157: Prompts

    Alarms, Alerts, Prompts (Continued) Prompts Prompt Meaning Response Air In Line Air detector has detected air Press continue soft key to prior to starting infusion or is in allow infusion to continue. An poor contact with set. alarm occurs if air detector detects an air bubble larger than configured threshold.
  • Page 158 Alarms, Alerts, Prompts (Continued) Prompts (Continued) Prompt Meaning Response Max Rate = XXX.X mL/h An attempt was made to enter Verify and reenter settings. a rate greater than maximum configured rate or instrument (XXX.X represents maximum has calculated a rate greater flow rate configured for than maximum configured instrument or profile.)
  • Page 159 Alarms, Alerts, Prompts (Continued) Prompts (Continued) Prompt Meaning Response Pressure Limit XXX mmHg An elevated pressure was Reload administration set and present in fluid path when verify no obstruction exists XXX represents configured pressure baseline was which could cause excess maximum pressure) established.
  • Page 160 Alarms, Alerts, Prompts (Continued) Prompts (Continued) Prompt Meaning Response Set Out Flow Regulator segment is not Reinstall Flow Regulator installed correctly. segment. Set Pressure Baseline Set Pressure Baseline was Press ok soft key to set selected in options mode. Pressure Baseline or press return soft key to go to exit.
  • Page 161 Alarms, Alerts, Prompts (Continued) Prompts (Continued) Invalid Keypress During Programming: The following Prompts may be seen if an invalid key is pressed during programming: Both A and B not Running, Channel Not On, Complete or OK Setup, No Numeric Entries, Select Channel. Invalid Keypress During Infusion: During an infusion, if an invalid key is pressed, the following prompts may be seen: Dose Rate Running, Loading Dose Running, Multi-Dose Running, Multi-Step Running, Pri Running, Sec Running, or Timer...

  • Page 162: Inspection Requirements

    Inspection Requirements To ensure the system remains in good operating condition, WARNING both regular and preventive maintenance inspections are Failure to perform these required. inspections may result in improper instrument operation. REGULAR INSPECTIONS CAUTIONS PROCEDURE FREQUENCY • Regular and preventive INSPECT FOR DAMAGE: maintenance inspections should Case...
  • Page 163 Cleaning (Continued) Use a soft cloth dampened with warm water and a mild, nonabrasive cleaning solution. • A soft-bristled brush may be used to clean narrow areas. • Use light pressure when cleaning pressure transducer and air-in-line detector areas of pumping channels. Flow sensor should be routinely cleaned by running warm water over it while actuating slider, and then thoroughly dried.

  • Page 164: Service Information

    Profiles feature is set to OFF. Technical Support Technical support, service information, applications, and manuals may be obtained by contacting a Cardinal Health representative. When submitting any request for service, include: • model number • a description of difficulty experienced •...

  • Page 165: Warranty

    This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Cardinal Health shall not be responsible for, any loss or damage arising in connection with the purchase or use of any SE Pump product which has been: repaired by anyone other than an authorized Cardinal Health Service Representative;...
  • Page 166 THIS PAGE INTENTIONALLY LEFT BLANK Troubleshooting and Maintenance Directions for Use ® Alaris SE Pump Models 7130/7131, 7230/7231...
  • Page 167 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 Cardinal Health, Inc. This Class A/ digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulation.
  • Page 168 Compliance (Continued) Electromagnetic Environment (Continued) Tables: The SE Pump is intended for use in the electromagnetic environments specified in the following tables. Table 1 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment - Guidance The SE Pump is suitable for use in all establishments, including domestic establishments and those directly connected to a public Group 1 CISPR 11...
  • Page 169 Compliance (Continued) Electromagnetic Environment (Continued) Table 2 Electromagnetic Immunity Emissions Test IEC 60601-1-2 Compliance Electromagnetic Environment - Guidance Test Level Level À IEC 61000-4-2 ±6 kV contact ±8 kV contact Floors should be wood, concrete, or ceramic tile. À Electrostatic ±8 kV air ±15 kV air If floors are covered with synthetic material,...
  • Page 170 Compliance (Continued) Electromagnetic Environment (Continued) Table 2 (Continued) Electromagnetic Immunity Emissions Test IEC 60601-1-2 Compliance Electromagnetic Environment - Guidance   Test Level Level <5% U <5% U IEC 61000-4-11 Mains power quality should be that of a typical (>95% dip in U (>95% dip in U commercial or hospital environment.
  • Page 171 Compliance (Continued) Electromagnetic Environment (Continued) Table 3 Electromagnetic Immunity - Life Support Equipment Ã Ä Immunity Test IEC 60601-1-2 Compliance Electromagnetic Environment - Guidance À Test Level Level IEC 61000-4-6 3 Vrms 10 Vrms Portable and mobile RF communications equipment Conducted RF 150 kHz - 80 MHz should be used no closer to the SE Pump (including...
  • Page 172 Compliance (Continued) Electromagnetic Environment (Continued) Ã Ä Å È Table 4 Recommended Separation Distances Reduce the potential for electromagnetic interference by maintaining a minimum distance between portable and mobile communications equipment (transmitters) and the SE Pump as recommended in this table, based on the maximum output power of the communications equipment. For transmitters rated at a maximum output power not listed in this table, the recommended separation distance (d) in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where...
  • Page 173 Compliance (Continued) Electromagnetic Environment (Continued) NOTES: À Compliance levels raised by IEC 60601-2-24 Á Performed at the minimum and maximum rated input voltage. Â U is the mains voltage prior to application of the test level. Ã At z and z, the higher frequency range applies.
  • Page 174 , AccuSlide ® , Guardrails ® and SmartSite ® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks belong to their respective owners. Regulations and Standards Directions for Use ® Alaris SE Pump Models 7130/7131, 7230/7231...
  • Page 175 Supplemental Information: ® Signature Edition GOLD Infusion System, Model 180 Empty Container Detector (ECD) This document provides supplemental information on emissions testing specifications located in ® Specifications section of Maintenance chapter of the Signature Edition GOLD Infusion System Directions For Use. ®...
  • Page 176 Directions for Use SUPPLEMENT Models 7130/7131 and 7230/7231 (With Guardrails ® Safety Software or ® Guardrails Safety Software Compatible) POWER POWER HOLD HOLD ml/hr ml/hr KVO OPT HLD PRI SEC HLD OPT KVO OPTIONS • Clear Enter ® Signature Edition GOLD Infusion System...
  • Page 183 Cardinal Health, 1180 Rolle, Switzerland www.cardinal.com/uk/alaris...
  • Page 184 Directions for Use Supplement ® Alaris SE Pump Models 71XX, 72XX December 2006 POWER HOLD ml/hr OPTIONS Clear Enter POWER POWER HOLD HOLD ml/hr ml/hr KVO OPT HLD PRI SEC HLD OPT KVO OPTIONS • Clear Enter ® Alaris Products...
  • Page 185 Fax: (46) 8 544 43 225 China. Fax: (36) 12 01 5987 Tel: (56) 8621-63844603 Tel: (56) 8621-63844493 Fax: (56) 8621-6384-4025 ©2006 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Directions for Use Supplement ® Alaris SE Pump Models 71XX, 72XX...
  • Page 186 Introduction About This Document This supplemental Directions for Use (DFU) provides an WARNING update to the Alerts information found in the "Troubleshooting Before using the Alaris ® SE pump, and Maintenance" chapter in the applicable DFU for each read all instructions in the ®...
  • Page 187 Trademarks ® Alaris is a registered trademark of Cardinal Health,Inc. or one of its subsidiaries. Directions for Use Supplement Introduction Alaris ® SE Pump Models 71XX, 72XX...
  • Page 188 Cardinal Health, 1180 Rolle, Switzerland www.cardinal.com/uk/alaris Direction for Use ® Alaris SE Pump Models 7130/7131, 7320/7231...

This manual is also suitable for:

Alaris 7230/7231

Table of Contents