Alaris SE User manual

Page 1
Directions for Use
Alaris® SE Pump
Models 7130/7131 and 7230/7231
Supports Guardrails® Suite MX
June 2006
POWER
OPT PRI HLD SEC KVO
PRI
1
4
7
.
ml/hr
SEC
OPTIONS
23
56
9
8
Clear
0
RUN
HOLD
Enter
A
RUN
HOLD
A B
HLD PRI SECKVO OPT
POWER
ml/hr
PRI
POWER
PRI SEC HLD
SEC
RUN
HOLD
OPTION
ml/hr
OPT KVO
B
1
2
3
5
4
7
6
9
8
Clear
0
Enter
Alaris® Products
Page 2
For service contact your local Affiliate Office or Distributor.
AE
Cardinal Health, PO Box 5527, Dubai, United Arab Emirates. Tel: (971) 4 28 22 842 Fax: (971) 4 28 22 914
DE
Cardinal Health, Pascalstr. 2, 52499 Baesweiler, Deutschland. Tel: (49) 2401 604 0 Fax: (49) 2401 604 121
IT
Cardinal Health, Via Ticino 4, 50019 Sesto Fiorentino, Firenze, Italia. Tél: (39) 055 30 33 93 00 Fax: (39) 055 34 00 24
US
Cardinal Health 10221 Wateridge Circle, San Diego, CA 92121, USA. Tel: (1) 800 854 7128 Fax: (1) 858 458 6179
AU
Cardinal Health, 8/167 Prospect Highway, Seven Hills, NSW 2147, Australia. Tel: (61) 2 9838 0255 Fax: (61) 2 9674 4444 Fax: (61) 2 9624 9030
ES
Cardinal Health, Avenida Valdeparra 27, 28108 - Alcobendas, Madrid, España. Tel: (34) 91 657 20 31 Fax: (34) 91 657 20 42
NL
Cardinal Health, Kantorenpand “Hoefse Wing”, Printerweg, 11, 3821 AP Amersfoort, Nederland. Tel: (31) 33 455 51 00 Fax: (31) 33 455 51 01
ZA
Cardinal Health, Unit 2 Oude Molen Business Park, Oude Molen Road, Ndabeni, Cape Town 7405, South Africa. Tel: (27) (0) 860 597 572 Tel: (27) 21 510 7562 Fax: (27) 21 5107567
BE
Cardinal Health, Otto De Mentockplein 19, 1853 Strombeek - Bever, Belgium. Tel: (32) 2 267 38 99 Fax: (32) 2 267 99 21
FR
Cardinal Health, Immeuble Antares - Technoparc, 2, rue Charles-Edouard Jeanneret.
78300 POISSY, France. Tél: (33) 1 30 06 74 60 Fax: (33) 1 39 11 48 34
NO
Cardinal Health Solbråveien 10 A, 1383 ASKER, Norge. Tel: (47) 66 98 76 00 Fax: (47) 66 98 76 01
CA
Cardinal Health, 235 Shields Court, Markham, Ontario L3R 8V2, Canada. Tel: (1) 905-752-3333 Fax: (1) 905-752-3343
GB
Cardinal Health, The Crescent, Jays Close, Basingstoke, Hampshire, RG22 4BS, United Kingdom. Tel: (44) 0800 917 8776 Fax: (44) 1256 330860
NZ
Cardinal Health, 14 George Bourke Drive Mt Wellington, Auckland PO Box 14234 Panmure, Auckland Tel: 09 270 2420 Freephone: 0508 422734 Fax: 09 270 6285
CN
Cardinal Health, Shanghai Representative Office, Suite 9B, Century Ba-Shi Building, 398 Huai Hai Rd(M.), Shanghai 200020, China. Tel: (56) 8621-63844603 Tel: (56) 8621-63844493 Fax: (56) 8621-6384-4025
HU
Cardinal Health, Döbrentei tér 1, H-1013 Budapest, Magyarország. Tel: (36) 14 88 0232 Tel: (36) 14 88 0233 Fax: (36) 12 01 5987
SE
Cardinal Health, Hammarbacken 4B, 191 46 Sollentuna, Sverige. Tel: (46) 8 544 43 200 Fax: (46) 8 544 43 225
General Contact Information
©200 6 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
GETTING STARTED
INTRODUCTION ................................................................................................................................................................................................ 1
UNPACKING ......................................................................................................................................................................................................... 3
CHECK-IN AND CONFIGURATION .......................................................................................................................................................... 4
Rate Accuracy Qualification Test ...................................................................................................................................................... 4
Alternative Rate Accuracy Qualification Test .............................................................................................................................. 8
Set Sensor Check / Pressure Calibration Verification Functional Test
Flow Stop Test ........................................................................................................................................................................................... 13
Ground Current Leakage Test ............................................................................................................................................................ 13
Ground Resistance Test ....................................................................................................................................................................... 13
Instrument Configuration ...................................................................................................................................................................... 13
ADMINISTRATION SET INFORMATION ................................................................................................................................................ 14
General ......................................................................................................................................................................................................... 14
SmartSite® Infusion Set ......................................................................................................................................................................... 14
Preparing Solution Container and Set ............................................................................................................................................ 15
Loading Set ................................................................................................................................................................................................ 16
Removing Set ............................................................................................................................................................................................ 18
Changing Solution Container .............................................................................................................................................................. 18
.......................................................................................................................................................................................... 11
PROGRAMMING
PROGRAMMING AND NAVIGATION TIPS ........................................................................................................................................... 19
Soft Keys ..................................................................................................................................................................................................... 19
Entering Values ......................................................................................................................................................................................... 19
Menus - With Guardrails® Suite MX Protection .......................................................................................................................... 20
Menus - NO Guardrails® Suite MX Protection ............................................................................................................................. 21
Split Screen (Dual Channel Only) ..................................................................................................................................................... 21
Powering On and Off .............................................................................................................................................................................. 21
Responding to Maintenance Reminder .......................................................................................................................................... 23
Responding to Time Set Reminder .................................................................................................................................................. 23
GUARDRAILS® SUITE MX PROMPTS .................................................................................................................................................... 24
Soft Limits ................................................................................................................................................................................................... 24
Hard Limits .................................................................................................................................................................................................. 24
PRIMARY INFUSION - WITH GUARDRAILS® SUITE MX PROTECTION .............................................................................. 25
Selecting New Patient and Profile Options ................................................................................................................................... 25
Primary Infusion Introduction ............................................................................................................................................................. 27
Continuous Infusion ................................................................................................................................................................................ 27
Pausing and Restarting Infusion ....................................................................................................................................................... 31
Making Changes During Continuous Infusion ............................................................................................................................. 31
Resuming Interrupted Infusion ........................................................................................................................................................... 32
KVO Mode .................................................................................................................................................................................................. 33
Resuming Operation from KVO Mode ............................................................................................................................................ 34
Clearing Volume Infused ...................................................................................................................................................................... 34
Bolus Dose ................................................................................................................................................................................................. 34
Delivering a Bolus Dose Prior to Beginning Continuous Infusion ...................................................................................... 35
Delivering a Bolus Dose During a Continuous Infusion .......................................................................................................... 36
Bolus Only ................................................................................................................................................................................................... 37
Stopping Bolus Dose
Repeating a Bolus Dose
Intermittent Infusion ................................................................................................................................................................................ 40
Making Changes During Intermittent Infusion ............................................................................................................................. 43
IV Fluid Infusion ........................................................................................................................................................................................ 44
.............................................................................................................................................................................. 39
....................................................................................................................................................................... 39
............................................................................................................. 11
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Table of Contents
i
Page 4
PROGRAMMING (Continued)
SECONDARY INFUSION - WITH GUARDRAILS® SUITE MX PROTECTION ...................................................................... 46
Introduction ................................................................................................................................................................................................. 46
Setup ............................................................................................................................................................................................................. 47
Secondary Intermittent Infusion ........................................................................................................................................................ 48
PRIMARY INFUSION - NO GUARDRAILS® SUITE MX PROTECTION ................................................................................... 52
Selecting New Patient Option-Profiles Feature Not Enabled (OFF) ................................................................................. 52
Basic Infusion ............................................................................................................................................................................................ 52
Promoting Basic Infusion to Guardrails® Suite MX Protection Infusion ........................................................................... 53
Promoting Basic Infusion to Guardrails® Drug Infusion .......................................................................................................... 53
Promoting Basic Infusion to Guardrails® IV Fluid Infusion ..................................................................................................... 55
Dose Rate Calculation- Drug? NO DOSE LIMIT-Profiles Feature Enabled (ON) ....................................................... 56
Dose Rate Calculation- Drug? NO DOSE LIMIT-Profiles Feature Not Enabled (OFF) ............................................ 58
LOADING DOSE ................................................................................................................................................................................................. 61
Programming ............................................................................................................................................................................................. 61
MULTI-DOSE ........................................................................................................................................................................................................ 63
Programming ............................................................................................................................................................................................. 63
Resuming an Interrupted Multi-Dose .............................................................................................................................................. 68
MULTI-STEP ......................................................................................................................................................................................................... 69
Programming ............................................................................................................................................................................................. 69
Making Changes During Multi-Step ................................................................................................................................................. 75
Resuming an Interrupted Multi-Step ............................................................................................................................................... 78
QUITTING MULTI-DOSE AND MULTI-STEP ....................................................................................................................................... 79
SECONDARY INFUSION - NO GUARDRAILS® SUITE MX PROTECTION ........................................................................... 80
Introduction ................................................................................................................................................................................................. 80
Basic Secondary Infusion-Profiles Feature Enabled (On) ..................................................................................................... 80
Basic Secondary Infusion-Profiles Feature Not Enabled (Off) ............................................................................................ 81
DYNAMIC MONITORING SYSTEM
MONITORING OPTIONS - GENERAL ..................................................................................................................................................... 83
Selecting Monitoring Option ................................................................................................................................................................ 84
MONITORING OPTIONS - RESISTANCE MODE .............................................................................................................................. 86
Detection of Downstream Occlusions ............................................................................................................................................. 86
Auto Restart Plus Feature .................................................................................................................................................................... 87
Resistance Alert ....................................................................................................................................................................................... 88
Resistance Trend Graphs .................................................................................................................................................................... 89
MONITORING OPTIONS - PRESSURE MODE .................................................................................................................................. 92
Detection of Downstream Occlusions ............................................................................................................................................. 92
Auto Restart Plus Feature .................................................................................................................................................................... 92
Adjustable Pressure Alarm .................................................................................................................................................................. 93
Pressure Baseline ................................................................................................................................................................................... 95
Pressure Trend Graphs ......................................................................................................................................................................... 97
UPSTREAM OCCLUSION DETECTION ................................................................................................................................................. 10 0
GENERAL SETUP AND OPERATION
AUDIO ADJUST .................................................................................................................................................................................................. 103
TAMPER RESIST ............................................................................................................................................................................................... 103
Locking and Unlocking Panel Lock .................................................................................................................................................. 103
ii
Table of Contents
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 5
GENERAL INFORMATION
WARNINGS AND CAUTIONS ...................................................................................................................................................................... 105
General ......................................................................................................................................................................................................... 105
Guardrails® Suite MX ............................................................................................................................................................................. 106
Administration Sets ................................................................................................................................................................................. 107
Epidural Administration ......................................................................................................................................................................... 107
Electromagnetic Compatibility ............................................................................................................................................................ 108
BATTERY MANAGEMENT SYSTEM ........................................................................................................................................................ 109
Battery Power Gauge and Indicator ................................................................................................................................................ 110
Battery Recharge ..................................................................................................................................................................................... 110
FLOW SENSOR .................................................................................................................................................................................................. 110
ALERTS COUNTER .......................................................................................................................................................................................... 112
Definitions ................................................................................................................................................................................................... 112
Viewing Alerts Counter ......................................................................................................................................................................... 113
NURSE CALL (7130/7230 ONLY) ............................................................................................................................................................... 114
Activating Nurse Call Feature ............................................................................................................................................................. 114
If an Alarm Occurs .................................................................................................................................................................................. 114
POLE CLAMP ...................................................................................................................................................................................................... 115
Changing Pole Clamp Orientation .................................................................................................................................................... 115
RS-232 COMPUTER LINK ............................................................................................................................................................................. 116
Connecting to a Computer .............................................................................................................................. ..................................... 116
Disconnecting from a Computer ....................................................................................................................................................... 117
FEATURES AND DISPLAYS ......................................................................................................................................................................... 118
Operating Features, Controls, Indicators ...................................................................................................................................... 118
Displays ........................................................................................................................................................................................................ 121
Feature Definitions .................................................................................................................................................................................. 122
CONFIGURABLE SETTINGS ...................................................................................................................................................................... 123
Configurable Option Definitions-General ...................................................................................................................................... 124
Configurable Option Definitions-Guardrails® Suite MX ........................................................................................................... 128
Configurable Options ............................................................................................................................................................................. 129
System Configurable Options ............................................................................................................................................................ 130
SPECIFICATIONS .............................................................................................................................................................................................. 130
SYMBOLS AND TERMS ................................................................................................................................................................................. 134
TRUMPET AND START-UP CURVES ..................................................................................................................................................... 137
Pressure Mode .......................................................................................................................................................................................... 138
Resistance Mode ..................................................................................................................................................................................... 140
High Resistance Mode .......................................................................................................................................................................... 142
TROUBLESHOOTING AND MAINTENANCE
GENERAL .............................................................................................................................................................................................................. 143
AIR IN LINE ASSEMBLY ................................................................................................................................................................................. 143
SINGLE OR ACCUMULATED AIR BUBBLE DETECTION (NO RESET FEATURE) .......................................................... 144
ALARMS, ALERTS, PROMPTS .................................................................................................................................................................. 145
Alarms ........................................................................................................................................................................................................... 146
Alerts ............................................................................................................................................................................................................. 15 0
Prompts ........................................................................................................................................................................................................ 151
INSPECTION REQUIREMENTS ................................................................................................................................................................. 156
CLEANING ............................................................................................................................................................................................................ 156
SERVICE INFORMATION .............................................................................................................................................................................. 158
Technical Support .................................................................................................................................................................................... 158
WARR ANTY ......................................................................................................................................................................................................... 159
Directions for Use
Table of Contents
Alaris® SE Pump
Models 7130/7131, 7230/7231
iii
Page 6
REGULATIONS AND STANDARDS
COMPLIANCE ..................................................................................................................................................................................................... 161
Electromagnetic Environment ............................................................................................................................................................ 161
Standards .................................................................................................................................................................................................... 168
TRADEMARKS .................................................................................................................................................................................................... 168
DIRECTIONS FOR USE SUPPLEMENTS
SUPPLEMENTS................................................................................................................................................
169
iv
Table of Contents
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 7
Introduction
Getting Started
This document provides directions for use for the SE Pump, Models 7130/7131 and 7230/7231. It is used in conjunction with:
®
Alaris
product administration set instructions Drug product labeling SE Pump Technical Service Manual Ground test equipment instructions ECG monitoring system instructions
The SE 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; such as, intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, and irrigation of fluid spaces.
The SE Pump is available as either a single or a dual channel pump that supports the Guardrails
®
Suite MX. The SE Dual Channel Pump is a two-channel device intended to deliver multiple infusions to a single patient.
Guardrails
®
Suite MX for the SE Pump brings a new level of medication error prevention to the point of patient care. Guardrails
®
Suite MX features programming guidelines for medication dosing, delivery rate, duration, bolus dose and bolus dose administration rate, concentration and optional initial programming values in up to 15 patient-specific care areas referred to as profiles. Each profile contains a specific Drug Library and an IV Fluid library as well as instrument configurations appropriate for the care area. Optional drug­specific or fluid-specific clinical advisories provide visual messages. Limits for each Guardrails
®
drug or fluid entry may include Hard Limits that cannot be overridden during infusion programming and/or Soft Limits that can be overridden, based on clinical requirements.
WARNING
Read all instructions before using
the SE Pump.
CAUTION
A Data Set is developed and approved by the facility’s own multi-disciplinary team using the Editor Software, the PC­based authoring tool. A Data Set is then transferred to the SE Pump by qualified personnel. Approved Data Sets are maintained by the Editor Software for future updates and reference.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Getting Started
1
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, then Guardrails
®
Suite MX protection is available. When the Profiles feature is not enabled (Off), or when no Data Set has been transferred to the SE Pump, Guardrails
®
Suite MX protection is not available (see "Primary Infusion – NO Guardrails
- NO Guardrails navigation may differ when Guardrails
®
Suite MX Protection", and "Secondary Infusion
®
Suite MX Protection"). Programming and
®
Suite MX software is
not in use.
Documentation provided with this product may reference product not present in your facility or not yet available for sale in your area.
A superscript number (for example, À) identifies additional information provided as a note at the end of the section.
Administration Sets: Reference “General Information” for specific “Administration Set Information”.
Alarms, Alerts, Prompts: Reference “Troubleshooting and Maintenance” for specific alarms, alerts and prompts.
®
Electromagnetic Environment: Reference “Regulations and Standards”, "Compliance”.
Contraindications: None known.
Warnings and Cautions:
Warnings and cautions provide information needed to safely and effectively use the SE Pump. Reference "General Information", "Warnings and Cautions".
A
DANGER
is an alert to an imminent hazard which could result in serious personal injury and/or product damage if proper procedures are not followed.
WARNING
A
is an alert to a potential hazard which could result in serious personal injury and/or product damage if proper procedures are not followed.
2
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 9
Introduction (Continued)
Warnings and Cautions: (Continued)
A
CAUTION
is an alert to a potential hazard which could result in minor personal injury and/or product damage if proper procedures are not followed.
DEFINED TERMS:
The following table identifies the defined terms used throughout this document for certain products and product features.
Product Name Defined Term
AccuSlide® flow regulator Flow Regulator Alaris® SE pump SE Pump Guardrails Guardrails® CQI Reporter CQI Reporter Guardrails® data set Data Set Guardrails® drug library Drug Library Guardrails® Editor Editor Software Guardrails® hard limit Hard Limit Guardrails® IV fluid IV Fluid Guardrails® soft limit Soft Limit SmartSite® needle-free valve Needle-Free Valve SmartSite® positive bolus needle-free valve Needle-Free Valve
®
clinical advisory Clinical Advisory
Unpacking
1. Remove instrument from carton.
2. Important: Plug instrument into an AC outlet a minimum
of 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.
3. Perform Periodic Inspections (reference "Troubleshooting
and Maintenance", “Inspection Requirements”).
See "General Information", "Configurable Settings" for a list of the configurable features.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
AC
WARNING
Failure to properly charge the battery results in an instrument
malfunction. Biomedical personnel in the facility are responsible for unpacking the instrument and ensuring the battery is fully charged before placing the instrument in use.
Getting Started
3
Page 10
Check-In and Configuration
This is a quick reference procedure for check-in and configuration of new and recently serviced instruments.
Rate Accuracy Qualification Test
This procedure is to be used only for the testing of an instrument during New Instrument Check-In or when just received from the Service Depot Center. This test is to verify that damage or changes to the instrument did not occur during shipment and handling.
WARNING
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 hospital-approved Data Set is loaded.
CAUTION
Charge the battery for a minimum
of 24 hours prior to performing the check-in and configuration procedures. Batteries without a full charge on initial use may become damaged and/or cause a malfunction.
Rate accuracy should be tested using a Model 80VCS Calibration Set. The system is designed to produce overall accuracy of ±5% for rates greater than 1 mL/h and up to
999.9 mL/h, and ±6.5% for rates equal to or less than 1 mL/h, 95% of the time with 95% confidence (reference "General Information", "Trumpet and Start-Up Curves" for additional information). The system performance with a calibration set produces a smaller variability. In order to ensure overall accuracy is achieved, new instruments are tested to an accuracy of ±3% with the Model 80VCS set during New Instrument Check-In.
Due to the dynamic monitoring feature, the rate is varied during operation. For this reason, automatic testers should not be used to check rate accuracy. Generally, these devices collect small samples and may cause the results to be incorrect, even though the instrument is accurate.
4
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
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.
Test Setup
Burette (50 ml)
Burette Clamp
Equipment Stand
ableor Bench
Water Source
30 ±1 in
76.2 cm±2.5
Table or Bench
IV Tubing
Three-Way
Stopcock
Used Fluid Receptacle
1. Fill solution container with clean tap water. Close Flow
Regulator clamp on 80VCS set and then insert spike into solution container.
2. Open Flow Regulator clamp and prime set. Ensure all air
is expelled from set. Close Flow Regulator clamp.
3. Connect output of set to one side of three-way stopcock.
4. Load set into instrument.
80VCS Calibration Set
Instrument Stand
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Getting Started
5
Page 12
Check-In and Configuration (Continued)
Rate Accuracy Qualification Test (Continued)
5. Close latch.
6. Verify no fluid flow or drops falling in drip chamber.
7. Plug instrument into a properly grounded AC outlet.
8. Set stopcock to output into a class A or B burette.
9. Press POWER key to turn channel on.
10. Set primary infusion rate to 400 mL/h.
11. Set VTBI to 20 mL.
12. Ensure instrument (both channels if dual channel) is set to
Pressure mode.
À
13. Press RUN/HOLD key to start primary infusion. Infuse
until tubing and burette are fully primed (approximately 1 minute).
14. Press RUN/HOLD key to stop infusion.
15. Adjust height of instrument and/or fluid container to attain
a head height of 30 ±1 inches / 76.2 ±2.5 centimeters between middle of pumping mechanism and fluid level in:
Á
bag or vented bottle (vent closed on administration set)
OR
drip chamber (unvented bottle with vent open on administration set).
16. Adjust fluid level in burette until meniscus is level with zero mark on burette.
Â
17. Verify primary infusion rate is 400 mL/h.
18. Reset VTBI to 40 mL and clear volume infused.
19. Press RUN/HOLD key to start primary infusion.
20. Instrument will run approximately 360 seconds (6 minutes) to complete delivery and then go into KVO mode. Stop instrument within 1 second of its entering KVO mode.
21. Make a note of volume collected in burette.
22. Note expected volume, as identified on 80VCS set insert.
23. Do not remove 80VCS set from instrument until one of following conclusions is determined:
6
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 13
Check-In and Configuration (Continued)
Rate Accuracy Qualification Test (Continued)
Instrument passes rate verification and calibration is
not needed.
Rate calibration number was changed and instrument
now passes verification.
Mechanism replacement is required.
24. Calculate volume accuracy, as follows:
Volumetric Volume Accuracy Error Computation
Vcollected = volume in burette in milliliters Vexpected = characterized volume printed on 80VCS set
insert
Step 1: A = Vcollected ÷ Vexpected Step 2: B = A x 100 Step 3: % Error (round % Error to nearest tenth of a percent)
= B – 100
25. Result should be 0.0±3%.
26. If volume accuracy does not fall within required range of ±3% from expected volume and test results were:
inside a range of -5.5% to +7.0% from expected
volume,
perform rate calibration (reference Technical Service Manual). Set rate calibration number to 0.0% before running rate test, to determine a new calibration number.
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 The factory default for the Monitoring Options mode is
Pressure.
Á A 30-inch head height was used in the initial qualification of
this process and is the recommended head height for the Check-In Rate Accuracy Test. Based on observed field use, a 24-inch head height was also tested and verified for the Rate Accuracy Specification.
 The instrument may need to be run to prime the line to the
zero level of the burette (step 13).
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Getting Started
7
Page 14
Check-In and Configuration (Continued)
Alternative Rate Accuracy Qualification Test
This procedure is to be used only for the testing of an instrument during New Instrument Check-In or when just received from the Service Depot Center. This test is to verify that damage or changes to the instrument did not occur during shipment and handling.
Make the following changes to Test Setup:
Burette and equipment stand have been replaced by digital
scale, Acculab Vic-212 or equivalent and 50 or 100 mL flask (plastic or glass).
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.
Do not use the Model 80VCS 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.
1. Fill solution container with clean tap water. Close Flow Regulator clamp on 80VCS Calibration Set and then insert spike into solution container.
2. Open Flow Regulator clamp and prime set. Ensure all air is expelled from set. Close Flow Regulator clamp.
3. Place flask in middle of scale.
4. Load set into instrument.
5. Close latch.
6. Verify no fluid flow or drops falling in drip chamber.
7. Plug instrument into a properly grounded AC outlet.
8. Place output of set so it drips into flask. (Do not let set rest on flask.)
9. Press channel’s POWER switch to turn channel on.
10. Set primary infusion rate to 400 mL/h.
8
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
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 Pressure mode.
À
13. Press RUN/HOLD key to start primary infusion. Infuse until tubing is fully primed (approximately 1 minute).
14. Press RUN/HOLD key to stop infusion.
15. Adjust height of instrument and/or fluid container to attain a head height of 30 ±1 inches between middle of pumping mechanism and fluid level in:
bag or vented bottle (vent closed on administration set)
OR
drip chamber (unvented bottle with vent open on
administration set).
16. Zero reading on scale.
17. Verify primary infusion rate is 400 mL/h.
18. Reset VTBI to 40 mL and clear volume infused.
19. Press RUN/HOLD key to start primary infusion.
20. Instrument will run approximately 360 seconds (6 minutes) to complete delivery and then go into KVO mode. Stop instrument within 1 second of entering KVO mode.
21. Make a note of scale reading in grams.
22. Note expected volume, as identified on 80VCS set insert.
23. Do not remove 80VCS set from instrument until one of following conclusions is determined:
Instrument passes rate verification and calibration is
not needed.
Rate calibration number was changed and instrument
now passes verification.
Mechanism replacement is required.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Getting Started
9
Page 16
Check-In and Configuration (Continued)
Alternative Rate Accuracy Qualification Test (Continued)
24. Calculate gravimetric accuracy as follows:
Gravimetric Volume Accuracy Error Computation
Vcollected = volume in flask in grams
Vexpected = characterized volume printed on 80VCS set
insert
Step 1: A = Vcollected / Vexpected Step 2: B = A x 100 Step 3: % Error (Round % Error to nearest tenth of a
percent.) = B – 100
25. Result should be 0.0 ±3%.
26. If volume accuracy does not fall within required range of ±3.0% from expected volume and test results were:
inside a range of -5.5% to +7.0% from expected
volume,
perform rate calibration (reference Technical Service Manual). Set rate calibration number to 0.0% before running rate test, to determine a new calibration number.
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 The factory default for the Monitoring Options mode is
Pressure.
10
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 17
Check-In and Configuration (Continued)
Set Sensor Check / Pressure Calibration Verification
1. Access DIAGNOSTICS MODE by pressing and holding upper left soft key on power-up. Reference Technical Service Manual, “Troubleshooting” chapter, for details or contact Cardinal Health Technical Support.
À
2. Advance to D6 page and choose Cal Pressure (both Channel A and Channel B for dual channel instruments).
3. Verify both 0 mmHg and 500 mmHg readings indicate Pass.
4. Install a standard set and close latch. Verify reading is over 170, to confirm set sensor operation.
5. Remove standard set and verify Sensor = reading is in
-80 to +30 mmHg range without set installed, to verify pressure calibration.
NOTES:
À “08.XX” in the illustrated display represents the current
software revision.
Á If the reading is out of range, reference the Technical Service
Manual, “Pressure Calibration” section, or contact Cardinal Health Technical Support for assistance.
Á
AB
DIAGNOSTICS MODE
ID No. : 000000000 SW Rev.: 08.XX PM Due : 52 weeks
page
OPTIONS
D
1
Functional Test
1. Turn instrument on without set installed. Verify it beeps and red alarm light flashes but does not stay lit.
2. Set infusion rate to 460 mL/h and VTBI to 100 mL.
3. With latch closed, press RUN/HOLD key and rate and VTBI ≠ 0 to cause Set Out and Air In Line messages.
4. Open latch.
5. Install primed administration set with latch open.
6. Verify instrument displays Air In Line and Latch Open messages.
7. Close latch and verify display returns to setup page.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Getting Started
11
Page 18
Check-In and Configuration (Continued)
Functional Test (Continued)
8. Perform Upstream Occlusion Test, as follows:
a. Verify infusion rate is set to 460 mL/h.
b. With instrument on hold, or at start-up, verify primary
VTBI is set to greater than 100 mL.
c. Press RUN/HOLD key to begin infusion.
d. Clamp off IV line just above instrument (about
2 inches) to simulate an upstream occlusion.
e. Verify instrument stops running, alarms, and displays
OCCLUSION UPSTREAM within 60 seconds.
f. Press RUN/HOLD key to silence alarm and put
instrument on hold.
g. Release or open clamp and remove from tubing.
h. Press RUN/HOLD key to resume infusion. Alarm
should not reoccur.
9. Perform Downstream Occlusion Test, as follows:
a. Continue infusing (from step 8h).
b. Verify rate is set to 460 mL/h.
c. Clamp off IV line just below instrument (about
2 inches) to simulate a downstream occlusion.
d. Allow instrument to run until it alarms OCCLUSION
DOWNSTREAM. Verify this occurs within 60 seconds.
e. Press RUN/HOLD key to silence alarm and put
instrument on hold.
f. Release or open clamp and remove from tubing.
g. Press RUN/HOLD key to resume infusion. Alarm
should not reoccur.
h. Press RUN/HOLD key to stop infusion.
12
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 19
Check-In and Configuration (Continued)
Flow Stop Test
1. With an administration set primed and loaded in instrument, turn power off.
2. With all tubing clamps open and fluid container 2 or more feet above instrument, verify no fluid flows through set.
3. Open latch and remove set. Verify no fluid flows through set.
Ground Current Leakage Test
Use a DNI Nevada Model 232D (or equivalent) to measure the ground leakage current. Refer to the test equipment’s operation manual for the proper setup and measurement technique. Leakage current must be ≤100μA for normal and reversed line polarity.
Ground Resistance Test
Use a DNI Nevada Model 232D (or equivalent) to measure the ground resistance. Measure resistance from the AC power plug ground pin to the screw for the power cord strap, or to the screw for the battery cover on the chassis. Refer to the test equipment’s operation manual for the proper setup and measurement technique. Resistance must be ≤0.10Ω.
Instrument Configuration
Instrument Configuration for the SE Pump with the Guardrails® Suite MX is set for each profile using the Editor Software, the PC-based authoring tool. The Data Set is then transferred to the SE Pump by qualified personnel.
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, then Guardrails
®
Suite MX protection is available.
Instrument configuration is set by qualified personnel in the Data Set or Configuration and Diagnostics modes. When the Profiles feature is not enabled (Off), or when no Data Set has been transferred to the SE Pump, Guardrails
®
Suite
MX protection is not available (see "Primary Infusion – NO
®
Guardrails
- NO Guardrails
Suite MX Protection" and "Secondary Infusion
®
Suite MX Protection").
CAUTION
Do not connect the ground
resistance probe to the pressure transducer.
®
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Getting Started
13
Page 20
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 administration.
For specific administration set instructions, reference directions for use provided with set.
Use aseptic technique when handling sets and syringes.
Administration sets are supplied with a sterile and non­pyrogenic fluid path for one time use. Do not re-sterilize or re-use.
For administration set replacement interval, refer to facility protocol and/or government standards (such as: CDC guidelines in the United States) and see "SmartSite Infusion Set" section of this Directions for Use (DFU).
®
Discard administration set per facility protocol.
For IV push medication (put instrument on hold), occlude tubing above injection port during administration.
Flush port(s) per facility protocol.
Place a sterile replacement cap on open end of tubing connector when not in use. Discard tubing when integrity has been compromised.
SmartSite® Infusion Set
The Needle-Free Valve is designed to permit injection and aspiration of fluids without the use of needles.
1. Use proper hand-hygiene procedures. Wash hands with conventional antiseptic-containing soap and water or disinfect with waterless alcohol-based gels or foams.
2. Prepare Needle-Free Valve.
Always swab top of valve port, prior to every access,
with sterile 70% isopropyl alcohol wipe and allow to
À
dry.
14
-- Continued Next Page --
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 21
Administration Set Information (Continued)
SmartSite® Infusion Set (Continued)
Replace every 72 hours or 100 activations, whichever
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.
Á
Preparing Solution Container and Set
Prepare the primary solution container in accordance with the manufacturer’s directions for use.
Use only sets dedicated for use with SE Pump.
WARNINGS
• Use only sets dedicated for
use with the SE Pump. The use of any other set may cause improper instrument operation, resulting in an inaccurate fluid delivery or other potential hazard.
Discard if packaging is not intact
or protector caps are unattached.
1. Slide Flow Regulator thumb clamp down until an audible click verifies it is in fully closed position.
2. Spike solution container.
3. Fill drip chamber to 2/3 full.
À
4. Invert Flow Regulator.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Flow Regulator
Thumb Clamp
Click
Getting Started
15
Page 22
Administration Set Information (Continued)
Preparing Solution Container and Set (Continued)
5. Slide Flow Regulator thumb clamp to open position to slowly prime set.
6. Close Flow Regulator clamp when priming is complete, as in Step 1. Verify no fluid is flowing.
7. A gravity flow rate may be adjusted with Flow Regulator thumb clamp, if desired.
NOTE:
À Open the vent cap on the spike if the container requires
venting.
Loading Set
1. Slide Flow Regulator thumb clamp down until an audible click verifies it is in fully closed position.
Slide up to open for priming.
Slide down to close for loading.
Thumb Clamp
Click
2. Using both hands, press top and bottom of Flow Regulator into instrument until it snaps into place.
a. Verify 3 gray fingers (clamp arms) on each side of
pumping mechanism have engaged Flow Regulator.
b. Let go of set. A properly loaded set should stay in
instrument.
16
Getting Started
Flow Regulator
AC
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 23
Administration Set Information (Continued)
Loading Set (Continued)
3. 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.
Verify thumb clamp has moved to open (up) position
prior to starting infusion.
WARNING
After set installation, verify no fluid
is flowing through the administration set’s drip chamber, to avoid free­flow.
CAUTION
Before operating instrument, verify that administration set is free from kinks and installed correctly in instrument.
4. Attach set to patient’s vascular access device.
5. Verify flow from IV container after starting infusion.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Getting Started
17
Page 24
Administration Set Information (Continued)
Removing Set
1. Place channel on hold.
2. Open latch.
Flow Regulator automatically closes to prevent
accidental unintended flow.
3. Press latch fully to right.
Set is ejected from instrument.
IV
Changing Solution Container
1. Place channel on hold.
2. Remove empty solution container.
3. Spike new container.
4. Ensure drip chamber is filled to 2/3 full.
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 prevent unintended flow.
CAUTION
Do not attempt to force the set
from the instrument. Send the instrument to qualified service personnel.
18
Getting Started
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 25
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. They serve a variety of functions, as indicated by the text in the display at the time. A soft key is active if there is a tick mark (y) next to the key.
If there is no tick mark next to the key, then it is not active and cannot be selected. [In the illustrated example Conc (concentration) is not active.] Pressing an inactive key results in an invalid keypress tone.
Active Soft Keys
Programming
AB
Rate = 56.0 mL/h Dose= 0.8 mg/kg/h Conc= 100 mg/ 100 mL Wt= 70 kg
menu
OPTIONS
ok
A
Entering Values
To enter programming values, select the desired parameter by pressing the corresponding soft key. The field is highlighted. To enter desired value, use the numeric keys then press the ENTER key.
A value must be highlighted to be changed.
A flashing highlight indicates that the entry is incomplete. Complete the entry and press the ENTER key.
To clear an existing value, press the CLEAR key. If the existing value should not be cleared, pressing the CLEAR key a second time (before pressing the ENTER key) restores that value.
When all parameters required on a programming setup screen have been entered, the ok soft key is used to confirm all entries and continue programming.
Active Soft Keys
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
19
Page 26
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 mode:
MENU (Primary Main Menu)
• BOLUS MENU
• SECONDARY MENU
À
Press menu soft key while in primary programming mode to display
MENU.
Press menu soft key while in bolus programming mode to display
BOLUS MENU.
Press menu soft key while in secondary programming mode to display
SECONDARY MENU.
AB
New Guardrails Drug New Guardrails Fluid Basic Infusion
MENU
AB
BOLUS MENU
Repeat Last Bolus New Bolus Quit Bolus
AB
Guardrails SEC Drug Basic SEC Return to PRI
OPTIONS
A
OPTIONS
A
OPTIONS
A
NOTE:
À When the Profiles feature is not enabled (Off), or when no
Data Set has been transferred to the SE Pump, Guardrails Suite MX protection is not available and these menus do not appear.
20
Programming
SECONDARY MENU
®
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 27
Programming and Navigation Tips (Continued)
K
Menus - NO Guardrails® Suite MX Protection
MENU screens for optional modes can be accessed using the OPTIONS key:
• MULTI-STEP MENU
• MULTI-DOSE MENU
DOSE RATE MENU
Split Screen (Dual Channel Only)
When both channels are infusing, a split screen showing programmed information for both channels displays automatically after one minute.
Press
Press
A B
key to switch immediately to split screen.
A
O
B
O
or
key to stop split screen.
Powering On and Off
1. To turn channel on, press channel's POWER key.
CAUTION
Guardrails® Suite MX protection is
not available within the MULTI-STEP, MULTI-DOSE OR DOSE-RATE MENU options.
AB
Fluid
Rate = 75.0
0.9% NS
VI = 40.9
A
5 mcg/kg/min
DOPamine
VI = 0.5
OPTIONS
B
Instrument performs a self test when first channel is
powered on.
All indicators and displays momentarily light.
An audio tone sounds.
• Hold indicator flashes.
-- Continued Next Page --
A
RUN
HOLD
HLD PRI SECKVO OPT
A B
POWER
ml/hr
PRI
PRI SEC HLD
POWER
SEC
RUN
HOLD
OPTIONS
OPT
WARNING
Each time the instrument is turned on verify and/or set the
monitoring mode, resistance alert and/or pressure alarm limit. If the monitoring mode, resistance alert and/or pressure alarm limit are not verified, the instrument may not be operating with the desired occlusion detection parameter(s).
ml
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
21
Page 28
Programming and Navigation Tips (Continued)
Powering On and Off (Continued)
System startup page displays briefly (08.XX in
example display represents current software revision; ID No. is instrument serial number).
CAUTIONS
Appearance of lines and/or dots
that remain on constantly when the instrument is powered on may indicate improper functioning of the Main Display. Although the instrument is functioning, return it to qualified service personnel.
• Inspect LCD for anomalies (improperly lit/unlit pixels).
AB
© 2002, 2006 Cardinal Health SW Rev. : 08.xx
ID No. : - - - - - - - - -
OPTIONS
When self test completes, if Guardrails® Suite MX protection is available, current profile screen appears.
If Profiles feature is not enabled, then NEW PATIENT? screen appears.
2. To power off, press and hold POWER key until display
turns off.
AB
Hospital Name
DataSet ID 123456789
Current Profile Is
Adult ICU
Accept Change
AB
NEW PATIENT ?
"Yes" Clears Previous
Patient Data
no
yes
OPTIONS
OPTIONS
A
22
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 29
Programming and Navigation Tips (Continued)
Responding to Maintenance Reminder
If the Preventive Maintenance Reminder option is enabled and the device is due for preventive maintenance a Maintenance Reminder message appears at power up.
1. Notify appropriate facility personnel if a Maintenance Reminder message appears.
2. If necessary, press continue soft key to temporarily bypass reminder.
Responding to Time Set Reminder
Following certain battery depleted conditions it is necessary to re-set the internal clock so that CQI Reporter data integrity is maintained. In such cases, a Verify Time reminder message appears at power up.
AB
AB
Accept
Maintenace
Reminder
continue
Verify Date / Time
Feb 28 2006
16:43
Skip
OPTIONS
A
OPTIONS
Change
1. Press Change soft key.
Time set screen displays.
2. Press soft key next to parameter to be changed.
Current value is highlighted.
3. To enter a new value, use numeric keypad, then press ENTER key.
4. Verify that all fields are correct then press ok soft key to continue programming.
AB
Month Day
Year Time
02 28
2006 16h 43min
ok
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
23
Page 30
Guardrails® Suite MX Prompts
Guardrails® Suite MX software allows the facility to create Soft and/or Hard Limits for Guardrails Concentration, Guardrails Administration Rate, Guardrails
®
Bolus Dose, Bolus Dose
®
®
continuous dose,
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
2
) and maximum rate (mL/h).
Additional prompts are provided if Time or VTBI are edited resulting in a rate change, or if a VTBI significantly larger or smaller than the bag volume is entered.
Soft Limits
If programmed parameter is outside Soft Limit for that care area, a prompt appears before programming can continue.
1. If it is inappropriate to override Soft Limit, press no soft key.
Drug set up page displays.
2. Use numeric keys to enter a new value, then press ENTER key.
WARNING
Prior to overriding a Soft Limit
prompt, confirm the infusion parameters are correct.
AB
OPTIONS
OR
3. If it is clinically appropriate and necessary to override Soft Limit, press yes soft key.
Programming may continue.
When a maximum dose limit is exceeded,
↑↑↑ precedes the drug
or fluid name. This indicates that the drug is infusing at a rate exceeding the defined maximum limit for that profile.
When a minimum dose limit is exceeded,
↓↓↓ precedes the drug
or fluid name. This indicates that the drug is infusing at a rate less than the defined minimum limit for that profile.
Hard Limits
If programmed parameter is outside the Hard Limit for that care area, a prompt appears indicating a value within range must be entered before programming can continue.
Use numeric keys to enter a new value, then press ENTER key.
alteplase
Exceeds Soft Limit:
0.81 mg/kg/h
Override Dose Limit?
no
AB
Rate = 600.0 mL/h
override?
DOPAmine
Exceeds Hard Limit:
50 mcg/kg/min REPROGRAM
yes
OPTIONS
24
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 31
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:
Current Profile is accepted and New Patient? - no is
selected.
Changing Profile
1. To change Profile, press change soft key.
Profile selection menu displays.
2. To view additional Profile selections, press page soft key.
3. Press soft key next to desired new Profile.
Confirm Profile screen appears.
AB
Hospital Name
DataSet ID 123456789
OPTIONS
Current Profile Is
Oncology
Accept Change
AB
Adult ICU
OPTIONS
A
Cardiac Care Unit Labor and Delivery Medical / Surgical
page
CAUTION
If the correct profile is not selected, the instrument may not
operate within the appropriate dosing limits and operating parameters.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
25
Page 32
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Selecting New Patient and Profile Options (Continued)
Changing Profile (Continued)
4. To confirm Profile selection, press ok soft key.
OR
To select another Profile, press return soft key.
Once confirmed:
Abbreviated Profile name appears in lower display.
All previous programming parameters are cleared.
MENU screen displays.
Accepting Profile
To retain currently active Profile, press Accept soft key.
NEW PATIENT? screen displays.
A
B
Confirm Profile
Adult ICU
return
AB
ok
New Guardrails Drug New Guardrails Fluid Basic Infusion
MENU
AB
Hospital Name
DataSet ID 123456789
Current Profile Is
Oncology
Accept Change
OPTIONS
A
OPTIONS
A
OPTIONS
Selecting New Patient Option
To indicate programming is for a new patient and clear all stored patient parameters from memory, press yes soft key.
All previous patient data clears and there is no option to
Resume Previous Drug or Resume Previous Fluid.
MENU screen displays.
OR
-- Continued Next Page --
26
Programming
AB
OPTIONS
NEW PATIENT?
“Yes” Clears Previous
Patient Data
no
yes
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 33
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.
MENU screen displays.
If last infusion on that channel was a Drug Library
entry, Resume Previous Drug appears as a MENU selection.
If last infusion on that channel was an IV Fluid,
Resume Previous Fluid appears as a MENU selection.
If last infusion on that channel was an optional mode
or a Basic Infusion, Return to ….? appears as a MENU selection.
Primary Infusion Introduction
The following procedures are to be used only when the drug to be infused is listed in the Drug Library. To access the Drug Library, a hospital-defined best-practice Data Set must be transferred using the Editor Software and the Profiles feature must be enabled.
Continuous Infusion
When using a drug listed in the Drug Library, the drug parameters are automatically calculated based on:
drug and concentration selected
weight entry (if required)
rate or dose entry
1. Press New Guardrails Drug soft key.
If 15 or less drugs are available in selected profile, a
list of drug names displays; otherwise, an alphabetic preselection menu displays.
AB
New Guardrails Drug New Guardrails Fluid Basic Infusion
MENU
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
27
Page 34
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Continuous Infusion (Continued)
2. To use pre-selection menu press soft key corresponding to first letter of desired drug.
3. Press soft key next to desired drug name to select it.
page soft key(s) may be used to view additional
selections.
If applicable, an optional hospital-defined therapy
or clinical indication for delivery of this infusion may appear (as in illustrated example, which reflects use of alteplase). Different limits can be defined for same drug with different therapeutic indications.
AB
Select Drug A - F Select DrugG-M Select DrugN-S Select Drug T - Z
menu
AB
acyclovir albumin 25% albumin 5% alteplase
menu
A
B
alteplase MI Stroke
OPTIONS
A
OPTIONS
A
page
OPTIONS
A
If applicable, a weight-based or non-weight-based option for delivery of this infusion may appear (as in illustrated example which reflects use of heparin).
If applicable, multiple concentration listings for delivery of this infusion may appear (as in illustrated example which reflects use of dopamine).
return
AB
Dose in?
Un/h Un/kg/h
return
AB
DOPamine
400 mg / 250 mL 800 mg / 250 mL
- - - - mg / - - - - mL
return
OPTIONS
A
OPTIONS
A
28
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 35
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Continuous Infusion (Continued)
4. Press soft key next to desired selection.
5. To confirm selection and continue programming, press ok
soft key.
If a different selection is desired, press return soft key to return to the drug list or press menu soft key to return to MENU screen, then navigate to desired selection and press ok soft key.
6. If facility has defined a Clinical Advisory for selected drug, a message appears. To indicate that information has been noted and continue programming, press ok soft key.
Infusion setup page displays.
7. An optional hospital-defined and editable starting value for continuous infusion dose may already be entered.
OR
To enter a value, use numeric data entry keys then press
ENTER key.
A
B
alteplase
stroke
100 mg/100 mL
Dose in mg/kg/h
menu return ok
AB
OPTIONS
OPTIONS
This Dosing Is For
Acute Ischemic
STROKE
ADVISORY
AB
Rate = - - - - - mL/h Dose= - - - - - mg/kg/h Conc= 100 mg/ 100 mL Wt= - - - - - kg
menu
BolusOnly
ok
OPTIONS
A
A
Dose field is highlighted for first entry, but soft keys
can be used to highlight other parameters for entry prior to dose. To automatically calculate dose instead of rate, press Rate soft key and enter a rate value. Once all entries have been completed, dose is automatically calculated.
If a drug with a defined standard concentration was
selected, Conc (concentration values, drug amount and diluent volume) are automatically entered. (Notice that these values are not editable).
If a drug with -- / -- mL was selected, Conc
(concentration values of drug amount and diluent volume), needs to be entered.
-- Continued Next Page --
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
29
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.
8. Verify that all parameters are correct and press ok soft key to confirm.
VTBI and VI setup page displays.
VTBI field is highlighted.
9. To enter desired VTBI, use numeric keys then press ENTER key.
VI field is highlighted.
AB
OPTIONS
Rate = 56.0mL/h Dose= 0.8 mg/kg/h Conc= 100 mg/ 100 mL Wt= 70 kg
menu
AB
alteplase
ok
OPTIONS
VTBI= 0.0 mL VI= 0.0 mL
menu
AB
Bolus
alteplase
ok
OPTIONS
VTBI= 100.0 mL VI=
mL0.0
A
A
A
10. If there is a VI value that needs to be cleared, press CLEAR key or press 0 (zero) key then press ENTER key.
11. To continue programming, press ok soft key.
RUN/HOLD page displays.
30
Programming
menu
Bolus
ok
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 37
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Continuous Infusion (Continued)
12. Verify that all parameters are correct, then press run soft key or RUN/HOLD key to start infusion
13. To briefly view setup parameters (therapy, concentration, patient weight, current profile) from RUN/HOLD page or during a running infusion, press
4
soft key.
Pausing and Restarting Infusion
1. An infusion may be paused temporarily by pressing 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.
AB
Rate = 56.0 mL/h Dose = 0.8 mg/kg/h VTBI = 100.0 VI = 0.0
alteplase
menu
AB
Rate = 56.0 mL/h
Conc = 100 mg/100 mL Wt = 70 kg Adult ICU
setup
Stroke
OPTIONS
A
run
OPTIONS
A
2. To restart infusion while on hold, press channel RUN/ HOLD key.
Making Changes During Continuous Infusion
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.
A
B
O
1. Select
O
or
key, as necessary.
2. Press soft key next to parameter to be edited.
Current value is highlighted.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
31
Page 38
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Making Changes During Continuous Infusion (Continued)
Making Changes to Rate, Dose or VTBI (Continued)
3. Make changes:
a. To enter a new value, use numeric keypad.
b. To reset Volume Infused to 0.0 mL, press CLEAR or
0 (zero) key.
4. To accept new value, press ENTER key.
Making Changes to Concentration or Patient Weight
Infusion must be paused before making changes. If a drug with a defined standard concentration was selected, Conc (concentration) values are not editable.
1. To pause infusion, press channel's RUN/HOLD key.
2. Press set up soft key.
3. Press soft key next to parameter to be edited.
Current value is highlighted.
4. To enter a new value, use numeric keypad then press ENTER key.
Resuming Interrupted Infusion
If a channel has been powered off during an infusion, previous programming may be resumed if:
One channel of a dual channel device remained on.
Current profile is accepted and New Patient? – no is
selected during start up (see "Selecting New Patient and Profile Options").
1. Select desired channel as necessary.
32
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 39
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Resuming Interrupted Infusion (Continued)
2. Press Resume Previous Drug soft key.
Previous drug review screen displays.
3. Press ok soft key to confirm drug, therapy, concentration and dosing units.
4. If facility has defined a Clinical Advisory for selected drug, a message appears. To indicate that information has been noted and continue programming, press ok soft key.
Previous infusion setup page appears.
5. Verify parameters are correct. If a change is required, see “Making Changes During Continuous Infusion”.
6. Press ok soft key to continue.
• RUN/HOLD page displays.
7. Verify that all parameters are correct, then press run soft key or RUN/HOLD key to start infusion.
AB
New Guardrails Drug New Guardrails Fluid
Resume Previous Drug
Basic Infusion
MENU
OPTIONS
A
KVO Mode
When the primary VTBI reaches 0.0mL, the instrument automatically switches to the configured KVO (keep vein open) rate, or remains at the current infusion rate, whichever is less.
KVO rate flashes in rate LED display.
Programmed infusion rate continues to display in Main
Display.
KVO flashes in infusion status bar.
KVO alert tone sounds (may be silenced for 2 minutes
using Silence key).
VTBI = 0 (INFUSION IN KVO in Models 7131/7231)
message flashes in Main Display.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
AB
Rate = 56.0 mL/h Dose = 0.8 mg/kg/h
VTBI = 0.0 VI = 100.0
Channel A
VTBI = 0
Programming
OPTIONS
A
33
Page 40
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Resuming Operation from KVO Mode
1. To place channel on hold, press RUN/HOLD key.
2. Press VTBI soft key.
VTBI is highlighted.
3. To enter desired VTBI, use numeric keys then press ENTER key.
4. To resume infusion, press run soft key or RUN/HOLD key.
Clearing Volume Infused
The volume infused counter increments as fl uids are infused through a given channel. All fl uids infused in primary mode, including boluses, all fl uids infused in secondary mode and all fl uids infused in KVO mode are counted.
1. To reset volume infused counter to 0.0mL, press VI soft key.
VI field is highlighted.
2. Press CLEAR key or press 0 (zero) key then press ENTER key.
Bolus Dose
A Bolus Dose can be programmed at the beginning of, or during a continuous infusion. The drug being programmed must be a bolusable drug selected from the Drug Library, as described in the following procedures.
Bolus volume must be at least 1 mL and not more than
999.9 mL. Programming a bolus dose that calculates a bolus
volume outside that range results in a message, "Bolus VTBI Less than 1 mL Not Allowed" or "Bolus VTBI More than
999.9 mL Not Allowed".
Bolus dose parameters may not be edited during bolus infusion. If new parameters are desired, select New Bolus Dose from the Bolus menu.
34
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 41
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Delivering a Bolus Dose Prior to Beginning
Continuous Infusion
1. Set up infusion as described in “Continuous Infusion” procedure, steps 1 - 10. Do not start infusion.
2. On VTBI and VI setup page, press Bolus soft key.
Bolus programming page displays.
Bolus field is highlighted.
3. An optional hospital-defined and editable starting value for bolus dose may already be entered.
OR
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.
If bolus is weight-based and weight has not yet been
programmed in same channel, Wt (patient weight in kg) needs to be entered.
If bolus is not weight-based, Not Used displays in Wt
field.
AB
alteplase
VTBI= 100.0 mL VI= 0.0 mL
menu
AB
Bolus = - - - - mg/kg Wt = - - kg
Time = - - min
menu
Bolus
Alteplase Bolus
OPTIONS
A
ok
OPTIONS
A
4. An optional hospital-defined bolus dose administration rate may have been used to calculate an editable Time in minutes (1-99) to deliver programmed bolus dose.
OR
To enter a Time value, use numeric data entry keys then press ENTER key.
5. Verify parameters are correct and press ok soft key (see "Guardrails
®
Suite MX Prompts").
Bolus RUN/HOLD page displays.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
AB
Bolus = 0.09 mg/kg Wt = 70 kg
Time = 1 min
Alteplase Bolus
menu
Programming
OPTIONS
A
ok
35
Page 42
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Delivering a Bolus Dose Prior to Beginning
Continuous Infusion (Continued)
6. 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
and “Bolus Dose Complete” briefly displays, and infusion automatically transitions to continuous rate.
Delivering a Bolus Dose During a Continuous Infusion
1. Press OPTIONS key.
2. Press Bolus soft key.
• BOLUS MENU displays.
3. Press New Bolus soft key.
OR
To repeat a previous bolus, press Repeat Last Bolus soft
key.
Bolus Programming page displays.
Bolus field is highlighted.
AB
Bolus = 0.09 mg/kg Wt = 70 kg
Time Left = 1 min
Alteplase Bolus
menu
AB
BOLUS MENU
Repeat Last Bolus New Bolus Quit Bolus
OPTIONS
A
run
OPTIONS
A
4. An optional hospital-defined and editable starting value for bolus dose may already be entered.
OR
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.
If bolus is weight-based and weight has not yet been
programmed in same channel, Wt (patient weight in kg) needs to be entered.
If bolus is not weight-based, Not Used displays in Wt
field.
36
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 43
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Delivering a Bolus Dose During a Continuous Infusion
(Continued)
5. An optional hospital-defined bolus dose administration rate may have been used to calculate an editable Time in minutes to deliver programmed bolus dose.
OR
To enter a value, use numeric data entry keys then press ENTER key.
6. Verify parameters are correct and press ok soft key to transition from continuous to bolus infusion (see "Guardrails
®
Suite MX Prompts").
When bolus dose completes, an audio tone sounds
and Bolus Dose Complete briefly displays, and infusion automatically transitions back to continuous rate.
Bolus Only
The Bolus Only feature is used to deliver single boluses from a fluid container without delivering a continuous infusion. The feature is not available once a continuous dose or rate has been entered, or if an initial value for continuous infusion dose has been entered in the Data Set.
1. Follow steps 1 - 6 in "Continuous Infusion". DO NOT enter a dose or rate.
2. Press BolusOnly soft key.
Bolus Programming page displays.
Bolus field is highlighted.
3. An optional hospital-defined and editable starting value for bolus dose may already be entered.
AB
Rate = 50.0 mL/h Dose = 0.9 mg/kg/h
Channel A
Bolus Dose Complete
AB
Rate = - - - - - mL/h Dose= - - - - - mg/kg/h Conc= 100 mg/ 100 mL Wt= - - - - - kg
menu
BolusOnly
OPTIONS
OPTIONS
A
A
OR
-- Continued Next Page --
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
37
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.
If bolus is weight-based and weight has not yet been
programmed in same channel, Wt (patient weight in kg) needs to be entered.
If bolus is not weight-based, Not Used displays in Wt
field.
4. An optional hospital-defined bolus dose administration rate may have been used to calculate an editable Time in minutes (1-99) to deliver programmed bolus dose.
OR
To enter a time value, use numeric data entry keys then press ENTER key.
5. Verify parameters are correct and press ok soft key (see "Guardrails
®
Suite MX Prompts").
Bolus Only bag volume confirmation page displays.
6. Verify that bag contains an adequate volume to deliver programmed dose as specified and press ok soft key.
Bolus RUN/HOLD page displays.
7. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
When bolus dose completes, an audio tone sounds
and Bolus Dose Complete displays until user takes action.
No continuous infusion or KVO rate occurs.
Dashes “----“ appear in Rate LED display.
No alarm occurs.
AB
Bolus Only
Make Sure Bag
Contains At Least
6.3 mL
return
AB
Bolus Dose Complete
menu
OPTIONS
ok
OPTIONS
A
8. Press menu key to return to Bolus Menu.
38
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 45
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Stopping Bolus Dose
1. To place channel on hold, press channel RUN/HOLD key.
2. Press menu soft key.
• Bolus Menu displays.
3. Press Quit Bolus soft key.
4. To start continuous infusion, if one was programmed, verify parameters are correct and then press run soft key or channel RUN/HOLD key.
Repeating a Bolus Dose
A bolus dose that has completed may be repeated. If a bolus dose was stopped prior to completion the Repeat Bolus Dose soft key becomes inactive.
1. Press Options key.
2. Press Bolus soft key.
• Bolus Menu displays.
3. Press Repeat Last Bolus soft key.
Bolus Programming page displays.
4. To accept current bolus dose and time values and begin bolus delivery, press ok soft key.
AB
BOLUS MENU
Repeat Last Bolus New Bolus Quit Bolus
AB
BOLUS MENU
Repeat Last Bolus New Bolus Quit Bolus
OPTIONS
A
OPTIONS
A
OR
To edit bolus or time, select desired field, use numeric data entry keys to enter a new value, then press ENTER key and press ok soft key to begin bolus delivery.
When bolus dose completes, an audio tone sounds,
Bolus Dose Complete briefly displays, and infusion automatically transitions to continuous rate if one was programmed.
If no continuous rate or dose was programmed an
audio tone sounds and Bolus Dose Complete displays until user takes action (see "Bolus Only").
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
39
Page 46
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)
• VTBI entry
time or rate entry
1. Press New Guardrails Drug soft key.
If 15 or less drugs are available in selected profile, a
list of drug names displays; otherwise, an alphabetic pre-selection menu displays.
2. To use pre-selection menu press soft key corresponding to first letter of desired drug.
3. Press soft key next to desired drug name to select it.
page soft key(s) may be used to view additional
selections.
AB
New Guardrails Drug New Guardrails Fluid Basic Infusion
MENU
AB
Select Drug A - F Select DrugG-M Select DrugN-S Select Drug T - Z
menu
AB
OPTIONS
OPTIONS
octreotide paclitaxel
pentostatin potassium CHLORIDE
menu
page
A
A
OPTIONS
A
If applicable, an optional hospital-defined therapy
or clinical indication for delivery of this infusion may appear (as in illustrated example, which reflects use of paclitaxel). Different limits can be defined for same drug with different therapeutic indications.
40
Programming
A
B
paclitaxel
OPTIONS
A
every three weeks weekly
return
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
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
of this infusion may appear (as in illustrated example which reflects use of vancomycin).
4. Press soft key next to desired selection.
AB
1000 mg / 200 mL 1000 mg / 250 mL
- - - - mg / - - - - mL
return
VANCOmycin
OPTIONS
A
5. To confirm selection and continue programming, press ok soft key.
If a different selection is desired, press return soft key
to return to drug list or press menu soft key to return to MENU screen, then navigate to desired selection and press ok soft key.
6. If facility has defined a Clinical Advisory for selected drug, a message appears. To indicate that information has been noted and continue programming, press ok soft key.
Intermittent infusion setup page displays.
7. 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).
A
B
paclitaxel
every three weeks
Dose in mg/m
menu
AB
Steroid Premeds
Non-PVC tubing
Filter Required
ADVISORY
OPTIONS
A
2
okreturn
OPTIONS
ok
-- Continued Next Page --
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
41
Page 48
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Intermittent Infusion (Continued)
If a drug with -- / -- mL was selected, Conc
(concentration values, drug amount and diluent volume), need to be entered. Drug amount is total dose of drug in fluid container. Diluent Volume is total volume of fluid container.
If selected drug is weight-based, Wt (patient weight in
kg) needs to be entered.
If selected drug is BSA-based, BSA (body surface
area in meters squared) needs to be entered.
If selected drug is not weight-based or BSA-based, Wt
or BSA field does not appear.
Once all required parameters have been entered, total
calculated dose displays. This value is not editable.
8. Verify that all parameters are correct and press ok soft key to confirm (see "Guardrails
®
Suite MX Prompts”).
AB
paclitaxel
Conc = - - - - mg/ - - - - mL
BSA = - - - - m
Dose = - - - - - mg/m
menu
AB
Conc = 280 mg/ 500 mL
BSA = 1.6 m
Dose =175 mg/m
menu
2
paclitaxel
2
OPTIONS
A
2
OPTIONS
A
2
ok
• Rate/VTBI/Time page displays.
VTBI value is highlighted.
An editable value derived from diluent volume is
automatically entered.
9. To accept value, press ENTER key.
OR
To enter another value, use numeric data entry keys then press ENTER key.
The VI field is highlighted.
10. If there is a VI value that needs to be cleared, press CLEAR key or press 0 (zero) key then press ENTER key.
42
Programming
A
B
Rate = 166.7 mL/h
VTBI= VI = 0.0 mL500.0 mL
Time=3h0min
paclitaxel
menu
rate - time
OPTIONS
A
ok
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 49
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
Intermittent Infusion (Continued)
11. An optional hospital-defined and editable starting value for time may already be entered.
OR
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.
Time can be entered to calculate rate or if rate entry
is desired, press rate -
- time, indicating that rate may be entered.
rate
soft key. It changes to
time
12. Verify that all parameters are correct and press ok soft key (see "Guardrails
®
Suite MX Prompts”).
• RUN/HOLD page displays.
13. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
14. To briefly view setup parameters (therapy, total dose, concentration, patient weight or BSA, current profile) from RUN/HOLD page or during a running infusion, press
4
soft key.
AB
Rate = 166.7 mL/h
VTBI = 500.0 mL VI = 0.0 mL
Time = 3 h 0 min
paclitaxel
menu
rate - time
OPTIONS
run
A
Making Changes During Intermittent Infusion
Intermittent infusions must be paused to change parameters (Rate, VTBI or Time) or to clear VI.
1. Press RUN/HOLD key for desired channel.
2. Press soft key next to parameter to be edited.
Current value is highlighted.
3. Make changes:
a. To enter a new value, use numeric keypad.
b. To reset volume infused to 0.0 mL, press CLEAR or 0
(zero) key.
4. To accept new value, press ENTER key.
Rate can be entered to calculate time or if time entry
is desired, press rate -
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
, indicating that time may be entered.
time
- time soft key. It changes to
rate
Programming
43
Page 50
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
IV Fluid Infusion
1. Press New Guardrails Fluid soft key.
If 15 or less fluids are available in selected profile, a
list of fluid names displays; otherwise, an alphabetic pre-selection menu displays.
2. To use pre-selection menu press soft key corresponding to first letter of desired fluid.
3. Press soft key next to desired fluid name to select it.
page soft key(s) may be used to view additional
selections.
If applicable, an optional hospital-defined therapy
or clinical indication for delivery of this infusion may appear. Different rate limits can be defined for same fluid with different therapeutic indications.
AB
New Guardrails Drug New Guardrails Fluid Basic Infusion
MENU
AB
Select Fluid A - F Select Fluid G-M Select Fluid N-S Select Fluid T - Z
menu
AB
TPN
menu
page
OPTIONS
A
OPTIONS
A
OPTIONS
A
4. Press soft key next to desired selection.
5. To confirm selection and continue programming, press ok soft key.
If a different selection is desired, press return soft key
to return to fluid list or press menu soft key to return to MENU screen, then navigate to desired selection and press ok soft key.
44
Programming
A
menu
B
Confirm fluid
TPN
OPTIONS
A
ok return
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 51
Primary Infusion - With Guardrails® Suite MX Protection (Continued)
IV Fluid Infusion (Continued)
6. 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.
IV Fluid setup page displays.
Rate field is highlighted.
7. To enter a value, use numeric data entry keys then press ENTER key (see "Guardrails
®
Suite MX Prompts”).
VTBI field is highlighted.
8. To enter a VTBI value, use numeric data entry keys then press ENTER key.
AB
0.22 micron filter Dedicated Line
ADVISORY
AB
Rate = - - - - - mL/h
VTBI = 0.0 mL VI = 0.0 mL
TPN
menu
OPTIONS
ok
OPTIONS
A
VI field is highlighted.
9. If there is a VI value that needs to be cleared, press
CLEAR key or press 0 (zero) key then press ENTER key.
10. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
11. To briefly view current profile from RUN/HOLD page or during a running infusion, press
4
soft key.
AB
Rate = 83.3 mL/h VTBI = 2000.0 mL
VI = 0.0 mL
TPN
menu
OPTIONS
A
run
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
45
Page 52
Secondary Infusion - With Guardrails® Suite MX Protection
Introduction
This mode is designed to support automatic secondary infusions (“piggybacking”) in the same channel. A secondary infusion can be programmed as a Basic SEC or Guardrails SEC drug. 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 instrument is programmed and delivering in the secondary mode, the primary infusion is temporarily stopped and fluid is drawn from the secondary container. Delivery from the primary container resumes when the fluid level in the secondary line is level with the fluid in the primary container.
Primary infusion must be on hold to program secondary infusion.
A secondary infusion may be programmed only after a primary IV Fluid (that supports secondary mode) or a primary Basic Infusion has been programmed.
A list of IV Fluid entries is created in the Data Set that is developed and approved by the facility’s own multidisciplinary team using the Editor Software, the PC-based authoring tool. Each entry is determined to be either appropriate to support secondary infusions or not. The secondary key is unavailable for selections that have been designated as inappropriate for secondary delivery. Pressing the SEC key after programming a fluid that does not support secondary infusions results in a message, “Secondary not allowed with this fluid”.
The maximum rate for a secondary infusion is 600 mL/h. For information regarding flow sensor use with secondary infusions, see "General Information", "Flow Sensor".
WARNINGS
Secondary applications require
the use of a check valve set on the primary IV line.
• The secondary solution container must be higher than the primary solution container.
• The secondary VTBI settings require consideration of variables; such as, factory overfill, medication additions. Underestimating the volume causes the remaining secondary solution to be infused at the primary rate; overestimating results in the primary solution being infused at the secondary rate. Multiple doses from a single container are not possible.
The clamp on the secondary administration set must be opened. If the clamp is not opened, the fluid is delivered from the primary container.
The secondary administration set must be primed prior to beginning the secondary infusion.
Ensure proper setup of secondary systems to make sure of proper flow.
46
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 53
Secondary Infusion - With Guardrails® Suite MX Protection (Continued)
Setup
1. Open secondary administration set package, remove set and close clamp.
2. Insert administration set spike into prepared fluid container and hang secondary container, following accepted hospital/facility procedure.
3. Fill drip chamber to 2/3 full.
4. Open secondary administration set clamp and prime set. Close clamp.
5. Attach secondary administration set to upper injection site on primary set.
6. Using hanger(s) provided with secondary administration sets, lower primary fluid container until bottom of secondary container is at least 9½” above fluid level in primary container.
Hanger
at least 9½”
Primary Container
Secondary Container
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
47
Page 54
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)
• VTBI entry
time or rate entry
Primary infusion must be on hold to program secondary infusion.
1. Press SEC key.
• Secondary Menu displays.
2. Press Guardrails SEC Drug soft key.
If 15 or less drugs are available in secondary library
of selected profile, a list of drug names displays; otherwise, an alphabetic pre-selection menu displays.
3. To use pre-selection menu press soft key corresponding to first letter of desired drug.
4. Press soft key next to desired drug name to select it.
AB
Guardrails SEC Drug Basic SEC Return to PRI
SECONDARY MENU
AB
Select Drug A - F Select DrugG-M
Select DrugN-S Select Drug T - Z
menu
AB
Tobramycin TOPOtecan
Trastuzumab VANCOmycin
menu
OPTIONS
A
OPTIONS
A
OPTIONS
A
48
-- Continued Next Page --
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 55
Secondary Infusion - With Guardrails® Suite MX Protection (Continued)
Secondary Intermittent Infusion (Continued)
If applicable, an optional hospital-defined therapy
or clinical indication for delivery of this infusion may appear (as in illustrated example, which reflects use of vancomycin). Different limits can be defined for same drug with different therapeutic indications.
If applicable, a weight-based, non-weight-based or
BSA-based option for delivery of this infusion may appear (as in illustrated example, which reflects use of acyclovir).
If applicable, multiple concentration listings for delivery
of this infusion may appear (as in illustrated example which reflects use of vancomycin).
A
B
VANCOmycin Central Peripheral
return
A
B
acyclovir
mg/kg
2
mg/m
return
AB
VANCOmycin
500 mg / 100 mL 1000 mg / 200 mL
- - - - mg / - - - - mL
return
OPTIONS
A
OPTIONS
A
OPTIONS
A
5. Press soft key next to desired selection.
6. To confirm selection and continue programming, press ok
soft key.
If a different selection is desired, press return soft key to return to drug list or press menu soft key to return to MENU screen, then navigate to desired selection and press ok soft key.
7. If a Clinical Advisory has been defined for selected drug, a message appears. To indicate that information has been noted and continue programming, press ok soft key.
Intermittent infusion setup page displays.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
49
Page 56
Secondary Infusion - With Guardrails® Suite MX Protection (Continued)
Secondary Intermittent Infusion (Continued)
8. 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).
If a drug with -- / -- mL was selected, Conc
(concentration values, drug amount and diluent volume), needs to be entered. Drug amount is total dose of drug in fluid container. Diluent volume is total volume of fluid container.
If selected drug is weight-based, Wt (patient weight in
kg) needs to be entered.
If selected drug is BSA-based, BSA (body surface
area in meters squared) needs to be entered.
If selected drug is not weight-based or BSA-based, Wt
or BSA field does not appear.
Once all required parameters have been entered, total
calculated dose displays. This value is not editable.
9. Verify that all parameters are correct and press ok soft key to confirm (see "Guardrails
®
Suite MX Prompts”).
• Rate/VTBI/Time page displays.
VTBI field is highlighted.
An editable value derived from diluent volume is
automatically entered.
10. To accept value, press ENTER key.
OR
To enter another value, use numeric data entry keys then press ENTER key.
VI field is highlighted.
11. If there is a VI value that needs to be cleared, press CLEAR key or press 0 (zero) key then press ENTER key. (This VI value includes all fluids infused on this channel in Primary and Secondary mode since last cleared.)
50
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
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.
OR
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.
Time can be entered to calculate rate or if rate entry
is desired, press rate -
- time, indicating that rate may be entered.
rate
soft key. It changes to
time
13. Verify that all parameters are correct and press ok soft key (see "Guardrails
®
Suite MX Prompts”).
A Secondary Clamp reminder message displays.
14. Verify that secondary clamp is open before proceeding, then press yes soft key.
• RUN/HOLD page displays.
15. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
16. To briefly view setup parameters (therapy, total dose, concentration, patient weight or BSA and current profile) from RUN/HOLD page or during a running infusion, press
4
soft key.
When secondary VTBI reaches 0.0mL:
© An audio tone sounds (if enabled).
© Channel _ Secondary Complete briefly displays.
© Infusion automatically transitions to primary rate.
AB
IS SECONDARY
OPTIONS
CLAMP OPEN?
yes
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
51
Page 58
Primary Infusion - NO 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.
Selecting New Patient Option - Profiles Feature Not
Enabled (OFF)
To indicate programming is for a new patient and clear all stored patient parameters from memory, press yes soft key.
• All previous patient data clears.
OR
To confirm programming is for same patient and retain all stored patient parameters, press no soft key.
Basic Infusion
If Guardrails® Suite MX protection is available and Basic Infusion is desired, it can be accessed through the MENU.
If the Profile feature is set to OFF in the instrument configuration, or no Data Set is loaded, the Basic Infusion page displays by default.
1. Press Basic Infusion soft key.
Basic Infusion RUN/HOLD page displays.
Rate field is highlighted.
AB
NEW PATIENT?
“Yes” Clears Previous
Patient Data
no
OPTIONS
yes
2. To accept current value, press ENTER key.
OR
To enter desired value, use numeric data entry keys then press ENTER key.
VTBI field is highlighted.
3. To accept value, press ENTER key.
OR
To enter another VTBI value, use numeric data entry keys then press ENTER key.
VI field is highlighted.
52
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 59
Primary Infusion - NO Guardrails® Suite MX Protection (Continued)
Basic Infusion (Continued)
4. If there is a VI value that needs to be cleared, press CLEAR key or press 0 (zero) key then press ENTER key.
5. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
6. To briefly view current profile from RUN/HOLD page or during a running infusion, press
Promoting Basic Infusion to
Guardrails® Suite MX Protection Infusion
4
soft key.
When the Profiles feature is set to OFF or when no Data Set has been transferred to the SE Pump, Guardrails
®
Suite MX
protection is not available and this section does not apply.
A basic infusion may be promoted to a continuous drug infusion or a fluid infusion with Guardrails
®
Suite MX protection
while infusing.
A basic infusion may not be promoted to an intermittent drug. If an intermittent drug is selected a Pri Running message is displayed.
Promoting Basic Infusion to
Guardrails® Drug Infusion
Infusion must be running in the Basic Primary Mode.
1. Select desired channel as necessary.
2. Press Options key.
3. Press Guardrails Menu soft key.
4. Press New Guardrails Drug soft key.
5. To use pre-selection menu press soft key corresponding to first letter of desired drug.
AB
Select Drug A - F Select DrugG-M Select DrugN-S Select Drug T - Z
menu
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
53
Page 60
Primary Infusion - NO Guardrails® Suite MX Protection (Continued)
Promoting Basic Infusion to
Guardrails® Drug Infusion (Continued)
6. Press soft key next to desired drug name to select it.
page soft key(s) may be used to view additional
selections.
7. To confirm selection and continue programming, press ok soft key.
If a different selection is desired, press return soft key
to return to drug list or press menu soft key to return to MENU screen, then navigate to desired selection and press ok soft key.
8. If a Clinical Advisory has been defined for selected drug, a message appears. To indicate that information has been noted and continue programming, press ok soft key.
Dose field is highlighted.
9. An optional hospital-defined and editable starting value for continuous infusion dose may already be entered.
AB
Alprostadil Bretylium Bumetanide Diltiazem
menu
OPTIONS
A
page
OR
To enter a value, use numeric data entry 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. To automatically calculate dose instead of rate, press rate soft key and enter a rate value. Once all entries have been completed, dose is automatically calculated.
If a drug with a defined standard concentration was
selected, Conc (concentration values, drug amount and diluent volume) is automatically entered. (Note that these values are not editable).
If a drug with -- / -- mL was selected, Conc
(concentration values, drug amount and diluent volume), needs to be entered.
-- Continued Next Page --
54
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 61
Primary Infusion - NO 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.
10. Verify that all parameters are correct and press ok soft key to confirm.
Promoting Basic Infusion to
Guardrails® IV Fluid Infusion
Infusion must be running in the Basic Primary Mode.
1. Select desired channel as necessary.
2. Press Options key.
3. Press Guardrails Menu soft key.
4. Press New Guardrails Fluid soft key.
5. To use pre-selection menu press soft key corresponding to first letter of desired fluid.
6. Press soft key next to desired fluid name to select it.
page soft key(s) may be used to view additional
selections.
7. To confirm selection and continue programming, press ok soft key.
If a different selection is desired, press return soft key
to return to fluid list or press menu soft key to return to MENU screen, then navigate to desired selection and press ok soft key.
AB
Select Fluid A - F Select Fluid G-M Select Fluid N-S Select Fluid T - Z
menu
AB
1/2 NS
Blood (RBCs) D5 1/2 NS D5 1/2 NS+KCL 10mEq/L
return
page
OPTIONS
A
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
55
Page 62
Primary Infusion - NO Guardrails® Suite MX Protection (Continued)
Promoting Basic Infusion to
Guardrails® IV Fluid Infusion (Continued)
8. 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.
IV Fluid setup page displays.
Rate field is highlighted and flashing indicating that
current value must be either approved or edited.
9. To accept current rate press ENTER key.
OR
To enter a value, use numeric data entry keys then press ENTER key.
Dose Rate Calculation-Drug? NO DOSE LIMIT - Profiles
Feature Enabled (ON)
The following procedures are to be used only when the drug to be infused is NOT listed in the Drug Library.
When using Drug? – NO DOSE LIMIT, drug parameters are automatically calculated based on:
• concentration
• weight entry (if required)
• rate or dose entry
1. Press New Guardrails Drug soft key.
If 15 or less drugs are available in selected profile, a
list of drug names displays; otherwise, an alphabetic pre-selection menu displays.
2. To use pre-selection menu press T – Z soft key, press
page soft key to go to end of drug list, then press Drug? – NO DOSE LIMIT soft key.
OR
-- Continued Next Page --
AB
MENU
Primary Infusion New Guardrails Drug Resume Previous Drug
AB
Select Drug A - F Select DrugG-M Select DrugN-S Select Drug T - Z
menu
OPTIONS
OPTIONS
A
A
56
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 63
Primary Infusion - NO 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 LIMIT soft key.
Dosing unit in dose/weight/time displays with dose
segment highlighted.
3. To scroll through units available, press and release soft key. When correct unit is displayed, press ENTER key.
If weight-based dosing is desired, press ENTER to
advance to time segment
OR
If non-weight-based dosing is desired, press
soft
key to clear segment, then press ENTER (weight field disappears).
If time unit is appropriate, press ENTER to advance to
concentration field.
OR
Press soft key to scroll through available time unit
choices. Press ENTER when correct unit displays.
If concentration unit is appropriate, press ENTER to
advance.
OR
Press
soft key to scroll through available
concentration unit choices. Press ENTER when correct unit displays.
AB
Drug? NO DOSE LIMIT
menu
AB
Dose in /kg/minmcg Conc in mg/mL Weight in kg
m e n u
A B
Dose in mcg/kg/min Conc in mg/mL Weight in kg
menu
page
OPTIONS
A
OPTIONS
A
o k
OPTIONS
A
ok
If weight field appears and weight entry in kg
(kilograms) is desired, press ok soft key to advance to programming page.
OR
If weight entry in lb (pounds) is desired, press soft
then press ENTER. Press ok soft key to advance to programming page. Patient weight in pounds is used to automatically calculate dose per kilogram per time.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
A B
Dose in mcg/kg/min Conc in mg/mL Weight in kg
menu
Programming
OPTIONS
A
ok
57
Page 64
Primary Infusion - NO Guardrails® Suite MX Protection (Continued)
Dose Rate Calculation-Drug? NO DOSE LIMIT - Profiles
Feature Enabled (ON) (Continued)
4. Enter parameters as needed.
Dose field is highlighted for first entry but soft keys can
be used to highlight other parameters for entry prior to dose. To automatically calculate dose instead of rate, press rate soft key and enter a rate value. Once all entries have been completed dose is automatically calculated.
5. Verify that all parameters are correct and press ok soft key to confirm.
VTBI and VI setup page displays.
VTBI field is highlighted.
6. To enter a VTBI value, use numeric data entry keys then press ENTER key.
VI field is highlighted.
7. If there is a VI value that needs to be cleared, press CLEAR key or press 0 (zero) key then press ENTER key.
8. To continue programming, press ok soft key.
• RUN/HOLD page displays.
AB
Rate = - - - - - mL/h Dose= - - - - - mg/kg/h Conc= - - - - - mL/h Wt= - - - - - kg
menu
BolusOnly
OPTIONS
A
9. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
10. To briefly view current setup parameters (concentration, patient weight, current profile) from RUN/HOLD page or during a running infusion, press
4
soft key.
Dose Rate Calculation-Profiles Feature Not Enabled (OFF)
This feature allows the clinician to select a drug name from a pre-set list or to select a generic calculation feature by selecting “Drug?” to calculate drug parameters for drugs not on the list. If the preset list is disabled in the instrument configuration settings, then only generic calculation is available. Parameters are calculated automatically based on:
• concentration
• weight entry (if required)
• rate or dose entry
58
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 65
Primary Infusion - NO Guardrails® Suite MX Protection (Continued)
Dose Rate Calculation-Profiles Feature Not Enabled (OFF)
(Continued)
1. Press OPTIONS soft key.
• Options page appears.
2. Press Dose Rate Calculator soft key.
AB
Resistance Trend Monitoring Options
Dose Rate Calculator Set Pressure Baseline
return
page
OPTIONS
A
3. Press Enter New Program soft key.
An alphabetic pre-selection menu is displayed.
4. To use pre-selection menu press soft key corresponding to first letter of desired drug.
5. Press soft key next to desired drug name to select it.
page soft key(s) may be used to view additional
selections.
If desired drug name is not listed, see “Drug? NO
DOSE LIMIT-Profiles Feature Enabled (On)”.
6. To approve all displayed information and advance to setup page press ok soft key
OR
To change concentration or weight units press soft key next to parameter to be changed.
To scroll through available selections, press
soft key appears.
soft
key. When desired unit displays, press ENTER key, then press ok soft key to continue programming.
AB
DOSE RATE MENU
Review/Resume Enter New Program Quit Program
A B
Dose in mcg/kg/min Conc in mg/mL Weight in kg
menu
OPTIONS
A
OPTIONS
A
ok
7. Pr e s s ok soft key to confirm selection and dosing units.
Infusion setup page displays.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
59
Page 66
Primary Infusion - NO Guardrails® Suite MX Protection (Continued)
Dose Rate Calculation-Drug? NO DOSE LIMIT - Profiles
Feature Not Enabled (OFF) (Continued)
8. 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. To automatically calculate dose instead of rate, press Rate soft key and enter a rate value. Once all entries have been competed, dose is automatically calculated.
Conc (concentration values of drug amount and
diluent volume) needs to be entered.
If drug is weight-based, Wt (patient weight) needs to
be entered.
If drug is not weight-based, Wt field does not appear.
9. When all fields have been completed, verify that all parameters are correct and press ok soft key to confirm
VTBI and VI setup page displays.
VTBI field is highlighted.
10. To enter a VTBI value, use numeric data entry keys then press ENTER key.
VI field is highlighted.
11. If there is a VI value that needs to be cleared, press CLEAR key or press 0 (zero) key then press ENTER key.
12. To continue programming, press ok soft key.
• RUN/HOLD page displays.
13. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
14. To briefly view current dose rate setup parameters (concentration, patient weight) from RUN/HOLD page or during a running infusion, press
4
soft key.
60
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 67
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. If delivering a bolus dose of medication to load prior to the start of a continuous infusion, see "Primary Infusion - With Guardrails
®
Suite MX Protection", "Bolus Dose". 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.
Verify the primary mode parameters prior to accessing the Loading Dose option.
Programming
1. Select desired channel, as necessary. Channel must be on hold in primary mode.
WARNING
This mode is useful for delivering fluid challenges. This feature is for delivery from primary containers only. Using this feature with 2 separate containers may result in unintended flow rates.
CAUTION
Guardrails® drug dosing limits are available only within the
New Guardrails Drug or New Guardrails IV Fluids option.
Dosing limits do not apply when using Loading Dose programming. Profile configurable options, as defined in the Data Set, do apply.
A
B
Rate= 25.0 mL/h VTBI= 10000 mL VI=
1.0
mL
PRIMARY
OPTIONS
A
2. Press OPTIONS key.
3. Press Loading Dose soft key.
Loading Dose infusion rate is highlighted.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
AB
Multi-Step Multi-Dose Loading Dose View Curr. Settings
return
page
Programming
OPTIONS
A
61
Page 68
Loading Dose (Continued)
OPTIONS
AB
A
LOADING DOSE
Primary Settings
Rate= mL/h200.0
VTBI= mL500.0
Programming (Continued)
4. If current value is appropriate, press ENTER key.
OR
To enter a new infusion rate, use numeric keypad and press ENTER key.
Loading Dose VTBI is highlighted.
5. If current value is appropriate, press ENTER key.
OR
To enter a new VTBI, use numeric keypad and press ENTER key.
À
6. To start loading dose infusion, press RUN/HOLD key.
7. To briefly view current profile press
4
soft key.
8. To briefly view primary settings (Pri Rate, Pri VTBI, Total VI) during loading dose infusion, press Primary Settings soft key.
9. To change Primary Settings during a loading dose infusion, press Primary Settings soft key.
AB
Rate= mL/h200.0
VTBI= mL500.0 Primary Settings
LOADING DOSE
OPTIONS
A
10. Press soft key next to parameter to be edited.
Current value is highlighted.
11. M a ke c hanges:
a. To enter a new value, use numeric keypad.
b. To reset volume infused to 0.0 mL, press CLEAR or 0
(zero) key.
12. To accept new value, press ENTER key.
13. When complete:
Loading Dose Complete is displayed.
Pump returns to Primary Infusion.
NOTE:
À The Loading Dose VTBI must be less than the primary VTBI.
62
Programming
AB
Rate= mL/h200.0
VTBI= 500.0 mL Primary Settings
LOADING DOSE
10% Resistance
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 69
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.
This program requires another infusing line to keep the vein open between programmed doses since there is no KVO infusion between doses or following program completion.
Programming
1. Select desired channel, as necessary. Channel must be on hold in primary mode.
CAUTION
Guardrails® drug dosing limits are available only within the
New Guardrails Drug or New Guardrails IV Fluids option.
Dosing limits do not apply when using Multi-Dose programming. Profile configurable options, as defined in the Data Set, do apply.
AB
Rate= 25.0 mL/h VTBI= 4.0 mL VI= 0.0 mL
Primary
OPTIONS
A
2. Press OPTIONS key.
3. Press Multi-Dose soft key.
4. Press Enter New Program soft key.
-- Continued Next Page --
AB
Multi-Step Multi-Dose Loading Dose View Curr. Settings
return
A B
MULTI-DOSE MENU Review/Resume Enter New Program Quit Program
page
OPTIONS
A
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
63
Page 70
Multi-Dose (Continued)
Programming (Continued)
Setup page appears with infusion rate highlighted.
5. To enter infusion rate, use numeric keypad. Press ENTER key.
6. To enter VTBI/Dose, use numeric keypad. Press ENTER key.
A B
Rate= ----- mL/h VTBI/Dose= ----- mL No. Doses= -­Frequency= -- h
menu
A B
Rate=250.0 mL/h VTBI/Dose= ----- mL No. Doses= -­Frequency= -- h
menu
A B
Rate=250.0 mL/h VTBI/Dose=100.0 mL No. Doses= -- Frequency= -- h
menu
OPTIONS
A
OPTIONS
A
OPTIONS
A
7. To enter number of doses, use numeric keypad. Press ENTER key.
8. To enter dose frequency (time interval from start of one dose until start of next), use numeric keypad. Press ENTER key.
64
Programming
A B
Rate=250.0 mL/h VTBI/Dose=100.0 mL No. Doses= 4 Frequency= -- h
menu
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 71
Multi-Dose (Continued)
Programming (Continued)
9. Verify that all parameters are correct then press ok soft key.
If Dose Complete Alert Option is enabled, DOSE
COMPLETE ALERT OPTION page appears.
10. To select On or Off, use soft keys.
11. To continue programming, press ok soft key.
À
To start first dose immediately, see “Starting First
Dose Immediately After Programming”.
To delay start of first dose, see “Delaying Start of First
Dose”.
A B
Rate=250.0 mL/h VTBI/Dose=100.0 mL No. Doses= 4 Frequency= 6 h
menu
A B
DOSE COMPLETE
ALERT OPTION
On
Off
menu
A B
DOSE COMPLETE
ALERT OPTION
On
Off
menu
OPTIONS
A
ok
OPTIONS
A
ok
OPTIONS
A
ok
NOTE:
À All doses must be programmed to start within 24 hours.
Starting First Dose Immediately After Programming
1. A displayed time of 0 hours, 0 minutes identifies that first dose starts immediately after programming.
2. To approve and advance to main hold page, press ok soft key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
A B
0 h
0 min Until First Dose VI= 0.0 mL
menu
Programming
OPTIONS
A
ok
65
Page 72
Multi-Dose (Continued)
Programming (Continued)
Starting First Dose Immediately After Programming (Continued)
3. To start infusion, press RUN/HOLD key or run soft key.
Delaying Start of First Dose
A B
Rate=250.0 mL/h VTBI=100.0 mL VI= 0.0 mL
Dose 1 of 4
menu
OPTIONS
A
run
1. To enter number of hours until first dose, use numeric keypad. Press ENTER key.
2. To enter number of minutes (0 to 59) until first dose, use numeric keypad. Press ENTER key.
3. To advance to timer hold page, press start timer soft key.
A B
0 h
0 min Until First Dose VI= 0.0 mL
menu
A B
3 h
0 min
Until First Dose VI= 0.0 mL
menu
A B
3 h 12 min Until First Dose VI= 0.0 mL
menu
OPTIONS
A
ok
OPTIONS
A
start timer
OPTIONS
A
start timer
66
-- Continued Next Page --
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 73
Multi-Dose (Continued)
Programming (Continued)
Delaying Start of First Dose (Continued)
Hourglass icon flashes to indicate timer is counting
down to start of dose.
Dose automatically starts its infusion when timer
reaches 0 hours, 0 minutes.
4. To briefly view Multi-Dose programmed information, press
4
soft key.
Changing Time Interval Until Next Dose
1. Press stop timer soft key.
AB
3h 12 min Until First Dose
stop timer
AB
Rate=250.0 mL/h VTBI=100.0 mL
100.0mL @ 250.0mL/h Q6
h x 4 VI=100.0
Adult ICU
AB
3h 12 min Until Dose 2 of 4
OPTIONS
A
OPTIONS
A
OPTIONS
A
2. To select a value for editing, press a soft key.
3. To enter new value, use numeric keypad. Press ENTER key.
4. When editing is complete, press start timer soft key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
A B
3 h 12 min Until Dose 2 of 4 VI= 100.0 mL
menu
A B
2 h 12 min Until Dose 2 of 4 VI= 100.0 mL
menu
stop timer
OPTIONS
A
start timer
OPTIONS
A
start timer
Programming
67
Page 74
Multi-Dose (Continued)
Resuming an Interrupted Multi-Dose
1. Select desired channel, as necessary.
2. Select New Patient and Profile Options, as necessary.
Return To Multi-Dose? page appears.
À
3. Press yes soft key.
• Pressing no soft key returns screen to primary setup
page.
4. To access setup parameters, press Review/Resume soft key.
If infusion was in progress when interrupted, see "If
Infusion Was In Progress When Interrupted”.
If infusion was not in progress when interrupted, see “If
Infusion Was Not In Progress When Interrupted”.
NOTE:
À Previous programming parameters will be preserved only
if current profile is accepted and NEW PATIENT?-NO is selected.
If Infusion Was in Progress When Interrupted
A B
Return To
Multi-Dose?
no
A B
MULTI-DOSE MENU Review/Resume Enter New Program Quit Program
OPTIONS
A
yes
OPTIONS
A
1. To approve and advance to main hold page, press ok soft key.
2. To resume infusion, press RUN/HOLD key or run soft key.
68
Programming
A B
Rate=250.0 mL/h VTBI/Dose=100.0 mL Frequency= 6 h DOSE 1 INCOMPLETE
menu
A B
Rate=250.0 mL/h VTBI=80.0 mL VI= 20.0 mL
DOSE 1 of 4
menu
OPTIONS
A
ok
OPTIONS
A
run
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 75
Multi-Dose (Continued)
Resuming an Interrupted Multi-Dose (Continued)
If Infusion Was Not in Progress When Interrupted
1. Press ok soft key.
2. Edit time to delivery of next dose, as necessary.
3. To begin timer’s countdown to delivery of next dose, press start timer soft key.
4. When final dose is complete:
Dose _ of _ Complete displays until user takes
action.
• No Continuous Infusion or KVO Rate occurs.
Multi-Step
A B
Rate=250.0 mL/h VTBI/Dose=100.0 mL Frequency= 6 h DOSE 1 COMPLETE
menu
A B
2 h
4 min Until Dose 2 of 4 VI= 100.0 mL
menu
OPTIONS
A
ok
OPTIONS
A
start timer
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 instrument parameters to be set up once and to deliver a sequence eliminating the need to change the rate and VTBI after each infusion step.
The infusion may be programmed in either rate and volume or volume and time. At completion of the last programmed step, the channel switches to the preset KVO rate or remains at the current rate, whichever is less.
Programming
1. Select desired channel, as necessary. Channel must be on hold in primary mode.
2. Press OPTIONS key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
CAUTION
Guardrails® drug dosing limits are available only within the
New Guardrails Drug or New Guardrails IV Fluid option. Dosing
limits do not apply when using Multi-Step programming. Profile configurable options, as defined in the Data Set, do apply.
Programming
69
Page 76
Multi-Step (Continued)
Programming (Continued)
3. Press Multi-Step soft key.
4. Press Enter New Program soft key.
5. Determine setup method:
Rate and Volume: Instrument calculates step
infusion time. Proceed to "Programming by Rate and Volume".
Volume and Time: Instrument calculates rate.
"Proceed to Programming by Volume and Time".
AB
Multi-Step Multi-Dose LoadingDose View Curr. Settings
return
A B
MULTI-STEP MENU Review/Resume Enter New Program Quit Program
A B
PROGRAMMING OPTIONS
Rate and Volume
Volume and Time
menu
page
OPTIONS
A
OPTIONS
A
OPTIONS
A
Programming by Rate and Volume
1. Press Rate and Volume soft key.
Step 1 of infusion sequence displays.
70
Programming
A B
PROGRAMMING OPTIONS
Rate and Volume Volume and Time
menu
A B
STEP 1 Rate= -------- mL/h VTBI= ----- mL Time= -- h -- min
menu
OPTIONS
A
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 77
Multi-Step (Continued)
Programming (Continued)
Programming by Rate and Volume (Continued)
2. To enter a rate, use numeric keypad. Press ENTER key.
3. To enter VTBI, use numeric keypad. Press ENTER key.
Time in hours and minutes is automatically calculated
and displayed.
4. To approve all displayed information and advance to step 2 of infusion sequence, press ok soft key.
5. To set up each additional step of infusion sequence, repeat steps 2 through 4.
A B
STEP 1 Rate= 25.0 mL/h VTBI= ----- mL Time= -- h -- min
menu
A B
STEP 1 Rate= 25.0 mL/h VTBI= 5.0 mL Time= 0 h 12 min
menu
OPTIONS
A
OPTIONS
A
ok
6. When all steps have been entered and accepted, press done soft key.
Review page(s) display 3 sequence steps at a time.
7. To approve and advance through review page(s), press ok soft key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
A B
STEP 4 Rate= ----- mL/h VTBI= ----- mL Time= -- h -- min
menu
AB
# RATE VTBI TIME 1 25.0 5.0 0h12m 2 50.0 25.0 0h30m 3 100.0 100.0 1h 0m
Programming
OPTIONS
A
done
OPTIONS
A
okmenu
71
Page 78
Multi-Step (Continued)
Programming (Continued)
Programming by Rate and Volume (Continued)
8. To clear VI, if desired, press CLEAR or 0 (zero) key. Press ENTER key.
9. To accept STEP TOTALS page, press ok soft key.
10. To start Multi-Step infusion program, press run soft key or RUN/HOLD key.
A B
STEP TOTALS (3) VTBI= 130.0 mL Time= 1 h 42 min VI 25.0 mL
menu
A B
STEP TOTALS (3) VTBI= 130.0 mL Time= 1 h 42 min VI 0.0 mL
menu
A B
Rate= 25.0 mL/h VTBI= 5.0 mL VI= 0.0 mL
STEP 1 of 3
menu
OPTIONS
A
ok
OPTIONS
A
ok
OPTIONS
A
runsetup
Programming by Volume and Time
1. Press Volume and Time soft key
72
Programming
A B
PROGRAMMING OPTIONS
Rate and Volume
Volume and Time
menu
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 79
Multi-Step (Continued)
Programming (Continued)
Programming by Volume and Time
Step 1 of infusion profile displays.
VTBI is highlighted.
2. To enter VTBI, use numeric keypad. Press ENTER key.
Time (hours) is highlighted.
3. To enter hours, use numeric keypad. Press ENTER key.
Time (minutes) is highlighted.
A B
STEP 1 Rate= ----- mL/h VTBI= ----- mL Time= -- h -- min
menu
A B
STEP 1 Rate= ----- mL/h VTBI= 5.0 mL Time= -- h -- min
menu
AB
STEP 1 Rate= ----- mL/h VTBI= 5.0 mL Time= 0 h -- min
m e nu
OPTIONS
A
OPTIONS
A
OPTIONS
A
4. To enter minutes (0-59), if desired, use numeric keypad.
Press ENTER key.
Volumetric rate is automatically calculated and displayed.
5. To approve all displayed information and advance to STEP
2 of infusion profile, press ok soft key.
6. To set up each additional step of infusion profile, repeat steps 1 through 4.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
A B
STEP 1 Rate= 25.0 mL/h VTBI= 5.0 mL Time= 0 h 12 min
menu
Programming
OPTIONS
A
ok
73
Page 80
Multi-Step (Continued)
Programming (Continued)
Programming by Volume and Time
(Continued)
7. When all steps have been entered and accepted, press done soft key.
Review page(s) display 3 profile steps at a time.
8. To approve and advance through review page(s), press ok soft key.
9. To clear VI, if desired, press CLEAR or 0 (zero) key. Press ENTER key.
A B
STEP 4 Rate= ----- mL/h VTBI= ----- mL Time= -- h -- min
menu
AB
# RATE VTBI TIME 1 25.0 5.0 0h12m 2 50.0 25.0 0h30m 3 100.0 100.0 1h 0m
A B
STEP TOTALS (3) VTBI= 130.0 mL Time= 1 h 42 min VI 25.0 mL
menu
OPTIONS
A
done
OPTIONS
A
okmenu
OPTIONS
A
ok
10. To approve STEP TOTALS page, press ok soft key.
74
Programming
A B
STEP TOTALS (3) VTBI= 130.0 mL Time= 1 h 42 min VI 0.0 mL
menu
OPTIONS
A
ok
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 81
Multi-Step (Continued)
Programming (Continued)
Programming by Volume and Time
(Continued)
11. To start Multi-Step infusion program, press RUN/HOLD key or run soft key.
Making Changes During Multi-Step
Select the desired channel, as necessary. The channel does not need to be on hold to clear the VI or to view the totals remaining.
Clearing Volume Infused
1. Press VI soft key.
A B
Rate= 25.0 mL/h VTBI= 5.0 mL VI= 0.0 mL
STEP 1 of 3
menu
A B
Rate= 25.0 mL/h VTBI= 4.0 mL VI= 1.0 mL
setup
STEP 1 of 3
10% Resistance
OPTIONS
A
run
OPTIONS
A
2. Press CLEAR or 0 (zero) key.
3. Press ENTER key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
75
Page 82
Multi-Step (Continued)
Making Changes During Multi-Step (Continued)
Viewing Totals Remaining
Press 4 soft key.
Time and VTBI remaining in Multi-Step program display for
a short interval.
Viewing or Editing
The channel must be on hold to view or edit the steps in the program.
A B
Rate= 50.0 mL/h VTBI= 25.0 mL VI= 5.0 mL
STEP 2 of 3
10% Resistance
AB
Rate= 50.0 mL/h VTBI= 25.0 mL
Totals Remaining
VTBI= 125.0 mL
Time= 1 h 30 min
Adult ICU
OPTIONS
A
OPTIONS
A
1. To place channel on hold, press RUN/HOLD key.
2. To return to review page(s), press setup soft key.
A tick mark (y) next to a step on review page(s)
indicates it has not started.
Only steps having a (y) can be edited.
Completed steps, or a step in progress, do not have
a (y).
A step number in progress is highlighted.
3. To advance through review page(s) of program, press ok soft key.
76
Programming
A B
Rate= 25.0 mL/h VTBI= 4.0 mL VI= 1.0 mL
STEP 1 of 3
menu
A B
# RATE VTBI TIME
1 25.0 5.0 0h12m
2 50.0 25.0 0h30m 3 100.0 100.0 1h 0m
menu
OPTIONS
A
runsetup
OPTIONS
A
ok
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 83
Multi-Step (Continued)
Making Changes During Multi-Step (Continued)
Viewing or Editing (Continued)
4. To select a step for editing, press a soft key.
5. To select value for editing, press a soft key.
6. To enter new value, use numeric keypad. Press ENTER key.
7. To return to review page(s) when programming is complete, press ok soft key.
8. To approve review page(s) and STEP TOTALS page, press ok soft key.
A B
STEP 2 Rate= 50.0 mL/h VTBI= 25.0 mL Time= 0 h 30 min
menu
A B
STEP 2 Rate= 25.0 mL/h VTBI= 25.0 mL Time= 1 h 00 min
menu
A B
# RATE VTBI TIME
1 25.0 5.0 0h12m
2 25.0 25.0 1h00m 3 100.0 100.0 1h 0m
menu
OPTIONS
A
ok
OPTIONS
A
ok
OPTIONS
A
ok
9. To resume infusion, press RUN/HOLD key or run soft key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
A B
Rate= 25.0 mL/h VTBI= 4.0 mL VI= 1.0 mL
STEP 1 of 3
menu
setup
Programming
OPTIONS
A
run
77
Page 84
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.
1. Select desired channel, as necessary.
2. Select New Patient and Profile Options, as necessary.
Return To Multi-Step? page appears.
Á
À
3. Press yes soft key.
• Pressing no soft key returns screen to primary setup
page.
4. Press Review/Resume soft key.
5. To resume program from point of interruption, press Continue Program soft key.
OR
To restart program at beginning of step 1, press Restart Program soft key.
A B
Return To
Multi-Step?
no
A B
MULTI-STEP MENU Review/Resume Enter New Program Quit Program
A B
STEP 1 of 3
In Progess Continue Program Restart Program
menu
OPTIONS
A
yes
OPTIONS
A
OPTIONS
A
6 Verify all settings are correct. If a change is required, see
“Making Changes During Multi-Step”.
78
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 85
Multi-Step (Continued)
Resuming an Interrupted Multi-Step (Continued)
7. To approve review page(s) and STEP TOTALS page,
press ok soft key.
8. To continue or restart program, press RUN/HOLD key or
run soft key.
NOTES:
À Previous programming parameters will be preserved only
if current profile is accepted and NEW PATIENT?-NO is selected.
Á If resuming an infusion on a dual channel instrument with an
infusion currently running, display goes directly to Return To Multi-Step? during startup.
A B
# RATE VTBI TIME
1 25.0 5.0 0h12m
2 25.0 25.0 1h00m 3 100.0 100.0 1h 0m
menu
A B
Rate= 25.0 mL/h VTBI= 4.0 mL VI= 1.0 mL
STEP 1 of 3
menu
setup
OPTIONS
A
ok
OPTIONS
A
run
Quitting Multi-Dose and Multi-Step
The channel must be on hold or the last dose complete.
1. Press menu soft key.
2. To return to primary setup page, press Quit Program soft
À
key.
NOTE:
À Primary setup page parameters may be different from those of
the Multi-Dose or Multi-Step program. Verify all settings prior to resuming an infusion.
A B
Rate= 25.0 mL/h VTBI= 4.0 mL VI= 1.0 mL
STEP 1 of 3
menu
A B
MULTI-STEP MENU Review/Resume Enter New Program Quit Program
setup
OPTIONS
A
run
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
79
Page 86
Secondary Infusion - NO 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. If secondary mode is OFF an invalid keypress tone sounds and "Secondary Not Allowed" displays when the SEC key is pressed.
1. Press SEC key
• Secondary Menu displays
2. Press Basic SEC soft key
Basic secondary programming page displays.
VTBI field is highlighted.
3. To enter desired VTBI, use numeric keys then press
ENTER key.
VI field is highlighted.
4. If there is a VI value that needs to be cleared, press
CLEAR key or press 0 (zero) key then press ENTER key.
Time is highlighted.
5. To enter a value, use numeric data entry keys to enter
hours (0-99), then minutes (0-59). Press the ENTER key to accept each entry.
Time can be entered to calculate rate or if rate entry
is desired, press rate -
- time, indicating that rate may be entered.
rate
soft key. It changes to
time
6. To continue programming press ok soft key.
A Secondary Clamp reminder message displays.
80
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 87
Secondary Infusion - NO Guardrails® Suite MX Protection (Continued)
Basic Secondary Infusion- Profiles Feature Enabled (On)
(Continued)
7. Verify that secondary clamp is open before proceeding,
then press yes soft key.
Basic secondary RUN/HOLD page displays.
8. Verify that all parameters are correct and press run soft key or RUN/HOLD key to start infusion.
9. To briefly view primary parameters (Pri rate, Pri VTBI) and current profile from RUN/HOLD page or during a running infusion, press
4
soft key.
10. When secondary infusion is complete:
An audio tone sounds (if enabled).
Channel _ Secondary Complete briefly displays.
Infusion automatically transitions to primary rate.
Basic Secondary Infusion- Profiles Feature
Not Enabled (Off)
AB
IS SECONDARY CLAMP
OPEN?
OPTIONS
yes
1. Press SEC key
Secondary setup page displays.
Secondary rate is highlighted.
2. If current secondary infusion rate is appropriate, press ENTER key.
OR
To enter a new rate, use numeric keypad then press ENTER key.
Maximum rate for secondary infusion is 600 mL/h.
Secondary VTBI is highlighted.
3. If Secondary VTBI is appropriate, press ENTER key.
OR
To enter a new VTBI, use numeric keypad then press ENTER key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Programming
81
Page 88
Secondary Infusion - NO Guardrails® Suite MX Protection (Continued)
Basic Secondary Infusion- Profiles Feature
Not Enabled (Off) (Continued)
4. To start secondary infusion, press RUN/HOLD key.
Secondary clamp reminder message displays.
5. Verify that secondary clamp is open before proceeding, then press yes soft key.
6. To briefly view primary settings during secondary infusion press Primary Settings soft key.
Primary rate (PriRate), primary volume to be infused
(PriVTBI) and total volume infused (ToalVI) are displayed.
Display returns to normal secondary page after 6
seconds.
7. To change Primary settings, press soft key for Pri Rate, Pri VTBI or Total V I to freeze display and highlight desired value, then edit as usual (see "Primary Infusion
- With Guardrails During Continuous Infusion").
®
Suite MX Protection", "Making Changes
8. When secondary infusion is complete:
An audio tone sounds (if enabled).
Channel _ Secondary Complete briefly displays.
Infusion automatically transitions to primary rate.
82
Programming
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 89
Dynamic Monitoring System
All features and options in this section are shown enabled. Options are enabled through the hospital Data Set profile configuration settings, or through the instrument 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. Resistance monitoring eliminates the impact of patient elevation and flow rate to provide the most direct assessment of patency. Components of this system are:
Monitoring Options: to select IV line/site monitoring
modes of resistance, high resistance, and adjustable or fixed pressure.
Auto Restart Plus Feature: allows instrument to
automatically resume operation when specific instrument operating conditions are met.
Adjustable Resistance Alert: to provide an early
warning of increases in downstream flow resistance.
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. It is a positive displacement delivery system, capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice, including resistances to flow imposed by small gauge catheters, filters and intra-arterial infusion. It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions.
Adjustable Pressure Alarm: to provide an early warning
of increases in downstream pressure.
Tren d Graph: to display downstream pressure or flow
resistance over time.
Pressure Baseline: to provide a starting point from which
to measure changes in system pressure.
Monitoring Options - General
IV lines, catheters, and applications create various levels of resistance to flow. Monitoring mode options are available to meet each clinical need.
Resistance: designed to monitor IV line/site resistance
providing optimum sensitivity for most IV applications.
High Resistance: designed to monitor IV line/site
resistance with optimum sensitivity where higher resistance catheters are used.
• Before each use, verify the
pressure or resistance alarm limits are appropriate for the
patient.
AB
Rate= 125.0 mL/h VTBI=1000.0 mL VI= 0.0 mL
Primary
50% Resistance
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Resistance Monitoring
Dynamic Monitoring System
83
Page 90
Monitoring Options - General (Continued)
Adjustable Pressure: designed to monitor IV line/
site pressure and provide user-adjustable pressure alarm limits. Used for Precision Flow mode or for high resistance systems; such as, infusion through transducers, into dialysis systems and through highest resistance catheters.
Pressure: designed to monitor IV line/site pressure and
alarm based on a fixed pressure limit.
NOTE:
À Precision Flow: in fixed and adjustable pressure modes, the
SE Pump provides enhanced flow continuity at rates below 50 mL/h.
For dual channel instruments, select the desired channel as necessary. The bar graph and numeric displays are not available when the split screen is displayed.
À
À
Selecting Monitoring Option
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
450 mmHg
Pressure Monitoring
OPTIONS
A
1. Press OPTIONS key.
2. Press Monitoring Options soft key.
AB
Rate= 125.0 mL/h VTBI=1000.0 mL VI= 0.0 mL
AB
Primary
Limit=250 mmHg
Resistance Monitoring Options Guardrails Library Set Pressure Baseline
return
Trend
®
page
OPTIONS
A
OPTIONS
A
84
Dynamic Monitoring System
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 91
Monitoring Options - General (Continued)
Selecting Monitoring Option (Continued)
3. Press soft key for Resistance, High Resistance or Adjustable Pressure.
À
4. Press ok soft key. Display automatically returns to normal operating screen.
Á
a. If Resistance option is selected, % Resistance
displays below bar graph while infusing.
Â
A B
Monitoring Options
Resistance High Resistance
Adjustable Pressure
OPTIONS
A
ok
WARNING
Each time the instrument is turned on, verify and/or set the
monitoring mode, resistance alert and/or pressure alarm limit. If the monitoring mode, resistance alert and/or pressure alarm limit are not verified, the instrument may not be operating with the desired occlusion detection parameter(s).
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
OPTIONS
A
b. If High Resistance option is selected, % Hi Resist.
displays below bar graph while infusing.
Ã
-- Continued Next Page --
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
50% Resistance
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
50% Hi Resist.
OPTIONS
Dynamic Monitoring System
A
85
Page 92
Monitoring Options - General (Continued)
Selecting Monitoring Option (Continued)
c. If Adjustable Pressure option is selected, pressure
system accuracy can be enhanced by ensuring no occlusion or other pressure source exists in IV line when activating RUN/HOLD.
NOTES:
À If pressure limit adjustment is available, selection reads
Adjustable Pressure; otherwise, it reads Pressure.
Á While the channel is on, the selected option, resistance alert
and pressure alarm thresholds remain in effect until changed by the operator.
 Resistance alert limit may be adjusted using the soft keys
located below the arrow symbols (see "Monitoring Options
- Resistance Mode", “Resistance Alert”).
à High Resistance alert limit may be adjusted using the soft
keys located below the arrow symbols.
Ä Pressure alarm limits may be adjusted when operating in
Adjustable Pressure mode using the soft keys located below the arrow symbols (see "Monitoring Options - Pressure Mode", “Adjustable Pressure Alarm”).
Å Maximum pressure limit settings may be configured by
qualified service personnel.
Ä Å
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
Limit=250 mmHg
OPTIONS
A
Monitoring Options - Resistance Mode
Detection of Downstream Occlusions
In the Resistance or High Resistance monitoring mode, a RESISTANCE ALERT condition occurs when the measured resistance reaches the alert limit.
86
Dynamic Monitoring System
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Resistance Alert
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 93
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.
An OCCLUSION DOWNSTREAM condition is also detected when the configured pressure limit is exceeded. This limit may be set, by qualified service personnel, from 1 mmHg to 600 mmHg ( Pressure Limit, Maximum).
When a Downstream Occlusion is detected, one of the following responses occur:
If Auto Restart Plus feature is on, Checking Line message
displays and audible tone sounds.
If Auto Restart Plus feature is off, OCCLUSION
DOWNSTREAM alarm occurs.
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%.
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Checking Line
A B
OCCLUSION
DOWNSTREAM
run
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Checking Line
OPTIONS
A
OPTIONS
A
OPTIONS
A
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Dynamic Monitoring System
87
Page 94
Monitoring Options - Resistance Mode (Continued)
Auto Restart Plus Feature (Continued)
If resistance measurements initiate the Checking Line condition, the channel continues infusing in order to determine if the measured flow resistance has changed. If the measured flow resistance falls to any value below 100% within 40 seconds, the channel automatically resumes normal operating conditions (excluding High Resistance Monitoring mode).
Pressure measurements initiate the Checking Line period when the pressure exceeds the configured limit. If the pressure falls to less than one-third of the configured limit within 40 seconds, normal flow resumes. If the condition is not cleared, the OCCLUSION DOWNSTREAM alarm occurs and infusion stops until manually restarted.
This feature can be configured through the hospital Data Set to allow from 1 to 9 Checking Line restarts. After the programmed number of restarts has occurred or the 40­second Checking Line period has been exceeded, the channel immediately alarms OCCLUSION DOWNSTREAM when resistance or pressure conditions indicate an occlusion.
Resistance Alert
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
90% Resistance
A B
OCCLUSION
DOWNSTREAM
run
OPTIONS
A
OPTIONS
A
The Resistance Alert provides an early warning of increasing flow resistance. The Resistance Alert marker can be set from 0% to 100% of scale in 5% increments. This feature can be enabled or disabled and a power-on default alert level is set through the hospital Data Set.
To optimize the alert feature, it is advisable to set the alert level 20-30% higher than the initial displayed resistance. Read the resistance approximately 2 minutes after starting an infusion.
Setting Alert Marker
To numerically display present alert level marker, press either
or soft key. Vertical line on resistance bar graph visually
indicates alert level.
Each additional press of either arrow soft key increases or decreases alert level marker and numeric value by 5%.
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
Alert = 70%
OPTIONS
A
88
Dynamic Monitoring System
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 95
Monitoring Options - Resistance Mode (Continued)
Resistance Alert
If Flow Resistance Exceeds Alert Level Marker
If flow resistance exceeds the alert level marker, a Resistance Alert message displays and an alert tone sounds. The
channel continues to infuse, and the message and tone continue until one of the following resistance levels occurs:
IV line/site resistance falls below alert level marker.
Resistance alert level marker increases above current
measured resistance value.
Resistance rises to 100%, initiating a Checking Line or
OCCLUSION DOWNSTREAM condition.
Resistance Trend Graphs
In Resistance and High Resistance monitoring modes, a trend graph displays flow resistance 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 are indicated by a tick mark (y) at the top of the trend screen.
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Resistance Alert
A B
100%
50
0
RESISTANCE
-12h
return
clear
OPTIONS
A
OPTIONS
A
now
time
Viewing Graphs
For dual channel instruments, select the desired channel, as necessary. The trend graph is not available while the split screen is displayed.
1. Press OPTIONS key.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
25% Resistance
OPTIONS
Dynamic Monitoring System
A
89
Page 96
Monitoring Options - Resistance Mode (Continued)
Resistance Trend Graphs (Continued)
Viewing Graphs (Continued)
2. Press Resistance Trend soft key.
3. To change graph time frame, press time soft key.
A dashed horizontal line represents current resistance
alert level.
Gaps in graph may indicate noninfusing conditions;
such as, turned off, on hold, in alarm.
If channel has been placed in Pressure Monitoring
mode for some portion of a trend graph window, resistance data is not available and zero values are plotted.
A tick mark (y) at top of graph indicates an occlusion.
When viewing Resistance Trend Graphs in High
Resistance mode, HI RESIST displays under graph.
AB
Resistance Trend Monitoring Options
Guardrails Library
Set Pressure Baseline
return
A B
100%
50
0
-12h
return
AB
100
%
50
®
page
RESISTANCE
clear
OPTIONS
A
OPTIONS
A
now
time
OPTIONS
A
Clearing Graphs
1. To clear graphed data, press clear soft key.
90
Dynamic Monitoring System
return
AB
100
50
return
0
%
0
HI RESIST
clear
RESISTANCE
clear
now-12h
time
OPTIONS
A
now-12h
time
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 97
Monitoring Options - Resistance Mode (Continued)
Resistance Trend Graphs (Continued)
Clearing Graphs (Continued)
2. Press ok soft key.
All data is cleared from graphs.
Returning to Normal Operating Screen
Press return soft key.
AB
return
AB
100
%
50
0
return
AB
All trend data
will be cleared
RESISTANCE
clear
OPTIONS
ok
OPTIONS
A
now-12h
time
OPTIONS
Normal operating screen appears.
Following events also turn off trend graph:
• Pressing RUN/HOLD key.
• An alarm.
Dual channel instrument: pressing
A B
.
Dual channel instrument: replaced with a split screen
display after 1 minute if both channels are infusing.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
100
%
50
return
AB
0
RESISTANCE
clear
now-12 h
time
OPTIONS
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
33% Resistance
Dynamic Monitoring System
A
A
91
Page 98
Monitoring Options - Pressure Mode
Detection of Downstream Occlusions
When using the Adjustable Pressure monitoring mode, a pressure alarm limit may be selected, in 25 mmHg increments, from 25 mmHg to the maximum configured pressure limit. When measured pressure exceeds this level, an OCCLUSION DOWNSTREAM condition occurs.
When a Downstream Occlusion is detected, one of following responses occurs:
If Auto Restart Plus feature is on, a Checking Line
message appears, along with an audible tone. (Reference “Auto Restart Plus Feature” for further details.)
If Auto Restart Plus feature is off, an OCCLUSION
DOWNSTREAM alarm occurs.
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
500 mmHg
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Checking Line
A B
OCCLUSION
DOWNSTREAM
OPTIONS
A
OPTIONS
A
OPTIONS
A
Auto Restart Plus Feature
The Auto Restart Plus feature provides the ability to automatically continue an infusion if downstream pressure measurements indicate that an occlusion condition has cleared within a 40-second Checking Line period (excluding High Resistance Monitoring mode).
600 mmHg
run
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Checking Line
OPTIONS
A
92
Dynamic Monitoring System
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
Page 99
Monitoring Options - Pressure Mode (Continued)
Auto Restart Plus Feature (Continued)
The Checking Line message and tone occur whenever a pressure measurement exceeds the selected alarm threshold. If the pressure falls to less than one-third of the alarm limit within 40 seconds, normal flow resumes. The Adjustable Pressure mode allows control of the pressure alarm limit. If the condition is not cleared, the OCCLUSION DOWNSTREAM alarm occurs and infusion stops until manually restarted.
This feature can be configured through the hospital Data Set to allow from 1 to 9 Checking Line restarts. After the programmed number of restarts has occurred or the 40­second Checking Line period has been exceeded, the channel immediately alarms OCCLUSION DOWNSTREAM when resistance or pressure conditions indicate an occlusion.
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 instrument confirmation settings if the Profiles feature is not enabled (OFF).
A B
DOWNSTREAM
run
OCCLUSION
OPTIONS
A
Setting Alarm Limit Marker
Pressing either arrow ( or ) soft key changes alarm limit by 25 mmHg in corresponding direction. It is advisable to select an alarm limit appropriate for flow rate. At lower flow rates, alarm limit should be set lower, to shorten time to alarm.
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
AB
Rate= 125.0 mL/h VTBI= 1000.0 mL VI= 0.0 mL
Primary
Limit = 450mmHg
Dynamic Monitoring System
OPTIONS
A
93
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.
First activation of RUN/HOLD for a new infusion
automatically establishes a pressure baseline based on current system pressure. An optimal baseline is maintained upon subsequent activations of RUN/HOLD, as follows:
- If current system pressure is same or higher than original baseline, pressure baseline does not change.
- If current system pressure is less than original baseline, system automatically resets to new system pressure value.
Pressure measurement can be optimized, particularly at low flow rates (less than 3 mL/h), by pausing and restarting at least once every 2 hours (for example, when reprogramming VTBI). This allows pressure baseline to calibrate based on current system pressure.
Prior to activation, ensure that pressure has not built up in IV line due to either occlusion or flow from other instruments through a common catheter. This will result in a more accurate pressure measurement.
When loading a set connected to a small diameter catheter, wait at least 5 seconds after loading set before activating RUN/HOLD. This allows pressure generated by loading process to dissipate and sensor to stabilize. (Very small PICC catheters; such as, 28 gauge/1.2 French, may require 60 seconds or more for stabilization.)
When multiple instruments are infusing through a common small diameter catheter, pressure measurement accuracy can be optimized by temporarily stopping all infusions, then restarting all instruments beginning with instrument delivering at lowest rate.
94
Dynamic Monitoring System
Directions for Use
Alaris® SE Pump
Models 7130/7131, 7230/7231
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