baxter Auto Syringe AS50, AS50 Operator's Manual

Operator’s Manual
Auto Syringe
AS50
Model AS50 Infusion Pump
Warning
There are risks associated with using anything other than the recommended IV extension sets with this device. Sets designated for use with this device are identified in the section “Simplified Instructions”. Baxter’s warranty on this device will be null and void and Baxter will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling. See the section “Precautions” for a complete list of warnings and cautions.
Computer Software Copyrights
©Copyright 1999, Baxter Healthcare Corporation. All rights reserved.
For use only by Baxter Healthcare Corporation. The software contains proprietary information belonging to Baxter Healthcare Corporation. The software must not be reproduced or disclosed to others without prior written approval. Any unauthorized use of this information may subject the user to substantial liability.
Documentation Copyrights
Duplication or distribution of this manual and any information contained within is strictly prohibited without the express written permission of Baxter. This manual and any information contained within, may not be reproduced, distributed, or transmitted in any form, or by any means, for any purpose, without the express written permission of Baxter. To order additional copies of this manual, or other related manuals, contact your local Baxter Service Center.
Disclaimer
The information in this document has been carefully examined and is believed to be entirely reliable. However, no responsibility is assumed for inaccuracies. Furthermore, Baxter reserves the right to make changes to any products herein to improve readability, function, or design. Baxter does not assume any liability arising out of the application or use of any product or circuit described herein; neither does it cover any license under its patent rights nor the rights of others.
Trademark Information
Baxter, the Baxter wordmark, Micro-Volume, and Auto Syringe are trademarks of Baxter International Inc. in the U.S. Other trademark applications pending. Terumo is a trademark of Terumo Medical Corporation. ASCEND,
and Hi-Tor Plus are trademarks of Huntington Professional Products. LpH SE and Septisol are trademarks of Steris Corporation. Cidex 7 is a trademark of Johnson & Johnson.
are the property of their respective owners.
Other product names appearing in this manual
TOR,
Table of Contents
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Notations Used in this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Special Precautions for Epidural Administration. . . . . . . . . . . . . . . . . . . . . . . . . . 7
Simplified Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Programming the Continuous Infusion Modes . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Programming the Timed Infusion Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
The Status Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
The Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
The Status Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Operating States. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Standby State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Run State. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Data Display and Entry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Protocol Library Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Bypassing the Protocol Library Feature. . . . . . . . . . . . . . . . . . . . . . . . . . 22
Serial Communication Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Infusion Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Continuous Infusion Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Timed Infusion Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Syringe Data Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Infusion Rate Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Deliverable Volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Detailed Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Preliminary Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Manual Purge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Mount the Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Turn the Pump On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Check the Lamp Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Using Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Programming mL/hr and mL/min Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Programming Units/hr, Units/min, mUnits/hr, and mUnits/min Modes. . . 35
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page i
Programming mg/hr, mg/min, mcg/hr, and mcg/min Modes . . . . . . . . . . 36
Programming mg/kg/hr, mg/kg/min, mcg/kg/hr, and mcg/kg/min Modes 37
Programming CUSTOM DILUTION Mode. . . . . . . . . . . . . . . . . . . . . . . . 39
Programming SINGLE DOSE Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Programming MANUAL SCHEDULE Mode . . . . . . . . . . . . . . . . . . . . . . 42
Programming AUTO SCHEDULE Mode . . . . . . . . . . . . . . . . . . . . . . . . . 45
General Programming Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Field Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Editing in Standby State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Programming Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Editing in Run State. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Edit Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Number Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Data Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Additional Functions and Operations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Purge Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Purge Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Purge Delivery Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Bolus Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Bolus Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Bolus Size Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Bolus Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Bolus Programming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Bolus Programming Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Bolus Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Bolus Delivery Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Bolus Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Bolus Editing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Repeating a Bolus Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Changing the Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Lock and Auto Lock Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
The Total Delivered Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Expanded Data Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Backlight Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Configuration Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Date and Time Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Software and Configuration Version Display . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Reviewing Configuration Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Configuration Review Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Configurable Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Protocol Library Group (
VIEW LIBRARY) . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Modes Group (VIEW MODES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Page ii Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
Syringes Group (VIEW SYRINGES). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Defaults Group (VIEW DFAULTS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Miscellaneous Group (VIEW MISC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Alerts Group (VIEW ALERTS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Terminating Configuration Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Custom Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Factory Standard Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Protocol Libraries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Pump Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Charging the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
IV Pole Clamp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
IV Pole Loop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Routine Cleaning and Disinfection Techniques . . . . . . . . . . . . . . . . . . . . 71
Conditions Requiring Service Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Daily Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Display, Battery, and Syringe Sensor Check. . . . . . . . . . . . . . . . . . . . . . 75
Keypad Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Battery Voltage Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
In Case of Difficulty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Failsafe Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Warranty and Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
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Page iv Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
About This ManualChapter 1
The Auto Syringe AS50 Infusion Pump Operator’s Manual is intended for use by trained
healthcare professionals familiar with infusions and infusion pump procedures.
Notations Used in this Manual
Note: Important information is preceded by the word “Note” in boldface type.
BOLD ITALIC TEXT Denotes text prompts as they appear on the pump’s status
display. For example, bottom line of the status display when selecting the mL/hr infusion mode.
BOLD TEXT Denotes the keys on the pump’s keypad. For example, the
text “press “1,” “2,” and “3,” and then press the key labeled “
ML/HR is the text that appears on the
123, CONFIRM” means: press the keys labeled
CONFIRM.”
(hh:mm) Denotes hours and minutes. The left two digits represent
hours, and the right two digits represent minutes.
Important precautions are denoted by an exclamation point enclosed in a triangle, as shown
below:
IMPORTANT: Read and understand all operating instructions and the “Precautions” on page 5
before using the Auto Syringe AS50 Infusion Pump.
!
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About This Manual
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Page 2 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
Device DescriptionChapter 2
The Auto Syringe AS50 Infusion Pump (hereinafter referred to as “the pump”) is designed
to meet the fluid and drug delivery requirements of today’s changing clinical environment.
It provides accurate, continuous or intermittent infusion of intravenous solutions, drug
solutions, whole blood, and packed red blood cells.
The pump is indicated for infusion via intravenous (IV), intra-arterial (IA), epidural, or
subcutaneous routes of administration. It can be piggybacked into an ongoing infusion
line to deliver secondary solutions automatically, precisely, and economically. Infusion
rates are programmable from 0.01 to 438 mL/hr.
The pump accepts standard disposable syringes from 1 mL to 60 mL in size. A numeric
keypad simplifies programming and makes the pump easy to use. During programming,
the status display prompts the user to enter data about the syringe and the infusion.
While the pump is running, the status display shows information about the infusion.
Safety and effectiveness are reinforced by pre-programmable bolus operation, titration of
a dose without interruption of fluid flow, and easily understood alarm and alert messages.
The pump includes an optional serial communication feature, which provides remote
computer control and monitoring capabilities. A standard 9-pin connector allows an
RS-232 communication link between the pump and the host computer. The “Auto Syringe
AS50 Infusion Pump Programmer’s Manual” describes the use of this feature.
The pump can be custom-configured to select key features that meet specific
requirements. Configurable options include:
Audio range
Auto default to previous mode
Backlight
Infusion mode selections
Keypad auto lock
Maximum infusion rates
Occlusion pressure sensitivity
Protocol library
Remote computer control
Syringe manufacturer, type and size selections
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 3
Device Description
The selected options can easily be reviewed and the chosen configuration can be changed to meet new or different requirements.
The pump operates on an internal rechargeable battery pack and can also be operated while attached to a “900-Series” battery charger (model number CAS40-01-900) or to a Multi-Charger (product code 1M8563).
The pump is supplied with a pole clamp and a built-in IV pole loop. The pump can also be used on a tabletop.
Information on writing custom software for the pump is available in the Auto Syringe AS50 Infusion Pump Programmer’s Manual. Information on troubleshooting and repair of the pump is available in the Auto Syringe AS50 Infusion Pump Service Manual.
Page 4 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
PrecautionsChapter 3
!
Federal (USA) law restricts this device to sale by or on the order of a physician.
The charger port is to be used only with “900 Series” chargers or other accessories that are
labeled specifically for use with Auto Syringe AS40A or AS50 Series Infusion Pumps, including
!
the 1M8563 Multi-Charger.
CAUTION: Refer all service, repair, and calibration to qualified technical
!
!
Though the factory-supplied configuration settings are suitable for most therapies, the
personnel.
CAUTION: Do not operate the Auto Syringe AS50 Infusion Pump in the presence of flammable anesthetics, oxygen-enriched, or explosive atmospheres.
operator and hospital professionals should verify that the pump’s settings are appropriate for the clinical application.
The Protocol Library feature is a configuration option developed to facilitate infusion
programming. Before using a protocol for any specific drug, refer to the full prescribing information supplied by the drug manufacturer.
As with all medical electronic equipment, care must be exercised to avoid exposing
this device to powerful sources of electromagnetic interference.
Do not expose the pump to X-rays, gamma rays, or other ionizing radiation, or to
strong electric or magnetic fields.
Do not autoclave, steam sterilize, EtO sterilize, or subject the pump or charger to
temperatures in excess of 104° F (40° C).
Do not use the following chemicals on the device, as they will damage the front panel:
acetone, acetoaldehyde ammonia, benzene, hydroxytoluene, methylene chloride, and ozone, Do not use cleaners containing n-alkyl dimethyl ethylbenzyl ammonium chloride unless they appear in the list of recommended cleaners in the Pump Maintenance section of this manual.
Do not use hard or sharp objects on the keypad.
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 5
Precautions
If a LINE OCCLUDED alarm occurs, RELIEVE THE RESIDUAL PRESSURE IN THE
SYRINGE BY RELEASING THE PLUNGER DRIVER. If the pressure is not relieved prior to clearing the occlusion, an unintentional bolus delivery may occur when the blockage is cleared. Check for kinked tubing, clogged catheter, closed stopcocks, etc. Check for foreign material preventing movement of the pump mechanism.
Be sure to PURGE THE SYSTEM OF ALL AIR BEFORE ADMINISTERING ANY
MEDICATION. Failure to follow this normal infusion procedure could precipitate serious consequences.
Remember that the volume of fluid contained in the connecting tubing is a residual
amount and cannot be infused. Allow for this extra volume of fluid when initially filling the syringe.
In MANUAL SCHEDULE mode, START must be pressed to deliver each dose and
continue the infusion regimen. Pressing any other key silences the audio portion of
DOSE DUE alarm and leaves the pump in Standby state, without initiating a dose
the delivery.
Although extreme care has been taken in assembly, component selection, and quality
control during manufacture of the Auto Syringe AS50 Infusion Pump, routine checks and maintenance procedures must be performed so that patients receiving infusions can be assured of trouble-free operation.
Caution must be exercised in the selection of drugs intended to be delivered via any
infusion pump. If the drug contained in the syringe will be exposed to extreme environmental conditions for prolonged time periods, IT IS IMPORTANT TO SELECT DRUGS THAT WILL NOT CHANGE PHARMACOLOGICALLY UPON SUCH EXPOSURE.
As with all automatic infusion devices, whenever a TOXIC OR DANGEROUS LEVEL
of drug is stored in the reservoir, CONSTANT MONITORING of the infusion is required.
CAUTION must be employed to assure that the Auto Syringe AS50 Infusion Pump is
in good working order before putting it into use. If the pump is being operated on battery power alone, ensure that the battery has been charged as described in this manual.
When the pump is first turned on, verify that the Lamp Test is accurate (see “Display,
Battery, and Syringe Sensor Check” on page 75).
Verify all program data before pressing START.
Wipe off spills immediately. Do not allow fluid or residues to remain on the pump.
Repeated incorrect identification of syringe size by Syringe Recognition may signify a
pump fault condition, or that a syringe manufacturer has made a dimensional change. The pump should be removed from service as soon as possible, so that the problem can be investigated.
Page 6 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
If the Size Override configuration option is enabled, an operator can manually
override the Syringe Recognition feature. Incorrect syringe information may cause delivery errors.
Special Precautions for Epidural Administration
Epidural administration of anesthetics is limited to short-term infusion (not to exceed
96 hours) with indwelling catheters specifically indicated for short-term anesthetic epidural drug delivery.
Epidural administration of analgesics is limited to use with indwelling catheters
specifically indicated for either short- or long-term analgesic epidural drug delivery.
To prevent infusion of drugs that are not indicated for epidural use, do not use IV
extension sets that incorporate injection sites during epidural delivery.
It is strongly recommended that pumps used for epidural drug delivery be clearly
differentiated from pumps used for other routes of administration.
WARNING: Epidural administration of drugs other than those indicated
!
for epidural use could result in serious injury to the patient.
Precautions
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 7
Precautions
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Page 8 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
Operation
ew
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5
6
0
5
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Simplified InstructionsChapter 4
Refer to the figure below for the location and description of the pump’s operating controls.
The item numbers shown in the figure are referenced throughout the operating
instructions also.
1. Status Display
2. Plunger Assembly
(Finger Grip, Plunger Clamp, Plunger Driver)
3. Status Panel
4. Keypad
5. Flange Slot
6. Barrel Clamp
7. Cradle
8. Charger Port
9. IV Pole Loop
10. Pole Clamp Mounting
Pins
11. Battery Cover
12. Pole Clamp Attach
Recess
13. Barrel Clamp Release
Levers
14. ON/OFF Switch
15. DB-9 RS-232 Serial
Communication Port
Front
Bottom
1
1
rest b
B
1
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 9
Simplified Instructions
GE
R
Note: Steps 1 and 2 can be performed after programming the pump if necessary (for
example, if using CUSTOM DILUTION mode).
1. Attach an IV extension set to the syringe and manually purge the air from the filled
syringe and tubing. Baxter recommends the following IV extension sets.
Catalog Number Description
2N3345 36” Micro-Volume IV extension set
2N3346 36” High Flow Rate IV extension set
2N3347 36” Micro-Volume IV extension set with 0.22 micron filter
2N3348 60” Micro-Volume IV extension set
2N3349 60” High Flow Rate IV extension set
2N3350 60” Micro-Volume IV extension set with 0.22 micron filter
PLUNGE
FLAN
2. Mount the syringe on the pump.
Pull out the plunger driver (2), slide it to top of the pump, and release it.
Using the lever (13) on the side or rear of the pump, release the barrel clamp (6).
Place the syringe in the cradle (7), making sure the syringe flange fits into
the slot (5).
Close the barrel clamp (6) firmly against the syringe barrel.
Pull out the plunger driver (2), slide it down to capture the top of the syringe
plunger, and push in firmly to capture syringe plunger.
3. Slide the ON/OFF switch (14) to the ON position.
4. Program the pump (see “Programming” on page 11).
5. Purge the syringe and tubing again to remove slack from the plunger driver.
Press PURGE, START to begin purging. Repeat if necessary.
Press STOP if necessary to stop purging.
6. Connect the IV extension set to the patient.
7. Press START to begin the infusion.
Page 10 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
Programming
Note: If the Protocol Library feature is enabled, a ▲▼ SELECT LIBRARY prompt is dis-
1. At the SELECT MODE ▲▼ prompt, use or as necessary to display the available
infusion mode selections. Press
2. Select the syringe manufacturer and size using or as necessary and complete
the data entry by pressing Override” on page 64.)
3. Enter the remaining program data as required. The current field is the one that is
flashing.
Press number keys to enter the desired value.
Simplified Instructions
played first. Use ▲, ▼ and
CONFIRM as required to select a protocol library. Next,
select a protocol from the library.
If the selected protocol specifies a default infusion mode, the pump skips step 1.
CONFIRM to select an infusion mode.
CONFIRM. (For use of the Size Override feature, see “Size
Press CONFIRM to complete the data entry.
4. To change programmed data:
Press or to move to the desired field.
Press EDIT. The current value flashes.
Press , , or number keys to change the value.
Press CONFIRM to complete the data entry.
5. To program or edit the bolus size:
Press BOLUS, EDIT.
Set the bolus size using the number keys.
Press START to deliver a bolus, or CONFIRM to store the bolus size.
6. To clear the Total Delivered display:
Use or to move to the TOTAL mL field.
Press EDIT, CLR to reset the total to 0.00.
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 11
Simplified Instructions
Programming the Continuous Infusion Modes
Programming for each infusion mode proceeds in the sequence shown in the following table, in top-to-bottom order.
Continuous Infusion Modes
Units/hr
Units/min
mL/hr
Step
1 Select mode,
2 Enter target rate in
3 Enter body weight
4 Enter drug
5 Enter infusion rate
6 Enter final volume
mL/min
syringe manufacturer, syringe size.
in mL/hr or mL/ min.
mUnits/hr
mUnits/min
Select mode, syringe manufacturer, syringe size.
concentration in Units/mL.
Enter dose in Units/hr, Units/min, mUnits/hr, or mUnits/min.
mcg/min
mcg/hr
mg/min
mg/hr
Select mode, syringe manufacturer, syringe size.
Enter drug concentration in mg/mL.
Enter dose in mcg/hr, mcg/min, mg/hr, or mg/min.
mcg/kg/min
mcg/kg/hr
mg/kg/min
mg/kg/hr
Select mode, syringe manufacturer, syringe size.
in kg.
Enter drug concentration in mg/ mL.
Enter dose in mcg/kg/hr, mcg/kg/min, mg/kg/hr, or mg/kg/min.
CUSTOM
DILUTION
Select mode, syringe manufacturer, syringe size.
mL/hr.
Enter body weight in kg.
Enter drug concentration in mg/ mL.
Enter target dose in mcg/kg/min.
in mL.
7 Enter volume limit
in mL.
8 Enter bolus size in
mL.
Notes:
mL = milliliters, kg = kilograms, mg = milligrams, mcg = micrograms, mUnits = milliunits.
• If the Protocol Library feature is active, these modes can be accessed directly by selecting
SELECT LIBRARY or SELECT PROTOCOL programming step.
the
• The mode, rate, concentration, dose, bolus size, and maximum bolus rate may be initialized automatically if a protocol is selected.
• Bolus programming is optional. Bolus programming may be disallowed if a protocol is selected.
Note: Custom Dilution mode:
•Press
Page 12 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
CONFIRM to acknowledge the displayed Drug Volume. Mix the indicated drug volume with sufficient IV fluid
to produce the Final Volume and fill the syringe. Follow manual purging and mounting procedures (see “Operation” on page 9).
Enter bolus size in Units.
Enter bolus size in mg.
Enter bolus size in mcg/kg or mg/kg.
See last Note below.
Enter bolus size in mcg/kg.
NONE (if available) at
Simplified Instructions
Programming the Timed Infusion Modes
Programming for each infusion mode proceeds in the sequence shown in the following table, in top-to-bottom order.
Timed Infusion Modes
Steps SINGLE DOSE MANUAL SCHEDULE AUTO SCHEDULE
1 Select mode, syringe
manufacturer, syringe size.
2
INFUSE field: Enter dose in mL. INFUSE field: Enter dose in mL. INFUSE field: Enter dose in mL.
3
OVER field: Enter dose duration
in hours and minutes (hh:mm).
4
5
6 When the
Note:
• If the Protocol Library feature is active, these modes can be accessed directly by selecting
Select mode, syringe manufacturer, syringe size.
OVER field: Enter dose duration
in hours and minutes (hh:mm).
EVERY field: Enter dose Interval
in hours and minutes (hh:mm).
NEXT DOSE IN field: Enter delay
to start of first dose in hours and minutes (hh:mm).
To start the first dose without delay, program
NEXT DOSE IN field to
0:00.
DOSE DUE alarm
occurs, press START to deliver one dose.
Select mode, syringe manufacturer, syringe size.
OVER field: Enter dose duration
in hours and minutes (hh:mm).
EVERY field: Enter dose Interval
in hours and minutes (hh:mm).
NEXT DOSE IN field: Enter
delay to start of first dose in hours and minutes (hh:mm).
To start the first dose without delay, program field to
SELECT LIBRARY or SELECT PROTOCOL programming step.
0:00.
NEXT DOSE IN
NONE (if available) at the
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 13
Simplified Instructions
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Page 14 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
General InformationChapter 1
Technical Specifications
Model: Auto Syringe AS50 Infusion Pump
Catalog Code: 1M8550
Size: approx. 3.4" x 2.6" x 10" (8.6 x 6.7 x 25 cm)
Weight: approx. 3.2 lb. (1.45 kg)
Flow Rate Accuracy: ± 3% of full scale plunger travel (not including syringe
Volume Accuracy: ± 3%, or ± 0.007" of travel, whichever is greater (not
tolerance)
including syringe tolerance)
Syringes: B-D 1, 3, 5, 10, 20, 30, 60 mL plastic
Sherwood Monoject 1, 3, 6, 12, 20, 35, 60 mL Terumo 1, 3, 5, 10, 20, 30, 60 mL
Flow Rate Range: 0.01 mL/hr to 438 mL/hr, depending on the syringe
Deliverable Volume: Full syringe volume for 1-60 mL syringes
Data Display: Self-prompting, multi-field LCD (Liquid Crystal Display)
Status Display: Nine-LED (Light Emitting Diode) array
Power Requirement: AC: 105-125V 60 Hz (battery charger)
DC: internal rechargeable battery pack
Battery Operating Time: 5 hours of operation at 100 mL/hr, or 12 hours of operation
at 2 mL/hr using a 60 mL syringe, following a charge of no less than 16 hours.
o
Temperature Range: 50
Keypad: Elastomeric type, with tactile feedback
F to 104o F (10o C to 40o C) Delivery of high viscosity
fluids at low temperatures is not recommended.
Construction: Water-resistant, high-impact plastic case with removable
elastomeric protective bumpers
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 15
General Information
OD
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OSE
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siz
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USE
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The Status Display
YRIN
The status display has eight information areas, called fields. Except for the text field at the bottom, each field displays three types of information:
INF
B
D
N
L LIMIT
k
nit
m
mgh
m mLmc
The markings on the left and right side of each field are
called annunciators. The left annunciators identify the type of data contained in the field, while the right annunciators identify the units of measure.
The central portion of each field displays variable
k
numeric data, either decimal numbers or time. This data generally represents either infusion program information or an active display such as a running total of the amount of drug infused.
The bottom field of the status display is a two-line text
display, used to prompt the programming sequence or to display a message about the infusion.
After the infusion mode has been selected, the pump automatically displays the necessary fields to be programmed. When the pump needs information, it provides a text prompt and flashes the current field.
Note: The pump’s backlight is on whenever the charger is connected and the pump is
switched on. The pump can also be configured to turn the backlight on for a spec­ified time (0 to 60 minutes) after each keypress when the charger is not con­nected. See the Auto Syringe AS50 Infusion Pump Technical Manual for details.
YRIN
code and syringe size in mL.
i
[B]
= B-D
[M]
= Monoject
[T]
= Terumo
Field #1 displays the syringe manufacturer
INF
Page 16 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
Field #2 displays the volume to be infused (mL), or the infusion rate (mL/hr or mL/min).
General Information
OD
g
C
s
g
OSE
g
g
TOT
s
g
O
TOT
O
Field #3 displays dose duration (HH:MM), or patient body weight (kg).
Field #4 displays dose interval (
HH:MM), drug
concentration (mg/mL, or U/mL), or bolus size (Units or mL).
Field #5 displays time remaining until the next dose is due (hh:mm), dose size (mcg/min, mcg/hr, mg/min, mg/hr, mcg/kg/min, mcg/kg/hr, mg/kg/min, mg/kg/hr, mU/min, mU/hr, U/min, or U/hr) or bolus size (mg, mcg/kg, mg/kg, or Units).
Field #6 displays total delivered (mL, mcg, mg, or grams), volume limit (mL), bolus size (mL), or final volume (mL).
B
N
D
V
k
nit
m
m mcgk
ram
mLmc
Field #7 displays total delivered (mL), or drug volume to be mixed with infusion base solution (mL).
Field #8 displays text prompts and messages.
V
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 17
General Information
S
5
GLR
OCK
3
M
The Keypad
Arrow Keys The up arrow key () increases a number,
The keypad includes a standard set of number keys and decimal point (referred to in this document as digit keys), arrow keys, and various function keys.
PUR
BOLU
L
NFIR
selects a different field, or displays the next item in a list. The down arrow key () decreases a number, selects a different field, or displays the previous item in a list.
Digit Keys The digit keys are used to enter numeric
values directly.
Function Keys These keys activate specific functions.
Action Keys These keys start and stop the pump motor.
START
STOP
Confirm Key This key is used to complete a
programming step, to respond to a prompt, or to display additional infusion program information.
Page 18 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
The Status Panel
RUN lights When the pump is in
General Information
the Run state, one or more of the green
RUN
lights are on.
When the pump is infusing, the three
RUN
lights flash in sequence, in a “falling drop” pattern.
When the pump is counting time until an infusion is to begin, only the top
RUN light flashes.
When a bolus or purge is in progress, all three flash simultaneously.
ALERT The red
ALERT light flashes during an alert or alarm. The
status display and remaining status lights may display additional information.
BATTERY When flashing, the red
battery charge is low. If the battery discharges significantly,
BATTERY light stays on constantly and the pump goes
the into a fail-safe alarm state.
ON CHARGE The green
ON CHARGE light indicates that the battery
charger is plugged in.
STANDBY The yellow
STANDBY light flashes to indicate that the pump
is in Standby state.
LOCK The yellow
SYSTEM The red
LOCK light indicates that the keypad is locked.
SYSTEM light indicates a malfunction. The pump
cannot operate until the problem is corrected. The infusion must then be reprogrammed.
RUN lights
BATTERY light indicates that the
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 19
General Information
Operating States
Standby State
When the pump is in Standby state, the infusion is stopped and the STANDBY light flashes. If the pump is left in Standby state for more than two minutes, a alert or alarm occurs.
Run State
There are two Run states: Run Delivering state and Run Counting state.
In Run Delivering state, the infusion program is running and the pump is delivering an infusion. The three
In Run Counting state, the infusion program is counting time until the next dose is due, and the pump is not delivering an infusion. The top
PUMP IS IDLE
RUN lights flash in a “falling drop” pattern.
RUN light flashes.
Note: Bolus and Purge operations are special infusion states. The
unison when bolusing or purging in both Standby and Run states.
Data Display and Entry
Numeric Data Numbers are displayed in a right-justified format. A leading
Time Data Fields In time fields, values are displayed right justified. Leading
Automatic Decimal If a number is entered without a decimal point, the pump
Flashing Data The data within a field flashes to show that the field has
Flashing Annunciators The annunciators for the current field flash. The current
RUN lights flash in
zero appears before decimal values when the field size permits. For example, the value “.12” is displayed as
0.12.
zero(es) are automatically entered if needed. For example, 1 minute is entered by pressing displayed as
0:01.
1, CONFIRM and is
automatically enters a decimal point to the right of the number when
CONFIRM is pressed.
been opened and is ready to be programmed or edited.
field will be opened for editing when
EDIT is pressed.
Data Test All entered data is tested when
CONFIRM is pressed. If the
entered value is too large or too small, the pump issues a
PUMP LIMIT alert and substitutes the nearest acceptable
value. Press
CONFIRM to accept the value, or enter a
different value.
Page 20 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
Arrow Keys Arrow keys can be used instead of individual digits for
Key Sounds An audible click provides confirmation of each keypress.
Dashes Dashes are displayed when a field is clear and open for
Protocol Library Feature
The Protocol Library feature is a configurable option that allows authorized personnel to store named sets or protocols of frequently used programming data. Protocols may also be grouped into libraries.
General Information
selecting predefined responses, incrementing or decrementing fields. In general, arrow keys cannot be used to initialize fields that have been cleared to dashes, except for syringe size and manufacturer fields.
The pump indicates an invalid keypress by sounding a short beep. Simultaneous keypresses are ignored.
programming. In general, digit keys must be used to enter a value in a dashed field. If an arrow key is pressed while dashes are displayed, the pump beeps and displays the message
USE DIGITS.
Using a protocol can simplify the programming process by providing default selections at some of the data entry steps. For instructions on selecting a protocol, see “Using Protocols” on page 32.
The Protocol Library feature is enabled or disabled through the pump configuration mode. This procedure can be done by authorized personnel on site, and is described in the Auto Syringe AS50 Infusion Pump Service Manual.
A protocol may specify any of the following:
Default Infusion Mode If a protocol specifies a default infusion mode, the infusion
mode programming step is skipped. The pump briefly displays the infusion mode name before proceeding directly to the syringe manufacturer programming step.
Default Concentration If a protocol specifies a default concentration, the default
value appears automatically at the start of the concentration programming step. This value may be changed, or it may be accepted by pressing
CONFIRM.
Default Dose or Rate If a protocol specifies a default dose or rate, the default
value appears automatically at the start of the
ENTER RATE programming step. This value may be
or changed, or it may be accepted by pressing
ENTER DOSE
CONFIRM.
Bolus Prevention If a protocol specifies bolus prevention, the pump will not
allow a bolus to be programmed or delivered. If pressed, the pump beeps and displays the message
ALLOWED
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 21
.
BOLUS is
NOT
General Information
Default Bolus Size If a protocol specifies a default bolus size, the default value
appears automatically when the Bolus Size field is first opened for editing. This value may be changed, or it may be accepted by pressing
Bolus Maximum Rate The bolus delivery rate is normally limited to the smaller of:
the limit specified by the RATE RANGE configuration option, or the maximum rate for the programmed syringe. If a protocol specifies a bolus maximum rate, the pump will further limit the bolus delivery rate so it does not exceed the specified bolus maximum rate, which is defined in terms of dosage (such as mcg/kg/min).
Bypassing the Protocol Library Feature
Note: The NONE selection may not be available, depending upon configuration.
CONFIRM.
Selecting Protocol Library feature and allows infusion mode selection and programming to proceed in the normal way.
NONE at the SELECT LIBRARY or SELECT PROTOCOL step bypasses the
Serial Communication Feature
The pump provides remote control and monitoring capabilities. A standard 9-pin connector (DB9) allows the connection of an RS-232 cable between the pump and a computer. The cable allows an operator at a remote computer to control pump operations and to query the pump for data such as infusion totals, program values, and operational status. The remote control feature is a configurable option. See the Auto Syringe AS50 Infusion Pump Programmer’s Manual for details.
Page 22 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
Infusion Modes
The pump provides 18 infusion modes, which fall into two major categories: continuous and timed infusions. Continuous infusions deliver at a steady, programmed rate. Timed infusions deliver one or more equal doses according to a programmed schedule. The infusion modes are briefly described below. For more information see “Detailed Instructions” on page 27.
Continuous Infusion Modes
mL/hr and mL/min: The rate of infusion is programmed in mL/hr or
Units/hr, Units/min, mUnits/hr and mUnits/min: The drug concentration is entered in
mg/hr, Mg/min, mcg/hr and mcg/Min: The drug concentration is entered in mg/mL, and
General Information
mL/min, depending on the mode selected. A volume limit can be programmed for these modes only.
units/mL, and the dose is entered in Units/hr, Units/min, mUnits/hr or mUnits/min, depending on the mode selected. The pump automatically displays the effective rate in mL/hr.
the dose is entered in mg/hr, mg/min, mcg/hr or mcg/min, depending on the mode selected. The pump automatically displays the effective rate in mL/hr.
mg/kg/hr, mg/kg/min, mcg/kg/hr and mcg/kg/min: The patient's body weight is
entered in kg, the drug concentration is entered in mg/mL, and the dose is entered in mg/kg/hr, mg/kg/min, mcg/kg/hr or mcg/kg/min, depending on the mode selected. The pump automatically displays the effective rate in mL/hr.
CUSTOM DILUTION: In this mode the pump is programmed for a continuous
infusion and the drug concentration is adjusted for a target infusion rate and dose. The target rate is entered in mL/hr, the patient’s body weight is entered in kg, the initial drug concentration is entered in mg/mL, the target dose is entered in mcg/kg/min, and the final volume is entered in mL. The pump calculates and displays the volume of drug (in mL) to be added to the infusion base solution to produce a final concentration that achieves the target rate and target dose. The final concentration is displayed when the infusion is initiated.
07-19-B3-430 Auto Syringe AS50 Infusion Pump Operator’s Manual Page 23
General Information
Timed Infusion Modes
SINGLE DOSE: In this mode, the pump is programmed to infuse a single
MANUAL SCHEDULE: In this mode, the pump is programmed to infuse a dose
AUTO SCHEDULE: In this mode, the pump is programmed to infuse a dose
dose over a specified period of time. The dose is entered in mL, and the time period is entered in hours and minutes.
over a specified period of time, and to repeat the dose at specified intervals. The dose is entered in mL, and the time period and interval are entered in hours and minutes.
The pump alerts the operator when a dose is due to start. The operator must then press
START to initiate each dose.
over a specified period of time, and to repeat the infusion at specified intervals. The dose is entered in mL, and the time period and interval are entered in hours and minutes.
Whereas to press
MANUAL SCHEDULE mode requires the operator
START to initiate each dose, AUTO SCHEDULE
mode automatically starts each dose when it is due.
Page 24 Auto Syringe AS50 Infusion Pump Operator’s Manual 07-19-B3-430
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