System Operating Manual
220 Pages
Preview
Page 1
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TM
TM
list numbers
430-10983-005 (A, 2011-02)
430-10983-005.book Page ii Friday, February 25, 2011 4:13 PM
430-10983-005.book Page i Friday, February 25, 2011 4:13 PM
Hospira GemStar™ Infusion System System Operating Manual For use with the Hospira GemStar™ Infusion System list numbers List 13086-36 List 13087-36 List 13088-36
PLEASE Read this entire manual before using the Hospira GemStar™ Infusion System This manual is designed for use by health care professionals, caregivers, and patients. The Hospira Technical Support Operations hotline is available 24 hours a day (in the USA) to provide consultation and technical assistance regarding the Hospira GemStarTM Infusion System .
Outside the USA:
Contact your local Hospira sales office
To order additional copies of this manual (List
13086/13087/13088) call your local Hospira representative
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Change History
ii
Part Number
Description of Change
Pages Changed
430-10983-001 (Rev. 03/06)
Original Issue
N/A
430-10983-002 (Rev. 07/06)
Second Release
All
430-10983-003 (Rev. 02/07)
Third Release
All
430-10983-004 (Rev. 03/09)
Fourth Release
All
430-10983-005 (Rev. 2011-02)
Fifth Release
All
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Contents 1. Introduction
1
GemStar™ Pump Layout... 2 GemStar™ Pump Components... 4 Therapies... 5 GemStar™ Pump Features... 6 Menu System... 7 Operating Modes... 9 Indications for Use... 10 Contraindications for Use... 11 Warnings and Cautions... 11
2. Basic Operation
19
Overview... 19 Selecting a Power Source... 20 Powering On the Pump... 27 Accessing the Programming Menu... 29 Programming the Pump... 30 Starting a New Container... 32 GemStarTM Pump Set... 32 Loading the Cassette... 35 Releasing the Cassette... 36 Priming a GemStarTM Pump Set... 37
3. Weight Dosed
53
Therapy Features and Specifications... 53 Weight Dosed Programming... 54 Auto KVO... 55 Rate Titration... 55 VTBI Titration... 56 Changing a Weight Dosed Program... 56 GemStar™ Weight Dosed Programming Worksheet... 57 Programming a Precedex® (dexmedetomidine hydrochloride injection) Delivery. 58 GemStar™ Precedex® (dexmedetomidine hydrochloride injection) Programming Worksheet... 59
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Contents 4. Pain Management
61
Therapy Features and Specifications... 61 Pain Management Programming... 63 Bolus Delivery... 64 Loading Dose Delivery... 66 Changing a Pain Management Program... 67
5. mL/hr Only
71
Therapy Features and Specifications... 71 mL/hr Only Programming... 72 Auto KVO... 73 Rate Titration... 73 VTBI Titration... 74 Piggybacking... 74 Changing a mL/hr Only Program... 77 mL/hr Only Programming Worksheet... 78
6. Intermittent
79
Therapy Features and Specifications... 79 Intermittent Programming... 80 Intermittent Delivery Interruptions... 82 Changing an Intermittent Program... 84 Intermittent Programming Worksheet... 85
7. Total Parenteral Nutrition (TPN)
87
Therapy Features and Specifications... 87 TPN Programming... 88 Changing a TPN Program... 89 TPN Auto Taper Down... 90 TPN Programming Worksheet... 91
8. Continuous Delivery
93
Therapy Features and Specifications... 93 Continuous Programming... 94 Rate Titration... 95 Piggybacking... 95 Changing a Continuous Program... 98
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Contents Continuous Programming Worksheet... 99
9. Variable Time
101
Therapy Features and Specifications... 101 Variable Time Programming... 102 Variable Time Delivery Interruptions... 103 Changing a Variable Time Program... 104 GemStar™ Variable Time Programming Worksheet... 105
10. Options Menu
107
Overview... 107 Tips for Using the Options Menu... 107 Review Program... 109 Histories... 109 Keypad Lock... 114 Change Pump Settings... 116 Set Clock... 118 Print... 119 Speed Protocol... 120 Next Dose... 121 Connecting to the Data Port... 122 Transferring Data Using a Computer... 127
11. Clinician Instructions
129
Clinician Locking Sequence Instructions... 130 Program and Deliver a Clinician Activated Loading Dose... 132 Shift Totals and History... 133
12. Troubleshooting
135
Alarm Messages... 136 Alert Messages... 145 Other Display Messages... 149
13. Maintenance
151
Pump Storage... 151 Cleaning and Disinfecting... 151 Repair... 153
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Contents 14. Operation Test
155
Equipment Required... 155 Test Setup... 156 Performing the Operation Test... 156 Printing Test Results... 161 GemStar™... 163 Operation Test Checklist... 163
15. Optional System Components
165
Connecting the Bolus Cord... 168 Using the Hospira Carrying Cases... 168 Using the GemStar™ Docking Station... 175
16. Pump Sets
179
17. GemStar™ Pump Specifications
183
Occlusion Information... 186
18. Warranty/Technical Assistance
199
A. Electrical Potentials
201
Guidance on EMC Compatibility... 201 Information Regarding Electrostatic Discharge (ESD)... 202
Index
203
IEC Symbols
vii
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IEC Symbols mbols
The ‘C’ and ‘US’ indicators adjacent to the CSA Mark signify that the product has been evaluated to the applicable CSA and ANSI/UL Standards, for use in Canada and the U.S., respectively. This ‘US’ indicator includes products eligible to bear the ‘NRTL’ indicator. NRTL, i.e. National Recognized Testing Laboratory, is a designation granted by the U.S. Occupational Safety and Health Administration (OSHA) to laboratories which have been recognized to perform certification to U.S. Standards.
Per IEC 60601-1 F-Type Applied Part complying with the highest degree of protection against electric shock. Type CF Applied Parts are parts suitable for direct Type CF those cardiac application. Temperature Limitation
Indicates compliance of this device to the Medical Device Directive 93/42/EEC
This product is required to comply with the EU Waste Electrical & Electronic Equipment (WEEE) Directive 2002/96/EC.
Authorized Representative: Hospira Finisklin Business Park Sligo, Republic of Ireland
Follow operating instructions NOTE on ME EQUIPMENT “Follow instructions for use” IEC 60878, Safety 01 b
Protection against vertically falling water drops.
Mandatory action ISO 7010-M001
The GemStarTM Pump has been assessed and complies with the following standard: IEC/EN 60601-1-2 (2001).
Caution
Manufactured by Hospira, Inc. Lake Forest, IL 60045, USA
Sterile Fluid Path (sterilized using irradiation)
Keep Dry
Do not reuse
Fragile, Handle with Care
This Side Up
Humidity Limitation
Atmospheric Pressure Limitation
DANGER: Possible explosion hazard exists if used in the presence of flammable anesthetics.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed practitioner. GemStar, LifeShield, HEMA, and CAIR are registered trademarks of Hospira, Inc. Luer Lock is trademark of Hospira, Inc. Seiko, Vesphene II se, Manu-Klenz, Formula C, Teflon, Velcro, CLAVE, and Microsoft, Windows, and Windows NT are not trademarks of Hospira. This document and the subject matter disclosed herein are proprietary information. Hospira retains all the exclusive rights of dissemination, reproduction, manufacture and sale. Any party using this documentation accepts it in confidence, and agrees not to duplicate it, in whole or in part, nor disclose it to others without the written consent of Hospira. ©Hospira, Inc. Printed in USA
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Notes
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Chapter 1
Introduction The GemStar™ Pump is a small and lightweight, single-channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar™ Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, the GemStar™ Pump is ideal for ambulatory patients. The following conventions are used throughout this manual: Convention
Use
Example
[ALL CAPS]
Pump keys
Press [YES/ENTER] to continue.
ALL CAPS
Display messages
The pump displays:
ENTER TO CONFIRM.
WARNING: A WARNING message contains special safety information and must be observed at all times. Failure to observe a warning message could be life threatening. CAUTION: A CAUTION contains information that could prevent irreversible product damage or hardware failure. Failure to observe a caution could result in serious patient or user injury.
d f d
Note: A NOTE contains information or examples to help explain instructions. Tip: A TIP contains information that makes the pump easier to use.
Note: Examples are provided only to help explain a pump function and may not be clinically relevant. Graphics are for illustrative purposes only and may not reflect the actual product.
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Chapter 1. Introduction
GemStar™ Pump Layout
Shown approximate size
2
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Chapter 1. Introduction 1
DISPLAY •
2
• •
Silences an alarm. This silences an alert for five minutes and an alarm for two minutes.
3
•
Stops infusion.
4
•
Starts infusion.
5
• •
Lights continuously when the pump is powered by AC mains. Flashes when the pump is powered by external batteries (e.g., battery pack). Not lit when using disposable AA batteries.
6
•
Powers the pump on or off. To power-off the pump, press and hold until the display clears.
7
• •
Returns to previous steps during programming. Exits Help, Change, and Options menus.
8
•
Displays the following menu items from the STOP or RUN mode*: New Container Change Program (or Titrate VTBI) New Program Piggybacking Resets a numeric value to zero.
•
Displays the pump’s status.
9
•
Displays the following Options Menu items from the STOP or RUN mode*: 1 Review Program 4 Pump Settings 7 Speed Protocol 2 Histories 5 Set Clock 8 Next Dose 3 Keypad Lock 6 Print
10
• • • • •
(UP & DOWN) Toggles between AM and PM in time-based entries. DOWN arrow scrolls through program review and help messages. DOWN arrow toggles between units of measure when entering concentrations. UP arrow enters a decimal point in numeric entries. Up arrow scrolls back by one screen in program review.
11
• •
Responds “YES” to display questions. Accepts entries and goes to the next step.
12
•
Responds “NO” to display questions.
13
• •
Displays information during programming steps and alarm conditions. Displays Shift Totals, except during programming steps and alarm conditions.
14
• •
Clears an AIR-IN-LINE alarm. Primes a GemStar™ Pump Set.
15 [0] - [9] •
Selects menu items and enters numeric values. If two numbers appear before a menu item (e.g., 02), press both number keys to select that item.
* Not all menu items are available with all modes.
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Chapter 1. Introduction
GemStar™ Pump Components 1
Bolus Button
Press this button to start a bolus delivery if available in the current program.
2
Pole Clamp Track
Use to connect to an optional pole clamp.
3
Cassette Release Button
Push down on this button to release the cassette.
4
Power Connector
Use to connect the AC mains adaptor.
5
Data Port Connector
Use to connect the GemStar™ serial cable.
6
Bolus Connector
Use to connect a bolus cord.
7
Tubing Channel
Place the pump set tubing in this channel.
8
Cassette Pocket
Load the cassette into this pocket.
9
I.V. Tubing Guide
Use to hold the I.V. tubing.
10 Battery Pack Connector
11 Battery Compartment
Top View
Use to connect the GemStar™ Rechargeable Battery Pack. Install two fresh, disposable AA batteries in this compartment.
Bottom/Side View
4
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Chapter 1. Introduction
Therapies
Critical care, pediatrics
Pain Management
Infusion of analgesics or anesthetics for patientcontrolled pain management (PCA), epidural infusion and parenteral administration of general I.V. fluids
AUT
mL/hr Only
Simple rate programming
Intermittent
Interval-based therapies such as antibiotics
TPN
Total Parenteral Nutrition fluid delivery
Continuous
Infusion of mg, mcg, or mL/hr with a selectable KVO (Keep Vein Open) option
Variable Time •
d
Chronotherapy
•
•
•
•
•
TA /DOPER U WN P TIT VTB RATE I OPT KVO IONA L
Weight Dosed
LO DOSADING E
Possible Applications O K VO TIT RAT RA TE E
Therapy
PI BACGGYKIN G BOL US
Seven types of therapy are available for infusion of medications and fluids. The following table lists possible applications and available features of each therapy.
•
•
•
• • •
•
•
• •
•
•
= Available
Note: Pain Management is the ONLY Therapy available for List 13088.
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Chapter 1. Introduction
GemStar™ Pump Features
6
Feature
Description
Reference Page
•
Adjustable Settings
Adjusts the distal occlusion pressure limits, air sensor sensitivity, real-time clock, and audible alarm volume.
Chapter 10 Options Menu
•
Alerts and Alarms
Signals audible and visual alarms when attention is required.
Chapter 1 Introduction, GemStar™ Pump Layout
•
Audible Keypad Response
Sounds a single beep when any key is pressed. If an invalid key is pressed, the pump sounds a flutter tone.
Chapter 1 Introduction, GemStar™ Pump Layout
•
Keypad Lock
Restricts access to various options. Four lock levels are available.
Chapter 10 Options Menu and Chapter 11 Clinician Instructions
•
New Container
Repeats the current program without reprogramming the pump.
Chapter 2 Basic Operation
•
Piggybacking Allows delivery from a secondary container during a Continuous or mL/hr Only program.
Chapter 8 Continuous Delivery and Chapter 5 mL/hr Only
•
Power-on Self-test
Performs a self-test each time the pump is powered on.
Chapter 2 Basic Operation
•
Operation Test
Performs user-assisted tests to verify the pump is operating properly.
Chapter 14 Operation Test
•
Program History
Maintains a history event log, with a date and time stamp of each event for each program. Review the history on the display, or download it to a printer or computer.
Chapter 10 Options Menu
•
Speed Protocols
Stores up to nine frequently used programs in the pump’s memory for quick access.
Chapter 10 Options Menu
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Chapter 1. Introduction
Menu System The GemStar™ Pump uses a menu system that provides step-by-step instructions through all of the pump’s functions. Refer to the following table for a list of functions in each menu. Use the keypad to select menu items, respond to display messages, and enter numeric values. For example, press [2] to select PAIN MANAGEMENT from the Programming Menu.
d
Note: Menu items may vary depending on the pump’s configuration.
f
Tip: A menu item does not have to be on the display to be selected. For example, when the Programming Menu first displays, only the first four therapies are shown. Instead of pressing the down arrow to see the other menu items, press [7] to go directly to Variable Time Programming.
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Chapter 1. Introduction
To display this menu:
Do this:
Menu Items Available
Programming Menu
1
1 2 3 4 5 6 7
WEIGHT DOSED PAIN MANAGEMENT mL/HR ONLY INTERMITTENT TPN CONTINUOUS VARIABLE TIME
1 2 3
CONTINUOUS* BOLUS* CONTINUOUS + BOLUS*
2
Press to display the Change menu. Select NEW PROGRAM.
Or *Delivery Mode Menu (For List 13088 Only)
Note: If a program is not currently stored in pump memory at power-on, the Programming Menu automatically displays after the self-test. Change Menu
Press
.
1 2 3 4
NEW CONTAINER NEW PROGRAM CHANGE PROGRAM PIGGYBACKING
Note: If the current therapy is Weight Dosed or mL/hr Only and the pump is in RUN mode:
3 TITRATE VTBI will replace
3 CHANGE PROGRAM on the menu display.
Note: Piggybacking is available only in mL/hr Only and Continuous therapies. Note: Menu items change depending on when Change Menu is viewed. Options Menu
8
Press
.
1 2 3 4 5 6 7 8
REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS SET CLOCK PRINT SPEED PROTOCOL NEXT DOSE
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Chapter 1. Introduction
For more information on:
Refer to the following pages:
Programming Menu
Chapter 2 Basic Operation, page 19.
Change Menu
For menu item [1], refer to Starting a New Container in Chapter 2 Basic Operation, on page 32. For menu items [2], [3], and [4], refer to the appropriate therapy chapter.
Options Menu
Chapter 10 Options Menu, page 107.
Operating Modes The GemStar™ Pump has four operating modes: Mode
Description
Help Mode
is pressed during The pump enters the HELP mode when programming or an alarm condition. The HELP mode displays additional information about the current condition.
Programming Mode
The pump enters the PROGRAMMING mode after the pump is powered on or when is pressed.
Run Mode
After is pressed, the pump enters the RUN mode, even when not infusing.
Stop Mode
When programming is complete, the pump enters the STOP mode until is pressed. When the programmed therapy is complete, and during certain alarm conditions, the pump automatically enters the STOP mode. Press to enter the STOP mode at any time, except during a CHECK CASSETTE alarm.
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Chapter 1. Introduction
Indications for Use Physicians or certified, licensed healthcare professionals should always oversee infusions. Healthcare professionals should always supervise pump users and instruct users in pump operation and troubleshooting. Instruction should include how to prevent intravenous (I.V.) related complications, including how to prevent accidental infusion of air. The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. Intended parenteral administrations include but are not limited to: intravenous (within a vein), arterial, subcutaneous (tissue just below the skin), regional (located to specific areas of the body) and epidural analgesia, intrathecal analgesia, intraspinal analgesia, combined spinal-epidural analgesia, short term epidural infusion, intraspinal (within the spinal canal), intrathecal (within the subarachnoid or subdural space), intraoperative sites (soft tissue, body cavity or surgical wounds), intraarticular (within a joint), intraperitoneal (within the peritoneal cavity), and intracerebroventricular infusions. The indications for use include hospital, homecare and ambulatory environments. The system has also been qualified for use in rotary wing aircrafts (e.g., helicopters). The pump must be used with sterile, dedicated, GemStar™ administration sets. Note: Epidural administration of anesthetics is recommended in the continuous mode only. Epidural administration of analgesics may be delivered by continuous, bolus, or continuous with bolus.
d
For epidural use, the administration of drugs is restricted to those anesthetic and analgesic drugs approved for continuous epidural administration: e.g., Chloroprocaine Hydrochloride USP, Lidocaine Hydrochloride USP, and Morphine Sulfate Injection USP (Preservative Free). WARNING: Delayed respiratory depression following continuous epidural administration of preservative-free morphine sulfate has been reported. For epidural administration, the following is recommended:
10
Hospira GemStar™ System Operating Manual