CURLIN MEDICAL 2000 Plus, 2000 CMS User Guide
CURLIN MEDICAL
(
)
User’s Manual
for use with the
2000 Plus and 2000 CMS
Ambulatory Infusion Systems
CURLIN MEDICAL, LLC
15751 Graham Street
Huntington Beach, CA 92649
Phone 714 893-2200 • Fax 714 894-2602
www.curlinmedical.com
For 24-hour Clinical or Technical Support call toll free:
1-888-287-5999
888-CURL-999
Covered by U.S. Patents 5,575,631 5,683,233 5,791,881 5,924,852 6,164,921 6,371,732 B1
Des. 408,911 Des. 437,547 S. Other U.S. and Foreign Patents Pending
Copyright © 2000/2002 CURLIN MEDICAL, LLC All Rights Reserved
0050
Revision E
Use with Software Rev. 40 for Curlin Medical 2000 Series Pumps
Reorder Number 340-9009
TABLE OF CONTENTS
INTRODUCTION .................... 1
Delivery Modes ................................ 1
Indications for Use ..........................2
Special Features of the 2000
Series Pump ...................................2
Regulatory Agency Approvals .........3
Warnings, Cautions, Notices...........4
Pump Illustrations and Features .....8
Disposable Administration Set
Illustrations and Features.............. 10
Preparing Medication for
Infusion/Changing IV Bags...........11
Opening and Closing the Pump
Door ............................................... 13
Choosing and installing the
Curlin Medical Administration
Set................................................... 14
Gravity Priming Set and Filter....... 14
Steps in Installing Administration
Set into Curlin Medical Pumps...... 15
Up Stream Occlusion Alarm
Feature ........................................... 16
Installing the Batteries and Using
External Power............................... 17
External Power Sources................. 19
Battery Pack................................... 19
AC Adapters ................................... 20
Attaching and Removing the
Bolus Cord ..................................... 21
LEARNING PUMP
FEATURES.............................. 23
Keypad Function............................ 24
LED Light Indicators ....................25
Audio Indicator.............................. 25
Display Screen ............................... 25
BASICS OF
PROGRAMMING ................... 27
Types of Display Screens .............. 27
Sample of an Action Field Screen...27
Sample of a Selection List Field ......27
Sample of a Data Entry Screen .......28
Sample of a Run Screen....................28
Sample of User Notification
Screen..................................................28
Using “Help” ................................ 29
Starting the Pump.......................... 29
Welcome Screen ................................29
Power Status Screen..........................30
Preventive Maintenance Screen.......30
Select Program or Bio-Med Setup
Screen..................................................30
Access Code....................................31
Clinician Access Code Screen..........31
BioMed Setup .................................31
Bio Med Setup Menu ........................31
Enable Therapy Menu ......................33
Patient History Log....................... 33
History Event Log.............................34
Clearing the History Log............... 35
Clearing Patient Information ........ 35
Changing Date and Time.............. 36
Change Date and Time Screen........36
Program ......................................... 37
Program/BioMed Setup Menu........37
Resume/Repeat Rx/New
Program Menu ...................................38
Resuming a therapy....................... 38
Repeating a Pre-Programmed
Therapy.......................................... 38
How to go to “New Program” ...... 39
Selecting a Therapy ....................... 39
Select Therapy Screen.......................39
I
TABLE OF CONTENTS
Entering or Changing Data
Fields.............................................. 40
CONTINUOUS THERAPY ... 41
Prescription Menus........................ 41
Continuous Pre-Prescription
Menu Screen...................................... 41
Continuous Delay Start Setting ...... 42
Run Options Screen......................... 42
Continuous Titration Limit
Screen ................................................. 43
Continuous Prescription Menu ...... 44
Run Options Screen......................... 45
Prime.............................................. 45
Prime Direction Screen.................... 45
Options .......................................... 46
Continuous Options Menu ............. 47
Continuous Titration Menu ............ 47
Air-In-Line Sensor Off Message
Screen ................................................. 48
Air-In-Line Sensor Set at 2.0ml
Alert Screen ....................................... 49
Reviewing or Changing the
Program ......................................... 49
Starting the Infusion ...................... 49
Continuous Run Screen................... 50
Continuous Information Screens ... 50
PCA Pre-Prescription Menu
Screen..................................................55
Administration Routes......................56
PCA Titrate Limits Screen ...............56
PCA Prescription Menu ...................58
Run Options Screen..........................59
Prime ............................................. 59
Prime Direction Screen ....................59
Options .......................................... 60
PCA Options Menu ..........................61
Clinician Dose Menu ........................61
Clinician Dose Run Screen ..............62
PCA Titrate Screen............................62
Air-In-Line Sensor Off Message
Screen..................................................63
Air-In-Line Sensor at 2.0ml Alert
Screen..................................................64
Reviewing or Changing the
Program ......................................... 64
Starting the Infusion...................... 65
PCA Run Screen................................65
PCA Information Screens................66
Interrupting an Infusion................ 66
Pause Menu Screen ...........................66
Resuming the Current Container.. 66
Run Options Screen..........................66
Interrupting an Infusion ................ 51
Pause Menu Screen........................... 51
Resuming the Current Container .. 51
Run Options Screen......................... 51
Hanging a New Container ............ 51
Entering a New Program............... 52
Infusion Complete ......................... 53
Continuous Infusion Complete...... 53
Stopping the Infusion .................... 53
Pause Menu Screen........................... 53
PCA THERAPY....................... 55
Prescription Menus........................ 55
Hanging a New Container ............ 67
Entering a New Program .............. 67
Infusion Complete......................... 68
PCA Infusion Complete...................68
Stopping the Infusion.................... 68
Pause Menu Screen ...........................69
TPN THERAPY WITH
AUTOMATIC RAMPING....... 71
Prescription Menus ........................71
TPN Pre-Prescription Menu
Screen..................................................71
TPN Delay Start Setting...................71
Run Options Screen..........................72
TPN Prescription Screen..................73
II
TABLE OF CONTENTS
Run Options Screen......................... 74
Prime.............................................. 74
Prime Direction Screen.................... 75
Options .......................................... 76
TPN Options Menu......................... 76
Air-In-Line Sensor Off Message
Screen ................................................. 77
Air-In-Line Sensor Set at 2.0ml
Alert Screen ....................................... 78
Reviewing or Changing the
Program ......................................... 78
Starting the Infusion ...................... 79
TPN Run Screen............................... 79
TPN Information Screens............... 80
Interrupting an Infusion ................80
Pause Menu Screen........................... 80
Resuming the Current Container ..80
Run Options Screen......................... 80
Hanging a New Container ............ 81
Entering a New Program............... 81
Infusion Complete ......................... 82
TPN Infusion Complete.................. 82
Stopping the Infusion .................... 83
Pause Menu Screen........................... 83
INTERMITTENT
THERAPY ............................... 85
Prescription Menus........................ 85
Intermittent Pre-Prescription
Menu Screen...................................... 85
Intermittent Delay Start Setting ..... 86
Run Options Screen......................... 86
Intermittent Prescription Menu...... 87
Run Options Screen......................... 89
Air-In-Line Sensor Set at 2.0ml
Alert Screen ........................................92
Reviewing or Changing the
Program ......................................... 93
Starting the Infusion...................... 93
Intermittent Run Screen...................93
Intermittent Information Screens ...94
Interrupting an Infusion................ 94
Pause Menu Screen ...........................95
Resuming the Current Container.. 95
Run Options Screen..........................95
Hanging a New Container ............ 95
Intermittent Dosing Schedule..........96
Entering a New Program .............. 96
Timing Rules when Interrupting
Intermittent Therapies .................. 97
Infusion Complete......................... 98
Intermittent Infusion Complete......98
Stopping the Infusion.................... 98
Pause Menu Screen ...........................98
VARIABLE THERAPY.......... 101
Prescription Menus ...................... 101
Variable Pre-Prescription Menu
Screen................................................101
Variable Delay Start Setting ...........102
Run Options Screen........................102
Variable Prescription Menu1 .........103
Variable Prescription Menu 2........104
Variable Prescription Menu 3........104
Variable Summary Screen...............105
Run Options Screen........................105
Prime ............................................106
Prime Direction Screen ..................106
Prime.............................................. 89
Prime Direction Screen.................... 89
Options .......................................... 90
Intermittent Options Menu............. 91
Air-In-Line Sensor Off Message
Screen ................................................. 92
Options .........................................107
Variable Options Menu ..................107
Air-In-Line Sensor Off Message
Screen................................................108
Air-In-Line Sensor Set at 2.0ml
Alert Screen ......................................109
III
TABLE OF CONTENTS
Reviewing or Changing the
Program ........................................109
Starting the Infusion .....................109
Variable Run Screen 1.................... 110
Variable Run Screen 2.................... 110
Variable Information Screens ....... 111
Interrupting an Infusion ............... 111
Pause Menu Screen......................... 111
Resuming the Current Container .111
Run Options Screen....................... 112
Hanging a New Container ...........112
Entering a New Program..............112
Infusion Complete ........................113
Variable Infusion Complete ......... 113
Stopping the Infusion ...................114
Pause Menu Screen......................... 114
TROUBLESHOOTING ........ 115
Alerts, Alarms, and Error Codes... 115
Operating Environment ............... 146
Maintenance .................................146
Limited Warranty .........................147
Procedure for Checking Pumps
Between Patients ..........................149
TECHNICAL
SPECIFICATIONS.................153
CLINICIAN
INFORMATION AND
ACCESS CODE ......................157
Clinician Access Code.....................157
Lock Setting Table ....................... 158
ACCESSORIES.......................137
AC Adapters/Chargers .................137
Battery Pack (340-2006) ................138
Soft Carry Packs............................139
Detachable Pole Clamps...............141
Remote Bolus Cord (340-2005) .....141
Lockable Safety Shells ..................142
Pump Holster (340-0111)...............142
Data Interface Cable (340-2011)....144
Palm Adapter Cable (350-2006) ....144
CLEANING,
ENVIRONMENTAL
CONDITIONS, AND
MAINTENANCE...................145
Cleaning ........................................145
Transport and Storage ..................146
IV
TABLE OF FIGURES
FIGURE 1.1 CURLIN MEDICAL AMBULATORY
PUMP—FRONT, TOP AND LEFT VIEW .... 8
FIGURE 1.2 CURLIN MEDICAL AMBULATORY
PUMP—BACK, BOTTOM, AND RIGHT
VIEW.................................................................. 9
FIGURE 1.3 SAMPLES OF CURLIN MEDICAL
ADMINISTRATION SETS.............................10
FIGURE 10.2 BATTERY PACK ............................. 138
FIGURE 10.3 SMALL FANNY PACK.................... 139
FIGURE 10.4 LARGE FANNY PACK ................... 139
FIGURE 10.5 SOFT SHOULDER PACK .............. 140
FIGURE 10.6 SOFT BACK PACK ......................... 140
FIGURE 1.4 SPIKING THE FLUID CONTAINER,
GRAVITY PRIMING THE SET AND USING
THE SLIDE CLAMP TO CLOSE THE
TUBING. ..........................................................11
FIGURE 1.5 CURLIN MEDICAL
ADMINISTRATION SET “INTEGRAL
FLOW-STOP” WITH BREAKAWAY TAB ....12
FIGURE 1.6 INTENTIONALLY OPENING THE
“INTEGRAL FLOW-STOP”...........................12
FIGURE 1.7 OPENING THE PUMP DOOR.........13
FIGURE 1.8 CLOSING THE PUMP DOOR ..........13
FIGURE 1.9 PROPER INSTALLATION OF THE
CURLIN MEDICAL ADMINISTRATION
SET INTO THE PUMP ..................................15
FIGURE 1.10 TOP CUTAWAY VIEW OF THE
CURLIN MEDICAL PUMP WITH CURLIN
MEDICAL ADMINISTRATION SET IN
PROPER INSTALLATION POSITION........ 16
FIGURE 1.11 INSTALLING BATTERIES INTO
THE CURLIN MEDICAL AMBULATORY
PUMP................................................................18
FIGURE 10.7 DETACHABLE POLE CLAMP ......141
FIGURE 10.8 REMOTE BOLUS CORD................141
FIGURE 10.9 SAFETY SHELLS............................ 142
FIGURE 10.10 PUMP “HOLSTER” ...................... 142
FIGURE 10.11 POLE CLAMP AND SAFETY
SHELL INSTALLATION............................. 143
FIGURE 10.12 DATA INTERFACE CABLE ........ 144
FIGURE 1.12 BATTERY PACK................................19
FIGURE 1.13 AC ADAPTERS...................................20
FIGURE 1.14 ATTACHING AND REMOVING
THE REMOTE BOLUS CORD......................21
FIGURE 2.1 KEY PAD ..............................................23
FIGURE 2.2 SAMPLE OF DISPLAY SCREEN ......26
FIGURE 5.1 PCA ADMINISTRATION ROUTE
DEFAULT SETTINGS....................................56
FIGURE 10.1 AC ADAPTERS/CHARGERS .........137
V
Chapter
Introduction
The
Curlin Medical
simple-to-learn technology to allow fast and easy access to the features of these pumps. With a little introduction and
training, an operator will quickly be able to program and use these pumps to deliver the therapies prescribed.
Note: Throughout this Manual the text will refer to the Curlin Medical pump. All the features
described here apply equally to the 2000 Plus and the 2000 CMS pumps, unless
specifically otherwise stated.
Infusion Pumps have been designed with the user in mind and have the latest in friendly,
Introduction
et’s begin by introducing you to the Curlin Medical pump, an easy-to-use,
ambulatory or pole mounted infusion device designed to meet the needs of the
hospital or alternate site patient. It operates accurately in any position, has a low rate
resolution of 2 microliters, and its small, compact, lightweight design allows mobility
L
The Curlin Medical pump can be carried in any of the four convenient carryall soft-packs, pole
mounted, placed into the locked “safety shells,” or set on a suitable surface for use.
Delivery Modes
The pump features five therapy delivery modes:
1 Continuous Infusion—Designed to allow a constant, programmed rate of infusion.
2 PCA or Patient Controlled Analgesia—Designed for therapies that require a continuous
rate of infusion, patient-controlled demand boluses, or both.
3 TPN with Automatic Ramping—Designed to allow a level rate of infusion of parenteral
nutritional products with the option of tapering at the beginning, end, or both beginning and
end of the infusion. This mode also has an early ramp-down feature.
4 Intermittent Delivery—Designed to deliver programmed intervals and rates of specified
amounts of infusates and to optionally deliver small amounts of the infusate between doses to
keep the patient’s access site patent.
for ambulatory patients.
5 Variable Program—Designed to allow varying amounts, rates, and times of delivery of
infusions up to twenty-four specified programs.
1 1
Indications for Use
The Curlin Medical pump can be used for intravenous, epidural, or subcutaneous therapies. It
can be used to deliver medications from the specially designed Curlin Medical medication
reservoir, syringes1 or from IV bags. A physician or a certified, licensed, healthcare practitioner
must oversee any therapy. Patients and caregivers using the Curlin Medical pump should be
instructed in its use by a qualified clinician and demonstrate an adequate level of proficiency in the
use of the pump.
Special Features of the 2000 Series Pump
• Automatic “quick-repeat” function
• Large font display
• Small, accurate, ambulatory, volumetric infusion pump that provides reliable and safe delivery
of infusion therapies.
• Cost effective, safe and easy-to-load disposable Curlin Medical administration sets featuring
a unique, spring-activated, self-clamping, set-based “Integral Flow-Stop” device that
automatically clamps the tubing when the door of the pump is opened and prevents
inadvertent fluid flow.
• User-friendly, easy-to-teach programming that shortens staff inservice time and patient
teaching time.
• “Helpful” help screens and display messages.
• Three tamper-resistant lock settings to assist in maintaining patient compliance and safety.
• Patient and therapy specific programming features via the Curlin Medical BIOMED
SETUP and Options Menus.
• Selection by user from three units of delivery, milliliters (ml), milligrams (mg), and micrograms
(mcg).
• Titration features in both PCA and Continuous therapies.
• Retention of programmed infusion settings until cleared by the clinician, thus eliminating the
need to reprogram before each use.
• Mandatory requirement of two independent key press actions before a running pump can be
turned off, thus minimizing the accidental interruption of a therapy in progress.
• Powered by two readily available, cost-effective “C” size alkaline batteries.
• Attractive yet robust design that is impact resistant and water resistant.
• Audio alarms that can be adjusted from 1 (very quiet) to 9 (loudest) to meet specific patient
and clinical setting needs but that cannot be totally disabled.
• Four sizes of convenient carry packs to assist the ambulatory patient in maintaining
independence of lifestyle. Backpack will accommodate pump, AC Adapter, and up to fourliter IV bag.
• Retained memory features that allow the pump to easily resume a therapy exactly from where
1
Some syringes are not qualified for use. Please call Curlin Medical for details
2 2
it left off when it is interrupted before completion or to repeat a therapy using the same
programmed prescription.
• Compact, lockable safety shells that provide additional security when needed and that are
designed to be free standing, pole mounted, or placed in the convenient, soft, carry case.
• Backlit illumination for display screen. Backlight remains on continuously if AC Adapter is in
use.
• Pump will not permit the user to enter any programming value that is outside of its
predetermined range.
• Integral Up as well as Down Occlusion alarms to notify user if an occlusion is present on
either side of the pumping chamber.
• Integral High Upstream pressure alarm to notify user of excessive upstream pressure.
• Integral Air-In-Line alarm to notify user of presence of air in the tubing.
• Adjustable Down Occlusion settings of “High” and “Low” to customize the pump’s down
pressure requirements.
• Patient side (downstream) “Line Pressure” displayed on CMS-enabled pumps.
Introduction
Regulatory Agency Approvals
INFUSION PUMP
WITH RESPECT TO ELECTRIC SHOCK, FIRE
AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL2601-1/CAN/CSA C22.2 NO. 601.1
70TK
• Underwriters Laboratories has evaluated the Curlin Medical Pump with International AC
Adapter (340-2022) to UL 2601-1 and CSA C22.2 No. 601-1 for General Standards of Safety
for Medical Equipment and found the Curlin Medical Pump to be compliant.
• Underwriters Laboratories has evaluated the Curlin Medical Pump with accessory
equipment, which is the Battery Pack (340-2006) and the AC Adapter (340-2004), to UL 544
and CSA C22.2 No. 125 Standards for Safety for Medical Equipment and they were found to
be compliant.
• TÜV PRODUCT SERVICE has evaluated the Curlin Medical Pump and the AC Adapter
(340-2004) for Electromagnetic Compatibility, to regulations EN 60601-1-1-2/1993 and EN
60601-2-24/1994 and both were found to be compliant.
IMPORTANT
INFORMATION
The indicator shown at the left appears throughout this manual to
emphasize important information in the operation of the Curlin
Medical Pump. Please read these sections carefully.
3 3
Warnings, Cautions, Notices
EXPLANATION FOR SYMBOLS on the Curlin Medical Pump with the Classified UL
2601-1 and CSA C22.2 No. 601-1 Label.
The meanings for the symbols on the pump are as follows:
Attention, consult ACCOMPANYING DOCUMENTS.
♥ Type CF Equipment
IPX1 Protected against dripping water.
INFUSION PUMP
WITH RESPECT TO ELECTRIC SHOCK, FIRE
AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL2601-1/CAN/CSA C22.2 NO. 601.1
70TK
INTERNALLY POWERED OR FOR USE WITH AC ADAPTER 340-2022
TYPE CF APPLIED PARTS
EQUIPMENT PROTECTED AGAINST DRIPPING WATER, IPX1
EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE
ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE
MODE OF OPERATION CONTINUOUS
EXPLANATION FOR SYMBOLS on the Curlin Medical Pump and Battery Pack label
for listing to UL 544 and CSA C22.2 No. 125.
The meaning for the symbols on the pump and battery pack label are as follows:
Attention, consult ACCOMPANYING DOCUMENTS
CAUTION: Refer servicing to qualified personnel
Risk Class 2 (Type BF Equipment)
DANGER – Risk of EXPLOSION if used in the presence of FLAMMABLE
ANESTHETIC
Use with Battery Pack Model No. 340-2006 or AC Adapter Model No. 340-2004 6.9 v DC
500mA
4 4
WARNINGS
• Use only Curlin Medical administration sets in your Curlin Medical pump. Use of
nonproprietary administration sets may alter accuracy in delivery of fluids and could result
in over or under infusions, leading to possible patient injury or death.
• Do not use this pump with a pressure cuff applied to the IV bag or medication reservoir
bag, and do not unduly squeeze or compress the bag during a running infusion.
• Remove all air from the administration set and IV bag or reservoir before connecting it to
a patient’s access site.
• Do NOT prime the administration set while it is connected to the patient’s access device.
Doing so could result in overdosing the patient and could cause injury or death.
• Do not attempt to open the pump’s housing. All service problems should be referred to
an appropriate service technician.
• Danger: Risk of explosion if used in the presence of flammable anesthetic or explosive
gasses.
Introduction
CAUTIONS
• U.S. federal law restricts this device to sale by or on the order of a physician or other
licensed practitioner.
• Visually inspect the pump, pumping chamber and administration set before use. Do not
use any pump or administration set that appears to be damaged or tampered with or if
there is any indication of improper function.
• Keep the pumping surfaces clean, dry, and free of fluid spillage at all times.
• This pump is fluid resistant and can withstand fluid spillage. It is not, however, designed
for total submersion as moisture buildup within the case could cause damage to the
operating components. Do not use the pump in the shower, sauna, or steam bath, and
do not position the pump where it could accidentally be dropped into a container of fluid
(e.g., basin, tub, or toilet). Avoid fluid contact with the power port and data port of the
pump.
• Do not try to insert foreign objects into any of the pump connectors, as such objects may
damage the pump.
• Use only Curlin Medical external power sources to power the Curlin Medical pump.
Using other power sources may result in circuitry or microprocessor damage.
• When using the AC Adapter, connect the plug only into a grounded AC outlet.
• Use only non-rigid, non-vented IV fluid containers unless an air vent adapter is in place
and the container is suspended from an IV pole.
• Do not unduly stretch the tubing of the administration set or leave the tubing in the
pump for more than twenty-four hours when the pump is not running.
• Use Curlin Medical administration sets with appropriate air-in-line filters any time the
Air-In-Line Sensor of the pump is disabled.
5 5
• If any signs or symptoms of infiltration or inflammation are noted at the infusion site,
stop the infusion and report it to the appropriate healthcare provider.
• Always use the slide clamp on the administration set as an additional precaution to
occlude the tubing before opening the door of the pump.
• Do not subject the pump to dropping or hitting against a hard surface. If at any time the
pump is dropped or hit, inspect it for signs of damage. If any damage is discovered,
report the damage to the healthcare provider for replacement of the pump.
NOTICES
• The Curlin Medical pump is not intended for the administration of blood or cellular
blood products.
• Dispose of all used administration sets in accordance with all applicable regulatory and
institutional policies.
• Teach users to check all tubing sites for proper aseptic connections and to check the
administration sets for air leaks before and during the infusion.
• To minimize the potential hazard of air bubble formation or “out-gassing,” administer all
medications at the proper temperatures, and remove medications from refrigerators as
specified by the healthcare provider or pharmaceutical manufacturer.
• Follow local governing ordinances and recycling plans regarding disposal or recycling of
device components. When the “C” size batteries are to be discarded, do not incinerate
them. Dispose of all used administration sets in accordance with all applicable regulatory
and institutional policies and directions.
• Adhere to any warnings, precautions, or recommendations stated by drug manufacturers
regarding the use of infusion pumps and disposable administration sets in the
administration of their specific products.
• Administer all drugs selected for epidural administration in accordance with the
indications included in the manufacturer’s package insert accompanying the drugs.
• Note that the administration of medications into the epidural space is limited to delivery
via specially designed indwelling catheters inserted by a qualified physician. Any patients
receiving epidural infusions should be managed and monitored by medical professionals
familiar with epidural administrations and their clinical management. Curlin Medical
offers administration sets specifically designed for epidural infusions with 0.22 micron
filters, no injection ports, and yellow striping to clearly identify the set for epidural use.
Any administration set being used for epidural infusions should be clearly labeled as such.
• Clean the pump, remote bolus cord, AC adapter, and battery pack with a soft, clean cloth
dampened in any of the following:
1 Warm soapy water (do not submerse)
2 Isopropyl alcohol
3 Household bleach, diluted 9:1 with water
4 Commercial disinfectant
When clean, dry pump and other items with a soft, clean, dry cloth.
6 6
• The soft carry packs are intended for single patient use. They may be cleaned in the
gentle cycle of a washing machine using cold water, no chlorine bleach, and line dried.
(They cannot be dried in a clothes dryer.)
• The Bolus/Data connector is to be used by the patient only for the connection of the
bolus cord with remote switch. Other accessory equipment connected to this digital
interface must be certified to the respective IEC/EN standards (i.e. IEC 950 for data
processing equipment and EN 60601-1 for medical equipment.) Furthermore, all
configurations shall comply with the system standard EN 60601-1. Anyone who
connects additional equipment to the signal input part or signal output part configures a
medical system, and is therefore, responsible that the system complies with the
requirements of the system standard EN 60601-1. If in doubt, consult the technical
services department or your local Curlin Medical representative.
• The Curlin Medical has been tested and found to comply with the European Standard
EN 60601-1-2:1993 and EN 60601-2-24:1994. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation.
• This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference to
other devices in the vicinity. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to
other devices, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one of more of the following measures:
Introduction
1 Reorient or relocate the receiving device.
2 Increase the separation between the equipment.
3 Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.
4 Consult the manufacturer or field service technician for help.
Note: For information regarding the clinician access code, read the chapter entitled, “Clinician
Information and Access Code.” When entered correctly, the access code allows a user to
change the lock settings of the pump and thereby change the settings of the pump.
Because the chapter entitled, “Clinician Information and Access
IMPORTANT
INFORMATION
Code” contains access code information, the entire chapter should be
removed before initial patient teaching and should not be left in the
manual while in the patient setting. Doing so could jeopardize the
security levels intended only for clinician use and access.
7 7
Pump Illustrations and Features
Data Interface/
Bolus Cord Port
Figure 1.1 Curlin Medical Ambulatory Pump—Front, top and left view
8 8
Introduction
Figure 1.2 Curlin Medical Ambulatory Pump—Back, bottom, and right view
9 9
Disposable Administration Set Illustrations and Features
Integral
These drawings are
NOT to scale.
Note: An important feature of the Curlin Medical administration set is the unique
design of the set-based “Integral Flow-Stop.” When the set is new, the “Integral
Flow-Stop” has a breakaway tab that keeps the “Integral Flow-Stop” open and allows
the tubing to be gravity primed. When you are ready to load the administration set
into the pump, remove this tab, and the “Integral Flow-Stop” will automatically clamp
the tubing. The Curlin Medical “Integral Flow-Stop” prevents inadvertent flow of
medication to the patient whenever the door of the pump is opened because the
“Integral Flow-Stop” automatically reacts to clamp the tubing. The “Integral FlowStop” can, however, be opened after the tab is broken away by intentionally squeezing
down on the movable spring action section of the “Integral Flow-Stop.” See Figure 1.6
for an illustration of how to intentionally open the “Integral Flow-Stop.” For a
complete listing of all available administration sets, see the Curlin Medical Product
Catalog.
CAUTION: USE ONLY CURLIN MEDICAL ADMINISTRATION SETS
WITH THIS PUMP
CURLIN
MEDICAL
Integral
Figure 1.3 Samples of Curlin Medical Administration Sets
10 10
W
p
A
Preparing Medication for Infusion/Changing IV Bags
hen using an IV bag, grasp the bag
spike firmly in one hand and the IV bag
spikespike completely into the port using
aseptic technique.
ort in the other, and insert the
Introduction
Holding the bag with
fill ports down allows
fluid to fill tubing and
displace the air in the
line. Be sure all air has
been removed from the
IV bag as well.
ir in the line moves down through
the tubing as the fluid fills.
Notice the breakaway tab on the
“Integral Flow-Stop” has been
removed. The set can be gravity
primed by intentionally squeezing
OPEN
In these illustrations,
the slide clamps are
shown in their open and
closed states.
CLOSED
the “Integral Flow-Stop” and thus
releasing the clamping action. ( See
Figures 1.5 & 1.6 )
Figure 1.4 Spiking the fluid container, gravity priming the set and using the slide clamp to
close the tubing.
11 11
T
wist and remove
breakaway tab from
“
Integral Flow-Stop”
Figure 1.5 Curlin Medical Administration set “Integral Flow-Stop” with breakaway tab
Squeeze “Integral Flow-Stop”
between thumb and forefinger
as shown to allow fluid to flow
through tubing after the
breakaway tab has been
removed.
Figure 1.6 Intentionally Opening the “Integral Flow-Stop”
12 12
Opening and Closing the Pump Door
The pump door, located on the top of the Curlin Medical pump, has a sturdy “over center”
latching mechanism, which assists in securely closing the door. Review the following illustrations:
Door Latch
(Lift to open)
2
1
Latch Hook
Latch Pins
To open the pump door:
1 Pull the door latch up, releasing
the latch hooks from the latch
pins.
2 Grasp the door latch and pull
upwards and to the right to open
the entire door mechanism.
Full range access is now available
for installing the Curlin Medical
Administration set. (See figures
1.9 and 1.10).
Introduction
Push down
Figure 1.7 Opening the pump door
To close the pump door properly,
move the entire door assembly to the
left and push downward until it is in
its closed position. Then push the
door latch down until it locks. The
“over-center” latching mechanism
assures that the door closes easily and
securely.
Figure 1.8 Closing the pump door
13 13
Choosing and installing the Curlin Medical Administration Set
A number of distinctively designed Curlin Medical administration sets are available to deliver
each prescription accurately. (See Curlin Medical “
Product Catalog
”.) Each set is designed to
meet the requirements of specific therapies, therefore, if a basic bag-spike set or a set with a
medication reservoir is needed, with or without air eliminating filters, etc., there are several
configurations from which to choose. Follow the healthcare provider’s protocols for preparing
the medication and the administration set before loading the set into the pump, remembering the
following basic rules:
1 Examine the packaging and the administration set before use to assure the package integrity.
Do not use the set if the protective caps are dislodged or if the package integrity is breached,
as fluid path sterility cannot be guaranteed under those circumstances.
2 Notice that there is an instructional insert included in the administration set package. This
insert includes written and graphic instructions for proper installation of the administration
set into the pump. It also lists the “fill volume” of the administration set. Allow for the
amount of the fill volume when determining the final IV bag volume.
Important Notification
A lack of compliance with proper positioning of the tubing could result in infusion inaccuracies.
Please center the tubing in the pumping area when installing the administration set.
Gravity Priming Set and Filter
1 To gravity prime the administration set, twist and remove the breakaway tab from the
“Integral Flow-Stop”, then spike the IV bag. Squeeze the “Integral Flow-Stop” between
your thumb and forefinger to allow fluid to flow through the tubing until all air is removed
from the IV bag and administration set. (See figures 1.5 and 1.6.) Release the “Integral FlowStop” to automatically clamp the tubing. To correctly prime a filtered set, hold the filter
in a vertical position with the flow downwards allowing the filter to completely fill
with fluid.
2 Close the slide clamp on the administration set before the door of the pump is opened. This
step along with the automatic clamping properties of the “Integral Flow-Stop” prevents
inadvertent fluid flow.
3 Use an administration set with an air-eliminating filter whenever the Air-In-Line Sensor is
disabled or set to “OFF.”
4 Follow CDC guidelines or Intravenous Nursing Standards of Practice Guidelines regarding
the frequency of changing the administration sets.
5 Use aseptic technique and universal precautions as directed by the policies of your healthcare
facility or institution.
6 Use only Curlin Medical administration sets with the Curlin Medical pump.
7 Dispose of administration sets in accordance with all applicable regulatory and institutional
policies and directions.
14 14
y
y
p
A
(
)
ir Detector
Note: Open the
slide clamp before
closing the pump
door
(Yellow)
Blue
Figure 1.9 shows the
Curlin Medical pump
with a cut-away of the
display screen allowing
ou to visualize the
receptacles for the
blue
small
Guide” on the right
side of the pump and
the larger
“Integral Flow-Stop”
on the left side of the
ump. The arrows, in
corresponding colors,
are visible on the
background surface of
the pump head and
indicate the proper
direction for placing
these locators into their
receptacles. Also, note
that the breakaway tab
has been removed from
the “Integral FlowStop”, allowing the
administration set to be
placed into the pump
correctly.
“Tubing
ellow
Introduction
Figure 1.9 Proper installation of the Curlin Medical Administration set into the pump
Steps in Installing Administration Set into Curlin Medical Pumps
1 Fully open the door of the pump.
2 Close the slide-clamp on the administration set.
3 Activate the Integral Flow-Stop by twisting and removing the breakaway tab.
4 Insert the blue tubing guide into the receptacle on right side of pump in the direction of the
blue arrow, positioning the tubing in front of the door hinge.
5 Center the tubing in the middle of the pumping fingers, covering the yellow dot.
6 Holding the yellow Integral Flow-Stop by the handle (see Figure 1.9), insert it on an angle into
the receptacle on the left side of the pump in the direction of the yellow arrow. CAUTION:
Do not press down on the top of the Integral Flow-Stop when inserting it into the
receptacle. This action could inadvertently open the Integral Flow-Stop and allow
fluid to flow through the tubing.
7 Open the slide-clamp on the administration set
8 Push the tubing slightly into the black Air Detector slot.
9 Fully close the door of the pump and latch it securely.
10 If the set is not primed, prime the set according to prime section in the relevant therapy
chapter.
11 Attach the primed set to the patient’s venous access device per agency protocols.
12 Dispose of used administration sets in accordance with all applicable regulatory and
institutional policies and directions.
15 15
i
p
T
“Flow-Stop”
handle
Air Detector
Slot
1 Insert blue “Tubing Guide” on right
side of pump with tubing in front of
the door. The Blue arrow on the
background surface of the pump head
ndicates direction and location for the
blue Tubing Guide.
2 Important: Center the tubing
horizontally over the pumping fingers
covering the yellow dot.
3 Insert yellow “Integral Flow-Stop”
on the left side of the pump. The
yellow arrow on the background
surface of the pump head indicates the
direction and location for the “Integral
Flow-Stop.”
CAUTION: Hold the “Flow-Stop
by the small handle. DO NOT
ress down on the top of the
“Integral Flow-Stop” when
inserting it into the receptacle.
his action could inadvertently
open the “Integral Flow-Stop” and
allow fluid to flow through the
tubing.
4 Press the tubing into the air detector
slot gently with index finger.
Figure 1.10 Top cutaway view of the Curlin Medical pump with Curlin Medical
Administration set in proper installation position
Up Stream Occlusion Alarm Feature
The Curlin Medical pump has an Up Stream Occlusion alarm feature, e.g., it detects low upstream pressure. This feature notifies you if an occlusion is present between the IV container and
the pump. If this alarm occurs, the display will read, “ALARM –UP OCCLUSION,” the alarm
will sound, the red LED light will blink, and the infusion will stop. This situation requires that you
press the “Pause” key, examine the administration set from the IV container to the pump for
potential causes of the occlusion. If a clamp is in place, open, or remove it; if the administration
set is kinked, straighten it. If indicated, close the slide clamp on the administration set and open
the door of the pump to verify that the set is correctly placed. Close the pump’s door and reopen
the slide clamp. When ready to begin infusing, select “RESUME” and then press the “RUN”
key.
The pump also detects excessive up stream pressure (pressure on the IV bag). The display will
read “ALARM – HIGH UP PRESSURE,” the alarm will sound, the red LED light will blink, and
the infusion will stop. If this situation occurs, relieve the source of excessive pressure on the IV
bag and when ready to begin infusing, select “RESUME” and then press the “RUN” key.
Note: The up stream occlusion detection is disabled during priming.
16 16
Installing the Batteries and Using External Power
The Curlin Medical pump can be powered solely with the use of two “C” size alkaline batteries
installed into the pump as shown in Figure 1.11. “C” size batteries are readily available at most
retail facilities that carry alkaline batteries. A second alternative for power is the portable,
rechargeable Battery Pack, shown in Figure 1.12. The third alternative for power is to use the AC
Adapter shown in Figure 1.13, allowing the pump to be connected to any approved, three-prong
electrical wall outlet.
The “C” size batteries will last approximately 30 hours at a rate of 125 ml/hour and over 85 hours
at rates of 2 ml/hr or less. Factors that influence battery life are the number of times the screen is
illuminated with a key press, the viscosity of the fluid being delivered, the age and temperature at
which the batteries have been stored. To extend the life of the batteries, patients can use the AC
adapter whenever they are stationary, e.g., at night.
The pump has a “low battery” alert that beeps periodically with a message appearing to tell you
when the power is low in the “C” size batteries and/or the battery pack. This alert gives you a
window of time to be sure you have back-up power (e.g. extra batteries, AC adapter, or a
recharged battery pack.) If you are infusing at high rates, you will have approximately one hour of
warning; if you are infusing at low rates (below 10 ml/hr), you will have a significantly longer time
interval before the batteries are completely empty.
Introduction
The user should be taught that whenever the “low battery” alert appears, to pause the therapy,
turn the pump off, and to replace both “C” size batteries. Then, turn the pump back on, select
resume to continue the therapy.
When the “empty battery” alarm occurs the pump will go into an alarm state and the infusion will
stop. If this occurs, turn the pump off, replace both of the “C” size batteries, turn the pump on,
and go to the “Resume” function to continue the therapy. All programming information is
retained. If the “C” size batteries are empty and you want to connect the AC adapter to power
the pump, turn the pump off first, plug in the AC adapter and then turn the pump back on.
Note: If you are operating the pump solely on the battery pack or the AC Adapter (no “C” size
batteries installed) and the power source is disconnected from the pump, the alarm will
sound, the infusion will stop, and the display screen will be blank. Turn the pump off
reconnect the power source, turn the pump on, and resume the therapy. All programmed
information is retained.
When replacing batteries, pause any infusion in progress by pressing the “PAUSE” key,
and then turn the pump off. Replace the batteries, and, when the pump is turned back on,
select “RESUME” to continue the therapy from the point at which it was interrupted.
,
17 17
The battery compartment door is located
on the back of the Curlin Medical pump.
To open the door, depress the recessed
release pin (it may be helpful to use a
small coin to depress the pin), slide the
battery door down, and remove it.
Replace the old batteries with two new
“C” size alkaline batteries. Install them
by depressing the coil spring with the
bottom of the battery and sliding the top
in place. Note: both positive poles are at
the top as shown in Figure 1.11. Always
replace both batteries. Slide the battery
compartment door back to its closed
position until the recessed pin locks into
place.
PLEASE NOTE:
Follow local governing ordinances and
recycling plans regarding disposal or
recycling of device components. When
the “C” size batteries are discarded do
not incinerate them.
Two “C size”
alkaline
batteries
Coil Springs
Battery
Compartment
Door
Recessed Release
Pin
Figure 1.11 Installing batteries into the Curlin Medical Ambulatory pump
IMPORTANT
INFORMATION
Whenever an external source is powering the pump, it is still
important to always install the two “C” size batteries. In the event of a
power failure or accidental power cord disconnection, the batteries
will power the pump without interrupting the therapy in progress. If
the batteries are in place when the power cord is disconnected, the
display will say “External Power Disconnected,” the alert beep will
sound, the batteries will take over powering the pump, and the
therapy will continue infusing.
18 18
External Power Sources
Battery Pack
The battery pack is an external, rechargeable, lead acid battery pack than can be used as an
additional, long-life, portable, external source of power. It is rechargeable by plugging the AC
Adapter into the recharging port. The battery pack is connected to the pump via the two-hole
port located on the bottom of the pump (as shown below). The two-pin connector plugs into the
receptacle correctly by aligning the red dots on each.
Note: Pause the pump and then turn it off before connecting the Battery Pack. Note also that
the connector is keyed with a “notch” at this red-dot location to guide alignment. To remove, pull
back on the locking sleeve to unlock and then pull gently to remove the connector from the
pump’s port.
Recharging port of
battery pack
Illustration of the bottom of
the Curlin Medical ambulatory
pump
Align the red dots
and the notches.
Then plug the twopin connector into
the two-hole
receptacle located
on the bottom of
the Curlin Medical
Ambulatory pump.
Introduction
To charge the Battery Pack:
Plug the AC Adapter into a grounded wall outlet and
then plug the AC Adapter into the recharging port of
the Battery Pack (see above). On initial use, the
Battery Pack should be charged for a full 24 hours, to
recharge takes approximately 12 hours (overnight).
Figure 1.12 Battery Pack
19 19
T
AC Adapters
There are two AC Adapters:
• The US Domestic AC Adapter has a three-prong plug to be plugged into a standard
three-prong, grounded wall receptacle and a six-foot cable which plugs into the power
outlet on the bottom of the pump.
• The Universal AC Adapter available for international use.
This accessory becomes the external power source when plugged directly into the Curlin
Medical pump (see Figure 1.2 for external power port location on the bottom of the pump).
The AC Adapter can also be used to recharge the portable battery pack by plugging the
connecting cable into the recharging port on the battery pack (see Figure 1.12). The two-pin
connector on the end of the cable plugs into the receptacles correctly by aligning the red dots on
each.
Note: Pause the pump and then turn it off before connecting the AC Adapter. Note, also that
the connector is keyed with a “notch” at this red-dot location to guide alignment. To
remove, pull back on the locking sleeve to unlock and then pull gently to remove the
connector from the battery pack or pump’s port.
US Domestic AC Adapter
Locking Sleeve
Universal AC Adapter
Locking Sleeve
wo-Pin Adapter plugs into port on bottom of the
pump for AC power or can be used to recharge the
battery pack by plugging into the recharging port
on the battery pack (see Figure 1.12). Note the
connector notched keying and red dot alignment.
To remove, pull back on the locking sleeve.
Figure 1.13 AC Adapters
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T
Attaching and Removing the Bolus Cord
When the PCA therapy is used, patient bolus dosing can be programmed. To facilitate ease of
patient self-dosing, the patient can use the Bolus key or the Remote Bolus Access Cord. The cord
is five feet long and has a patient access button at the top of the remote cord. The four-pin
adapter plugs into the four-hole port on the left side of the pump (see Figure 1.14 below). This
port may be covered with a plastic plug. If so, remove the plug to access the port. To correctly
connect the bolus cord, align the red dot and the connector’s keyed notch with the red dot and
notch in the port on the left side of the pump. When the cord is plugged into the pump it is
locked in place by the locking sleeve. To remove the cord, pull back on the soft, green locking
sleeve and disengage the cord from the pump by pulling it straight out of the access port.
Because bolus dosing is applicable only in PCA therapy, if the cord is left in place and the button
is pushed while any other therapy is infusing, an alert message will appear on the display screen
stating: “Not in PCA No Bolus Allowed.”
Bolus/Data
Port on Left
side of Pump
Introduction
Remote bolus
access port
Locking Sleeve
Four-pronged adapter
plugs into access port on
left side of pump as
shown.
o remove bolus cord, pull back on locking
sleeve and pull cord straight out of access
port.
Figure 1.14 Attaching and removing the remote Bolus Cord
21 21
22 22
3
5
986
4
2
Learning Pump Features
Chapter
Learning to operate the
Curlin Medical
pump requires a few basic points of understanding that remain constant
in every therapy. It may be helpful to read through these steps first, and then go back and use them to operate the
Curlin Medical
irst, examine the key pad and the functions of the individual keys. Knowing how the
keys, especially the dual function keys, work will allow you to give commands to the
F
pump.
pump.
Display
Screen
LED
Indicators
1
7
7
Learning Pump
10
Figure 2.1 Key Pad
23 23
Keypad Function
1 ON/OFF: Used to turn the pump on and off. When the pump is running, however, the
“PAUSE” key must be used to stop the infusion first and then the “OFF” key can be pressed
to turn the pump off. This requirement prevents the interruption of an infusion by a single
accidental press of the “OFF” key.
2 RUN/PAUSE: Used to start or pause the motor of the pump, which, in turn, starts or
pauses fluid delivery. When the pump is running, pressing this key will pause the pump.
When the pump is paused, pressing this key during the “Run Options” menu will start the
pump. This key is also used to terminate a pump alarm.
Note: If the cause of the alarm is not resolved when the pump is “Resumed,” the alarm will
recur.
3 ⇑ Up arrow: Used to scroll the highlight bar or field cursor up on the display screen.
Note: The Up arrow will not accept a selection which must be made with a YES/ENTER
or NO/CHANGE key.
4 ⇓ Down arrow: Used to scroll the highlight bar or field cursor down on the display screen.
Note: The Down arrow will not accept a selection which must be made with a
YES/ENTER or NO/CHANGE key.
5 NO/CHANGE: Used to respond “NO” to data or questions presented or to reject or to
change highlighted data.
Note: The Curlin Medical pump requires you to actively change a selection. The Up arrow
or Down arrow will not change a selection.
6 YES/ENTER: Used to respond “YES/ENTER” to data or questions presented or to
“accept” highlighted data when prompted to press “enter” key.
Note: The Curlin Medical pump requires you to affirmatively accept a selection. The Up
arrow or Down arrow will not accept a selection.
7 HELP/OPTIONS: Used to request a help screen when the pump is paused or is at the
“Infusion Complete Screen.” It is also used to access the options screen when the pump is
running. When the options screen is displayed, help is again available with this key. When in
a help screen, use the arrow keys to scroll through the help message, and then press the help
key again to exit help.
8 ./SILENCE: Used as a decimal point when programming numeric data. Used also to
temporarily silence the alarm (for one-minute intervals).
9 PRIME/BOLUS: Used to prime fluid through the tubing to clear it of air or to administer
a patient demand bolus dose of medication in PCA therapy.
10 0 - 9 Numeric keys: - Used for data entry.
24 24
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