PainSmart™ IOD User Manual REV C

Important Safety Note 4 When using a Curlin Infusion Pump in a life sustaining situation, use AC Adapter, and provide an extra set of “C” cell batteries in addition to the batteries that are installed in the pump. 4 Check pump between patient use per procedure (see maintenance chapter). 4 Prior to Programming Load Dose, refer to Important Information in the appropriate Therapy chapters.

CURLIN MEDICAL

User Manual for use with the

PainSmartTM IOD Ambulatory Infusion System

Manufactured by ZEVEX, Inc. 4314 ZEVEX Park Lane Salt Lake City, UT 84123 USA Phone 801.264.1001 Fax 801.264.1051 www.moog.com/medical

Medical Device & QA Services 76 Stockport Road, Timperley Cheshire WA15 7SN United Kingdom

0123

For 24-hour Clinical or Technical Support call toll free: 1-800-970-2337

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 © 2000/2004 Moog, Inc. All Rights Reserved

Revision C

Reorder Number 360-9043

TABLE OF CONTENTS INTRODUCTION ...1 Delivery Mode and Routes ... 1 Indications for Use ... 1 Special Features of the PainSmart™ IOD Pump ... 2 Regulatory Agency Approvals ... 3 Warnings, Cautions, Notices ... 4 List of Abbreviations ... 8

FEATURES OF THE PUMP AND ADMINISTRATION SETS ... 11 Pump Illustrations and Features ... 11 Disposable Administration Set Illustrations and Features ... 13

LEARNING PUMP FEATURES ... 33 Keypad Function ... 34 Description of the Info-OnDemand (IOD) Feature of the Moog Curlin Infusion PainSmart™ IOD Pump ... 35 Info-On-Demand (IOD) Key Functions ... 36 Description of the Custom Features ... 39 Improved Pump Display ... 40 LED Light Indicators ... 41 Audio Indicator ... 41 Display Screen ... 41

Preparing Medication for Infusion/Changing IV Bags... 14

BASICS OF PROGRAMMING ... 43

Opening and Closing the Pump Door ... 16

Types of Display Screens ... 43 Sample of an Action Field Screen ... 43 Sample of a Selection List Field ... 43 Sample of a Data Entry Screen ... 44 Sample of a Run Screen ... 44 Sample of User Notification Screen ... 44

Choosing and Installing the Curlin Medical Administration Set ... 17 Gravity Priming Set and Filter ... 17 Steps in Installing Administration Set into Curlin Infusion Pumps ... 18 Up Stream Occlusion Alarm Feature ... 19 Installing the Batteries and Using External Power... 20 Curlin Pump Battery Replacement ... 22 External Power Sources ... 25 Battery Pack ... 25 AC Adapter/Charger ... 31 Bolus Cord Use ... 32

I

Using “Help” ... 45 Starting the Pump... 45 Welcome Screen ... 45 Power Status Screen ... 46 Preventive Maintenance Screen... 46 Select Program or Bio-Med Setup Screen ... 46 Access Code ... 47 Clinician Access Code Screen ... 47 BioMed Setup ... 47 Bio Med Setup Menu ... 47 Enable Therapy Menu ... 49 Patient History Log ... 49 History Event Log ... 50

TABLE OF CONTENTS Clearing the History Log ... 51 Clearing Patient Information ... 51 Changing Date and Time ... 52 Change Date and Time Screen ...52 Program ... 53 Program/BioMed Setup Menu ...53 Resume/Repeat Rx/New Program Menu ...53 Resuming a Therapy ... 54

Reviewing or Changing the Program ... 71 Starting the Infusion ... 71 PCA Run Screen ... 71 PCA Information Screens ... 72 Interrupting an Infusion... 72 Pause Menu Screen ... 73 Resuming the Current Container .. 73 Run Options Screen ... 73

Repeating a Pre-Programmed Therapy ... 54

Hanging a New Container ... 73

How to Go to “New Program” ... 55

Infusion Complete ... 75 PCA Infusion Complete ... 75

Entering or Changing Data Fields ... 55 Programming PainSmart pump with Protocol Library Safety System ... 55

PCA IV THERAPY ... 60 Prescription Menus ... 60 PCA-IV Pre-Prescription Menu Screen ...60 Administration Routes ...61 PCA medLIMITS™ Setup Screen..62 PCA Prescription Menu...63 Run Options Screen ...64 Prime ... 64 Prime Direction Screen...65 Options ... 60 PCA Options Menu ...60 Clinician Dose Menu ...61 Clinician Dose Run Screen ...61 Shift Totals Screens ...61 Hourly Totals Screen...62 Clear Hourly Totals Screen ...69 PCA Titrate medLIMITS™ Screen ...69 Air-In-Line Sensor Off Message Screen ...64 Pump Will Sense 2ml Alert Screen ...70 II

Entering a New Program ... 74

Stopping the Infusion ... 75 Pause Menu Screen ... 75

PCA EPIDURAL THERAPY.. 72 Prescription Menus ... 72 EPI Pre-Prescription Menu Screen ... 72 Administration Routes ... 73 EPI medLIMITS Setup Screen ... 79 EPI Prescription Menu ... 80 Run Options Screen ... 81 Prime ... 81 Prime Direction Screen ... 82 Options ... 83 EPI Options Menu ... 83 Clinician Dose Menu ... 84 Clinician Dose Run Screen... 84 Shift Totals Screens ... 84 Hourly Totals Screen ... 80 Clear Hourly Totals Screen ... 80 EPI Titrate MedLIMITS™ Screen ... 81 Air-In-Line Sensor Off Message Screen ... 82 Pump Will Sense 2ml Alert Screen ... 82 Reviewing or Changing the Program ... 88

TABLE OF CONTENTS Starting the Infusion ... 88 EPI Run Screen ...88 EPI Information Screens...89 Interrupting an Infusion ... 85 Pause Menu Screen...90 Resuming the Current Container .. 90 Run Options Screen ...85 Hanging a New Container ... 90 Entering a New Program... 91 Infusion Complete ... 92 PCA Infusion Complete ...92 Stopping the Infusion ... 92 Pause Menu Screen...92

TROUBLESHOOTING ... 90 Alerts, Alarms, and Error Codes ... 90

ACCESSORIES ... 114 Detachable Pole Clamps... 114 Remote Bolus Cord (350-2026) ... 115 Lockable Safety Shells ... 116 Pump Holster (340-0111) ... 117 Keypad Covers ... 118

CLEANING, ENVIRONMENTAL CONDITIONS, AND MAINTENANCE... 119 Cleaning ... 119 Transport and Storage ...120 Operating Environment...120 Maintenance ...120 Limited Warranty ...120 Procedure for Checking Pumps Between Patients ...122

TECHNICAL SPECIFICATIONS... 126 III

CLINICIAN INFORMATION AND ACCESS CODE ... 134

Clinician Access Code...134

Lock Setting Table ... 135

PAINSMARTTM IOD CATALOG NUMBERS ... 136

TABLE OF FIGURES Figure 2.1 Curlin Infusion Ambulatory Pump – Front, Top and Left View ... 11

Figure 5.1 PCA Administration Route Default Settings ... 57

Figure 2.2 Curlin Infusion Ambulatory Pump – Back, Bottom, and Right View12

Figure 6.1 PCA Administration Route Default Settings ... 74

Figure 2.3 Sample of Curlin Infusion Administration Sets ...13

Figure 8.1 Detachable Pole Clamp ... 109 Figure 8.2 Remote Bolus Cord ... 110

Figure 2.4 Spiking the Fluid Container, Gravity Priming the Set and Using the Slide Clamp to Close the Tubing...14

Figure 8.3 Safety Shells ... 111 Figure 8.4 Pole Clamp and Safety Shell Installation... 112

Figure 2.5 Curlin Infusion Administration Set “Integral Flow-Stop” with Breakaway Tab ...15

Figure 8.5 Pump “Holster”... 112 Figure 8.6 Keypad Covers ... 113

Figure 2.6 Intentionally Opening the “Integral Flow-Stop” ...15 Figure 2.7 Opening the Pump Door ...16 Figure 2.8 Closing the Pump Door ...16 Figure 2.9 Proper Installation of the Curlin Infusion Administration Set into the Pump ...18 Figure 2.10 Top Cutaway View of the Curlin Infusion Pump with Curlin Infusion Administration Set in Proper Installation Position ...19 Figure 2.11 Curlin Pump Battery Replacement ...21 Figure 2.15 Attaching and Removing the Remote Bolus Cord ... 32 Figure 3.1 Curlin Pump Features ... 33 Figure 3.2 6000 CMS PainSmartTM IOD Keypad with Info-On-Demand Feature ... 33 Figure 3.3 Sample of Display Screen ... 42 Figure 4.1 History Event Log ... 50 IV

1

Chapter

Let us first review the delivery modes and routes, indications for use, special features, regulatory agency approvals and warnings, cautions and notices relating to the Curlin Infusion Pumps.

L

et’s begin by introducing you to the Curlin Infusion 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 for ambulatory patients.

The Curlin Infusion 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 Mode and Routes PainSmart™ IOD is a PCA or Patient Controlled Analgesia pump designed for therapies that require a continuous rate of infusion, patient-controlled demand boluses, or both. Three Administration Routes, namely intravenous (IV), epidural (EPI) and subcutaneous (SQ); and three Units of delivery, namely milligrams (mg), micrograms (mcg) and milliliters (ml) are available. With the help of a software program purchased from Moog, an institution can configure the Administration Route to be fixed as IV, EPI or SQ. If any Administration Route is selected as “Fixed,” it is the only Route available to the user (other Routes will not be displayed) and cannot be re-enabled in the Biomed Setup menu. Similarly, the Units of delivery can be fixed as mg, mcg or ml. If any Unit of delivery is selected as “Fixed,” it cannot be modified by the clinician/user in the Biomed Setup menu. Indications for Use The Curlin Infusion pump can be used for intravenous, epidural, or subcutaneous therapies. If Epidural is selected, the Therapy Identifier bar in the Prescription Menu will display EPI instead of PCA. It can be used to deliver medications from the specially designed Curlin Infusion 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 Infusion pump should be instructed in its use by a qualified clinician and demonstrate an adequate level of proficiency in the use of the pump.

1

Some syringes are not qualified for use. Please call Moog for details.

1

Introduction

Introduction

•

Special Features of the PainSmart™ IOD Pump Small, accurate, ambulatory, volumetric infusion pump that provides reliable and safe delivery of infusion therapies.

•

The Info-On-Demand feature of the Curlin Infusion PainSmart™ IOD pump safely provides additional information to the user when the pump is in the “RUN” mode.

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Customized Maximum Basal Rate Limit.

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Customized Maximum Bolus and Dose Limits.

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Customized Lock Level setting.

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Large screen with Tallman Lettering.

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Larger font, single information display.

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Patient side (downstream) “Line Pressure” displayed.

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medLIMITS™ features.

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PCA dose and medLIMITS™ schedules that can be maintained on Repeat.

•

Pump will not permit the user to enter any programming value that is outside of its predetermined default range, or further restricted through medLIMITS™.

•

Ability, at the institution level, to configure the pump for specific Administration Route or Units of Measure: °

Units (Factory, ml, mg, mcg, ml fixed, mg fixed or mcg fixed);

°

Route (Intravenous, Epidural, Subcutaneous, Intravenous fixed, Epidural fixed or Subcutaneous fixed).

•

Patient and therapy specific programming features via the Curlin Infusion BIOMED SETUP and Options Menus (when not limited by the institution).

•

Selection by user from three units of delivery, milliliters, milligrams, and micrograms (when not limited by the institution).

•

Choice of five or nine digits Clinician Access Code.

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Maintenance Due Date that is automatically set, the first time, after 12 hours of use.

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Shift Totals that can be greater than 24 hours.

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Hourly Totals.

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Automatic scrolling of the programmed prescription with “quick-repeat” function.

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Cost effective, safe and easy-to-load disposable Curlin Infusion 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.

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User-friendly, easy-to-teach programming that shortens staff inservice time and patient teaching time.

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“Helpful” help screens and display messages.

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Three tamper-resistant lock settings to assist in maintaining patient compliance and safety.

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Retention of programmed infusion settings until cleared by the clinician, thus eliminating the 2

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.

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Powered by two readily available, cost-effective “C” size alkaline batteries.

I M P O R T A N T I N F O R M A T I O N

disabled.

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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

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Four sizes of convenient carry packs to assist the ambulatory patient in maintaining independence of lifestyle.

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Retained memory features that allow the pump to easily resume a therapy exactly from where it left off when it is interrupted before completion or to repeat a therapy using the same programmed prescription.

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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.

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Backlit illumination for display screen. Backlight remains on continuously if AC Adapter is in use.

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Integral Up as well as Down Occlusion alarms to notify user if an occlusion is present on either side of the pumping chamber.

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Integral High Upstream pressure alarm to notify user of excessive upstream pressure.

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Integral Air-In-Line alarm to notify user of presence of air in the tubing.

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Adjustable Down Occlusion settings of “High” and “Low” to customize the pump’s down pressure requirements. Regulatory Agency Approvals

INFUSION PUMP WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1/CAN/CSA C22.2 NO. 601.1 70TK

•

Underwriters Laboratories has evaluated the Curlin Infusion Pump with International AC Adapters (360-2022KIT) to UL 60601-1 and CSA C22.2 No. 601-1 for General Standards of Safety for Medical Equipment and found the Curlin Infusion Pump to be compliant.

•

Underwriters Laboratories has evaluated the Curlin Infusion Pumps with accessory equipments Battery Pack (350-9262) and the International AC Adapters (360-2022KIT)to IEC 60601-2-24. Particular requirements for safety of infusion pumps and controllers and they were found to be compliant.

•

Underwriters Laboratories has evaluated the Curlin Infusion Pump and the AC Adapter (360-2022KIT) for Electromagnetic Compatibility, to regulations EN 60601-1-1-2/1993 and 3

Introduction

•

EN 60601-2-24/1994 and both were found to be compliant. The indicator shown at the left appears throughout this manual to emphasize important information in the operation of the Curlin Infusion Pump. Please read these sections carefully. Warnings, Cautions, Notices EXPLANATION FOR SYMBOLS on the Curlin Infusion Pump with the Classified UL 60601-1 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 UL60601-1/CAN/CSA C22.2 NO. 601.1 70TK

INTERNALLY POWERED OR FOR USE WITH AC ADAPTER 340-2022/360-2022 and 340-2026/360-2026 DEFIBRILLIATION PROOF 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 WARNINGS

•

Prevent direct exposure to radiations. Secure an essential infusion pump outside of the radiation field using extension tubing if required.

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Use only Curlin Infusion administration sets in your Curlin Infusion 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.

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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.

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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. 4

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NOTE: Anti-siphon Valve (ASV) administration sets can be used to provide additional free-flow protection. •

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.

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Danger: Risk of explosion if used in the presence of flammable anesthetic or explosive gasses. CAUTIONS

•

U.S. federal law restricts this device to sale by or on the order of a physician or other licensed practitioner.

•

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.

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Use only Curlin Infusion external power sources to power the Curlin Infusion pump. Using other power sources may result in circuitry or microprocessor damage.

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When using the AC Adapter, connect the plug only into a grounded AC outlet.

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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.

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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.

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Use Curlin Infusion administration sets with appropriate air-in-line filters any time the Air-In-Line Sensor of the pump is disabled.

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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.

5

Introduction

Damage to the pump due to dropping or impact while the door is open can cause intermittent free flow conditions and loss of pump accuracy, but may not be visible through inspection. Volumetric testing is the only method to confirm proper function.

NOTICES

•

The Curlin Infusion 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.

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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.

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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.

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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. Moog 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.

•

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.)

6

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 Moog representative.

•

The Curlin Infusion Pump 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: 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.

I M P O R T A N T I N F O R M A T I O N

Because the chapter entitled, “Clinician Information and Access 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

Introduction

•

#BOLS/hr

BASL BG BOL INT CLIN CLRHRLY CONCEN dd DN Occlu EPI HH:MM HX INF IV KVO LPRES MAX MCG medLMTS MG MIN ML

= Bolus attempted Options hourly screen shows amount of bolus doses attempted = Basal Basal rate or continuous basal infusion maximum varies by route of infusion, intravenous, epidural or subcutaneous = Bolus given Options hourly screen shows amount of bolus doses infused = Bolus Interval Allows clinician to enter RX amount of time 0-60 min between patient-activated bolus dosing for pain management = Clinician Clinician dose is the option to give an additional prescribed dose by a clinician = Clear hourly Option to clear hourly totals of amount infused = Concentration Concentration is the amount of milligrams or micrograms per milliliter of solution = Day To set date enter 2 digit day = Down Occlusion Occlusion pressure in the line between the pump and the patient access site, as a kink in tubing, blockage in access site (infiltration) or clamp on = Epidural To inject anesthetic into the spinal canal = Hours and Minutes To set time enter Military 24 hour or AM/PM 12 hour = History The patient history log is a cumulative record of the last 6,000 events that have occurred in the pump = Infusion Fluid or medication pumping into the patient via intravenous, subcutaneous, or epidural routes = Intravenous To give fluids or medication directly into the venous circulation via peripheral or central circulation = Keep vein open To infuse a very small amount of fluid to keep vein patent = Line Pressure In CMS-enabled pumps shows downstream pressure to patient in millimeter of mercury = Maximum = Microgram = Sets soft limits for medication being infused = Milligram = Minimum Minimum amount of time between patient boluses = Milliliter

8

Introduction

∆ RATE ∆ TIME AMT AMT TBI BA

List of Abbreviations

= Number of Bolus Doses per hour In Patient controlled analgesia the number of boluses allowed per hour 0-15 = Amount rate may be changed = Interval until rate may be changed = Amount = Amount to be infused

mm MX

PCA PT RX SENS SQ VOL yy

9

Introduction

OPT

A unit of liquid measure 1/1000 of a liter = Month To set date enter 2 digit month = Maximum Upper limit of a bolus or patient demand dose, or infusion rate = Options Once prescription is programmed, this key provides customizing features as locking programs from changes, alarm volume, battery level, amount of air detection, adjust occlusion alarm, hourly totals, shift totals, clinician dosing = Patient controlled analgesia Pain control by continuous rate of infusion with options for patient controlled demand boluses = Patient Person receiving infusion = Prescription Written order for medication with instructions of how to administer as time, dose, amount, limits, and route = Sensor Air in line sensor will detect the amount of air in the tubing = Subcutaneous To give fluids or medication just below the skin, also (SC) = Volume Amount of fluid in intravenous bag, medication reservoir or syringe = Year To set date enter 2 digit year

2

Chapter

The Curlin Infusion PainSmartTMIOD Pumps have been designed with the user in mind and have the latest in friendly, 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. Pump Illustrations and Features Pump Door LED Status Indicator

Display Screen

Pump Door Instruction Label Door Latch Run/Pause Key On /Off Key

Help/Option Key

Data Interface/ Bolus Cord Port

Down Arrow Yes/Enter Key

Data/Bolus Port Unique Keyhole

Prime/Bolus Key

Up Arrow Decimal Point/ Silence Key

No/Change Key Numeric Keys

Figure 2.1 Curlin Infusion Ambulatory Pump – Front, Top, and Left View

11

Pump & Set Features

Features of the Pump and Administration Sets

Serial Number Label

Battery Compartment Door with Caution Label

Recessed release Pin for Battery Door

External Power Jack Port (2 Pin Port)

Right View Pump Door

Power Jack’s Unique Keyhole

Figure 2.2 Curlin Infusion Ambulatory Pump – Back, Bottom, and Right View

12

Disposable Administration Set Illustrations and Features

Male Luer Lock

Integral FlowStop with breakaway tab

Slide Clamp

Tubing Guide

Bag Spike

These drawings are NOT to scale.

Pump & Set Features

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 2.6 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. Note: Administration sets with anti-siphon valve protection can also be used for additional free-flow protection.

CAUTION: USE ONLY CURLIN INFUSION ADMINISTRATION SETS WITH THIS PUMP

CURLIN MEDICAL

Integral FlowStop with breakaway tab

Slide Clamp Male Luer Lock

Tubing Guide

Figure 2.3 Sample of Curlin Infusion Administration Sets

13

Medication Reservoir

Preparing Medication for Infusion/Changing IV Bags

When using an IV bag, grasp the bag spike firmly in one hand and the IV bag spike-port in the other, and insert the spike completely into the port using aseptic technique. 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.

Air in the line moves down through the tubing as the fluid fills.

OPEN

Notice the breakaway tab on the “Integral Flow-Stop” has been removed. The set can be gravity primed by intentionally squeezing the “Integral Flow-Stop” and thus releasing the clamping action. ( See Figures 2.5 & 2.6 )

CLOSED

In these illustrations, the slide clamps are shown in their open and closed states.

Figure 2.4 Spiking the Fluid Container, Gravity Priming the Set, and Using the Slide Clamp to Close the Tubing

14