Moog CURLIN INFUSION PainSmart User Manual Download Page 3

Page: 3 / 141

User Manual

for use with the

PainSmart™

and

PainSmart™

IOD™

Ambulatory Infusion Systems

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

Manufactured by

ZEVEX, Inc.

4314 ZEVEX Park Lane

Salt Lake City, UT 84123 USA

Phone 801.264.1001

Fax 800.778.3135

www.moog.com/medical

For 24-hour Clinical or Technical Support call toll free:

1-800-970-2337

Revision I

Reorder Number 360-9043

Summary of Contents for CURLIN INFUSION PainSmart

Page 1: ...User Manual for use with the PainSmart and PainSmart IOD Ambulatory Infusion System Moog Medical Devices Group tf 800 970 2337 ph 801 264 1001 fx 801 264 1051 www moog com medical...

Page 2: ...se 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...

Page 3: ...71 732 B1 Des 408 911 Des 437 547 S Other U S and Foreign Patents Pending Copyright 2000 2011 Moog Inc All Rights Reserved Manufactured by ZEVEX Inc 4314 ZEVEX Park Lane Salt Lake City UT 84123 USA Ph...

Page 4: ...xternal Power Sources 28 AC Adaptor Charger 34 Bolus Cord Use 34 Bolus Cord Use 35 LEARNING PUMP FEATURES 36 Keypad Function 37 Description of the Info On Demand IOD Feature Optional of the Moog Curli...

Page 5: ...64 PCA medLMTS Setup Screen 65 PCA Prescription Menu 66 Run Options Screen 67 Prime 67 Prime Direction Screen 68 Options 69 PCA Options Menu 69 Clinician Dose Menu 70 Clinician Dose Run Screen 70 Shi...

Page 6: ...Storage 109 Operating Environment 109 Maintenance 109 Limited Warranty 109 Procedure for Checking Pumps Between Patients 111 TECHNICAL SPECIFICATIONS 115 CLINICIAN INFORMATION AND ACCESS CODE 125 Cli...

Page 7: ...Proper Installation of the Moog Curlin Infusion Administration Set into the Pump 23 Figure 2 10 Top Cutaway View of the Moog Curlin Infusion Pump with Moog Curlin Infusion Administration Set in Proper...

Page 8: ...ftware 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...

Page 9: ...d Route Intravenous Epidural Subcutaneous Intravenous fixed Epidural fixed or Subcutaneous fixed Patient and therapy specific programming features via the Moog Curlin Infusion BIOMED SETUP and Options...

Page 10: ...llumination for display screen Backlight remains on continuously if AC Adaptor is in use Integral Up as well as Down Occlusion alarms to notify user if an occlusion is present on either side of the pu...

Page 11: ...sult 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 C...

Page 12: ...uld result in over or under infusions leading to possible patient injury or death Visually inspect the pump pumping chamber and administration set before use Do not use any pump or administration set...

Page 13: ...ilet 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 Moog Curlin Inf...

Page 14: ...c 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 administratio...

Page 15: ...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 doe...

Page 16: ...mount of milligrams or micrograms per milliliter of solution dd Day To set date enter 2 digit day DN Occlu Down Occlusion Occlusion pressure in the line between the pump and the patient access site as...

Page 17: ...tals clinician dosing PCA Patient Controlled Analgesia Pain control by continuous rate of infusion with options for patient controlled demand boluses PT Patient Person receiving infusion RX Prescripti...

Page 18: ...he 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 us...

Page 19: ...n Ambulatory Pump Back Bottom and Right View Recessed Release Pin for Battery Door External Power Jack P ort 2 Pin Port Battery Compartment Door with Caution Label Serial Number Label Right View Pump...

Page 20: ...he Integral Flow Stop will automatically clamp the tubing The Moog Curlin Medical Integral Flow Stop prevents inadvertent flow of medication to the patient whenever the door of the pump is opened beca...

Page 21: ...18 Preparing Medication for Infusion Changing IV Bags Figure 2 4 Spiking the Fluid Container Gravity Priming the Set and Using the Slide Clamp to Close the Tubing 2 2...

Page 22: ...19 Figure 2 5 Curlin Infusion Administration Set Integral Flow Stop with Breakaway Tab Figure 2 6 Intentionally Opening the Integral Flow Stop Pump Set Features...

Page 23: ...mp Door The pump door located on the top of the Moog Curlin Infusion pump has a sturdy over center latching mechanism which assists in securely closing the door Review the following illustrations Figu...

Page 24: ...21 Figure 2 8 Closing the Pump Door Pump Set Features...

Page 25: ...nal IV bag volume 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 Flo...

Page 26: ...flow through the tubing 7 Push the tubing slightly into the black Air Detector slot 8 Open the slide clamp on the administration set 9 Fully close the door of the pump and latch it securely 10 If the...

Page 27: ...ontainer 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 administ...

Page 28: ...longer operate due to empty batteries At higher infusion rates your advance warning will be less The user should be taught that whenever the low battery alert appears to pause the therapy turn the pu...

Page 29: ...penny pry up and out on the top edge of the battery to cause the battery to pop out Use the same technique on the second battery Do not use a screwdriver or other sharp objects to pry batteries out o...

Page 30: ...e battery case can occur Damaged springs can create a situation in which the battery overheats If the battery or the pump becomes excessively warm to the touch do not attempt to remove the batteries S...

Page 31: ...000 or PainSmart infusion pump for an extended period of time without being connected to a power outlet The battery pack allows the user to operate the pump for a minimum of 24 hours at 125mL hr in ad...

Page 32: ...e battery pack the LED will either flash yellow or not illuminate Warnings The external battery pack should be used with new C cell batteries in the pump to avoid interruption of the infusion if the c...

Page 33: ...to when using this DFU Environmental Storage Temperature 20 C to 65 C Atmospheric pressure 500hPa to 1060hPa Humidity 10 to 90 Operational Temperature 5 C to 40 C Atmospheric pressure 650hPa to 1020hP...

Page 34: ...arge LED light will illuminate yellow if the battery needs to be recharged See below Charge the battery pack for 15 hours or until the LED turns green indicating the battery is fully charged Pump Set...

Page 35: ...r the battery pack being at a location where the temperature is not between 5 and 40 degrees celsius If the fault condition persists then the battery pack should be returned to Moog Medical Devices Gr...

Page 36: ...to recharging the battery pack Maintenance There is no need to fully discharge the batteries periodically since Li Ion batteries do not have a memory effect The battery pack enclosure may be cleaned...

Page 37: ...acle by aligning the red dots on each The International AC Adapters 47685 and 58831 available for international use The two pin connector plugs into the receptacle by aligning the key on the connector...

Page 38: ...is completed no beep will occur The cord is five feet long and has a patient access button at the top of the remote cord The four pin adaptor with the unique key plugs into the four hole port with the...

Page 39: ......

Page 40: ...ery therapy It may be helpful to read through these steps first and then go back and use them to operate the Moog Curlin Infusion pump irst examine the key pad and the functions of the individual keys...

Page 41: ...CHANGE Used to respond NO to data or questions presented or to reject or to change highlighted data Note The Moog Curlin Infusion pump requires you to actively change a selection The Up arrow or Down...

Page 42: ...quested will be displayed for 8 seconds and then the display will return to the previous infusion screen One exception is the HrlyTot 5 key The information for the HrlyTot 5 key will be displayed for...

Page 43: ...the charge left in the batteries and not intended to give specific representation of the battery life Furthermore the bar graph should NOT be used to check the state of the external NiMH battery pack...

Page 44: ...allowed 6 Therapy Information ThrpyInfo The information displayed in this screen is from the pre prescription menu and includes Units Concentration Administration Route and Load Dose Changes to this s...

Page 45: ...onse to the DONE CLEAR question and the pump will go back to the running screen Press the CLRShft 9 key again to verify that the values are reset or cleared To EXIT the Shift Totals screens without cl...

Page 46: ...Basal Rate Limit is factory set to be 9 9 for IV administration route if you enter 21 for BASL RATE an alert message will appear GREATER THAN MAX FIELD LIMIT MAX 9 9 The values you are allowed to ente...

Page 47: ...ates an Infusion Complete Alarm status with KVO or a Down Occlusion Alarm with automatic restart 5 Yellow and Green indicates a Standby status with automatic start This occurs when a 0 basal rate and...

Page 48: ...ting which therapy is running or which programming screen is being considered This identifier also has another function and that is to alert you when more text exists either above the top line or belo...

Page 49: ......

Page 50: ...n the cursor is highlighting the correct field and you press the YES ENTER key the pump accepts the selection and executes that action In the example above the pump would proceed with steps to resume...

Page 51: ...the time remaining for the infusion No action is required on a run screen therefore no highlight bar appears In some therapies a field may toggle to give the operator more information i e the REMAIN...

Page 52: ...ll hear three beeps as each of the LED indicators blink If any one of the green yellow or red LED lights fails to light or to blink return the pump for service If the self test fails the alarm will so...

Page 53: ...the date has been reset during the actual maintenance performance The pump may continue to be used after the maintenance due date but should be returned for its routine maintenance at the earliest op...

Page 54: ...code numbers do not instead five asterisks appear If the four five configuration is selected the personal identification number is recorded in the history file for the purpose of providing an audit t...

Page 55: ...ID This feature gives the programmer the option to use the numeric keypad to enter his or her assigned ID number up to ten digits If this option is not to be used it can be left blank and skipped usi...

Page 56: ...main menu There are two choices OFF and ON When MANUAL PROGRAM is set to OFF the PROGRAM menu option is not available on the main menu a To enable MANUAL PROGRAM press the NO CHANGE key until the sel...

Page 57: ...the history log is full it will overwrite on a first in first out basis Note The patient history log should be printed before clearing occurs if a hard copy record is required The history log when pri...

Page 58: ...TIENT HISTORY To print the patient history log connect the Data Interface Cable to the communication port on left side of the pump before selecting this command FOLLOW DIRECTIONS THAT ACCOMPANY THE DA...

Page 59: ...t history log from the pump When you select YES ENTER the pump displays When you select YES the history log is cleared and the display returns to the BioMed Setup Menu Selecting NO aborts the feature...

Page 60: ...d will not appear Press the NO key until the correct selection appears on the field and then press the YES ENTER key to choose the selection and move the cursor to the next field c Time Use the numeri...

Page 61: ...a Select Therapy Screen appears prompting you to select a therapy If a therapy has been programmed the following screen appears Resume Repeat Rx New Program Menu There are three different ways that yo...

Page 62: ...y and you wish to select a therapy at this time move the cursor to REPEAT Rx and press the YES ENTER key This action will take you to the Select Therapy Screen and allow you to choose which of the pro...

Page 63: ...rrent schedules and continue with the programming of the pump Answering NO will return you to the prior screen How to Go to New Program NEW PROGRAM If the cursor is moved to this field and the YES ENT...

Page 64: ...ss the YES key to accept confirm a field entry and the NO key to reject change a field entry Note Library therapies may have soft or hard limits set for various values For PCA therapies Hard or soft l...

Page 65: ...New Library Therapy NEW PROGRAM If the cursor is moved to this field and the YES ENTER key is pressed the display changes to allow you to select which Library Therapy you wish to program 1 If the des...

Page 66: ...field to confirm choices NO to change Note this should be done prior to priming the set tubing on the pump 13 When you reach the RUN to START Screen for the second time you can now prime the set tubi...

Page 67: ...he cursor will automatically advance through the prescription menus You can stop the auto advance function by pressing any key except ON OFF and then complete the confirmation of the prescription by p...

Page 68: ...gs are listed in the left screen Each field is individually explained below Note Some of the lines are abbreviated to fit on the display screen The full descriptions appear below 1 UNITS Allows you to...

Page 69: ...l be delivered at the fixed bolus delivery rate when the RUN key is pressed to start the PCA infusion The amount of the loading dose is included in the displayed Amount Infused and is logged into the...

Page 70: ...ime set at their default settings of 0 and press YES ENTER to move to the next field d Max BOLS Maximum Bolus Dose Use this field to set the upper limit of the Patient Bolus or Patient Demand dose If...

Page 71: ...than four fields of text or information to be considered P C A P r e s c r i p t i o n M e n u Note The PCA therapy can be programmed for Basal Rate continuous infusion only for Patient Bolus patient...

Page 72: ...numeric keys to enter the corrected information and press YES ENTER to accept the new data If all the fields are acceptable at the DONE prompt press the YES ENTER key to move on to the next screen Be...

Page 73: ...The pump will then beep once and require repressing and holding the PRIME key again until 6 more milliliters is delivered Continue this process until all air has been purged from the IV bag and the a...

Page 74: ...RLY will return you directly to the ACCEPT OPT field The following screen displays the PCA Therapy Options available When you open this menu use the up and down arrows to move the highlight bar to the...

Page 75: ...cts the clinician dose in progress and when this dose is complete reverts back to reflecting the container in progress This graphic bar will toggle with Line Pressure L Press which displays the curren...

Page 76: ...ld The field will change to read CLEAR press the YES key now to clear A lock level 3 will require an access code entry before allowing the user to clear the Shift Totals 4 HRLY TOT Hourly Totals To vi...

Page 77: ...s parameters within the predefined prescription limits Whenever any value is changed using the medLMTS option the new value will appear on the prescription menu when it is reviewed If a delta time rat...

Page 78: ...will remain in effect until a new therapy is programmed 8 AIR SENS Air In Line Sensor This feature allows you to select the amount of air the pump will detect in the administration set tubing before i...

Page 79: ...internal batteries or external power If the active source is the batteries a graph will indicate approximately how much charge remains in the batteries To access this information select ON and press...

Page 80: ...r will toggle with Line Pressure L Press which displays the current patient side downstream pressure in the administration set in millimeter of mercury mmHg units 3 The third line displays the total v...

Page 81: ...er move the cursor to REPEAT Rx see following section R u n O p t i o n s S c r e e n a Press the RUN key to resume the therapy b Press the NO key to go back to the programming screen to make changes...

Page 82: ...o the above Run Options Screen If the current therapy is still in progress when the REPEAT Rx function is selected the following screen will appear a This screen is a reminder that the infusion is not...

Page 83: ...the YES ENTER key If a prescription has previously been entered for the therapy mode you wish to program the following screen will appear c If you want to save the current prescription press the NO C...

Page 84: ...prescription press the YES ENTER key at this field The following screen will then appear asking whether or not you wish to maintain the current Bolus or MedLMTS Schedule Press YES ENTER to maintain th...

Page 85: ...ess the YES ENTER key when this field is highlighted and the display will return to the Select Therapy Screen The lock setting can control access to this function Note The therapy is complete therefor...

Page 86: ...seconds if it is a user initiated alert such as a wrong key press If it is an automatic alert occurring while a therapy is infusing such as low battery the message displays for twenty seconds If it is...

Page 87: ...rt Unable to change clinician dose while clinician dose in progress Cause A clinician dose is in progress and a new clinician dose value is entered that is not 0 or the current dose amount Resolution...

Page 88: ...tion Recheck the data entry LCD Display ALERT AMT TBI LESS THAN AMT INFUSED Alert Unable to change amount to be infused to an amount less than what has already infused Cause Occurs when user tries to...

Page 89: ...lert Invalid calculated time Cause The calculated time for the therapy based on the values entered for Volume Amount and Rate exceeds the therapy time limit of 288 00 HH MM 167 59 HH MM Software Versi...

Page 90: ...valid Cause Delay start time entered is less than one minute or greater than 24 hours from the current system time Resolution Reset Delay Start Time to fall within pump limits To obtain the current d...

Page 91: ...n the source container is sufficient to complete the current therapy If the volume is insufficient add another source container or stop the infusion LCD Display ALERT EXCEEDS POSSIBLE DOSES PER HR Ale...

Page 92: ...odify original Rx programmed LCD Display ALERT INSUFFICIENT VOLUME MAX DOSES _____ Alert Bag Volume value is insufficient to deliver the remaining Cause Occurs whenever the prescription is changed so...

Page 93: ...replace the batteries See chapter 1 of the User s Manual for instructions on battery change LCD Display ALERT MAX CHANGES FOR PERIOD REACHED Alert The maximum number of changes for the current delta...

Page 94: ...no key presses Resolution Complete the activity for the displayed menu The pump may also be turned off however all programming that was not complete will be discarded If the pump was running and the O...

Page 95: ...echeck all data entered for prescription If programming a new TPN therapy NEW PROGRAM selected and the ramp time is a requirement enter the ramp time s and total time first followed by the next govern...

Page 96: ...the Rx will be erased will be displayed When the therapy for the new program is chosen entry of a new prescription will be required To continue the current therapy in progress press NO The Pause menu...

Page 97: ...The value entered for the Variable Dose Amt or Time field will cause no remaining amount or time for a subsequent Resolution Recheck data entry If this is a new program reprogramming of the therapy wi...

Page 98: ...installed while the pump is running Resolution Check the door latch assembly and securely close the door If the door was closed properly re install the set according to the installation instructions S...

Page 99: ...ministration set and IV bag or reservoir per protocol Disconnect from patient s access site before using prime function LCD Display ALARM DOWN OCCLUSION Alarm Occlusion between pump and patient access...

Page 100: ...tion Install appropriate Moog Curlin Infusion Administration set for desired therapy Use ONLY Moog Curlin Infusion Administration sets If the blue tubing guide on the administration set has been damag...

Page 101: ...ble connection between the pump and the PDA or PC LCD Display INFUSION COMPLETE Alarm Infusion Complete Cause Programmed Amount to be Infused is depleted to 0 Resolution If the therapy is to be repeat...

Page 102: ...rary Protocol or revise the Library Protocol LCD Display ALARM INVALID ROUTE FOR PUMP CONFIGURATION Alarm Invalid Route for Pump Configuration Cause The Library Protocol Route is not valid for the pum...

Page 103: ...ilure Bad Down Strain Beam Bad Up Strain Beam Bad Encoder Bad Analog to Digital Conversion Bad Clock Bad Air In Line comparator register reading from FPGA Bad Door Sensor Empty Lithium Battery Bad Tri...

Page 104: ...n Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Turn Pump OFF ON...

Page 105: ...ed Release It Otherwise Report Error Code To Factory If Key Was Pressed Release It Otherwise Report Error Code To Factory Otherwise Report Error Code To Factory If Key Was Pressed Release It Otherwise...

Page 106: ...ry Report Error Code To Factory Report Error Code To Factory Report Error Code To Factory Report Error Code To Factory Report Error Code To Factory Report Error Code To Factory Error Code LCD Displaye...

Page 107: ...22 Turn Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Turn Pump OFF ON Call Provider Configuration Settings May Have Been Compromised Display String Oversize...

Page 108: ...a complete and updated list refer to the Moog website www moog com medical Detachable Pole Clamps The pole clamps attach to the Lockable Safety Shells or the Pump Holster and can accommodate a pole of...

Page 109: ...r the patient s use in administering bolus dosing in the PCA therapy This accessory cannot be used in any therapy except PCA and if it is left connected for any other therapy an alert message will dis...

Page 110: ...ministration set and the pump and yet allow access to the pump s keypad controls communication connectors and battery compartment door The 250 mL safety shell will also secure syringes and is availabl...

Page 111: ...to securely be mounted onto a pole and yet allow the user easy access to the display keypad controls battery compartment and connectors for external power or communications Figure 8 5 Pump Holster Al...

Page 112: ...keypad The keypad covers are available in four configurations Type 0 340 0142 covers all the keys Type I 340 0142 01 covers all the keys with the exception of the SILENCE and RUN PAUSE keys Type II 34...

Page 113: ......

Page 114: ...ned with a cloth dampened with any of the following solutions and dried with a soft cloth without harming the pump Clean the pump remote bolus cord AC adaptor safety shells holster and battery pack wi...

Page 115: ...dly or any time a pump appears to be tampered with or shows any indication of not performing to standards the pump should be returned to the healthcare provider dispensing the pump At no time should u...

Page 116: ...imited to use not in compliance with the User s Manual or use with non approved accessories The pump is a sealed unit and the fact that the seal has been broken will be considered conclusive evidence...

Page 117: ...an outpatient home care or alternate care setting the pump must be checked between patients using the following procedure Inpatient Hospital Environment Moog Medical offers delivery sets with an anti...

Page 118: ...confirm that no cuts or tears exist Confirm that the door is well aligned by closing it with no unreasonable interference Verify that the power and bolus data connectors are securely mounted on the ca...

Page 119: ...ured on the measurement device Passing measurement is 9 4 g to 10 4 g 9 4 mL to 10 4 mL h When INFUSION COMPLETE displays verify that the audio alarm beeps and that the green LED is flashing 3 CHECK A...

Page 120: ...l battery Observe that the Auxiliary Alarm System is activated with the red LED and beeper on constant not intermittently beeping With the battery still out of the pump press the ON OFF button to turn...

Page 121: ......

Page 122: ...aterial Operating Environment Storage Environment Height Width Depth Weight Operating Temperature Operating Relative Humidity Storage Temperature Range Storage Relative Humidity 20 to 140 F 5 to 95 37...

Page 123: ...tion set usage not to exceed 72 hours follow standards of practice for set changes Proprietary Moog Curlin Infusion non DEHP PVC administration sets available in different configurations Non filtered...

Page 124: ...2 hrs 15 minutes 16 minutes 1min 30 seconds 15 seconds 5 seconds For filtered sets Rate 0 1 mL hr 1 mL hr 10 mL hr 50 mL hr 125 mL hr Low Pressure 9 hr 15 minutes 50 minutes 4 min 30 seconds 50 second...

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Page 132: ...de If the five digit code is valid the display will automatically move to the requested screen or field The four digit personal identification number appears on the screen but the access code numbers...

Page 133: ...vironment specified below The customer or the user of the PainSmart IOD 6000 CMS and 6000 CMS IOD should assure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 610...

Page 134: ...sites survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz the higher the f...

Page 135: ...centration New Program Utilize MedLMTS Option Program MedLMTS Limits Change Administration Route New Program Program Loading Dose Program Clinician Dose PCA PCA PCA PCA PCA PCA PCA PCA PCA PCA PCA PCA...

Page 136: ...evel setting If a locked out function is requested such as PRIME in lock setting 3 a screen will appear requesting the entry of the access code When the correct code is entered the locked out function...

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Page 138: ...te 360 1300 E4 mL EPI 9 White 360 1300 E5 mg IV 5 White 360 1300 E6 mg IV 9 White 360 1300 E7 mL IV 5 White 360 1300 E8 mg IV 9 Green 360 1300 E9 mL EPI 5 White 360 1300 E10 mg IV 5 Green Pump has bee...

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