ACCLAIM encore System Operating Manual Rev Oct 2005

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System Operating Manual

CHANGE HISTORY

i

PART NUMBER

DESCRIPTION OF CHANGE

REVISED PAGES

430-96202-001 (Rev. 09/98)

Original release

New

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Second release

All

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Third release

All

430-96202-A03 (Rev. 6/99)

Updated Cover Updated Change History Updated Troubleshooting Updated Part Number only

Front, back i 36 17, 55

430-96202-004 (Rev. 9/99)

Fourth release

All

430-96202-A04 (Rev. 9/99)

Updated Cover Updated Change History Updated Titration Instructions Updated Part Number only

Front, back i 26 27, 55

430-96202-B04 (Rev. 6/00)

Updated Cover Updated Change History Updated Copyright Clarified Text Updated Part Number only

Front, back i iii 20, 21, 24, 25, 27 26, 28, 29, 32, 33, 53, 55

430-96202-C04 (Rev. 4/01)

Updated Cover Updated Change History Updated Contents Updated Copyright Clarified Text Updated Graphics Removed Section Updated Part Number only

Front, back i ii iii 10, 18, 19, 36 7, 13, 15, 16, 24, 25, 26 17 27, 28, 29, 34, 35, 37, 38, 40, 43, 46, 53, 54, 55

430-96202-D04 (Rev. 08/04)

Changed Abbott to Hospira Verbiage

Front and Back Covers, Change History, ii, iii, 4 thru 6, 9, 10, 12, 14, 18, 35, 39, 41, 43, 44, 47 thru 49 and 53 thru 55

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Fifth Release

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AcclaimTM encore Infusion System

Contents Section 1, Introduction... 1-1 user qualification... 1-2 conventions... 1-3 warnings, cautions, and notes... 1-3 PRECAUTIONS... 1-4 artifacts... 1-4 healthcare professional and patient related... 1-5 epidural administration... 1-6 battery operation... 1-7 sets and accessories... 1-7 general... 1-9

Section 2, Getting Started... 2-1 UNPACKING... 2-1 SELF-TEST... 2-1

Section 3, COMPONENTS... 3-1 OPERATING KEYS... 3-2 ADDITIONAL FEATURES... 3-4

Section 4, Instructions For Use... 4-1 SETUP... 4-1 CONTAINER AND SET PREPARATION... 4-2 container preparation... 4-2 priming the primary set... 4-3 preparing for secondary delivery... 4-4 LOADING THE TUBING... 4-5

Section 5, Programming... 5-1 PRIMARY ONLY DELIVERY... 5-3 to titrate or change a primary delivery rate while infusing . 5-4 SECONDARY DELIVERY (PIGGYBACK MODE)... 5-5 to titrate or change a secondary delivery rate while infusing... 5-7

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System Operating Manual to stop a secondary delivery in progress... 5-7 VOLUME/TIME DELIVERY... 5-8 DOSE CALCULATION FOR MICROGRAM DELIVERY (OPTIONAL)... 5-10 to program the acclaim encore infusion pump for microgram delivery... 5-10 TO TITRATE IN MICROGRAM DOSING (OPTIONAL)... 5-13 to change dose... 5-13 to titrate vtbi (while infusing)... 5-13 TPN MODE DELIVERY... 5-15 to program the acclaim encore for tpn delivery... 5-15 KVO OPERATION... 5-18 CHANGING CONTAINERS... 5-19 PURGE FEATURE... 5-20 CLEARING TOTAL VOLUME... 5-21 to clear the total volume that has been delivered... 5-21 OPTIONAL USER SETTINGS... 5-22 to check all three settings... 5-23 Air-in-Line Sensitivity... 5-24 LOCKOUT... 5-26 REMOVAL OF TUBING... 5-27

Section 6, TROUBLESHOOTING... 6-1 ALARMS... 6-1 ALERTS... 6-5 MALFUNCTIONS... 6-6 to verify the malfunction... 6-6 TECHNICAL ASSISTANCE... 6-6

Section 7, Cleaning, Maintenance, and Storage... 7-1 CLEANING AND SANITIZING... 7-1 BATTERY MAINTENANCE... 7-2 STORAGE... 7-3 SERVICE... 7-3

Section 8, SPECIFICATIONS...8-1 PHYSICAL... 8-1 ELECTRICAL... 8-1 ENVIRONMENT... 8-2

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AcclaimTM encore Infusion System TRANSPORT AND STORAGE ENVIRONMENT... 8-2 DELIVERY RATE RANGE... 8-2 DOSE CALC RANGE... 8-2 TPN RANGE... 8-3 VTBI RANGE... 8-3 DISTAL OCCLUSION RANGE... 8-3 MAXIMUM INFUSION PRESSURE... 8-3 DISTAL OCCLUSION DETECTION TIME & BOLUS VOLUME... 8-4 DELIVERY ACCURACY... 8-4 TRUMPET CURVES... 8-5 example... 8-6

Section 9, Warranty... 9-1

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System Operating Manual

NOTES

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AcclaimTM encore Infusion System SECTION 1

Introduction This manual contains instructions for using the AcclaimTM encore Infusion Pump. For the purpose of making this manual easier to read, the Acclaim encore Infusion Pump will be simply referred to as the Acclaim encore, pump or device, throughout the remainder of this manual. The Acclaim encore is an infusion system designed to meet the growing demand for hospital, alternate site, and home healthcare standardization. The Acclaim encore is designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. These features make the Acclaim encore a convenient and costeffective infusion system. The pump may be mounted on an IV stand. The following features are included in the Acclaim encore: • Easy to use interface • Large LCD screen • Numeric keypad entry • Micro/Macro fluid delivery from 1.0 - 99.9 mL/hr in 0.1 mL/hr increments and 100 - 999 mL/hr in 1 mL increments • Panel back illumination on AC power • Battery backup • Wide range of standard administration sets and accessories including LifeShieldTM needleless sets • Primary/Secondary delivery including automatic piggyback • Dose Calc for weight-based (mcg/kg/min) delivery rate settings • TPN mode for easy taper calculation • Purge feature for easy removal of air • Three occlusion pressure settings

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System Operating Manual • Air-in-line sensitivity- three optional settings • Keep Vein Open (KVO) • Panel lockout switch • Anti free-flow protection using slide clamp and tubing latch • Automatic self-test • Infinite memory retention • Audible alarm volume selection • Alarm history • Epidural delivery • Volume/Time programming for automatic primary or secondary flow rate calculation • Optional secondary alert

USER QUALIFICATION The Acclaim encore is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the pump and the administration of parenteral and enteral fluids and drugs and whole blood or red blood cell components. This training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.

WARNING THIS PUMP CAN ADMINISTER ONLY THOSE ANESTHETICS/ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED BY THE DRUGS’ FDA APPROVED LABELING). EPIDURAL ADMINISTRATION OF DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.

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AcclaimTM encore Infusion System CONVENTIONS This section describes the conventions used throughout this manual: CONVENTION

APPLICATION

EXAMPLE

Italic

Reference to a section, figure, or table

(See Figure 3-1, Priming Cassette)

Function or mode specific instructions

Primary Only: Attach an empty container...

[ALL CAPS]

Keys or touchswitches on the pump are described all caps in brackets

[SILENCE]

ALL CAPS Initial Caps lowercase

Screen displays and pump labels (as appropriate)

BATTERY

Bold

Emphasis

...sets are supplied Sterile and are for...

WARNINGS, CAUTIONS, AND NOTES Alert messages used throughout this manual are described below. Pay particular attention to these messages.

WARNING A WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE THREATENING. CAUTION: A CAUTION USUALLY APPEARS IN FRONT OF A PROCEDURE OR STATEMENT. IT CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE. NEGLECTING TO PAY ATTENTION TO A CAUTION COULD RESULT IN SERIOUS PATIENT OR USER INJURY. NOTE: A Note highlights information that helps explain a concept or procedure.

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System Operating Manual

This symbol directs the user to consult accompanying documents. NOTE: Figures are rendered as graphic representations to approximate the actual product; therefore, figures may not exactly reflect the product.

PRECAUTIONS For optimum operation of the Acclaim encore Infusion Pump, observe the following precautions.

ARTIFACTS Nonhazardous, low level electrical potentials are commonly observed when fluids are administered using infusion pumps. These potentials are well within accepted safety standards, but may create artifacts on voltage sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infusion pump instead of some other source in the environment, set the infusion pump so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by the electronic noise generated by the infusion pump. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring equipment system documentation for setup and maintenance instructions. The Acclaim encore system is designed to operate normally in the presence of most encountered EMF conditions. In the event of extreme levels of interference, such as encountered next to

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AcclaimTM encore Infusion System an electrosurgical generator, it is possible that the normal operation of a sensor or microcomputer might be disrupted. Even in this event, the outcome would likely be a detected system malfunction and would not result in a hazard to patient or operator. Use of radio frequency emitting devices such as cellular telephones and 2-way radios in close proximity of this device may affect its operation.

HEALTHCARE PROFESSIONAL AND PATIENT RELATED Product checkout should be performed by qualified personnel only. Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement. Consult the drug container labeling to confirm drug compatibility, concentration, delivery rates, and volumes are all

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System Operating Manual suitable for intermittent or continuous secondary or piggyback delivery mode. Uncontrolled flow or no flow could occur if tubing not properly seated in the tubing channel. Pull tubing straight, but do not stretch it during the loading process. Stretching tubing could result in underdelivery of fluids. Always place filters distal to the infuser to minimize the possibility of underdelivery or an air-in-line alarm due to outgassing. Before opening the tubing door, close the roller clamp on the primary set. When starting an infusion, confirm that there is flow in the drip chamber after pressing the [START] key. Setting the primary rate greater than the secondary rate will result in a more rapid infusion of any residual secondary drug remaining in the line. When using the pump for piggyback delivery, confirm that the fluids being administered are chemically and physically compatible. In vitro studies have suggested that packed red blood cells with unusually high hematocrit be diluted with blood-compatible fluids, such as 0.9% Sodium Chloride Injection, USP, to decrease hemolysis and increase flow rate. To prevent freeflow, close the roller clamp on the primary set before removing the administration set from the pump. Do not depress the green slide clamp slot tab while removing the tubing and slide clamp. Doing so could allow free flow to occur.

EPIDURAL ADMINISTRATION This device can be used to provide anesthesia or analgesia via the Epidural route for short-term infusion (up to 96 hours), with the following recommendations:

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AcclaimTM encore Infusion System • Only anesthetic/analgesic agents approved for Epidural administration (as indicated or allowed by the drugs’ FDA approved labeling) • Nylon catheter (Hospira List No. 1193) or a Teflon® catheter (Hospira List No. 6947) • Pump sets labeled for Epidural use without injection or Ysites • Labeling (pump and sets) to indicate on-going Epidural administration NOTE: Facilities practicing epidural anesthesia/analgesia must be staffed and equipped to manage cardio-pulmonary resuscitation. Supplies should include oxygen, naloxone, and other appropriate resuscitative drugs and equipment. Continuous monitoring (e.g., oximetry) is recommended for the patient during epidural administration, as well as frequent patient observation for side effects (for up to 24 hours) following completion of drug administration by the epidural route. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED.

BATTERY OPERATION The battery may not be fully charged upon receipt. Connect the device to AC power for at least eight hours. If the BATTERY alarm sounds, connect to AC power immediately, as the alarm indicates the battery is low.

SETS AND ACCESSORIES The Acclaim encore is compatible with a wide variety of Hospira administration sets.

WARNING USE ONLY RECOMMENDED HOSPIRA GRAVITY SETS WITH GREEN SLIDE CLAMPS.

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System Operating Manual NOTE: Accessories are updated without notice. Contact a Hospira representative for current listings. Guidelines for choosing recommended administration sets: • When using administration sets with filters, only Hospira sets that include high pressure filters (i.e., can withstand up to 45 psig) should be used. The filter must be placed distal to the pump • Standard 0.100 ID gravity sets with roller clamp distal to green slide clamp may be used with this pump • Do not use: • Any sets without green slide clamps • Any burette sets with automatic shutoff valves or flapper valve sets • Any tubing that is .120 ID, .054 ID, .043 ID, or .033 ID • Any sets with flashback bulbs or latex sleeves on the distal end of the tubing Special sets are available for the delivery of nitroglycerin, epidural infusion, 3-in-1 TPN, fats, enteral feedings, and blood. Sets should be changed in accordance with current, recognized guidelines of IV therapy. Discard sets per hospital procedures. IV infusion sets with integral nonblood filters are not for use in the administration of blood, blood products, emulsions, suspensions, or any medications not totally soluble in the solution being administered. These medications may be administered through the lower Y-injection site, below the filter.

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AcclaimTM encore Infusion System GENERAL Possible explosion hazard exists if used in the presence of flammable anesthetics. Product damage may occur unless proper care is exercised during unpacking and checkout. Do not use the device if it appears damaged in any way. Do not place the device in service if it fails the self-test (see Section 2.2, Self-Test for detailed information). Use of radio frequency emitting devices such as cellular telephones, and two-way radios in close proximity of this pump may affect its operation. This unit may be affected when used in close proximity to some Electrosurgical Units (ESU) when used at high power settings. Be sure to place the pump and administration sets away from the ESU device and its cables. The screen displays total volume delivered in 0.1 mL increments from 1.0 to 99.9 mL. 100 to 9999 mL are displayed in 1-mL increments. Any fraction of a milliliter delivered is not displayed, but is retained in memory.

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AcclaimTM encore Infusion Systems SECTION 2

Getting Started This section describes the initial checkout procedures for the Acclaim encore Infusion Pump.

Unpacking Product damage may occur unless proper care is exercised during unpacking and checkout. Do not use the pump if it appears damaged in any way. The battery may not be charged upon receipt. Inspect the pump packaging for visible shipping damage. If any damage is found, contact the delivering carrier immediately. Carefully remove the pump from the shipping carton. Retain the packing slip and save all packing material in case the pump is damaged or fails the self-test and has to be returned to Hospira. Inspect the pump thoroughly for damage. CAUTION: IF THE PUMP APPEARS TO BE DAMAGED; CONTACT HOSPIRA (SEE SECTION 6.4, TECHNICAL ASSISTANCE).

Self-Test CAUTION:

DO NOT PLACE THE PUMP IN SERVICE IF IT FAILS THE

SELF-TEST.

Connect the AC power cord to AC power, then confirm that the AC power indicator illuminates (below the ON/OFF key). Place a primed administration set into the tubing door (see Section 4.0, INSTRUCTIONS FOR USE). Close the door. Turn the pump on by pressing [ON/OFF].

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System Operating Manual The LCD screen displays all the symbols briefly. Verify that the screen display exactly matches the illustration shown at the right. VTBI TOTAL If the LCD screen does not TIME TOTAL VOLUME match the illustration, remove MG /KG MG/ML/HR MCG/KG/MIN DELIVERED the Acclaim encore from service and contact the hospital repair facility or Hospira Technical Support Operations. BATTERY AIR IN LINE OFF LOCKED CLEAR VTBI COMPLETE CHECK SETTINGS STOPPED KVO DOOR OCCLUSION SET PRIMARY SECONDARY DOSE UP RATE WEIGHT CONC. DILUENT TAPER DOWN

After the Acclaim encore completes self-testing, disconnect it from AC power and confirm that BATTERY displays on the screen (indicating battery power is in use). To ensure the battery is fully charged, remove the administration set, then reconnect the Acclaim encore to AC power for a minimum of eight hours in OFF (CHARGE) mode. NOTE: If an alarm occurs during the self-test, note the message, then take the appropriate corrective action (see Section 6.0, TROUBLESHOOTING). Repeat the self-test. If the alarm recurs, remove the Acclaim encore from service and contact Hospira Technical Support Operations. NOTE: The Acclaim encore provides an optional Dose Calc function. This function is not enabled (off) when shipped from the factory. When not enabled, the [Dose Calc] key does not respond to user input. To enable the Dose Calc function (per hospital protocol), contact your facilities Biomedical Department.

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AcclaimTM encore Infusion System SECTION 3

COMPONENTS The front and back of the Acclaim encore Infusion Pump components are illustrated below. External Tube Guide

LCD Screen Numeric Keypad

Programming (Operating) Keys PRIMARY

AC Power Indicator

RATE

VTBI

TPN

1

DOSE CALC

4

ON/OFF CHARGE

SECONDARY RATE

VTBI

2

3

CLR VOL

5

6

SILENCE

7

8

9

CLR

0

Door

STOP START

Pump Operating Indicator

Door Handle

IV Pole Clamp Knob

Audio Switch

Lockout Switch

Power Cord

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Operating Keys PRIMARY DELIVERY: Selects the primary fluid delivery rate. The delivery rate is programmed using the numeric keypad. The rate range is 1.0 to 99.9 mL/hr in 0.1 mL/hr increments and 100 to 999 mL/hr in 1 mL/hr increments. Selects the primary fluid volume to be infused/delivered (VTBI). The VTBI rate is programmed using the numeric keypad. The VTBI range is 1.0 to 99.9 mL in 0.1 mL increments and 100 to 9999 mL in 1 mL increments.

RATE

VTBI

SECONDARY DELIVERY: Selects the secondary fluid delivery rate. The delivery rate is programmed using the numeric keypad. The rate range is 1.0 to 99.9 mL/hr in 0.1 mL/hr increments and 100 to 999 mL/hr in 1 mL/hr increments. Selects the secondary fluid volume to be infused/delivered (VTBI). The VTBI range is programmed using the numeric keypad. The VTBI range is 1.0 to 99.9 mL in 0.1 mL increments and 100 to 9999 mL in 1 mL increments.

TPN:

RATE

VTBI

TPN

Delivers a set volume of fluid over a selected time (hours) including the ability to input taper up duration and taper down duration in minutes.

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