Abbott APMII Operators Manual

Contents Warranty

............................

Change History.

a Introduction

ii

........................ vi

l-1

................... .............

l-3

....................

1-3

The Abbott Quick-Loadm Pump Set APMTM II Accessories

Indications for Use ...................... 1-4 Contraindications for Use .................. 1-4 Warnings and Cautions

0 Setup

...................

.......................

l-5

2-1

...........

2-1

installing Disposable Batteries .............. Installing the Battery Pack ................ Connecting the AC Power Supply ............ Connecting the Bolus Cord ...............

2-1 2-2 2-3 2-3

Power Source(s) and Bolus Cord Setup

............. 2-4 Cartridge Set and Container Setup Preparing the Cartridge Set and Container ....... 2-4 Gravity Priming the Set ................. 2-5 Attaching the Anti-Siphon Valve Extension Set ..... 2-6 Loading the Cartridge .................. 2-7 Purging the Complete Set .................. 2-8 2-9 Using the Lockbox ...................... Using the Pole Clamp .................... 2-10

Using the Carrying Case

430-600032-001 (Rev. 6/05)

.................. .2-10

iv

System Operating Manual

0 Programming

..................

3-1

Programming Tips and Information .............. 3-l Turning On the APM II .................... 3-2 Programming the Pump ................... 3-3

0 Operation A

....................

4-1

Starting delivery

.......................

4-l

Stopping delivery

.......................

4-l

Delivering a Loading Dose

..................

4-2

Delivering a Bolus (or PCA) Dose

..............

4-3

Clearing Amounts at Start of Shift

..............

4-3

Reviewing the Program

....................

4-4

Changing the Program

....................

4-4

Repeating the Program

....................

4-5

...................

4-5

Entering a New Program

................

4-6

.....................

4-6

Displaying the Date and Time Changing the Clock.

.................

4-7

.....................

4-8

Changing the Air Sensitivity Locking the Keypad

4-9 Locking the Keypad ................... 4-9 Unlocking the Keypad .................. 4-9 Activating the Automatic Keypad Lock .......... Deactivating the Automatic Keypad Lock ....... 4-10

0 Program History ................. History Review Tips and Information

5-l

..............

5-3 5-3

.................

5-3

Displaying the History Event Log Displaying the Amounts Delivered Printing the Program History

.............

5-I

...............

430-600032-001 (Rev. 6105)

Maintenance

...................

6-1

Cleaning and Disinfection .................. 6-l Cleaning the Optics ..................... 6-2 Battery Pack Recharging ................... 6-3 Storage and Memory Protection ............... 6-3 Functional Testing ...................... 6-4 Repair ............................ 6-4 n

U Alerts & Alarms

c

.................

Customer Support ...................... Displaying Software Version ................. Guide to Alerts and Alarms ................. Amount Too Large Alert ................. Amount Too Small Alert ................. Call Back or Start Alert ................. 1 and 4 Hour Limit Alert ................. Almost Empty Alert ................... Empty Alert ....................... Check Printer Alarm ................... Check Cartridge Alarm ................. Occlusion Alarm ..................... Air-in-Line Alarm ..................... Power Alarms ...................... Purge Overuse Alarm .................. Malfunction Alarm .................... System Alarm ......................

0 Specifications @ Installation Test

. . . . . . . . . . . . . . . . . .

.................

1

7-l 7-l 7-1 7-2 7-2 7-2 7-2 7-2 7-3 7-3 7-3 7-4 7-4 7-5 7-5 7-6 7-6 7-8

8-1 9-1

Physical Inspection ...................... 9-l Operation Verification .................... 9-2 Abbott Pain Manager II (APM TM II) Installation Test Record . 9-9 43MOO032-A01 (Rev. 2/96)

vi 0

System Operating Manual

Change History

Pat? Number

Description of Change

430-600032-001 (Rev. 6/95)

Original Issue

430-600032-A01 (Rev. 2/96)

Correct bolus cord list number; add

note regarding priming before starting loading dose; add notes regarding delivery of bolus and loading doses

Pages Changed

Cover, v, vi, l-3,3-4 to

3-6, Section 9, back cover

with hour limit set; add Section 9, Installation Test; add CE Mark

43CMI0032-A01 (Rev. 2/96)

0

Introduction

The Abbott Pain Manager II (APMTM II) is a single-channel infusion pump that delivers analgesia to patients in the hospital, in outpatient treatment centers, and in the home. The pump is designed for pain management protocols, e.g., epidural, Patient Controlled Analgesia (PCA), and can also be used for other therapies that require infusion delivery schedules of continuous rates at or below 25 milliliters per hour (mIJhr), continuous with bolus, or bolus only Three programming options are available: Continuous Bolus or PCA Only Both Continuous and Bolus or PCA The APM II infuses in three units of delivery: milliliters milligrams (mg), or micrograms (pg).

(mL),

A loading dose may be set for delivery during programming, when programmingis complete, or after the pump is started. Programmed bolus (or PCA) doses are delivered using the bolus cord. A keypad lock option is available to control access to pump functions. Safety features include built-in alarms for an improperly installed cartridge, air or occlusion in the line, low power, and device malfunction. For a complete list of alerts and alarms, go to Section 7, Alerts and Alarms. The pump maintains a timed history of each event (for example, bolus requests made and delivered) and any alarms that may occur that can be reviewed on the screen or printed. The APM II has three power source options: two disposable 9-V batteries, an AC power adapter, or a rechargeable snap-in battery pack. A lockbox, pole clamp, and carrying case are available as accessories to allow the pump to be mounted on an IV pole or carried over a shoulder or around the waist. The figure on the next page shows the APM II’s operating controls. 430-600032-001 (Rev. 6/05)

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System Operating Manual

SILENCE l Silences various alarms RUN/STOP l Starts or stops delivery HISTORY l Accesses program, shift, and container information l

Prints program, shift, and container information

during programming REVIEW/CHANGE l Reviews and than

l

Press and hold to purge the pump

LOADING DOSE l Enters and delivers a loading dose UP and DOWN arrows l Scroll through history log l Up arrow enters decimal

l

l

Accepts values entered during programming Access various operating features

YES and NO l Respond to questions during programming ON/OFF l Turns the power on or off

430-600032-001 (Rev.

6/05)

APM II Introduction

1-3

0 The Abbott Quick-Load” Pump Set The APM II can be operated with an Abbott Quick-LoadTM set (e.g., List No. 13580), which is a sterile, single-use, disposable set. Contact an Abbott Laboratories representative for appropriate set

configuration. The minimum elements required for use with the APM II pump include one of each of the following: Non-vented, collapsible fluid container l Abbott Quick-Load pump set * Patient access device l

Accessories such as air eliminating filters and extension sets may be added to the line as required by the therapy. ‘Ib use an Abbott Quick-Load set, follow directions included with the set.

Cl APMTM II Accessories These accessories are available for use with the APM II: AC Power Supply, List 13036 Powers the APM II. Do not use the power supply with other products. Battery Pack System, List 13886 Two rechargeable Battery Packs and the Battery Charger. Battery Pack, List 13887 Powers the APM II pump during periods of ambulation or when use of AC power is not desirable. Battery Charger, List 13888 Charges the Battery Pack. Bolus Cord, List 13701 Allows bolus requests to be made up to 6 feet away from the pump. Carrying Case, List 13959 Carries a 250 mL or smaller container of solution and the APM II pump with batteries or battery pack installed. 43~600032-A01 (Rev. 2/96)

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System Operating Manual

Lockbox, List 13955 Secures the pump and 250 mL or smaller container of solution or 30 mL Abbott prealed syringe. Access is provided for connection of bolus cord, AC Power Supply, and printer. Lockbox Key, List 13387 Replacement key for Lockbox. Pole Clamp, List 13230 Attaches the pump to an IV pole. Pole Clamp Adapter, List 13728 Printer Cables, Lists 13007 and 13008 13007 for Seiko’ DPU411 printer 13008 for Kodak Diconix* 150+ & 180si printers Allows the event history log to be printed.

0 Indications for Use The pump is suitable for intravenous (central line or peripheral access), arterial, subcutaneous, and epidural infusion. Pump users should be under the supervision of a healthcare professional and should be instructed in using and troubleshooting the pump. Instruction 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. Approved anesthetic drugs (e.g., Chloroprocaine Hydrochloride USP, Lidocaine Hydrochloride USP) and analgesic drugs (e.g., Morphine Sulfate Injection, Preservative-Free USP) can be administered epidurally through recommended device sets without Y-injection sites.

Cl Contraindications for Use The pump should not be used by patients who do not have the mental and physical capability or emotional stability to receive infusion therapy with this device. Physicians or certified, licensed healthcare professionals should always oversee therapy Drugs not compatible 430-600032-001 (Rev.

6/95)

APM II Introduction

1-5

with silicone rubber or PVC plastic, or not stable under infusion conditions should not be used with this system. The drug reservoir should preferably be a nonvented, collapsible container or syringe. If a vented fluid container is used, it should be suspended Tom an IV pole and used with a Universal Adapter Pin (List 17015-48).

0 Warnings and Cautions The following is a list of warnings and cautions that should be heeded when operating the APM II. Attention should be given to all alert messages. General:

Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed practitioner. Manual references to specific values are approximate only unless indicated otherwise. Air-in-line sensitivity values are approximate only. For those patients who are likely to be adversely affected by unintended operations and failures, including interrupted medication or fluid delivery from the device, close supervision and provision for immediate corrective action should be provided. Regarding Drugs Used, Cartridge Sets, and Containers:

Never use drugs that are incompatible with silicone rubber or PVC plastic. To reduce loss of potency for drugs known to be absorbed by plastic and silicone, begin infusion as soon as practical after priming the set. Use of high flow rates during infusion will minimize drug absorption. Do not use medications which are unstable under infusion conditions. Always use connections with luer lock fittings. Use aseptic technique with all fluid path connections. Remove the protective coverings as assembly progresses. Always close the slide clamps before removing the cartridge from the pump. 43CMOOO32-001 (Rev. 6/05)

I-6 l

l

System Operating Manual

Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement. Never use vented fluid containers (e.g., glass or rigid plastic) unless suspended from a pole and a Universal Adapter Pin, List No. 17015-48, is in place.

Regarding Air-In-Line and Infusion: l l

l

Stop infusion if signs or symptoms of infiltration occur. To reduce the risk of infusing air, use an air-eliminating filter when the air-in-line alarm is off. Always remove all air from the cartridge, tubing and injection site. Always disconnect the set from the patient prior to priming.

Regarding Epidural Administration

The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. For epidural use, the administration of drugs is restricted to those anesthetic and analgesic drugs approved for continuous epidural administration: Chloroprocaine Hydrochloride USP, Lidocaine Hydrochloride USP and Morphine Sulfate Injection USP, (Preservative Free). For epidural administration, the following is recommended: - Nylon or [email protected] catheter - Pump sets without Y-sites - Epidural stickers for the pump indicating ongoing epidural administration Epidural administration of drugs should be limited to medical professionals familiar with associated techniques and patient management problems. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration. Facilities practicing epidural administration must be equipped with resuscitative equipment, oxygen, naloxone, and other resuscitative drugs. Adequate monitoring equipment (e.g., Oximetry), is recommended for continuous monitoring of the patient during epidural administration. Patients must be observed for side effects frequently in a fully equipped and staffed environment for at least 24 hours following completionPIof drug administration by the epidural route. 430-600032-001 (Rev.

6/95)

APM II Introduction

I-7

WARNING: Delayed respiratory depression following continuous epidural administration of preservative-free morphine sulfate has been reported. The epidural space has 58 openings through which fluid can exit. Pressure buildup during administration is transient. However, if a large volume of fluid is administered over a short time period, the pressure takes longer to return to normal. If over-delivery occurs during administration, observe the patient closely for compression on the spinal cord (disorientation, headache, transient neuralgias) and drug overdose. Epidural administration of anesthetics is limited to the continuous mode only. Epidural administration of analgesics may be delivered by continuous, bolus, or continuousibolus. Regarding Pump Operation:

If the pump does not perform as stated in this manual, remove from service immediately. Always connect to grounded AC outlet when using the AC power supply. Do not use non-Abbott AC power supplies with the APM II as this may result in damage to the pump’s circuitry. Pump performance may vary with use of batteries other than g-volt [email protected] alkaline batteries. Installing batteries is recommended, regardless of the power source used, to provide continuing operation if AC power fails. Always replace both batteries with new batteries when a change is required. Always avoid sources of high intensity electromagnetic radiation (e.g., radio transmitters, MRI scanners, microwave ovens, X-ray machines, and CAT scanners). Possible explosion hazard exists if used in the presence of flammable anesthetics. Never use the pump in the presence of flammable or explosive vapors. Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. 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 [email protected] 1 (Rev. 6/05)

1-8

System Operating Manual

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 device instead of some other source in the environment, set the infusion device so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by electronic noise generated by the infusion device. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring system documentation for setup and maintenance instructions. Regarding Handling and Maintenance:

Product damage may occur if proper care is not exercised during unpacking, installation, and use. Should the pump inadvertently be subjected to mishandling, check connections and programmed data to confirm no damage has occurred. Always avoid dropping or hitting the pump. If the pump is dropped or hit, always verify programmed data. Never use sharp objects (e.g., fingernails, pens, pencils or other probes) to program or clean the pump. To avoid mechanical or electronic damage, never submerge pump in water or other fluids and avoid fluid spills. If pump becomes wet, dry it immediately. Check connections and programmed data. Some cleaning and sanitizing compounds may slowly degrade components made from some plastic materials. Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride. Do not sterilize by heat, steam, ETO, or radiation. Apply disinfectants to the outside surface of the pump only. Do not use abrasive cleaners or materials on the pump. Using abrasive cleaners or cleaning solutions not recommended by Abbott Laboratories may result in product damage. Use only the AC power supply delivered with the APM II to charge the battery pack. Always remove batteries if pump is to be stored for an extended period of time.

43O-6OOCB2-001 (Rev. 6/95)

Q

Setup

This section describes how to set up the following elements of the APM II system: Power sources - batteries, battery pack, and AC power supply Bolus cord Cartridge set and container Accessories - lockbox, pole clamp, and carrying case

0 Power Source(s) and Bolus Cord Setup Install batteries, the battery pack, or the AC power supply before using the APM II. If bolus or PCA delivery is desired, connect the bolus cord. 0 Installing Disposable Batteries

!III install batteries, complete the following steps: l

Turn the pump off and remove the battery door on the back of the P-P.

l

l

Insert two 9-V batteries into the compartment; be sure the positive and negative battery terminals are placed according to the diagram in the battery compartment. Replace the battery door.

Two (2)

9 Volt Batteries

43MOOO32-001 (Rev. 6/95)

2-2

System Operating Manual

CAUTION: To assure proper pump operation, always replace both batteries with fresh alkaline batteries when a change is required. Installing batteries is recommended regardless of the power source used to provide continuing operation if AC power fails.

0 Installing the Battery Pack ‘III install the battery pack, complete the following steps: l l l l

Remove the battery compartment door. Remove the disposable batteries, if installed. Slide the battery pack into the battery compartment. While pressing the battery pack in place, rotate its knob clockwise to lock it into position.

III remove the pack, rotate its knob counter-clockwise and slide the pack out. For charging instructions, go to page 6-3, Battery Pack Recharging.

Open and lock knob 430-600032-001 (Rev.

6/05)

2-3

APM II Setup

iUPPlY

B

0 Connecting the AC Power Supply ‘Ib connect the AC power supply, complete the following steps: l l

Insert the pin connector into the port on the bottom of the pump. Plug the AC power supply into a standard wall outlet (grounded 110 volt).

CAUTION: Always connect to grounded AC outlet when using the AC power supply. WARNING: Use of power adapters other than Abbott approved power adapter could damage the internal electronic components of the device which may cause a malfunction of the device.

0 Connecting the Bolus Cord Tb connect the bolus cord, insert the pin connector into the port on the pump. 430-600032-001 (Rev.

6/95)

2-4 0

System Operating Manual

Cartridge Set and Container Setup

Before programming the pump, prepare the cartridge set and container for delivery, gravity prime the set, attach the anti-siphon valve extension set (if required), and load the cartridge in the pump. CAUTION: To prevent contamination, use aseptic technique with all fluid path connections. Remove protective coverings as assembly progresses.

0

Preparing the Cartridge Set and Container 0

Open the delivery set package and remove the contents. If using a cartridge set with an anti-siphon valve extension, separate the cartridge set and extension set and return the extension set to the package.

0

0

I

Loosen, but do not remove, the protective cover from the distal male adapter.

Confirm that the cartridge is in

the open position with the dot inside the parallel lines. The cartridge must be open to allow fluid to flow through the tubing.

430-6OOQ32-001 (Rev. 6/95)

2-5

APM II Setup

0 Gravity Priming the Set The set should be gravity primed before loading into the pump to eliminate air from the tubing. 0

Remove the protective covers from the fluid container administration port and the cartridge set piercing pin. Turn the flexible fluid container so port is toward the ceiling and insert the piercing pin.

0

l

430600032-001 (Rev. 6/05)

Confirm that the slide clamp is open and allows fluid to flow through the tubing.

Roll or squeeze the end of the fluid container to force fluid through the tubing and out of the distal (patient) end of the cartridge set.

2-6

System Operating Manual

l

l

Turn the control knob on the cartridge to the closed position. Confirm the dot is inside of the red circle.

Close the slide clamp.

0 Attaching the Anti-Siphon Valve Extension Set 0

Remove anti-siphon valve extension set from packaging. Remove protective covers from the male connector on the and the cartridge set anti-siphon valve extension set, then aseptically connect two sets.

Distal male adapter

l

Confirm that the slide clamp on anti-siphon valve extension set is open.

430-600032-001 (Rev.

6/95)

APM II Setup

2-7

0 Loading the Cartridge Open the pump latch by sliding the latch down, then out. Confirm the cartridge is closed (dot is inside the red circle). Align the cartridge to fit the shape of the cartridge channel. The tab labeled DO NOT REMOVE should be to the left and the rotor should be positioned over the motor shaft.

Push cartridge into cartridge channel until firmly seated. Close the pump latch by sliding the latch down, in and up. Confirm that the cartridge is locked into place.

43MOOO32-001 (Rev. 6/95)

2-8

System Operating Manual

0 Purging the Complete Set Purge the complete set (container, cartridge set, and anti-siphon valve extension set) before an infusion or between changes in medication bags. WARNING: Remove air from the tubing before connecting the set to the patient.

In the stop mode, press [PURGE].

Press [YES].

1

I

DISCONNECT FROM PATIENT NOW

This message displays briefly. No response required. Press and hold [PURGE]. Note: The purge overuse alarm will activate if [PURGE] is held for four minutes. Press [ENTER] + [A] + [A] to silence alarm and return to stop mode. If purging will take more than four minutes to complete, release [PURGE] before alarm occurs, press [YES] to indicate purge is complete, then press [PURGE] again and follow the steps above.

I

I

PURGING 0.0 MG

This message flashes while purging is in process. Unit displayed (mL, mg, or pg) is based on program entered. 430-600032-001 (Rev.

6/95)

2-9

APM II Setup

When [PURGE] is released this display appears. To continue purging, press [NO]. If purging is finished, press [YES] to return the pump to the stop mode. The purged amount is limited to the amount delivered in four minutes. Note: The volume purged is not added to the volume infused count, but is stored in the history event log.

0 Using the Lockbox The lockbox secures the pump with the cartridge and fluid reservoir in place. A key locks the lockbox door. A pole clamp attaches the lockbox to a vertical, round, or square IV pole 0.5-1.5 inches (1.3-3.8 cm) in diameter. The lockbox provides access to the remote bolus port, the AC power port, and the printer port. The lockbox cannot secure the pump while the rechargeable battery pack is installed. ‘lb secure the pump in the lockbox, complete the following steps: Open the lockbox door with the key. Place the fluid bag or syringe in the back of the lockbox. Note: Confirm the piercing pin and the tubing between the bag/syringe and the pump are not kinked. The pump signals an occlusion only if the kink is between the pump and the patient. Slide the pump with the installed cartridge from right to left in the front of the lockbox. Confirm that the tubing and cords emerge from the lockbox through the appropriate openings. Close the lockbox door and lock with the key. Secure the lockbox to the IV pole with the pole clamp. Confirm that the lockbox is secure on the IV pole when the door is opened. 430+00032-001 (Rev. 6/05)

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System Operating Manual

0 Using the Pole Clamp If a lockbox is not used, the pump can be secured to an IV pole by using the pole clamp package. To attach the pump to the pole clamp, screw one half of the two piece pole clamp package into the large hole on the top left side of the back of the pump, then slide the pump onto the pole clamp.

0 Using the Carrying Case The pump and the fluid bag can be placed in the carrying case for transportation. The carrying case strap can be adjusted to carry the case over a shoulder or around the waist. Note: Confirm that the tubing between the fluid bag and the pump is not kinked. The pump signals an occlusion only if the kink is between the pump and the patient. To use the carrying case, proceed as follows: Unzip the top of the case and release all [email protected] straps. Place the pump and installed cartridge in the lid so the back of the pump faces up and the display screen is visible through the clear window of the case. Secure the wide straps across the width of the pump and secure the long black strap across the length of the pump. Release the black retaining straps. Open the Velcro pocket flap in the bottom of the case. Insert the fluid container with the spike connection on the open side of the pocket. Secure the Velcro pocket flap and secure the black retaining straps over the pocket flap and the tubing in the Velcro tubing guides. Verify the patient side of the tubing and the remote bolus cord (if connected) emerges through the carrying case from the zipper gap, then zip the case closed.

430-600032-001 (Rev.

6/95)

0

Programming

0 Programming Tips and Information Use the number keys to make value selections and press [ENTER] to accept; e.g., press [2] + [0] + [ENTER] to enter 20.

Ioi A

Press [A] to place a decimal point in a numeric value. Press [RESET] before pressing [ENTER] to return an incorrect numeric value to zero.

'ENTER' IF DONE

About 5 seconds after selecting a numeric value you will be reminded to press [ENTER] to confirm that value.

If a value entered is too small, this message AMOUNT TOO SMALL flashes; the pump defaults to zero. If a value entered is too large, this message

AMOUNT TOO LARGE flashes; the pump defaults to zero.

ROUNDING

Volumes in mg or pg may be rounded down to the nearest 0.1 mL equivalent. The pump makes the calculation, then displays the rounded value for confirmation. Variable characters are shown in this manual as x. The actual displays you will see depend upon choices you make during programming.

43MOOO32-001 (Rev. 6/95)

3-2 0

System Operating Manual

Turning On the APM II

I

UNIT SELF-TEST IN PROGRESS

I

Press [ON/OFF] to power on the pump. The

pump begins a self-test. No response required.

The current program mode displays, if it was not cleared before power-off. The current time and date display for several seconds afier the self-test. If the time or date are incorrect, program the pump, then change the setting. For instructions, go to page 4-6, Changing the Clock. Press [YES] to clear and enter a new program and history or [NO] to keep the current program and history. If [NO] is pressed, the pump enters the stop mode. Press [RUN/STOP] to begin delivery. To retain history and enter a new program, refer to page 4-5, Entering a New Program. If [YES] is pressed, this message appears indicating the pump is clearing the program and history; no response required. The previous program and history are cleared. The pump automatically advances to the first programming screen.

(KEYPAD1

If the keypad is locked and [YES] is pressed to clear the history, this message displays briefly. The pump automatically advances to the stop mode. For information, refer to page 4-8, Locking the Keypad. 430-600032-001 (Rev.

6/95)

3-3

APM II Programming

0 Programming the Pump Step 1 - Choose delivery mode

Press [YES] to program in the epidural mode. Press [NO] to advance to the PCA mode display screen. Press [YES] to program in the PCA mode.

Step 2 - Choose type of delivery Press [I], [2], or [3] to select type of delivery.

If PCA mode has been selected, the second line will display 2 PCA ONLY.

Step 3 - Choose unit of delivery

Press [YES] if programming in mg/mL. Press [NO] to scroll to next screen. Press [YES] if programming in pg/mL. Press [NO] to scroll to next screen. Press [YES] if programming in mL. Press [NO] to scroll back to mg/mL screen. The unit selected carries through the remaining steps automatically. For continuous mL programming, go to Step 4; for bolus only mL, go to Step 5. 43MiIOO32-001 (Rev. 6/95)

3-4

I’““““?% 1

System Operating Manual

Select the concentration of mg/mL or pg/mL.

press [ENTER].

For bolus only programming, go to Step 5.

Step 4 - Set continuous delivery rate SET RATE x xx/HR

Select the rate. Press [ENTER].

Step 5 - Program loading dose

Press [YES] or [NO] to indicate if a loading -1 dose is

&sired.

If [NO] is pressed, go to Step 6 for bolus or PCA programming or Step 7 for continuous programming. Select the loading dose. Press [ENTER].

Press [YES] to begin loading dose immediately. [NO] to hold the loading c dose fo;later Press delivery . Note: The [PRIME] key can be used to prime the set before [YES] is pressed to deliver the loading dose. If [YES] is pressed, this display appears. Press [LOADING DOSE] to begin delivery. The amount infused displays while delivery

430-600032-A01 (Rev. 2/96)

3-5

APM II Programming

When delivery is complete, go to Step 6 for bolus or PCA programming or Step 7 for continuous programming. Step 6 - Program bolus or PCA dose

Select the bolus dose amount (mL, mg, or

pg). Press JSETl [ENTER].

If PCA mode has been selected, the pump willdisplay SET PCA DOSE.

71

Select the bolus lockout time (from 5 to 999).

Press [ENTER].

If PCA mode has been selected, the pump willdisplay PCA LOCKOUT . 4

OR 1 HR LIMIT'

Press [YES] to set a limit on the amount of drug the patient can be given in one or four hours. If no limit is desired, press [NO] and go to Step 7. Note: In epidural mode, a default one-hour limit of 25 mL is set (or equivalent in mg or pg). If [NO] is pressed to bypass the limit option, this default remains active. This default limit can be raised or lowered by answering [YES] to set a limit. Note: A bolus in progress will not be stopped until the individual bolus volume has been delivered, therefore, a bolus delivery initiated before the programmed limit has been reached may exceed the limit at the completion of the bolus. Note: Loading doses are not included in the limit volume and a limit in effect does not prevent a delivery of a loading dose.

43MOO032-A01 (Rev. 2/96)

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System Operating Manual

Press [I ] or [4] to choose the length of limit.

Select the maximum volume (continuous plus bolus amount) that can be delivered over a one-hour or four-hour period. Press [ENTER].

Step 7 - Program container size

Select the container size. Press [ENTER].

Note: Volume that is used when purging the pump with the [PURGE] key is subtracted from the container but is not added to the amount infused. Step 8 - Select air sensitivity

High = alarm at approx. 100 pL of air. Low = alarm at approx. 300 pL of air. Off=airalarmoff. AIR SENSITIVITY l=HI 2=LOW 3=OFF

Press VI, VI, or [3] to select air alarm sensitivity setting. The setting selected displays for several seconds, then the pump saves the program and enters the stop mode. Go to page 2-8, Purging the Complete Set, for instructions.

CAUTION: To reduce the risk of infusing air, use an air-eliminating filter when the air-in-line alarm is off. 43tMO0032-A01 (Rev. 2/96)

Operation 0 Starting delivery Before starting an infusion, confirm the following: All the set connections are secure. Air is removed from the container and the tubing. Slide clamps are open. Any clamps on the patient access device are open. In the stop mode, press [RUN/STOP].

TOTAL x xx / x xx/HR RATE

The pump enters the run mode. A bar icon (/) rotates while the pump is operating. The total increases as the infusion continues.

0 Stopping delivery

-1 PRESS RUN/STOP TO INFUSE

430-600032-001 (Rev. 6/95)

In the run mode, press [RUN/STOP].

The pump enters the stop mode.

4-2

System Operating Manual

0 Delivering a Loading Dose If a loading dose is set during programming and not delivered at that time, it can be delivered at the start of the program or delayed for delivery during infusion. I

I

PRESS RUN/STOP TO INFUSE

In the stop mode, press [RUN/STOP]. If a loading dose is available, the following message appears automatically. Press [YES] to begin loading dose. Press [NO] to hold the loading dose for delayed delivery (see instructions below). Press [LOADING DOSE] to begin delivery.

DEL. LOAD DOSE x xx 1

1

I

I

TOTAL x xx / x xx/HR RATE

The amount infused displays while delivery is in progress. When the loading dose is complete, the pump automatically enters the run mode. The dose amount is logged to the history and the bolus lockout time is set (if applicable). Subsequent bolus requests are ignored until the lockout time has elapsed.

> Delayed Loading Dose Delivery

If a loading dose is held for delivery during infusion, the user will not be prompted again to deliver the loading dose. ‘Ib deliver the delayed loading dose, place the pump in the stop mode, press [LOADING DOSE], and follow the steps above. After the loading dose completes, press [RUN/STOP] to begin delivery again - restart of infusion is not automatic if the loading dose is delivered after the start of the program. 430-600032-001 (Rev. 6195)

4-3

APM II ODeration

Cl Delivering a Bolus (or PCA) Dose 9311 start a bolus delivery, press the button on the end of the bolus

cord. The pump sounds three beeps and delivery begins, The amount infused accrues as the delivery progresses. If the bolus delivery does not start, it may be locked out by one of the following conditions: l l l

Bolus lockout period is in effect. One-hour or four-hour amount limit is in effect. Loading or bolus dose delivery already is in progress.

After a bolus is delivered, the amount is added to the totals in the shiR volumes and program volumes in the event history log and the bolus delivered count is incremented. When a bolus is requested the demand count is incremented.

0 Clearing Amounts at Start of Shift PRESS RUN/STOP TO INFUSE

In the stop mode, press [RESET].

Press [I].

SHIFT RESET

No response required. The pump returns to the stop mode. Note: When new shift totals are cleared, the Shift Information in the History Event Log is reset to zero; the program amounts continue to accumulate. Refer to page 5-2 for an example of the History Event Log.

43MCK1032-001 (Rev. 6195)

4-4

System Operating Manual

0 Reviewing the Program Press [REVIEW/CHANGE] from the run or

stop mode to review the current program.

Press [I].

Press [A] or [HISTORY] to scroll through the program parameters. Press [v] to scroll back to the previous screen. REVIEW COMPLETED To end review, press any key other than [A], [VI, or [HISTORY]. The pump returns a TO VIEW

to the mode it was in when the review was requested.

0 Changing the Program /

‘“~~SRWW~T”

1

I:\ Press

1

C HAN GE PROG

RAM 12 1 NEW PROGRAM

In the stop mode, press [REVIEW/CHANGE].

[2].

Press [I]. A screen listing the mode and type of delivery displays briefly, followed by the first program parameter screen. For each program parameter, the current entry displays or flashes. Press [ENTER] or indicated key, e.g., [YES], to accept parameter as shown or change entries as desired. Every parameter must be confirmed to complete the change program function, After the air sensitivity setting is confIrmed the pump enters the stop mode. 430-600032-001 (Rev.

6/95)

4-5

APM II Operation

0 Repeating the Program In the stop mode, press [RESET].

Press [2].

No response required. The pump returns to the stop mode.

0 Entering a New Program PRESS RUN/STOP TO INFUSE

1 REVIEW

In the stop mode, press [REVIEW/CHANGE].

Press [2].

2 CHANGE

1 CHANGE PROGRAM hSS[2]. 2 NEW PROGRAM

Press [YES] to clear the history, or press [NO] to clear only the current program. The pump enters the programming mode. instructions, Go to page 3-3, Programming.

/ EP1~~?kl?~E For

43MOOO32-001 (Rev. 6/95)

4-6

System Operating Manual

0 Displaying the Date and Time

1 ‘“~~“1~~~~‘“” 9-40

In the stop mode, press [ENTER], then press

j and

hold [I].

PM The display will remain active as long as [ I]

1;,ZZ~ 95 1z:G is pressed,

0 Changing the Clock ,

The clock operates up to one year with the power off or with the batteries removed. The clock, however, needs adjusting for time zones or for daylight saving time changes.

(

'"~~sRRsT0"

1

In the stop mode, press [ENTER], then [2].

[ ~~;F+URRL$K? / Press [YES] for the 12-hour clock or [NO] if

a 24-hour clock is desired.

Press [YES] for the 24-hour clock or [NO] to return to the la-hour display. Use the arrows keys to select the month. Press [ENTER]. Screens appear for the day, year, hour, minute, AM or PM (for the la-hour clock only), and day of the week. Use the number or arrow keys as indicated to make changes. Press [ENTER] to accept each screen. The changed time and date briefly display, then the pump returns to the stop mode. 430-600032-001 (Rev.

6/95)

4-7

APM II Operation

0 Changing the Air Sensitivity lb change the sensitivity setting, complete the following steps: l l l l

Place the pump in the stop mode Press [ENTER], then [7]. Follow the steps below (determined by the current setting). After a selection is made, the new setting displays briefly, then the pump returns to the stop mode.

If current setting is HIGH sensitivity:

If [NO] is pressed, this screen appears. Press [YES] to select OFF or [NO] to retain HIGH.

If current setting is LOW sensitivity: [YES] to select HIGH.

[NO] to select OFF.

If [NO] is pressed, this screen appears. Press ALARM? YES OR NO [YES] to select OFF or [NO] to retain LOW.

If current setting is OFF (no sensitivity): I

I

HIGH SENSITIVITY Press [YES] to select HIGH. ALARM? YES OR NO Press [NO] to select LOW.

(LOW SENSITIVITY

ALARM? YES OR NO

43CMOOO32-001 (Rev. 6/95)

j

If [NO] is pressed, this screen appears. Press [YES] to select LOW or [NO] to retain OFF.

4-8

System Operating Manual

0 Locking the Keypad Locking the keypad restricts access to programming, purging, clearing the event history log, and setting the clock. For convenience, two types of keypad lock are available: Keypad Lock

Allows the keypad to be locked and unlocked on an as needed basis. Automatic Keypad Lock

Requires the user to lock the keypad each time the pump is placed in the run mode. With this feature activated, the pump will not run unlocked. The automatic lock may be a Full Lock or Container Lock, which allows the container and shift to be reset. To access restricted functions, the user can unlock the keypad, but must reactivate the keypad lock before the pump will run. Deactivating the automatic lock is a separate step from unlocking the keypad. The following functions are available when the keypad is locked: Turning the pump on or off. Starting or stopping the pump. Delivering a bolus (if available). Silencing an alarm. Displaying the date and time. Displaying software version and system error status. Displaying and printing the shift information, container information, or history event log. Unlocking the keypad. With Container Lock only: all of the above plus resetting the container and shift totals.

430-600032-001 (Rev.

6/95)

4-9

APM II Operation

Remove this page to secure the keypad lock. 0 Locking the Keypad In the stop mode, press the following keys about one per second to lock the keypad: [ENTER] + [v] + [v] + [v]

Confirmation message appears briefly on the second line.

0 Unlocking the Keypad In the stop mode, press the following keys about one per second to unlock the keypad: [ENTER] + [A] + [A]

Confirmation message appears briefly on the second line.

0 Activating the Automatic Keypad Lock PRESS RUN/STOP TO INFUSE

In the stop mode, press [ENTER], then [8].

Press [YES]. If [NO] is pressed the pump returns to the stop mode. Press [I] or [2] to choose the type of lock.

43MOOO32-001 (Rev. 6/95)

4-10

System Operating Manual

Type of lock chosen displays briefly, then the pump returns to the stop mode. When [RUN/STOP] is pressed this message appears. Press [YES] to lock the keypad and start delivery. If [NO] is pressed the pump returns to the stop mode and does & begin delivery. This message appears briefly as the pump enters the run mode; no response required. To access restricted functions without deactivating the automatic lock, place the pump in the stop mode then press the following keys about one per second to unlock the keypad: [ENTER] + [A]

+ [A]

0 Deactivating the Automatic Keypad Lock In the stop mode, press [ENTER], then [8].

Press [YES].

No response required. The pump returns to the stop mode.

430-6ooo32-001 (Rev. 6/95)

0

Program History

0 History Review Tips and Information The pump maintains a history event log that registers the type of event (bolus request, start delivery, etc.), time of event, and action resulting (e.g., bolus delivered or not delivered). The log has a 256 event storage capacity When the log limit is reached and not cleared, events continue to be registered; however, the oldest registered event is replaced by the newest event. For convenience, the shift amounts delivered or container amounts delivered may be viewed independently of the entire history log. Arecord can be printed that lists current program parameters, shift information, container information, and the event log (a sample is shown on the following page). To review the current program on screen, refer to page 4-4, Reviewing the Program.

The [HISTORY] key accesses the history menu and scrolls through the log. During a review, press and release [HISTORY] to scroll through the log one screen at a time or press and hold [HISTORY] to scroll quickly through the log. You can also press and release or press and hold [A] to scroll through the log. Press and release the [v] key to scroll back one screen or press and hold [v] to scroll quickly back through the log. To stop a review, press any other key. If no key is pressed for 30 seconds, the pump automatically returns to the mode it was in when [HISTORY] was pressed.

43rM410032-001 (Rev. 6195)

5-2

System Operating Manual

******************* * * ABBOTT * * PAIN MANAGER PUMP * * PATIENT RECORD *******************

Pump Name

PATIENT NAME:

Space to Record

Patient Identification and Medication Information

PATIENT ID: DRUG ADMINISTERED: PM 03:36 AUG

03, 95

Current Program

EPIDURAL MODE CONTINUOUS + BOLUS SETTINGS: DRUG CONCENTRATION DELIVERY RATE LOADING DOSE BOLUS DOSE BOLUS LOCKOUT 4 HOUR LIMIT CONTAINER SIZE AIR ALARM ON HIGH

1.0 MG/ML 5.0 MG/HR 1.0 MG 0.5 MG 005 MINUTES 30.0 MG 500.0 MG

SHIFT CLEARED 03:llPM AUG 03 BOLUS DELIVERED BOLUS DEMANDS BOLUS TOTAL LOADING DOSE SHIFT TOTAL PROGRAM CLEARED BOLUS DELIVERED BOLUS DEMANDS BOLUS TOTAL LOADING DOSE VOLUME INFUSED VTBI HISTORY CLEARED

Shift Information

0000 0000 0.0 MG 0.0 MG 2.0 MG 03:10PM AUG 03

Container Information

0000 0000 0.0 MG 0.0 MG 2.0 MG 498.0 MG 3:lOPM AUG 03

EVENT LOG:

Event Log

PM 03:36 PRINT PM 03:12 START INFUSION PM 03:llSHIFT CLEARED PM 03:10 NEW CONTAINER 03:lO HISTORY CLEARED PM ************ ******* * * VERIFIED BY * ************x***** ******************* * * END OF EVENT LOG * * * * *********x****x 430-600032-001 (Rev.

6105)

5-3

APM II Proqram History

0 Displaying the History Event Log In run or stop mode, press [HISTORY].

/Z

1 REVIEW HISTORY Press[l].

/ Press [HISTORY] or [A] to scroll through the

IHISTORY C LEARED

9

: 4 0 PM, AUG

3

log; press [v] to scroll back. Press any other key to stop the review.

0 Displaying the Amounts Delivered In run or stop mode, press [HISTORY].

Press [I] to display shift information or [2] to display container information.

9 : 4 0 PM, AUG

Press [HISTORY] or [A] to scroll through the log; press [v] to scroll back. Press any other key to stop the review.

0 Printing the Program History The history event log can be printed by connecting the pump to a printer. Two custom printer cables are available. (refer to page l-4 for list numbers). The cables are not interchangeable. CAUTION: Printers should be operated on battery power when used with the APM II. Do not connect the AC power supply to a printer. 430-600032-001 (Rev.

6/95)

5-4

System Operating Manual

To print from the APM II, complete the following steps: 0 0

0

0 0

Connect the cable to the printer per manufacturer’s instructions. Insert the cable pin connector into the port on the bottom of the P-P. Before the printer is powered on, set the dipswitches or printer settings as shown below. Load paper and place the printer ON LINE. In run or stop mode, press [PRINT] to start printing.

P Seiko DPU411 Dipswitch Settings Switch 2

I

P Kodak Diconix 150+ Dipswitch Settings

P Kodak Diconix 180si Printer Settings

Generate the Current Printer Settings printout and confirm that they match the required settings. (Sample default printout) Current Printer Settings (1) Emulation = SP Command Set (2) Page Length = 11 inches (3) Perforation Skip =off (4) Character Set = USA (5) Character Default = Roman8 =CR (6) Carriage Return = LF+CR (7) Line Feed = Unidirectional (8) Graphic Print Dir (9) LF/Graphic/Pitch Mode = Normal = RDY/BUSY (10) Protocol = None (11) Parity (12) Data Length = 8 bits (13) Baud Rates (Stop Bits) = 9600 (1)

Required Settings Epson FX-85 11 inches On USA changes to Set 1 CR+LF LF Unidirectional Normal RDY/BUSY None 8 bits 2400 (1) 430-600032-001 (Rev.

6/05)

0 0

Maintenance

CAUTION: To avoid mechanical or electronic damage, do not immerse pump in any fluids or cleaning solutions. Some cleaning and sanitizing compounds may slowly degrade components made from some plastic materials. Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride. Do not sterilize by heat, steam, ETO, or radiation. Apply disinfectants to the outside surface of the pump only. Do not use abrasive cleaners or materials on the pump. Using abrasive cleaners or cleaning solutions not recommended by Abbott Laboratories may result in

product damage. To avoid pump damage, cleaning solutions should be used only as directed in the table on the following page. The disinfecting properties of cleaning solutions vary; consult the manufacturer for specific information. Never use sharp objects such as pens, pencils, fingernails, paper clips, needles, etc., to clean the pump.

0 Cleaning and Disinfection The pump case exterior and cartridge channel should be kept clean and free of contamination. Establish a routine schedule for cleaning the APM II. Tb clean the APM II, complete the following steps: l l

Turn off the pump. Clean the exposed surfaces of the pump with a soft, lint-free cloth dampened with the appropriate cleaning solution listed in the table on the following page. The pump is not affected by the appropriate cleaning solutions.

43MOOO32-001 (Rev. 6/05)

6-2

l l

System Operating Manual

Note: Not all cleaning solutions are disinfectants. Check product labeling. Wipe the solution from the pump surface with a moistened cloth. Dry the pump after cleaning. Cleaning Solutions Cleaning Solution

Manufacturer

Preparation

Super [email protected]

S. M. Edison Chemical Co.

Per manufacturer’s recommendation

[email protected] II se

Calgon Vestal Laboratories

Per manufacturer’s recommendation

[email protected]

Calgon Vestal Laboratories

Per manufacturer’s recommendation

Formula CW

Diversey Corp.

Per manufacturer’s recommendation

Household bleach

Various

Per hospital procedures; do not exceed one part bleach in four parts water

0 Cleaning the Optics The area containing the optics surfaces, located in the cartridge channel, should be cleaned on a regular basis. CAUTION: If the optics surfaces are not kept clean and free of detergent film, the pump’s ability to detect air in the tubing or occlusion in the tubing between the pump and the patient may be impaired. %I clean the pump optics:

Remove the cartridge, if installed. Use a moist cotton swab to clean the pump optics and cartridge channel. Dry the pump optics and cartridge channel after cleaning. Assure that the optics surfaces are free of detergent film. 430-600032-001 (Rev.

g/95)

APM II Maintenance

6-3

0 Battery Pack Recharging Use the battery charger to recharge the battery pack. Abattery pack will fully recharge in four to six hours. Unused battery packs should be charged on a monthly basis to ensure adequate charge for patient use. Note: The battery charger is designed for use with the Abbott List

13887 only Do not use the battery charger with other battery packs. CAUTION: Use only the AC power supply delivered with the APM II

to charge the battery pack. ‘lb recharge the battery pack, complete the following steps: 0 I

0

0

0

Plug the battery recharger into an AC power outlet. Insert the battery pack into the charger cup. Do not force the battery pack into the charger cup. The battery pack will fit into the charger cup one way only. When the battery pack is inserted, the charger’s yellow light illuminates. When the battery pack is fully charged, the charger’s green light illuminates. During charging, the battery pack is warm. If the battery pack becomes hot to the touch, remove it immediately and unplug the battery charger. Contact Abbott Clinical Support for assistance.

0 Storage and Memory Protection Store the APM II in a cool, dry place. Remove the disposable batteries or the battery pack before storing the pump. Program and event history are protected in the software memory for at least one year when power is removed from the pump.

43MOOO32-001 (Rev. 6/95)

6-4

System Operating Manual

0 Functional Testing Abbott Laboratories recommends performing the tests outlined in the APM II Installation l&t Guide (List No. 13965-04-65) every 12 months to verirjr that the pump is functioning properly

0 Repair The APM II has no user-serviceable components, with the exception of disposable batteries. Homecare Customers: Call your healthcare professional or homecare company regarding any required service or repairs. Do not attempt to repair the pump for any reason. The APM II is covered by a manufacturer’s warranty for one year after purchase (refer to page v). During this time, opening the pump case for any reason voids this warranty Refer all service to qualified and trained personnel only. AnApM II Technical Service Manual is available to qualified service personnel.

430-600032-001 (Rev.

6/95)

0

Alerts & Alarms

This section contains information on audible and visual alarms that may occur with the APM II. CAUTION: If the pump does not perform as stated in this manual, stop using it immediately.

0 Customer Support The healthcare professional should contact either an authorized Abbott representative or the Abbott Clinical Customer Support hotline, available 24 hours a day, for consultation and technical assistance. To return a pump for service, first contact Abbott Clinical Customer Support to receive a Returned Goods Authorization (RGA) number, then return the pump to Abbott AIS Technical Service. Abbott Clinical Customer Support:

l-800-338-7867 Abbott AIS Technical Service 15330 Avenue of Science, Suite 100 San Diego, CA 92128

0 Displaying Software Version The sofiware version can be displayed from the stop mode by pressing and releasing [ENTER], then pressing and holding [5]. to hold [S] to retain the display. The stop mode display returns when [5] is

430-600032-001 (Rev.

6B5)

7-2

System Operating Manual

0 Guide to Alerts and Alarms 0 Amount Too Large Alert Message displays briefly after pressing MOUNT TOO LARGE [ENTER] when programming a value. Program value has been requested that pump cannot deliver. Pump displays zero.

0 Amount Too Small Alert Message displays briefly after pressing AMOUNT TOO SMALL [ENTER] when programming a value. Program value has been requested that pump cannot deliver. Pump displays zero.

0 Call Back or Start Alert START

Intermittent beepinglMessage alternateswith PRESS RUN / STOP

Pump is programmed but has not been placed in run mode. Press [SILENCE] to mute alarm for three minutes. Press [RUN/STOP] to start pump.

0 1 and 4 Hour Limit Alert /x / HOUR LIMIT

~~~~~a~~~m

The 1 or 4 hour limit has been exceeded. No action required.

430-600032-001 (Rev.

6195)

7-3

APM II Alerts & Alarms

0 Almost Empty Alert

ALMOST EMPTY

Intermittent beeping Message flashes

Delivery will complete in less than 30 minutes for rates above 1 mL/hr. For rates below 1 mL/hr, less than 1 mL remains to be delivered. For bolus or PCA only delivery, delivery will complete during the next bolus delivery. Press [SILENCE] to silence alarm for lo-minute interval. Press [RUN/STOP] to stop pump and clear the message.

0 Empty Alert

Pump has completed delivery. Press [SILENCE] to mute alarm for two minutes. Press [RUN/STOP] to stop pump and clear the message.

0 Check Printer Alarm CHECK PRINTER

Intermittent beeping Message flashes

If no printer is attached, this alarm occurs when the print key has been pressed accidentally. If a printer is attached, the printer is not responding. Press [SILENCE] to mute alarm for two minutes. Check connections, press [PRINTJ to clear the alarm; then press [PRINT] again to begin printing. Refer to printer manual as required.

43MOOO32-001 (Rev. -5)