Abbott APMII Operators Manual

Contents Warranty

...

Change History.

ii

... vi

a Introduction ... ...

l-3

...

1-3

The Abbott Quick-Loadm Pump Set APMTM II Accessories

l-1

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

...

l-5

0 Setup ... 2-1 Power Source(s) and Bolus Cord Setup

...

2-1

installing Disposable Batteries ... 2-1 Installing the Battery Pack ... 2-2 Connecting the AC Power Supply ... 2-3 Connecting the Bolus Cord ... 2-3 ... 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 Entering a New Program ... 4-5 Displaying the Date and Time Changing the Clock.

... 4-6

Changing the Air Sensitivity Locking the Keypad

... 4-6

... 4-7

... 4-8

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 ... 5-I History Review Tips and Information Displaying the History Event Log Displaying the Amounts Delivered Printing the Program History

... 5-l

5-3 ... 5-3

...

... 5-3

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

...

1

7-l

Customer Support ... 7-l Displaying Software Version ... 7-1 Guide to Alerts and Alarms ... 7-2 Amount Too Large Alert ... 7-2 Amount Too Small Alert ... 7-2 Call Back or Start Alert ... 7-2 1 and 4 Hour Limit Alert ... 7-2 Almost Empty Alert ... 7-3 Empty Alert ... 7-3 Check Printer Alarm ... 7-3 Check Cartridge Alarm ... 7-4 Occlusion Alarm ... 7-4 Air-in-Line Alarm ... 7-5 Power Alarms ... 7-5 Purge Overuse Alarm ... 7-6 Malfunction Alarm ... 7-6 System Alarm ... 7-8

0 Specifications @ Installation Test

...

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

System Operating Manual

0 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

Cover, v, vi,

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

3-6, Section

Pages Changed

l-3,3-4 to 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

Accepts values entered during programming l Access various operating features l

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)

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System Operating Manual

Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement. l 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. l

Regarding Air-In-Line and Infusion:

Stop infusion if signs or symptoms of infiltration occur. l To reduce the risk of infusing air, use an air-eliminating filter when the air-in-line alarm is off. l

l

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 Teflon@ 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 Duracell@ 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 43@600032-00 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.

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. l Replace the battery door.

l

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

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)