Summit Medical ambiT Military PCA Pump User manual

®
®
PATIENT MANUAL
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
Military PCA Pump

Become Familiar with the ambIT®Pump
Solution Container
Cassette
Pump Display
RUN/PAUSE
Button
Tubing
Clamp
Tubing
Clamp
BOLUS
Button
ON/OFF
Switch
ambIT® Military PCA Pump
To Solution Container
To Patient
Cassette
Shaft
(Side View of Cassette)
Filter

Table of Contents
Denitions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Pump Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pause Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Resume Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Silence Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Bolus Activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pump Power ON and OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Battery Installation and Replacement . . . . . . . . . . . . . . . . . . . . . . 7
Summary of Operating Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Visible and Audible Alarm and Signal Table . . . . . . . . . . . . . . . . . . 9
General Care Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Customer Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

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Definitions and Symbols
1
Denitions and Symbols
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. Failure to
observe a CAUTION could result in serious patient or user injury.
Note:
A note highlights information that acts as a reminder or helps explain a
concept or procedure.
This international symbol means: Attention, consult accompanying
documents.
Protected from dripping water.
This is the IEC symbol for TYPE BF equipment.
• IEC Classication Internally Powered.
The ambIT® Military PCA Pump complies with EN 60601-1:1990 including
amendments A1 and A2; IEC 60601-1:1998; IEC 60601-2-24:1998;
CAN/CSA C22.2 No. 601-M90 with supplement No. 1-94; UL2601-1:1997
with amendments 1 and 2.
This CE symbol certies that the product complies with the essential
requirements of the Medical Device Directive.
The “NRTL/C” indicator adjacent to the CSA (Canadian Standards
Association) Mark signies that the product has been evaluated to the
applicable ANSI/UL and CSA standards, for use in the U.S. and Canada.
NRTL (Nationally Recognized Testing Laboratory) is a designation granted
by the U.S. Occupational Safety and Health Administration (OSHA) to
laboratories which have been recognized to perform certication to U.S.
Standards.

Definitions and Symbols
2
Single-use only (Cassettes)
Keep away from heat
Keep dry
Temperature limitation
Sterilized using irradiation
DEHP-free uid path
LATEX-free
Indicates which tubing connects to the
solution container
Indicates which tubing connects to the
patient
Bolus
Program Lockout
Bolus Lockout Time in hours : minutes
Bolus Volume in milliliters
Volume in milliliters
To Solution Container
To Patient
Cassette
Shaft
(Side View of Cassette)

Definitions and Symbols
3
Basal Infusion Rate in ml/hr
Number of Boluses Delivered
Number of Bolus Requests
Volume to be Infused
RUN/PAUSE Button
BOLUS Button
Low/Dead Battery Indicator
Alarm Indicator
Military PCA Pump Display
Pump Power ON
Pump Power OFF
Battery Orientation

Warnings
4
Warnings
Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
This product should only be used by a physician or by a trained individual
under direct supervision of a physician.
Read instructions before use. The Pump must be used strictly in accordance
with these instructions.
Safe use of this Pump is the primary responsibility of the user. The user is
responsible for monitoring this Pump. Contact Clinical/Technical Support if
Pump appears to be operating incorrectly.
All patients should be given a Patient Manual and instructed to read it
carefully.
The Pump must be used only by the person for whom it is prescribed.
Patients should never perform any function or push any button unless
instructed by their health care professional.
Do not allow the Pump to get wet. If the Pump is immersed in any liquid, it
must be replaced with a new Pump.
Transport and storage conditions: -7ºC to 70ºC (20ºF to 158ºF), 10% to 90%
relative humidity and 500 hPa to 1060 hPa atmospheric pressure.
Operating conditions: 10ºC to 43ºC (50ºF to 110ºF), 10% to 90% relative
humidity and 500 hPa to 1060 hPa atmospheric pressure.
Never attempt to open the Pump case. Only the battery cover may be
removed when changing batteries. If the Pump is dropped, it must be
replaced with a new Pump.
This Pump is not to be used for infusion of blood or blood products.
This Pump is not to be used for infusion of life sustaining medications.
Failure to follow manufacturer’s instructions while replacing batteries may
result in loss of program settings and report data. Dispose of batteries
properly after use.
This Pump does not have an air in-line alarm. A Cassette with an air
elimination lter is available.
Safety hazards such as under infusion may be associated with external radio
frequency interference (RFI) or electromagnetic radiation. Typical equipment
which may generate such radiation include x-ray machines, MRI equipment,
and any other non-shielded electrical equipment.

Pump Description
5
ambIT®Military PCA Pump Description
Indications for Use
The ambIT®Military PCA Pump is intended for use by a physician or by a trained individual under direct
supervision of a physician. The Military PCA Pump is used to infuse medicines and/or uids into patients
primarily for pain management. Modes of action are generally intravenous, epidural and/or regional.
Note:
Any use of the Pump other than those indicated herein is regarded as an off-label use.
Note:
Summit Medical Products, Inc. does not recommend or endorse any one specic medication to be used with
the ambIT®Family of Pumps. The medical provider is the sole individual who decides upon the prescribed
medication, pump programmed parameters, method and location of infusion.
Pump Control Buttons
The RUN/PAUSE button is located just below the Pump display. This button is used to start, pause, or resume the
infusion, and to silence alarms. The RUN/PAUSE button toggles between RUN and PAUSE. A blinking green RUN
light (inside the BOLUS button) and “ml” (volume infused) in the Pump display indicate that the Pump is infusing.
If the infusion is paused, a blinking PAUSE symbol ( l l ) appears in the Pump display and two (2) beeps sound every
four (4) minutes, indicating that the Pump infusion has been temporarily stopped.
The BOLUS button is located below the RUN/PAUSE button, and when pressed in RUN mode, the Pump will deliver
the programmed bolus dose. During bolus delivery, the green RUN light (inside the BOLUS button) will double blink.
Solution Container
Cassette
Pump Display
RUN/PAUSE
Button
Tubing
Clamp
Tubing
Clamp
BOLUS
Button
ON/OFF
Switch
ambIT® Military PCA Pump
Filter

Operation
6
Operation
Normal Operation
During normal operation, the green RUN light (inside the BOLUS button) will
start to blink and the “ml” (volume infused) will appear in the Pump display.
Pause Infusion
To PAUSE the infusion, press and hold the RUN/PAUSE button for ve (5)
seconds until one (1) beep is heard. The Pump will beep two (2) times, the
green RUN light will stop blinking, and the PAUSE ( l l ) icon will blink in the
Pump display. If left in PAUSE, the Pump will beep two (2) times every four
(4) minutes.
Note:
PAUSE temporarily stops the infusion. While in PAUSE, the infusion is
delayed. This allows for changing the Cassette, solution container, or
batteries.
Resume Infusion
To resume the infusion from PAUSE, press and hold the RUN/PAUSE button
for ve (5) seconds. The green RUN light (inside the BOLUS button) will
start to blink, and the “ml” (volume infused) will appear in the Pump display.
The infusion will resume at the same point at which the Pump was placed in
PAUSE.
Silence Alarm
To silence an alarm, press and release the RUN/PAUSE button. When the
alarm has been silenced, the Pump will remain in PAUSE. Once the cause
of the alarm has been corrected, press and hold the RUN/PAUSE button for
ve (5) seconds to resume the infusion.
Note:
If the Pump alarms due to downstream pressure (occlusion alarm), and the
cause of the alarm is corrected without intervention, the alarm will silence
and the Pump will resume the infusion automatically.
Bolus Activation
The BOLUS button is located on the Pump directly below the RUN/PAUSE
button. Every time the BOLUS button is pressed during the infusion, the
Pump will beep once. If the bolus dose is permitted, the Pump will begin
bolus administration. During bolus infusion, the green RUN light will double
blink. If the BOLUS button is pressed during the Bolus Lockout Time, the
Pump will beep once, but no bolus will be delivered.
Pump Display
RUN/PAUSE
Button
BOLUS Button

Operation
7
Step 1 Step 2 Step 3
Pump Power ON and OFF
To power ON the Pump:
Rotate the battery cover clockwise until the ( I) mark on the cover lines up
with the ( I) mark on the Pump.
To power OFF the Pump:
STEP 1: Place the Pump in PAUSE.
STEP 2: Rotate the battery cover counterclockwise until the (O) mark
on the cover lines up with the ( I) mark on the Pump. (See
illustration at left.)
Battery Installation and Replacement
The Pump is powered by two (2) AA alkaline 1.5V batteries.
Caution:
Summit Medical Products, Inc. has not tested all rechargeable batteries with
the Pump; therefore we cannot ensure that a specic rechargeable battery will
power the Pump for a period of time. The battery condition and Pump settings
will determine how the battery will perform in the Pump. For this reason, the
time before the low battery alarm occurs and the time between low and dead
battery alarms is difcult to predict with non-alkaline batteries. We recommend
that you change the batteries at the end of each therapy.
The Pump memory is designed to retain program settings and infusion
history for up to six (6) months without power. Failure to follow manufacturer’s
instructions while replacing batteries may result in loss of program settings
and report data. Do not store batteries in the Pump.
Battery Installation
To install batteries:
STEP 1: Insert batteries according to illustration at left.
STEP 2: Place battery cover on Pump as illustrated in diagram (OFF
symbol (O) on cover slightly to the left of the ( I) mark on Pump).
STEP 3: Rotate battery cover clockwise to the OFF (O) position.
Battery Replacement
To replace batteries:
STEP 1: Place Pump in PAUSE.
STEP 2: Rotate battery cover counterclockwise slightly to the left of the
OFF (O) position until cover stops or meets resistance.
STEP 3: Remove cover and replace batteries as described above.
Resuming Infusion After Battery Replacement
First, power Pump ON. Pump will be in PAUSE mode.
Press the RUN/PAUSE button one (1) time. Pump display will scroll through
program settings, then the Pause ( l l ) icon will appear in the display.
Press and hold the RUN/PAUSE button for ve (5) seconds to resume the
current infusion program.
Caution:
Verify that the Pump is in PAUSE before removing batteries.
Power ON Power OFF
Counterclockwise

Operation and Troubleshooting
8
Summary of Operating Controls
Troubleshooting
Problem
No display
Constant beeping during
infusion; “OCL” in display
Continuous tone
Blood backed into tubing
Resolution
• Verify that Pump power is in the ON position
• Verify proper battery placement
• Replace batteries
Fluid path occlusion
• Verify that tubing clamps are open
• Check for kink in tubing
Malfunction
• Immediately close tubing clamp
• Possible dead battery alarm, replace batteries (battery icon visible)
• Gently press on top of Cassette to ensure proper placement
• Manufacturer’s service/assistance may be required
• Verify that Pump is in RUN mode
• Notify healthcare professional
To:
Start Infusion
Pause
Infusion
Silence
Alarm
Deliver Bolus
Steps to Take
Press and hold
RUN/PAUSE button
for 5 seconds
Press and hold
RUN/PAUSE button
for 5 seconds
Press and release
RUN/PAUSE button
Press and release
BOLUS button
Audible Indicator
1 Beep
2 Beeps
(every 4 minutes)
Alarm sound stops
1 Beep
Visual Indicator
Green RUN light blinks
(inside BOLUS button) and
“ml” (volume infused) is in
Pump display
Pause ( l l ) icon ashing
in display; Green RUN light
(inside BOLUS button)
stops blinking
Pause ( l l ) icon ashing
in display; Green RUN light
(inside BOLUS button)
stops blinking
Green RUN light double
blinks (inside BOLUS
button)

Visible and Audible Alarms and Signals
9
Visible and Audible Alarm and Signal Table
Status
Pump Infusing
Normally
Infusion Paused
Infusion
Complete
Bolus Infusion
Occlusion Alarm
Cassette not
Attached to
Pump
Malfunction
Malfunction
Low Battery
Dead Battery
Malfunction
Malfunction
BOLUS Button
Visual Indicator
Green RUN light
(inside BOLUS button)
blinking, and “ml”
(volume infused) in
display
“Pause” icon blinking
in display; Green RUN
light off
“Bag” icon blinking
Green RUN light (inside
BOLUS button) double
blinks; “Bolus” icon in
display
“Alarm” icon and “OCL”
in display
“Alarm” icon and “MA”
in display
“Alarm” icon and “MA”
in display
“Alarm” icon and “MA1”
in display
“Battery” icon blinking
“Battery” icon and
“Alarm” icon in display
“Alarm” icon and “EE1”,
“EE2”, “EE3”, “EE4”,
“EE5”, “EE6”, or “EE7”
in display
“Alarm” icon and
“CPU”, “RA”, or “RO”
in display
“REL” in display
Audible
Indicator
None
2 Beeps every
4 Minutes
1 Long Tone
followed by
3 Short Beeps;
repeats every
4 Minutes
1 Beep
Constant
Beeping
Constant Tone
Constant Tone
Constant Tone
5 Short Beeps
every 4 Minutes
Constant Tone
10 Short Beeps
Constant Tone
Constant
Beeping
Comments
Periodic movement of Cassette
gears is normal.
“Infusion Complete” alert will sound
every 4 minutes.
1 beep will sound every time the
BOLUS button is pressed during
RUN mode.
Press RUN/PAUSE button to silence
alarm. Press and hold RUN/PAUSE
button to restart Pump. If unable
to resolve (silence) alarm, contact
health care professional.
Press RUN/PAUSE button to
silence alarm. Gently press on
top of Cassette to ensure proper
placement. Resume infusion.
Immediately close tubing clamp.
See Page 8 – Troubleshooting.
Press RUN/PAUSE button to
silence alarm. Gently press on
top of Cassette to ensure proper
placement. Resume infusion.
Replace batteries as soon as
possible.
Press RUN/PAUSE button to silence
alarm. Alarm and battery icons
will remain on. Replace batteries
immediately.
Immediately close tubing clamp
and turn off Pump. Contact Summit
Medical Products, Inc. by calling the
toll free number on the Pump.
Immediately close tubing clamp
and turn off Pump. Contact Summit
Medical Products, Inc. by calling the
toll free number on the Pump.
Release the BOLUS button.
Icon

General Care Instructions
10
General Care Instructions
The patient should be careful to protect the Pump at all times. The Pump
should not be dropped, stored in freezing -7ºC (20ºF) temperatures, left in
direct sunlight, or exposed to excessive heat 70ºC (158ºF). The Pump should
only be operated between 10ºC and 43ºC (50ºF and 110ºF).
Pump and components should be stored in a dry, cool place until used.
The Pump can be cleaned by wiping its surface with a slightly damp cloth.
Use only mild detergent soaps.
To disinfect the Pump, use a cloth slightly dampened with any of the
following:
• A fresh solution of one (1) part household bleach to nine (9) parts water
• 70% Isopropyl alcohol
• Equivalent disinfectant product
Warning:
Pump failure may be caused by the application of cleaning solutions other
than those recommended by the manufacturer.
Do not immerse the Pump or sterile Cassette in any cleaning solutions.

Customer Assistance
11
Customer Assistance
For Customer Assistance, please contact your distributor or Summit Medical
Products, Inc. at:
Summit Medical Products, Inc.
2480 South Main, Suite 212
Salt Lake City, Utah 84115, USA
Toll Free: [phone]
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
Web Site: www.ambitpump.com
European Representative:
Medical Technology Promedt Consulting GmbH
Altenhofstraße 80
66386 St. Ingbert
Germany
Copyright © 2010 All rights reserved.
This document contains proprietary information and may not be reproduced,
published or distributed in any form, in whole or in part, without written
authorization from Summit Medical Products, Inc.
62749.01 02/10

ambIT®Military PCA Ambulatory
Infusion Pump is a trademark of:
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