Sorenson Medical Ambulatory Infusion Therapy PCA User manual

P C A
P A T I E N T M A N U A L
PCA

B ecome F amiliar with the P ump
F
F
C as s ette
S olution C ontainer
T ubing
C la mp
T ubing
C la mp
O N/O F F
S witch
R U N/P AUS E
B utton
R emote
B olus B utton
P ump Dis pla y
ambIT ™P C A P ump
Manua l
B O L U S
B utton

Definitions and S ymbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
P ump Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
P aus e Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
R esume Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
S ilence Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
P C A Bolus Activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
P ump P ower ON and OF F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
B attery Installation and R eplacement . . . . . . . . . . . . . . . . . . . . . . . . . . .7
S ummary of Operating C ontrols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Visible and Audible Alarms Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
G eneral C are Ins tructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
C us tomer Ass istance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
© C opyright 2003 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 S orenson Medical, Inc.
62089.03 05/04
T a b l e o f C o n t e n t s

1
DE FINITIONS AND S YMB OL S
1.1 Definitions and S ymbols
Warning:
A warning message contains special safety emphasis and must be
observed at all times. F ailure to observe a WAR NING message is
potentially life threatening.
C aution:
A caution usually appears in front of a procedure or statement. F ailure to
observe a C AUTION could result in s erious 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.
P rotected from dripping water.
This is the IE C symbol for TY P E BF equipment.
¥ IE C C las sification Internally P owered.
¥ The ambIT ª P C A P ump complies with E N 60601-1:1990
including amendments A1 and A2; IE C 60601-1:1998; IE C 60601-2-
24:1998; C AN/C S A C 22.2 No. 601-M90 with supplement No. 1-94;
UL2601-1:1997 with amendments 1 and 2.
This C E symbol certifies that the product complies with the essential
requirements of the Medical Device Directive.
The ÒNR T L/C Óindicator adjacent to the C S A (C anadian S tandards
Association) Mark signifies the product has been evaluated to the applicable
ANS I/UL and CS A standards, for use in the U.S . and C anada. NR TL
(Nationally R ecognized Testing Laboratory) is a designation granted by the
U.S .Occupational S afety and Health Administration (OS HA) to laboratories
which have been recognized to perform certification to U.S . S tandards.
I PX 1
0482

2
D e f i n i t i o n s a n d S y m b o l s
Do not re-us e (C as settes)
K eep away from heat
K eep dry
Temperature limitation
S terilized using irradiation
LAT E X-free
Indicates which tubing connects
to the s olution container
Indicates which tubing connects
to the patient
B olus
P rogram Lockout
B olus Lockout Time in hours : minutes
B olus Volume in milliliters
B as al Infusion R ate in ml/hr
C ass ette S haft

Number of boluses delivered
Number of bolus requests
Volume to be Infused
R U N/PAU S E B utton
B OL US B utton
Low/Dead B attery Indicator
Alarm Indicator
ambIT ª P C A P ump Display
P ump P ower ON
P ump P ower OF F
B attery orientation
3
D e f i n i t i o n s a n d S y m b o l s

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.
R ead instructions before us e. T he P ump mus t be used s trictly in
accordance with these instructions.
S afe use of this P ump is the primary responsibility of the user. The user is
responsible for monitoring this P ump. C ontact clinical/technical support if
P ump appears to be operating incorrectly.
All patients should be given a P atient Manual and instructed to read it
carefully.
The P ump must be used only by the person for whom it is prescribed.
The patient should never perform any function or push any button unless
instructed by their healthcare professional.
During operation, maintain fluid container at or near the level of the P ump.
Do not allow the P ump to get wet. If the P ump is immersed in any liquid, it
must be replaced with a new P ump.
Transport and storage conditions: -7ºC to 70¼C (20¼F to 158¼F), 10% to
90% relative humidity and 500 hP a to 1060 hP a atmos pheric pres sure.
Operating conditions: 10¼C to 43¼C (50¼F to 110¼F ), 10% to 90% relative
humidity and 500 hP a to 1060 hP a atmospheric pres sure.
Never attempt to open the P ump case. Only the battery cover may be
removed when changing batteries. If the P ump is dropped, it must be
replaced with a new P ump.
This P ump 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.
Use only dis pos able AA alkaline 1.5V batteries in the P ump. F ailure to
follow manufacturerÕs instructions while replacing batteries may result in
los s of program settings and report data. Dispos e of batteries properly
after use.
S afety hazards such as under infusion may be associated with external
radio frequency interference (R F I) or electromagnetic radiation. Typical
equipment which may generate such radiation include x-ray machines, MR I
equipment, and any other non-shielded electrical equipment.
Failure to use the approved S orenson Medical, Inc., remote B OL US
button
could result in an inadvertent bolus dose.
4
W a r n i n g s

ambIT ™ P C A P ump Des c ription
T he ambIT ª P C A Ambulatory Infusion P ump is intended for the ambulatory
infusion of fluids and medications. The P ump has simple controls that are
easily operated.
The R UN/PAUS E button is located just below the P ump display. This button
is used to start, pause or resume the infusion and silence alarms. T he
R UN/PAUS E button toggles between R un and P ause. A blinking green R un
light (inside the B olus button) and ÒmlÓ(volume infused) in the P ump display
indicate the P ump is infusing. If the infusion is paused, a blinking Pause
symbol (ll) in the P ump display and two (2) beeps every four (4) minutes
indicate that the P ump infusion has been temporarily stopped. The B OLUS
button is located below the R UN/P AUS E button. When pressed in R un mode,
the P ump will deliver the porgrammed bolus dose. During bolus delivery, the
green R un light (inside the B olus button) will double blink.
F
F
C as s ette
S olution C ontainer
T ubing
C lamp
T ubing
C lamp
ON/OF F
S witch
R UN/P AUS E
B utton
R emote
B olus B utton
P ump Dis pla y
ambIT ™ P C A P ump
Manual
B OLUS
B utton

Normal Operations
During normal operation, the green R un light (inside the B olus button) will
start to blink and the ÒmlÓ(volume infused) will appear in the P ump display.
P aus e Infus ion
To PA US E the infusion, press the R U N/PAUS E button. T he P ump will beep
two times , the green R un light will stop blinking and the P ause ( ll ) icon will
blink in the P ump display. If left in P ause, the P ump 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 C assette, solution container, or batteries .
R es ume Infus ion
To resume the infusion from PA US E , push the R UN/PAUS E button.
The display will show the ÒmlÓ(volume infused) and the green R un light will
start to blink. The infusion will resume at the same point as when the P ump
was placed in P aus e.
S ilence Alarms
To silence an alarm, push the R UN/PAUS E button. When the alarm has
been silenced, the P ump will remain in P ause. Once the cause of the alarm
has been corrected, press the R UN/PAUS E button to resume the infusion.
Note:
If the P ump alarms due to downstream pressure and the cause of the alarm
is corrected without intervention, the alarm will silence and the P ump will
resume the infusion automatically.
P C A B olus A ctivation
The P CA (Patient Controlled Analgesia) B OLUS button is located on the
Pump directly below the R UN/PAUS E button. E very time the B OL US button
is pressed during the infusion, the P ump will beep once. If the bolus dose is
permitted, the Pump will begin bolus administration. During bolus infusion, the
green R un light will double blink. If the B OLUS button is pressed during the
bolus lockout time, the pump will beep once, but no bolus will be delivered.
Note:
¥A remote B OLUS button may also be used.
¥ C onnect remote B OL US button to the P ump before placing P ump in
R un mode.
6
P ump Display
R UN/P AUS E
Button
Manual BOLUS
Button

P ower O N and OF F
To power on the P ump, R otate the battery cover clockwise until the ( I )
mark lines up with the ( I )mark on the P ump.
To power off the P ump:
S T E P 1: P lace the P ump in PAUS E .
S T E P 2: R otate the battery cover counterclockwis e until the ( O ) mark
lines up with the ( I )mark on the P ump. S ee illus tration below.
B attery Ins tallation and R eplacement
T he P ump is powered by two (2) disposable AA alkaline 1.5V batteries .
C aution:
The P ump memory is designed to retain program settings and infusion
history for up to s ix (6) months without power. F ailure to follow
manufacturer's instructions while replacing batteries may result in los s of
program settings and report data. Do not s tore batteries in the P ump.
B attery Ins tallation
To install batteries s ee illustration to left.
S TE P 1: Ins ert batteries according to illustration
S T E P 2: P lace battery cover on P ump as illustrated in diagram (OF F
s ymbol ( O ) on cover s lightly to left of the ( I )mark on P ump)
S T E P 3: R otate battery cover clockwise to the OF F ( O ) pos ition
B attery R eplac ement
To replace batteries:
S T E P 1: P lace P ump in PA US E
S T E P 2: R otate battery cover counterclockwise slightly to the left of the
OF F ( O ) position until the cover s tops or meets res istance.
S T E P 3: R emove cover and replace batteries as described above.
R es uming Infus ion after B attery R eplacement
F irst power P ump on. P ump will be in P ause mode.
P ress the R UN/P AUS E button one (1) time. P ump data will scroll and the
P A US E ( ) icon will appear in the P ump display.
I I
P ress the R UN/PAUS E button a second time to resume the current infusion.
C aution:
¥ Verify the P ump is in P ause mode before removing batteries.
¥ When replacing batteries in the P ump, always us e new batteries.
7
O p e r a t i o n s
S tep 1 S tep 2 S tep 3
P owe r O F F
C ounterclockwis e
P owe r O N

8
Operations and Troubleshooting
To: Steps to Take Audible Indicator
None
2 beeps
Alarm sound stops
Visual Indicator
Start Infusion Press RUN/PAUSE
button
Green Run light blinks
(inside BOLUS button)
and “ml”(volume infused)
is in Pump display
Pause ( ll ) icon flashing
in display
Pause ( ll ) icon flashing
in display
Press RUN/PAUSE
button one time
Press RUN/PAUSE
button one time
Silence
Alarm
1 Beep Green Run light double
blinks
Press BOLUS button
one time
Note:
Patient may use manual
or remote BOLUS button.
Bolus
Delivery
Pause
Infusion
Summary of Operating Controls
No display
Continuous tone
Blood backed in tubing
Resolution
Troubleshooting
Problem
•Insert fresh batteries
•Verifyproper battery placement
•VerifyPump power is inthe “ON”position
Constant beeping during
infusion
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
•Gently press on top of cassette to ensure proper placement.
•Manufacturer's service/assistance may be required
•Verify Pump is in Run mode
•Notify healthcare professional

9
Visible and Audible Signal Table
Status
Infusion Paused
Low Battery
Dead Battery
Malfunction
None
Constant
Beeping
Constant Tone
Constant Tone
Constant Tone
Comments
Icon
Visible and Audible Signal Table
Visual Indicator Audible
Indicator
Pump Infusing
Normally
Green Run light
(inside BOLUS
button) blinking, and
“ml”(volume infused)
in display.
Periodic movement of
Cassette gears is normal.
“Pause”icon blinking
in display. Green Run
light off.
2 beeps every
4 minutes
Infusion
Complete
“Bag”icon
illuminated
1 long tone
followed by 3
short beeps.
Repeats every 4
minutes
“Infusion Complete”alert
will sound every 4
minutes.
Bolus
Infusion
Occlusion
Alarm
Green Run light
(inside BOLUS
button) double blinks.
“Bolus”icon is
displayed.
1 Beep 1 beep will sound every
time the BOLUS button
is pressed during Run
mode.
Cassette not
Attached to
Pump
“Alarm”icon
illuminated with
“OCL”in display
“MA”and “Alarm”
icon
Press RUN/PAUSE button
to silence alarm. Press
RUN/PAUSE button to
restart Pump. If unable to
resolve (silence) alarm,
contact health care
professional.
“Battery”icon
blinking
5 short beeps
every 4 minutes
Replace batteries as
soon as possible.
“Battery”icon,
“Alarm”icon
illuminated
Press RUN/PAUSE button
to silence alarm. Alarm
and battery icons will
remain on. Replace
batteries immediately.
Press RUN/PAUSE button
to silence alarm. Gently
press on top of Cassette
to ensure proper
placement. Resume
infusion.
“MA”and “Alarm”
icon illuminated
Immediately close tubing
clamp.
See Troubleshooting.

G E NE R AL C AR E INS TR UC TIONS
T he patient s hould be careful to protect the P ump at all times . T he P ump
should not be dropped, stored in freezing -7ºC (20¼F ) temperatures , left in
direct sunlight or expos ed to exces s ive heat 43¼C (110¼F ). T he P ump
should only be operated between 10¼C and 43¼C (50¼F and 110¼F ).
P ump and components should be stored in a dry, cool place until used.
T he P ump can be cleaned by wiping its surface with a s lightly damp cloth.
Us e only mild detergent s oaps.
To disinfect the P ump, use a cloth s lightly dampened with any of the
following:
¥A fresh s olution of one (1) part hous ehold bleach to nine (9) parts water.
¥ 70% Isopropyl alcohol.
¥ E quivalent disinfectant product.
Warning:
P ump failure may be caus ed by the application of cleaning solutions other
than those recommended by the manufacturer.
Do not immerse the P ump or sterile C assette in any cleaning solutions .
10
G e n e r a l C a r e I n s t r u c t i o n s

C US TOME R AS S IS TANC E
F or C us tomer Ass istance, pleas e contact your distributor or
S orenson Medical, Inc. at:
S orens on Medical, Inc .
1375 Wes t 8040 S outh
Wes t J ordan, Utah 84088-8320, US A
Toll F ree:[phone]
P hone: [phone]
F ax:[phone]
e-mail: service@ sorensonmedical.com
Web S ite: www.sorensonmedical.com
E uropean R epres entative:
Medical T echnology P romedt C ons ulting G mbH
Altenhofstrabe 80
66386 S t. Ingbert
G ermany
11
C u s t o m e r A s s i s t a n c e

The ambIT™PCA Ambulatory
Infusion Pump is a trademark of: