Patient Manual
15 Pages
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PCA P
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B ec ome F amiliar with the P ump
S olution C onta iner
C a s s ette
P ump Dis pla y R U N /P AU S E B utton Ma nua l B OLUS B utton
T ubing C la mp
T ubing C la mp
O N /O F F S witch
F F
a mbIT ™P C A P ump
R emote B olus B utton
Ta ble o f C o n te n ts
Definitions and S ymbols...1 Warnings...4 P ump Des cription...5 Operation...6 Normal Operation...6 P aus e Infus ion...6 R es ume Infus ion...6 S ilence Alarms...6 P C A B olus Activation...6 P ump P ower ON and OF F...7 B attery Ins tallation and R eplacement...7 S ummary of Operating C ontrols...8 Troubles hooting...8 Vis ible and Audible Alarms Table...9 G eneral C are Ins tructions...10 C us tomer As s is tance...11
© C opyright 2003 All rights res erved. T his document contains proprietary information and may not be reproduced, publis hed or dis tributed in any form, in whole or in part, without written authorization from S orens on Medical, Inc. 62089.03 05/04
DE F INIT IONS A ND S Y MB OL S 1.1 Definitions and S ymbols Warning: A warning mes s age contains s pecial s afety emphas is and mus t be obs erved at all times . F ailure to obs erve a WAR NING mes s age is potentially life threatening.
C aution: A caution us ually appears in front of a procedure or s tatement. F ailure to obs erve a C AUT ION could res ult in s erious patient or us er injury.
Note: A note highlights information that acts as a reminder or helps explain a concept or procedure.
T his international s ymbol means : Attention, cons ult accompanying documents .
I PX 1
P rotected from dripping water.
T his is the IE C s ymbol for T Y P E B F equipment. ¥ IE C C las s ification Internally P owered. ¥ T he 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 60601-224:1998; C AN/C S A C 22.2 No. 601-M90 with s upplement No. 1-94; UL2601-1:1997 with amendments 1 and 2.
0482
T his C E s ymbol certifies that the product complies with the es s ential requirements of the Medical Device Directive. T he ÒNR T L/C Óindicator adjacent to the C S A (C anadian S tandards As s ociation) Mark s ignifies the product has been evaluated to the applicable ANS I/UL and C S A s tandards , for us e in the U.S . and C anada. NR T L (Nationally R ecognized Tes ting Laboratory) is a des ignation granted by the U.S .Occupational S afety and Health Adminis tration (OS HA) to laboratories which have been recognized to perform certification to U.S . S tandards .
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D e fin itio n s
and
S ymbols
Do not re-us e (C as s ettes )
K eep away from heat
K eep dry
Temperature limitation
S terilized us ing irradiation
LAT E X-free
Indicates which tubing connects to the s olution container C as s ette S haft
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 Infus ion R ate in ml/hr
2
D e fin itio n s
and
S ymbols
Number of bolus es delivered
Number of bolus reques ts
Volume to be Infus ed
R UN/PAUS E B utton
B OL US B utton
Low/Dead B attery Indicator
Alarm Indicator
ambIT ª P C A P ump Dis play
P ump P ower ON
P ump P ower OF F
B attery orientation
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Warnings
Warnings F ederal (U.S .A.) law res tricts this device to s ale by or on the order of a phys ician. T his product s hould only be us ed by a phys ician or by a trained individual under direct s upervis ion of a phys ician. R ead ins tructions before us e. T he P ump mus t be us ed s trictly in accordance with thes e ins tructions . S afe us e of this P ump is the primary res pons ibility of the us er. T he us er is res pons ible for monitoring this P ump. C ontact clinical/technical s upport if P ump appears to be operating incorrectly. All patients s hould be given a P atient Manual and ins tructed to read it carefully. T he P ump mus t be us ed only by the pers on for whom it is pres cribed. T he patient s hould never perform any function or pus h any button unles s ins tructed by their healthcare profes s ional. 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 immers ed in any liquid, it mus t be replaced with a new P ump. Trans port and s torage conditions : -7ºC to 70¼C (20¼F to 158¼F ), 10% to 90% relative humidity and 500 hP a to 1060 hP a atmos pheric pres s ure. Operating conditions : 10¼C to 43¼C (50¼F to 110¼F ), 10% to 90% relative humidity and 500 hP a to 1060 hP a atmos pheric pres s ure. Never attempt to open the P ump cas e. Only the battery cover may be removed when changing batteries . If the P ump is dropped, it mus t be replaced with a new P ump. T his P ump is not to be us ed for infus ion of blood or blood products . T his pump is not to be us ed for infus ion of life s us taining medications . Us e only dis pos able AA alkaline 1.5V batteries in the P ump. F ailure to follow manufacturerÕs ins tructions while replacing batteries may res ult in los s of program s ettings and report data. Dis pos e of batteries properly after us e. S afety hazards s uch as under infus ion may be as s ociated with external radio frequency interference (R F I) or electromagnetic radiation. Typical equipment which may generate s uch radiation include x-ray machines , MR I equipment, and any other non-s hielded electrical equipment. F ailure to us e the approved S orens on Medical, Inc., remote B OL US button could res ult in an inadvertent bolus dos e.
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ambIT ™ P C A P ump Des c ription T he ambIT ª P C A Ambulatory Infus ion P ump is intended for the ambulatory infus ion of fluids and medications . T he P ump has s imple controls that are eas ily operated. T he R UN/PAUS E button is located jus t below the P ump dis play. T his button is us ed to s tart, paus e or res ume the infus ion and s ilence alarms . T he R UN/PAUS E button toggles between R un and P aus e. A blinking green R un light (ins ide the B olus button) and ÒmlÓ(volume infus ed) in the P ump dis play indicate the P ump is infus ing. If the infus ion is paus ed, a blinking P aus e s ymbol ( ll ) in the P ump dis play and two (2) beeps every four (4) minutes indicate that the P ump infus ion has been temporarily s topped. T he B OLUS button is located below the R UN/P A US E button. When pres s ed in R un mode, the P ump will deliver the porgrammed bolus dos e. During bolus delivery, the green R un light (ins ide the B olus button) will double blink.
S olution C onta iner
C a s s ette
P ump Dis pla y R U N /P AU S E B utton Ma nua l B OLUS B utton
T ubing C la mp
T ubing C la mp
O N /O F F S witch
F F
a mbIT ™ P C A P ump
R emote B olus B utton
P ump Dis play R UN/P AUS E B utton
Manual B OLUS B utton
Normal Operations During normal operation, the green R un light (ins ide the B olus button) will s tart to blink and the ÒmlÓ(volume infus ed) will appear in the P ump dis play.
P aus e Infus ion To PA US E the infus ion, pres s the R UN/PAUS E button. T he P ump will beep two times , the green R un light will s top blinking and the P aus e ( ll ) icon will blink in the P ump dis play. If left in P aus e, the P ump will beep two (2) times every four (4) minutes .
Note: P ause temporarily stops the infusion. While in P ause, the infusion is delayed. T his allows for changing the C assette, solution container, or batteries.
R es ume Infus ion To res ume the infus ion from PA US E , pus h the R UN/PAUS E button. T he dis play will s how the ÒmlÓ(volume infus ed) and the green R un light will s tart to blink. T he infus ion will res ume at the s ame point as when the P ump was placed in P aus e.
S ilenc e A larms To s ilence an alarm, pus h the R UN/PAUS E button. When the alarm has been s ilenced, the P ump will remain in P aus e. Once the caus e of the alarm has been corrected, pres s the R UN/PAUS E button to res ume the infus ion.
Note: If the P ump alarms due to downs tream pres s ure and the caus e of the alarm is corrected without intervention, the alarm will s ilence and the P ump will res ume the infus ion automatically.
P C A B olus A c tivation T he P C A (P atient C ontrolled Analgesia) B OL US button is located on the P ump 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 P ump will begin bolus administration. During bolus infusion, the green R un light will double blink. If the B OL US button is pressed during the bolus lockout time, the pump will beep once, but no bolus will be delivered.
Note: ¥ A remote B OL US button may als o be us ed. ¥ C onnect remote B OL US button to the P ump before placing P ump in R un mode.
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O pe r a tio n s
P ower ON and OF F To power on the P ump, R otate the battery cover clockwis e 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 PA US E . P ower O N
P ower O F F C ounterclockwis 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 eplac ement T he P ump is powered by two (2) dis pos able AA alkaline 1.5V batteries .
C aution: T he P ump memory is des igned to retain program s ettings and infus ion his tory for up to s ix (6) months without power. F ailure to follow manufacturer's ins tructions while replacing batteries may res ult in los s of program s ettings and report data. Do not s tore batteries in the P ump.
S tep 1
S tep 2
S tep 3
B attery Ins tallation To ins tall batteries s ee illus tration to left. S T E P 1: Ins ert batteries according to illus tration S T E P 2: P lace battery cover on P ump as illustrated in diagram (OFF symbol ( O ) on cover slightly to left of the ( I mark ) on P ump) S T E P 3: R otate battery cover clockwis e to the OFF ( 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 counterclockwis e s lightly to the left of the OF F ( O ) pos ition until the cover s tops or meets res is tance. S T E P 3: R emove cover and replace batteries as des cribed above.
R es uming Infus ion after B attery R eplac ement F irs t power P ump on. P ump will be in P aus e mode. P res s the R UN/P A US E button one (1) time. P ump data will s croll and the P A US E ( I I ) icon will appear in the P ump dis play. 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 aus e mode before removing batteries . ¥ When replacing batteries in the P ump, always us e new batteries .
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O p e r a t i o n s a n d Tr o u b l e s h o o t i n g
Summary of Operating Controls To:
Steps to Take
Audible Indicator
Start Infusion
Press RUN/PAUSE button
None
Green Run light blinks (inside BOLUS button) and “ml” (volume infused) is in Pump display
Pause Infusion
Press RUN/PAUSE button one time
2 beeps
Pause ( ll ) icon flashing in display
Silence Alarm
Press RUN/PAUSE button one time
Alarm sound stops
Pause ( ll ) icon flashing in display
Bolus Delivery
Press BOLUS button one time
1 Beep
Green Run light double blinks
Visual Indicator
Note: Patient may use manual or remote BOLUS button.
Troubleshooting
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Problem
Resolution
No display
• Insert fresh batteries • Verify proper battery placement • Verify Pump power is in the “ON” position
Constant beeping during infusion
Fluid path occlusion • Verify that tubing clamps are open • Check for kink in tubing
Continuous tone
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
Blood backed in tubing
• Verify Pump is in Run mode • Notify healthcare professional
V i s i b l e a n d A u d i b l e S i g n a l Ta b l e
Visible and Audible Signal Table Status
Icon
Visual Indicator
Audible Indicator
Comments
Pump Infusing Normally
Green Run light None (inside BOLUS button) blinking, and “ml” (volume infused) in display.
Infusion Paused
“Pause” icon blinking 2 beeps every in display. Green Run 4 minutes light off.
Infusion Complete
“Bag” icon illuminated
“Infusion Complete” alert 1 long tone will sound every 4 followed by 3 minutes. short beeps. Repeats every 4 minutes
Bolus Infusion
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.
Occlusion Alarm
“Alarm” icon illuminated with “OCL” in display
Constant Beeping
Press RUN/PAUSE button to silence alarm. Press RUN/PAUSE button to restart Pump. If unable to resolve (silence) alarm, contact health care professional.
Cassette not Attached to Pump
“MA” and “Alarm” icon
Constant Tone
Press RUN/PAUSE button to silence alarm. Gently press on top of Cassette to ensure proper placement. Resume infusion.
Low Battery
“Battery” icon blinking
5 short beeps every 4 minutes
Replace batteries as soon as possible.
Dead Battery
“Battery” icon, “Alarm” icon illuminated
Constant Tone
Press RUN/PAUSE button to silence alarm. Alarm and battery icons will remain on. Replace batteries immediately.
Malfunction
“MA” and “Alarm” icon illuminated
Constant Tone
Immediately close tubing clamp. See Troubleshooting.
Periodic movement of Cassette gears is normal.
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G e n e r a l C a r e In s tr u c tio n s
G E NE R A L C A R E INS T R UC T IONS T he patient s hould be careful to protect the P ump at all times . T he P ump s hould not be dropped, s tored in freezing -7ºC (20¼F ) temperatures , left in direct s unlight or expos ed to exces s ive heat 43¼C (110¼F ). T he P ump s hould only be operated between 10¼C and 43¼C (50¼F and 110¼F ). P ump and components s hould be s tored in a dry, cool place until us ed. T he P ump can be cleaned by wiping its s urface with a s lightly damp cloth. Us e only mild detergent s oaps . To dis infect the P ump, us e a cloth s lightly dampened with any of the following: ¥ A fres h s olution of one (1) part hous ehold bleach to nine (9) parts water. ¥ 70% Is opropyl alcohol. ¥ E quivalent dis infectant product.
Warning: P ump failure may be caus ed by the application of cleaning s olutions other than thos e recommended by the manufacturer. Do not immers e the P ump or s terile C as s ette in any cleaning s olutions .
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C u s to m e r A s s is ta n c e
C US TOME R A S S IS TA NC E F or C us tomer As s is tance, pleas e contact your dis tributor or S orens on Medical, Inc. at:
S orens on Medic al, Inc . 1375 Wes t 8040 S outh Wes t J ordan, Utah 84088-8320, US A
Toll F ree:(877) 352-1888 P hone: (801) 352-1888 F ax:(801) 352-1818 e-mail: s ervice@ s orens onmedical.com Web S ite: www.s orens onmedical.com
E uropean R epres entative: Medical T echnology P romedt C ons ulting G mbH Altenhofs trabe 80 66386 S t. Ingbert G ermany
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The ambIT™ PCA Ambulatory Infusion Pump is a trademark of: