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ambIT Pump
®
C L I N I C I A N
M A N U A L
.
®
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
0088
IPX1 IP22
0088
Become Familiar with the ambIT® Pump
Solution Container
Cassette
.
Pump Display
RUN/PAUSE
Button
Tubing
Clamp
BOLUS
Button
Tubing
Clamp
ON/OFF
Switch
ambIT® Pump
Remote
BOLUS Button
(optional for
select models)
To Solution Container
(Side View of Cassette)
Cassette
Shaft
Continuous Pumps
have FUNCTION
Button in place of
BOLUS Button
To Patient
i
Ta b le o f C o n t e n t s
SECTION 1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1
1.1 Definitions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
1.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
1.3 Overview and Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4
1.4Product
Overview.
Description
. . . . . . .. .. .. .... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
SECTION 2 SET UP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10
2.1 Required Materials. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 Priming Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.3 Attach Cassette to Pump. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
13
2.4 Remove Cassette from Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5
2.5Changing
ChangingFluid
FluidReservoir
Reservoir. ... .... .. . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
. .14
2.62.6
Battery
Battery
Installation
Installation
andand
Replacement.
Replacement.
. . ... . . ...... . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.5.1
2.6.1 Battery
BatteryInstallation.
Installation.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 14
2.6.2 Battery Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.7 Pump Power ON and OFF. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
SECTION 3 PROGRAMMING INSTRUCTIONS. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 General Information. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1.1 General Program Parameters. . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1.2 Summary of General Program Controls . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2 PreSet Pump Programming Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2.1 Pump Delivery Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2.2 Programming Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2.3 Program Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 PCA Pump Programming Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.1 Basal Rate with Patient Controlled Bolus. . . . .. . . . . . . . . . . . . . . . . . . .
3.3.2 Basal Rate Only . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .
3.3.3 Patient Controlled Bolus Only. . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .
3.3.4 PCA Programming Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.5 PCA Program Review. . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .
3.4 Continuous Pump Programming Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4.1 Programming Steps Continuous Pumps . . . . .. . . . . . . . . . . . . . . . . . . .
3.4.2 Program Review. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 4 OPERATING INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Start Infusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 Pause Infusion. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3 Resume Infusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4 Silence Alarm. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5 Bolus Activation. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6 Summary of Operating Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 5 INFUSION HISTORY REPORTS. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1 Pump Infusion History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2 Clearing Pump Infusion History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 6 PATIENT LOCKOUT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1 To Lock the Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2 To Unlock the Pump. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16
16
16
17
17
18
19
21
22
22
22
22
23
24
25
25
26
27
27
27
27
27
28
28
29
29
29
30
30
31
SECTION 7 ALARMS AND SIGNALS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
7.1 Visible and Audible Alarm and Signal Exception for Continous Pumps . . . . . . 32
7.2 Visible and Audible Alarm and Signal Table. . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SECTION
SECTION
8 TROUBLESHOOTING.
8 TROUBLESHOOTING.
. . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 33
8.1 Troubleshooting Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SECTION 9 SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
SECTION 10 DELIVERY RATE ACCURACY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
SECTION 11 GENERAL CARE INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11.1 Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 12 ELECTROMAGNETIC IMMUNITY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 13 CUSTOMER ASSISTANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ii
40
40
41
44
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Se c t io n 1 • In t ro d u c t io n
SECTION 1
INTRODUCTION
1.1 Definitions 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.
This international symbol means: Attention, consult accompanying
documents.
This is the IEC symbol for TYPE BF Applied Part.
• IEC Classification Internally Powered.
The ambIT® Pump complies with ES 60601-1 2012 Edition 1 including
amendment 1; CSA C22.2 NO. 60601-1:2014 Ed.3; IEC 60601-1:2005+CO
RR.1:2006+CORR.2:2007+AM1:2012; IEC 60601-1-6 2013 Ed. 3.1; IEC
60601-1-8 2012 Ed. 2.1; IEC 60601-1-11 2010; 60601-2-24 2012 Ed. 2; IEC
62304 2006 Ed. 1; IEC 62366:2007 (First Edition) +A1:2014; IEC 60601-12:2007 (Third Edition_2007-03)
0088
NRTL/C
This CE symbol certifies 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 signifies 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 certification to U.S.
Standards.
1
Sect ion 1 • Intr oduction
IPX1
IP22
Protected from dripping water.
Protected against insertion of fingers and will not be
damaged or become unsafe during a specified test in which
it is exposed to vertically or nearly vertically dripping water.
Single-use only (Cassettes)
Keep away from heat
Keep dry
CAUTION: This device is restricted to
sale by or on the order of a physician
Temperature limitation
Sterilized using irradiation
To Solution Container
DEHP-free fluid path
(Side View of Cassette)
Not made with natural rubber latex
Indicates which tubing connects
to the solution container
Indicates which tubing connects
to the patient
Bolus
2
Cassette
Shaft
To Patient
Se c t io n 1 • In t ro d u c t io n
Program Lockout
Bolus Lockout Time in hours : minutes
Bolus Volume in milliliters
Volume in milliliters
Basal Infusion Rate in ml/hr
Number of Boluses Delivered
Number of Bolus Requests
Volume to be Infused
RUN/PAUSE Button
or
BOLUS or FUNCTION Button
Low/Dead Battery Indicator
Alarm Indicator
ambIT® Pump Display
3
Sect ion 1 • Intr oduction
Pump Power ON
Pump Power OFF
Battery Orientation
Program Lockout Code
Program Lockout Mode
Pump Program Mode
Review Pump Program
Infusion History Report
Pump Infusion History Cleared
4
Se c t io n 1 • In t ro d u c t io n
1.2 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: -25ºC without relative humidity control; and 70ºC at relative humidity up
to 93%, non-condensing.
Operating conditions: +5ºC to +40ºC; relative humidity range of 15% to 93%, non-condesing; and an
atmospheric pressure of 700 hPa to 1060 hPa.
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.
The lay responsible organization must contact it’s local authorities to determine the proper method of
disposal of potentially biohazardous parts and accessories.
This Pump does not have an air in-line alarm. A Cassette with an air elimination filter is available.
Safety hazards with the ambIT Pump including 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.
Use of any remote bolus switch other than the approved Summit Medical Products Remote Bolus Button
could result in an inadvertent bolus dose.
Do not use any other administration set other than the approved ambIT Cassettes. Pump will not function
properly with any other administration sets.
No modification of this equipment is allowed.
5
Sect ion 1 • Intr oduction
Cassette tubing or bolus chord may cause strangulation if used improperly.
If equipment is tampered with to the point where it is ineffective, consult your physician.
Keep out of reach of animals or children.
The ambIT® Pump Cassette is a sterile, disposable administration set.
•Carefully examine each Cassette before use. Make sure there are no damaged, or missing parts.
•Do not use a Cassette if the outer package is torn, punctured, wet or damaged.
•Do not touch sterile open end of tubing. Use aseptic technique.
•Do not re-sterilize Cassette.
Protection from air infusion:
•The solution must be provided in a non-vented, collapsible container.
•Remove all air from solution container and tubing before use.
Safety hazards are associated with the interconnection of other infusion systems. Refer to: Terry, Judy
(Ed.), Intravenous Therapy, W. B. Sanders Co. 1995, pp 192–193.
The Cassette should not be used for infusion volumes greater than two (2) liters.
In order to minimize the possibility of infection, Cassettes should be changed in accordance with your
institution’s policies.
When the desired volume to be infused has been delivered, the empty solution container must be
changed. Failure to do so may result in cessation of fluid delivery.
Before starting therapy, check that all connections are secure and there are no leaks in the fluid path.
Bolus and infusion history reports should never take the place of good clinical judgment. Always perform a
clinical evaluation whenever interpreting these reports.
Infusing viscous solutions (e.g. D25W) into high pressures (e.g. approaching 300mm Hg) may decrease
volumetric accuracy.
Protection from Unintended Bolus:
The unintended bolus volume that could be released into a patient prior to clearing a downstream
occlusion may be released by breaking the seal on luer connection between the pump and the catheter.
Breaking the luer connection between the catheter and the pump may introduce contamination into the
fluid path. Do not try to clear the unintended bolus volume if any concerns exist with regard to introducing
contamination.
The maximum unintended bolus volume released into the patient when occluded on the downstream side
is between 0.05-0.10 ml. A single stroke of one infusion is 0.05 ml. Since these amounts are similiar, there
is no risk of over infusing and the unintended bolus may not need to be removed.
6
Se c t io n 1 • In t ro d u c t io n
1.3 Overview and Indications for Use
The ambIT® Family of Pumps are designed for the ambulatory infusion of fluids and medications. The Pumps have simple controls
that are easily operated by both caregivers and patients. References to the Remote Bolus Switch apply only to pumps with the Remote
BOLUS Port. See page i to determine if pump has a Remote BOLUS Switch Option. The operator position with respect to the device is
considered arms length (no more than 0.5 meters direct view).
There are three categories of pumps within this manual: PreSet, Continuous, and PCA. The PreSet Category of pumps contain five
programming options on the back of the pump. Continuous pumps allow for continuous infusion. All other pumps are PCA pumps. Below
are the indications for use and descriptions of these three categories. Please see Section 9 for individual pump specifications.
Note: Any use of the Pump other than those indicated below is regarded as an off-label use. None of the ambIT Pumps are
equipped with an air detection circuit, therefore if infusion of air could cause harm to the patient, it is recommended to use a
filtered cassette or air elimination filter.
Note: Summit Medical Products, Inc. does not recommend or endorse any one specific 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.
Note: The suitability of this product for use with any specific patient is to be determined solely by the healthcare provider.
The healthcare provider should understand the interaction between the infusion characteristics of the Pump, the physiological
response of a patient to the drug (overall and at the infusion site), the pharmacokinetics of the drug, any potential adverse effects,
etc. in order to decide if the Pump should be used to infuse any medication into any part of a specific patient’s body. The sales
people and manufacturer of the ambIT® Pump can only provide general guidelines regarding the set up and programming of the
Pump, and may also provide journal articles referring to applications. They are neither qualified nor permitted to provide specific
recommendations for treating any specific patient. In general, in order to avoid complications, use the lowest flow rate, volume
and drug concentration required to produce the desired result.
PreSet Pumps
The ambIT® Pumps with PreSet Settings are intended for use by surgeons and anesthesiologists for the perioperative and post
operative infusion of local anesthetics and narcotics for pain management and regional anesthesia. Routes of administration
include intravenous, subcutaneous, intramuscular, perineural and epidural. The ambIT® Pumps with PreSet Settings are also
intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close
proximity to nerves when compared with narcotic only pain management.
The ambIT® Pumps with PreSet Settings should be used with filtered cassettes for IV and epidural uses. Otherwise non-filtered
cassettes may be suitable for use. These pumps simplify pump programming by providing the clinician with the option to choose from
four (4) preprogrammed infusion protocols (PRO1 - PRO4), or to program infusion parameters individually (PRO5).
Using Program 5, the clinician may select different delivery profiles, which include: basal rate only, basal rate with patient controlled
bolus, or patient controlled bolus only.
Note for PreSet Pumps: Some ambIT® Pumps with PreSet Settings have a limited life of 2000 ml total infusion. Once 2000 ml has
been reached, the Pump will continue to infuse uninterrupted as programmed, until the current infusion program is complete. After the
infusion beyond 2000 ml has been completed, the next time the Pump is powered on the ALARM icon
and “EEE” will appear in the
display, indicating that the Pump has reached its end of life, and must be replaced.
PCA Pumps
The ambIT PCA Pumps are intended for use by a physician or by a trained individual under direct supervision of a physician. The
ambIT PCA Pump is used to infuse medicines and/ or fluids into patients primarily for pain management. Modes of action are
generally intravenous, epidural and/ or regional.
The ambIT® PCA Pumps should only be used with filtered cassettes because air detection is not available for IV applications. They
do not include PreSet settings. The clinician may select different delivery profiles, which include: basal rate only, basal rate with
PCA (Patient Controlled Analgesia) bolus, or PCA bolus only.
Continuous Pumps
The ambIT® Continuous Pumps should only be used with filtered cassettes because air detection is not available for IV
applications. They are intended for continuous volumetric delivery of intravenous medicines and/ or fluids into patients at a
consistent volume for prescriptive treatment by a physician (or veterinarian for Vet Pumps). These pumps contain no bolus
feature.
7
Sect ion 1 • Intr oduction
1.4 Product Description
Cassette
ambIT® Pump
Pump Display
RUN/PAUSE
Button
BOLUS
Button
®
ON/OFF
Switch
F
F
ambIT® Pump
Remote
BOLUS Button
(optional)
The Pump program is determined by selecting the desired parameters
during PROGRAM MODE. A specific combination of pressing the Pump’s
buttons allows the user to access PROGRAM MODE. This specific
combination of pressing buttons is designed to prevent inadvertent or
unauthorized adjustments.
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 MODE and
PAUSE MODE. A blinking green RUN light (inside the BOLUS or
FUNCTION button) and “ml” (volume infused) in the Pump display indicate
that the Pump is infusing. The table in Section 7 of this manual completely
describes each alarm and signal.
If the infusion is paused, a flashing PAUSE icon ( 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 or FUNCTION button is located below the RUN/PAUSE
button. When the BOLUS button is pressed during RUN MODE, the Pump
will deliver the programmed bolus dose. During bolus delivery, the green
RUN light (inside the BOLUS button) will double blink.
ambIT® Cassette
The Cassette contains a rotary mechanism that pumps the infusion
solution at an accurate and controlled rate.
During Cassette priming, fluid will flow freely through the tubing (Figure 1).
Top View of Cassette
(Figure 1)
After priming, snapping the Cassette bottom disc into the body of the
Cassette closes the fluid path, preventing the free flow of fluid (Figure 2).
When primed, the Cassette simply snaps onto the Pump.
Note:
Cassette Bottom Disc
(Figure 2)
8
Once the cassette bottom is snapped into place (see section 2), the rollers
engage and compress the tubing preventing fluid from flowing unless the
pump is rotating and moving the fluid. If a downstream occlusion occurs,
the pump will alarm and notify the user.
Se c t io n 1 • In t ro d u c t io n
Solution Container
Cassette
.
Pump Display
RUN/PAUSE
Button
Tubing
Clamp
BOLUS
Button
Tubing
Clamp
ON/OFF
Switch
ambIT® Pump
Remote
BOLUS Button
(optional for
select models)
To Solution Container
(Side View of Cassette)
Cassette
Shaft
To Patient
Continuous Pumps
have FUNCTION
Button in place of
BOLUS Button
9
Sect ion 2 • S et U p
SECTION 2
SET UP
(See Diagram on Page 9)
Warning: Protection from air infusion
•The infusion solution must be provided in a non-vented, collapsible container.
•Remove all air from solution container and tubing before use.
Note:
It is the responsibility of the healthcare provider to ensure that the patient is educated in the proper use of
the Pump.
It is the responsibility of the healthcare provider to modify any guidelines provided to the patient along with
the Pump as appropriate for the individual patient’s clinical status and medication provided.
2.1 Required Materials
Warning:
It is recommended that an air elimination filter be used to protect from air embolism. Some ambIT
Cassettes already contain a filter. If cassette already has filter, it is not recommended to use a separate air elimination filter.
Infusion with the ambIT® Pump requires the use of one of the following ambIT® Cassettes:
•Item # 220139: ambIT® Cassette, Filterless, Spike
•Item # 220140: ambIT® Cassette, Filter, Spike (1.2 micron air eliminating filter)
•Item # 220140 Y: ambIT® Cassette, Filter, Spike with Yellow Striped Tubing (1.2 micron air
eliminating filter)
•Item # 220266: ambIT® Cassette, Filter, Male Luer (1.2 micron air eliminating filter)
•Item # 220267: ambIT® Cassette, Filterless, Male Luer
The Cassette is a sterile, disposable administration set. The upstream (short) tubing of the Cassette
connects to a non-vented, collapsible solution container. Once the Cassette has been primed, the
downstream extension (long) tubing of the Cassette connects to the patient’s access device.
Note:
Accessories such as MediBag™ solution containers and carrying pouches may be added as required by
the therapy. Contact Summit Medical Products, Inc. for a complete listing of all optional accessories.
2.2 Priming Cassette
Warnings:
Do not use a Cassette if the outer package is torn, punctured, wet or damaged.
Do not touch sterile open ends of the tubing. Use aseptic technique.
Remove all air from solution container and tubing before use.
Verify that all connections are secure before starting therapy, and check fluid path for leaks.
10
Se c t io n 2 • Se t U p
If filled solution container is not going to be used immediately, clamp the tubing and cap the female
luer connector with the protective cap provided, to prevent contamination.
Always verify that the Cassette bottom disc is snapped closed before attaching the Cassette to the
Pump.
Protective Cover
To prime the Cassette, follow these steps:
STEP 1
Remove the protective cover from the bottom of the Cassette
(see illustration at left).
STEP 2
Connect the solution container to the short tubing of the
Cassette using aseptic technique.
STEP 3
Release all clamps on tubing.
STEP 4
Invert the solution container to allow air to be evacuated first
before priming the Cassette with fluid (see illustration at left).
STEP 5
Gently squeeze the solution container to force fluid and air
upward through the tubing and Cassette. Continue until the
solution has completely filled the tubing and all air bubbles
have been removed.
STEP 6
After priming, close the fluid path by snapping the Cassette
bottom disc into the Cassette body. This will prevent free flow.
Warning:
Failure to properly snap the disc into the Cassette body may
result in incorrect flow rates or free flow conditions.
Note:
In the event that the Cassette bottom disc is snapped closed
before the priming process is complete, place the Cassette
onto the Pump (not attached to patient) and use the BOLUS
button to complete the priming of the Cassette.
11
Sect ion 2 • S et U p
STEP 7
Cassette Shaft
Bend/Break Points
Bend or break away the wings of the protective cover. Place the protective cover back onto the Cassette (insert Cassette shaft into
octagonal opening). Use the protective cover to rotate the Cassette
shaft counterclockwise three (3) or four (4) times.
Note:
The Cassette shaft can also be rotated by hand.
Top of Protective Cover
(Octagonal Opening)
Bottom of Protective
Cover (Round Opening)
Note:
Most “MA” alarms can be resolved by pressing and releasing the RUN/PAUSE button to silence the alarm. To restart the infusion, press and release the RUN/PAUSE button. If the alarm persists, contact Summit Medical Products, Inc.
STEP 8
Make sure the patient is instructed on the proper use of the Pump.
Note:
The filter bonded to the ambIT® Filtered Cassette tubing is an airelimination filter (AEF). The AEF has two membranes. The larger
membrane is a hydrophilic membrane and the smaller membrane is
a hydrophobic membrane. The hydrophobic membrane will not allow
water to flow through. Some other liquids, such as organic liquids,
can allow water to flow through the hydrophobic membrane.
Rotate shaft
using protective
cover
– OR –
Rotate shaft
by hand
12
When the filter is dry both the hydrophilic membrane and the
hydrophobic membrane will allow air through. Once the hydrophilic
membrane comes in contact with water (is “wetted”), air will not
flow through the membrane until the bubble point is reached. (The
bubble point is the pressure required to force air through the wetted
hydrophilic membrane).
Due to the nature of the hydrophilic membrane, it is important to
prime the ambIT® Filtered Cassette without getting water in the filter.
This will allow air to flow through very easily. Once the filter is wet, it
may be more difficult to prime, because the air has a much smaller
area to flow out of (air will only flow out of the smaller hydrophobic
membrane).
Se c t io n 2 • Se t U p
2.3 Attach Cassette to Pump
Tubing on
Left Side of
Pump
Larger Tab on
Right Side
Sensor
Alignment
Insert the Cassette onto the top of the Pump, as shown.
Align and gently squeeze the tabs on the Cassette to
attach onto the Pump.
Note:
Once the cassette has been properly placed on the
pump, free-flow (unimpeded flow due to forces not
associated with the pump), cannot occur.
ambIT® Pump
2.4 Remove Cassette from Pump
To remove the Cassette, press both Cassette release
tabs at the same time and lift the Cassette off the Pump.
Caution:
Do not remove the Cassette while the green RUN light
is blinking. Always place the Pump in PAUSE MODE
first.
F
F
13
Sect ion 2 • S et U p
2.5 Changing Fluid Reservoir
Warning:
Follow your healthcare providers’ procedures to properly change the fluid
reservoir without contaminating the fluid path. It is beyond the scope of this
manual to provide training on connecting or disconnecting the standard
luer or spike connections to bags. If you are unsure of how to perform this
task, consult your facility or supervising physician.
Prior to changing the fluid reservoir put the pump in PAUSE mode (see
section 4.2 for instructions).
2.6 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 non-alkaline or
rechargeable batteries with the Pump; therefore we cannot ensure that
a specific non-alkaline or rechargeable battery will power the Pump for
a specific 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 difficult to predict with non-alkaline or rechargeable
batteries. The manufacturer recommends that the batteries be changed at
the end of each therapy.
Remove Battery Cover
The Pump memory is designed to retain program settings and infusion
history for up to six (6) months without power. Failure to follow the
manufacturer’s instructions while replacing batteries may result in loss of
program settings and report data. Do not store batteries in the Pump.
2.6.1 Battery Installation
To install batteries:
Insert Batteries and
Replace Cover
14
STEP 1:Rotate the battery cover counterclockwise slightly to the
left of the OFF (O) position, until the cover stops or meets
resistance.
STEP 2:Remove the cover and insert the batteries according to the
illustrations at left.
STEP 3: Place the battery cover onto the Pump as illustrated in the
diagram (OFF symbol (O) on the cover slightly to the left of
the ( I ) mark on the Pump).
STEP 4:Rotate the battery cover clockwise to the OFF (O) position.
Se c t io n 2 • Se t U p
2.6.2 Battery Replacement
Warning:
When reinstalling batteries, always verify correct program
settings before restarting infusion.
To replace batteries:
STEP 1:Place the Pump in PAUSE MODE (see Section
4.2).
STEP 2:Rotate the battery cover counterclockwise slightly to
the left of the OFF (O) position, until the cover stops
or meets resistance.
STEP 3:Remove the cover and replace the batteries
according to the instructions in Section 2.6.1.
STEP 4:Power ON the Pump according to the instructions in
Section 2.7.
After battery replacement and power ON, the Pump will return to
PAUSE MODE.
Press and release the RUN/PAUSE button to review the current
program settings.
Press and release the RUN/PAUSE (hold for five (5) seconds
if military pump) button a second time to resume the current
infusion program.
Caution:
Verify that the Pump is in PAUSE MODE before removing the
batteries.
2.7 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.
Note:
After the power on self-test, the Pump will beep twice and go
into PAUSE MODE. The clinician can then program the Pump or
resume current infusion settings.
To power OFF the Pump:
Power ON
Power OFF
Counterclockwise
STEP 1:Place the Pump in PAUSE MODE (see Section
4.2).
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).
15
Sect ion 3 • P r ogr am m ing Inst r u c t i o n s
SECTION 3
PROGRAMMING INSTRUCTIONS
3.1 General Information
The Pump must be programmed and have the history cleared before administering solution. The Pump has
two (2) buttons, the RUN/PAUSE button and the BOLUS or FUNCTION button. A specific combination of
pressing these buttons sets the Pump program.
To enter PROGRAM MODE:
STEP 1: Place the Pump in PAUSE MODE.
STEP 2: Press and hold both the RUN/PAUSE button and the BOLUS or FUNCTION button for two (2)
seconds until one (1) beep is heard.
“PRO” will momentarily appear in the Pump display. Depending on the type of pump, a certain icon will flash in
the Pump display.
The Pump can be reprogrammed during infusion, without clearing the Infusion History, by placing the Pump
in PAUSE MODE and then entering PROGRAM MODE. See Programming Steps for specified pump (listed
below.)
The Pump can be reprogrammed after clearing the Infusion History (see Clearing Pump Infusion History in
3.1.2 Summary) by entering PROGRAM MODE and selecting the desired parameters.
The remaining steps for programming the Pump are described in the following sections:
•Section 3.2 for all pumps with PreSet Settings on back of the pump.
•Section 3.3 for all pumps with PCA protocols that do not contain PreSet Setting on back of pump.
• Section 3.4 for all Continuous pumps with no PreSet Settings and FUNCTION in place of BOLUS button.
Note:
The BOLUS button on the Pump must be used to program the Pump (not the Remote BOLUS button).
When attempting to program/reprogram the Pump, “LOC” will appear in the Pump display if the Pump program
is in LOCKOUT MODE (see Section 6 – Patient Lockout).
The Pump program must be unlocked for programming/reprogramming and clearing Infusion History.
3.1.1 General Program Parameters
Warning:
When the desired Volume to be Infused has been delivered, and the “Infusion Complete” alert has sounded, the Pump will
deliver a Keep Vein Open (KVO) or Keep Open Rate (KOR) rate of (0.5 ml/hr) until the Pump is reset (history cleared) or
turned off. If the Basal Infusion Rate is less than 0.5 ml/hr, the Pump will continue at the set basal rate.The Pump should
be programmed by a physician or under the direction of a physician. Patients should be instructed not to program the
Pump or attempt to change the program.
A. The parameters that may be programmed into the Pump are as follows
Note:
Only Basal Infusion Rate and Volume to Be Infused can be programmed into Continuous Pumps.
•
Basal Infusion Rate: The constant infusion flow rate provided by the Pump. Basal Infusion Rate is
expressed in milliliters per hour (ml/hr).
16
S ecti on 3 • P r ogr am m ing Instr u c t i o n s
•
Bolus Dose Volume: The amount of medication infused upon request by pressing the BOLUS
button. Bolus Dose Volume is expressed in milliliters (ml).
•
Bolus Lockout Time: The time period after the last bolus delivery in which another bolus is
not allowed. The BOLUS button will not deliver a bolus during this time. Bolus Lockout Time is
expressed in hours and minutes (hh:mm).
•
Volume to be Infused: The total amount of fluid in the solution container to be infused. When this
amount has been infused, the “Infusion Complete” alert (one (1) long tone followed by three (3)
short beeps every four (4) minutes) will sound and the BAG icon
will appear in the Pump display.
Volume to be Infused is expressed in milliliters per hour (ml/hr).
3.1.2 Summary of General Program Controls (Applicable to all pumps)
Activity
Program/Reprogram Pump
Steps
From PAUSE MODE, press and hold
both the RUN/PAUSE button and the
Audible
1 Beep
Visual
“PRO” - Parameters can now be
changed
BOLUS button until 1 beep is heard
Review and verify program
settings
Review Infusion History
While the Pump is in PAUSE MODE,
press and release the BOLUS button
While the Pump is in PAUSE MODE,
press and hold the BOLUS button until
1 beep is heard
Clear Infusion History and
begin new infusion
“RX” - Display cycles through each
1 Beep
Upon entering INFUSION HISTORY
MODE (above), release the BOLUS
button and immediately press and
hold the BOLUS button again until 1
beep is heard
programmed parameter
“HX” - Display cycles through each
1 Beep
Infusion History parameter
“HX 0” - Display shows “HX 0”
1 Beep
to verify that the history has been
cleared
3.2 PreSet Pump Programming Options
The ambIT® Pump with PreSet Settings has five (5) programs from which the clinician may choose. The
first four (4) programs (PRO 1 - 4) each contain a preset infusion protocol with a preset Basal Rate, Bolus
Dose Volume, Bolus Lockout Time, and at least one (1) Infusion Volume. Program 5 allows the clinician to
program the Basal Rate, Bolus Dose Volume, Bolus Lockout Time and Infusion Volume individually. Refer
to the table on the back of the Pump for the parameter settings for each preset protocol (PRO 1 - 4).
Note:
Summit Medical Products, Inc. produces multiple ambIT® Pumps with PreSet Settings. Each set of preset
infusion protocols is distinguished by a specific pump color and model number (example: Pump number
220326 (shown below) is always dark gray, and always has the same four (4) preset infusion protocols
available). The preset settings can be found on the label on the back of each Pump.
Note:
The Pump shown on the next page is for example only.
See Programming Table on next page. After setting the Basal Rate, Bolus Dose Volume, and Bolus
Lockout Time in Program 5, or if you have selected a preset infusion protocol (PRO 1 - 4) with more than
one Infusion Volume available, the Volume to be Infused must be programmed. Refer to the table on the
back of the Pump for the volume settings available for each program.
17
S e c t i o n 3 • P r o g ra mmin g In s t ru c t io n s
Please refer to the table on the back of your Pump for the specific infusion protocols available to you.
Bolus (ml)
Lockout Time
Infusion Volume (ml)
PRO1
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
PRO2
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
PRO3
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
PRO4
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
Specified on
back of Pump
SET OWN
SET OWN
SET OWN
SET OWN
Bolus
(ml)
Lockout
Time
Infusion Volume
(ml)
0.5
1.0
30 min
100 – 400
PRO2
1.0
1.0
30 min
100 – 400
PRO3
2.0
1.0
30 min
100 – 400
PRO4
4.0
2.0
30 min
100 – 400
PRO5
SET OWN
SET OWN SET OWN
25 – 1000
504 West 8360 South
Sandy, Utah 84070 USA
Basal Rate
(ml/hr)
PRO1
[email protected]
www.ambitpump.com
Number
P/N 62825.01
ambIT PreSet Program Table
Program
123456
No. 220326
PRO5
USA/Can: 877-352-1888
U.S. Patent 6,685,450
Tel: (801) 352-1888
Assembled in Mexico
Basal Rate (ml/hr)
SUMMIT MEDICAL PRODUCTS, INC.
Program #
3.2.1 Pump Delivery Profiles
The ambIT® Pump can be programmed to provide three (3) profiles:
•Basal Rate with Patient Controlled Bolus
•Basal Rate Only
•Patient Controlled Bolus Only
Refer to the table on the back of the Pump to see which type of profile each preset program delivers.
A. Basal Rate with Patient Controlled Bolus
To customize a basal rate with a patient controlled bolus delivery profile, select Program 5 and set the
Basal Infusion Rate (ml/hr), Bolus Dose Volume (ml), Bolus Lockout Time (hh:mm), and Volume to be
Infused (ml) to the desired parameters.
B. Basal Rate Only
To customize a basal rate only profile, select Program 5 and set the desired Basal Infusion Rate (ml/hr).
Set the Bolus Dose Volume to “0”, then set the desired Volume to be Infused (ml).
Note:
If the Bolus Dose Volume is set to “0”, Bolus Lockout Time will not display for programming.
C. Patient Controlled Bolus Only
To customize a patient controlled bolus only profile, select Program 5 and set the Basal Infusion Rate to
“0”. Set the desired Bolus Dose Volume (ml), Bolus Lockout Time, and Volume to be Infused (ml).
18
S e c t i o n 3 • P r o g ra mmin g In s t ru c t io n s
3.2.2 Programming Steps
A. Programming Pump with a Preset Infusion Protocol (PRO 1 - 4)
ACTION
SOUND PUMP DISPLAY
1. Enter PROGRAM MODE:
From PAUSE MODE, press and hold both the
RUN/PAUSE button and the BOLUS button until
1 beep is heard.
1 Beep
“PRO” is displayed for 2
seconds to indicate that the
Pump is in PROGRAM MODE.
2. Select Program (1 - 4):
Press the RUN/PAUSE button to scroll up or
press the BOLUS button to scroll down through
Program numbers 1 - 4. When the desired
program number appears in the display, press
and hold either the RUN/PAUSE button or the
BOLUS button until 1 beep is heard to accept
the setting.
1 Beep
“PRO” is displayed followed
by a flashing number.
1 Beep
followed
by
2 Beeps
“ml” is displayed and BAG
icon flashes.
If pump has different volume options such as
the military pump, continue to step 3. If the
selected program has only one Infusion Volume
setting, Step 3 will be skipped. (Refer to the
table on the back of your Pump for the specific
preset infusion protocols available to you.)
3. Set Volume to be Infused:
(A) Press the RUN/PAUSE button to increase
the number or press the BOLUS button to
decrease the number. (B) When the desired
number appears in the display, press and hold
either the RUN/PAUSE button or the BOLUS
button until 1 beep is heard to accept the
setting.
If the option is available to set each digit, repeat
Steps 3(A) and 3(B).
ml
Volume to be Infused is
displayed in ml.
Volume to be Infused is established.
1 Beep Volume to be Infused is established.
followed
by
2 Beeps
4. Pump returns to PAUSE MODE.
PAUSE icon flashes.
Note: To confirm program
settings (Section 3.1.2), access “RX” by pressing
and releasing the BOLUS button. After scrolling
through the programmed settings, the Pump will
automatically return to PAUSE MODE.
Note: Numbers shown here are for example only.
19
Sect ion 3 • P r ogr am m ing Inst r u c t i o n s
B. Programming PreSet Pump with a Custom Infusion Protocol (PRO 5)
ACTION
SOUND PUMP DISPLAY
1. Enter PROGRAM MODE:
From PAUSE MODE, press and hold both the
RUN/PAUSE button and the BOLUS button
until 1 beep is heard.
1 Beep “PRO” is displayed for 2
seconds to indicate that the
Pump is in PROGRAM MODE.
2. Select Program 5:
Press the RUN/PAUSE button to scroll up or
press the BOLUS button to scroll down through
Program numbers 1 - 5 until “PRO5” appears
in the display. Press and hold either the RUN/
PAUSE button or the BOLUS button until 1 beep
is heard to accept the setting.
1 Beep “PRO5” is displayed and the
number flashes.
3. Set Basal Flow Rate:
(A) Press the RUN/PAUSE button to increase
the number or press the BOLUS button to
decrease the number (0 - 20). (B) When the
desired number appears in the display, press
and hold either the RUN/PAUSE button or the
BOLUS button until 1 beep is heard to accept
the setting.
1 Beep Number left of decimal point
and “ml/hr” flash.
Repeat steps 3(A) and 3(B) to set the digit to the
right of the decimal point (0.0 - 0.9).
ml/hr
Basal Flow Rate is displayed in ml/hr.
1 Beep Number right of decimal point
and “ml/hr” flash.
Basal Flow Rate is established.
4. Set Bolus Dose Volume:
(A) Press the RUN/PAUSE button to increase
the number or press the BOLUS button to
decrease the number (0 - 20). (B) When the
desired number appears in the display, press
and hold either the RUN/PAUSE button or the
BOLUS button until 1 beep is heard to accept
the setting.
Repeat steps 4(A) and 4(B) to set the digit to the
right of the decimal point (0.0 - 0.9).
1 Beep Number left of decimal point,
“ml” and BOLUS icon flash.
ml/hr
ml
Bolus Dose Volume is displayed in ml.
1 Beep Number right of decimal point,
“ml” and BOLUS icon flash.
ml
Bolus Dose Volume is
established.
5. Set Bolus Lockout Time:
Press the RUN/PAUSE button to increase the
time or press the BOLUS button to decrease
the time. When the desired lockout time appears
in the display, press and hold either the
RUN/PAUSE button or the BOLUS button until
1 beep is heard to accept the setting.
1 Beep “hr:min” is displayed and BOLUS,
LOCK, and CLOCK icons flash.
Bolus Lockout Time is displayed
in hours and minutes.
Note: If Bolus Dose Volume is set to “0” this
step will be skipped.
Bolus Lockout Time is established.
6. Set Volume to be Infused:
Press the RUN/PAUSE button to increase the
number or press the BOLUS button to decrease
the number. When the desired number appears
in the display, press and hold either the
RUN/PAUSE button or the BOLUS button until 1
beep is heard to accept the setting.
1 Beep
followed
by
2 Beeps
7. Pump returns to PAUSE MODE.
“ml” is displayed and BAG
icon flashes.
ml
Volume to be Infused is
displayed in ml.
Volume to be Infused is established.
PAUSE icon flashes.
Note: To confirm program
settings (Section 3.1.2), access
“RX” by pressing and releasing the BOLUS button. After
scrolling through the programmed settings, the Pump will
automatically return to PAUSE MODE.
To accept the current program settings in each step without making any changes, press and hold either the
RUN/PAUSE button or the BOLUS button for two (2) seconds until one (1) beep is heard.
Note: Numbers shown here are for example only.
WARNING: When the Pump is programmed, any lockout time in effect will be cleared. A bolus dose could
be requested and delivered immediately upon starting the Pump, and could result in serious injury or death.
20
S e c t i o n 3 • P r o g ra mmin g In s t ru c t io n s
3.2.3 Program Review
Caution:
After programming the Pump, always verify the program by performing a program review.
To review the Pump program:
STEP 1:Place the Pump in PAUSE MODE.
STEP 2:Press and release the BOLUS button.
“RX” will appear in the display and the Pump will scroll through each programmed parameter in the
sequence shown on the table below. After the review, the Pump will return to PAUSE MODE, and will
be ready to begin or resume the infusion.
Note:
The Remote BOLUS button may be used for Program Review.
Symbols
Parameter
“PRO”
Program Number (1-5)
“ml/hr”
Basal Flow Rate
BOLUS
icon and “ml”
BOLUS
, LOCK
BAG VOLUME
and CLOCK
icon and “ml”
Bolus Dose Volume
icons and “hr:min”
Bolus Lockout Time
Total Volume to be Infused
Note:
The Bolus Lockout Time will not be displayed if the Bolus Dose Volume is set to “0”.
21
Section 3 • P r ogr am m ing Ins t r u c t i o n s
3.3 PCA Pump Programming Options
The ambIT® PCA Pump can be programmed to provide three (3) delivery profiles:
•Basal Rate with Patient Controlled Bolus
•Basal Rate Only
•Patient Controlled Bolus Only
Refer to the table below for all available program settings.
Available Program Settings
Basal Flow Rate (ml/hr)
0 – 20 in 0.1 ml/hr increments
Bolus Dose Volume (ml) 0 – 20 in 0.1 ml increments, 40 ml for some pumps
Bolus Lockout Time (hh:mm) 00:05 -12:00 (Increments vary for different pumps)
Volume to be Infused (ml) 25 - 1000 (Increments vary for different pumps)
3.3.1 Basal Rate with Patient Controlled Bolus
To program a basal rate with a patient controlled bolus delivery profile, set the Basal Infusion Rate (ml/hr),
Bolus Dose Volume (ml), Bolus Lockout Time (hh:mm), and Volume to be Infused (ml) to the desired
parameters.
3.3.2 Basal Rate Only
To program a basal rate only delivery profile, set the desired Basal Infusion Rate (ml/hr). Set the Bolus
Dose Volume to “0”, then set the desired Volume to be Infused (ml).
Note:
If the Bolus Dose Volume is set to “0”, Lockout Time will not display for programming.
3.3.3 Patient Controlled Bolus Only
To program a patient controlled bolus only delivery profile, set the Basal Infusion Rate to “0”. Set the
desired Bolus Dose Volume (ml), Bolus Lockout Time (hh:mm), and Volume to be Infused (ml).
22
Se c t ion 3 • P r ogr am m ing In s t r u c t i o n s
3.3.4 PCA Pump Programming Steps
ACTION
SOUND PUMP DISPLAY
1. Enter PROGRAM MODE:
From PAUSE MODE, press and hold both the RUN/PAUSE
button and the BOLUS button until 1 beep is heard.
1 Beep “PRO” is displayed for 2
seconds to indicate that the
Pump is in PROGRAM MODE.
2. Set Basal Flow Rate:
1 Beep Number left of decimal point
(A) Press the RUN/PAUSE button to increase the number
and “ml/hr” flash.
or press the BOLUS button to decrease the number (0 20). (B) When the desired number appears in the display,
press and hold either the RUN/PAUSE button or the BOLUS
button until 1 beep is heard to accept the setting.
Basal Flow Rate is displayed in ml/hr.
Repeat steps 2(A) and 2(B) to set the digit to the right of the 1 Beep Number right of decimal point
decimal point (0.0 - 0.9).
and “ml/hr” flash.
ml/hr
ml/hr
Basal Flow Rate is established.
3. Set Bolus Dose Volume:
1 Beep Number left of decimal point,
(A) Press the RUN/PAUSE button to increase the number
“ml” and BOLUS icon flash.
or press the BOLUS button to decrease the number (0 20). (B) When the desired number appears in the display,
press and hold either the RUN/PAUSE button or the BOLUS
button until 1 beep is heard to accept the setting.
Bolus Dose Volume is displayed in ml.
Repeat steps 3(A) and 3(B) to set the digit to the right of the 1 Beep Number right of decimal point,
decimal point (0.0 - 0.9).
“ml” and BOLUS icon flash.
ml
ml
Bolus Dose Volume is
established.
4. Set Bolus Lockout Time:
Some pumps allow you to set the hours and minutes
separately. This is not a requirement for all pumps. (A)
Press the RUN/PAUSE button to increase the time or press
the BOLUS button to decrease the time. (B) When the
desired time appears in the display, press and hold either
the RUN/PAUSE button or the BOLUS button until 1 beep is
heard to accept the setting.
If the option is available to set hours and minutes
separately, repeat steps 4(A) and 4(B).
5. Set Volume to be Infused:
Some pumps allow you to set each digit separately. (A)
Press the RUN/PAUSE button to increase the number or
press the BOLUS button to decrease the number. (B) When
the desired number appears in the display, press and hold
either the RUN/PAUSE button or the BOLUS button until 1
beep is heard to accept the setting.
If the option is available to set each digit, repeat steps 5(A)
and 5(B) for each digit.
6. Pump returns to PAUSE MODE.
1 Beep “hr:min” is displayed, BOLUS,
LOCK, and CLOCK icons and
number being programmed flash.
Bolus Lockout Time is
displayed in hours and minutes.
Note: If Bolus Dose Volume is set to “0” this
step will be skipped.
Bolus Lockout Time is established.
1 Beep “ml” is displayed, BAG
followed icon and number being
programmed flash.
by
2 Beeps
ml
Volume to be Infused is displayed in ml.
Once all digits have been programmed, the
volume to be infused is established.
PAUSE icon flashes.
Note: To confirm program
settings (Section 3.5), access
“RX” by pressing and releasing the
BOLUS button. After scrolling through
the programmed settings, the Pump will
automatically return to PAUSE MODE.
To accept the current program settings in each step without making any changes, press and hold either the
RUN/PAUSE button or the BOLUS button for two (2) seconds until one (1) beep is heard.
Note: Numbers shown here are for example only.
WARNING: When the Pump is programmed, any lockout time in effect will be cleared. A bolus dose could
be requested and delivered immediately upon starting the Pump, and could result in serious injury or death.
23
S e c t i o n 3 • P r o g ra mmin g In s t ru c t io n s
3.3.5 PCA Program Review
Caution:
After programming the Pump, always verify the program by performing a program review.
To review the Pump program:
STEP 1:Place the Pump in PAUSE MODE.
STEP 2:Press and release the BOLUS button.
“RX” will appear in the display and the Pump will scroll through each programmed parameter in the
sequence shown on the table below. After the review, the Pump will return to PAUSE MODE, and will
be ready to begin or resume the infusion.
Note:
The Remote BOLUS button may be used for Program Review.
Symbols
Parameter
“ml/hr”
Basal Flow Rate
BOLUS
icon and “ml”
BOLUS
, LOCK
BAG VOLUME
and CLOCK
icon and “ml”
Bolus Dose Volume
icons and “hr:min”
Bolus Lockout Time
Total Volume to be Infused
Note:
The Bolus Lockout Time will not be displayed if the Bolus Dose Volume is set to “0”.
24
S e c t i o n 3 • P r o g ra mmin g In s t ru c t io n s
3.4 Continuous Pump Programming Options
3.4.1 Programming Steps For Continuous Pumps
ACTION
SOUND PUMP DISPLAY
1. Enter PROGRAM MODE:
From PAUSE MODE, press and hold down both
the RUN/PAUSE button and the FUNCTION
button until 1 beep is heard.
1 Beep
“PRO” is displayed for 2
seconds to indicate that the
Pump is in PROGRAM MODE.
2. Set Flow Rate:
(A) Press the RUN/PAUSE button to increase
the number or press the FUNCTION button to
decrease the number (0 - 12). (B) When the
desired number appears in the display, press
and hold either the RUN/PAUSE button or the
FUNCTION button until 1 beep is heard to
accept the setting.
1 Beep
Number at far left of decimal
point and “ml/hr” flash.
Repeat steps 2(A) and 2(B) to set the digit
immediately to the left of the decimal point
(0 - 9).
1 Beep
For rates less than 50 ml/hr: Repeat steps
2(A) and 2(B) to set the digit to the right of the
decimal point (0.0 - 0.9).
1 Beep
3. Set Volume to be Infused:
(A) Press the RUN/PAUSE button to increase
the number or press the FUNCTION button
to decrease the number (0 - 9). (B) When the
desired number appears in the display, press
and hold either the RUN/PAUSE button or the
FUNCTION button until 1 beep is heard to
accept the setting.
1 Beep
“ml” is displayed, BAG
icon and number being
programmed flash.
Repeat steps 3(A) and 3(B) to set rate for the
10’s and 1’s digits (0 - 9).
1 Beep
Note 1: If the 100’s digit is set to ‘0’, the
minimum digit in the 10’s will be ‘2’. If the 100’s
digit is set to ‘0’ and the 10’s digit is set to ‘2’,
the minimum digit in the 1’s will be ‘5’.
“ml” is displayed, BAG
icon and number being
programmed flash.
Note 2: For some pumps the maximum volume
that can be set is 9999. For these pumps,
repeat steps 3(A) and 3(B) to program all digits.
4. Pump returns to PAUSE MODE.
ml/hr
Flow Rate is displayed in ml/hr.
Number immediately left of
decimal point and “ml/hr”
flash.
Number right of decimal point
and “ml/hr” flash.
ml/hr
ml/hr
Flow Rate is established.
ml
ml
Volume to be Infused is
displayed in ml.
Volume to be Infused is
established.
2 Beeps Pause indicator flashes.
Pump is ready to infuse.
To accept the current program settings in each step without making any changes, press and hold either
the RUN/PAUSE button or the FUNCTION button for two (2) seconds until one (1) beep is heard.
Note: Numbers shown here are for example only.
25
Section 3 • P r ogr am m ing Inst r u c t i o n s
3.4.2 Program Review
Caution:
After programming the Pump, always verify the program by performing a program review.
To review the Pump program:
STEP 1:Place the Pump in PAUSE MODE.
STEP 2:Press and release the FUNCTION button one (1) time.
“RX” will appear in the display and the Pump will scroll through each programmed parameter in the
sequence shown on the table below. After the review, the Pump will return to PAUSE MODE, and will
be ready to begin or resume the infusion.
Symbols
Parameter
“ml/hr”
BAG VOLUME
26
Basal Flow Rate
icon and “ml”
Total Volume to be Infused
Sect ion 4 • Oper ating Instr uc t i o n s
SECTION 4
OPERATING INSTRUCTIONS
4.1 Start Infusion
Note:
Before starting infusion, the Pump must be programmed. See Section 3 –
Programming Instructions for details.
Pump Display
RUN/PAUSE
Button
BOLUS Button
To begin an infusion, with the Pump in PAUSE MODE, press and release
the RUN/PAUSE button. The RUN/PAUSE button is located directly
below the Pump display.
The first time an infusion is started after programming, or after Power
ON, the program settings will be reviewed. After this review the Pump will
return to PAUSE MODE.
Press and release the RUN/PAUSE button again to start the infusion.
The green RUN light (inside the BOLUS or FUNCTION button) will start
to blink, and “ml” (volume infused) will appear in the Pump display.
4.2 Pause Infusion
To pause the infusion, press and release the RUN/PAUSE button (hold
for five (5) seconds if a military pump). The Pump will beep two (2) times,
the green RUN light will stop blinking, and the PAUSE icon ( l l ) will flash
in the Pump display. If left in PAUSE MODE, the Pump will beep two (2)
times every four (4) minutes.
Note:
Pausing the Pump temporarily stops the infusion. While in PAUSE
MODE, the infusion is delayed. This allows for changing the Cassette,
solution container, or batteries.
4.3 Resume Infusion
To resume the infusion from PAUSE MODE, press and release the
RUN/PAUSE button. If a military pump, press and hold for five (5)
seconds until one (1) beep is heard.
The green RUN light (inside the BOLUS or FUNCTION button) will start
to blink, and “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 MODE.
4.4 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 MODE.
Once the cause of the alarm has been corrected, press and release the
RUN/PAUSE button to resume the infusion. If a military pump, press
and hold for five (5) seconds until one (1) beep is heard 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.
27
S e c t i o n 4 • Op e ra t in g In s t ru c t io n s
4.5 Bolus Activation
Note:
Continuous pumps have a FUNCTION button instead of a Bolus button. See section 4.5a for
Continuous Pumps
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.
Note:
•When Bolus Dose Volume is set to 0 ml, no bolus will be delivered when the BOLUS
button is pressed.
•Flow rate during bolus is 100 ml/hr.
•The BOLUS button is disabled if the total Volume to be Infused has been delivered.
During this time, if the BOLUS button is pressed, the “Infusion Complete” alert will
sound.
•A Remote BOLUS button may also be used.
4.5a FUNCTION Button Activation
Pressing the FUNCTION button while in RUN MODE will toggle the display between Total
Volume Infused and Total Elapsed (RUN) Time.
Note:
•The maximum volume displayed is 9999 ml, and the maximum time displayed is 999
hours.
•Elapsed time (RUN time) will be displayed as hr:min up to 99:59. After 100 hours,
elapsed time will be displayed as hours only, up to 999 hours.
4.6 Summary of Operating Controls
To:
Steps to Take
Start Infusion
Program the Pump, then press
and release the
Audible Indicator
1 Beep
Visual Indicator
Green RUN light (inside the BOLUS
button) blinks, and “ml” (volume
infused) is in the Pump display
RUN/PAUSE button. Hold for 5
seconds on military pumps before
releasing
Pause Infusion
Press and release the
RUN/PAUSE button. Hold for 5
2 Beeps
(every 4 minutes)
seconds on military pumps before
PAUSE icon ( l l ) flashes in the
display; Green RUN light (inside the
BOLUS button) stops blinking
releasing.
Silence Alarm
Press and release the
Alarm sound stops
PAUSE icon ( l l ) flashes in the
display; Green RUN light (inside the
RUN/PAUSE button
BOLUS button) stops blinking
Deliver Bolus
(Does not apply
to Continuous)
28
Press and release the BOLUS
button
Note:
Patient may use the BOLUS
button on the Pump or a Remote
BOLUS button
1 Beep
Green RUN light (inside the BOLUS
button) double blinks
Sect ion 5 • Infusion H istor y R e p o r t s
SECTION 5
INFUSION HISTORY REPORTS
5.1 Pump Infusion History
To obtain the Pump Infusion History:
STEP 1:Place the Pump in PAUSE MODE.
STEP 2:Press and hold the BOLUS or FUNCTION button for two (2) seconds until one (1) beep is
heard and “HX” is displayed.
Note:
• The Remote BOLUS button may be used to review Infusion History.
• The PCA and PreSet Pumps will cycle through all of the following parameters.
• The Continuous Pump will only cycle through volume infused and elapsed time.
Infusion History
Visual Indicator
Total volume infused, including boluses, in ml
ml
Total number of boluses actually delivered No. and
Total number of bolus requests
No. and
Elapsed time (time Pump has been in RUN MODE
since history was cleared)
**After 100 hours, Pump will only display
hours (not minutes)
and
hr:min
The displayed parameters indicate history since the last time the Pump history was cleared, as explained
in Section 5.2.
5.2 Clearing Pump Infusion History
To clear the Pump Infusion History:
STEP 1:Place the Pump in PAUSE MODE.
STEP 2:Press and hold the BOLUS or FUNCTION button for two (2) seconds until one (1) beep is
heard to enter INFUSION HISTORY MODE.
STEP 3:Upon entering INFUSION HISTORY MODE (“HX”), release the BOLUS or FUNCTION
button and immediately press and hold the BOLUS or FUNCTION button again until “HX 0”
appears in the Pump display. This indicates the clearing of the Pump Infusion History.
Note:
•The Pump program must be unlocked for programming, reprogramming and clearing Infusion
History.
•When attempting to clear the Pump Infusion History, “LOC” will appear in the Pump display if the
Pump program is in LOCKOUT MODE (see Section 6 – Patient Lockout).
•The BOLUS or FUNCTION button on the Pump must be used to clear the Infusion History (not the
Remote BOLUS button).
29
S e c t io n 6 • Pa t ie n t L o c k o u t
SECTION 6
PATIENT LOCKOUT
The Pump has been designed with patient lockout features:
LEVEL 1 – SOFTWARE: The steps required for entering the Pump’s PROGRAM MODE should not be
revealed to the patient. This prevents unauthorized tampering with the infusion parameters, and prevents
the Infusion History from being cleared.
LEVEL 2 – ACCESS CODE: The Pump’s LOCKOUT MODE is accessed by following these steps:
STEP 1:Place the Pump in PAUSE MODE.
STEP 2:Enter PROGRAM MODE by pressing and holding both the RUN/PAUSE button and the
BOLUS or FUNCTION button for two (2) seconds until one (1) beep is heard and “PRO”
appears in the Pump display.
STEP 3:Release both buttons and immediately press and release both the RUN/PAUSE button and
the BOLUS or FUNCTION button again. Four (4) dash symbols ( - - - - ) will appear in the
display.
6.1 To Lock the Pump
After accessing LOCKOUT MODE (see above), a lock code is entered into the Pump by entering a
number in each digit space of the display, starting from the right.
STEP 1: First digit space flashing.
STEP 2:Press the RUN/PAUSE button to increase the number or press the BOLUS button to
decrease the number.
STEP 3:When the desired number appears in the display, press and hold either the RUN/PAUSE
button or the BOLUS or FUNCTION button for two (2) seconds until one (1) beep is heard.
STEP 4:Repeat steps 1-3 to program the second through fourth digits.
Note:
•The clinician may program one, two, three, or four digits into the Pump for the lock code.
•If programming only one, two, or three digits into the Pump for the lock code, when the desired
code is programmed (eg: 12 or 123), press and hold both the RUN/PAUSE button and the BOLUS
or FUNCTION button for two (2) seconds until one (1) beep is heard. This will accept the shortened
code and lock the Pump program.
After completing LOCKOUT MODE, the Pump will return to PAUSE MODE and the LOCK icon
will appear in the display. Current program settings can be resumed by pressing and releasing the
RUN/PAUSE button.
30
Sect ion 6 • P atient Lockout
6.2 To Unlock the Pump
To unlock the Pump program, the clinician accesses LOCKOUT MODE, as described above. The preprogrammed code is re-entered into the Pump by entering a number into each digit space of the display,
starting from the right.
STEP 1:First digit space flashing.
STEP 2:Press the RUN/PAUSE button to increase the number or press the BOLUS button to
decrease the number.
STEP 3:When the desired number appears in the display, press and hold either the RUN/PAUSE
button or the BOLUS button for two (2) seconds until one (1) beep is heard.
STEP 4: Repeat steps 1-3 to enter the second through fourth digits.
Note:
•If entering only one, two, or three digits for the lock code, when the code is entered (eg: 12 or 123),
press and hold both the RUN/PAUSE button and the BOLUS button for two (2) seconds until one (1)
beep is heard. This will accept the shortened code and unlock the Pump program.
•After unlocking, the Pump will return to PAUSE MODE. The clinician can now reprogram the Pump,
clear the history, or verify and resume the current program settings.
•In the event that a code is forgotten, contact Summit Medical Products, Inc. for technical support.
•The Pump program must be unlocked for programming, reprogramming and clearing Infusion
History.
SECTION 7
ALARMS AND SIGNALS
Note:
The alarm in table 7.1 applies to the Continuous pump only, and supersedes any alarm in table 7.2 that
includes a bolus
function. All other alarms in table 7.2 can be applied to the continuous pump.
7.1 Visible and Audible Alarm and Signal Exception for Continuous Pump
Priority
Status
Low
Pump Infusing
Normally
Icon
Visual Indicator
Audible
Indicator
Comments
Green RUN light (inside
the FUNCTION button)
blinks, and “ml” (volume
infused) or “hr:min”
and CLOCK icon
(elapsed time) is in the
display
None
Periodic movement of the Cassette
gears is normal.
31
S e c t i o n 7 • A la rms a n d Sig n a ls
7.2 Visible and Audible Alarm and Signal Table
Visual Indicator
Audible
Indicator
Comments
Pump Infusing
Normally
Green RUN light (inside
the BOLUS button)
blinks, and “ml” (volume
infused) is in the display
None
Periodic movement of the Cassette gears
is normal.
Infusion Paused
PAUSE icon flashes in
the display; Green RUN
light is off
2 Beeps every
4 Minutes
Infusion Complete
BAG icon flashes in the
display
1 Long Tone
followed by
3 Short Beeps;
repeats every
4 Minutes
The “Infusion Complete” alert will sound
every 4 minutes.
Bolus Infusion
Green RUN light (inside
the BOLUS button)
double blinks; BOLUS
icon is in the display
1 Beep
1 beep will sound every time the BOLUS
button is pressed during RUN MODE.
Occlusion Alarm
ALARM icon and “OCL”
are in the display
Low
Cassette not
Attached to Pump
ALARM icon and “MA”
are in the display
High
Malfunction
ALARM icon and “MA”
are in the display
Constant Tone
Immediately close the tubing clamp.
See Section 8 – Troubleshooting.
High
Malfunction
ALARM icon and “MA1”
are in the display
Constant Tone
Press the RUN/PAUSE button to silence the
alarm. Gently press on top of the Cassette to
ensure proper placement. Resume infusion.
Low Battery
BATTERY icon flashes in 5 Short Beeps
every 4 Minutes
the display
Replace the batteries as soon as possible.
Dead Battery
BATTERY icon and
ALARM icon are in the
display
Constant Tone
Press the RUN/PAUSE button to silence
the alarm. The ALARM and BATTERY
icons will remain on. Replace the batteries
immediately.
Malfunction
ALARM icon and “EE1”,
“EE2”, “EE3”, “EE4”,
“EE5”, “EE6”, or “EE7”
are in the display
10 Short Beeps
Immediately close the tubing clamp and
turn off the Pump. Contact Summit Medic al
Products, Inc. by calling the toll free number
on the Pump.
High
Malfunction
ALARM icon and “CPU”,
“RA”, or “RO” are in the
display
Constant Tone
Immediately close the tubing clamp and
turn off the Pump. Contact Summit Medical
Products, Inc. by calling the toll free number
on the Pump.
Low
BOLUS Button
“REL” is in the display
Constant Beeping
Release the BOLUS button.
Near end of
Infusion, Approx.
10% of charge
remaining.
Slow flashing bag icon in 3 pulses over 2
seconds every 30
display window
seconds
Priority Status
Low
Low
High
Low
High
Low
Low
High
Low
Icon
Constant Beeping Press the RUN/PAUSE button to silence
Only Non-latching the alarm. Press the RUN/PAUSE button
to restart the Pump. If unable to resolve
Alarm
(silence) the alarm, contact Summit Medical
Products, Inc.
Press the RUN/PAUSE button to silence the
Constant Tone
alarm. Gently press on top of the Cassette to
ensure proper placement. Resume infusion.
Press function button to allow alarm to give
3 pulses every 4 minutes until empty bag
alarm occurs.
Note: Alarms cannot be disabled or modified.
Note: When batteries are removed the alarms are cleared. When pump is powered on it will detect any alarm
conditions that are still present.
32
Sect ion 8 • Tr oubleshooting
SECTION 8
TROUBLESHOOTING
8.1 Troubleshooting Table
Problem
Resolution
Reference
Cassette will not prime
• Verify that all tubing clamps are open
• If a spike set is used, verify that the spike is
completely inserted into the solution container
• Verify that the Cassette bottom disc has not
been snapped into the Cassette body
Section 2
Cassette will not attach
to Pump
• Verify proper Cassette placement onto the Pump Section 2
• Verify that the Cassette bottom disc has been
snapped into the Cassette body
No display
• Verify that the battery cover is in the ON position Section 2
• Verify proper battery placement
• Replace the batteries
Constant beeping during
infusion; “OCL” in display
Fluid path occlusion
• Verify that all tubing clamps are open
• Check access device patency
• Check for kinks in the tubing
Section 4
Continuous tone
Malfunction
• Possible dead battery alarm (BATTERY icon
visible), replace the batteries
• Press on the Cassette top to ensure proper
placement
• Check the Cassette
- Remove the Cassette from the Pump
- Rotate the Cassette shaft counterclockwise
one (1) time
- Replace the Cassette onto the Pump
• Press and release the RUN/PAUSE button to
resume infusion
• If “MA” continues:
- Immediately close the tubing clamp
- Manufacturer’s service/assistance may be
required
Section 7
Blood backed into tubing
• Verify that the tubing is connected correctly:
Patient side connected to Patient, Bag side
connected to Bag
• Verify that the Pump is in RUN MODE
• Attempt to clear the tubing by delivering a Bolus
• If unable to clear the tubing by delivering a
Bolus, close the tubing clamp and replace the
Cassette
• If the situation continues, manufacturer’s
service/assistance may be required
33
S e c t io n 9 • Sp e c if ic a t io n s
SECTION 9 SPECIFICATIONS
ambIT® Pumps
Basal Flow Rates*
• PCA
• Military
• PreSet
• Continuous
• PreSet PCA
• PreSet PCRA
• Teleflex PCA
• Veterinary
Bolus Dose Volume*
• PCA
• Military
• PreSet
• Continuous
• PreSet PCA
• PreSet PCRA
• Teleflex PCA
• Veterinary
Bolus Lockout Times (hr:min)*
• PCA
0 to 20 ml/hr in 0.1 ml/hr steps
0 to 20 ml/hr in 0.1 ml/hr steps
0 to 20 ml/hr in 0.1 ml/hr steps
0.0 to 50 ml/hr in 0.1 ml/hr steps
50 to 125 ml/hr in 1.0 ml/hr steps
0 to 20 ml/hr in 0.1 ml/hr steps
0 to 20 ml/hr in 0.1 ml/hr steps
0 to 20 ml/hr in 0.1 ml/hr steps
0.0 to 49.9 ml/hr in 0.1 ml/hr steps
50 to 125ml/hr in 1.0 ml/hr steps
0 to 20 ml in 0.1 ml steps
0 to 20 ml in 0.1 ml steps
0 to 20 ml in 0.1 ml steps
(No Bolus)
0 to 20 ml in 0.1 ml steps, 40 ml
0 to 20 ml in 0.1 ml steps
0 to 20 ml in 0.1 ml steps
(No Bolus)
00:05, 00:10, 00:15, 00:20, 00:30, 00:45, 1:00, 1:30, 2:00,
4:00, 8:00, 12:00
• Military
00:05, 00:10, 00:15, 00:20, 00:30, 00:45, 1:00, 1:30, 2:00,
4:00, 8:00, 12:00
• PreSet
00:05, 00:10, 00:15, 00:20, 00:30, 00:45, 1:00, 1:30, 2:00,
4:00, 8:00, 12:00
(No Bolus Lockout)
00:05, 00:10, 00:15, 00:20, 00:30, 00:45, 1:00, 1:30, 2:00,
3:00 (PRO3 only) 4:00, 8:00, 12:00
• Continuous
• PreSet PCA
• PreSet PCRA
00:05, 00:10, 00:15, 00:20, 00:30, 00:45, 1:00, 1:30, 2:00,
4:00, 8:00, 12:00
• Teleflex PCA
• Veterinary
00:05 to 12:00 in 1 minute steps
(No Bolus Lockout)
*If the back of your pump contains a program table, please refer to the table for specific infusion
protocols.
34
S e c t io n 9 • Sp e c if ic a t io n s
Volumes to be Infused (ml)*
• PCA
25, 50, 75, 100, 150, 200, 250, 300, 350, 400, 450, 500, 600,
700, 800, 900, 1000
• Military
25, 50, 75, 100, 150, 200, 250, 300, 350, 400, 450, 500, 600,
700, 800, 900, 1000
• PreSet
25, 50, 75, 100, 150, 200, 250, 300, 350, 400, 450, 500, 600,
700, 800, 900, 1000
• Continuous
• PreSet PCA
25-999 ml in 1.0 ml steps
25, 50, 75, 100, 150, 200, 250, 300, 350, 400, 450, 500, 600,
700, 800, 900, 1000
25, 50, 75, 100, 150, 200, 250, 300, 350, 400, 450, 500, 600,
700, 800, 900, 1000
• PreSet PCRA
• Teleflex PCA
• Veterinary
25 to 1000 in 1 ml steps
25-9999 in 1.0 ml steps
The Following Specifications are the same for All Pumps
Stroke Volume
50 microliters
Bolus Delivery Rate
100 ml/hr
Minimum Sound Pressure Level
Volumetric Accuracy
Pump Mechanism
Maximum Infusion/Occlusion Pressures
45 dBA at 1 meter
± 6%
Microprocessor Controlled Rotary-Peristaltic
25 +/- 12 psi
Maximum Activation Time of Occlusion Alarm
4 Hours
(minimum rate) at Minimum Occlusion Pressures
Maximum Activation Time of Occlusion Alarm
(intermediate rate) at Maximum Occlusion
Pressures
90 Seconds
Dimensions
2.16 in. x 1.4 in. x 6.875 in. (55 mm x 36 mm x 175 mm)
Weight
4.7 ounces (133.2 grams) without batteries
6.4 ounces (181.4 grams) with batteries
Power Supply
2 AA alkaline 1.5V batteries
Battery Life (rate dependent)
Up to 14 Days
Operating Controls
RUN/PAUSE Button, BOLUS Button, Remote BOLUS Button
(optional), ON/OFF Twist Cap
Display, Audible Alarms, Signals and Reports
• Run Indicator Light
• Bolus Infusing
• Pause Indicator
• Occlusion Downstream (25 +/- 12 psi)
• Cassette Not Mounted on Pump
• Low Battery
• Dead Battery
• Malfunction
• Infusion Complete
*If the back of your pump contains a program table, please refer to the table for specific infusion
protocols.
35
S e c t io n 9 • Sp e c if ic a t io n s
History Reports
• Volume Infused
• Boluses Delivered
• Boluses Requested
• Elapsed Time
Delivery Profiles
• Basal Rate + Bolus
• Basal Rate Only
• Bolus Only
Estimated life span for the following Pumps:
• PCA • Military • Continuous • PreSet PCA
• PreSet PCRA • Teleflex PCA • Veterinary
• Approx. 2 years depending on usage and treatment
Estimated life span for the following PreSet Pumps:
• 2000 ml (end of life is after completion of current
• PreSet • UMROI PreSet • St. Luke’s PreSet
infusion)
• Virginia Mason PreSet • RA PreSet
This device is restricted to sale by or on the order of a physician.
36
Sect ion 1 0 • D eliver y R ate A c c u r a c y
SECTION 10
DELIVERY RATE ACCURACY
The following curves show Pump delivery accuracy for bolus and basal infusions. The bolus accuracy is
shown at different volumes over a number of sequential bolus events. The basal accuracy is shown as
trumpet curves under different conditions of flow rate and delivery pressures. These graphs are applicable
for all ambIT® Pump Cassettes.
The ambIT® Pump uses a rotary peristaltic mechanism to deliver fluid. Each rotation of the peristaltic
mechanism delivers 50 μl of fluid. During bolus delivery, the Pump delivers a prescribed volume at a flow
rate of 100 ml/hr. Bolus accuracy is shown as the percent error for the actual vs. prescribed bolus volume.
This error is measured sequentially over a number of bolus events at a minimum bolus volume (0.1 ml)
and a maximum bolus volume (20 ml). During basal delivery, the Pump delivers fluid at a prescribed
flow rate. The flow rate is controlled by the time interval between rotations of the peristaltic mechanism.
The trumpet curves are used to describe the flow rate in basal mode. The trumpet curve defines, for a
programmed flow rate, the maximum and minimum percentage variation from the expected flow rate for
given time intervals measured from start-up. Over short time intervals, fluctuations in flow rate have a
greater effect on accuracy as represented by the “bell” portion of the trumpet curve. As the time interval
increases, short term fluctuations have little effect on accuracy as represented by the narrower portion of
the trumpet curve.
The user is directed to these curves in order to be aware of the delivery profile of the ambIT® Pump and to
ensure that the delivery profile is acceptable for the drug being infused, its concentration, and the drug’s
rate of delivery.
20 ml/hr Flow Rate
25.0
20.0
15.0
% Error
10.0
5.0
0.0
-5.0
EP Max
EP Min
-10.0
-15.0
0
2
4
6
8
10
Observation Window (min)
12
14
16
18
37
S e c t i o n 1 0 • D e liv e ry R a t e A c c u ra c y
20 ml/hr + 100 mmHg Back Pressure
10.0
8.0
% Error of Flow
6.0
4.0
2.0
0.0
-2.0
-4.0
EP Max
EP Min
-6.0
-8.0
-10.0
0
5
10
15
20
Observation Window (min)
25
30
35
30
35
20 ml/hr - 100 mmHg Back Pressure
4.0
2.0
0.0
-2.0
% Error
-4.0
-6.0
-8.0
-10.0
EP Max
EP Min
-12.0
-14.0
-16.0
0
5
10
15
20
Observation Window (min)
25
Supply Container Below Pump
20 ml/hr, for 2 hours
6.0
4.0
2.0
0.0
% Error
-2.0
-4.0
-6.0
-8.0
EP Max
EP Min
-10.0
-12.0
-14.0
0
38
5
10
15
20
Observation Window (min)
25
30
35
Sect ion 1 0 • D eliver y R ate A c c u r a c y
0.1 ml/hr Flow Rate
6000.0
5000.0
% Error
4000.0
3000.0
EP Max
EP Min
2000.0
1000.0
0.0
-1000.0
-2000.0
0
2
4
6
8
10
Observation Window (min)
12
14
16
18
25 0.1 ml Bolus Doses
5.0%
4.5%
4.0%
3.5%
% Error
3.0%
2.5%
2.0%
1.5%
1.0%
0.5%
0.0%
1
2 3
4
5
6 7
8 9
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Bolus Number
25 20ml Bolus Doses
3.5%
3.0%
2.5%
% Error
2.0%
1.5%
1.0%
0.5%
0.0%
-0.5%
-1.0%
1
2 3
4
5
6 7
8 9
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Bolus Number
39
Sect ion 11 • Gener al C ar e Ins t r u c t i o n s
SECTION 11
GENERAL CARE INSTRUCTIONS
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.
The patient should be careful to protect the Pump at all times. The Pump should not be dropped.
Transport and storage conditions: -25ºC without relative humidity control; and 70ºC at relative humidity up
to 93%, non-condensing.
Operating conditions: +5ºC to +40ºC; relative humidity range of 15% to 93%, non-condesing; and an
atmospheric pressure of 700 hPa to 1060 hPa.
The Pump and components should be stored in a dry, cool place until used.
No sterilization of the pump is required. Disinfect the pump before and after every patient use, procedure,
and transfer of patients.To clean and 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
No maintenance of the pump is required, and no calibration is required. Contact Summit Medical Products,
Inc. if a functional test is desired.
Note:
For storing and transporting the Pump, a cap should be placed on the Pump to protect the pressure
switch.
11.1 Warranty Information
Contact your local sales representative for warranty and extended warranty lengths.
This warranty will not apply to ambIT® Pumps that have been, in the judgment of Summit Medical
Products, Inc., damaged in whole or in part due to misuse, abuse, negligence, alteration, improper
installation, being dropped, or otherwise used in a manner inconsistent with its labeling and packaging.
To obtain warranty service, the Pump and Cassette must be returned to Summit Medical Products, Inc.
postage prepaid. The replacement of a Pump and Cassette will not extend the original term set forth
above.
40
SEC T ION 1 2 • EM C
SECTION 12
Electromagnetic Immunity
Mobile RF communications equipment can effect the operation of the ambIT Pump.
ambIT Pumps that have a remote bolus cord connector should only be used with the Summit
Medical Remote Bolus Button. Use of any remote bolus switch other than the approved ambIT
PCA Remote Bolus Switch manufactured by Summit Medical Products, Inc. (Product #220265)
could result in an inadvertant bolus dose. It may also result in increased EMISSIONS or
decreased IMMUNITY of the device.
The ambIT Pump should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the ME Equipment should be observed to verify normal
operation in the configuration in which it will be used.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The ambIT Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the
pump should assure that it is used in such an environment
Emissions test
RF emissions
Compliance
CISPR 11
Group1
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Electromagnetic environment - guidance
The ambIT Pump uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment
Class B
The ambIT Pump is suitable for use in all
establishments.
Not Applicable
Not Applicable
IEC 61000-3-3
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The ambIT Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the
pump should assure that it is used in such an environment
Immunity Test
IEC 60601
test level
Electrostatic
discharge (ESD)
± 8 kV contact
IEC 61000-4-2
± 15 kV air
Compliance Level
8 kV
15 kV
Electromagnetic environment
- guidance
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
41
SEC T ION 1 2 • EM C
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The ambIT Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the
pump should assure that it is used in such an environment
Immunity Test
IEC 60601
test level
Compliance Level
Electromagnetic environment guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the ambIT Pump,
including cables, than the recommended separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
[31] V
[31] V/m
d = 1.16 P
d = 1.16
80 MHz to 800 MHz
d = 2.33
800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in wattes (W)
according to the transmitter manufacturer and d is the recommended
separation distances in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than
the compliance level in each frequency
range.b
Interference may occur in the vicinity
of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propogation is affected by absorption
and reflection from structures, objects and people.
a
b
42
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with most
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should
be considered. If the measured field strength in the location in which the ambIT Pump is used exceeds the applicable
RF compliance level above, the ambIT Pump should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the ambIT Pump.
Over the frequency rang 150 kHz to 80 MHz, field strengths should be less than [V1] V/m
SEC T ION 1 2 • EM C
Recommended separation distances between
portable and mobile RF communications equipment and the [ME EQUIPMENT or ME SYSTEM]
The ambIT Pump is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the ambIT Pump can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the ambIT Pump as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = 1.16
d = 1.16
d = 2.33
0,01
0.116
0.116
0.233
0,1
0.367
0.367
0.737
1
1.16
1.16
2.33
10
3.67
3.67
7.368
W
11.6
23.3
11.6
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
43
S e c t i o n 1 3 • C u s t o me r A s s is t a n c e
SECTION 13
CUSTOMER ASSISTANCE
For Customer Assistance, please contact your ambIT® distributor,
or Summit Medical Products, Inc. at:
Summit Medical Products, Inc.
504 West 8360 South
Sandy, Utah 84070
USA
Toll Free: (877) 352-1888
Phone: (801) 352-1888
Fax: (801) 352-1818
E-mail: [email protected]
Web Site: www.ambitpump.com
European Representative:
Medical Technology Promedt Consulting GmbH
Altenhofstraße 80
66386 St. Ingbert
Germany
Copyright © 2015 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.
44
ambIT® Infusion Pump is a trademark of:
63076.00 1/15
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