Summit Medical ambIT User manual

®
.
0088
0459
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
CLINICIAN MANUAL
ambIT®PIB Pumps
IP22

Become familiar with the ambIT
®pump
.
Solution container
Tubing
clamp
BOLUS
button
ambIT
®
Pump
ON/OFF
switch
Remote BOLUS switch
(optional)
Tubing
clamp
Pump display
RUN/PAUSE
button
Cassette
To solution container
(Side view of cassette)
Cassette shaft
To patient

i
Table of Contents
SECTION 1 - INTRODUCTION........................................................................................................1
1.1 Definitions and Symbols.......................................................................................................1
1.1.1 Definitions ....................................................................................................................1
1.1.2 Definition of Symbols..................................................................................................2
1.2 Warnings.................................................................................................................................7
1.2.1 Sterile, Disposable (Single-Use) Administration Set ..............................................8
1.2.2 Protection From Air Infusion.....................................................................................8
1.2.3 Protection From Unintended Bolus ..........................................................................9
1.2.4 Use of ambIT
®
PIB Pumps in MRI Environment ....................................................9
1.3 Indications for Use.................................................................................................................9
1.4 Product Description ............................................................................................................10
1.4.1 Product Overview .....................................................................................................10
1.4.2 ambIT
®
Pump User Interface ...................................................................................18
1.4.3 ambIT
®
Cassette .........................................................................................................18
SECTION 2 - SET UP .........................................................................................................................20
2.1 Required Materials ..............................................................................................................20
2.2 ambIT
®
Cassette ...................................................................................................................21
2.3 Priming the Cassette ...........................................................................................................21
2.4 Attach Cassette to Pump ....................................................................................................24
2.5 Remove Cassette from Pump.............................................................................................24
2.6 Changing Fluid Reservoir ..................................................................................................25
2.7 Battery Installation and Replacement...............................................................................25
2.7.1 Battery Installation ....................................................................................................25
2.7.2 Battery Replacement .................................................................................................26
2.8 Pump Power On and Off....................................................................................................27
SECTION 3 - PROGRAMMING INSTRUCTIONS ....................................................................28
3.1 General Information............................................................................................................28
3.2 Program Options .................................................................................................................29
3.2.1 PCA Mode ..................................................................................................................29
3.2.2 PIb Mode.....................................................................................................................34
3.2.3 P+P Mode....................................................................................................................37
3.3 Program Review...................................................................................................................42
SECTION 4 - OPERATING INSTRUCTIONS .............................................................................43
4.1 Start Infusion........................................................................................................................43
4.1.1 PCA Mode Start Infusion .........................................................................................43
4.1.2 PIb Mode Start Infusion............................................................................................43
4.1.3 P+P Mode Start Infusion ..........................................................................................44
4.2 Pause Infusion......................................................................................................................44
4.3 Resume Infusion ..................................................................................................................44
4.4 Silence Alarm .......................................................................................................................45
4.5 Bolus Activation...................................................................................................................45
4.6 Summary of Operating Controls.......................................................................................46

ii
SECTION 5 - INFUSION HISTORY REPORTS...........................................................................47
5.1 Pump Infusion History.......................................................................................................47
5.1.1 PCA Mode Infusion History ....................................................................................47
5.1.2 PIb Mode Infusion History.......................................................................................48
5.1.3 P+P Mode Infusion History .....................................................................................48
5.2 Clearing Pump Infusion History.......................................................................................49
SECTION 6 - PATIENT LOCKOUT ...............................................................................................50
6.1 Accessing Lockout Mode....................................................................................................50
6.2 To Lock the Pump................................................................................................................50
6.3 To Unlock the Pump ...........................................................................................................51
SECTION 7 - ALARMS AND SIGNALS .......................................................................................52
SECTION 8 - TROUBLESHOOTING.............................................................................................54
SECTION 9 - SPECIFICATIONS.....................................................................................................55
SECTION 10 - DELIVERY RATE ACCURACY............................................................................57
10.1 Data from Volumetric Accuracy Testing .........................................................................58
10.2 Factors That May Affect Volumetric Accuracy...............................................................58
SECTION 11 - GENERAL CARE INSTRUCTIONS....................................................................63
11.1 Warranty Information.........................................................................................................63
11.2 Cleaning and Disinfecting Instructions............................................................................64
SECTION 12 - ELECTROMAGNETIC IMMUNITY (EMC) ......................................................65
SECTION 13 - CUSTOMER ASSISTANCE ..................................................................................67

Section 1 • Introduction
1
SECTION 1 - INTRODUCTION
1.1 Definitions and Symbols
1.1.1 Definitions
ANALGESIA: Relief from pain.
BASAL FLOW RATE: The continuous flow rate. It occurs when the pump is not delivering
a bolus in PCA mode. The basal flow rate is adjustable and has units of milliliters per hour
(ml/hr).
BOLUS: A volume of medication infused over a relatively short period of time.
1
The bolus
is infused at the bolus flow rate. A bolus is delivered when a patient requests it by pushing the
BOLUS button or the optional remote BOLUS switch. A bolus is sometime referred to as a PCA
bolus. The bolus has units of milliliters (ml).
BOLUS/DOSE FLOW RATE: The flow rate at which a bolus or dose is delivered. It is a
higher flow rate than the basal flow rate. In the ambIT
®
PIB pumps, the bolus flow rate varies
from 210 ml/hr to 125 ml/hr, depending on the energy left in the battery. Flow rate accuracy
is not affected by the bolus flow rate. See Section 1.4.1 for an explanation of how the bolus flow
rate changes. The bolus/dose flow rate is not adjustable.
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. Cautions are found throughout
this document emphasized with grey shading.
DOSE: A volume of medication infused over a relatively short period of time
2
and is
programmed to occur at regularly scheduled intervals. Sometimes a dose is referred to as a PIB
or as a PIEB. In this manual, the term “dose” will be used when discussing either PIB or PIEB.
The dose has units of milliliters (ml).
INTERVAL OR DOSE INTERVAL: The time between the start of one dose and the start
of the next dose. The dose interval has units of hours and minutes (hh:mm).
INTERVAL LIMIT (“IL”): The maximum amount that can be delivered within a dose
interval, or, if there is no dose programmed, it is the maximum bolus volume allowed to be
programmed. This setting is only applicable to PIB + PCA (“P+P”) mode for PIB-IL pumps.
LOCKOUT TIME: The time between the end of one bolus or dose and the start of the next
bolus or dose. The lockout time has units of hours and minutes (hh:mm).
NOTE: A note highlights information that acts as a reminder or helps explain a concept or
procedure.
P+P: An acronym for a combination of programmable intermittent bolus (“PIB”) and patient
controlled analgesia (“PCA”) and allows for dose volumes occurring at set intervals, as well as
optional boluses.
1 The bolus is delivered at a higher flow rate than the basal rate; therefore, for a given volume, the bolus is delivered faster.
2 The dose is delivered at a higher flow rate than the basal rate; therefore, for a given volume, the dose is delivered fast.

Section 1 • Introduction
2
PCA: An acronym for patient controlled analgesia. If a pump is in PCA mode and the patient
has been prescribed a bolus volume, then PCA allows for a lay user to periodically give the
patient a bolus of medication. If the infusion is into the epidural space the PCA is referred to as
patient controlled epidural analgesia (PCEA).
PIB (PIb): An acronym for programmable intermittent bolus. If the infusion is into the
epidural space, the PIB or PIb is referred to as programmable intermittent epidural bolus (PIEB
or PIEb).
3
Within this manual, when referring to the pump itself, “PIB” is used; when referring
to the dose, display or mode, “PIb” is used.
VOLUME TO BE INFUSED: The total amount of fluid in the solution container or
reservoir to be infused. The volume to be infused has units of milliliters (ml).
WARNING: A warning message contains special safety emphasis and must be observed at
all times. Warnings are found at Section 1.2, as well as throughout this document emphasized
with grey shading. Failure to observe a warning message is potentially life threatening.
1.1.2 Definition of Symbols
Consult instructions for use.
International symbol meaning “Attention, consult accompanying
documents.”
IEC symbol for “Type BF Applied Part.” (IEC Classification: Internally
powered.)
The ambIT
®
pump complies with ES 60601-1:2012, 1st Edition, including
Amend. 1; CSA C22.2 NO. 60601-1:2014, 3rd Edition; IEC 60601-1:2005,
including Corr. 2:2007 and Amend. 1:2012; IEC 60601-1-6:2013, Edition
3.1; IEC 60601-1-8:2012, Edition 2.1; IEC 60601-1-11:20105; 60601-2-
24:2012, Edition 2; IEC 62304:2006, 1st Edition; IEC 62366:2007, 1st
Edition, and Amend. 1:2014; IEC 60601-1-2:2014, 4th Edition, 2014-02.
CE symbol certifying that the product complies with the essential
requirements of the Medical Device Directive.
3 In some publications, the PIb is referred to as an “automated bolus” or “automated mandatory bolus.” This usage is less
common than PIb or PIEb.
0088
®

Section 1 • Introduction
3
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 that have been recognized to perform
certification to U.S. standards.
Underwriters Laboratories (UL) symbol certifying that the product
meets OSHA required safety standard.
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.
Indicates the medical device manufacturer, as defined in EU Directives
90/385/EEC, 93/42/EEC and 98/79/EC.
Indicates the Authorized Representative in the European Community.
Indicates the date after which the medical device is not to be used.
Indicates the manufacturer’s batch code so that the batch or lot can be
identified.
Indicates the manufacturer’s serial number so that a specific medical
device can be identified.
Single-use only (cassettes)
Keep away from heat
IP22

Section 1 • Introduction
4
Keep dry
Caution: This device is restricted to sale by or on the order of a
physician.
Temperature limitation
Sterilized using irradiation
DEHP-free fluid path
Not made with natural rubber latex
Indicates which tubing connects to
the solution container
Indicates which tubing connects to
the patient
Bolus
Program lockout
To patient
To solution container
Cassette
shaft
(side view of cassette)

Section 1 • Introduction
5
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
BOLUS button
Low/dead battery indicator
Alarm indicator
ambIT
®
pump display
Pump power on

Section 1 • Introduction
6
Pump power off
Battery orientation
PIb mode
PCA mode
P+P mode
Program lockout code
Program lockout mode
Pump program mode
Review pump program
Infusion history report
Pump infusion history cleared
Bolus button on
Bolus button off