ambIT Pump Patient Manual April 2020

Become familiar with the ambIT® pump Solution container

Cassette

.

Pump display RUN/PAUSE button

BOLUS button

Tubing clamp

Tubing clamp

ON/OFF switch ambIT® Pump

Remote BOLUS button (optional)

To solution container (Side view of cassette)

Cassette shaft

To patient

Continuous pumps have FUNCTION button in place of BOLUS button

Table of Contents SECTION 1 - INTRODUCTION...1 1.1 Definitions and Symbols...1 1.1.1 Definitions...1 1.1.2 Definition of Symbols...3 1.2 Warnings...6 SECTION 2 - PRODUCT DESCRIPTION...8 2.1 Welcome to the ambIT® Pump Family...8 2.2 What to Expect?...9 SECTION 3 - OPERATION...10 3.1 Your Pump’s Control Buttons...10 3.2 Attach Cassette to Pump ...11 3.3 Battery Replacement...11 3.4 Pump Power On and Off...13 3.5 Pause Infusion...14 3.6 Resume Infusion...14 3.7 Silence Alarm...14 3.8  The BOLUS Button...15 3.9 The FUNCTION Button...15 3.10 Summary of Operating Controls...16 SECTION 4 - ALARMS AND TROUBLESHOOTING...17 SECTION 5 - GENERAL CARE INSTRUCTIONS...20 SECTION 6 - ELECTROMAGNETIC IMMUNITY (EMC)...22 SECTION 7 - CUSTOMER ASSISTANCE...24

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For Technical/Customer Assistance: Toll Free: 1 (800) 444-2728 Email: [email protected]

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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

1.1.1 Definitions ANALGESIA: Relief from pain. BASAL FLOW RATE: The continuous flow rate. BOLUS: A volume of medication infused over a relatively short period of time. If the healthcare provider has prescribed a bolus option, the bolus is delivered when requested by pushing the BOLUS button or the optional remote BOLUS switch. 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 that occurs at regularly scheduled intervals. INFUSION: The introduction of a saline or other solution via the tubing into the body. 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 (hr:min). KINK: A twist or curl of the tubing caused by its doubling or bending upon itself. A kink may stop or reduce the infusion rate (i.e., cause an occlusion; see definition below.) 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 (hr:min). ML: Milliliter; one-thousandth of a liter; shown as “ml” on pump and throughout manual. NOTE: A note highlights information that acts as a reminder or helps explain a concept or procedure. 1

Sect ion 1 • Intr oduction

OCCLUSION: Closure or blockage of the tubing. PAUSE MODE: The pump is on, but not infusing medication. PCA: An acronym for patient controlled analgesia. RUN MODE: The pump is on and infusing medication. TUBING CLAMPS: A device found on the tubing used to open or close the flow of solution through the tubing. See diagram on inside cover. 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.

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Se c t io n 1 • In t ro d u c t io n

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. 606011:2014, 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 60601-1-11:2015; 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. The cUL mark applies to products intended for the Canadian market that have been tested and found to comply with the requirements of CAN/CSA 22.1-12, which is the Canadian Electrical Code issued by the Canadian Standards Association. 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 3

Sect ion 1 • Intr oduction

and Health Administration (OSHA) to laboratories that have been recognized to perform certification to U.S. standards.

IP22

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. Any natural or legal person established within the Union that places a device from a third country on the Union market. Medical device Indicates the manufacturer’s serial number so that a specific medical device can be identified. CAUTION: This device is restricted to sale by or on order of a physician. To solution container

Indicates which tubing connects to the solution container Indicates which tubing connects to the patient

To patient

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(side view of cassette)

Cassette shaft

Se c t io n 1 • In t ro d u c t io n

Bolus Program lockout Volume in milliliters Infusion completed RUN/PAUSE button PAUSE indicator BOLUS button FUNCTION button Low/dead battery indicator Alarm indicator ambIT® pump display

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Sect ion 1 • Intr oduction

Pump power on Pump power off

Battery orientation

1.2

Warnings

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. This pump must be used only for the person for whom it was prescribed. 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 technical/customer support if pump appears to be operating incorrectly. See page ii or Section 7. Never perform any function or push any button unless instructed by your healthcare provider or by following the instructions in the manual. Do not allow the pump to get wet. If the pump is immersed in any liquid, it must be replaced with a new pump. Never attempt to open the pump case. Only the battery cover may be removed when changing batteries. Do not drop the pump. If the pump is dropped, it must be replaced with a new pump.

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Se c t io n 1 • In t ro d u c t io n

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. Contact the local authorities to determine the proper method of disposal of potentially biohazardous parts and accessories. Safety hazards with the ambIT® pump, including under-infusion, may be associated with external radio frequency (RF) interference or electromagnetic radiation. Typical equipment that may generate such radiation includes x-ray machines, magnetic resonance imaging (MRI) equipment, and any other non-shielded electrical equipment. The cassette tubing or BOLUS switch cord may cause strangulation if used improperly. The pump should not be disassembled or modified by any user. If equipment is tampered with to the point it is ineffective, consult the prescribing physician. Keep out of reach of animals or children.

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Sect ion 2 • P r oduct D escr ipti o n

SECTION 2 - PRODUCT DESCRIPTION 2.1

Welcome to the ambIT® Pump Family

You have been provided with this manual to better assist you in your therapy goals. Your doctor has prescribed an ambIT® Infusion Pump to best assist you with your personal needs. There are a variety of different ambIT® pumps, some that have bolus buttons and some that do not. The differences between these buttons are described in Sections 3.8 and 3.9. Your pump is also equipped with notifications that sometimes are referred to as alarms and alerts. We have provided a table for you to become familiar with in Section 4. The ambIT® Family of pumps are used for infusing antibiotics, chemotherapy, pain medications, and other therapies. In general, our pumps are not used for life-sustaining medications. These highly accurate electromechanical devices are capable of assisting you with your therapy goals while allowing you the freedom to move about. Please do not tamper with your pump. Your doctor has programmed it to deliver a very precise amount of medication, and tampering with it may inhibit any prescribed therapies. This manual will help you understand how to activate the BOLUS/ FUNCTION button, power on and off the pump, start infusion, stop or pause infusion, change batteries and respond to alarms and alerts. This pump is capable of more functions but if you have not been trained by your healthcare provider then please do not attempt any function other than what this manual provides. Any other operations such as changing the reservoir bag, administration set or dressings and removal of catheters, etc. are the responsibility of your healthcare provider. This is an ambulatory pump; as such you are free to walk around with your pump if it’s not against your doctor’s orders. Your pump will not interfere with electronics in your home, and is easy to have with you while doing most activities. Please do not shower with your pump. While it will repel water, it is not intended to be fully submerged, and its life span will diminish if not treated properly.

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S e c t i o n 2 • Pro d u c t D e s c rip t io n

2.2

What to Expect?

When the pump is running or infusing there will be a number in the display and a green light flashing in the BOLUS or FUNCTION button (See illustration in Section 3.1). You will periodically hear the gears turning as the pump infuses medication. If the display shows a pause symbol or two lines flashing, it is in pause mode and is not infusing medication. To resume your infusion therapy simply press and release the RUN/PAUSE button (see Section 3.6). If your healthcare provider has given you the option to request a bolus, pushing the BOLUS button will deliver the additional medication. After a bolus has been delivered, a lockout time occurs during which another bolus will not be given. The primary purpose of the lockout time is to make sure the patient does not receive too much medication if they repeatedly request more. A secondary purpose of the lockout time is to allow the medication to act and relieve the pain prior to infusing any additional medication. If you have any questions regarding your pump, you may contact technical/ customer assistance (see page ii or Section 7). Please keep in mind that we cannot answer therapy specific questions.

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Sect ion 3 • Oper ation

SECTION 3 - OPERATION NOTE:

Pump display may not be clearly visible in bright light. Shading the display will allow viewing of the display by the user. 3.1

Pump run mode display RUN/ PAUSE button BOLUS button

Pump pause mode display RUN/ PAUSE button

FUNCTION button

Your Pump’s Control Buttons

All of our ambIT® pumps have similar control buttons. The RUN/PAUSE button is located just below the pump display. This button is used to start, pause, or resume the infusion, and to silence alarms. The RUN/PAUSE button toggles between run 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. If the infusion is paused, a flashing pause icon ( I I ) will appear 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 FUNCTION button is pressed during run mode, the pump will toggle between the amount of medication infused and the total time the pump has been infusing. When the BOLUS button is pressed during run mode, the pump will deliver the programmed bolus. During bolus delivery, the green run light (inside the BOLUS button) will double blink. We know you’ll find your ambIT® experience positive during your therapy and we would love to hear your feedback. To share your story, please contact us at [email protected].

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Se c t io n 3 • Op e ra t io n

3.2 Attach Cassette to Pump Sensor alignment

Tubing on left side of pump

Larger tab on right side

In the event the cassette becomes detached from the pump, it will be necessary to re-attach the cassette. Insert the cassette onto the top of the pump, as shown. Align and gently squeeze the tabs on the cassette to attach to the pump. 3.3

ambIT® pump

Battery Replacement

The pump is powered by two AA 1.5V batteries. Alkaline batteries are recommended.

CAUTION: 

Make sure the pump is in pause mode before turning off the pump and removing the batteries. Failure to do so may cause loss of timing and a delay in therapy. The pump will not sound an alarm if it is turned off without being placed in pause mode.

CAUTION: 

Summit Medical Products, Inc. has not validated all types of batteries (non-alkaline, rechargeable, specific brands, previously-used, etc.) and cannot ensure that any specific battery will power the pump for a specific period of time. The battery condition and pump settings will determine how the battery will perform with regard to 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.

NOTE:

It is recommended that the batteries be changed when the low battery alarm occurs.

The pump memory is designed to retain program settings and infusion history for up to six 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.

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Sect ion 3 • Oper ation

To replace batteries: If the pump is in run mode, place the pump in pause mode by pushing the RUN/PAUSE button (see Section 3.5). Step #1

Rotate the battery cap counter-clockwise until the line ( I ) on the pump is slightly to the right of the OFF (O) position (i.e., until the battery cap stops or meets resistance).

Twist left to unlock battery cap

Step #2

Remove the battery cap and remove the batteries according to the illustrations at the left. Step #3

Insert new batteries and replace the battery cap. Place the battery cap onto the pump as illustrated to the left (The OFF (O) symbol on the battery cap will be slightly to the left of the ( I ) mark on the pump).

Step #4 Insert batteries and replace battery cap

Rotate the battery cap clockwise to the OFF (O) position. Power on the pump according to the instructions in Section 3.4. After the batteries are replaced and the pump is powered on, the pump will return to pause mode.

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Se c t io n 3 • Op e ra t io n

Press and release the RUN/PAUSE button. The current settings will be displayed. Press and release the RUN/PAUSE button a second time to resume the infusion. 3.4

Pump Power On and Off

CAUTION: 

Always place the pump in pause mode prior to turning the pump off. Failure to do so may cause the therapy to be delayed and/or history to be lost. The pump will not sound an alarm if the pump is not placed in pause mode prior to being turned off. To power on the pump: Rotate the battery cap 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. Power ON clockwise

To power off the pump: Step #1

If the pump is in run mode, place the pump in pause mode by pushing the RUN/PAUSE button (see Section 3.5). Step #2

Rotate the battery cap counter-clockwise until the (O) mark on the battery cap lines up with the ( I ) mark on the pump (see illustration at left). Power OFF counterclockwise

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Sect ion 3 • Oper ation

3.5 Pause Infusion CAUTION: 

Always place the pump in pause mode prior to turning the pump off. Failure to do so may cause the therapy to be delayed and/or history to be lost. The pump will not sound an alarm if the pump is not placed in pause mode prior to being turned off. To pause the infusion, press and release the RUN/PAUSE button. The pump will beep two times, the green run light will stop blinking, and the pause mode icon ( I I ) will flash in the pump display. If left in pause mode, the pump will beep two times every four minutes.

NOTE:

Pausing the pump temporarily stops the infusion. While in pause mode, the infusion is delayed. This allows for changing the batteries and turning off the pump. 3.6 Resume Infusion To resume the infusion from pause mode, press and release the RUN/PAUSE button. The green run light (inside the BOLUS/FUNCTION button) will start to blink, the “ml” icon and the volume infused will appear in the pump display. The infusion will resume at the same point at which the pump was last placed in pause mode. 3.7 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, resume the infusion (see Section 3.6).

NOTE:

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If the pump sounds an alarm due to downstream pressure (occlusion alarm), and the cause of the alarm is corrected without intervention, the alarm will silence itself and the pump will resume the infusion automatically.

Se c t io n 3 • Op e ra t io n

3.8  The BOLUS Button (not applicable to pumps with FUNCTION button) The BOLUS button is located on the pump directly below the RUN/PAUSE button. Each time the BOLUS button is pressed during the infusion the pump will beep once. If the bolus is permitted (the lockout time has elapsed), the pump will begin bolus administration. During bolus infusion, the green run light will double blink. If the BOLUS button is pressed during the lockout time, the pump will beep once but no bolus will be delivered. If using the ambIT® KIDS PIB, your physician may have deactivated the BOLUS button. If so, a remote BOLUS switch must be connected to the pump in order to administer a BOLUS when allowed. To connect the remote BOLUS switch to the pump, locate the remote BOLUS switch port on the right side of the pump and open the black rubber plug. Insert the metal tip into the remote BOLUS switch port. Once connected, press and release the black button found at the end of the body of the switch to administer the bolus. See diagram on inside front cover. NOTE:

The bolus activation function is only available when the physician has prescribed a bolus option.

NOTE:

The BOLUS button is disabled if the infusion is complete. During this time, if the BOLUS button is pressed, the “infusion complete” alarm will sound.

NOTE:

A remote BOLUS switch may also be used to request a bolus. 3.9

The FUNCTION Button

The FUNCTION button is located on the pump directly below the RUN/PAUSE button. When the FUNCTION button is pressed during run mode, the display will toggle between the amount of medication infused and the total time the pump has been infusing.

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Sect ion 3 • Oper ation

3.10 Summary of Operating Controls AUDIBLE INDICATOR

VISUAL INDICATOR

Press and release the RUN/ PAUSE button. The RUN/ PAUSE button will need to be pressed again if the pump has just been turned on.

One beep

Green run light (inside the BOLUS button) blinks, the “ml” icon and volume infused is in the pump display.

Pause infusion

Press and release the RUN/ PAUSE button.

Two beeps (every four minutes)

Pause icon ( I I ) flashes in the display; green run light (inside the BOLUS button) stops blinking.

Silence alarm

Press and release the RUN/ PAUSE button.

Alarm sound stops

Pause icon ( I I ) flashes in the display; green run light (inside the BOLUS button) stops blinking.

Press and release the BOLUS button.

One beep

Green run light (inside the BOLUS button) double blinks.

One beep

Green run light (inside the BOLUS button on the pump) double blinks.

ACTION

STEPS TO TAKE

Start infusion

Deliver bolus using BOLUS button on pump

Deliver bolus using remote BOLUS switch

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To connect the remote BOLUS switch to the pump, locate the remote BOLUS switch port on the right side of the pump and open the black rubber plug. Insert the metal tip into the remote BOLUS switch port. Once connected, press and release the black button found at the end of the body of the switch to administer the bolus.