M.D. Resource K Pump User manual

198-003 K Pump IFU Rev D 1
K PUMP
Instructions for Use

198-003 K Pump IFU Rev D 2
Table of Contents
Symbols.............................................................................................................. 3
Introduction, Disclaimer and Contact Information ........................................... 4
Overview & Intended Use ................................................................................. 5
Warning and Safety Information ....................................................................... 6
Chapter 1: Getting Started ................................................................................. 7
Chapter 2: Identifying the K Pump.................................................................... 9
Chapter 3: Accessories..................................................................................... 10
Chapter 4: Connecting Accessories / Devices................................................. 10
Chapter 5: Activating the K Pump................................................................... 12
Chapter 6: Cleaning the K Pump..................................................................... 13
Chapter 7: Support & Warranty Information .................................................. 14
Chapter 8: Troubleshooting............................................................................. 15
Appendix A: Technical Specifications............................................................ 16
Appendix B: Parts & Accessories.................................................................... 17
Appendix C: EMC & Other Interference ........................................................ 18

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Symbols
The following symbols appear on the exterior of the product or elsewhere in this User’s Manual.
Caution: Federal Law (U.S.A) restricts this device to use by, or on the order of, a physician.
Consult Instructions for use
Authorized representative in the
European Community
Caution: General Warning
CAUTION: Federal Law (U.S.A)
restricts this device to use by, or on
the order of, a physician.
Power ON
Date of Manufacture
Power OFF
Manufacturer
CAUTION: Risk of electrical shock. Do not
open case.
Serial Number
Special disposal for Electronic Waste
required.
LNE/G-Med (notified body)
identification number
European Conformity
Catalog Number
SGS Product Certification Mark
Temperature limit for Operating
environment (on Device label)
Temperature limit for Transport and
Storage environment (on Box label)
Relative Humidity Limitation for operating
environment (on Device label)
Relative Humidity for Transport and
Storage environment (on Box label)
Atmospheric Pressure limit for
Operating environment (on Device
label)
Atmospheric Pressure limit for
Transport and Storage environment
(on Box label)
Keep Dry

198-003 K Pump IFU Rev D 4
Introduction, Disclaimer and Contact Information
Introduction
Thank you for choosing the M.D. Resource K Pump. The K Pump is a peristaltic pump using
three rollers to create pumping action. This manual provides instruction for operation, maintenance,
and troubleshooting procedures for the K Pump. Users should be trained in its use and applicable
medical procedures.
Disclaimer
Medical Device Resource Corporation provides the following cautions to the reader of this
manual:
-M.D. Resource may change all or part of this manual without notice.
-All rights are reserved. Reproduction or duplication of all or part of this manual, in any
form, is prohibited without the explicit written permission of M.D. Resource.
-M.D. Resource assumes no responsibility for damage or injury from use of the K Pump
not in accordance with the instructions provided in this manual.
Contact Information
Company
Medical Device Resource Corp
Advena Ltd.
Location
5981 Graham Court
Livermore, CA 94550
Pure Offices, Plato Close
Warwick CV34 6WE, UK
Customer Support
800.633.8423
[phone]
Orders / Tech Support
510.732.9950
Web Address
http://www.mdresource.com
http://www.advenamedical.com
E-Mail
[e-mail]
[e-mail]
Modifications
Modifications to any component of this device may create possible hazards and/or impair the safe
use of this product during procedure. Any requests for changes in design or use should be sent or
communicated to proper M.D. Resource personnel.

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Overview & Intended Use
Document Overview
This K Pump Instruction for Use provides information about using the K Pump infiltrator, set-up,
performing cleaning / troubleshooting, and obtaining support.
Product’s Intended Use
The K Pump is designed to infiltrate tumescent fluid into a patient during cosmetic or plastic
surgery procedures.
Electronic Accessories and Equipment
Following is a list of approved electrical accessories for the K Pump:
-Power Supply: Power supply is IEC 60601-1 3rd Edition compliant, medical grade; Input
100-240V~1.6a, Max 50-60Hz; Output 24V~2.1a, 50W Max.
-Power Cord: Any six-foot hospital-grade power cord
Optionally if using with M.D. Resource LS system, any 24”
Universal jumper cord
-Foot Pedal: Only use foot pedal supplied by M.D. Resource. To minimize trip hazard,
our recommended maximum length is three meters.
Use of accessories, transducers, and cables other than those sold by Medical Device Resource
may result in system failure, increased EMC emissions, and/or decreased EMC immunity of the
K Pump.
Electromagnetic Interference
This Pump should not be used adjacent to or stacked on other equipment except M.D. Resource
LS2 aspirator pump. If it is used in a stacked configuration, care should be taken to observe
normal operation of system components.
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put in service according to instructions and the EMC information included in Appendix C.

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Warning and Safety Information
Warning
General Warnings and Cautions are labeled on the housing and in the manual. All warnings and
cautions should be familiar to, and reviewed by, all personnel prior to a procedure. These
cautions and warnings are considered essential to the safety of personnel, patients, equipment,
and property.
-This device must be used by a trained professional with current knowledge regarding the
use of the correct drug, the correct cannula size and the safe dosage. Orders for dosage
must be by a physician.
-This device is not intended for intravascular delivery.
-User must be aware of fluid level in IV bag. Empty bag will cause insufficient delivery.
-User must be aware of proper tube management to prevent leaks or pinching.
-To avoid risk of electric shock, this equipment must only be connected to a supply main
with protective earth.
-Do not exceed the limits of 0 to 10 on the flow control, overturning may cause damage to
the speed control.
Safety Guidelines
The K Pump is designed to ensure both the highest level of product quality and safety for the
user. To maintain both quality and safety, follow the guidelines and instructions in this
document.
Use K Pump only as intended.
Store the K Pump within 0°–40° C.
Avoid prolonged exposure to direct sunlight.
If any cord or cable is frayed or damaged, replace it immediately with another of the same type
and rating as supplied by M.D. Resource.
To clean the exterior of the K Pump, follow, the UL 60601-1 standard for use in a hospital
environment; see “Cleaning the K Pump” section for more information.
Indoor Use Only

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Chapter 1: Getting Started
This chapter contains information about properly unpacking and setting up your K Pump.
Unpacking the K Pump
-When the K Pump arrives, check the shipping box for any apparent damages (i.e., holes
in the box or a crushed top). Open the box and inspect each product.
-Inspect the K Pump for physical damage while unpacking. Contact M.D. Resource
immediately if any physical damage is observed.
-If the K Pump is for evaluation, keep the shipping box. These are needed to return the
unit.
Removing the Product from the Shipping Box
-Remove the styrofoam placed on top of the box.
-Remove and set aside the K Pump Instructions for Use. Do not discard.
-Remove the accessories placed inside of the box.
-Remove the K Pump and plastic protective cover from the product.

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Setting Up
Assembly
Prior to the delivery of fluids:
Attach transformer to power cord and plug this assembly and footswitch into back of K Pump. If
used in conjunction with a TMD, attach the umbilical from the K Pump to the TMD.
Turn the power ON (switch located on top of the pump)
Rotate the speed control knob to a low setting (i.e.; 3-5)
Using the proper sterile technique, open the tubing and place into sterile field.
If an infiltration handle is utilized, ensure the unit is sterile and place into the sterile field.
Fluid Connection
Non-sterile assistant should lift the pump lever to open the pump mechanism.
Sterile operator should hand off the “spike” end of the tubing to the assistant.
Assistant should place the silicone section of tubing into the pump mechanism (NOTE: Fluid
flow will be from left to right when facing the pump)
Close the Pump Lever. If the lever is not closed completely, the pump will NOT operate. The
pump also has two Tubing Retainers, tubing stabilization devices, on each side of the pump head,
which can be lowered to hold the tubing in place.
Non-sterile assistant should close the clamp on the tubing, introduce the spike into the bag and
then open the clamp on the tubing.
If an infiltration handle is utilized, attach the delivery end of the tubing to the handle.
Attached the infiltration cannula to the tubing or handle depending on your configuration.
The pump can now be activated. With the speed setting low, depress and release the footswitch
to start the flow of fluid. Observe the tubing while the fluid primes the tubing. When fluid flows
through the distal end of the needle, the operator should press the footswitch again to stop the
flow of fluid. At this point, the tubing is primed. (NOTE: Failure to prime the tubing, handle and
needle, can result in the introduction of air into the perivenous space, which can significantly
distort the view of the operator)
Fluid Delivery
Adjust the speed control to the desired level. (Generally between 5 and 7)
The pump is activated by pressing the footswitch and releasing; deactivation of the pump is
accomplished by pressing the footswitch a second time and releasing.
If using a handle, the operator must also depress the flow control button on the infiltration handle
after activating the pump. Release of the button will stop fluid flow, even if the pump is still
running. Operator should deactivate the pump immediately after releasing the flow button on the
handle.

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Chapter 2: Identifying the K Pump
This chapter contains information about identifying K Pump features and the accessories required to
configure your device for use.
K Pump Features
-The following two illustrations are designed to help you to become familiar with the
standard features of your K Pump:
-Control Speed
-For lifting
Speed Control Knob

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Chapter 3: Accessories
Standard Accessories Supplied
-K Pump Instructions for Use
-Hospital Grade Power Cord
-Foot Pedal
-Power Adapter
Optional Accessories Available
-Disposable AutoFuse 3/8” OD Tubing (Sterile)
-Disposable AutoFuse Tubing with “Y” bifurcation (Sterile)
-Infiltration Cannulae (Custom made. Please call for size, shape, tip, and handles)
Optional Device’s Used in Conjunction
-Tumescent Measuring Device
-LS2 Liposuction Aspirator
To place an order for the accessories or the devices listed above, contact M.D. Resource. at
510.732.9950 or call toll free 800.633.8423.
(Refer to Appendix B for further listings of parts & accessories)
Chapter 4: Connecting Accessories / Devices
This chapter contains information about properly routing accessories on your K Pump.
Connecting Standard Accessories
-Position the posterior side of the K Pump in front of you.
-Obtain the power adapter and insert one end into any one of the power inlets (See
pictorial representation, Page 8 –Power Inlet).
-Note - The second power inlet is used for the optional Tumescent Measuring Device if
purchased.