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

198-003 K Pump IFU Rev D 3
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.

198-003 K Pump IFU Rev D 5
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.

198-003 K Pump IFU Rev D 6
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

198-003 K Pump IFU Rev D 7
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.

198-003 K Pump IFU Rev D 8
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.

198-003 K Pump IFU Rev D 9
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

198-003 K Pump IFU Rev D 10
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.

198-003 K Pump IFU Rev D 11
-Attach the “Hospital Grade” Power Cord to the transformer and the other end to wall
socket.
-Lastly, take the “Foot Pedal” and insert the tubing end into the bulkhead connectors (See
pictorial representation, Page 8 –Bulkhead Connector).
Note: For safety, only use the specified parts supplied by M.D. Resource. (Refer to Page 16 for
Technical Specifications and Page 17 for Parts & Accessories).
Connecting Optional Accessories
Tubing to K Pump, IV Bag, and Cannula:
-Position the anterior side of the K Pump in front of you.
-Shift the pumphead lever to the left. This will enable the channel of the pumphead to
open and unlock.
-Obtain the sterile AutoFuse Tubing and locate its flexible portion.
-Note - This portion will be inserted into the channel of the pumphead.
-Starting from left to right, carefully insert the tubing through the channel.
-Now shift the lever to the right to close and lock the tubing in place.
-Adjust the clips accordingly located on the pumphead to stabilize the tubing.
-Next insert the spiked end of the tubing to the IV bag.
-Lastly insert the other end of the tubing to the Cannula.
Note: In the event of fluid dripping from the needle after the Pump has been stopped, we
suggest:
-Use a stopcock connector, or trumpet-valve type infiltration handle with infiltration
needle attached.
-Bend and kink the tubing when you do not want any flow.
-Secure the pinch valve included on the tube set near the IV bag.
Connecting Optional Devices
oTo LS2 Liposuction Aspirator
-Perform “Connecting Standard Accessories” Steps 1 to 3 (Page 10), but instead of
inserting one end of the Power Cord to wall socket, insert it into the LS2 socket.

198-003 K Pump IFU Rev D 12
-Obtain the LS2 “Hospital Grade”Universal power cord and insert one end to the LS2 and
the other end to wall socket.
Note: Refer to your LS2 User & Technical Manual for further instructions on how to set-up your
aspirator.
oTo Tumescent Measuring Device, TMD
-Perform “Connecting Standard Accessories” Steps 1 to 3 (Page 10).
-Obtain the Conductor Cable and insert one end into the TMD and the other end into one
of the Power Inlets of the K Pump.
Note: Refer to your TMD User Manual for further instruction on how to set-up your tumescent
measuring device.
Note: For safety, only use the specified parts supplied by M.D. Resource. (Refer to Page 16 for
Technical Specifications and Page 17 for Parts & Accessories).
Note: The K Pump uses a power adaptor to isolate itself from the mains. For safe operation,
only use genuine parts supplied by M.D. Resource.
Chapter 5: Activating and Deactivating the K Pump
This chapter contains information about activating and deactivating your K Pump.
Activation
-Turn the main power switch “ON”
-Locate the control knob and rotate the speed to #3 setting.
-Depress the foot pedal to activate the K Pump. The foot pedal controls
the peristaltic Pump when the main power switch is “ON”
Note - One or both pneumatic footswitches can be used to turn the pump on and off. The
footswitches may be operated in any sequence to activate or deactivate the pumping action.
Deactivation
-Depress the Foot Pedal to deactivate the K Pump.
-Turn the main Power Switch “OFF”

198-003 K Pump IFU Rev D 13
Chapter 6: Cleaning the K Pump
This chapter provides information regarding the proper cleaning of your K Pump.
Cleaning the External Case
-When cleaning your K Pump, turn off the main power switch and then disconnect from
the power source.
-Wipe down all external surface area with a cloth:
For dirt, stains, and/or dried substances - Remove by using any mild nonabrasive
cleanser. The surface may then be wiped clean with a damp cloth.
For minor scratches –Remove by using white polishing compounds.
Note: Use a short stiff-bristled brush if the substances become ingrained in the case.
Note: Avoid spraying liquid in connection portals.

198-003 K Pump IFU Rev D 14
Chapter 7: Support & Warranty Information
This chapter provides information regarding obtaining support, if necessary, from M.D. Resource.
Support
-Should your K Pump require repair, contact M.D. Resource. to obtain an RMA (Return
Merchandise Authorization) to return the unit to M.D. Resource. for servicing to maintain
the product’s warranty. Any unit received without an RMA will be returned at the
owner’s expense. See the warranty for more information, or contact M.D. Resource. for
questions related to service and/or warranty coverage.
Medical Device Resource Corp
5981 Graham Court,
Livermore, CA 94550
800.633.8423 –Toll Free
510.732.9950 –Customer Support
510.785.8182 –Fax
http://www.mdresource.com
Warranty
-M.D. Resource products are manufactured to be used by qualified medical personnel
trained and skilled in their use.
-M.D. Resource products are warranted to be free from manufacturing defects in materials
and workmanship for a period of one year from date of purchase. M.D. Resource. will
repair or replace, free of charge, any part, or parts that are defective in material or
workmanship during that time period. Transportation charges on parts submitted for
repair or replacement under this warranty must be borne by purchaser. This warranty
does not apply to damages caused by misuse, mishandling, improper operation, and/or by
abuse of the product. There is no other expressed warranty including those of fitness or a
particular purpose, to the extent permitted by law and all implied warranties are excluded.

198-003 K Pump IFU Rev D 15
Chapter 8: Troubleshooting
This chapter contains information about troubleshooting your K Pump.
The following table describes some of the most common troubleshooting options for the K
Pump:
Topic
Possible Cause
Possible Solution
Pump not operating
Power Switch not “ON”.
Turn Power Switch “ON”
Power Adapter not plugged
into wall outlet.
Plug Power Adapter into
outlet.
Power Adapter not plugged
into unit.
Plug Power Adapter into
Power Inlet. Depress Foot
Pedal.
Foot Pedal not activated.
Depress Foot Pedal.
Foot Pedal(s) do not
activate the Pump.
Foot pedal cable not
connected.
Connect Foot Pedal cable to
the Bulkhead Connectors.
Foot pedal broken or torn
Replace Foot Pedal.
Power Switch not “ON”
Turn Power Switch “ON”
Pump does not start when
Foot Pedal is depressed.
Fluid flow is too low`.
Increase the speed by
turning the control knob
clockwise.
Wrong tubing in Pumphead
Contact M.D. Resource. to
obtain proper tubing for the
unit

198-003 K Pump IFU Rev D 16
Appendix A: Technical Specifications
Electrical Specification
Input
100 - 240 VAC ~ 1.6A MAX, 50 - 60 Hz (not user-selectable)
Output
+24V --- 2.1A
Output Power
50W MAX
Speed Control
1 Min to 10 Max (10 - 1000 ml/min Open Flow)
Mechanical Specification
Flow Rate
10-1000 ml/min (depending upon tubing selection and flow
setting)
Panel Indicators
Green Indicator LED Light ON –Power ON
Safety
Shock Protection
Class I
Safety
Over-speed protector; manual safety cut-off switch
Operating Requirements
Operating Temperature
10° to 40° Celsius
Operating Humidity
10% to 90% (non-condensing)
Storage Requirements
Storage Temperature
0° to 40° Celsius
Storage Humidity
10% to 90% (non-condensing)
Atmospheric Pressure: 98 kPa - 105 kPa
Weight Limits & Maximum Dimensions
Dimensions
6 1/2” (L); 9 1/2” (W); 7 1/2” (H) max
Weight
Approximately 5.0 lbs (without accessories)

198-003 K Pump IFU Rev D 17
Appendix B: Parts & Accessories
Topic
Parts & Accessories
Part Number
Standard Accessories
K Pump IFU
198-003
Hospital Grade Power Cord
109-066
Foot Pedal
AS4500-P Low 10
Power Adapter
109-064
Optional Accessories
Disposable 3/8” OD AutoFuse
Tubing
AFTD
Disposable 3/8” OD AutoFuse
Tubing with “Y” bifurcation
AFTDY
Cannulae
Custom-Please call for sizes
Optional Devices
Tumescent Measuring Device
TMD
TMD Conductor Cable
116-093
LS2 Liposuction Aspirator
LS2-SP or LS2-DP
LS2 Universal Power Cord
109-070
Replacement Parts
Power Supply
Manufacturer: Globtek
Model # GTM21097-5024
115-003
For Replacement Parts,please contact M.D. Resource. to service or repair these parts. Do not
attempt to service or repair these items. Refer to Page 7 - Support & Warranty to follow instructions
on how to return the unit to M.D. Resource.
WARNING - Risk of Electrical Shock. No user serviceable parts inside.

198-003 K Pump IFU Rev D 18
Appendix C: EMC & Other Interference
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The K Pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the K Pump should assure that it is used in such an
environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF Emissions
CISPR 11
Group 1
The K Pump uses RF energy only for
internal function. Therefore, RF emissions
are very low and are not likely to cause any
interference in nearby electronic
equipment.
RF Emissions
CISPR 11
Class A
K Pumps are suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes,
Harmonic
Emissions
IEC 61000-3-2
Class A
Voltage
Fluctuations
/ flicker emissions
IEC 61000-3-3
Complies

198-003 K Pump IFU Rev D 19
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The K Pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the K Pump should assure that it is used in such an environment. Use of
accessories, transducers, power cords, and cables other than those sold by Medical Device
Resource Company may result in system failure, increased EMC emissions, and/or decreased
EMC immunity of the K Pump. If used adjacent to, or stacked with other equipment; all such
equipment should be closely monitored to ensure normal operation.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic Immunity
Guidance
Electrostatic
Discharge
(ESD)
IEC61000-4-2
+ 6 kV contact
+ 8 kV air
+ 6 kV contact
+ 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+ 2 kV for power
supply lines
+ 1 kV for
input/output lines
+ 2 kV for power
supply lines
+ 1 kV for
input/output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+ 1 kV
differential mode
+ 2 kV common
mode
+ 1 kV
differential mode
+ 2 kV common
mode
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
<5% UT(>95%
dip in UT) for 0.5
cycle
40% UT(60% dip
in UT) for 5 cycles
70% UT(30% dip
in UT) for 25
cycles
<5% UT(95% dip
in UT) for 5
seconds
<5% UT(>95%
dip in UT) for 0.5
cycle
40% UT(60% dip
in UT) for 5
cycles
70% UT(30% dip
in UT) for 25
cycles
<5% UT(95%
dip in UT) for 5
seconds
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
KPump requires continued operation
during power mains interruptions, it is
recommended that the KPump be
powered from an uninterruptible
power supply (UPS).
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Not applicable –KPumps are not Life-Supporting / KPumps not affected by EMI in range from
150 kHz to 80 MHz or 80 MHz to 2.8 GHz
Note: UTis the a.c. mains voltage prior to application of the test level

198-003 K Pump IFU Rev D 20
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The K Pump is intended for use in the electromagnetic environment specified below. The
customer r the user of the K Pup should ensure that it is used in such an environment
Immunity Test
IEC 60601 Test
Level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the K Pump and K Pump cabling
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended Separation Distance
𝑑 = 1.17√𝑃0 MHz to <80 MHz
𝑑 = 1.17√𝑃80 MHz to <800 MHz
𝑑 = 2.33√𝑃800 MHz to 2.5 GHz
Where P is the maximum output power
rating of the transmitter in watt (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters
as determined by an electromagnetic site
survey should be less that the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM broadcast, and TV broadcast
cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic
site survey should be considered. If the measured field strength in the location in which the
K Pump is used exceeds the applicable RF compliance level above, the K Pump should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Pump.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.