Smiths Medical Medfusion 3500 User manual

Medfusion®Syringe Pump
Model 3500
Operator’s Manual
Software Version 6
This manual and its contents are valid for use with software Version 6 (V6)
f

Medfusion® Model 3500 pump V6 Operator’s Manual
ii
Technical Assistance
e issue date of this manual is included on the back
cover. If your manual is a year or more old, contact
Smiths Medical to see if a newer manual is available.
If you have comments or questions concerning the
operation of the Medfusion®Syringe Pump Model
3500 Version 6 (Medfusion®Model 3500 pump V6),
please call the appropriate number given below.
When calling, please specify the pump’s soware
version. is information is located on the start-up
screen.
Our sta at Smiths Medical in the USA is available to
help clinicians 24 hours a day with the programming
and operation of the Medfusion®Model 3500 pump
V6.
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 USA
Tel: [phone] (USA), [phone]
www.smiths-medical.com
A printed copy of this manual is available upon
request.

Medfusion® Model 3500 pump V6 Operator’s Manual
iii
Table of Contents
Important Safety Information 1
Warnings.....................................................................................1
Cautions......................................................................................4
Symbols.......................................................................................5
Introduction 6
Indications for use.....................................................................6
Contraindications......................................................................7
About the pump 8
Features and Controls...............................................................8
Keypad closeup ....................................................................9
Pump Customization and General
Programming 11
Custom Conguration........................................................... 11
General Programming........................................................... 13
Exceeding limits...................................................................... 13
How pump settings and limits are prioritized.................... 13
User dened pump Congurations ..................................... 14
What are Congurations?................................................ 14
When are Drug Programs used?..................................... 14
Who can use these Drug Programs?.............................. 14
Types of programmable Library Categories.................. 14
Using a Custom Conguration............................................. 15
Using Quick Libraries............................................................ 16
PharmGuard® Safety Soware: Dose Protocol
Protection..................................................................... 18
So limits........................................................................... 18
Hard limits......................................................................... 18
Adjusted limits in reverse............................................ 19
Overridden limits in reverse....................................... 19
Invalid infusion parameter combination .................. 19
PharmGuard® Supported Syringes (PSS) Series 2.............. 20
Navigating the pump menus................................................. 21
e Workow Process...................................................... 21
Guidelines for enhanced pump performance 23
Always use the smallest syringe for volume of uid
being delivered ............................................................ 23
Bolus Volume .......................................................................... 24
Use appropriate internal diameter tubing ........................... 24
Programming an Infusion 25
Turn the pump on .................................................................. 25
Turning the pump o....................................................... 26
Selecting a Delivery Mode and Programming an
infusion ........................................................................ 27
General Infusion Programming Procedure .................. 28
Selecting an Infusion.............................................................. 29
Select a Prole (Custom Conguration) ....................... 30
Select a Category .......................................................... 31
Select a Drug Program ................................................ 31
Select a Delivery Mode (Medfusion® Standard
Conguration).............................................................. 32
Loading a syringe and syringe model setup........................ 33
Unloading the syringe ................................................. 37
Programming Infusions......................................................... 38
Continuous mode: mL/hr............................................... 38
Dose / Min and Dose / Hr............................................... 39
Dose / Day ......................................................................... 41
Dose / Time ....................................................................... 43
Body weight/surface area infusion deliveries ............... 45
Volume / weight infusions............................................... 47
Dose/kg/time (dose/m2/time)......................................... 49
Volume / weight / time..................................................... 51
Volume / time.................................................................... 53
Intermittent volume / time ............................................. 54
Recall last settings............................................................. 56
Priming the system................................................................. 58
Options 60
Bolus dosing............................................................................ 61
Bolus programming.......................................................... 61
Bolus delivery.................................................................... 63
Continuing an interrupted bolus dose ...................... 64
Bolus dose rate reduction ................................................ 65
Loading doses ......................................................................... 67
Set up loading dose........................................................... 67
Delivering a loading dose ................................................ 69
Continuing an interrupted loading dose .................. 70
Loading dose rate reduction............................................ 71
Volume limit ........................................................................... 73
Setting volume limit ........................................................ 73
Keep Vein Open (KVO) rate................................................. 75
Programming KVO rate .................................................. 75
Standby .................................................................................... 77
Programming standby...................................................... 77
Delayed start ........................................................................... 79
Programming delayed start............................................. 79
Periodic callback alarm ......................................................... 80
Programming periodic callback alarm .......................... 80
Override and toggle features................................................. 82
Change to Dose / Change to Volume ............................ 82
Override occlusion limit ................................................. 83
Override alarm loudness ................................................. 84
Disable/enable FlowSentry™ pressure monitoring ....... 85
Disable/enable near empty alarm tone .......................... 85
Disable/enable vol empty alarm tone............................. 86
Infusion Delivery 87
Starting & stopping infusion delivery.................................. 87
Start delivery from pause................................................. 87
Starting delivery from standby or delayed start............ 88
Stopping delivery.......................................................... 88
Continuing interrupted delivery................................ 88
Flush feature............................................................................ 89
Volume only ...................................................................... 89
Continuing an interrupted ush infusion................. 90
Volume and time............................................................... 91
Time to occlusion ................................................................... 93
Occlusion trend graph during delivery ............................... 93
FlowSentry™ pressure monitoring (rapid occlusion
detection) ...................................................................... 93
Post occlusion bolus reduction ...................................... 94
Making changes during delivery .......................................... 95
Changing delivery rate..................................................... 95

Medfusion® Model 3500 pump V6 Operator’s Manual
iv
Changing rate during delivery ................................... 95
Changing the rate when paused................................. 96
Total volume, program volume / dose delivered................ 97
Displaying “Program Volume Delivered” (PVD) /
“Program Dose Delivered” (PDD) ............................ 97
Clearing total volume, program volume, or program
dose delivered............................................................... 98
Keypad lock ............................................................................ 99
Alarms & remedies 100
Alarms / alerts types............................................................. 100
Re-displaying an alarm message................................... 101
“User Callback” alarm ......................................................... 102
Syringe Empty Alarm Process ............................................ 102
“Syringe Near Empty” alarm......................................... 102
“Syringe Volume Near Empty” alarm .......................... 102
“Syringe Empty” alarm .................................................. 103
System Advisory - Maintenance is Recommended ......... 103
System Failures ..................................................................... 103
General system alarms & alerts .......................................... 104
System Failure and Advisory Alarms................................. 108
Battery Alarms ................................................................ 108
System Failure Alarms ................................................... 109
System Advisory Alarms................................................ 109
Battery and AC power operation 111
On screen display of internal battery power level
gauge........................................................................... 112
Battery guidelines .......................................................... 112
Poleclamp use 113
Rotating/detachable poleclamp (standard)....................... 113
Assembling the rotating/detachable poleclamp.......... 114
EMC information for the Medfusion® Model 3500
pump V6 .................................................................... 115
Use of cables .................................................................... 115
Stacked equipment ......................................................... 115
Technical specifications & other information 116
Pump development standards ............................................ 116
Medical Electrical Equipment Safety ........................... 116
Electromagnetic Compatibility..................................... 116
Miscellaneous Standards................................................ 117
Compliance using: .......................................................... 118
Technical specications ....................................................... 122
Specications................................................................... 122
Safety Features 126
Safety Features and Fault Detection................................... 126
Hardware Safety Features.......................................... 126
Soware Safety Features ...................................................... 126
Hardware-related Soware Safety Features ............ 126
Program Memory - Check FLASH memory POST
or BGND ................................................................. 126
RAM Memory Check - RAM BGND ..................... 126
Motor Circuit Check - pump motor phase A or B
POST and Motor rate error during operation.... 126
Keyboard Encoder Check - Control key POST or
BGND ..................................................................... 126
Data Handling Soware Safety Features ........................... 126
Data Stored in EEPROM - Critical data POST or
EEPROM timeout or Primary/Secondary
critical data corrupted ........................................... 126
Data Used in Calculations - Critical data failure ... 126
Timer Data Registers - Time base BGND, time of
day clock POST, time of day clock timeout........ 127
Additional Technical Information 128
Medfusion® Standard Syringes............................................ 128
PharmGuard® Supported Syringes (PSS) Series 2 ...... 128
Flow rate & minimum volume by manufacturer &
size - Standard syringes............................................. 129
Concentration and dosing units ........................................ 131
PharmGuard® soware limits ............................................. 131
Conguration options.......................................................... 132
General Options.............................................................. 132
Auto Prompt Options..................................................... 134
Program Options ............................................................ 135
Device Setup Features .................................................... 136
Flow Delivery Graphs .......................................................... 136
Start-up curves over stabilization period................ 137
Trumpet curves over T2 period ............................... 137
Magnetic Resonance Imaging (MRI) Information .......... 138
MRI Related Testing....................................................... 138
Image Distortion............................................................. 138
Cleaning and care................................................................. 139
Maintenance & service ........................................................ 140
Periodic maintenance..................................................... 140
Using Smiths Medical USA service assistance............ 141
Returning a pump to the USA for repair..................... 142
Collect Separately ................................................................. 143
REACH Information............................................................ 143
Limited Warranty 144
Index 145

1
Medfusion® Model 3500 pump V6 Operator’s Manual
Important Safety Information
WARNING: Read this entire manual before using
the Medfusion®Model 3500 pump V6. Failure to
follow the instructions and important information
contained in this manual, or improper/inadequate
troubleshooting can lead to death or serious
injury. Warnings, cautions and other important
safety information can be found in this section,
and throughout the manual (they are contained
within lines above and below in the main part of the
manual). See the Alarms and Remedies section for
information on troubleshooting pump alarms.
e term WARNING is used in this manual to
indicate a hazard that has the potential to cause injury
or death to a patient or user. e term CAUTION
is used to indicate a hazard that has the potential to
cause damage to the product or other property.
Warnings
• To avoid risk of explosion, never use the pump in
the presence of ammable anesthetics, oxygen-
enriched atmospheres, or explosive gases.
• Due to risk of explosion, never use this pump
inside a hyperbaric chamber. If the patient is
placed in a hyperbaric chamber while connected
to a pump located outside the chamber, delivery
accuracy can be aected. Due to pressure changes
on the IV tubing, under-delivery can occur during
compression, and over-delivery can occur during
decompression.
• Medical Electrical Equipment needs special
precautions regarding EMC and needs to be
installed and put into service according to the EMC
information provided.
• Portable and mobile Radio Frequency (RF)
communications equipment can aect medical
electrical equipment.
• is equipment/system is intended for use by
healthcare professionals only.
• e unauthorized modication of this product
may constitute a safety hazard, which could lead to
patient injury or death, as well as the potential for
property damage (including the risk of re). Use
only Smiths Medical supplied service/replacement
parts, including the battery pack. Unauthorized
modication and/or the use of unauthorized
service/replacement parts will also void the Limited
Warranty.
• Before using any Medfusion®Model 3500 pump
V6, users must be thoroughly familiar with the
contents of the operator’s manual, including all
warnings, cautions, and instructions for use.
• e user should ensure that the performance
oered by the pump is t for the intended use and
that the pump is not used in any way or for any
purpose other than its intended purpose.
• is pump is not to be used in any intra-articular
space infusion.
• If the pump is used to deliver life-sustaining
medications, an additional pump must be available
for situations where an interruption in infusion
could be dangerous.
• Do not use on the inlet side of Extracorporeal
Membrane Oxygenation (ECMO) systems where
the negative pressure is greater than negative
100mm Hg as the high negative pressures can
result in uncontrolled uid ow.
• e pump must be positioned in an MR
environment such that it is secured to a non-
moveable object and the magnetic fringe eld does
not exceed 150 gauss. Exposing the Medfusion®
Model 3500 pump V6 to magnetic elds that exceed
150 gauss presents a risk of becoming a projectile
hazard and can lead to possible patient injury or
death. Irreversible damage to the pump can also
occur, rendering it inoperable.
• Conrm All Settings. Before starting any delivery,
always conrm the accuracy of all infusion values
to the original order. Programming the pump at a
delivery rate other than that prescribed will cause
inappropriate delivery.
• Always read manufacturer precautions and
guidelines for medications, uids, syringes
and administration sets used with this pump.
Medications or uids may interact with the plastic
components of the infusion syringe and sets.
• Only use the Medfusion®Standard Syringes Series
2 (supplied with PharmGuard®Toolbox 2, Version
3, and included in the Medfusion®Standard
Conguration), or the models and sizes available
as part of the PharmGuard®Supported Syringes
(PSS) Series 2, and always conrm that the syringe
model and size displayed on the pump matches

2
Medfusion® Model 3500 pump V6 Operator’s Manual
the model and size loaded onto the pump. Use of
unapproved syringes may cause improper pump
operation resulting in inaccurate uid delivery or
occlusion sensing or other potential hazards.
• Verify that the plunger holders securely capture the
syringe plunger. Make sure to capture the syringe
barrel and ange. Failure to properly secure the
syringe could result in uncontrolled uid ow to
the patient.
• Always use the P function on the pump when
loading a new syringe in order to remove any
mechanical slack. Failure to prime correctly can
delay infusion delivery and cause Total Volume
Delivered to read higher than the amount actually
delivered to the patient.
• Periodically check the uid pathway and all
connections (including the catheter/administration
set connection) for leaks. Leaks in the system may
cause uid loss resulting in under-delivery, as well
as allowing an opening for contamination.
• Always turn o uid ow to patient in tubing via
clamp or stopcock before loading or unloading a
syringe. Uncontrolled uid ow can occur when
infusion set is not clamped or turned o resulting
in inappropriate delivery rate.
• NEVER prime any syringe while connected to
a patient infusion site, as this may cause over-
infusion.
• To avoid air embolism, always purge all air from
syringe and infusion lines before connecting to the
patient.
• Once the syringe and tubing system is connected
to the patient, raising the system above the patient
(even briey) can cause signicant bolusing due
to changes in hydrostatic pressure. Lowering the
system below the patient (even briey) can cause
signicant interruptions in ow due to changes in
hydrostatic pressure. is could cause improper
pump operation resulting in inaccurate uid
delivery. Place the pump as close to the patient’s
infusion site as possible.
• Use the smallest syringe size necessary to deliver
the uid or medication. Using a large syringe at
very low rates (below Minimum Recommended
Rate for the syringe) may cause improper pump
operation, delayed occlusion sensing, larger post
occlusion bolus at higher occlusion limit settings,
delivery inaccuracies, or other potential hazards.
Bolus Volume: Delivering a bolus volume less than
the recommended bolus volume for the syringe
used may result in delivery inaccuracies. Use an
infusion set with the smallest diameter tubing
available that does not result in excessive back
pressure at the desired ow rate. Consider priming,
loading, bolus, and ush rates when selecting an
infusion set.
• Larger size syringes at occlusion setting HIGH may
produce a post occlusion bolus larger than 0.3 mL
due to excessive syringe plunger tip compliance.
• When using Quick Libraries, preset values are
automatically inserted without pausing to verify
each setting. e B I screen displays
immediately aer selecting/conrming the drug
program. Verify the infusion parameters before
starting the delivery. Certain data elds may not be
programmed (e.g. patient weight) and require data
entry before the infusion will proceed.
• If a system failure alarm occurs and cannot be
cleared by powering the pump down then back
up, the pump cannot be used. Remove it from use
and send it to a trained biomedical technician for
service.
• Any external power source connected to the DC
jack must be IEC 60601-1 certied for medical
equipment Type CF and meet Safety Class II
requirements. Connecting any external power
source to the Medfusion®Model 3500 pump V6
creates a medical device system. erefore, the user
is responsible for compliance with IEC 60601-1
standards (see Technical Specications section for
DC power input function).
• Electric Shock hazard. e only means of removing
AC power is to disconnect the AC power cord.
While the AC power cord is attached to the pump
and plugged into an AC outlet, live mains voltage
is present inside the pump.
• Ensure that the ± 2% accuracy specication (±
syringe accuracy) is taken into account when
programming the pump and/or lling a syringe.
If accuracy is of prime concern, use only syringes
that meet the ± 2% requirement of the ISO 7886-2
Standard. Failure to do so may result in medication
in the syringe becoming depleted sooner or later
than expected.

3
Medfusion® Model 3500 pump V6 Operator’s Manual
• Use of cables other than as listed and with
equipment other than those specied may result in
increased EMC emissions or decreased immunity
of the pump.
• e pump should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is
necessary, the user should verify normal operation
of the pump in the conguration in which it is to be
used.
• To avoid electric shock, before cleaning, always
switch electrically operated equipment o and
disconnect from AC power source.
• To avoid electric shock, only trained biomedical
service personnel may service this pump. Service
personnel should disconnect the AC power cord
before servicing the pump.
• Alwaysmaintainthispumpfollowingmanufacturer
recommended instructions in the Technical Service
Manual. Improperly maintained pumps may cause
either under-infusion or over-infusion to patient.
• To avoid electric shock, users should never open the
pump case or battery compartment for any reason.
Service personnel should always disconnect the AC
power cord before servicing the pump.
• Never use a dropped or obviously damaged pump.
Withdraw it from service until a trained biomedical
technician can test it.
• ere are potential health hazards associated with
improper disposal of batteries, electronics, and
contaminated (used) infusion sets and syringes.
Disposeofusedbatteries,infusionsets,syringes,and
other used accessories, or a pump that has reached
the end of its useful life, in an environmentally safe
manner, and according to any regulations that may
apply.

4
Medfusion® Model 3500 pump V6 Operator’s Manual
Cautions
• Federal (USA) law restricts this device to sale by or
on the order of a physician.
• ALWAYS verify that the soware version of the
pump (displayed on screen during power-up)
and Operator’s Manual are the same. Refer to this
manual’s front page.
• NEVER use sharp objects to depress keypad keys
on the pump. is may damage the pump by
rendering keypad keys inoperable.
• is pump is designed to be used in a horizontal
position. If the pump is operated in any other
position (including vertical), there is an increased
potential for uid leaking into the pump. If uid
leakage into a pump is suspected, remove it from
use until a trained biomedical technician can test it.
• Always verify the stability of the object to which the
pump is mounted (for instance, an IV pole) before
using the poleclamp. Failure to verify the stability
could cause the object to tip, with the possibility of
causing damage to the pump and other equipment
If the poleclamp is not adequately tightened, it
could cause the pump to fall.
• DO NOT USE cleaning solutions containing:
acetone, ammonia, ammonium chloride (including
Hyamine 1622), aromatic solvents (such as paint
thinner, toluene, methylbenzene), chlorinated
solvents (such as methyl ethyl ketone (MEK),
trichloroethane), ether (such as ethylene glycol
monobutyl ether, diethylene glycol butyl ether) or
oxidizing acids (such as phosphoric acid, sulfuric
acid or accelerated hydrogen peroxide).
Use of the solutions or solvents listed as DO
NOT USE could damage plastic parts and cause
premature failure or device malfunction.
• Use only the recommended cleaning/disinfecting
agents and method. Use of cleaning/disinfecting
agents and method other than those listed may
cause damage to the pump and will void the
warranty.
• e pump is “spray resistant” from the top and
sides but not “water proof”. NEVER spray cleaning
or other uids directly into openings on the bottom
of the pump as pump damage may occur.
• e pump is not certied “waterproof”. Never
immerse the pump in water or other uids as this
can render the pump inoperable.
• Avoid wiping or spraying the barrel clamp rod
and syringe plunger driver rod (see page 8) as
they are coated with a light layer of grease (refer
pump to service personnel if these parts require
cleaning).
• NEVER use light oil sprays (e.g., WD40®) to clean
or lubricate pump. ese oils contain chemicals
that can damage the plastic of the pump.
• NEVER sterilize the pump in a steam autoclave or
gas sterilizer. Using autoclave or gas sterilization
can seriously damage the pump and will void the
warranty.

5
Medfusion® Model 3500 pump V6 Operator’s Manual
Symbols
e following is a list of symbols which may appear on
the pump (or on its labeling or accessories), as well as
certain technical terms, along with an explanation of
what they mean.
fCaution
7Do not reuse
<Catalog number
>Serial number
8Use by
JDate of manufacture
HManufacturer
Not made with natural rubber latex
6CAUTION: Federal (USA) law restricts
this device to sale by or on the order of a
physician.
@Authorized Representative in the European
Community
PTemperature limitation
_Humidity limitation
iAtmospheric pressure limitation
JType CF equipment (protection from
electric shock)
ZCollect Separately
MR (Magnetic Resonance) Conditional
KClass II Equipment in which protection
against electric shock relies on double
or reinforced insulation instead of basic
insulation. Accessible metal components
of pump enclosure use this higher level of
insulation instead of safety grounding.
AIndicates the product was designed
and manufactured in accordance with
applicable standards/guidelines and may be
sold in the EU (European Union).
UL Mark for Canada and the United States.
Indicates the product was manufactured in
accordance with the requirements of UL
(Underwriter’s Laboratory).
ÖExternal DC jack connection. Tip (negative
sign) is for power ground and ring (positive
sign) is for positive power connection.
Symbol for infrared serial communications
port on pump
V ~ Operating voltage range for alternating
current (i.e. AC or mains) power source
IPX3 Equipment that is ingress protected from
uid spraying at a vertical angle from above,
and from angles to 60° on either side of
vertical
îNon-ionizing radiation
ÜPins of connectors and other areas
identied with this ESD Warning symbol
should not be touched. Connections should
only be made when ESD precautionary
measures are used.
For an explanation of the symbols that appear on the
pump keypad, see “Keypad Closeup” and the tables
that follow (page 9).

6
Medfusion® Model 3500 pump V6 Operator’s Manual
Introduction
CAUTION: ALWAYS verify that the soware
version of the pump (displayed on screen during
power-up) and Operator’s Manual are the same. Refer
to this manual’s front page.
e Medfusion®Model 3500 pump V6 is a small,
lightweight and portable syringe infusion pump.
e pump oers a variety of delivery modes
programmable to meet specic patient care needs.
e actual modes available on a given pump, and
their location on a given screen, depend on the
custom setup. Fluids can be delivered from a variety
of syringe sizes (1-60 mL) and syringe manufacturers
in various delivery modes.
e Medfusion®Model 3500 pump V6 is equipped
with PharmGuard®Medication Safety Soware, an
intuitive system designed to enhance safety while
maintaining simplicity, which can allow streamlined
implementation and improved work ow.
A pump Conguration is created on a PC
using the PharmGuard®Toolbox 2, Version 3
soware (PharmGuard®Toolbox 2), and then the
Conguration is sent to the pump. e Conguration
may contain global settings, Prole denitions, library
denitions, Drug Programs and syringe denitions
(see page 14 for discussion about libraries).
e Medfusion®Model 3500 pump V6 imports and
exports data to assist in history data management.
e pump communicates via the IR port on the rear
of the pump. Pump Congurations and rmware can
be updated, and infusion settings and events history
downloaded in combination with the PharmGuard®
Toolbox 2 soware application.
e pump also has the FlowSentry™ pressure
monitor (rapid occlusion detection) feature, which
is a comprehensive array of pressure-related safety
features, including rapid alarm response and
reduced false alarms. Pressure trending is shown
in the pump display, allowing earlier opportunities
for intervention, as well as a post-occlusion bolus
reduction feature.
Indications for use
e Medfusion®Model 3500 pump V6 is indicated
for the following uses:
• In the administration of uids requiring precisely
controlled infusion rates including blood or
blood products, lipids, drugs, antibiotics, enteral
solutions and other therapeutic uids.
• By the following delivery routes: arterial, epidural,
intravenous, intrathecal, subcutaneous and
enteral.
• By the following delivery modes: continuous,
volume/time, mass, body surface area, body
weight, intermittent and bolus.
• In critical care, anesthesia, neonatal and pediatric
applications or other healthcare settings where
the use of the syringe infusion pump can be
monitored or supervised by a clinician.
• Inside the MRI room mounted outside the 150
Gauss line and with shielded magnets of eld
strength of 1.5 Tesla.
WARNINGS:
• is equipment/system is intended for use by
healthcare professionals only.
• Before using any Medfusion®Model 3500 pump
V6, users must be thoroughly familiar with the
contents of the operator’s manual, including all
warnings, cautions, and instructions for use.
• e user should ensure that the performance
oered by the pump is t for the intended use and
that the pump is not used in any way or for any
purpose other than its intended purpose.
• is pump is not to be used in any intra-articular
space infusion.
• If the pump is used to deliver life-sustaining
medications, an additional pump must be
available for situations where an interruption in
infusion could be dangerous.
• e pump must be positioned in an MR
environment such that it is secured to a non-
moveable object and the magnetic fringe eld does
not exceed 150 gauss. Exposing the Medfusion®
Model 3500 pump to magnetic elds that exceed
150 gauss presents a risk of becoming a projectile
hazard and can lead to possible patient injury or
death. Irreversible damage to the pump can also
occur, rendering it inoperable.

7
Medfusion® Model 3500 pump V6 Operator’s Manual
CAUTION: NEVER use sharp objects to depress
keypad keys on the pump. is may damage the
pump by rendering keypad keys inoperable.
• Only the Medfusion®Standard Syringes Series
2 (supplied with PharmGuard®Toolbox 2,
and included in the Medfusion®Standard
Conguration), or the additional syringe models
and sizes available as part of the PharmGuard®
Supported Syringes (PSS) Series 2 (see page 20),
may be used on the pump.
• Ensure all medications or uids are compatible
with the syringe, catheters, tubing, and ttings
used in the infusion setup.
• Always ensure uids are compatible with each
other when infusing more than one uid or
medication through the same infusion site. If
connecting more than one pump to the same
infusion site, use one-way checkvalves to prevent
pumps from interfering with each other. Verify
that the pumps will operate together without
alarming.
Contraindications
WARNING: ECMO use: Do not use on the inlet side
of Extracorporeal Membrane Oxygenation (ECMO)
systems where the negative pressure is greater than
negative 100mm Hg as the high negative pressures
can result in uncontrolled uid ow.

8
Medfusion® Model 3500 pump V6 Operator’s Manual
About the pump
Features and Controls
Following are several illustrations showing the various
controls, connectors and features of the Medfusion®
Model 3500 pump V6.
7 Syringe Plunger Driver: Once loaded and delivery
is started, the driver pushes the plunger forward
at a controlled, precise rate to deliver uid.
8 Syringe Plunger Release Lever: Squeeze the release
lever to allow placement of the syringe plunger
onto the holder during loading, or to remove it
during unloading.
9 Keypad: See Keypad closeup (page 9) for
identication of the individual keypad keys and
what they are used for.
10 AC Power Connection Port: Plug the AC power
cord into connection port to allow pump to
operate on AC (mains) power.
1 Display: pump operating and status information
appears on the display. e lower portion of
the display corresponds with the 4 ‘sokeys’
(their function changes depending on the pump
programming being accomplished) on the
keypad.
2 Tubing Holders: read infusion set tubing
between holders to prevent kinking at syringe
tip.
3 Carrying Handle
4 Syringe Barrel Clamp: e clamp holds the syringe
barrel securely in place.
5 Syringe Barrel Flange Clip: When loading a
syringe, slide the syringe ange into the clip.
6 Syringe Plunger Holders: Holds the syringe
plunger securely in place.


*

PRIME / BOLUS
*


9
Medfusion® Model 3500 pump V6 Operator’s Manual
11 Optional Poleclamp Mount: If desired, attach the
optional poleclamp here.
12 External DC Power Connector Port: Plug approved
external DC power supply into port.
Note: e DC Connector Port is functional only
on pumps where the External DC Jack Connection
symbol (Ö) appears on the pump serial number
label (located on the bottom of the pump).
13 Infrared Connection Port: Align RS232 converter
box or IR-to-USB with port to allow upload of
data from and download of data to a pump from
a PC. See Technical Specications.
Keypad closeup


10
Medfusion® Model 3500 pump V6 Operator’s Manual
Key When pump is paused When pump is delivering
Alarm Silence (í)Silences audible alarm. Allows operator
to switch the display backlight from
bright to dim or dim to bright. Allows
redisplay of the text for the last active
alarm.
Silences audible alarm. Allows operator to
switch the display backlight from bright to
dim or dim to bright.
Power ()Silence certain active alarms. Push and
hold to turn pump o.
Silence certain active alarms (some alarms
must be silenced with íbefore will
function). Push and release, then push and
hold to turn pump o.
Menu keys (softkeys) Function is dened on the display. Function is dened on the display.
Back (â)Reverts to a previous step or level. Reverts to a previous step or level if adjusting
settings. Briey displays the battery life
indicator and PDD/PVD.
Numbers & Decimal Set number values or selects menu
items.
Set number values or selects menu items.
Stop ()N/A Stops delivery (pump remains on).
Start (É)Starts delivery. N/A
Prime / Bolus ()Begins priming aer conrmation. Displays the programmed bolus programming
or conrmation/B D screen.
Indicator What it means
ò- Alarm e Alarm indicators (yellow or red) are on whenever the pump is in an alarm
condition. e specic details of each alarm are covered in the Alarm section later in
this manual.
ô- AC Line e AC Line indicator (green) is on whenever the pump is connected to “mains” line
power. It is o when the pump is not connected to an active AC line.
õ- Battery e Battery indicator (green) blinks on & o whenever the pump is operating on
internal battery power, and remains on when battery is charging.
ö- Lock e Lock indicator indicates the pump has been locked into its current operational
mode.
While this indicator is lit, the keypad is locked and no changes can be made to settings.
Attempting to stop or change an infusion while locked will result in an alarm and an
informational message.
ù- Infusing e Infusing indicators are 3 green lights, which illuminate in sequence right to le
when the pump is infusing.
During intermittent volume over time delivery mode, a single Infusing indicator lights
during the time between infusions.
When the pump is o or stopped, the Infusing indicator is not lit.

11
Medfusion® Model 3500 pump V6 Operator’s Manual
Pump Customization and General Programming
Custom Configuration
Generally speaking, pump customization is
performed before a pump is used on a patient (see the
diagram on page 12).
Customization is accomplished using PharmGuard®
Toolbox 2. Once the custom Conguration is created
and validated, PharmGuard®Toolbox 2 is used to
send it to the pump. Depending on the settings and
features chosen in customization, certain features
may or may not be available when programming any
specic pump. Each user is responsible to determine
which features are present on the pump they are using
and to program them accordingly.
For this reason, the following warning is included
throughout the steps for programming and delivering
uids throughout this manual:
WARNING: Conrm All Settings. Before starting
any delivery, always conrm the accuracy of all
infusion values to the original order. Programming
the pump at a delivery rate other than that prescribed
will cause inappropriate delivery, which can result in
serious injury or death.

12
Medfusion® Model 3500 pump V6 Operator’s Manual
PharmGuard® Toolbox 2
Create a custom Conguration (settings and
Drug Programs), validate Conguration,
then send to pump using PharmGuard®
Toolbox 2 (see the product literature
supplied with the product for more
information)
Types of Delivery Modes Possible
Dose / Day Dose / m2 / Min mL / Kg / Time
Dose / Hour Dose / Min Volume Over Time
Dose / Kg / Day Dose / Time Dose / Kg / Time
Dose / Kg / Hr Intermit Volume / Time Dose / M2/ Time
Dose / Kg/ Min mL / Hr
Dose / m2 / Day mL / Kg / Hr Other mode:
Dose / m2 / Hr mL / Kg / Min Recall Last Settings
These are the types of infusion modes possible. Some are manual
(in that they can be used in Drug Programs or can be menu items
on their own), while others can only be used in the creation of
Drug Programs (such as Dose / Kg / Time and Dose / M2/ Time)
Possible Options
Bolus Dose
Delayed Start
KVO
Loading Dose
Override Alarm Loudness
Override Occlusion Limit
Periodic Callback Alarm
Standby
Toggle Vol Empty Tone
Toggle FlowSentry
Toggle Near Empty Tone
Toggle PVD / PDD
Volume Limit
Not all options are available in all
delivery modes or Drug Programs
Send Configuration
Flush feature may be used in some
modes
The Customization
Process
Medfusion®Model 3500 Pump V6
“Medfusion® Standard Conguration”
includes manual delivery modes, some
options and a variety of syringes. No Drug
Programs are available in the Standard
Conguration
Medfusion®Model 3500 Pump V6
With Custom Conguration

13
Medfusion® Model 3500 pump V6 Operator’s Manual
General Programming
e Medfusion®Model 3500 pump V6 has a variety
of delivery modes that are customizable by the user.
e actual modes available on a given pump, and their
location on a given screen, depend on the custom
setup performed.
All customization is accomplished using the
PharmGuard®Toolbox 2 soware, including which
syringes and features are available on the pump, as
well as hard and so limits on values (see below and
page 18 for discussion about hard and so limits).
e modes and programming steps described in this
chapter, and the steps given for programming them,
are based on general setup parameters.
Which of the features and functions are available on
a specic pump, and how the screens associated with
them appear, depends entirely on how the pump was
customized. If the functions and screens on a pump
look dierent than those shown here, it is due to this
customization.
It is possible that a pump is customized so that
an infusion cannot be programmed without rst
entering a user ID, or so that certain proles cannot
be accessed without rst entering a passcode. If that
is the case, a prompt to enter an ID or a passcode is
displayed when attempting to program an infusion.
WARNING: Always read manufacturer precautions
and guidelines for medications, uids, syringes and
administration sets used with this pump. Medications
or uids may interact with the plastic components of
the infusion syringe and sets. is interaction may
result in serious injury or death.
Exceeding limits
e pump has two types of programmed infusion
limits, Hard limits and So limits.
• Hard Limits – Values that cannot be exceeded
under any conditions. Hard limits show up as
Max and Min on the pump. If an attempt is made
to exceed a hard limit, a screen similar to the
following gure displays.
BACKSPACE ENTER
INPUT OUT OF RANGE - GREATER THAN MAX VALUE
CLEAR
mL
62
DISABLE
MAX: 59
HIGH: 50
LOW: 10
MIN: 1
e pump then prompts entry of a new value.
• So Limits - e normal range. So Limits show
up as Low and High on the pump. ey are the
normal upper and lower limits. A value above or
below the Low or High limit can be entered (so
long as it does not exceed the Min or Max). If
the so limits are exceeded, the pump prompts
to rst silence an alarm, then conrm or cancel
the override condition, as shown in the following
screen.
NO
CONFIRM LIMIT OVERRIDE?
OVERRIDE
mL
55
MAX: 59
HIGH: 50
LOW: 10
MIN: 1
It is possible that a pump is customized so that limits
cannot be exceeded unless a user ID is entered. If that
is the case, a prompt to enter an ID is displayed.
“Limit” style alerts are advisories that occur for
various reasons (usually during programming). A
non-repeating audio alarm sounds and a message
is displayed for 3 seconds. To re-display the alert
message, press í. e pump records exceeded limits
and attempts to exceed limits.
How pump settings and limits
are prioritized
ere can be a number of limits imposed on pump
settings, for instance the rate is limited by the syringe
size being used, as well as any hard and/or so limits
imposed in the drug program. e most restrictive
limit takes priority.
Additionally, available Options for delivery can be
set for proles as well as individual drug programs.
In these cases, the settings for the drug program
take priority over prole settings. For example, the
Bolus option may be enabled for a prole, but a
drug program within that prole may have the bolus
option disabled.

14
Medfusion® Model 3500 pump V6 Operator’s Manual
User defined pump
Configurations
is chapter describes the Medfusion®Model 3500
pump V6 Conguration.
What are Configurations?
A Conguration is a database of pump settings
organized into Proles, Categories and Drug
Programs. e Conguration has global settings
that are applicable to the pump operations. e
Conguration may have up to 16 Proles. Each
Prole has a set of Prole-level settings and also
up to 8 Categories. Each Category may contain up
to 36 Drug Programs. ere is a special category
called a Quick Library. A Quick Library contains
Drug Programs that have all infusion parameters
pre-specied to allow quick start of an infusion.
A Conguration is dened here as a stored record
of infusion settings that load from memory. ese
programs are stored in memory indenitely (over 10
years) or until overwritten.
e Conguration is set up using PharmGuard®
Toolbox 2. When it is completed it should be
validated by the person responsible for custom
conguration before the pumps are delivered to a
work area.
When are Drug Programs used?
Every unit, department, organization, or hospital has
standard ways of delivering medications or uids. e
custom setup enables the use of programs of stored
presets.
Using the PharmGuard®Toolbox 2 Soware,
the PharmGuard®Toolbox 2 Administrator will
establish the pump Conguration that implements
the standard infusions for the unit, department,
organization, or hospital. is process is described in
the PharmGuard®Toolbox 2 User’s Manual.
Who can use these Drug Programs?
Anyone who is authorized to use the infusion pump
can use programs from the available libraries.
Types of programmable Library
Categories
ere are two types of Library Categories in the
Medfusion®Model 3500 pump V6:
Library
Category
Type
What it does
Standard Standard library categories contain
programs with parameters that are
applied when programming an infusion.
ese libraries require stepping through
and reviewing each setting. is allows
modifying standard settings while stepping
through preset values.
Quick A quick category contains drug
programs with the presets necessary for
programming an infusion. However, they
do not pause at each level for entry of the
settings.
Instead, the entire set of values is
programmed at one step including syringe
model and size. e B I
screen, where all infusion values are
shown, displays at once. At that point,
conrm all the settings are correct, then
press to begin delivery.
WARNINGS:
Conrm All Settings. Before starting any delivery,
always conrm the accuracy of all infusion values
to the original order. Programming the pump at a
delivery rate other than that prescribed will cause
inappropriate delivery, which can result in serious
injury or death.
When using Quick Libraries, preset values are
automatically inserted without pausing to verify
each setting. e B I screen displays
immediately aer selecting/conrming the drug
program. Verify the infusion parameters before
starting the delivery. Certain data elds may not be
programmed (e.g. patient weight) and require data
entry before the infusion will proceed.
Displaying Quick Library Options: e steps in
this section are hypothetical. e Medfusion®
Model 3500 pump V6 is shipped with a Medfusion®
Standard Conguration, and without any Proles,
Categories and Drug Programs. So the actual Quick
Libraries available depend entirely on the custom
Conguration sent to the pump.

15
Medfusion® Model 3500 pump V6 Operator’s Manual
13% SaLine mL/kg/time
2abeLcet 2 mg/mL
3acycLovir (Zovirax)(kg doSing)
4ambiSome 2 mg/mL
PAGE
PRESS NUMBER TO SELECT
1/8
PREV NEXT
Using a Custom Configuration
PharmGuard®Toolbox 2 allows a facility to create
a custom Conguration and send it to the pump for
use. If proles are created in the Conguration, the
pump displays the P Menu. If the desired
prole isn’t displayed on the rst screen press More
for additional selections.
1. If a prole listing isn’t displayed on the
S  P menu, press More
to nd it on another screen; otherwise it
is necessary to create that prole using
PharmGuard®Toolbox 2. For example,
if “4” at right is selected, the G
P prole opens (proles names are
customized per facility preference, so will
not be the same as those shown in the
following screens).
2. Library categories in the prole are
displayed. Select a category from the menu.
For example: if “1” at right is selected, then
the drug program category G P A - D
opens.
3. Custom drug programs are displayed on
the Drug Program screen. To use a drug
program, use the number keys to select the
desired drug program (see page 31 for a
full explanation of this screen).
For example: if entry “2” is selected, the
preset infusion parameters for A 
/L is chosen.
4. You are next prompted to load a syringe,
then conrm & accept each level of settings
by pressing Enter. Some data elds may
require data input prior to proceeding (e.g.
Patient Weight).
WARNING: Conrm All Settings. Before starting
any delivery, always conrm the accuracy of all
infusion values to the original order. Programming
the pump at a delivery rate other than that
prescribed will cause inappropriate delivery, which
can result in serious injury or death.
5. When all settings are conrmed, the B
I screen is displayed. Use the Prime
feature, then press to begin the infusion.
PRESS THE NUMBER TO SELECT THE PROFILE
MORE
1aneStHeSia 5cardiac
2nicU 6Hem/onc
3PicU 7ticU
4generaL PedS 8ed
MORE
CHG PROFILE
PRESS THE NUMBER TO SELECT generaL PedS
1GEN PEDS A - D 5GEN PEDS Q - Z
2GEN PEDS E - I 6bLood ProdUctS
3GEN PEDS J - M 7enteraL FeedS
4GEN PEDS N - P

16
Medfusion® Model 3500 pump V6 Operator’s Manual
Using Quick Libraries
Smiths Medical ships the infusion pump with the
Medfusion®Standard Conguration that does not
include a Quick Library.
e proles, categories and custom drug programs
available on a pump depend on the conguration
set up by the person responsible for custom
conguration. Quick Libraries is an option that
can be set-up in custom conguration. is option
designates a category in a prole as a Quick Library.
A prole with Quick Library enabled displays a list of
custom drug programs.
1ProPoFoL 10 mg/mL
2vecUroniom 1 mg/mL (or)
3dobUtamine 200 mcg/mL (or)
4doPamine 1600 mcg/mL (or)
MAIN MENU
PRESS NUMBER TO SELECT
1/1
Rather than the CHG Prole key displayed on
standard library category screens, the Quick Library
will have Main Menu on the far le. When Main
Menu is pressed, another selection screen is displayed,
with the additional categories and delivery modes for
the selected prole.
MORE
1Anesthesia A-D 5Anesthesia Q-Z
2Anesthesia E-I
3Anesthesia J-M
4Anesthesia N-P
CHG PROFILE
PRESS THE NUMBER TO SELECT aneStHeSia
QUICK LIBRARY
e sokey on the far le of this screen reects the
name of the Quick Library (the above is an example
only). Press this key to re-enter the Quick Library.
e Quick Library is exited when Main Menu is
pressed. e CHG Prole key responds the same here
as with all others.
(If there is only one prole on the pump, and a
Quick Library is enabled, the drug programs in the
designated Quick Library will display on screen aer
the pump is turned on and completes its self tests.)
e drug programs in a Quick Library have
been customized with default values for infusion
parameters that may include: syringe model and
size, dose, volume, weight, delivery time, etc. Setting
default values in the custom program allows the user
to proceed from the drug program selection screen
to the nal conrmation screen (provided the loaded
syringe matches the default syringe in the drug
program).
e Quick Library program’s preset values are
loaded automatically into the pump provided that
you have loaded a syringe of the manufacturer and
size programmed for this library entry. Press É
to begin the preset infusion aer verifying infusion
settings and using the Prime feature. Some data elds
may be blank and require data entry to proceed.