MATERIAL SPECIFICATION FOR DOCUMENT 204026

MATERIAL NUMBER
204026

MATERIAL TYPE/COLOR

2.1

COVERS:
9.0 X 11.5 65 Lb Grey speckletone. Cover smooth finish.
Trim cover to 8.5 X 11 with full bleed.

2.2

INTERNAL PAGES
8.5 X 11 20 Lb. White Opaque Paper, Offset.

2.3

BINDING:
Unicoil Binding System, Color: College Orange, sized to match the document. Cover stock and internal pages will
be drilled to match the Unicoil configuration.

PRINT COLORS

3.1

FRONT COVER
The front cover will be single-sided, produced using xerographic methods from provided camera-ready originals,
or printed directly from provided electronic masters.

3.2

REAR COVER:
The rear cover will be left blank.

3.3

INTERNAL PAGES
Internal pages will be double-sided, produced using xerographic methods from provided single-sided cameraready originals, or printed from provided electronic masters. All internal copy will be black and white.

CERTIFICATION
Certification is not required; however, a packing list with the following information is required:

MEDRAD Material Number

Purchase Order Number

Quantity Shipped

North America Headquarters

MEDRAD Service Department
One MEDRAD Drive
Indianola, PA 15051-0780
U.S.A.
Tel: 412-767-2400
Fax: 412-767-4126

Nihon MEDRAD KK
2-4-9, Umeda, Kita-ku,
Osaka, 530-0001
Japan
Tel: +81 (0) 66-133-6250
Fax:+81 (0) 66-344-2395

European Headquarters
MEDRAD Europe B.V.
Postbus 205
6190 AE Beek
The Netherlands
Tel: +31-0-43 3585601
Fax:+31-0-43 3656598

2009, MEDRAD INC. All rights reserved.

Reproduction of this manual is strictly prohibited without express written
consent of MEDRAD, INC.
For more information about MEDRAD products and services, please visit
WWW.MEDRAD.COM

ii

Table of Contents

Table of Contents
1 - Introduction .......................................................................... 1-1
Important Safety Notice ...............................................................................1-1
Indications for Use ......................................................................................1-1
Contraindications ........................................................................................1-1
Restricted Sale ............................................................................................1-1
Trademarks .................................................................................................1-1
Disclaimers ..................................................................................................1-1
Symbols ......................................................................................................1-2
Warnings .....................................................................................................1-3
Cautions ......................................................................................................1-5
Notes ...........................................................................................................1-5

2 - System Basics ...................................................................... 2-7

System Overview ........................................................................................2-7
Button Descriptions and Functions .............................................................2-9
System Safety Checks ..............................................................................2-12
Pump Accuracy .........................................................................................2-12
Start-up Curves .........................................................................................2-13
Trumpet and Flow Rate .............................................................................2-13

3 - Installation and Setup ........................................................ 3-17

Charging the Pump: ..................................................................................3-18
Installing the Pump into a Bracket .............................................................3-19
Positioning the Bracket on the Pole ..........................................................3-20

4 - Operational Verification ..................................................... 4-21

Setup .........................................................................................................4-21
Verify Free Flow Protection .......................................................................4-21
Verify Flow Rate Accuracy ........................................................................4-22
Verify Pressure Limit .................................................................................4-23
Verify Battery Life ......................................................................................4-23

5 - Troubleshooting ................................................................. 5-25

Troubleshooting an Alarm .........................................................................5-25
Error Messages .........................................................................................5-26
Error Messages .........................................................................................5-26
Troubleshooting ........................................................................................5-28

6 - Disassembly/Reassembly ................................................. 6-29

Separating Front and Rear Housings ........................................................6-29
Reassembly of Front and Rear Housings .................................................6-29
Replacement of Pump Door ......................................................................6-29
Replacement of Pump Assembly ..............................................................6-30
Removal of Pressure Sensor ....................................................................6-30
Replacement of Front Housing Air Sensor. ...............................................6-30
Replacement of Pressing Plate .................................................................6-30
Replacement of Main and Motor P. C. Boards ..........................................6-31

7 - Parts List ............................................................................. 7-33

iii

Continuum MR Compatible Infusion System

iv

1 - Introduction

1 - Introduction
Important Safety
Notice

This device is intended to be used by medical professionals with adequate

training and experience.

Indications for Use

The Continuum MR Compatible Infusion System is designed for patients who

require maintenance medications and fluids during an MR procedure. It is
designed to provide infusion therapy directly prior to, during, and immediately
after the MR procedure, functioning while either stationary or mobile. The
system is to be used by trained medical staff, primarily critical care,
emergency room and radiology nursing staff.

Contraindications

The Continuum MR Compatible Infusion System is not intended to provide

long-term patient care outside the MR environment, or in any situation other
than as described. DO NOT use the Continuum MR Compatible Infusion
System with MR scanners having a field strength greater than 1.5T. The
administration sets are not intended for multiple use or to deliver blood, blood
products, or nitroglycerin.

Restricted Sale

Federal (USA) law restricts this device to sale by or on the order of a

physician.

Trademarks

MEDRAD, is a registered trademark of MEDRAD, INC.

Disclaimers

External wiring and modifications disclaimers: MEDRAD disclaims liability for

any modifications or interfaces with other equipment which are not in
conformity with the specifications and information contained within this
manual.
Accessory equipment connected to the Continuum MR Compatible Infusion
System must be certified according to IEC/EN 60601-1 standard.
Furthermore, all configurations shall comply with system standard IEC/EN
60601-1-1. Anyone who connects additional equipment to the signal input or
output part configures a medical system and is therefore responsible that the
system complies with the requirements of the standard IEC/EN 60601-1-1. To
obtain on-site consulting or consulting references, contact MEDRAD Service.

1 -1

Continuum MR Compatible Infusion System

Symbols

The following symbols are used on the MEDRAD Continuum MR Compatible

Infusion System and its components.
CSA Mark.
Single use only. The use of single-use disposable components on more than
one patient is a biological hazard. Do not reuse single-use disposable
components.

IPX0

The Battery Charger is rated IPX0.

IPX1

The Continuum Pump is rated IPX1; protection against vertically falling water
drops.
Type CF applied part.
Date of Manufacture.

SN

Serial Number.

P1

Indicates plug that connects to J1 on the charger.

J1

Indicates plug that connects to P1 on the back of the pump.

Alternating Current.
Direct Current.
Functional Earth Ground.
Indicates that this device conforms to the requirements of the European
Medical Device Directive 93/42/EEC.
Do not dispose of in municipal waste. Symbol indicates separate collection for
electrical and electronic equipment. (WEEE Directive 2002/96/EEC). NOTE:
Does not apply to the battery.
Do not dispose of battery in municipal waste. Symbol indicates separate
collection for battery is required.
Recycle batteries following hospital protocols and local environmental
regulations.
Do not incinerate. Keep away from fire or other sources of extreme heat.

1-2

1 - Introduction
This manual contains important information about use of the MEDRAD
Continuum MR Conpatible Infusion System.
MEDRAD urges you to read this manual carefully, become familiar with the
procedures and system functions that it describes, and follow its
recommendations to assure proper use of the system.
Labels on the system or statements in this manual preceded by any of the
following words and/or symbols are of special significance, intended to help
you to operate the system in a safe and successful manner:
WARNING: Indicates that the information is a warning. Warnings
advise you of circumstances that could result in injury or death to the
patient or operator. Read and understand the warnings before
operating the infusion system.
CAUTION: Indicates that the information is a caution. Cautions advise
you of circumstances that could result in damage to the device. Read
and understand the cautions before operating the infusion system.
Note:

Warnings

Indicates that the information that follows is additional

important information or a tip that will help you recover from
an error or point you to related information within the manual.

DO NOT connect a gravity fed fluid source directly to an unused "Y"

connector luer port on the disposable set. This could result in the freeflow of fluid directly into the patient catheter. Serious injury or death could
result from connecting a gravity fed fluid source directly to an unused "Y"
connector luer port on the disposable set.
DO NOT place a gravity fed fluid source more than 5 feet (1.5 m) above
the infusion site. This could result in the free-flow of fluid directly into the
patient catheter. Disconnect the disposable set from the patient prior to
removing the disposable set from the pump.
Serious injury or death may result from exposure to hazardous voltages
existing within the charger. Disconnect the charger from mains prior to
opening the casing.
Fire hazard: To avoid an electrical fire, assure the correct types of fuses are
used for replacement.
Explosion hazard: Do not use the infusion system in the presence of
flammable gases such as certain anesthetics.
The battery charger is NOT MR-compatible. Do not take the battery
charger into the MR scan room.
DO NOT attach more than three pumps at one time onto the IV pole. Use
of more than three pumps at one time may compromise the accuracy of the
individual pumps and/or the system.
Unsafe operation may result from using improper accessories. Use only
accessories and options provided by MEDRAD designed for this system.
DO NOT use a kinked or occluded IV line. A kinked or occluded I.V. line
may impair the operation of the pump and the accuracy of the infusion. Before
operation, verify that the IV line is not kinked or occluded.

1 -3

Continuum MR Compatible Infusion System

DO NOT remove the pump from the bracket while in the MR scan room.
The pump contains ferromagnetic material and may be attracted towards the
magnet. To prevent potential injury and equipment damage, the pump must
be in its bracket and the I.V. Pole casters locked when in the MR scan room.
Pull on the bottom of the pump to ensure that it is secure in the bracket prior
to entering the MR scan room. Lock the I.V. Pole casters when the system is
positioned near the bore of the MR scanner.
DO NOT operate the Continuum MR Compatible Infusion System with
any IV line other than those supplied by MEDRAD. Use of IV lines other
than MEDRADs may impair the operation of the pump and the accuracy of an
infusion.
Operating the Continuum MR Compatible Infusion System at
temperatures other than within the range of 5C (41F) to 40C (104F),
may affect accuracy. The pump should only be operated within a
temperature range of 5C (41F) to 40C (104F).
DO NOT use the pump while it is connected to the charger. Battery
charging is enabled as long as the charger cord is connected to the mains
and the pump is in the charger. Switching the pump off does not disconnect it
from the mains. To disconnect from the mains, remove the charger cord from
the mains.
The I.V. lines of this product contain DEHP, a chemical known to the
state of California to cause birth defects or other reproductive harm.
Please visit www.Medrad.com/DEHP for more information regarding DEHP in
our products.
Dropping the Continuum MR Compatible Infusion System could cause
damage to components. If the pump is dropped, return the pump to
MEDRAD for inspection by qualified service personnel.
Patient infection may result from the use of non-sterile components.
Maintain sterility of all disposable components using aseptic techniques.
DO NOT open batteries. DO NOT dispose of batteries in a fire. Improper
disposal of battery may result in explosion, leakage, or personal injury.
Follow all local regulations concerning the disposal of spent Lithium-Ion
batteries or contact MEDRAD for assistance.
DO NOT operate the pump for more than four continuous hours. The
battery will become depleted and the pump will cease to function if the pump
is operated longer than four hours.
DO NOT connect the patient to the pump(s) until the set-up and priming
of any IV lines is complete. This could result in the infusion of air into the
body.
Hazardous voltage. Before cleaning, always unplug the charger from AC
power, turn the pump off, and remove the battery from the pump.
DO NOT connect to an existing IV line with microbore tubing when rapid
administration is required. Use of IV lines with a very small inner diameter
may affect the accuracy of the system at high flow rates.
DO NOT use damaged components. Patient or operator injury may result if
damaged components are used. Visually inspect all components before use.

1-4

1 - Introduction
DO NOT prime the I.V. line while connected to the patient catheter.
Priming the I.V. line while connected to the catheter could result in
unintentional fluid delivery to the patient. Disconnect the IV line from the
patient before starting the priming procedure.
DO NOT use the administration set for longer than 4 hours . Use of the
administration set for longer than 4 hours could result in inaccurate fluid
delivery. Replace the administration set every 4 hours.
Any adjustments, maintenance, or repair of the uncovered pump should
be performed by MEDRAD Service Representatives only. Any
adjustments, maintenance, or repair of the uncovered pump may impair the
operation of the Continuum MR Compatible Infusion System and/or the
accuracy of an infusion.

Cautions

Leaving the battery in a discharged state for a long period of time may
damage the battery. To prevent the battery from becoming fully depleted,
always store the pump in the charger.
DO NOT clean the pump or charger with chemicals such as Xylene, Acetone
or similar solvents. These chemicals can cause damage to the plastic
components and paint. Use a lint-free cloth dampened with warm water and a
mild detergent or disinfectant.
DO NOT immerse the pump or charger into any type of liquid. Immersing the
Continuum pump into liquid could cause damage to components.
DO NOT use the system immediately after being brought indoors from
extreme outside temperatures. Condensation may cause electrical damage to
the pump system. Battery damage could occur if left in a temperature warmer
than 50C. Allow the system to stabilize at room temperature before use.

Notes

When positioning more than one bracket on a pole, be sure that the pumps
are facing in the same direction so that the brackets interlock.
Replace the battery every 1000 cycles.
When delivering one fluid, use only the primary IV line and a clamp.
When a programmed set of parameters results in a calculated infusion flow
rate with a 100th digit between 0.05 and 0.09, the pump automatically rounds
the flow rate to the next higher 10th digit (for example, 0.55 ml/h will be
rounded to 0.6 ml/hr). If a 100th digit is between 0.01 and 0.04, the pump
automatically rounds the flow rate to the current 10th digit (for example,
0.53 ml/hr will be rounded to 0.5 ml/hr).
Any attempt to install, modify or repair a medical device such as the MEDRAD
Continuum MR Infusion System without adequate training may result in
personal or patient injury or property damage.
If the fluid contained in the line is the patient's most critical therapy, prime the
fluid through the end of the MEDRAD primary IV line. This will take
approximately twenty seconds and will assure the delivery of immediate
therapy to the patient. Disconnect the IV line from the patient before starting
the priming procedure.

1 -5

Continuum MR Compatible Infusion System

The Priming Flow Rate is performed at a rate of 1600 - 1800 mL/h.
Warnings, cautions, and notes are also located throughout this manual,
where applicable.

1-6

2 - System Basics

2 - System Basics
System Overview

The Continuum MR Compatible Infusion System is designed for patients who

require maintenance medications and fluids during an MR procedure. It is
intended to provide infusion therapy directly prior to, during, and immediately
after the MR procedure. The duration of use for the system, including
administration sets, is intended to be four hours per patient. The system is to
be used by trained medical staff, primarily critical care, emergency room and
radiology nursing staff. It is not intended to provide long-term patient care
outside of the MR environment
The Continuum MR Compatible Infusion System provides the following
features:

Continuous Program

Dose Program

Non-Weight Dose Program

Automatic Bolus

Automatic free-flow protection integral to the IV line for fluid

source placed up to 5 ft (1.5 m) above the infusion site

Up to three channel fluid delivery into a single line

Rechargeable battery.

2-7

Continuum MR Compatible Infusion System

The Continuum MR Compatible Infusion System (standard) consists of the
following components

3
6

7
8

1 - IV Pole (1X)

5 - IV pole base with casters (1X)

2 - Infusion Pumps (2X)

6 - Charger (2X)

3 - Mounting Brackets with hangers* (2X)

7 - Standard Administration Kit (1X)

4 - Fluid cup (1X)

8 - Secondary Administration Line (1X)

*The mounting bracket includes built-in hangers to conveniently hang extra

disposable tubing.
All Continuum MR Compatible Infusion Systems also include an Operation
Manual.

2-8

2 - System Basics

Button Descriptions
and Functions

To assure proper use of the system, MEDRAD urges you to read this manual
carefully, become familiar with the procedures and system functions, and
follow the recommendations.
Front of Continuum MR Compatible Infusion Pump
1
2
3

Info

START
OK

STOP
NO

PRIME
BOLUS

ON
OFF

4
5
6
7
8
9

1 - DISPLAY SCREEN:

2 - UP ARROW:

START
OK

Scrolls up through options

3 - START/OK:

STOP
NO

Displays instructions

Starts infusion
Confirms parameter selection

4 - STOP/NO:

Stops infusion
Silences an alarm condition
Pauses priming
Zeroes the displayed value during programming
Erases the last digit during programming
Returns to previous screen.

2-9

Continuum MR Compatible Infusion System

PRIME
BOLUS

5 - PRIME/BOLUS:

Primes the IV line and eliminates air during procedure.

A graph appears on the display screen showing the priming volume with
the current value increasing until reaching set volume.
Delivers bolus during an infusion.

6 - POWER ON/OFF:

ON
OFF

Turns the system on, by pressing and holding the button until the self-test
screen appears.
Turns the system off, by pressing and holding the button until the graph is
black and a beep is generated.

7 - LED DISPLAY:

Green Indicator
Lights during system self-test

Red Indicator
Indicates an alarm state with a continuous red light

Info

Indicates infusion delivery with a green blinking light.

Lights when the pump is in a stand-by mode during programming.

8 - INFO:
Displays:

Infused Volume

Total Volume to be Infused

Battery Status

Tube Temperature

Time Left (if option enabled)

Option Selection Screen

Patient Weight

Drug Concentration

Programmed Dose

Time and date

Pressing continuously, locks and unlocks the keypad.

9 - DOWN ARROW:

Scrolls down through options.

NUMERIC KEYS

Set parameters.

Info

2 - 10

2 - System Basics
Continuum Infusion Pump with Door open

Info

START
OK

STOP
NO

PRIME
BOLUS

ON
OFF

1
2
7

4
5

Open Door description

No.

Area

Function

Latch Holder

Holds the door closed when latch is in

vertical position.

Pressure sensor

Detects downstream tubing restriction and

occlusion. Alarm level can be adjusted to
suit patient needs.

Keyway

Guides the IV line.

Pressing Plate

Connected to the door by two springs.

Pump door

Covers the pressing plate.

Air sensor - front

Ultrasonic air detector, which is mounted on

the front housing.

Air sensor - door

Mounted on the door.

Flow Direction

Shows direction of pump operation.

2 - 11

Continuum MR Compatible Infusion System

System Safety
Checks

The following details outline the safety checks designed into the system, to
minimize the possibility of under or over infusions.
Free Flow Protection
WARNINGS:
DO NOT connect a gravity fed fluid source directly to an unused
"Y" connector luer port on the disposable set. This could result
in the free-flow of fluid directly into the patient catheter. Serious
injury or death could result from connecting a gravity fed fluid source
directly to an unused "Y" connector luer port on the disposable set.
DO NOT place a gravity fed fluid source more than 5 feet (1.5 m)
above the infusion site. This could result in the free-flow of fluid
directly into the patient catheter. Disconnect the disposable set from
the patient prior to removing the disposable set from the pump.
The system's customized IV lines are equipped with a check valve that
prevents free flow towards the patient when the IV line is not attached to the
pump. When the pump is attached to the IV line and delivering fluid, the
pressure delivered by the pump opens the valve.
Automatic Bolus Function
The automatic bolus function is designed to reduce the bolus that may occur
upon the release of an occlusion following an occlusion alarm. Upon the
detection of an occlusion, the alarm is activated and the pump returns the IV
line pressure to neutral within 15 seconds. Neutral line pressure is achieved
by reverse operation of the pumping mechanism and measurement of the IV
line pressure through the in-line pressure detection system.
Air-in-Line Accumulation
To improve the detection of air in the IV line, the Continuum MR Compatible
Infusion System utilizes an air-in-line accumulation detection system in
addition to the standard single bubble detection. This feature monitors the
volume of air that passes through the IV line by accumulating the volume of
individual bubbles over a 15 minute time interval. Infusion of 1ml of air within
15 minutes is not considered to be a safety hazard. Although an individual
bubble may not exceed the pre-programmed threshold for an individual
bubble, the cumulative volume of bubbles in the 15 minute time interval may
exceed 1 ml and initiate an air-in-line alarm. This accumulation feature is
particularly useful with infusions for patients who are highly sensitive to air
(i.e. infants, neonates, children) or when infusing products that create
significant volumes of small air bubbles.
Maximum Flow Rate
This function allows the setting of maximum flow rate for any programmed
infusion. It is accessible through the Adjust Setting menu. The maximum flow
rate is especially useful for pediatric and critical patients because it minimizes
the risk of over-infusion.

Pump Accuracy

The following graphs and curves were derived from testing described in
IEC60601-2-24. Testing was performed under normal conditions at room
temperature (72 degrees). Any deviations from normal conditions and room
temperature may cause changes in the accuracy of the pump.

2 - 12

2 - System Basics

Start-up Curves

The start-up curves represent continuous flow versus operating time for two
hours from the start of the infusion. They exhibit the delay in onset of delivery
due to mechanical compliance and provide a visual representation of
uniformity. Trumpet curves are derived from the second hour of this data. Test
performed according to IEC 60601-2-24 standard.

Trumpet and Flow

Rate

With the Continuum MR Compatible Infusion System, as with all infusion

systems, the action of the pumping mechanism and variations cause shortterm fluctuations in rate accuracy.
The following curves show typical performance of the system in two ways:
1. The accuracy of fluid delivery over various time periods is measured
(trumpet curves).
2. The delay in onset of fluid flow when infusion commences (start up
curves).
Trumpet curves are named for their characteristic shape. They display
discrete data averaged over particular time periods or "observation windows",
not continuous data versus operating time. Over long observation windows,
short-term fluctuation has little effect on accuracy as represented by the flat
part of the curve. As the observation window is reduced, short-term
fluctuations have greater effects as represented by the "mouth" of the
trumpet.
Knowledge of system accuracy over various observation windows may be of
interest when certain drugs are being administered. Short-term fluctuations in
rate accuracy may have clinical impact depending on the shelf-life of the drug
being infused and the degree of inter-vascular integration, the clinical effect
cannot be determined from the trumpet curves alone.

2 - 13

Continuum MR Compatible Infusion System

Start-up Graph at 25 ml/h (Initial Period)

50
45
40

Flow (ml/hr)

35
30
25
20
15
10
5
0
0

20

40

60
Tim e (m in)

2 - 14

80

100

120

2 - System Basics

Trumpet Graph at 25 ml/h (2nd hour of delivery)

10
2nd Hour Q (Flow Rate) = 24.64

A (Accuracy) = -1.44%

Flow Error (%)

6
4
2
0
-2
-4
-6
-8
-10
2

11

19

31

Observation Window (m in)

E Max

E Min

Overall Mean Error

Trumpet Graph at 25 ml/h (4th hour of delivery)

10
4th Hour Q (Flow Rate) = 24.76

A (Accuracy) = -0.96%

Flow Error (%)

6
4
2
0
-2
-4
-6
-8
-10
2

11

19

Observation Window (m in)

E Max

E Min

2 - 15

Overall Mean Error

31

Continuum MR Compatible Infusion System

2 - 16

3 - Installation and Setup

3 - Installation and Setup

The Continuum MR Compatible Infusion System is compatible with MR
scanners with strengths up to and including 1.5T. The disposables design
allows the placement of the pump near the patient and the scanner bore.
The Continuum MR Compatible Infusion System operates on battery power.
When fully charged, the battery will provide four hours of operation at an
infusion rate of 1200ml/h. Two of the operational hours can be used during
patient transportation and setup.
Warnings:
DO NOT remove the pump from the bracket while in the MR scan
room. The pump contains ferromagnetic material and may be
attracted towards the magnet. To prevent potential injury and
equipment damage, the pump must be in its bracket and the I.V. Pole
casters locked when in the MR scan room. Pull on the bottom of the
pump to ensure that it is secure in the bracket prior to entering the
MR scan room. Lock the I.V. Pole casters when the system is
positioned near the bore of the MR scanner.
DO NOT use the pump while it is connected to the charger.
Battery charging is enabled as long as the charger cord is connected
to the mains and the pump is in the charger. Switching the pump off
does not disconnect it from the mains. To disconnect from the mains,
remove the charger cord from the mains.
DO NOT operate the pump for more than four continuous hours.
The battery will become depleted and the pump will cease to function
if the pump is operated longer than four hours.
Cautions:
To prevent the battery from becoming fully depleted, always store the
pump in the charger when the pump is not in use. It is recommended
that the battery is fully charged at all times.
DO NOT use the system immediately after being brought indoors
from extreme outside temperatures. Condensation may cause
electrical damage to the pump system. Battery damage could occur if
left in a temperature warmer than 50C. Allow the system to stabilize
at room temperature before use.
NOTE:

Any attempt to install, modify or repair a medical device such as

the MEDRAD Continuum MR Infusion System without adequate
training may result in personal injury, property damage or patient
injury.

3 - 17

Continuum MR Compatible Infusion System

Charging the Pump:

1. Connect the charger unit to AC power, and verify that the AC indicator is
lit.
2. Put the pump into the charger top first, until it clicks into place.

IPX1

P1

J1

INPUT 7.2V
1450mAh Li-ion Battery
OR 9V
800 mA Pump Charger
One Medrad Drive,
Indianola, PA 15051-0780
Model No. 3009135
201553 Rev.

Made in Israel

Patents Pending

3. The battery is charging when the red battery LED on the front of the
charger is lit. The battery is fully charged when the green battery LED is
lit.

AC Indicator

Release Button

4. Remove the pump from the charger by pressing the release button and
lifting the pump up from the charger.
CAUTION: Leaving the battery in a discharged state for a long period
of time may damage the battery.

3 - 18

3 - Installation and Setup

Installing the Pump

into a Bracket

Warning: DO NOT remove the pump from the bracket while in the
MR scan room. The pump contains ferromagnetic material and may
be attracted towards the magnet. To prevent potential injury and
equipment damage, the pump must be in its bracket and the I.V. Pole
casters locked when in the MR scan room. Pull on the bottom of the
pump to ensure that it is secure in the bracket prior to entering the MR
scan room. Lock the I.V. Pole casters when the system is positioned
near the bore of the MR scanner.
Make certain that the system is outside of the MR scan room when the pumps
are installed or removed from the brackets.
1. Hold the pump with the face of the pump facing outward. Tilt the top of the
pump toward the bracket at about a 20 degree angle. Insert the top of the
pump into the bracket. Slide the tabs on the sides of the pump up and
under the slots on the side of the bracket.
2. Rotate the bottom of the pump into the bracket.
3. Pull on the bottom of the pump to ensure it is secure in the bracket.
The pump may be removed from the mounting bracket for connection to the
patient while outside of the MR scan room.

3 - 19

Continuum MR Compatible Infusion System

Positioning the
Bracket on the Pole

To position the bracket on the pole, first

determine the desired height for the pump.
To raise the bracket:
1. Hold the bracket and loosen the retention
knob (located on the rear of the bracket).
If more than one pump is on the pole,
start with the top pump.
2. Slide the bracket up to the desired
position and tighten the retention knob.
To lower the bracket:
1. Hold the bracket and loosen the retention
knob (located on the rear of the bracket).
If more than one pump is on the pole,
start with the bottom pump.
2. Slide the bracket down to the desired
position and tighten the retention knob.
NOTE:

When positioning more than one bracket on a pole, be sure that

the pumps are facing in the same direction so that the brackets
interlock.

3 - 20

4 - Operational Verification

4 - Operational Verification
Setup

This checkout procedure for the Medrad Continuum MR Compatible Infusion

System assumes whomever is performing the procedure is familiar with
infusion pumps. Refer to the Medrad Continuum User's Manual for specific
operating instructions.
1. Remove the plunger from a 60 mL syringe.
2. Attach the Medrad Continuum administration set to the 60 mL syringe.
Note that the syringe is above the
discharge end of the administration set.

3. Install the administration set into the Continuum pump.

4. Fill the syringe with tap water.
5. Prime the administration set.
6. Once the administration set is primed stop the pump by pressing the Stop/
No button.
7. Remove power from the pump.

Verify Free Flow

Protection

1. Note the amount of water remaining in the syringe.

2. Open the door of the pump and remove the administration set from the
pump.
3. Allow the pump to sit for approximately five minutes. Ensure that less
than 2 mL has drained from the syringe.
4. Install the administration set into the Continuum Pump.
5. Remove the Free Flow Valve from the administration set.
6. Allow the pump to sit for approximately five minutes. Ensure that less
than 2 mL has drained from the syringe.

4 - 21

Continuum MR Compatible Infusion System

Verify Flow Rate

Accuracy

1. Install a new administration set into the Continuum pump and close the
pump door.
2. Apply power to the pump.
3. Ensure the water level in the syringe is 60 mL.

Fill the
syringe to the
60mL mark.

4. Ensure the pump is in Continuous mode.

5. Set the pump for 100 mL/Hr and 500 mL.
6. Ensure the output end of the administration set is in a container or
otherwise terminated so the discharged water will not damage any
surrounding objects.
7. Start the pump and a timer.
8. At the conclusion of 30 minutes stop the pump.
9. Note the water level in the syringe. It must be 5 - 15 mL

The water
level must be
between 5 mL
and 15 mL.

4 - 22

4 - Operational Verification

Verify Pressure
Limit

1. Connect the output of the administration set to a pressure measuring

device.
2. Set the pump's pressure limit to high.
3. Refill the syringe to approximately 30 mL.
4. Start the pump.
5. Ensure the pump sounds an occlusion error and the pressure generated
is 8-13 psi.
6. Remove power from the pump and remove the administration set.

Verify Battery Life

1. Charge the batteries for 24 hours.
2. Ensure the green battery charged indicator is illuminated.
3. Completely fill the administration set with water making a closed loop
ensuring no air bubbles are in the tubing.

4. Insert the administration set into the pump.

5. Apply power to the pump.
6. Set the pump for 500 mL/Hr and 2500 mL.
7. Start the pump.
8. Allow the pump to run for four hours.
9. At the end of the four hours ensure the pump is still running.
10.

Recharge the batteries until the green battery charged indicator is

illuminated.

11.

Discard the administration sets used in this checkout.

12. The MEDRAD Continuum pump is now ready for use.

4 - 23

Continuum MR Compatible Infusion System

4 - 24

5 - Troubleshooting

5 - Troubleshooting
Table 1: Troubleshooting an Alarm
Description

Result

Possible Cause

Required Action

Air in Line

Infusion stops

Air is present in the administration set.

Disconnect from the patient. Press

STOP/NO. Remove the air as
described in section 4. Press
START/OK to resume.

Air in Line

The roller or clip clamp on the existing

patient administration set is closed.

Press stop to mute

The line was not loaded correctly.

Open the roller or clip clamp on the

existing patient administration set.
Re-load the IV line.

Down Occlusion

Infusion stops

Administration set is kinked.

Straighten the administration set.

Down Occlusion

Cannula is blocked.

Change the cannula.

Press stop to mute

Administration set loaded incorrectly.

Remove clip clamp.

Clip clamp on patient extension set is

closed.
Pump unattended

Pump Unattended

Pump operation
stops.

Low Battery

End Battery

End Battery

Fatal Error

Error (number)

Press START/OK to resume.

Pump left in the stop state more than

two minutes.

Press start key

Low Battery

Two minutes have elapsed without a

button press.

Pump will only run

for another 15
minutes (at 1200
ml/h). The LED
blinks red in
between normal
green blinking.

15 minutes of battery life are remaining

(at 1200ml/h).

The alarm will sound, and "Low

Battery" will flash in the display
screen. The pump will automatically
resume normal operation with the
alarm sequence repeating for at
least 15 minutes.

Pump operation
stops.

Battery is depleted.

Recharge battery.

Pump operation
stops.

Fatal internal error has occurred.

Record the error number and call

MEDRAD.

Program ends.

The program was completed.

Enter a new program.

Pump will not

start.

Administration set loaded incorrectly.

Load administration set with key in

keyway.

Settings cannot
be changed.

Lock mode is turned on.

Turn off Lock Mode.

If procedure is not complete,

change the battery or use another
pump.

Send for Service

End Program

End Program
Press Stop to mute
Missing Key

MISSING KEY
Set Key & Close Door
Lock Mode

LOCK MODE

5 - 25

Continuum MR Compatible Infusion System

Error Messages

Table 2: Error Messages

Alarm or
Complaints
Error 1, 11, 12, 13
and 26

Probable Cause
Mechanical malfunction

Action
When the motor cant turn,
check for Mechanical
obstruction. Rotate the plates
together with the shafts. If the
plates dont rotate properly tighten them to the shaft.
Else: replace motor pcb.

Electronic malfunction - The

pumps motor turns without
control.

Visually check the encoders (all

channels) and look to see
whether the encoder LEDs or
phototransistor are damaged or
dirty. If dirt is discovered, clean
it.
Else: replace motor pcb.

External interrupt or electronic

malfunction (electrostatic
discharge).
- Encoder plate not mounted
properly.

- Restart the pump.

- Encoder LEDs or
phototransistors are damaged.

- Replace motor pcb.

- In case motor cannot turn.

- If the problem persists.

- Remount the encoder plate.

- Replace pumping block.

- Replace main PCB.

Error 7

Very low reading during

operation.

Call MEDRAD.

Error 10

Mechanical malfunction.

Turn the pump off and on again,

and set pump to operate on
0.1 ml/hr rate, if problem
continues send to service.

Error 14

Microprocessor malfunction.

Replace main pcb.

Error 15

Microprocessor malfunction.

Replace main pcb.

Error 16

Electronic malfunction.

Replace main pcb.

Error 17

Electronic malfunction.

Replace main pcb.

Error 19

Electronic malfunction, motor

failure during on/off test.

Restart the pump. If the

problem continues, replace
main pcb.

Error 20

Microprocessor malfunction.

Replace main pcb.

Error 21

Microprocessor malfunction.

Replace main pcb.

Error 23

External Timer Battery depleted.

Turn the pump off and on again.

If the problem continues,
replace Li-ion 3V Battery.

5 - 26

5 - Troubleshooting

Table 2: Error Messages

Alarm or
Complaints

Probable Cause

Action

Error 24, 28 & 32

External interrupt or electronic

malfunction (electrostatic
discharge).

Turn pump off and on again. If

the problem continues, replace
main pcb.

Error 25

Battery malfunction.

Make sure pump can be

operated on battery power or
replace battery.

External interrupt or electronic

malfunction (electrostatic
discharge).

Restart the pump.

Pump contacts are not clean.

Make sure pump contacts are

clean or replace battery.

Short in DC Connector.

Remove mechanical obstruction

from the connector or replace
battery.

Electronic malfunction.

Replace main pcb.

Error 27

Electronic malfunction.

Replace main pcb.

Error 28

Encoder detects external light.

Make sure pump case is not

broken and that it is closed with
4 screws holding it in place.

Encoder malfunction.

If pump is properly closed,

replace motor pcb.

Memory malfunction.

Turn the pump off and on again.

If the problem continues:

Error 30

Call MEDRAD.
Error 32

External interrupt.

Turn the pump off and on again.

If the problem continues,
replace the main pcb.

Error 33

Microprocessor malfunction.

Replace the main pcb.

Error 34

Microprocessor malfunction.

Replace the main pcb.

Error 35

Wrong Pressure Calibration.

Call MEDRAD.

Error 39

Microprocessor malfunction or
software code corrupted.

Call MEDRAD.

5 - 27

Continuum MR Compatible Infusion System

Table 3: Troubleshooting
SYMPTOM

PROBLEM

REMEDY

No LEDs are illuminated

when
the pump is in the charger.

There is no AC power at
the charger.

Check the power chord

ends are securely
connected
to the AC outlet and the
charger.

The red battery charging or

the green battery charged
indicators do not illuminate
while the pump is in the
charger and the yellow
power light is illuminated.

F1 on the Continuum motor

PCB is open.

Replace F1.

The battery pack is not

functional.

Replace the battery pack

The green battery charged

indicator does not light after
the battery has been on
charge for more than five
hours.

The battery pack is not

functional.

Replace the battery pack.

The battery output is less

than 7.2VDC.

The battery is discharged.

Connect the pump to a

charger.

The battery pack is not

functional.

Replace the battery pack.

The administration set is

not positioned properly in
the pump.

Reposition the
administration set
according to the Operation
Manual.

The roller clamp is closed.

Open the roller clamp.

The administration set in

use is not the proper set for
use with the Continuum.

Replace the administration

set with one designed for
use with the Continuum
Pump.

There is an air in line alarm.

5 - 28

6 - Disassembly/Reassembly

6 - Disassembly/Reassembly
Separating Front
and Rear Housings

NOTE:

Carefully remove and preserve labels as required in order to

remove hardware and seperate pump halves.

1. Turn the pump of and lay it face down on an anti-static work surface.
2. Remove the battery.
3. Being careful to preserve the serial number tag, remove the tag from the
back of the pump.
4. Remove the two screws that were covered with the serial number tag and
the two at the upper edge of the battery recess.
5. Separate the front and rear housings being careful not to pull on the
power wires.
6. Disconnect the power wires from the front housing.

Reassembly of Front
and Rear Housings

1. Connect the power wires to connector JP.

2. Ensure the power wires are secured under the retaining tab.
3. Place the front and rear housings together ensuring no wires are pinched
and that the two housings are flush with no gaps.
4. Replace the four screws holding the halves of the pump together.
5. Reattach all labels removed for disassembly.
6. Turn the pump on and ensure it successfully completes self test.
7. Perform operational verification per Section 4.

Replacement of
Pump Door

1. Open the door by pulling on the release leaver on the right side of the
pump.
2. Remove the two on the sides of the door near the bottom of the pump.
3. Remove the air sensor from the door.
4. Push the door shaft from the air sensor side and remove it.
5. Pull the door and pressing plate away from the pump.
6. Remove the pressing plate and springs from the door.
7. Replace the door and reassemble the pump Taking care that the pressing
plate springs are positioned properly.
8. Perform operational verification per Section 4.

6 - 29

Continuum MR Compatible Infusion System

Replacement of
Pump Assembly

1. Remove the pump door as described in "Replacement of Pump Door".

2. Separate the front and rear halves of the housing.
3. Remove the flow direction label.
4. Remove the door hook screws and the hook.
5. Remove the four pumping block screws securing the pumping block to
the front housing.
6. Disconnect the motor connector on the main PCB.
7. Push the pumping block out by pushing the "ears" of the pump assembly.
8. Replace the pump assembly and reassemble the pump.
9. Perform operational verification per Section 4.

Removal of Pressure
Sensor

1. Separate the front and rear housings of the pump.

2. Remove the pump door as described in "Replacement of Pump Door".
3. Remove the pumping block as described in "Replacement of Pump
Assembly".
4. Remove the pump handle.
5. Remove the screws holding the pressure sensor the front housing.
6. Pull the pressure sensor from its compartment.
7. Install the replacement sensor and reassemble the pump.
8. Perform operational verification per Section 4.

Replacement of
Front Housing Air
Sensor.

1. Separate the front and rear housings of the pump.

2. Disconnect the air sensor at connector JP4.
3. The air sensor is gled to the front housing. Pry to remove the old sensor
from the front housing.
4. Replace the air sensor with a new one. The air sensor front was glued to
a distance of 2.2mm. Check that the distance is correct and perform air
sensor testing.
5. Glue the sensor at a distance of 2.3mm. (Use a spacer to put between
the sensor to assure distance until the glue is dry.)
6. Perform operational verification per Section 4.

Replacement of
Pressing Plate

1. Remove the door (see Replacement of Pump Door).

2. Replace the pressing plate.
3. Reassemble in reverse taking care that the pressing plate springs are
positioned properly.
4. Perform operational verification per Section 4.

6 - 30

6 - Disassembly/Reassembly

Replacement of
Main and Motor P. C.
Boards

1. Separate the front and rear housings (see Separating Front and
Rear Housings).
2. Remove the pump door (see Replacement of Pump Door).
3. Hold the pump with the keypad facing up.
4. Remove the pumping block (see Replacement of Pump Assembly).
5. Place the pumping block with the pumping fingers facing up.
6. Remove the screws securing the P. C. Boards to the front housing.
7. Remove the P. C. Boards and replace the appropriate board.
8. Reassemble the pump in reverse order taking care not to turn the
pumping block over allowing the pumping fingers to fall out of the
pumping block.
9. Perform operational verification per Section 4.

6 - 31

Continuum MR Compatible Infusion System

6 - 32

7 Parts List

7 - Parts List

Main PCB 3009138

Motor PCB 3009136

Door 3009158

7- 33

Continuum MR Compatible Infusion System

Pressure Sensor 3009156

Motor 3009162

Pressing Plate 3009159

7 - 34

7 Parts List

Pumping Block 3009161

with Pumping Fingers 3009163

Pumping Fingers 3009163

Battery 3009140

7- 35

Continuum MR Compatible Infusion System

Excenter 3009164

Display 3009157

Pump Housing 3009152

7 - 36