Codman NeuroscienceRL 914205 MedStream Control Unit User Manual 204268A DRAFT MEDSTREAM CU IFU 06 14 06
Codman Neuroscience SARL MedStream Control Unit 204268A DRAFT MEDSTREAM CU IFU 06 14 06
Users Manual 1
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204268 DRAFT Rev A MedStream Control Unit IFU 1 of 18 6/15/2006
Codman Neuro Sciences (logo)
MedStream™ Control Unit
Codman Neuro Sciences Sàrl
Rue Girardet 29
CH 2400 Le Locle, Switzerland
+41 32 933 83 00
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767-0350 USA
800 225 0460
+1 508 828 3000
Codman (logo)
A division of Johnson & Johnson Medical Ltd.
Coronation Road, Ascot
Berkshire SL5 9EY
United Kingdom
0086 0889
Authorized 20XX
LCN 204268-001/A
2006 Codman & Shurtleff, Inc.
(recycle symbol) Printed mm/yy
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Table of Contents
Brief Product Description
Indications
Contraindications
WARNINGS
PRECAUTIONS
Adverse Events
PRODUCT DESCRIPTION
Control Unit
Control Unit Audible Signals and Alarms
Function and Intended Application
Universal Battery Charger
USB Printer Cable
INSTRUCTIONS FOR USE
Setting Up the Control Unit
Communicating with a MedStream Pump
Positioning the Control Unit for Transmission
to a Pump
Turning Off the Control Unit
Safety Information
Preventive Maintenance
Cleaning
Disinfection
Sterilization
Service and Repair
End of Useful Life
Control Unit Technical Specifications
Control Unit Environmental Conditions
Warranty
Appendix A – Tables
Table 1 Guidance and Manufacturer’s Declaration
– Electromagnetic Emissions
Table 2 Guidance and Manufacturer’s Declaration
– Electromagnetic Immunity
Table 3 Guidance and Manufacturer’s Declaration
– Electromagnetic Emissions, Equipment and
Systems That Are NOT Life-supporting
Table 4 Recommended Separation Distances
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IMPORTANT INFORMATION
Please Read Before Use
MedStream™ Control Unit
FCC ID: T9I-914205
IC: 6518A-914205
IMPORTANT: This equipment has been tested and
found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC
Rules. These limits are designed to provide
reasonable protection against harmful interference
when the equipment is operated in a commercial
environment. This equipment generates, uses,
and can radiate radio frequency energy and, if not
installed and used in accordance with the
instruction manual, may cause harmful
interference to radio communications. Operation
of this equipment in a residential area is likely to
cause harmful interference in which case the user
will be required to correct the interference at his
own expense.
IMPORTANT: This device complies with the Class
B limits for radio noise emissions as set out in the
interference-causing equipment standard entitled
“Digital Apparatus“ ICES-003 of Industry Canada.
Operation is subject to the following two
conditions: (1) this device may not cause
interference, and (2) this device must accept any
interference, including interference that may cause
undesired operation of the device.
Brief Product Description
The MedStream Control Unit is part of a system for the intrathecal
delivery of selected drugs for pain management or relief of
spasticity. It is designed for communicating with and
programming the MedStream™ Implantable Programmable
Infusion Pump.
CAUTION: Do not use the MedStream Control Unit without
ensuring a thorough familiarity with the information contained
in this manual, the pump instructions and the MedStream Control
Unit Programming Guide. Failure to adhere to these instructions
can result in patient complications ranging from failure of the
intended therapy to drug underdose or overdose.
Indications
The MedStream Control Unit is used to program the MedStream
Implantable Programmable Infusion Pump for the medication
therapy indicated in the pump Instructions for Use.
Contraindications
There are no known contraindications for the use of the control
unit.
Observe all contraindications relating to the use of the
prescribed drug.
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WARNINGS
Do not modify or change the control unit. Unauthorized
changes or modifications to the control unit might cause a
malfunction that could result in serious patient injury or death and
could void the user’s authority to operate the equipment.
Immediately investigate with the control unit if the pump alarm
sounds. Immediately empty the pump reservoir if the error
message is “Pump Hardware Failure.” These conditions can
cause a drug overdose. See the MedStream Control Unit
Programming Guide for further information.
Do not open the control unit case. There are no user serviceable
parts. See Service and Repair.
Do not immerse the control unit in liquid. Damage to the unit
may result.
Do not use the control unit in the presence of flammable gases or
near flammable materials.
PRECAUTIONS
Do not use the MedStream Control Unit with any other
programmable infusion pump.
Do not rely only on the “fuel gauge” indicator on the control unit
screen to determine precisely the life of the pump battery. This
indicator provides an estimate of the remaining useful life of the
pump battery.
Do not place the pump on a metal surface when using the control
unit for preoperative preparation.
Do not expose the control unit or the hardware key to
electromagnetic fields or ionizing radiation, such as MRI or X-
rays.
Be aware that medical electrical equipment needs special
precautions regarding electromagnetic compatibility. This
equipment must be installed and put into service according to the
electromagnetic compatibility information provided in this manual.
Be aware that portable and mobile RF communications
equipment can affect medical electrical equipment.
Be aware that the use of cables other than those included with
the control unit can result in increased emissions or decreased
immunity of the equipment.
Avoid using the control unit adjacent to or stacked with other
electronic equipment. If adjacent or stacked use is necessary,
observe the system to verify normal operation in the configuration
in which it will be used.
Use only the battery charger provided to recharge the control unit
battery.
Avoid exposing the control unit to ultraviolet light.
Do not remove the hardware key from its slot in the control unit.
The Control Unit software will lock if the hardware key is missing
or damaged.
Do not remove or replace the control unit battery.
Use only with computer equipment that complies with
IEC60950-1.
Adverse Events
There are no known adverse events associated with use of the
MedStream Control Unit.
PRODUCT DESCRIPTION
Control Unit
The MedStream Control Unit is a hand-held, battery-powered,
electronic module that houses power and control logic circuits.
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The control unit uses radiofrequency to communicate with a
MedStream pump. Use the control unit to:
• prepare the pump preoperatively
• initialize the pump and start infusion postoperatively
• refill the pump
• noninvasively check the status of an implanted pump and
change the infusion parameters
• deliver a bolus dose of medication directly from the
pump’s drug reservoir
• view a log of transactions performed with the control unit
• transmit a record of a past transaction or of a pump’s
current settings to a compatible computer printer
The control unit (see Figure 1) includes the following features:
• Liquid crystal display (LCD) screen
• Power/Escape button
• Roller key and Back button for navigating screens
• Antenna
• Hardware key
• USB port for printer
• USB port for PC
• Strap
• Battery charger connection
• Transmit button
Also included, but not shown:
• Universal battery charger
• USB printer cable, 1.5 m
Control Unit Audible Signals & Alarms
When communication with the pump is successful, the control unit
emits a 1-second beep. If communication is not successful, the
control unit emits a longer beep (2 seconds) in a lower tone.
The control unit will emit several short beeps to alert the user to a
warning or an error condition. Check the LCD screen for the
warning message. Refer immediately to the MedStream Control
Unit Programming Guide for information regarding warnings and
errors and the audible signals. Take appropriate action.
Control Unit Function and Intended Application
The MedStream Control Unit is intended for programming the flow
parameters of an implanted MedStream Implantable
Programmable Infusion Pump and for transmitting other
information to the pump memory.
Universal Battery Charger
Use the battery charger provided with your control unit to recharge
the control unit battery. See the instruction booklet packaged with
the battery charger. You can operate the control unit while the
battery is charging.
Before first use you must charge the control unit for at least 5
hours.
Periodic Recharging Requirements
• Recharge the battery at least every 70 days.
• Whenever possible, allow the battery to fully recharge; i.e.,
recharge overnight.
• Periodically perform a complete discharge/ recharge cycle.
• Use the control unit with the battery at 40% or more of full
charge.
CAUTION: Use only the battery charger included with the control
unit to recharge the control unit battery.
USB Printer Cable
Use only the cable provided to connect the control unit to a
computer printer. See the MedStream Control Unit Programming
Guide for instructions and for a list of compatible printers.
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CAUTION: Use only the USB printer cable included with the
control unit to connect the control unit to a computer printer.
Use only with the computer printers listed in the MedStream
Control Unit Programming Guide, which comply with IEC 60950-1.
INSTRUCTIONS FOR USE
Setting up the Control Unit
Before first use, use the battery charger provided to charge the
control unit for at least 5 hours.
Turn the control unit on by pressing the Power/Escape button.
The first time you use the control unit, you must:
• select the language
• set the date
• set the time
All other functions of the control unit are disabled until this
information is entered. See the MedStream Control Unit
Programming Guide for set-up instructions.
Communicating with a MedStream Pump
You must use the control unit to prepare the pump before
implantation and to start the infusion post- operatively. Step by
step instructions are included in the Control Unit Programming
Guide and in the instructions packaged with the pump.
You must use the control unit for tasks associated with continuing
therapy. See the programming guide for instructions regarding:
• Refilling the drug reservoir
• Administering a bolus dose
• Stopping the infusion
• Changing the infusion parameters
• Responding to a pump alarm
You also use the control unit to
• Display a log of the past 100 transactions performed with
the control unit
• Sort the transaction log by date, pump identification
number, or patient identification
• Transmit a transaction report to a compatible printer. See
the Programming Guide for instructions and for a list of
compatible printers.
Positioning the Control Unit for Transmission
to a Pump (see Figure 2)
When you use the control unit to communicate with the pump, you
must first position the control unit antenna so it encircles the
patient’s skin over the implanted pump. Each time the control unit
screen displays “Activate Transmission?” you will:
1. Open the antenna to between 110º and 180º
2. Slip your hand through the handle on the back of the control
unit
3. Position the control unit so the antenna surrounds the
implanted pump and is not more than 7 cm above the top
surface of the pump
4. Hold the control unit steady while pressing the Transmit
button or the Roller key to activate the transmission, until the
transmission is complete
Turning Off the Control Unit
Press and hold the Power/Escape button for three seconds to turn
off the control unit.
If you do not manually turn off the control unit after each use, the
control unit enters the power saver mode to conserve battery
power (if the power saver mode has not been deactivated). After
10 minutes of inactivity, the control unit enters a lower power
mode. Although the screen is turned off, the control unit is still on.
To turn the screen back on, press the Power/Escape button.
After an additional 15 minutes in the power saver mode, the
control unit will power off.
Instructions for deactivating the power saver mode appear in the
Control Unit Programming Guide. When the power saver mode is
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deactivated, a message regarding this status will appear when the
power is turned on.
Safety Information
The MedStream Control Unit (catalog no. 91-4205) complies with
the requirements of:
47 CFR Parts 1, 2, and 15 Federal Communications
Commission Rules and Regulations
ICES-003 Digital Apparatus
IEC/EN 60601-1-1 Medical Electrical Equipment – Safety
Requirements for Medical Electrical Systems
IEC/EN 60601-1-2 Medical Electrical Equipment –
Electromechanical Compatibility
IEC/EN 60601-1-4 Medical Electrical Equipment –
Programmable Electrical Medical Systems
RSS 102 Radio Frequency Exposure Compliance of
Radiocommunication Apparatus (All Frequency Bands)
RSS 210 Low-power License-exempt Radiocommunication
Devices (All Frequency Bands): Category I Equipment
Preventive Maintenance
The control unit performs a self-diagnostic test each time the
power is turned on. No user maintenance is required.
Cleaning
Cleaning the Outer Case
Clean the outer case of the control unit with a water-dampened
cloth. Do not allow excessive moisture into the control unit.
CAUTION: Do not immerse the control unit in liquid. Do not
clean the programmer with aromatic or chlorinated hydrocarbons.
Cleaning the Display
Do not use any cleaning agents on the display. Clean the display
only with a soft, dry, lint-free cloth.
NOTE: Scratches on the display can adversely affect device
operation by interfering with display option selection. If scratches
are present, the control unit might need to be repaired or
replaced.
Cleaning the Antenna
Clean the exterior surfaces of the antenna with a damp sponge or
soft cloth moistened with water, mild detergent or alcohol. Prevent
liquid from entering any system components.
Disinfection
Wipe the outer case of the control unit with antibacterial solution if
it is to be used in the sterile field.
Sterilization
CAUTION: Do not sterilize the control unit or the battery charger.
The control unit, USB cable, battery charger and hardware key
are nonsterile. To use the control unit and accessories in the
sterile field, wrap in sterile plastic drapes.
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Service and Repair
Send the MedStream Control Unit for service or repair to:
Codman Neuro Sciences Sàrl
Rue Girardet 29
CH 2400 Le Locle
Switzerland
Always include a repair purchase order and a written description
of the problem.
End of Useful Life
Dispose of the equipment in accordance with local ordinances.
Control Unit
Technical Specifications
Internal Power Supply
(non-removable) Lithium ion rechargeable battery
Nominal voltage: 11.1 V
Minimum capacity: 1850mAh
Battery configuration: 3S1P
Active current limitation: 4.65A ± 1.05A
Charger max. voltage 12.6 V DC
Charger max. current 1.2 A DC
Approximate stand-
alone operating time
(20 radiofrequency
communications with
the pump)
9.5 h
Maximum battery
recharge time 5 h
Weight 750 g
Dimensions 130 mm W x 60 mm H x 110 mm D
Materials – Outer
Surfaces Case: ABS and SANTOPRENE®
elastomer
Strap: PVC and polyester
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Control Unit
Environmental Conditions
Operating Conditions
Temperature Range: 10°C to 40°C
Humidity Range: Relative Humidity 30% to 75% non-
condensing
Pressure Range: Atmospheric Pressure 700 hPa – 1060
hPa
Transport & Storage Conditions
Temperature Range: Transport: -20 ° C to +50° C
Storage: +5 ° C to +30 ° C
Humidity Range: Relative Humidity 10% to 85% non-
condensing
Pressure Range: Atmospheric Pressure 500 hPa – 1060
hPa
Warranty
Codman & Shurtleff, Inc., warrants that this medical device is free
from defects in both materials and workmanship for one (1) year
from the date of purchase. Any other express or implied
warranties, including warranties of merchantability or fitness,
are hereby disclaimed. Suitability for use of this medical
device for any particular surgical procedure should be
determined by the user in conformance with the
manufacturer’s instructions for use. There are no warranties
that extend beyond the description on the face hereof.
™ MedStream is a trademark of Codman Neuro Sciences Sàrl
CODMAN is a registered trademark of Codman & Shurtleff, Inc.
® SANTOPRENE is a registered trademark of Advanced Elastomer
Systems, L.P.
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Appendix A: Tables
Table 1
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The MedStream Control Unit (Model No. 91-4205) is intended for use in the electromagnetic environment specified below. The
customer or the user of the MedStream Control Unit should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions
CISPR 11 Group 1 The MedStream Control Unit uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11 Class B
Harmonics
IEC 61000-3-2 Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3 Complies
The MedStream Control Unit is suitable for use in all establishments,
including domestic, and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic
purposes.
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Table 2
Guidance and Manufacturer’s Declaration –Electromagnetic Immunity
The MedStream Control Unit (Model No. 91-4205) is intended for use in the electromagnetic environment specified below. The customer
or the user of the MedStream Control Unit should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are synthetic, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
(EFT)
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips
and dropout
IEC 61000-4-11
>95% dip for 0.5 cycle
60% dip for 5 cycles
30% dip for 25 cycles
>95% dip for 5 sec
>95% dip for 0.5 cycle
60% dip for 5 cycles
30% dip for 25 cycles
>95% dip for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be that
of a typical commercial or hospital environment.
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Table 3
Guidance and Manufacturer’s Declaration –Electromagnetic Emissions
Equipment and Systems That Are NOT Life-supporting
The MedStream Control Unit (Model No. 91-4205) is intended for use in the electromagnetic environment specified below. The customer
or the user of the MedStream Control Unit should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
10 Vrms for ISM Bands
3 V/m
80 MHz to 2.5 GHz
V1 = 3 Vrms
V1 = 10 Vrms for
ISM Bands
E1 = 10 V/m
Portable and mobile RF communications equipment should be
separated from the MedStream Control Unit by no less than the
distances calculated/listed below:
D = (3.5/V1)(Sqrt P)
150 kHz to 80 MHz
D = (3.5/E1)(Sqrt P)
80 to 800 MHz
D = (7/E1)(Sqrt P)
800 MHz to 2.5 GHz
where P is the max power in watts and D is the recommended
separation distance in meters.
Field strengths from fixed transmitters, as determined by an
electromagnetic site survey, should be less than the compliance
levels (V1 and E1).
Interference may occur in the vicinity of equipment containing a
transmitter.
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Table 4
Recommended Separation Distances
Between Portable and Mobile RF Communications Equipment and
the MedStream Control Unit (Model No. 91-4205)
Equipment and Systems That Are NOT Life-supporting
The MedStream Control Unit (Model No. 91-4205) is intended for use in an electromagnetic environment in which radiated disturbances are
controlled. The customer or the user of the MedStream Control Unit can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment and the MedStream Control Unit as recommended below, according to the
maximum output power of the communications equipment.
Max Output Power (Watts)
Separation (m)
150 kHz to 80 MHz
D = 1.17 (Sqrt P)
Separation (m)
80 MHz to 800 MHz
D = 0.35 (Sqrt P)
Separation (m)
800 MHz to 2,5 GHz
D = 0.7 (Sqrt P)
0.01 0.12 0.04 0.07
0.1 0.37 0.11 0.22
1 1.17 0.35 0.70
10 3.69 1.11 2.21
100 11.67 3.50 7.00
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Figure 1
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Figure 2
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Symbols:
Authorized European Representative
Prescription device only (USA)
Manufacturer
Made In
Attention, consult accompanying document
Type BF – Equipment with an electrical path to the patient, not including direct cardiac application
Transport temperature limitations
Electrical and electronic equipment. Return waste to collection system or treatment and recycling facilities. Applicable in the
EU. Follow disinfection instructions before return.
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This product intentionally generates RF energy which may cause interference
xxxx
This product is ETL listed