Codman NeuroscienceRL 914205 Users Manual

DRAFT
Codman Neuro Sciences (logo)
MedStream™ Control Unit
Codman Neuro Sciences Sàrl
Rue Girardet 29
CH 2400 Le Locle, Switzerland
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
204268 DRAFT Rev A MedStream Control Unit IFU 1 of 18 6/15/2006
DRAFT
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
204268-5 DRAFT: MedStream Control Unit IFU 2 of 18 6/15/2006
DRAFT
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.
204268-5 DRAFT: MedStream Control Unit IFU 3 of 18 6/15/2006
DRAFT
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 X­rays.
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.
204268-5 DRAFT: MedStream Control Unit IFU 4 of 18 6/15/2006
DRAFT
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.
204268-5 DRAFT: MedStream Control Unit IFU 5 of 18 6/15/2006
DRAFT
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
204268-5 DRAFT: MedStream Control Unit IFU 6 of 18 6/15/2006
+ 12 hidden pages