Medtronic 37751 Users Manual

Neurological
Date
24 August 2004
This Document is the Property of Medtronic, Inc. and must be accounted for. Information hereon is confidential. DO NOT reproduce it, reveal it to unauthorized persons or send it outside Medtronic wit hout proper authorization.
Medtronic Confidential
Medtronic Confidential
Title
Model 37751 INSR patient manual
Writer
Theresa King-Hunter
Part No. Part No. Rev Comments
A08366001 A Global market release
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R
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9. Graphics Content and Layout to be as shown and per Medtronic electronic file that is supplied (stored) by Medtronic Neuro.
Page 1
Form MEDN-0043 version 6.0
PatntFC.fm 8/23/04 7:57 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN
RECHARGER 37751
Charging System user manual
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c Rx Only
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2005
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Medtronic®, Restore™, and SoftStart™ are trademarks of Medtronic, Inc.
c FCC Information
The following is communications regulation information on the Model 37751 Patient Programmer.
FCC ID: LF537751
This device complies with part 15 Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.
IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product.
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Contents
Label symbols 6
1Introduction9
Purpose of the device 10 Warnings 10 Precautions 11 How to use this manual 13 Parts of your charging system 15 How your charging system works 17 Recharger keys and screens 19
Recharger keys 19 Recharger screens 21
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2 Using your charging system 25
Battery and charging information 26
Neurostimulator battery status 29 Charging your neurostimulator battery 32
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Recharger and Neurostimulator 26 Recharger 27 Neurostimulator 28
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Turning the neurostimulator ON and OFF while charging 39
Accessories 41
Using the recharger pouch 41 Using the charging system carrying
case 41
Identification label 41
3 Troubleshooting 43
Recharger screens 44
Warning screens 44 Information screens 49
Possible problems and solutions 56 User assistance 63
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4 Maintenance 65
Recharger maintenance tasks 66
Cleaning and care 72 Safety and technical checks 73 Battery and device disposal 75
Contents
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Declaration of conformity 75
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Checking the recharger battery 67 Charging your recharger battery 69
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Specifications 76
Glossary 78
Index 80
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Label symbols
Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply.
CE
0123
Caution: consult accompanying
w
documents
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Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC.
The use of this device might be subject to individual country licensing regimes in Europe.
n
Label symbols
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Serial number
Storage temperature
Relative humidity
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kPa
y
Atmospheric pressure
IEC 60601-1/EN60601-1, Type BF equipment
Non-ionizing electromagnetic radiation
L
Class II equipment
System meets the applicable Canadian [C22.2-601.1-M90 (R2001)] and US (UL 60601-1:2003) electrical safety standard requirements.
c For USA audiences only
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1 Introduction
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Purpose of the device
The Medtronic Model 37751 Charging System is designed to charge the Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulation System is intended to provide electrical stimulation to relieve severe, intractable pain. Restore Neurostimulation System indications, contraindications, risks and benefits, warnings, precautions, and individualization of treatment information is located in the Model 37742 Patient Programmer: Pain Therapy User Manual.
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Warnings
DO NOT use the recharger on an unhealed wound. The recharger, antenna, and belt are not sterile, and contact with the wound can cause an infection.
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Do not use the AC power supply near water or during a lightning storm. Electric shock, serious injury, or death may result.
Precautions
Charge the neurostimulator when you see a low battery ( ) screen on the patient programmer or recharger; this prevents the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function. Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:
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Battery function is restored; however,
Battery function is not restored, and the
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charging sessions may be more frequent because battery capacity has been reduced.
neurostimulator must be surgically
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replaced. Battery function is not restored because:
The neurostimulator battery is permanently damaged.
The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the neurostimulator will reach end of service. Surgery is required to replace the neurostimulator.
Do not expose the recharger or antenna to extremely hot [eg, hot cars, saunas, or direct sunlight; +40°C (104°F)] or cold [eg, walk-in freezers; –20°C (–4°F)] environments. The recharger and antenna are sensitive to temperature extremes and can become damaged.
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Use only the Medtronic neurological
charging system components to charge your recharger. Use of non-Medtronic
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charging equipment to charge the recharger can damage your charging system components.
When operating a charging system, use special care near flammable or explosive atmospheres. An interaction between the flammable or explosive atmospheres and the battery in the device could occur. The consequences of using a battery­powered device near flammable or explosive atmospheres are unknown.
How to use this manual
This manual is designed to help you understand your charging system. Ask your clinician to explain anything that is unclear.
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Chapter 1, “Introduction,” describes the
recharger keys and screens and how the system works.
Chapter 2, “Using your charging system,” describes the recharger and how to perform specific tasks.
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Chapter 3, “Troubleshooting,” describes recharger warning and information screens, how to solve possible charging system problems, and who to contact if your recharger is lost or broken.
Chapter 4, “Maintenance,” describes how to care for your recharger and contains system specifications and battery information.
A glossary is provided at the end of this manual.
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Parts of your charging system
Recharger
AC power supply
Power cord
Figure 1.1 Parts of your charging system.
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Belt
Antenna
Recharger: The recharger is a hand-held device for charging the battery in your neurostimulator. It can also turn your neurostimulator ON or OFF. The display on the recharger provides information on your charging system.
AC power supply and power cord: This device is used to charge the recharger using AC power. If you need to charge your
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neurostimulator but your recharger battery is low, connect your recharger to the AC power supply to conduct a charging session. The power cord plugs into an electrical outlet and connects the AC power supply to the recharger. The power supply is a universal component.
Note: Use only the power supply provided by Medtronic with your charging system.
Antenna: The antenna connects to the recharger to establish communication with your neurostimulator. You can adjust a dial on the antenna to improve the charging efficiency between the recharger and the neurostimulator.
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Belt: The belt allows you to keep the antenna
directly over your neurostimulator during a charging session.
Pouch: The recharger fits into a pouch that can be attached to the belt so you can maintain your normal activities during a charging session.
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System carrying case: The carrying case is used to store the recharger, the charging system components, and your patient programmer.
How your charging system works
The charging system is used to charge your implanted neurostimulator battery. The battery in your recharger is similar to the rechargeable batteries commonly found in electronic devices. The battery typically lasts for approximately 5 years, depending upon your therapy needs and how often you use your recharger.
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Rechargeable batteries lose some of their power every day, even when not used. Charging sessions restore power to the recharger battery.
Caution:
Charge the neurostimulator when you see
a low battery ( ) screen on the patient programmer or recharger; this prevents
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the battery from overdischarging (see glossary). If the neurostimulator battery is allowed to overdischarge, charging is not possible; however, the clinician may be able to restore the battery function. Allowing the neurostimulator battery to overdischarge will permanently affect the neurostimulator in one of the following ways:
Battery function is restored; however,
charging sessions may be more frequent because battery capacity has been reduced.
Battery function is not restored, and the
neurostimulator must be surgically replaced. Battery function is not restored because:
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The neurostimulator battery is permanently damaged.
The neurostimulator battery has been overdischarged and restored twice before. The third time the battery is overdischarged, the
Printing instructions:
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neurostimulator will reach end of service. Surgery is required to replace the neurostimulator.
Recharger keys and screens
Recharger keys
Five keys on the recharger allow you to control the recharger and turn your neurostimulator ON and OFF.
NEUROSTIMULATOR ON
NEUROSTIMULATOR OFF
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START CHARGE/TEST
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STOP CHARGE
AUDIO CONTROL
Figure 1.2 Recharger keys.
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•NEUROSTIMULATOR ON : Tur n s your neurostimulator ON.
•NEUROSTIMULATOR OFF : Turns your neurostimulator OFF.
•START CHARGE/TEST : Begins charging the neurostimulator.
•STOP CHARGE : Ends or interrupts charging the neurostimulator.
•AUDIO CONTROL : Turns your recharger
ON.
Note: When your recharger is ON, pressing the AUDIO CONTROL key turns audible status tones ON and OFF. The AUDIO CONTROL key is also used to display the recharger battery status.
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Recharger screens
Figure 1.3 shows the recharger screens.
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Status row
Charge
progress row
Neurostimulator charging session screen.
Charge
efficiency row
Recharger charging session screen.
Figure 1.3 Recharger screens.
The screens are separated into either two or three rows of icons.
Status row – Displays icon information for the recharger or neurostimulator.
During a neurostimulator charging session, on the status row you will see:
Neurostimulator is ON ( ) or OFF ( )
Audio (sound) is ON ( ) or OFF ( )
Battery charge status of the recharger
( , needs recharging to full, respectively)
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The recharger is plugged into the AC power supply ( ). If the recharger is not plugged into a power supply, this area of the screen will be blank.
During a recharger charging session, the status row displays:
Audio (sound) is ON ( ) or OFF ( )
Charge progress row – Indicates the
progress of the charging session. During a neurostimulator charging session,
you will see:
Current charge status of the neurostimulator battery. A flashing battery icon ( ) indicates the neurostimulator is charging. When charging is complete, the NEUROSTIMULATOR CHARGING COMPLETE screen will display.
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During a recharger charging session, you will see:
Current charge status of the recharger battery. A flashing battery icon ( ) indicates the recharger is charging. When charging is complete, the RECHARGER
CHARGING COMPLETE screen will display.
The connection icon ( ), indicating that the power supply is connected to an operational electrical outlet.
Charge efficiency row – Displays a series of boxes indicating the efficiency of the charging signal between the neurostimulator and recharger. More solid black boxes (a maximum of eight) indicate a more efficient charging signal and a shorter charging session ( ). The least efficient charge is indicated by empty boxes ( ). If you see six empty boxes, adjust the antenna to continue charging.
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2 Using your
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This chapter includes information on:
the recharger battery and the charging procedure.
neurostimulator battery status icons.
charging your neurostimulator.
how to turn your neurostimulator ON or OFF during a charging session.
the charging system accessories.
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Battery and charging information
Recharger and Neurostimulator
Charge the recharger or neurostimulator even if you are not using them for an extended period of time.
Using your charging system 2
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