Medtronic 8880T2 User Manual
NEUROMODULATION
63
CONFIDENTIAL
DOCUMENT/RECORD
This document/record is electronically controlled, printed copies are considered uncontrolled.
Identifier Version Author
NDHF1205-121337 10.0 Karyn Van Erem
Title:
8880CW 8880T2 Technical Manual for Agency Testing
Pages:
(including this page)
APPROVALS
Signed By Responsibility Date/Time (GMT)
Karyn Van Erem Technical Communications Approver 9/27/2012 3:55:45 PM
Form MEDN-0500 version 3.0
Filename Date Time
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Medtronic Neuromodulation Clinician
Programmer
and Model 8880T2 Telemetry Head
8880CW
Technical Manual
! USA
Rx only
M937825A001 Rev X 2013- 03
2013
Filename Date Time
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7 x 9 inches (178 mm x 229 mm)
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Label symbols
Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols
that apply.
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Consult instructions for use
-XX °C
-XX °F
EC
MR
XX °C
XXX °F
REP
Temperature limitation
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.
Manufacturer
Authorized representative in the European community
For USA audiences only
Non-ionizing electromagnetic radiation
IEC 60601-1/EN60601-1, Type BF Equipment
Medical – General Medical Equipment as to electrical shock, fire and mechanical hazards only in
accordance with ANSI/AAMI ES 60601-1 and CAN/CSA C22.2 No. 60601-1.
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product
according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal
of this product.
Magnetic Resonance (MR) Unsafe
Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products Pollution Control
Symbol. (The date in this logo means the environmental protection use period of the product.)
Package contents:
Serial number
REF
PIN No.
LOT
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Product number or Catalog number
PIN number
Lot number
3
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Medtronic® is a trademark of Medtronic, Inc., registered in the U.S. and other countries.
Bluetooth
PostScript
PCL
®
is a registered trademark of Bluetooth SIG, Inc.
®
(PS) is a trademark of Adobe Systems, Inc., registered in the U.S. and other countries.
®
(Printer Command Language) is a registered trademark of Hewlett-Packard Company.
This device complies with Industry Canada license-exempt RSS standard(s). 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.
FCC Information
The following communications regulation information applies to the Model 8880CW Clinician
Programmer and the Model 8880T2 Telemetry Head.
FCC ID: LF58880CW and LF58880T2
These devices comply with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept
any interference received, including interference that may cause undesired operation.
IMPORTANT: Changes or modifications to these products not authorized by Medtronic, Inc.,
could void the FCC Certification and negate your authority to operate these products.
FCC Class B
NOTE: 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 in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
—Consult the dealer or an experienced radio/TV technician for help.
FCC 15.407(e)
According to FCC 15.407(e), the device is intended to operate in the frequency band of 5.15 GHz to
5.25 GHz under all conditions of normal operation. Normal operation of this device is restricted to indoor
use only to reduce any potential for harmful interference to co-channel MSS operations.
FCC RF Radiation Exposure
1. This device must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment.
FCC 95.1215
This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95
of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150 -
460.000 MHz band in the Meteorological Aids (ie, transmitters and receivers used to communicate
weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept
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interference that may be caused by such stations, including interference that may cause undesired
operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical
Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although
this transmitter has been approved by the Federal Communications Commission, there is no guarantee
that it will not receive interference or that any particular transmission from this transmitter will be free
from interference.
FCC 95.1217
This device may not interfere with stations operating in the 400.150 - 406.000 MHz band in the
Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept
any interference received, including interference that may cause undesired operations.
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Table of contents
Device description 9
Package contents 9
Device specifications 9
Declaration of Conformity 12
Instructions for use 12
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Electrical and operating characteristics 9
Storage and operating characteristics 11
Component identification 12
Programmer component identification 12
Telemetry head component identification 14
Docking station component identification 16
Setting up the programmer and docking station 17
Inserting the rechargeable battery 18
Connecting the power supply and cord 19
Connecting to the USB port 20
Using the docking station 20
Using the telemetry head 23
Connecting to and disconnecting from the programmer 23
Turning the telemetry head on or off 25
Telemetry head LED indicators 25
Initiating telemetry 26
Positioning the telemetry head in a sterile field 27
Programmer function overview 28
Turning the programmer on 28
Data entry using the programmer touchscreen 29
Configure initial user settings 33
Overview of programmer desktop 35
Turning the programmer off 36
Putting the programmer into Standby 36
Programmer Control Panel 37
Messages 38
Control Menu 38
Utilities 40
Managing the programmer system 40
Patient Data Center 45
Patient Record Security 46
Patient List 46
Session List 47
Reports 49
Moving patient records from one programmer to another 50
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Maintenance 51
Troubleshooting 57
Safety and technical checks 60
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Removing patient records from the programmer without exporting 51
Installing or removing the programmer battery 52
Charging the programmer battery 54
Changing the batteries in the telemetry head 55
Calibrating the touchscreen 57
Cleaning 57
Clinician programmer error messages 57
Network connection troubleshooting 58
Printer connection troubleshooting 59
Resetting the Patient data security password 59
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Device description
The Medtronic Neuromodulation Model 8880CW Clinician Programmer is a portable device used to
program Medtronic Neuromodulation devices. The programmer is equipped with a color touchscreen,
Bluetooth
(USB) port, rechargeable battery, and docking capability. Network connectivity is provided so that
reports can be printed, saved, or sent via email. Refer to the System Components sheet provided with
the programmer for a list of the available system components.
The Medtronic Neuromodulation Model 8880CW Clinician Programmer is intended for use with
Medtronic Neuromodulation therapies and devices. The Model 8880T2 Telemetry Head is intended for
use in conjunction with the Model 8880CW Clinician Programmer for communication with Medtronic
Neuromodulation implantable therapy devices. Refer to specific therapy and device guides for complete
information.
Package contents
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®
wireless technology, wireless local area network (WLAN) connection, universal serial bus
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The programmer package contains:
One programmer with software
▪
Three stylus pens
▪
One rechargeable battery
▪
One power supply and cord
▪
Product literature
▪
Note: Some system components, including the telemetry head, are packaged separately from the
programmer.
Device specifications
Electrical and operating characteristics
Table 1. Electrical and operating characteristics for the programmer and system components
Description Specification
Model 8880CW Clinician Programmer
Power source Internally powered by a rechargeable lithium ion battery
Operating type Continuous
Length 255 mm (10 in)
and also powered by mains electricity through a power
supply
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Table 1. Electrical and operating characteristics for the programmer and system components (continued)
Description Specification
Width 43 mm (1.7 in)
Height 255 mm (10 in)
Weight (maximum) 1.5 kg (3.3 lbs)
Screen XGA TFT LCD
LED backlit
1024 x 768 pixels
32 bit color
Size: 264 mm (10.4 in)
Database encryption method AES128
Wireless communication types Bluetooth module integrated circuit # SMWBTM-203B
WLAN module supports 802.11 a/b/g/n
Connections USB port
Docking connection
Model 8880T2 Telemetry Head
Power source Internally powered by 2 AAA alkaline batteries
(nonrechargeable, LR03)
Operating type Continuous
Length 61 mm (2.4 in)
Width 25 mm (1 in)
Height 155 mm (6.1 in)
Weight 255.14 g (0.56 lb)
Communication types/connections Bluetooth module integrated circuit # STA2500D
Proprietary connector
Model 885010 USB System Connector Cable
Length 1.83 m (6 ft)
Rechargeable battery
Type Lithium-ion
3760 mAH 11.1 Vdc
Chemical class 9
UN classification number UN3480
Watt-hour rating 42
Charging time 2.5 hours
Run time (maximum) 3.5 to 4.5 hours (Depends on user settings and number of
cycles.)
Length 112 mm (4.4 in)
Width 14 mm (0.55 in)
Height 113 mm (4.4 in)
Weight 300 g (0.66 lb)
Power supply
Input 100-240 VAC, 47-63 Hz, 1.62-0.72 A
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Table 1. Electrical and operating characteristics for the programmer and system components (continued)
Description Specification
Output 15 V DC, 4.2 A maximum
Length 3 m (approximately 10 ft)
Docking station
Power source Mains electricity through a power supply
Operating type Continuous
Length 264 mm (10.4 in)
Width 49 mm (1.9 in)
Height (with leg pushed in) 282 mm (11.1 in)
Height (cradle only) 241 mm (9.5 in)
Weight 460 g (1 lb)
Connections Ethernet port (if present) supports 10 megabit per second
Video Electronics Standards Association (VESA)/wall or
arm mount of cradle
Battery charger
Power source Mains electricity through a power supply
Operating type Continuous
Input voltage 15 V
Charging method Constant current and voltage
Charging current 2.3 A
Length 157 mm (6.2 in)
Width 55 mm (2.1 in)
Height 35 mm (1.4 in)
Weight 285 g (0.63 lb)
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(Mbps) and 100 Mbps operations
VGA output connector (optional)
USB port
75 mm (2.95 in) x 75 mm (2.95 in)
Storage and operating characteristics
Table 2. Storage and operating characteristics for the programmer and telemetry head
Programmer –20 ºC (–4 °F) to 60 ºC (140 °F) 0 ºC (32 °F) to 40 ºC (104 °F)
Telemetry head –40 °C (–40 °F) to 70 °C (158 °F) 10 ºC (50 °F) to 40 ºC (104 °F)
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Storage temperature Operating temperature
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Declaration of Conformity
Medtronic declares that the Medtronic Neuromodulation Model 8880CW Clinician Programmer,
software, and Model 8880T2 Telemetry Head are in conformity with the essential requirements of
Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC
on Active Implantable Medical Devices.
For additional information, contact the appropriate Medtronic representative listed on the inside back
cover of this manual.
Instructions for use
Component identification
Programmer component identification
The front of the programmer is equipped with a color touchscreen display and light-emitting diode (LED)
indicators (Figure 1 on page 13). See Table 3 on page 12 for a description of the programmer LED
indicators.
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The Power button is on the left side of the programmer.
The bottom of the programmer is equipped with a power jack, USB port, and docking connector
(Figure 2 on page 14).
Note: The USB port on the programmer should only be used to connect a USB flash drive, the USB
system connector cable, or a USB printer cable.
The back of the programmer is equipped with a slot for the stylus, camera with light, slot for the
rechargeable battery, Battery Release button, and speaker (Figure 3 on page 14). Serial number
information is also displayed on the back of the programmer.
Table 3. Programmer LED indicators
LED indicator Behavior Description
Bluetooth capability
Solid blue The capability of the programmer to use Bluetooth wireless technology is
Off The capability of the programmer to use Bluetooth wireless technology is
enabled. For more information see "Managing the programmer system"
on page 40.
disabled. For more information see "Managing the programmer system"
on page 40.
Radio-frequency identification (RFID)
Feature is reserved for future use.
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LED indicator Behavior Description
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Table 3. Programmer LED indicators (continued)
Wireless local area network (WLAN) capability
Solid blue The capability of the programmer to connect to a wireless network is
enabled. For more information see "Managing the programmer system"
on page 40.
Off The capability of the programmer to connect to a wireless network is
disabled. For more information see "Managing the programmer system"
on page 40.
Power/Battery status
Solid green Mains electricity through the power supply is being used, the battery has
sufficient charge, or the battery has been fully charged.
Solid red The battery is low.
Solid orange The battery is charging.
Flashing orange The programmer is in standby mode.
Off The programmer is off.
Power button
LED indicators
Touchscreen
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Figure 1. Programmer (front).
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Docking connector
Power jack USB port
Figure 2. Programmer (bottom).
Stylus
(Connected)
Battery
Stylus slot
Figure 3. Programmer (back).
Speaker
Power button
RFID
(Reserved for future use)
Camera with light
Battery release
button
Telemetry head component identification
The telemetry head is handheld and battery-operated. Communication between the telemetry head and
the programmer can occur wirelessly using Bluetooth technology or wired using the Model 885010 USB
System Connector Cable.
The front of the telemetry head is equipped with power and communication status LED indicators, a
Communicate button, battery compartment, and accessory connector. See Table 5 on page 25 for a
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description of the telemetry head LED indicators. The right side of the telemetry head is equipped with a
Power button. The left side of the telemetry head is equipped with a proprietary connector for the USB
System Connector Cable. See Figure 4.
The back side of the telemetry head displays the device label, which shows where the internal antenna
is located (Figure 5 on page 16). The back of the telemetry head is also equipped with an accessory
connector, which can be used to attach the telemetry head to the docking station for storage. See
"Using the docking station" on page 20 for more information.
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Proprietary connector
Communicate button
LED indicators
Accessory connector
Battery compartment
Figure 4. Telemetry head (front and right sides).
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Power button
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Accessory connector
Internal antenna
Figure 5. Telemetry head (back).
Docking station component identification
The docking station allows the programmer to be docked for charging while providing additional
connections.
The front of the docking station is equipped with a power status LED indicator and cradle for the
programmer that contains docking pins (Figure 6). A solid green LED indicates power is present.
The back of the docking station may be equipped with an Ethernet port with LED indicators, USB port,
video graphics array (VGA) output connector, and power jack (Figure 7 on page 17).
Note: The USB port on the docking station should only be used to connect a USB flash drive, the USB
system connector cable, or a USB printer cable.
The back leg of the docking station is equipped with an accessory connector, which can be used to
attach the telemetry head for storage. See "Using the docking station" on page 20 for more
information.
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Docking pins
Power indicator
Cradle
Figure 6. Docking station (front).
Ethernet port (optional) Power jack
USB port
VGA output connection (optional)
Figure 7. Docking station (back).
Setting up the programmer and docking station
#Caution: If the programmer system components were transported or stored above or below the
specified operating temperature range, allow the items to stabilize at room temperature until they
return to operating temperature. Using the programmer system components within operating
temperature range ensures device functionality.
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wWarning: Do not simultaneously touch the patient and any metal conductive surfaces (eg, battery
contacts) of the programmer system components while the power supply is plugged into mains wall
power. There is a potential danger of electric shock, which may result in damage to the device and
injury to the patient and/or user.
wWarning: To prevent harm to the patient, any person connecting a peripheral device (eg, printer) to
the programmer or docking station is responsible for ensuring that:
the peripheral device is certified according to the IEC 60950 (for data processing equipment) or
▪
the IEC 60601 (for medical equipment) (eg, keep IEC 60950 certified peripheral devices at least
2 meters from the patient; this satisfies the requirement of IEC 60601-1).
an isolation transformer (ie, component included in the power supply that comes with the
▪
peripheral device) is used to power the peripheral device if the device will be used in the vicinity
of a patient.
the system formed by connecting the peripheral device to the programmer or docking station
▪
meets the requirement of IEC 60601-1 3
electrical systems.
If there is doubt about the IEC certification of peripheral devices, consult the peripheral device
manufacturer.
1
rd
edition clause 16, safety requirement for medical
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The following equipment may be used in the vicinity of the patient (ie, 2 meters):
Clinician programmer
▪
Telemetry head
▪
USB system connector cable
▪
Rechargeable battery
▪
Power supply and cord
▪
Docking station
▪
Printer USB cable
▪
The following equipment may not be used in the vicinity of the patient:
Battery charger
▪
2
Inserting the rechargeable battery
The first time the programmer is used, the battery should be installed and mains electricity through the
power supply should be connected for at least 4 hours to charge the battery. For instructions on
inserting the battery, see "Installing or removing the programmer battery" on page 52.
1
An isolation transformer is a transformer that is used to transfer electrical power from an electrical outlet to a device while isolating the powered device
from the power source.
2
An isolation transformer must be used to power the printer.
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