Boston Scientific CRM293604 2936 User Manual physician manual
Boston Scientific Corporation 2936 physician manual
User Manual
Operator’s Manual
Heart Failure PARTNER™
Model 2936
Heart Failure Diagnostic
Retrieval System
The following symbol is a trademark of Guidant Corporation:
Interrogation symbol
Table of Contents (English) 1
Table of Contents (English)
Product Description 3
Intended Use 4
Contraindications 4
Warnings and Precautions 4
Federal Communications Commission (FCC) 5
Package Contents 5
Contacting Guidant 5
Inspection and Setup 6
How to Interrogate an Implanted Heart Failure Device 6
How to Print Reports 8
Qualified Printers 10
How to Delete Diagnostic Records 10
HF PARTNER Device Functions 11
Language selection 11
Speaker control 12
2Table of Contents (English)
Voice Messages 12
Reminder Label 15
How to Care for the HF PARTNER Device 16
Cleaning 17
Operating Temperatures 17
Battery Replacement 17
Pairing the HF PARTNER Device with a Compatible Printer 19
Troubleshooting 20
Specifications 23
Explanation of Product Markings 24
Package Content Symbols 25
Product Description 3
Product Description
The Heart Failure (HF) PARTNER™ system consists of a Model 2936 HF PARTNER
device, a printer adapter, and a printer. The HF PARTNER device is a handheld,
battery-powered product used to communicate with an implanted device. It provides
easy access to patient and device diagnostic data by interrogating the patient’s
implanted heart failure device and sending the data to a printer through the printer
adapter.
Figure 1. Model 2936 HF PARTNER device with lighted symbols and buttons
shown.
Press blue PRINT
button to request
reports
Press green INTERROGATE button
to interrogate implanted device
Interrogation symbol
Record Transmission
symbol
Fault Detected
symbol
Delete symbol
4Intended Use
Intended Use
The HF PARTNER device is intended for use in a clinical setting. Physicians and
clinicians can use the HF PARTNER device to collect device and patient diagnostic
data from an implanted heart failure device and send the data to a paired printer only.
The HF PARTNER device has no programming abilities, or ability to provide therapy
of any kind.
The HF PARTNER device can be used with any compatible Guidant cardiac
resynchronization therapy (CRT) device except CONTAK CD. To verify compatibility,
please call Guidant Technical Services. See “Contacting Guidant” on page 5.
Contraindications
There are no contraindications for the HF PARTNER device.
Warnings and Precautions
• Use of the HF PARTNER device is for medical professionals only and should be
used within a clinical setting.
• Only a clinician/medical professional can make diagnostic or interpretive
decisions regarding the health of a patient based on the data presented or
acquired by the HF PARTNER device.
Figure 2. Reminder instructions on back of the HF PARTNER device.
Federal Communications Commission (FCC) 5
• Only Guidant-recommended accessories, such as the Bluetooth enabled printer
and Bluetooth accessory should be used with the HF PARTNER device.
• The HF PARTNER device is not intended to sound any physiological alarms.
Federal Communications Commission (FCC)
This device complies with Title 47, Part 15 of the FCC 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 of the device.
CAUTION: Changes or modifications not expressly approved by Guidant could void
the user’s authority to operate the equipment.
Package Contents
The following items are included in the HF PARTNER device package:
• Model 2936 HF PARTNER device with batteries installed
• Operator’s manual
• Warranty
• Blank notebook
• IFU poster
• Guidant brand label
• Declaration letter
Contacting Guidant
Use the following methods to contact Guidant Technical Services:
• US 1.800.CARDIAC (1.800.227.3422)
• European +32 2 416 93 57 or eurtechservice@guidant.com
6Inspection and Setup
Inspection and Setup
Inspect the HF PARTNER device, printer and printer adapter package contents for
any signs of damage or defects. If any defect or damage is visible, contact your
Guidant sales representative or call Guidant Technical Services. See “Contacting
Guidant” on page 5.
The following steps explain how to setup your HF PARTNER system:
1. Connect the USB cable to the printer adapter and the USB port on the printer.
2. Attach the printer adapter power cord to the printer adapter and plug the printer
adapter power cord into a standard wall outlet.
3. Attach the printer power cord to the printer power input and plug the other end of
the power cord into a standard wall outlet.
4. Press the printer ON button.
Press the green INTERROGATE button to ensure that the HF PARTNER device
is operational; the symbols on the front will light up and a voice message will be
heard.
How to Interrogate an Implanted Heart Failure
Device
Use the following steps to interrogate an implanted heart failure device using the
HF PARTNER device:
1. Press the green INTERROGATE button . The “Interrogation requested” voice
message will be heard, followed by “Locate implanted device”.
2. Move the HF PARTNER device over the patient’s implanted device (Figure 3).
The visual indicators on the front of the HF PARTNER device will light in
consecutive sequence until the communication with the implanted device is
established. During interrogation, the Interrogation light will blink while data
is transmitting. At the end of a successful interrogation, the HF PARTNER device
How to Interrogate an Implanted Heart Failure Device 7
will emit the “Interrogation complete” message. The Interrogation light will
stay on for five seconds after successful interrogation.
NOTES:
• You have about 10 seconds from the time you press a button until you locate the
implanted device. If the HF PARTNER device is unable to locate the device, the
voice command “Locate implanted device” will be repeated. Position the top half
of the HF PARTNER device over the implanted device and move the
HF PARTNER device slowly. If the interrogation is unsuccessful, hold the
HF PARTNER device over the patient's implanted devices with the button and
lights AWAY from you.
• If the interrogation was unsuccessful, the HF PARTNER device will notify you by
communicating “Interrogation unsuccessful, please interrogate again”. Repeat
the interrogation process until you receive the “Interrogation complete” message.
• If you hear the “Locate implanted device” message (NOT followed by the
“Interrogation unsuccessful, please interrogate again” message), you have
requested the interrogation of an incompatible device. Ensure that you have a
compatible Guidant device.
• If communication is lost during interrogation, the visual indicators on the front of
the HF PARTNER device will light in consecutive sequence. Reposition the
Figure 3. Hold the HF PARTNER device over the patient’s implanted device, with
buttons and lights toward you.
8How to Print Reports
HF PARTNER device over the patient’s implanted device to resume
communication.
• If the implanted device exhibited a lead or heart failure device fault, including
when the implanted device’s battery is due for replacement, the fault detected
light will stay on for five seconds after completion of the interrogation.
Contact the physician who follows this patient’s implanted device.
How to Print Reports
The HF PARTNER device prints a Diagnostic report that provides patient diagnostic
data collected by the device. You may choose to print the last record or all records in
the device memory.
Use the following steps to print desired reports:
1. Place the HF PARTNER device near the printer adapter and press the appropri-
ate button sequence (Figure 4). To print the last record, press the blue PRINT
button once. To print all records press the blue PRINT button twice. All
lights will flash sequentially while the HF PARTNER device is looking for a printer.
2. When a printer is located, you will hear the “Connecting” message. The record
transmission light will blink while data is transmitting. Continue to keep the
HF PARTNER device near the printer adapter. Upon successful data transfer you
will hear the “Records transmitted” message and the report will print.
3. After printing is complete, the record transmission light will stay on for
five seconds.
Diagnostic Report
Last record requested
All records requested
How to Print Reports 9
The Diagnostic report will include the following information:
• Patient Data
• Events Summary
• Counters and Histograms
• Atrial Arrhythmia Counters
• Battery Status
• Device Settings
• Trends (includes Activity Log, Heart Rate [HR] trends, Heart Rate Variability
[HRV], Autonomic Balance Monitor [ABM], and Standard Deviation of Averaged
Normal R to R intervals [SDANN])
If four or more events have occurred since the last device physician follow-up with a
programmer, a list of up to 50 of these events will appear at the end of the report.
This report will also document whether a problem with the implanted device system
has been detected. The following messages may be seen on the report:
Figure 4. Hold the HF PARTNER device near the printer adapter.
Printer adapter Printer
10 Qualified Printers
• Implanted device fault
• Lead fault
• Battery fault
If you see any of these messages, contact the physician who follows this patient’s
implanted device.
NOTES:
• The availability of each report feature is dependent upon the device interrogated.
Refer to the heart failure device’s system guide for information about available
features or call Guidant Technical Services. See “Contacting Guidant” on page 5.
• If the HF PARTNER device is unable to interpret the information from the
implanted device, the record will show ???. Interrogate the implanted device
using a Guidant programmer to receive more information. See “Contacting
Guidant” on page 5.
• The HF PARTNER device can store up to 10 records. When the HF PARTNER
device memory is full, the oldest record will be deleted to allow the newest record
to be stored. The delete light will stay on for three seconds.
Qualified Printers
The HF PARTNER system will be provided with a tested and qualified printer. To
verify compatibility of other printers, please call Guidant Technical Services. See
“Contacting Guidant” on page 5.
How to Delete Diagnostic Records
Use the following steps to delete all of the diagnostic records stored in the
HF PARTNER device’s memory:
HF PARTNER Device Functions 11
1. Press the blue PRINT button and the green INTERROGATE button
within three seconds. You will hear the “Confirm request to clear all records”
message. The “Delete” light will flash.
2. Press the blue PRINT button within 10 seconds of the voice message to
confirm that you want to delete the records. Otherwise, the HF PARTNER device
will time-out and no records will be deleted. The “Delete” light will stay on for
five seconds to indicate the records have been deleted.
NOTE: When 10 records are stored in the HF PARTNER device, the device will
automatically delete the oldest record.
HF PARTNER Device Functions
NOTE: When using the HF PARTNER device, the button sequences for all
commands must be pressed within three seconds.
Language selection
The HF PARTNER device allows a choice of English, French, German, Italian,
Portuguese and Spanish languages for the voice messages and printed reports.
English is the default language. Follow the steps below to select the desired
language:
1. Press the green INTERROGATE button twice and the blue PRINT button
once within three seconds. This will put the HF PARTNER device into Con-
figuration Mode. You will hear a tone from the HF PARTNER device.
2. Press the green INTERROGATE button once to access the Language List.
The HF PARTNER device will verbally cycle through the list of available
languages.
3. Press the blue PRINT button when the desired language is identified. You
will hear a tone from the HF PARTNER device indicating the selected language
has been implemented.
12 Voice Messages
Subsequent communication will remain in that language until it is changed by
accessing the Configuration Mode. All diagnostic reports will print in the selected
language.
Speaker control
The speaker of your HF PARTNER device can be turned On or Off by pressing the
green INTERROGATE button three times within a three second period of time.
When the speaker is turned Off, the “Speaker Off” message will be heard. A tone will
be heard when the speaker is turned back On.
Voice Messages
Table 1 lists the voice messages that you may hear and the associated action. The
Speaker Control must be On to hear these messages. The voice message is shown
in bold text.
Table 1. Voice Messages
Interrogation Requested
Action: You pressed the green INTERROGATE button .
Interrogation completed
Action: The interrogation has been successfully completed.
Locate Implanted Device (followed by the message interrogation unsuc-
cessful, please interrogate again)
Action: You pressed the green INTERROGATE button . You should move the
HF PARTNER device over the patient’s implanted device to initiate
communication between the HF PARTNER device and heart failure device.
Locate implanted device (NOT followed by the message interrogation
unsuccessful, please interrogate again)
Action: You requested the interrogation of an unsupported heart failure device.
Voice Messages 13
Interrogation unsuccessful, please interrogate again
Action: The diagnostic interrogation request was unsuccessful. Interrogate the
device again.
Connecting
Action: You requested that a diagnostic report be sent to the enabled printer and
pointed the HF PARTNER device toward the printer adapter. Connection with the
printer adapter can take up to 30 seconds.This message is repeated up to two
times while attempting to connect with the printer system.
Last record requested
Action: You requested to print the most recent record using the "Last record
requested" command. Place the HF PARTNER device near the printer adapter to
print the record.
All records requested
Action: You requested to print all saved records by using the “Print all records”
command. Place the HF PARTNER device near the printer adapter to print all of
the saved records.
Records transmitted
Action: You requested to print one or more records, which were successfully
transmitted to the printer.
Records not transmitted
Action: The requested print command was not completed successfully. Repeat
the command to print the desired record.
No record to transmit
Action: You requested to print a record, but no records are stored in the
HF PARTNER device’s memory.
Table 1. Voice Messages (Continued)
14 Voice Messages
Confirm request to clear all records
Action: You pressed the blue PRINT button and green INTERROGATE
button ; the HF PARTNER device will ask you to confirm that you want to
delete all records. Press the blue PRINT button within 10 seconds of this
voice message to confirm that you want to delete all records.
Battery Low
Action: You should replace the HF PARTNER device batteries. This voice
message will be heard with the speaker control turned On or Off.
Speaker Off
Action: You turned the speaker Off.
PARTNER Fault Detected
Action: The HF PARTNER device failed a self-test due to a reason other than
depleted batteries. A system status report can be printed from a qualified printer.
You should call Guidant Technical Services to report the problem. See
“Contacting Guidant” on page 5.
Language list
Action: You pressed the green INTERROGATE button once while the
HF PARTNER device was in Configuration Mode. This accessed the list of
available languages. Now you can select your preferred language by pressing the
blue PRINT button . See “Language selection” on page 11.
Printer paper error
Action: The printer is out of paper or there is a paper jam. If it is out of paper,
reload paper. If the paper is jammed, clear the paper path of any obstruction.
Printer toner error
Action: The printer is out of toner; replace the toner cartridge. This message will
also be heard when the wrong toner cartridge has been inserted.
Table 1. Voice Messages (Continued)
Reminder Label 15
Table 2 provides a summary of HF PARTNER device commands and their associated
button sequences.
Reminder Label
Before you hold the HF PARTNER device over your patient’s implanted device, you
can use the label on the back of the HF PARTNER device to remind you which
buttons to push (Figure 5). Read the instructions in this book for full details.
Printer status error
Action: There are several errors that may cause this message: the printer top
may be open, the printer carriage may be jammed, or the printer may be busy.
Table 2. HF PARTNER Device Commands
Interrogate Implanted Device
Print Last record
Print All records
Print Status Report page
Volume On/Off
Clear All records
Language selection
Printer Pairing
Table 1. Voice Messages (Continued)
16 How to Care for the HF PARTNER Device
How to Care for the HF PARTNER Device
The HF PARTNER device is designed to be handled on a daily basis. However, the
following precautions should be taken to avoid damaging or breaking the unit.
CAUTIONS:
• Do not drop or mishandle the unit in a manner that would cause damage.
• Avoid getting liquid on the unit other than cleaning it with a moistened cloth.
• Do not submerge the unit in liquid.
• Do not use abrasive cloth or solvents to clean the unit.
• Do not open the unit except to change the battery.
NOTE: In case of accidental submergence in liquid, remove the batteries, dry the
HF PARTNER device with a soft cloth, then allow air to circulate around it for a
minimum of 24 hours. For example, place it in front of a fan. Then install new
batteries. If the HF PARTNER device does not function properly, call Guidant
Technical Services. See “Contacting Guidant” on page 5.
Figure 5. Reminder label on the back of the HF PARTNER device.
Multiple buttons means to push the
buttons in the sequence shown and
wait for requested information.
One button means to push the button
just once and wait for the requested
information.
The buttons in the parenthesis ( )means to
press those buttons first.
Battery Replacement 17
Cleaning
When necessary, clean the HF PARTNER device with a soft cloth moistened in water
or mild detergent. Do not allow moisture to accumulate on or around the labels,
speaker holes, or the case seam.
Operating Temperatures
The HF PARTNER device will operate with best results at temperatures between 10°
C and 50° C (50° F and 122° F). Keep the HF PARTNER device within this range of
temperatures if possible. Allow it to warm up if it has been in colder conditions. Avoid
leaving it in direct sunlight or in unventilated enclosed spaces.
Battery Replacement
The HF PARTNER device is shipped with the required two 3.0 volt CR2 batteries
installed.
Replace the batteries when:
• You receive a Battery Low audible message.
• The symbols don’t light up when you press the green INTERROGATE button
or blue PRINT button .
CAUTIONS:
• When the unit is open while changing the battery, do not attempt to disassemble
any other part. The unit may not function properly.
• Do not remove the batteries within 5 minutes of performing an operation. Failure
to adhere to this recommendation could place the HF PARTNER device in an
unusable state.
1. Flip up the quarter turn fastener ring.
2. Turn the fastener one quarter turn counter-clockwise.
18 Battery Replacement
3. Slide the rubber case bottom off.
4. Remove the batteries from the HF PARTNER device.
Figure 6. Turning the fastener.
Figure 7. Removing the bottom case.
Pairing the HF PARTNER Device with a Compatible Printer 19
5. Insert the new batteries.
6. Replace the rubber case bottom on the HF PARTNER device.
7. Properly dispose of the old batteries.
8. Press the green INTERROGATE button to ensure that the HF PARTNER
device is functioning properly.
Pairing the HF PARTNER Device with a Compatible
Printer
A printer must be paired to the HF PARTNER device to transmit a diagnostic report
securely. Reports can only be printed to a paired printer. The HF PARTNER system is
paired before it is shipped; however, follow these steps to set up the printer should
you get a new system component:
1. Go into the configuration mode by pressing the green INTERROGATE button
twice and the blue PRINT button once within three seconds.
Figure 8. Removing the batteries from the HF PARTNER device.
20 Troubleshooting
2. Wait for the configuration mode tone to sound, then press the blue PRINT button
.
3. When a printer has been located, a double tone will be heard and a system
status page will be printed.
4. Press the blue PRINT button within 60 seconds of the double tone to
confirm.
5. The double tone will then be heard again.
6. If the double tone is heard but the status page is not being printed, or is being
printed from the wrong printer, press the green INTERROGATE button to
start the pairing process again.
7. If the double tone is heard but the user does not press any button within
60 seconds, the pairing will fail.
8. If pairing failed for any reason, a low-pitched double tone will be heard.
NOTE: Before beginning the pairing process, verify the printer power is On and there
are no printer errors (e.g., paper jams, no paper, etc.).
Troubleshooting
Problem Possible Solution
Symbols do not light up. Change the batteries.
Voice messages sound crackly. Change the batteries.
Symbols flash randomly when a
button is pressed.
Change the batteries.
New batteries have been inserted, but
button presses do not turn the
HF PARTNER device On.
Check if the batteries are inserted properly
(see “Battery Replacement” on page 17). If it
still doesn’t turn On, call Guidant Technical
Services. See “Contacting Guidant” on
page 5.
HF PARTNER device buttons were
pressed but no function was
performed
The HF PARTNER device may be
completing the previous function. Wait
three seconds and press the desired
command sequence again.
Troubleshooting 21
You replaced the batteries but still
received the “Battery low” message.
If you just printed diagnostic reports, let the
HF PARTNER system recharge for 30 to 60
minutes. If you still hear this message after
letting the batteries recharge, call Guidant
Technical Services. See “Contacting
Guidant” on page 5.
The HF PARTNER device cannot
communicate with an implanted
device.
• Move the HF PARTNER device around
gently until communication is made with
the implanted device (see Figure 3 on
page 7), or try repositioning the
HF PARTNER device (such as turning it
over).
• Verify the implanted device is a
compatible Guidant device.
Voice messages cannot be heard. Turn the speaker On using the steps on
page 12.
Voice messages are no longer in the
language of your choice.
The selected language may have been
changed. Reset the HF PARTNER device to
the language of your choice. See “Language
selection” on page 11.
The report won’t print • Change the distance between the
HF PARTNER device and printer.
Optimal performance is 3-15 feet.
• Check that the printer adapter is turned
On (look for flashing lights when the
transmission occurs).
• Check the printer for warning lights.
• Pair with printer again.
System status report will not print
properly during printer pairing
If a new printer is being used, the printing of
the test page may interfere with the pairing.
Clear the printer and start the pairing
process again.
Problem Possible Solution
22 Troubleshooting
The printed reports appear
incomplete (only black lines or only
colored areas printed)
Check the printer cartridges and replace if
empty.
The printed reports appear faded Replace the printer’s toner cartridges.
The printer won’t turn On Check the power cord and make sure it is
plugged in to a standard wall outlet and
securely attached to the printer.
The printer adapter won’t turn On Check the power cord and make sure it is
plugged in to a standard wall outlet and
securely attached to the printer adapter.
Can’t pair the HF PARTNER device
with printer
Change the distance between the
HF PARTNER device and printer. Optimal
performance is 3-15 feet. Verify the printer
has no errors.
Printer error message while pairing;
printer did not have error and was not
paired to
A printer in the area was found with an error.
Repeat the pairing process again to search
for the printer you would like to use.
Problem Possible Solution
Specifications 23
Specifications
Plastic Box Dimensions (inches): 6.75 x 2 x 6.63
Device Dimensions (inches): 4.7 x 2.8 x 1.1
Power Source: Two 3.0 volt CR2 batteries
Battery Longevity: Approximately 80 uses (one use includes one interrogation
and one printed report)
Operating Temperature: 10° C to 50° C (50° F to 122° F)
Storage Temperature: -20° C to 55° C (-4° F to 131° F)
Relative Humidity: Up to 85%, noncondensing
Mode of Operation: Capable of continuous use per UL 60601-1:2003 Medical
Electrical Equipment, Part 1: General Requirements for Safety
Classification with Respect to Electric Shock: Internally powered
Protection from Electric Shock (IEC 601-1:2002): Type BF
Protection Against Ingress of Liquids: Ordinary equipment
Safety and EMC Compatibility Standards: IEC 68 Magnetic Materials, IEC
60601-1-2:2001/EN60601-1-2:2001 Medical Electrical Equipment covering
safety and EMC, EN 300-330-2 V1.1.1 Radio Equipment and systems, EN 300-
328 V1.4.1 Data Transmission Equipment in 2.4 GHz ISM band and EN 301-489-
01 V1.3.1 Electromagnetic compatibility and Radio matters
24 Explanation of Product Markings
Explanation of Product Markings
Refer to the Instructions For Use
SN Serial Number
Conformity with the applicable EU Directives; AIMD 90/385/EEC,
RTTE Dir 99/5/EC, and EMC Directive 899/335/EEC, with
involvement of Notified Body No. 0086.
(Medical Electrical Equipment)
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL
60601-1/CAN/CSA C22.2 NO. 601.1 9P96
Conformity with applicable portions of UL60601-1:2002 and UL 94
Non-ionizing electromagnetic radiation (UL 60601-1:2002)
Type BF Equipment
DANGEROUS VOLTAGE
Conformity with the applicable portions of Directive 2002/96/EC.
FCC #/
Canadian
FCC ID: ESCCRM293604
IC: 4794A-CRM29364
Bluetooth
Qualification
Body (BQB)
Bluetooth Qualification Certificate
Contains radio module FCC ID: POOWML-C09XX
!
Package Content Symbols 25
Package Content Symbols
Package contents
HF PARTNER device with batteries installed
Refer to the Instructions For Use
Radio and Telecommunications Terminal
Equipment (RTTE). Indicates that device does
not operate in a harmonized bandwidth.
+
!
26 Package Content Symbols
Guidant Corporation
4100 Hamline Avenue North
St. Paul, MN 55112-5798 USA
Tel: 651.582.4000 Fax: 651.582.4166
Medical Professionals: 1.800.CARDIAC (227.3422) Toll Free
Patients and Families: 1.866.GUIDANT (484.3268) Toll Free
www.guidant.com
© 2005 Guidant Corporation
All rights reserved. 357182-003A US 2/05
*357182-003*