Medtronic 2696 Users Manual
220875_fcv.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
implant_R02
MODEL 2696 INCHECK
Patient Assistant
Physician’s manual
TM
/
Caution: Investigational device.
Limited by federal law (USA) to
investigational use.
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
220875_fcv.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
Explanation of symbols on the packaging and literature
w
Attention: See accompanying documentation
implant_R02
y
n
i
c
only
Type BF equipment
Battery polarity as shown
Serial number
Storage temperature
For United States audiences only
Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician
Medical device
Telemetry (communication signal) status light lit
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
220875_fcv.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Explanation of symbols on the device
AF?
Query button (Press to request implanted device
to check for AF)
OK symbol (AF is not present)
AF symbol (AF is present)
Therapy button (Press to instruct implanted
device to deliver atrial cardioversion therapy)
Record Symptoms button (Press to instruct the
implanted device to record cardiac activity)
Record symbol (recorded cardiac activity)
Medtronic Confidential
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y
Type BF equipment
Low Batteries symbol
Battery polarity as shown
w
c
only
220875001 Rev A Printing instructions: doc#163256;
Attention: See accompanying documents
For United States audiences only
Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician
refer to “Implant man.” row in the
applicable table.
220875_fcv.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
implant_R02
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
220875TOC.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
Table of contents
1 Description and intended use 7
2 Contents of the Patient Assistant box 8
2.1 Inspection 9
2.2 Installation and setup 9
3 Checking the patient’s heart rhythm 9
3.1 How to check the patient’s heart rhythm 9
3.2 Response when a query is requested 12
4 Requesting atrial cardioversion therapy 13
4.1 How to request cardioversion therapy 13
4.2 Response when therapy is requested 15
4.3 When the Therapy button will appear 16
4.4 If therapy is not delivered 16
5 Recording cardiac information 17
5.1 How to record cardiac information 17
5.2 Response when record symptoms is requested 18
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6 Battery information 19
6.1 Replacement batteries 19
6.2 When to install batteries 19
6.3 How to install new batteries 20
7 Maintenance 21
7.1 Care and handling 21
7.2 Cleaning 22
7.3 Service 22
5
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
220875TOC.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
7.4 Disposal 22
8 Troubleshooting 23
9 Specifications 25
9.1 Device specifications 25
9.2 Safety and compatibility standards 26
Medtronic Confidential
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6
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
220875_CH.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
implant_R02
1 Description and intended use
The Model 2696 InCheckTM Patient Assistant shown on Figure 1
is a hand-held, battery powered, radio frequency communication
device. The Patient Assistant communicates with certain
implantable Medtronic cardiac devices that provide patientactivated features. See the manual for the implanted device for
compatibility information.
The Patient Assistant can send simple programming commands
to the implanted device, and receive and display information about
the patient’s cardiac rhythm.
Telemetry status
light
AF?
Query button, press to check
for AT/AF episode detection
Record Symptoms
button, press to
record cardiac event
data
Symbol and button
display area
Wrist strap
connector
Figure 1. Patient Assistant (Not actual size)
Intended use – The Patient Assistant is intended for
unsupervised patient use away from a hospital or clinic. The
Patient Assistant activates one or more of the patient
management features in the implanted device, depending on the
implanted device model and the programmed features:
■
To verify whether the implanted device has detected a
suspected atrial arrhythmia.
7
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
220875_CH.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
■
To initiate recording of cardiac event data in the implanted
Medtronic Confidential
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device memory.
■
To request atrial cardioversion therapy, if supported by the
implanted device and patient activated therapy has been
previously programmed by the physician. Therapy is allowed
when the implanted device is currently detecting an atrial
arrhythmia episode and all conditions for delivering therapy
have been met.
Note:
■
Ventricular arrhythmia therapy cannot be patient activated
using the Patient Assistant.
2 Contents of the Patient Assistant box
The following should be found in the Patient Assistant box:
■
One Patient Assistant
■
Two N-size 1.5 V batteries
■
One carrying case
■
One wrist strap
■
One physician’s manual
■
One quick reference guide/patient ID card
■
Two warranty cards (USA and outside USA)
■
One patient manual
The Patient manual includes blank lines in sections 3 and 7 for the
patient’s prescription information. This information includes when
to use the Patient Assistant, which button to press and what
actions to take for each reply.
8
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
220875_CH.fm 3/13/03 10:11 am
UC200203829 EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
implant_R02
The Quick Reference Guide/Patient ID Card provides a more
portable version of the basic instructions for using the Patient
Assistant. Blank lines are provided for name and telephone
number information.
2.1 Inspection
Inspect the Patient Assistant for damage or defects. If the case is
cracked or other defects are discovered, return the Patient
Assistant to Medtronic.
2.2 Installation and setup
Place new batteries in the Patient Assistant (see page 20).
Press either front panel button to test the Patient Assistant. The
telemetry status light flashes green for about 15 seconds, and the
Patient Assistant gives a short beep. This confirms that the
batteries can operate correctly.
Provide the necessary information in the Patient manual and
Quick Reference Guide/Patient ID Card.
Refer to the implantable device reference manual for information
about its features that apply to the Patient Assistant.
3 Checking the patient’s heart rhythm
3.1 How to check the patient’s heart rhythm
Note: The Patient Assistant may not communicate at full
strength outside the range of 8 °C (16 °F) to 43 °C (110 °F).
1. Press the Query button. Verify that the telemetry status light
flashes green, and the Patient Assistant gives a short beep. If
these responses do not occur, see page 23.
9
220875001 Rev A Printing instructions: doc#163256;
refer to “Implant man.” row in the
applicable table.
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