Operating Instructions

VisionTM 5L Digital Holter Recorder

Document Number: 010-1646-00

Revision: C
 Caution: U.S. Federal law restricts this device to sale by or on the
order of a physician.

Copyright © 2004 Quinton Cardiology, Inc.

All rights reserved.
Authorized Representative
Manufactured for per MDD 93/42/EEC
Quinton Cardiology, Inc.
MDSS
3303 Monte Villa Parkway
Burckhardtstrasse 1
Bothell, Washington 98021-8969
D-30163 Hannover, Germany
Customer Service: (800) 426-0337 or (425) 402-2000
Technical Support: (800) 333-7770 or (608) 764-1919
www.quinton.com
 Table of Contents
Overview ..........................................................................................................1
Description ................................................................................................ 1
Indications for Use .................................................................................... 1
Precautions ............................................................................................... 3
Electrode Application ................................................................................ 4
Operation .........................................................................................................5
Initialize the Flashcard .............................................................................. 5
How to Record .......................................................................................... 5
Recording Display..................................................................................... 7

Patient Event Marker ................................................................................ 7

Early Out and Real Time ECG Display..................................................... 7

Session Complete..................................................................................... 7

Analyzing the ECG Data ........................................................................... 7

Service & Maintenance ..................................................................................8

Maintenance ............................................................................................. 8
Cleaning .................................................................................................... 8

Service ...................................................................................................... 8
Troubleshooting ........................................................................................ 9
Service Items & Accessories .................................................................. 10
Specifications............................................................................................... 11
Electrode Placement ................................................................................... 12
3 Channel (5 lead) Electrode Placement ................................................ 12
3 Channel (7 lead) Electrode Placement ................................................ 13
 Vision 5L Holter Recorder

Overview

Description
The Vision 5L Holter recorder is a battery operated solid
state recorder designed for 24 to 48 hour continuous
recording of ambulatory ECG data and the ability to
detect and record pacemaker pulses in accordance with
appropriate AAMI pacer detection criteria.

The Vision 5L is an AAMI Type I device, which is part of

a conventional AECG monitoring system where the
ECG is recorded on a Compact Flash memory card
installed in the Vision 5L. After the recording is
complete, the Flash memory card is removed and
placed in a Card Reader connected to the Vision Series
Holter Analysis system. Follow the instructions
provided with your Vision Series system to down load
and analyze the recorded ECG data. The Vision 5L is
compatible with Windows 98SE or higher and only
computers complying with EN60950 should be used.

Indications for Use

The Vision 5L Holter recorder is intended for patients
requiring ambulatory (Holter) monitoring from 1 to 48
hours. Such monitoring is most frequently used for the
indications below:
1. Evaluation of symptoms suggesting arrhythmia or
myocardial ischemia.
2. Evaluation of ECG documenting therapeutic
interventions in individual patients or groups of
patients.
3. Evaluation of patients for ST segment changes.
4. Evaluation of a patient's response after resuming
occupational or recreational activities (e.g., after
M.I. or cardiac surgery.)
5. Clinical and epidemiological research studies.
6. Evaluation of patients with pacemakers.
7. Reporting of time and frequency domain heart rate
variability.
8. Reporting of RR Interval.

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 Vision 5L Holter Recorder

Recorder Components

Patient Cable
LCD Display

Enter
Left Right Up Down Button

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 Vision 5L Holter Recorder

Equipment Symbols

Symbol Description
Type B equipment.

Consult manual.
Complies with the Medical Device
0086 Directive of the European Union.
Year of Manufacture

SN Serial Number
REF Catalog/reorder number

Precautions
• Patient leads must be removed from electrodes
before defibrillation.
• When using Pacer Detect, the physician should be
aware that false positive and false negative pacer
detects may occur.
False positives - may result from poor electrode
hook-up or high noise conditions.
False negatives - may occur with bipolar pacers
due to a weak pacer pulse signal at the patient's
skin surface.
• When reviewing ECG data the presence of
pacemaker signals in the ECG trace should not be
considered true representations of the actual
pacemaker stimulus amplitude.
• Observe local laws for disposal of alkaline batteries.
• Do not leave the batteries in the recorder when it is
not in use. Damage from corrosion could result.
• For the best recording results, the patient should be
instructed to avoid close proximity to heavy
electrical equipment or other sources of
electromagnetic interference such as electric
blankets, heating pads etc.

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 Vision 5L Holter Recorder

Electrode Application
• It is recommended that trained medical personnel
handle the application of electrodes.
• Use only electrodes designed for longer term Holter
monitoring.
• Proper preparation of the patient's skin is absolutely
essential for obtaining a quality ECG recording.
Refer to your electrode provider for instructions on
skin preparation techniques.
• Apply electrodes per Electrode Placement diagrams
on page 12 in this manual, or as instructed by the
physician.

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 Vision 5L Holter Recorder

Operation

Initialize the Flashcard

Refer to the Operating Instructions of your Vision
Series system for the initialization procedure.

NOTE: The Vision 5L Holter Recorder is only

compatible with the compact flash card provided,
part number 010-1640-00. The compact flash card is
exclusively for use with the Vision 5L Holter
Recorder, and is not compatible with other Holter
recorders.

CAUTION: Flashcard must be initialized prior to

recording. Otherwise, ECG data from previous
recording is retained.

How to Record
1. Install initialized Flashcard observing correct
insertion direction and method.

It is recommended that the Flashcard be

installed first before installing the battery.
2. Install fresh AA alkaline battery in the Vision 5L.
Be sure to observe the correct battery polarity.
3. Hook up the patient to the device via the patient
cable.

CAUTION: Insert the patient cable in the orientation

as shown in the picture on page 2. The patient cable
will require a very firm squeeze on the locking clip
of the cable plug in order to install or remove it from
the Vision 5L. However, it only needs to be removed
in the event of damage.

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 Vision 5L Holter Recorder

To turn on the recorder push any one of the keypad

buttons. A splash screen will be displayed for a couple
seconds, then the trace screen will be displayed.

The device will not turn on unless a cable is

plugged in.

4. Push the "◄" and "►" keypad buttons to change

the active screen.
5. To input Patient ID choose “Input Patient ID” from
the proper screen. Scroll Numerical line for Patient
ID using ◄, ►, ▲, and ▼ buttons. “ENTER” button
selects each entry of Patient ID.
6. It is recommended that, after the patient hook
up is complete, the device be inserted in the
Vision 5L pouch to be worn by the patient either
on the belt or with the shoulder strap.
Screen Description
Trace Displays the signal trace in real time, pacer
pulse marks | if selected. There is one screen
for each ECG channel.
• The gain setting is the same for all channels.
• Pacer pulse marks | are displayed below the trace
to indicate each pacer pulse detection.
Settings For setting the record time, user language,
LCD contrast. To change settings, press the
“ENTER” button for set mode. To change
fields, push the ▲ and ▼ buttons. To change
values push the ◄ and ► buttons. Push
“ENTER” again to save and exit.
• The default for pacer detect is OFF. It must be
turned ON for each procedure in which it will be
used.
Date/Time For setting the date and clock. To set the clock,
press “ENTER” for set mode. To change fields,
push the ▲ and ▼ buttons. To change values
push the ◄ and ► buttons. Push “ENTER”
again to save and exit.
About Unit information and Copyright notice
Start After configuring or reviewing all the settings,
select the start screen and push the “ENTER”
button. This will start the recording.

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 Vision 5L Holter Recorder

Recording Display
The Vision 5L displays the current time and the
remaining recording time.

Patient Event Marker

To register an event, push the “ENTER” button.

Early Out and Real Time ECG Display

Hold the◄ arrow button and the “ENTER” button
simultaneously to access the menus for Early Out and
Real Time Display. The Early-Out feature allows a
trained individual to stop a recording before the
selected recording time has elapsed. When viewing the
Real Time Display, the user can return to the recording
screen manually, or the Vision 5L will automatically
return after five minutes have elapsed. Real Time mode
does not interrupt recording.

Caution: Do not remove Flashcard or battery until

session is complete or Early Out procedure is
finished.

Session Complete
Remove the Compact Flash memory card, disconnect
the patient leads from the electrodes, and dispose of
the electrodes. The patient cable connector can remain
connected to the Vision 5L for the next procedure.
Remove and properly dispose of the alkaline battery
according to local laws.

Analyzing the ECG Data

Insert the Compact Flash memory card into the Flash
card reader of the Vision Series system on which the
ECG analysis is to be performed.

Once the data transfer is complete, the previous

patient’s name and any other information written on the
Compact Flash memory card’s label should be
removed. Be sure to initialize the Flashcard prior to next
use.

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 Vision 5L Holter Recorder

Service & Maintenance

Maintenance
Cleaning
Dampen a soft cloth with mild detergent and water to
clean the recorder, lead wires, and belt clip. Remove
the battery before cleaning the recorder.

Service
If there is a problem with the recorder, review the
problem descriptions and solutions listed below. If
additional assistance is required contact Burdick
Technical Support. (Contact Technical Support before
returning a recorder to make shipping arrangements.)

Phone: (800) 333-7770

(608) 764-1919
E-mail: [email protected]

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 Vision 5L Holter Recorder

Troubleshooting

Symptom Recommended Solution

No display Ensure patient cable is
connected.
Ensure battery is inserted with
correct polarity.
Install new alkaline battery
Low battery Inspect battery compartment,
clean contacts if necessary.
Install new alkaline battery.
Battery does not Ensure new alkaline battery is
last 24 or 48 hours being used.
Noise artifacts on Ensure all electrodes are
ECG signal securely attached to the patient.
Replace the patient cable.

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 Vision 5L Holter Recorder

Service Items & Accessories

Description Part Number

128 MB Compact Flash Card 010-1640-00
3 Channel Recorder Prep Kit, 043250
with 5 electrodes
3 Channel Recorder Prep Kit, 043272
with 7 electrodes
5 Lead Patient Cable 010-1642-00
7 Lead Patient Cable 010-1643-00
Pouch with Strap and Belt 010-1644-00
Belt Clip 010-1645-00
Operating Instructions 010-1646-00

NOTE: The Vision 5L Holter Recorder is only

compatible with the compact flash card listed
above. The compact flash card is exclusively for
use with the Vision 5L Holter Recorder, and is not
compatible with other Holter recorders.

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 Vision 5L Holter Recorder

Specifications
Functional
Channels 3
Resolution 8-10 bit sampling, 4X Oversampling
Programmable
Recording Full disclosure
Download interface Removable Compact Flash
(Non-volatile)
Sample rate 200/sec
Frequency response 0.05Hz to 60Hz, @ -3dB
Signal verification LCD display
Pacemaker Detection

Memory
Recording time 24 or 48 hours
Type Non-volatile Flash Memory
Capacity 128MB (Removable)

Physical
Dimensions 3.75” x 3.00” x 0.90” (95 x 76 x 23mm)
Weight with batteries 4 oz. (114 grams)
Enclosure Molded plastic (UL 94V-0)
Operating position Any orientation

Electrical
Gain settings 1X
Connector 20 pin
Patient cable 5 or 7 lead

Environmental
Operating temperature 0° C (32° F) to 45° C (113° F)
Non-operating -20° C (-4° F) to 65°C (149° F)
temperature
Operating humidity 10% to 95% (non-condensing)
Non-Operating humidity 5% to 95% (non-condensing)

Battery
Type (1) AA Alkaline IEC-LR6
Life 48 hours

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 Vision 5L Holter Recorder

Electrode Placement

3 Channel (5 lead) Electrode Placement

Five color-coded leadwires are utilized to create a 3
channel ECG recording.

5 Lead Electrode Placement

# Channel Color Placement

1 3- White Below right clavicle, just lateral to the
midclavicular line
2 1-, 2- Red Top of the sternum
3 2+, 3+ Black Eighth rib at the left midclavicular line
4 1+ Brown Fifth rib at the left anterior axillary line
5 Reference Green Eighth rib at the right midclavicular
line

NOTE:

BROWN – RED = Channel 1

BLACK – RED = Channel 2
BLACK – WHITE = Channel 3

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 Vision 5L Holter Recorder

3 Channel (7 lead) Electrode Placement

Seven color-coded leadwires are utilized to create a 3
channel ECG recording.

7 Lead Electrode Placement

# Channel Color Placement

1 1- White Below left clavicle, just lateral to the
midclavicular line
2 1+ Red At the fourth rib to the left of the sternal
border
3 2- Black Below right clavicle, just lateral to the
midclavicular line
4 2+ Brown Fifth rib at the left anterior axillary line
5 3- Blue At manubrium sterni
6 3+ Orange Sixth rib at the left midclavicular line
7 Reference Green Lower right chest wall, rib

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 Vision 5L Holter Recorder

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Bothell, Washington 98021-8969 608-764-1919