DR512-VX3

Recorder
Manual
Series E

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160 Deerwood Circle
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Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
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INTENDED USE / INDICATIONS:

The DR512 VX3 digital Holter recorder is intended for the recording and storage of long-term
ECG data collected from ambulatory patients. The recorder is used under the order of a
physician, who reviews the data after downloading and processing by a Holter playback system.
The physician determines the presence of normal and abnormal ECG data during the events of
the patient’s daily activity.

CONTRAINDICATIONS: None known

PRECAUTIONS:

Caution: Follow proper patient preparation procedures before recording. Improper patient
preparation may result in a poor quality ECG trace.

Caution: Avoid exposure to inclement weather without proper protection by wearing recorder
under a coat. Exposure to excessive moisture may damage components.

Caution: Avoid wearing recorder in shower or bath. Exposure to excessive moisture may
damage components, or may compromise electrode contact, resulting in a poor quality ECG
trace.

Caution: Federal Law restricts this device to sale by or on the order of a physician (or properly
licensed practitioner).

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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
 Table of Contents

DESCRIPTION 4

OPERATION 5

BATTERY INSTALLATION 7

ELECTRODE APPLICATION 8

ELECTRODE PLACEMENT CHART 9

RECORDER PREPARATION 10

MAINTENANCE 12

TROUBLE SHOOTING 13

SPECIFICATIONS 14

ASSEMBLY DRAWING 15

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160 Deerwood Circle
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Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
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 DESCRIPTION
The DR-512 VX3 is a lightweight, compact, digital Holter Recorder, designed for reliability and
ease of use in ambulatory ECG applications. Because the digital design has no moving parts,
the VX3 should operate as much as 10 times longer between service intervals as compared to
tape based Holter recorders.

A Liquid Crystal Display (LCD) assists the Holter technician in verifying proper patient hookup,
thus eliminating the need for expensive test cables previously used to interface to EKG
machines. The VX3 can be configured as a 7-lead 3 channel , 5-lead 3 channel , 5-lead 2
channel or 3-lead 2 channel recorder by simply changing the patient cable.

Data is conveniently stored on a reusable Compact Flash-card, thus eliminating the need for
cassette tapes. Digital technology also eliminates tape based variables such as tape head
frequency variations, distortion problems, tape speed variations, and tape brand
inconsistencies.
You can expect to have a more accurate ST Segment and R-R interval reading when all of these
variables are removed.

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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
 Operation

PATIENT EVENT BUTTON:

Pressing the event button while recording will store a time stamp reference on the flash
card. The event time, when used in conjunction with a patient diary, provides a physician
with the ability to correlate patient symptoms with the ECG data.

PATIENT CABLE:

The color coded Patient Cable must be removed from the shipping container and
attached to the Patient Input Connector on the VX3 Care should be used to insure proper
alignment of the connector before tightening the cable to the recorder. Do not over-
tighten. Recorder input configuration is automatically selected by the attachment of the
appropriate patient cable. The choices are 7-lead 3-channel, 5-lead 3-channel, 5-lead 2-
channel and 3-lead 2-channel.

See figure 1 for proper cable selection.

Desired Cable Identified

Configuration Part Number By

7-Lead VX-T73-40 White Collar

3-Channel

5-Lead VX-T53-40 Black Collar

3-Channel

5-Lead VX-T52-40 Red Collar

2-Channel

3-Lead VX-T32-40 Green Collar

2-Channel

Figure 1.

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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
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EARLY TERMINATION OF RECORDING:

The recorder will automatically terminate the recording after 24 hours. To terminate the
recording before 24 hours, simply remove the battery and flash card. A loss of up to 7 minutes of
data is
normal and is to be expected if recording is terminated early. Removal of the flash card during
the first 10 minutes of recording will result in a flash card with no data stored on it.

STORAGE MEDIA:

The VX3 utilizes a Compact Flashcard to store ECG data. The Compact Flashcard is reusable
and with proper care and use should last for hundreds of recordings. Always keep the flash card
away from moisture and inspect the pin holes for foreign matter before each insertion. When
preparing for a recording session, install the flash card first before installing the batteries. The
flash card access is located in the battery compartment. Insert and remove the flash card as
shown in figure 2.

Insertion Ejection

Figure 2

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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
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 BATTERY INSTALLATION:
The VX3™s power source consists of either 2 Alkaline AA Batteries or one quality 9V alkaline
battery. Install as shown below. The proper installation is also displayed on the inside of the
battery
compartment. Rechargeable batteries are not recommended.

Note: The Compact Flashcard must be installed before installing the power source. If you
install the power source before the flash card, you will hear a warning beep until the
power source is removed and the flash card is inserted first. This is to ensure the flash
card is properly initialized before any patient data is stored.

OR

Two (2) 1.5 Volt AA One (1) 9 Volt

Alkaline Alkaline
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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
Primary Care Diagnostics Page 8 of 17
160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
 ELECTRODE APPLICATION
MATERIALS NEEDED:

1. Silver chloride disposable electrodes designed for 24 hour Holter monitoring.

2. 4x4 Prep Pads.

3. Isopropyl alcohol.

Note: Do not use 12-lead ECG or Stress Test Electrodes. Use electrodes designed for
longer term 24 hour monitoring.

PREPARATION:

Proper patient preparation is the key variable in Holter monitoring. Without good patient
preparation, a quality ECG tracing and an accurate analysis is not possible.

The following steps are recommended:

1. Select an electrode placement from electrode placement charts.

2. Shave electrode areas if needed. Wipe the skin in the electrode areas with an alcohol
prep pad.

3. Wipe the skin in the electrode areas with an alcohol prep pad again to ensure the area
is free of any oil.

4. Dry the electrode application areas with a lint free cloth.

5. Remove the backing from the pre-gelled disposable electrode.

Carefully place an electrode on each of prepared skin surface sites. Take care to place the
gelled electrode firmly in contact with the skin surface.

Note: To help achieve a good electrode placement, it is often beneficial to attach a patient lead
to the electrode before placing electrode on patient.

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Phone: 423-638-8568 or 731-352-0212
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 Electrode Placement Chart
7-LEAD 3-CHANNEL
Seven lead wires are utilized to create a three channel ECG recording. (For a 5-lead 2-Channel
configuration omit Orange and Blue leads).

WHITE: Channel 1 (-), Place at the top of the sternum .

RED: Channel 1 (+), Place on the left side at the V3 position, on a rib.
BROWN: Channel 2 (-), Place at the top of the sternum, adjacent to the white lead.
BLACK: Channel 2 (+), Place on the left side at the V5 position, on a rib.
BLUE: Channel 3 (-), Place at the top of the sternum, adjacent to the white lead.
ORANGE: Channel 3 (+), Place on the right side at the V1 position on a rib.
GREEN: Ground, Place on the right side opposite V5 position.

NOTE:
CHANNEL 1 = WHITE (-) RED(+)
CHANNEL 2 = BLACK(-) BROWN(+)
CHANNEL 3 = BLUE (-) ORANGE(+)
ELECTRODE PLACEMENT CHART

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160 Deerwood Circle
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Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
 RECORDER PREPARATION
MATERIALS NEEDED:

1. A Lexar, Delkin or Sandisk 64 or 96 MB Compact Flashcard.

2. Two AA alkaline batteries or one 9V alkaline battery. Rechargeable batteries are not
recommended.
3. Patient diary.
4. Digital recorder.
5. Patient cable.
6. Disposable electrodes designed for long term monitoring.
7. Carrying case and belt.

OPERATOR:

1. Prepare patient as previously described in Electrode Application.

2. Inspect cable for signs of wear. Ensure that the patient cable is properly connected to the patient
input connector at the top of the recorder.
3. Insert the flash card.
4. Install new alkaline battery(s). Battery condition will be shown on the recorder’s display.

Note: All previous ECG patient data stored on the flashcard will be erased once the new battery
is installed.

RECORDER:

5. Recorder should beep once and the LCD will start up if:
a) Above sequence was followed.
b) Battery(s) is good.
c) Recorder is operating properly.

Note: Recorder will sound warning beeps and display Low Battery if the power level of the
battery is low

6. If no flash card or an unsupported card is detected, the recorder will beep continually and the
LCD will indicate the flash card is not inserted or is unrecognized.

OPERATOR:

7. If the battery indicator indicates a low battery condition battery(s) must be replaced.
8. If recorder does not beep, continually beeps, sounds a two tone alarm, or the LCD displays
flashcard not inserted, remove the battery, inspect the flash for proper
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160 Deerwood Circle
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Phone: 423-638-8568 or 731-352-0212
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Fax: 423-638-1901 or 731-352-0211
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insertion and reinstall both. If the problem persists, refer to the Trouble Shooting section.
9. Attach recorder leads to electrodes on patient.
RECORDER:

10. Recorder will initialize, format the flash card and perform self tests. This may take from 30
seconds to 4 minutes depending on type flash card.
11. After formatting the flash card, the recorder will display the patient’s ECG waveform.

OPERATOR:

12. Use the LCD display to verify a good patient hook up

a) Operator may cycle between displaying three channels of ECG data at once or each
of the three channels separately. Switch between the displays by pressing event button
once for each selection.

13. After a good patient hook up is confirmed, press and hold the event button for 4 seconds.
This will start patient ECG data acquisition. This is the start time for the Holter recording.

Note: The recorder will automatically enter the ECG acquisition mode if the event button is not
pressed and held for 4 seconds within 15 minutes of entering the ECG display mode.

RECORDER:

14. Recorder will beep once and display Start Time 00:00:00. This indicates the start time for the
recording.
15. The recorder will flash Recording for the next 24 hours.

OPERATOR:

16. Place recorder in protective pouch and secure to patient with the belt strap.
17. Inform the patient about:
a) The use of the event button and patient diary.
b) Keeping the recorder away from moisture.
c) Not removing the flash card or battery(s).

Note: If the battery(s) is removed and reinstalled, the recorder will restart, erasing all previously
recorded data.

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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
 MAINTENANCE
CLEANING:

The exterior of the DR-512 VX3 Digital Holter Recorder may be wiped clean with a soft cloth
dampened with Isopropyl alcohol. Do not use harsh cleaning agents to clean the unit. Do not
immerse the unit in any liquid. Clean cables as described below. When the carrying case
becomes soiled the operator has the option to purchase a new pouch or wash the existing
pouch in cold water with a mild detergent.

STORAGE:

Although the Compact Flashcard is very durable, it should be stored within the recorder or
original jewel case when it is not being used. This will reduce the possibility of dust or moisture
damaging the flashcard. Never store the VX3 with a battery in it.

PATIENT CABLE:

Clean the cables with a hospital approved cleaning procedure such as those recommended by
AAMI or AORN. Wiping the cables with a solution of soap and water followed by a rinse with
water is a simple yet effective method to clean the cables. Do not immerse the cables in water.
The cables may be disinfected by wiping the cables with a 1:10 solution of Chlorine bleach and
water or a 2% Gluteraldehyde solution such as Cidex tm. The cables should then be rinsed and
wiped dry. Worn or damaged patient cables are the most common cause of poor recordings.
Successive poor ECG tracings may indicate the patient cable needs to be replaced.

BAD WEATHER CONSIDERATIONS:

Always protect the recorder from coming into contact with moisture. In rain or snow conditions,
protect the recorder from bad weather elements by wearing the recorder inside a coat.

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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
 TROUBLE SHOOTING GUIDE
IF THE UNIT IS NOT FUNCTIONING PROPERLY, PLEASE CONTACT YOUR DEALER FOR
ASSISTANCE.

THE VX3 HAS NO USER SERVICEABLE PARTS

SYMPTOM POSSIBLE CAUSE:

 NO TONE OR DISPLAY AFTER INITIAL INSTALLATION OF BATTERIES.

1) BATTERY IS VERY WEAK

2) BATTERY IS INSTALLED INCORRECTLY

 LCD DISPLAYS "FLASH CARD NOT INSERTED" AND THE UNIT BEEPS
CONTINUOUSLY AFTER BATTERY IS INSTALLED

1) THE FLASH CARD IS NOT INSTALLED COMPLETELY

A) REMOVE BATTERY
B) INSTALL FLASH CARD
C) REINSTALL BATTERY

 THE UNIT SOUNDS A CONTINUOUS TWO TONE ALARM AND DISPLAYS "FLASH
CARD NOT RECOGNIZED"

1) NON-SUPPORTED FLASHCARD INSTALLED

2) FLASH CARD DID NOT INITIALIZE PROPERLY
A) REINSTALL BATTERY

 THE UNIT BEEPS CONTINUOUSLY AND DISPLAYS "REPLACE BATTERY"

1) BATTERY IS WEAK REPLACE BATTERY

 ONE CHANNEL HAS LOW AMPLITUDE, EXCESSIVE ARTIFACT OR WANDERING

BASELINE

1) BAD LEADWIRE SET

2) POOR HOOK-UP ECG

 DATA IS NOT OBSERVED AFTER RECORDING SESSION IS COMPLETE

1) POOR BATTERY
2) UNIT WAS RAN FOR LESS THAN 10 MINUTES BEFORE REMOVING BATTERY OR
FLASH CARD

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 3)FLASH CARD OR RECORDER HAS MALFUNCTIONED

SPECIFICATIONS
PHYSICAL:

Enclosure ABS,IPX0
Weight 4 ounces - 113 grams
Dimensions 4.46 x 2.75 x 1.02 (inches) - 113 x 70 x 26
(mm)
Operating Temp 0 to 60 Degrees C
Non Operating Shock 26in / 66cm drop
Operating Position Any Orientation
Humidity 90% (non condensing)
Storage Media IDE/PCMCIA Compact Flash
Standard
(64 Meg minimum)
FUNCTIONAL:

Recording Time 24 Hours (Standard)

Channels 3
Sample Rate 224 per channel/sec.
Resolution 8 Bits
Analog Bandwidth .05 to 100Hz-3dB
Input range 5.0 mV
Battery (alkaline) 2 AA or 1 9V
Patient Input 3,5 or 7 lead configuration.
CMRR 60 dB

The VX3 is compliant with IEC 60601-1as a Type BF, internally powered device designed for
short time operation DR512 VX3 DIGITAL HOLTER RECORDER

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Phone: 423-638-8568 or 731-352-0212
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 Assembly Drawing

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160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com
Primary Care Diagnostics Page 17 of 17
160 Deerwood Circle
McKenzie, Tennessee 38201
Phone: 423-638-8568 or 731-352-0212
Cell: 423-914-2986 or 731-234-5095
Fax: 423-638-1901 or 731-352-0211
Email sales@primarycarediagnostics.com