DR512-VX3
Recorder
Manual
Series E
Primary Care Diagnostics
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 [email protected]
Page 1 of 17
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).
Primary Care Diagnostics
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 [email protected]
Page 2 of 17
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
Primary Care Diagnostics
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 [email protected]
Page 3 of 17
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.
Primary Care Diagnostics
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 [email protected]
Page 4 of 17
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 2channel.
See figure 1 for proper cable selection.
Desired
Configuration
Cable
Part Number
Identified
By
7-Lead
3-Channel
VX-T73-40
White Collar
5-Lead
3-Channel
VX-T53-40
Black Collar
5-Lead
2-Channel
VX-T52-40
Red Collar
3-Lead
2-Channel
VX-T32-40
Green Collar
Figure 1.
Primary Care Diagnostics
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 [email protected]
Page 5 of 17
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
Primary Care Diagnostics
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 [email protected]
Page 6 of 17
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
Alkaline
Primary Care Diagnostics
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 [email protected]
One (1) 9 Volt
Alkaline
Page 7 of 17
Primary Care Diagnostics
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 [email protected]
Page 8 of 17
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.
Primary Care Diagnostics
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 [email protected]
Page 9 of 17
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:
RED:
BROWN:
BLACK:
BLUE:
ORANGE:
GREEN:
NOTE:
Channel 1 (-), Place at the top of the sternum .
Channel 1 (+), Place on the left side at the V3 position, on a rib.
Channel 2 (-), Place at the top of the sternum, adjacent to the white lead.
Channel 2 (+), Place on the left side at the V5 position, on a rib.
Channel 3 (-), Place at the top of the sternum, adjacent to the white lead.
Channel 3 (+), Place on the right side at the V1 position on a rib.
Ground, Place on the right side opposite V5 position.
CHANNEL 1 = WHITE (-) RED(+)
CHANNEL 2 = BLACK(-) BROWN(+)
CHANNEL 3 = BLUE (-) ORANGE(+)
ELECTRODE PLACEMENT CHART
Primary Care Diagnostics
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 [email protected]
Page 10 of 17
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
Primary Care Diagnostics
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 [email protected]
Page 11 of 17
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.
Primary Care Diagnostics
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 [email protected]
Page 12 of 17
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.
Primary Care Diagnostics
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 [email protected]
Page 13 of 17
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
3)FLASH CARD OR RECORDER HAS MALFUNCTIONED
Primary Care Diagnostics
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 [email protected]
Page 14 of 17
SPECIFICATIONS
PHYSICAL:
Enclosure
Weight
Dimensions
Operating Temp
Non Operating Shock
Operating Position
Humidity
Storage Media
ABS,IPX0
4 ounces - 113 grams
4.46 x 2.75 x 1.02 (inches) - 113 x 70 x 26 (mm)
0 to 60 Degrees C
26in / 66cm drop
Any Orientation
90% (non condensing)
IDE/PCMCIA Compact Flash Standard
(64 Meg minimum)
FUNCTIONAL:
Recording Time
Channels
Sample Rate
Resolution
Analog Bandwidth
Input range
Battery (alkaline)
Patient Input
CMRR
24 Hours (Standard)
3
224 per channel/sec.
8 Bits
.05 to 100Hz-3dB
5.0 mV
2 AA or 1 9V
3,5 or 7 lead configuration.
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
Primary Care Diagnostics
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 [email protected]
Page 15 of 17
Assembly Drawing
Primary Care Diagnostics
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 [email protected]
Page 16 of 17
Primary Care Diagnostics
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 [email protected]
Page 17 of 17