Caird Technology HRV VX3+ User manual

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HRV VX3+
Recorder
Manual
Series E
Caution: FEDERAL LAW RESTRICTS THIS DEVICE FOR SALE TO OR ON
THE ORDER OF A PHYSICIAN.
Caution: Carefully read all instructions prior to use. Observe all
warnings and precautions noted in these directions. Failure to
do so may result in patient complications.

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Table of Contents
Notices:
Conventions Used In This Manual………………………………………… 3
Manufacturer’s Responsibility……………………………………………… 3
User Responsibility………………………………………………………….. 3
Equipment Identification…………………………………………………….. 3
Copyright and Trademark Notices…………………………………………. 3
Other Important Information………………………………………………… 4
User safety information:
Intended Use…………………………………………………………………. 4
Explanation of Symbols……………………………………………………... 4
Warnings……………………………………………………………………… 5
Cautions………………………………………………………………………. 6
Notes………………………………………………………………………….. 6
Section 1: Introduction
Purpose Of The User Manual………………………………………………. 7
System Description………………………………………………………….. 7
System Illustration…………………………………………………………… 7 / 8
Section 2: Getting Started
Secure Digital Card………………………………………………………….. 9
Battery………………………………………………………………………… 9
Screen Navigation…………………………………………………………… 10
Selecting Features and Preferences ...…………………………………… 11
Start Up…………..…………………………………………………………… 11
Setup Menu…………………………………………………………………… 11
Set ID………………………………………………………………………….. 11
Set Name……………………………………………………………………… 12
Pacemaker…………………………………………………………………….. 12
Sample Rate…………………………………………………………………… 12
Record Length…………………………………………………………………. 12
Real Time Clock……………………………………………………………….. 13
Patient Cable…………………………………………………………………… 13
Patient Preparation……………………………………………………………. 13
Patient Hookup………………………………………………………………… 14 / 15
Section 3: Recording An HRV ECG
Data File Check…….………………………………………………………….. 15
Event Button …………………………………………………………………… 15
HRV Test Sequence …..……………………………………………………… 16
Data Retrieval………………………………………………………………….. 17
Recorder Messages……………………………………………………………. 17
Section 4: Device Maintenance
Inspection and Cleaning………………………………………………………. 18
Battery Maintenance and Precautions………..………………...…………… 18
VX3+ Specifications………………………………………………………….. 19
Service/Technical Support …………………………………………………. 19 / 20
Electromagnetic Emissions ……………………………………………...... 21 / 22 / 23 / 24

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Notices
Conventions Used in this Manual
WARNING:
Warning statements describe conditions or actions that can result in
personal injury or loss of life.
CAUTION:
Caution statements describe conditions or actions that can result in damage to
the equipment or loss of data.
NOTE: Notes contain additional information on usage.
Manufacturer’s Responsibility
CAIRD TECHNOLOGY INC. considers itself responsible for effects on safety and performance
only if:
1. Readjustments, modifications or repairs to the CAIRD TECHNOLOGY INC. HRV recorders are
carried out only by CAIRD TECHNOLOGY INC.-authorized personnel.
AND
2. The CAIRD TECHNOLOGY INC. VX3+ is used as presented in this manual.
The warranty is only valid if you use CAIRD TECHNOLOGY INC. -approved replacement parts
and accessories.
User Responsibility
The user of this product is responsible for ensuring the implementation of a satisfactory
maintenance schedule. Failure to do so may cause undue failure and possible health hazards.
Equipment Identification
CAIRD TECHNOLOGY INC. equipment is identified by a serial number on the back of the device.
Please take care not to deface these numbers.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part
of this document may be photocopied, reproduced or translated to another language without prior
written consent of Caird Technology Inc.

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Other Important Information
CAIRD TECHNOLOGY INC. reserves the right to change or amend this manual at anytime
without notice. CAIRD TECHNOLOGY INC. makes no warranty of any kind with regard to this
material, including, but not limited to, the implied warranties of merchantability and fitness for a
particular purpose. CAIRD TECHNOLOGY INC. shall not be liable for errors or omissions that
may appear in this document. CAIRD TECHNOLOGY INC. makes no commitment to update or to
keep current the information contained in this document. Before using the CAIRD TECHNOLOGY
INC. VX3+ HRV Recorder, read this manual in its entirety and become thoroughly familiar with
the contents. VX3+ User Manual Doc VZ-2080 rev. 0.3
User Safety Information
Intended Use
The VX3+ HRV recorder is a small, portable, digital HRV recorder intended for use by medical
professionals to acquire ECG data from a single patient in a clinical, point of care or outpatient
setting. ECG data is first recorded to a Secure Digital (SD) card and then transferred to a HRV
analysis system for review by a physician or other qualified professional.
Explanation of Symbols

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Warnings
1. This device captures and presents data reflecting a patient’s physiological condition that when
reviewed by a trained medical professional can be useful in determining a diagnosis. However,
the data should not be used as sole means for determining a patient’s diagnosis.
2. Use of accessories other than those recommended by CAIRD TECHNOLOGY INC. may
compromise product performance.
3. To maintain designed operator and patient safety, any peripheral equipment and
accessories that can come in direct patient contact must be in compliance with IEC 601-1
and IEC 601-2-47.
4. Hardware is designed to meet or exceed IEC 601-1-2, however some environmental
electrical interference may cause an artifact in the ECG. The quality of ECG signals may
be adversely affected by electromagnetic interference from environmental sources
resulting in non-physiological waveforms with the potential for misinterpretation.
5. This device is not intended for use during an MRI.
6. Before performing defibrillation or applying any high frequency surgical equipment to a
patient, remove VX3+ leads and electrodes from the chest area. Cable leads or
electrodes trapped under defibrillator pads or paddles during defibrillation or electrodes in
contact with high frequency electrosurgical equipment can cause patient burns.
7. Once one or more VX3+ patient leads are connected to a patient, do not allow patient
leads to meet with any grounded or live parts. Contact could cause unacceptable levels
of electrical current to flow to the patient.

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Cautions
1. To prevent possible damage to the keypad, do not use sharp or hard objects to depress
keys.
2. Although the plastic enclosure is designed for a clinical environment and can resist
moisture, neither the device nor patient cables should be cleaned by submersing into a
liquid, autoclaving or steam cleaning. Wipe the exterior surfaces with a cloth dampened
with warm water and mild detergent solution and then dry with a clean soft cloth.
3. No serviceable parts are inside. Only qualified service personnel may remove screws on
the enclosure. The warranty is void if anyone other than qualified service personnel
tampers with the device.
4. Do not pull or stretch patient cables, as this could result in mechanical and/or electrical
failures. Store patient cables after use by forming them into a loose loop.
5. Align patient cable connector and VX3+ socket before plugging in patient cable. Forcing
misaligned connectors can damage connector pins.
6. Avoid shock or sudden impact.
Notes:
1. Excessive patient movement could interfere with the operation of the device.
2. Proper patient preparation is important to successful application of ECG electrodes and
operation of the device.

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Section 1: Introduction
This manual is written for clinical professionals. It is assumed that the reader has a working
knowledge of medical terminology and procedures as required for monitoring cardiac patients.
Purpose of the User Manual
The User Manual describes how to safely operate the VX3+ HRV recorder. In the manual, the
following are described:
•Preparing the device for use
•Understanding and using the keyboard, screen and menu sequence.
•Acquiring and storing ECG.
•Maintenance
System Description
The VX3+ HRV recorder is a portable, battery-operated HRV recorder used by trained
technicians to collect ECG data from patients in a clinical, point-of-care or outpatient setting.
Data is recorded to a Secure Digital (SD) card and then transferred to a HRV system for review
by a physician or other qualified professional.

C a i r d T e c h n o l o g y I n c .
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205 Camden Chase
Columbia, S.C. 29223
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Section 2: Getting Started
A Secure Digital (SD) card and a battery must be installed to operate the VX3+. The SD card
must be installed before the battery is installed.
Secure Digital (SD) Card
The VX3+ stores acquired ECG data to a standard SD card with capacity between 128mb and
2GB. Industrial style SD cards are suggested. To insert the SD card, remove the battery cover
on the back of the recorder and insert the card face up as shown in Fig 2.1. Push it into the slot
until it clicks into place. To remove the SD card, push the card into the slot and it will release.
You can then pull the card out of the slot. The battery must be removed prior to inserting or
removing the SD card.
Battery
The VX3+ uses one alkaline AA battery (IEC-LR6). No other batteries may be used. To install
the battery, remove the battery door on the back of the device, and place as shown on the
placement reference molded on the inside of the battery compartment.
If a battery has power, but is too weak to run a 24-hour study, the recorder will beep continuously
and display a low battery warning. The VX3+ monitors battery voltages during a study. It will run
until the charge falls below an acceptable level. When this occurs the VX3+ will shut down.
Note: A loss of up to 2 minutes data may occur if the battery is removed during a recording.

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NOTE: If the VX3+ will not be in use for a prolonged period of time, remove the battery
from the device.
Caution: INSERT BATTERY AS DIRECTED IN THIS MANUAL. IMPROPER
INSTALLATION COULD DAMAGE THE DEVICE AND IMPACT THE DEVICE’S
ABILITY TO PERFORM THE PATIENT’S ECG TEST.
Caution: THE BATTERIES USED IN THIS DEVICE MAY PRESENT A FIRE OR
CHEMICAL BURN HAZARD IF MISTREATED. DO NOT DISASSEMBLE, HEAT
ABOVE 100° C (212° F) OR INCINERATE.
Caution: KEEP THE BATTERY COMPARTMENT DRY. DO NOT IMMERSE IN
WATER. DISPOSE OF ALL BATTERIES PROPERLY. DO NOT DISPOSE IN TRASH.
KEEP AWAY FROM CHILDREN.
Screen Navigation
The VX3+ use various menus to set preferences and enter patient information. Four keys, left,
right, up and down, are used to navigate the menus. The enter key is used to make a selection of
a highlighted item.