IntriCon RX92369 User Manual
Generic / Preliminary
Sirona
USER MANUAL
Caution: FEDERAL LAW RESTRICTS THIS DEVICE FOR SALE TO OR ON THE
ORDER OF A PHYSICIAN.
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.
IntriCon Datrix
340 State Place
Escondido, CA 92029
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Table of Contents
Notices ................................................................................................................................ 3
User Safety Information...................................................................................................... 4
Warnings............................................................................................................... 4
Cautions ................................................................................................................ 5
Notes:.............................................................................................................................. 5
Section 1: Introduction....................................................................................................... 6
Section 2: Getting Started.................................................................................................. 6
Front Panel.......................................................................................................................... 7
Section 3: Initial Device Setup ........................................................................................... 8
Section 4: Attaching Recorder to Patient............................................................................ 8
Patient Cable...................................................................................................................9
Patient Preparation.......................................................................................................... 9
Patient Hookup................................................................................................................9
Section 5: Instructions for Patient.................................................................................... 10
RECORD Button .......................................................................................................... 11
SEND Button................................................................................................................ 11
SIRONA Patient Interface Light Signals...................................................................... 13
Section 6: Device Maintenance ....................................................................................... 14
Inspection and Cleaning................................................................................................ 14
Testing...........................................................................................................................14
SIRONA DATASHEET................................................................................................... 17
Service/Technical Support:............................................................................................... 18
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Notices
Conventions Used in this Manual
WARNING Warning statements describe conditions or actions that can result in
CAUTION Caution statements describe conditions or actions that can result in
NOTE Notes contain additional information on usage.
Manufacturer’s Responsibility
IntriCon Datrix considers itself responsible for effects on safety and performance only if:
1. Readjustments, modifications or repairs to the IntriCon Datrix Holter/Event recorders are
carried out only by IntriCon Datrix authorized personnel.
2. The IntriCon Datrix SIRONA is used as presented in this manual.
The warranty is only valid if you use IntriCon Datrix 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 Identifica tion
IntriCon Datrix equipment is identified by a serial number on the back of the device. 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 IntriCon Datrix.
Other Important Information
IntriCon Datrix reserves the right to change or amend this manual at anytime without notice.
IntriCon Datrix 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. IntriCon
Datrix shall not be liable for errors or omissions that may appear in this document. IntriCon Datrix
makes no commitment to update or to keep current the information contained in this document.
Before using the IntriCon Datrix SIRONA Holter/Event recorder read this manual in its entirety
and become thoroughly familiar with the contents.
personal injury or loss of life.
damage to the equipment or loss of data.
AND
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User Safety Information
Intended Use
The SIRONA APETS recorder is a small, portable, digital Holter/Event 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 Holter/Event analysis system for review by a physician or other qualified professional.
Explanation of Symbols
IP54
READ MANUAL FIRST
KEEP AWAY FROM MOISTURE
TYPE BF DEVICE
DC CURRENT
NON-IONIZING RADIATION
ELECTRONIC EQUIPMENT
DISPOSE OF PROPERLY
MANUFACTURER / MANUFACTURE YEAR
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.
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2. Use of accessories other than those recommended by IntriCon Datrix 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
60601-1.
4. Hardware is designed to meet or exceed IEC 60601-1-2, 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 SIRONA 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 SIRONA 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.
8. The equipment is not intended for infants weighing less than 10 kgs.
Cautions
1. Although the plastic enclosure is designed for a clinical environment and can resist
moisture, neither the device nor patient cables should be subjected to autoclaving or
steam cleaning.
2. Recommended cleaning procedure is to 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. The case cannot be opened without destroying it.
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 key and SIRONA key 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.
3. This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation. Changes or modifications not expressly approved by IntriCon for compliance
could void the user’s authority to operate the equipment.
4. This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the wireless transmission off
and on,then the user is encouraged to consult the dealer.
Formatted: Bullets and Numbering
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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 SIRONA Holter/Event recorder, Smart
Dock and linkStream. In the manual, the following are described:
Preparing the device for use
Understanding and using the keyboard
Acquiring and storing ECG data
Transmitting stored ECG data
Maintenance
System Description
The SIRONA Holter/Event recorder is a portable, battery-operated ambulatory ECG recorder
used by trained technicians to collect ECG data from patients in a clinical, point-of-care or
outpatient setting. SIRONA provides ECG waveform analysis and automated transmission of
ECG data for review by a physician or other qualified professional. ECG data is stored on an
internal SD card and can be accessed through the Smart Dock interface or by transmitting the
data over a telephone line. Smart Dock is an interface between a PC based application called
Sirona Viewer and the SD card in Sirona. Smart Dock has two functions –
linkStream is an accessory which provides the convenience of checking lead hook-up wirelessly.
1) Charge the battery in Sirona
2) Access the data stored on the SD card in Sirona
Deleted: ¶
Deleted: ¶
Section 2: Getting Started
Batteries
The Sirona uses an internal lithium polymer battery that is not accessible in the field. The battery
is designed to last for the life of the product.
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: DISPOSE OF ALL BATTERIES IN ACCORDANCE WITH ALL
APPLICABLE LOCAL REGULATIONS
KEEP AWAY FROM CHILDREN.
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Deleted: IRONA
Front Panel
LED
The Sirona front panel contains two buttons and five LED lights (Light Emitting Diodes) as
follows:
Record Button
Send Button
Record Green or Red LED
Lead-off Red
Battery Green or Red LED
LED
Button
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