Cardionet 1009 C3 monitor User Manual 5

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Document ID	741225
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Document Description	User Manual 5
Short Term Confidential	No
Permanent Confidential	No
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Document Type	User Manual
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Filesize	42.51kB (531408 bits)
Date Submitted	2006-12-21 00:00:00
Date Available	2006-12-22 00:00:00
Creation Date	2006-10-19 15:29:39
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Document Lastmod	2006-11-16 17:35:22
Document Title	User Manual 5
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Troubleshooting
Problem
Monitor
battery
power drains
quickly
5. T ROU BL E SHOOT I NG
Monitor
screen is
blank
Possible Solutions
Ensure battery is being fully recharged every day. A full recharge
takes approximately 4 hours and will last 16 hours.
Ensure the monitor is being placed in the base correctly. If the
monitor does not make contact with the plug in the base, it may
not recharge.
It could be that the monitor is not turned on.
Ensure the monitor is turned on by confirming that the LED light
is flashing red or green. If the monitor is asleep, press the blue
button. The screen should light up. If it doesn’t, the monitor may
be low on power. Return the monitor to the base for recharging.
Monitor
beeps while
you are in
bed
It is possible for your body to block communications between the
sensor and monitor. This will cause warning beeps. To avoid beeps
and maintain the communications link, place the sensor near the
monitor on the bed next to you. Try not to lie on top of it or to get
between the sensor and monitor while you are sleeping.
Your phone
line is busy
When the monitor is in the base station and sending information it
will use your telephone line. If someone calls you while the monitor
is using the line, they will get a busy signal. If you try to place a call
while the monitor is transmitting data, you will hear a high- pitched
sound. This is the sound of monitor data being transmitted.
Skin is
irritated or
reddened
If you notice that the skin under or around your electrode pads is
becoming sensitive, irritated or painful, or if you develop a rash,
please call the CardioNet Patient Service Center immediately at 1866-426-4401. Some people are sensitive or allergic to adhesives.
CardioNet will send you another type of electrode pad.
Sensor belt If you’re wearing a thicker belt and finding that it is difficult to
clip is difficult slide on the Sensor Belt Clip, first remove the CardioNet Sensor
to put on
from the clip. Slide just the clip onto your belt and then reposition
the sensor on the clip.
54 Troubleshooting
Precautions
PRECAUTIONS
DISPOSE OF BATTERIES PROPERLY
Observe all local laws for the disposal of alkaline batteries.
WHEN NOT IN USE, REMOVE SENSOR BATTERY
Do not leave the battery in the sensor when it is not in use.
AVOID ELECTROMAGNETIC INTERFERENCE
POTENTIAL FOR ELECTROMAGNETIC INTERFERENCE
There is a potential for electromagnetic interference to other devices while using the
CardioNet Service.
USE WITH IMPLANTED PACEMAKERS AND ICDs ( DEFIBRILLATORS)
If you have an implanted pacemaker or defibrillator (ICD), the manufacturer may have recommended you take certain precautions when using a cellular phone. Since the CardioNet
monitor contains a cellular phone, you should take the same precautions when carrying
and using the monitor. In general, most manufacturers recommend the following:
• You should keep a distance of at least six inches (15 cm) between the cellular phone
and a pacemaker or defibrillator.
• You should hold the cellular phone on the opposite side of the body from the pacemaker or defibrillator.
• Don’t carry a cellular phone in a breast pocket or on a belt if that would place the
phone within six inches of the pacemaker or defibrillator.
• You should refer to the manufacturer’s information for guidance regarding your pacemaker or ICD and interference issues.
Troubleshooting
55
5. T ROU BL E SHOOT I NG
For the best recording results, you should avoid close proximity to heavy equipment or
other sources of electromagnetic interference such as electric blankets, heating pads,
water beds, etc.
Cautions
CAUTIONS
POWER DOWN Monitor AND SENSOR BEFORE SHOWERING
Power down the monitor and remove the sensor before showering. The CardioNet sensor
and monitor are water resistant, not waterproof.
DO NOT GET THE Monitor AND SENSOR WET
5. T ROU BL E SHOOT I NG
Make sure the monitor and sensor stay dry at all times.
LIMITATIONS OF COVERAGE
CardioNet’s ability to obtain information regarding a cardiac event and to contact you or
your physician in a timely manner is limited by a number of factors including:
• Transmission of information about a cardiac event to CardioNet‘s Monitoring Center
is potentially limited by the availability of standard telephone lines and/or cellular phone
coverage.
• There is an inherent time delay from the time that an event is detected to when the
events are analyzed and confirmed by a Certified Cardiac Technician (CCT).
• There is an inherent time delay from when the event is analyzed and confirmed by
the CCT to when CardioNet is able to make contact with you or your physician.
• If you or your physician are not accessible by telephone, CardioNet will not succeed
in making contact with you or your physician
56 Troubleshooting
Warnings
WARNINGS
FOR ADULT USE ONLY
The CardioNet System is intended for Adult Use only. It shall not be use on infants weighing less than 22 pounds.
FOR USE WITH TELEPHONE SYSTEM
Any patient whose life may be put at significant risk by the unavailability of the telephone
system should not be monitored by the CardioNet System.
NOT AN APNEA Monitor
USE ONLY WITH CARDIONET ELECTRODES
While wearing the CardioNet sensor, use only electrodes provided by CardioNet.
NOT AN EMERGENCY RESPONSE SERVICE
CardioNet is not an emergency response service. If you experience any symptoms that
concern you, seek medical help.
DO NOT TAMPER WITH DEVICE
There are no serviceable parts in the CardioNet System components. Removing the cover
of any component may alter device performance.
DO NOT TAMPER WITH Monitor BATTERY
The monitor battery can present a fire or chemical burn hazard if mistreated. Do not
disassemble, heat above 80C (176 F), incinerate, or recharge using any device other than
the base or the CardioNet supplied power cord.
USE ONLY CARDIONET POWER CORD
Do not use any power cord for the base other than the one provided in the CardioNet
service kit.
DO NOT CONNECT ANY DEVICE TO THE PC PORT ON THE MONITOR
The PC port is to be used only by CardioNet personnel.
DO NOT USE NEAR FLAMMABLE ANESTHETIC
Units are not to be used in the presence of flammable anesthetic.
Troubleshooting
57
5. T ROU BL E SHOOT I NG
The CardioNet monitor is not to be used as an apnea monitor.
6
S PECI F I C AT I O N S ,
COMP L I A N C E &
S YMB O L S
In this Chapter:
•
Specifications
•
Equipment Symbols
•
In Home Requirements
•
FCC Compliance
6 . SPE CI F IC AT IONS
Specifications
P H YSICAL
Sensor
3 inches x 4 inches x 1 inch ; Weight: 4.0 oz. with battery
Sensor Neck Strap
Adjustable 20 to 32 inches
Monitor
6 inches x 3 inches x 0.8 inches; Weight: 8 oz.
LCD
2.27 inches x 1.7 inches; Touch screen: color, backlit
Base
7 inches x 4 inches x 2.5 inches; Weight: 12 oz.
f U NCTIONAL
Sample Rate
250 samples per second
Resolution
12 bits
Dynamic range
+/- 5 mV
Bandwidth
0.1 to 40 Hz
Channels
Battery Life: Monitor
Up to 16 hrs (with cleared memory & fully recharged battery)
Battery Life: Sensor
24 hrs (1 AA Alkaline)
Leakage Current
Less than .1 µ A Electrodes
T ransmission
Sensor to Monitor
900 MHz ISM band RF transmission, digital error corrected.
150 foot range. Retransmission if data is corrupted.
Monitor to Center
CDMA (PCS and cellular) wireless, digital error corrected. Telephone line modem, digital error corrected.
O perating Conditions
Operating Tempera- Sensor: 20 - 45 o C; Monitor ; 0 - 45 o C
Operating Humidity
10% - 95% noncondensing
Storage Temperature
-20 - 65 o C noncondensing
Storage Humidity
5% - 95% noncondensing
Operation Altitude
700 - 1060 millibars
60
Specifications
Specifications
Base
Power in (15V, 1.2A max); Phone in (RJ-11); Phone out (RJ-11)
Monitor
Power in (15V, 1.2A max)
W A LL ADAPTOR
Manufacturer
Friwo, Inc (15V, 1.0A)
Model Number
FW755M/15
Note: Both the monitor and sensor are internally powered
S T ANDARDS COMPLIANCE
Monitor
EN60601-1; AAMI EC-38; FCC Parts 2,15,22,24
Sensor
EN60601-1; AAMI EC-38; FCC Part 15
Base
EN60950; AAMI EC-38; FCC Part 15, 68
AECG Equipment
Type I
Note: This equipment has been tested and found to comply with the limits for medical
devices to the IEC 601-1-2:1993, EN60601-1-2:1994, Medical Device Directive 93/42/EEC
or the Electromagnetic Compatibility Directive 89/336/EEC (use applicable directive).
These limits are designed to provide reasonable protection against harmful interference
in a typical medical 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 other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does cause
harmful interference to other devices, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected
• Consult the manufacturer or field service technician for help
Specifications
61
6 . SPE CI F IC AT IONS
C O NNECTIONS
Equipment Symbols
6 . SPE CI F IC AT IONS
SN
BF Type Equipment
Consult Users Manual /
Patient Education Guide
Serial Number
In Home Requirements
1. Touch tone, pulse telephone or cellular / PCS wireless coverage suitable for
data transmission
2. AC powered outlet
FCC Compliance
This device complies with part 15 and 68 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 interference received including interference that may cause undesired
operation.
fcc id
Sensor ISM
QBI-1008
Monitor ISM
QBI-1009
Monitor Cell Modem
Q9EQ2438F-M
62
Specifications
FCC Compliance
FCC Rules Part 15
The Model 1004 has been tested and complies 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 when the equipment is operated in a residential
environment. This equipment generates, uses, and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction manual, can cause harmful interference to radio communications.
CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY CardioNet Inc. COULD
VOID THE USER’S AUTHORITY TO OPERATE THE EQUIPMENT
FCC Rules Part 68 REGISTRATION
Model 1004 complies with FCC Rules, Part 68. On this equipment is a label that contains,
among other information, the FCC Part 68 registration number.
REN
The Ringer Equivalence Number (REN) is used to determine the quality of devices that
may be connected to the telephone line. Excessive RENs on the telephone line may result
in the devices not ringing in response to an incoming call. In most, but not all areas, the
sum of RENs should not exceed five (5.0). To be certain of the number of devices that
may be connected to a line, as determined by the total RENs, contact the local telephone
company.
NOTE: RENs are associated with loop-start and ground-start ports. It is not used for
E&M and digital ports. The REN assigned to the Model 1004 is 0.16. If requested, this
information must be given to the telephone company.
Service
In the event of equipment malfunction, all repairs should be performed by
CardioNet, Inc. or an authorized agent. It is the responsibility of users requiring
service to report the need for service to CardioNet, Inc. or to one of our
authorized agents. Service can be facilitated through our office at: CardioNet, Inc.
1010 Second Avenue, Suite 700 San Diego, CA 92101 619-243-7500.
The telephone company can ask you to disconnect the equipment until the problem is
corrected or until you are sure that the equipment is not malfunctioning.
The Model 1004 interface connects to the Public Switched Telephone Network through a
FCC registered NCTE which specifies the type of network jack to be used.
Specifications
63
6 . SPE CI F IC AT IONS
F C C COMPLIA NCE
6 . SPE CI F IC AT IONS
FCC Compliance
F C C COMPLIA NCE
Disruption of the Network
If the Model 1004 disrupts the telephone network, the telephone company can discontinue your service temporarily. If possible, the telephone company will notify you in
advance. If advance notice is not practical, they will notify you as soon as possible. You
are also informed of your right to file a complaint with the FCC.
Telephone Company Facility Changes
The telephone company can make changes in its facilities, equipment, operations, or
procedures that can affect the operation of your equipment. If they do, you should be
notified in advance so you have an opportunity to maintain uninterrupted telephone
service.
FCC RADIO FREQUENCY EXPOSURE INFORMATION
In August 1996, the Federal Communications Commission (FCC) of the United States,
with its action in Report and Order FCC 96-326, adopted an updated safety standard for
human exposure to radio frequency (RF) electromagnetic energy emitted by FCC regulated transmitters. Those guidelines are consistent with the safety standard previously
set by both U.S. and international standards bodies. The design of this device complies
with the FCC guidelines and these international standards. Use only the supplied antenna. Unauthorized antennas, damaged antennas, modifications, or attachments could
impair call quality, damage the device, or result in violation of FCC regulations. Please
contact CardioNet if damage to the unit is apparent.
BODY-WORN OPERATION
This device was tested and was found to comply with the FCC exposure requirements. The
device was also tested and found to comply with SAR (Specific Absorption Rate) testing.
For more information about RF exposure, please visit the FCC website at www.fcc.gov.
64
Specifications


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