Respironics SmartMonitor2 Operator's Manual
Professional Operator’s Manual
Warranty
Respironics warrants that the monitor will be free from defects in materials and workmanship for a period
of one year from the time of purchase. Respironics accessories are warranted to be free of defects in
materials and workmanship for a period of 90 days from the time of purchase.
The Respironics equipment and authorized accessories are designed to function as described in the
operator’s manual. The user/owner of this equipment shall have sole responsibility and liability for any
injury to persons or damage to property (including this equipment) resulting from:
Operation not in accordance with supplied operating instructions;
Maintenance not in accordance with authorized maintenance/operational instructions;
Service by anyone other than a factory authorized service representative;
Modification of the equipment or accessories; or
Use of damaged or unauthorized components and accessories.
THIS LIMITED WARRANTY IS IN LIEU OF ANY AND ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE; TO THE EXTENT THAT STATE OR FEDERAL LAW PROHIBITS EXCLUSIONS OF
IMPLIED WARRANTIES, ANY SUCH IMPLIED WARRANTY IMPOSED BY LAW SHALL BE LIMITED TO A PERIOD
OF NINETY (90) DAYS FROM THE DATE OF THE INITIAL PURCHASE FROM RESPIRONICS.
User/Owner Responsibility
This Respironics equipment and the authorized accessories are designed to work as described in the
operator's manual. The user(s) of this equipment should not use parts that have failed, exhibit excessive
wear, are contaminated, or otherwise ineffective. The monitor and its accessories should not be modified.
The following list incorporates the owner's responsibilities:
Periodic check, maintenance, and calibration of equipment;
Replacement of components as required for safe and reliable operation;
Replacement of ineffective parts with parts supplied by Respironics, Inc.;
Equipment which is not functioning properly must not be used until all necessary maintenance has
been completed and a factory-authorized service representative has certified the equipment as ready
for use;
The monitor and any of its accessories should not be modified;
As a general rule, the proper performance of this monitor should be verified with a Respironics Model
5000 Simulator according to the Checkout Procedure Manual #H580-4000-00 between each patient
use and/or every 6 to 12 months, whichever is more frequent.
The user of this equipment is responsible for reading, understanding, and following the Warning and
Caution statements throughout this manual.
Table of Contents
Table of Contents
Introduction ..................................................................................................................... 1
Unpacking and Inspection ............................................................................................................................ 1
About this Manual......................................................................................................................................... 1
Indications for Use .................................................................................................................................... 1
What is the Purpose of the SmartMonitor 2?............................................................................................ 1
Summary of Clinical Performance Evaluation .......................................................................................... 1
Warnings and Cautions................................................................................................... 7
Warnings....................................................................................................................................................... 7
Cautions........................................................................................................................................................ 9
How Does the SmartMonitor 2 Work?........................................................................... 11
How the Alarms Operate ............................................................................................................................ 11
Electrical Ratings ........................................................................................................................................ 12
Environmental Conditions........................................................................................................................... 12
IEC Classification........................................................................................................................................ 12
Symbols Table ............................................................................................................................................ 12
FCC Part 68 Notice..................................................................................................................................... 13
Industry Canada CS-03 Notice................................................................................................................... 14
FCC Part 15................................................................................................................................................ 14
Getting to Know the Monitor ......................................................................................... 15
SmartMonitor 2 Features............................................................................................................................ 15
Top Panel Features ................................................................................................................................ 15
POWER Button ........................................................................................................................................15
RESET Button..........................................................................................................................................15
Front Panel Features .............................................................................................................................. 16
Patient Input Connector ...........................................................................................................................16
Respiration Lights ....................................................................................................................................16
Heart Lights..............................................................................................................................................16
Speaker....................................................................................................................................................16
System Lights...........................................................................................................................................16
Side Panel Features ............................................................................................................................... 17
Self-Test Connector .................................................................................................................................17
Memory Card (Optional) ..........................................................................................................................17
Back Panel Features............................................................................................................................... 18
Remote Alarm (Optional) .........................................................................................................................18
Modem (Optional) ....................................................................................................................................18
DC Power.................................................................................................................................................18
I/O Connector...........................................................................................................................................18
Setting Alarm and Recording Limits.............................................................................. 19
Manual Set-Up............................................................................................................................................ 19
To Set or Modify Parameters Manually, Enter Menu Mode.....................................................................19
The SmartMonitor 2 Parameters..............................................................................................................20
System Set-up Menu ...............................................................................................................................27
View Menu Mode .....................................................................................................................................28
Using Auxiliary Equipment ............................................................................................ 29
Using the Respironics Model 930 Oximeter............................................................................................... 29
Table of Contents
Dealer Preparation for Home Setup.............................................................................. 31
Home Setup.................................................................................................................. 33
Step 1: Set the SmartMonitor 2 on a Clean, Flat Surface. ..................................................................... 33
Step 2: Connect the Patient Cable to the SmartMonitor 2...................................................................... 33
Step 3: Connect the Lead Wires to the Patient Cable. ........................................................................... 34
Step 4: Connect the Lead Wires to the Electrodes................................................................................. 34
Step 5: Attach the Electrodes to the Infant Belt. ..................................................................................... 35
Step 6: Wrap the Electrode Belt around the Baby.................................................................................. 35
Step 7: Connect the Power Cord/Battery Charger. ................................................................................ 38
Responding to Alarms................................................................................................... 39
Patient Alarm .............................................................................................................................................. 39
Testing the Alarm........................................................................................................................................ 39
If an Alarm Sounds ..................................................................................................................................... 39
Responding to System Alarms ................................................................................................................... 41
Reducing False Alarms................................................................................................. 43
Monitoring the Baby ...................................................................................................... 45
Turning the SmartMonitor 2 on................................................................................................................... 45
Turning the Monitor off - Sibling Alarm....................................................................................................... 45
If there is an internal software error, a special power off procedure is required. ....................................... 45
Press and hold the RESET button, while still holding down the RESET button press and hold the
POWER button. Hold both buttons down for 5 seconds. ........................................................................... 45
Release POWER button; continue to hold the RESET button until the monitor turns off. .............. 45
Monitoring the Baby's Breathing................................................................................................................. 46
Respiration Light ......................................................................................................................................46
Apnea Light..............................................................................................................................................46
Monitoring the Baby's Heart Activity........................................................................................................... 47
Heart Rate Light.......................................................................................................................................47
High Heart Rate Light ..............................................................................................................................47
Low Heart Rate Light ...............................................................................................................................47
Portable Operation of the SmartMonitor 2 .................................................................... 49
Charging the SmartMonitor 2 Battery......................................................................................................... 49
SmartMonitor 2 Battery Pack...................................................................................................................... 50
Battery Installation Instructions ..................................................................................... 51
Transferring SmartMonitor 2 Information ...................................................................... 53
Memory Management in the SmartMonitor 2 ............................................................................................. 53
To recover the old data using a PCMCIA card ........................................................................................53
To recover the old data by downloading using Synergy-E ......................................................................53
Modem Download....................................................................................................................................... 53
Modem Auto Dial .................................................................................................................................... 54
Modem Auto Answer in Communications Mode..................................................................................... 54
Modem Auto Answer in Monitor Mode.................................................................................................... 55
Transferring SmartMonitor 2 Data to a Memory Card ................................................................................ 56
Transferring SmartMonitor 2 Data Using a Computer................................................................................ 57
Communications Mode Setup................................................................................................................. 57
Caring for the SmartMonitor 2....................................................................................... 59
Cleaning Instructions .................................................................................................................................. 59
Insect Infestation Decontamination Procedures......................................................................................... 59
Table of Contents
Performing a Functional Self-Test.............................................................................................................. 60
Self-Test Troubleshooting .......................................................................................................................... 61
Troubleshooting ............................................................................................................ 63
Ordering Information ..................................................................................................... 65
Glossary........................................................................................................................67
Appendix A ................................................................................................................... 69
Flow Chart of SmartMonitor 2 Parameters................................................................................................. 69
Specifications................................................................................................................ 71
Index ............................................................................................................................. 73
Table of Contents
Introduction
Introduction
Unpacking and Inspection
When you receive the SmartMonitor® 2, unpack the shipping case and:
Carefully examine the contents.
Save the shipping carton.
Make sure you have all the necessary items and that they are not damaged.
Report anything missing or damaged to Respironics.
About this Manual
This manual provides all the information you need to set up and operate the Respironics SmartMonitor 2
and explains how to use it to monitor the baby's vital functions. Carefully read and understand this manual
before using the system. Words that appear in Bolded Italics are defined in the Glossary in the back of
this manual.
Indications for Use
The SmartMonitor 2 is intended for use in continuous monitoring of heart rate and respiration of infant
patients in a home, hospital or portable environment. Its primary function is detection of central apnea.
Its secondary function is measurement of heart rate.
What is the Purpose of the SmartMonitor 2?
SmartMonitor 2 is an apnea monitor designed to monitor and record the baby's breathing (respiration)
and heart (cardiac) activity. The monitor alerts you if either of these activities exceeds the limits
prescribed by the physician.
Patient alarm limits are set by the health care professional before the SmartMonitor 2 monitor is delivered
to the patient. During monitoring, when the baby's breathing effort and heart activity are not within these
set boundaries, an indicator light comes on and an alarm sounds. This manual explains how to set up the
SmartMonitor 2, how to monitor the baby, and how to transfer information.
Other devices may be used with the SmartMonitor 2. Refer to the section Using Auxiliary Equipment for
further information.
Summary of Clinical Performance Evaluation
The SmartMonitor 2 was evaluated in a clinical study according to the most recent FDA
recommendations. These recommendations are available in the “Guidance for Apnea Monitor 510(k)
Submission” released in 2002.
Study Design
Methods
This was a multi-center, prospective, non-randomized study carried out at six clinical sites in the
United States. Infants in nurseries and other settings appropriate for attended monitoring, who
were considered to be appropriate candidates for cardio-respiratory monitoring, were recruited
and enrolled into the study.
Enrollment was competitive and each site was instructed to continue patient enrollment until a
sample size of at least 100 qualified central apneas was obtained.
1
Introduction
Inclusion Criteria
Exclusion Criteria
Each patient was connected to a data acquisition system that included the Respironics Inc.
SmartMonitor and SmartMonitor 2 and the Alice System. Respiration and heart rate signals were
recorded using infant electrocardiogram electrodes. The Alice system was used to gather
physiological signals and record signals for airflow, breathing effort, and movement.
All Alice System data were reviewed by a qualified, credentialed clinician, using an Alice
polysomnograph system. Waveforms were manually reviewed and scored on an electronic
medium. The beat/breath detection and alarm channels from the SmartMonitor and SmartMonitor
2 were hidden prior to scoring by the clinician. The clinician identified apnea, bradycardia, and
tachycardia events on the Alice System.
Events were identified as required by the Guidance for Infant/Child Apnea Monitor 510(k)
Submissions, released 2002.
Results
Summary of Results
Compared to the SmartMonitor, the new SmartMonitor 2 identified 6.8% more apneas. The
SmartMonitor 2 also had 12.3% fewer false alarms and missed 6.8% fewer central apneas than
the SmartMonitor. The results of this study demonstrate that the new SmartMonitor 2 is
substantially equivalent to the predicate SmartMonitor. A detailed breakdown of study results is
provided in the following sections.
Spontaneously breathing, newborn infant (≤ 12 months of age), either gender without
regard to ethnicity.
Appropriate candidate for cardio-respiratory monitoring including any one or more of the
following:
Any candidate with one or more of the following was excluded from enrollment:
• Diagnosis of cardiac, respiratory or neurological disease
• Witnessed or suspected episodes of apnea or periodic breathing
• Gestational age less than or equal to 36 weeks
• History of sibling(s) experiencing ALTE’s or SIDS
• Patients requiring supplemental oxygen
• Presence of an artificial airway
• Receiving mechanical ventilation
• Receiving continuous positive airway pressure (CPAP)
• Presence of a cardiac or diaphragmatic pacemaker
2
Recruitment Summary
Total # Enrolled # Evaluated # with 1 or more central apneas Total # of apneas in analysis
54 patients
Two patients were enrolled but not included in the evaluation. Only the first six apneas were used from
any individual patient.
Demographic Summary
Introduction
52 patients
35 patients
Ethnicity
142
Clinical Site
Site #1
Site #2
Site #3
Site #4
Site #5
Site #6
Total 52 24 28 33 8 2 8 1 2220.65
Number of
Patients
10 6 4 10 0 0 0 0 1779.70 31.10
5 4 1 3 2 0 0 0 2340.40 32.80
10 2 8 2 2 2 3 1 3746.90 39.20
7 3 4 4 2 0 1 0 1387.00 30.00
13 4 9 8 1 0 4 0 1504.46 29.77
7 5 2 6 1 0 0 0 2565.43 34.86
#
Male
#
Female
Cauca
-sian
African
American
Asian
Hispanic
Other
Mean Birth
Weight
(grams)
(Mean
Value)
Mean
Gestational
Age
(Weeks)
32.95
(Mean
Value)
3
Diagnosis Summary
Diagnosis
Site # 1
Site #2
Site #3
Site #4
Site #5
Introduction
Site #6
Totals by
Diagnosis
Prematurity 10 0 0 7 13 0
RDS, Resp. Failure, HMD 3 0 0 3 5 0
ALTE, Apnea, AOI, AOP 8 2 8 6 5 4
Bronchiolitis, Pneumonia, RSV 0 3 0 1 0 6
Gastro-Esophageal Reflux 0 0 0 2 1 1
Broncho-Pulmonary Dysplasia 0 0 0 2 2 0
Other 5 2 5 10 10 2
Totals by Site 26 7 13 31 36 13 126
Results for Both Monitors by Site
SmartMonitor SmartMonitor 2
Study Site
Site #1
Site #2
Site #3
Site #4
Site #5
Site #6
Totals
SmartMonitor
Apnea with Alarm
68 73 5 6.8
The sensitivity for SmartMonitor is 100*68/142 = 47.89% with 95% confidence limits (39.44%, 56.42%). The
positive predictive value for SmartMonitor is 100*68/165 = 41.21% with exact 95% confidence limits (33.62%,
49.13%).
The sensitivity for SmartMonitor 2 is 100*73/142 = 51.41% with 95% confidence limits (38.25%, 54.30%).
The positive predictive value of Smart Monitor 2 is 100*73/158 = 46.20% with exact 95% confidence limits
(38.25%, 54.30%).
Apnea
with Alarm
25 21 20 28 21 17
2 2 3 2 2 3
3 12 6 3 13 6
10 21 10 11 11 9
21 19 25 18 19 28
7 22 10 11 19 6
68 97 74 73 85 69
Analysis of Results
No Apnea
with Alarm
SmartMonitor 2
Apnea with Alarm
Apnea
without Alarm
(SmartMonitor 2 – SmartMonitor)
Apnea
with Alarm
Difference
No Apnea
with Alarm
Apnea
without Alarm
% Difference
30
11
33
10
4
4
34
4
SmartMonitor
No Apnea with Alarm
(False Alarm)
97 85 -12 -12.3%
The false apnea rate for SmartMonitor is 97/(95.95) = 1.01.
The false apnea rate for SmartMonitor 2 is 85/95.95 = 0.89.
SmartMonitor Apnea
with No Alarm
(Missed Event)
74 69 -5 -6.8%
SmartMonitor 2
No Apnea with Alarm
(False Alarm)
SmartMonitor 2
Apnea with No Alarm
(Missed Event)
(SmartMonitor 2 – SmartMonitor)
(SmartMonitor 2 – SmartMonitor)
Difference
Difference
Introduction
% Difference
% Difference
5
Introduction
6
Warnings and Cautions
Warnings and Cautions
Please read this section carefully before using the SmartMonitor 2 to monitor a baby's breathing and
heart activity.
Warnings
A warning indicates a potentially harmful situation.
1. SmartMonitor 2 may not be able to detect all episodes of inadequate breathing. If a baby has apnea
due to choking (obstructive apnea), the monitor could mistake movement caused by choking for
breathing.
2. SmartMonitor 2 is a monitoring device only. It does not prevent the loss of breathing or heart activity,
nor will it restore breathing or heart activity. It will not prevent death.
3. Anyone using the SmartMonitor 2 to monitor an infant should be trained in current infant
Cardiopulmonary Resuscitation (CPR), which is a proper way to restore breathing and heart
activity.
4. The SmartMonitor 2 is not intended for use with cardiac or diaphragmatic pacemaker patients.
5. When using the monitor near patients on oxygen, the monitor must be kept at least three (3) feet
away from the oxygen tank (source) or other flammable gases to prevent a fire hazard.
6. Place the monitor on a sturdy and level surface to prevent the monitor from falling.
7. Do not place the monitor on the floor. It may become a tripping hazard.
8. Do not place the monitor in the crib. The baby may roll on the hard surface and be injured.
9. Use only those accessories provided by Respironics with this monitor.
10. Do not allow the patient cable, lead wires or power cord/battery charger cable to become tangled,
coiled, crossed, or wrapped around the baby’s neck, arms, or legs. This could result in strangulation.
11. Do not connect to an electrical outlet controlled by a wall switch to prevent inadvertently turning the
power off to the monitor.
12. Do not block the speaker or place items in front of the speaker located on the front of the unit. This
could prevent the monitor alarm from being heard.
13. Never use the monitor on the baby while the baby is being bathed. This could result in electrical
shock and/or damage to the equipment.
14. Disconnect the power cord/battery charger and phone line during lightning storms to reduce risk of
electrical shock to the baby.
15. Remove the electrode belt and the lead wires when the baby is not being monitored. Long-term wear
may be uncomfortable.
16. Never use an extension cord with the power cord/battery charger as this may cause a fire and/or
tripping hazard.
17. Be aware of signal interference that can occur from external sources. Electronic signals are required
for the SmartMonitor 2 to function. Sources of external interference could cause the monitor to miss
apnea and heart rate alarms. Even though the monitor contains methods and techniques which can
provide protection from external sources of interference, you should operate the monitor as follows:
• Keep monitoring equipment, patient and patient leads at least three (3) feet away from all
electrical appliances. Some examples of this include TV sets, electric blankets, air conditioners,
microwave ovens, cordless telephones, cellular phones, waterbeds, and home computers.
• Synthetic fabric from draperies or rugs can also cause interference due to static electricity.
Touching a conductive material with a grounded path, such as a wall or crib, before handling the
patient or the SmartMonitor 2 often prevents static build-up problems.
7
Warnings and Cautions
• Strong transmitter signals from TV, radio, airport, police, fire, and ambulance stations could be
picked up as heart and/or breath signals. If located less than one (1) mile from one or more of
these sources, the monitor may be affected.
18. In some locations, the monitor will not work properly. If the monitor is affected by external interference
in the area, you may not be able to use the monitor. Contact Respironics for further assistance. Use
of a third (RL) electrode may help reduce electrical interference.
19. If monitoring two or more infants in the same area, keep the monitors, patient, patient cables and lead
wires at least three (3) feet apart. Having the patient cables and lead wires close together may cause
missed apneas due to interference.
20. Do not connect the infant to the SmartMonitor 2 if the monitor is placed in the Communications Mode.
The apnea and heart alarms do not work when the SmartMonitor 2 is in this mode.
21. Do not use the SmartMonitor 2 at the same time as other impedance monitors. This may cause
missed apneas due to interference.
22. Do not rock the baby or sleep in the same bed with the baby while monitoring. Touching or moving
near the baby, monitor, or cables could cause the monitor to miss apneas.
8
Warnings and Cautions
Cautions
A caution indicates a condition that may lead to equipment damage, malfunction, or inaccurate operation.
Federal law (US) restricts this device to sale by, or on the order of a licensed physician. This
instrument should be used only under the supervision of a physician.
1. Perform the functional self-test if the SmartMonitor 2 has been x-rayed by an airport security check.
2. Do not place liquids on or near the SmartMonitor 2. Liquids may damage the electronic components
inside the monitor. Should liquid spill onto monitor, shut monitor off and call Respironics to have it
serviced.
3. Do not send information via modem during electrical storms. Information could be lost or equipment
could be damaged.
4. Handle the lead wires carefully to prevent them from breaking inside the insulation. Always grasp the
lead wire at the strain relief area to remove them from the electrodes or patient cable.
5. Insure that the auxiliary devices used do not exceed SELV (Safety Extra Low Voltage) levels as
described in EN60601-1. It is the dealer’s responsibility to ensure that auxiliary devices comply with
either UL2601-1 or UL544.
9
Warnings and Cautions
10
How Does the SmartMonitor 2 Work?
How Does the SmartMonitor 2 Work?
SmartMonitor 2 monitors and records a patient's breathing (respiration) and heart (cardiac) activity and
alerts the caregiver if either of these activities exceeds the limits prescribed by the physician.
The patient alarm limits are set before the SmartMonitor 2 is given to the patient. If during monitoring the
patient's breathing effort and heart activity is not within these set boundaries, an indicator light comes on
and an alarm sounds.
This manual explains how to set up the SmartMonitor 2, how to monitor a patient, how to transfer the
information to the physician, and how to use other devices with SmartMonitor 2.
A baby's breathing is measured by placing two electrodes on the baby's chest under his or her arms. As
the baby's chest moves during breathing, the impedance between the electrodes changes. The
SmartMonitor 2 detects these changes to determine the baby's breathing effort. If the SmartMonitor 2
does not detect these changes in breathing effort for longer than the physician-ordered time, a light will
come on and an alarm will sound.
SmartMonitor 2 also uses the electrodes on the chest to monitor heart activity by picking up the electrical
changes produced by the heart. If the SmartMonitor 2 detects the heart rate limit outside the range
ordered by the physician, a light will come on and an alarm will sound.
How the Alarms Operate
Whenever the patient’s breathing effort and heart activity are not within the limits set by the physician, an
indicator light will come on and an alarm will sound. The SmartMonitor 2 has two types of alarms: patient
and system.
Patient Alarms: A beeping alarm indicates one of the following patient alarm events:
Apnea: Baby has stopped breathing for longer than the limit set by the physician
Low Heart: Heart Rate is lower than the limit set by the physician
High Heart: Heart Rate is higher than the limit set by the physician
System Alarms: A constant audible alarm indicates one of the following SmartMonitor 2 conditions:
Loose lead
Low Battery
Memory Full (or Memory Almost Full)
Accidental Power-Off
Internal System Error
Lights on the SmartMonitor 2 indicate which of these conditions exists. See the section on Monitoring the
Baby for more information about alarms.
The SmartMonitor 2 may also alarm if there is an internal system error. If the monitor alarms and
the lights are not illuminated, or if all of the lights are blinking on-and-off, look at the LCD display
on the bottom of the unit. If there is an internal error, a code will be displayed and logged into the
memory. Discontinue use of monitor and contact Respironics Technical Support 1-800-345-6443.
11
How Does the SmartMonitor 2 Work?
Electrical Ratings
Model 4009 power cord/battery charger: 120VAC 60Hz 7.2W
Model 4011 power cord/battery charger: 230VAC 50Hz 7.2W
SmartMonitor 2: 10.5-11.5VDC 0.1-1A
Model 418 Ni-MH Rechargeable Battery Pack: 6VDC 1.85Ah or greater
Environmental Conditions
Operating Temperature: 5ºC to 45ºC
Operating Humidity: 20%RH to 95%RH, non-condensing
Storage Temperature: -20ºC to +65ºC
Storage Humidity: 10%RH to 95%RH, non-condensing
Battery Charging Temperature: 10ºC to 35ºC
IEC Classification
The SmartMonitor 2 is classified as:
Class II/Internally Powered
Type BF Applied Part
Ordinary Protection against the ingress of liquids
Not suitable for use in the presence of a flammable anesthetic mixture with air or with nitrous oxide
Continuous Operation
Symbols Table
Symbol Definition
IOIOI
Attention: Important information that should be read
Attention: Read accompanying documents
Type BF Applied Part also shows Patient Cable Connector
location
Serial Port
Reset Button
Power Off/On Button
Apnea Alarm Light
Respiration Light
Low Heart Rate Alarm Light
High Heart Rate Alarm Light
Low Battery Light
12
How Does the SmartMonitor 2 Work?
Symbol Definition
Memory Full Light
Loose Lead Light
Heart Rate Light
Power Light
Alternating Current (charging)
Direct Current (power connection)
Power Cord Connector Position
In-put / Out-put connection
Modem Port
Remote Alarm Connection
Serial Number
Part Number
Three Electrodes per package
- - -
REF
3
SN
/
FCC Part 68 Notice
The SmartMonitor 2 complies with Part 68 of the FCC Rules. On the bottom of the SmartMonitor 2 are
labels that contain, among other information, the FCC Registration Number and Ringer Equivalent
Number (REN) for this equipment. If requested, this information must be provided to your telephone
company.
The REN is used to determine the quantity of devices that may be connected to your 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 the RENs should not exceed five (5.0). To be certain of the
number of devices that may be connected to the line, as determined by the total number of RENs, contact
the telephone company to determine the maximum RENs for the calling area.
If the SmartMonitor 2 causes harm to the telephone network, the telephone company will notify you in
advance that temporary discontinuance of the service may be required. But if advance notice is not
practical, your telephone company will notify you as soon as possible. Also, you will be advised of your
rights to file a complaint with the FCC if you believe it is necessary.
Your telephone company may make changes in its facilities, equipment, operation, or procedures that
could affect the operation of the equipment. If this happens, your telephone company will provide
advance notice in order for you to make the necessary modifications to maintain uninterrupted service.
If trouble is experienced with the SmartMonitor 2, please contact the Respironics Service Center at 1800-345-6443 for repair and/or warranty information. If the trouble is causing harm to the telephone
network, your telephone company may request that you remove the equipment from the network until the
problem is resolved.
13
How Does the SmartMonitor 2 Work?
Industry Canada CS-03 Notice
NOTICE: The Industry Canada (IC) label on the SmartMonitor 2 identifies certified equipment. This
certification means that the equipment meets certain telecommunications network protective, operational,
and safety requirements as prescribed in the appropriate Terminal Equipment Technical requirements
document (s). The Department does not guarantee the equipment will operate to the user’s satisfaction.
Before installing the SmartMonitor 2, users should ensure that it is permissible to be connected to the
facilities of the local Telecommunications Company. The equipment must also be installed using an
acceptable method of connection. The customer should be aware that compliance with the above
conditions might not prevent degradation of service in some situations.
The Respironics Service Center should coordinate repairs to certified equipment at 1-800-345-6443. Any
repairs or alterations made by the user to this equipment, or equipment malfunctions, may give the
telecommunications company cause to request the user to disconnect the equipment.
Users should ensure, for their own protection, that the electrical ground connections of the power utility,
telephone lines, and internal metallic water pipe system, if present, are connected together. This
precaution may be particularly important in rural areas.
Caution
appropriate electric inspection authority, or electrician, as appropriate.
The Ringer Equivalent Number (REN) assigned to the SmartMonitor 2 provides an indication of the
maximum number of terminals allowed to be connected to a telephone interface. The termination of an
interface may consist of any combination of devices subject only to the requirement that the sum of
Ringer Equivalent Numbers of all the devices does not exceed five (5.0).
: Users should not attempt to make such connections themselves, but should contact the
FCC Part 15
NOTE: 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 when the equipment is operated in a commercial environment. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instruction manual, may cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in which case the user will be
required to correct the interference at his own expense.
14
Getting to Know the Monitor
Getting to Know the Monitor
When you receive the SmartMonitor 2, make sure that you have all the necessary items and that they are
not damaged. Immediately report anything missing or damaged to Respironics.
The standard package should include the following:
SmartMonitor 2
Soft Carrying
Case (not shown here)
Power cord/battery
charger
SmartMonitor 2
Parents’ Guide
Parents’ Guide
Patient Cable
Electrodes
Lead Wires
Electrode belt
Symbol Reference Card
(not shown here)
1 to 2 Phone Jack
Adapter (not shown
here)
SmartMonitor 2 Features
This section describes the physical features of the
SmartMonitor 2 unit.
Top Panel Features
POWER Button
The gray POWER button turns the SmartMonitor 2 on. When
you turn the monitor on, all lights and the alarm come on briefly
and the monitor performs a system test. After a pause,
monitoring will begin.
To turn the monitor off do the following:
Press and hold the blue RESET button.
Press and release the gray POWER button.
Wait 2 seconds, and then release the RESET button.
RESET Button
The blue RESET button resets the alarm lights on the
SmartMonitor 2. It also silences the Memory Full (or Memory
Almost Full) and Low Battery warning alarms. For more
information, see the section on Responding to Alarms. The
RESET button also answers a ringing modem phone call when
in monitoring mode.
Reset
Button
There are two styles of top panels.
Illustrated here are the two different
styles.
reset
power
Power Off/On
Button
Remember that the RESET button will not silence patient or loose lead alarms.
15
Front Panel Features
Getting to Know the Monitor
Patient Input Connector
The Patient Input connector is for
the Patient Cable.
Respiration Lights
The green respiration light blinks
with each breath the SmartMonitor
2 detects. The red apnea light will
come on if the SmartMonitor 2
detects a pause in breathing that is
longer than the limit set by the
physician.
Heart Lights
The green heart light blinks with each heartbeat the SmartMonitor 2 detects. The red high light comes on
when the SmartMonitor 2 detects a heart rate higher than the limit set by the physician. The red low light
comes on when SmartMonitor 2 detects a heart rate lower than the limit set by the physician.
Speaker
The SmartMonitor 2 speaker allows you to hear any alarm that sounds during monitoring.
System Lights
The lights across the bottom of the front panel indicate if the SmartMonitor 2 is working properly:
Light Indicates
Power
Charger
Low battery
Memory Full
Loose lead
The power to the SmartMonitor 2 is on.
The battery charger is on and plugged into the SmartMonitor 2.
The battery power is low and needs to be charged.
The SmartMonitor 2 memory is full or almost full.
An electrode, cable, or lead wire connection is loose at one of the
plug-in-ports or the electrodes are not making good contact with the
patient’s skin.
16
Side Panel Features
Getting to Know the Monitor
LA
Connection
!
RA
Connection
Self-Test Connector
You use the self-test connector when performing a Functional Self-Test to make sure the lead wires,
patient cable, and SmartMonitor 2 are working properly. See the section, Performing a Functional Self-
Test for more information.
Memory Card (Optional)
The Memory Card transfers monitor data out of the monitor to give to the physician. See the section on
Transferring Monitor Memory for more information.
Push button
to remove
Memory Card
d
r
a
C
y
r
Memory Card
o
m
e
M
17
Getting to Know the Monitor
Back Panel Features
Remote Alarm (Optional)
The Remote Alarm allows you to
hear the audible alarms from a
different room.
Modem (Optional)
The SmartMonitor 2 may be equipped with a modem to transfer the SmartMonitor 2 memory to
the physician. See the section on Transferring Monitor Memory for more information. See the
sections on FCC Part 68 and IC CS-03 for information on connecting the modem to the
telephone line.
DC Power
Use the DC Power connector with the power cord/battery charger. Whenever the SmartMonitor 2
is not in portable use (on battery power only) it should be connected to the battery charger.
I/O Connector
This connector connects the SmartMonitor 2 with other devices. Ensure that the devices used do
not exceed SELV (Safety Extra Low Voltage) levels as described in EN60601-1.
.
18
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