Iradimed IRM01 MRI WIRELESS ECG ePOD User Manual LiNQ Operation Manual

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Document ID	3331667
Application ID	82h85DZrhv7+wi9wgrRzYQ==
Document Description	User Manual Part 2
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Date Submitted	2017-03-24 00:00:00
Date Available	2017-09-20 00:00:00
Creation Date	2017-03-13 15:20:56
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Document Title	LiNQ Operation Manual
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Document Author:	Kevin Jirka

•
•
Do not place the NIBP cuff over a wound, as this can cause further injury.
Do not place the NIBP cuff on the same or adjacent arm to a mastectomy, or where the
lymph nodes were removed, or if a shunt is on that arm. This can lead to bruising,
inaccurate readings, or negatively impact the drainage of fluids because of temporary
interference to blood flow.
CAUTION
• Only use recommended MRI NIBP cuffs and tubing identified in section 9.2.
• In AUTO Mode, the monitor displays results of the last measurement until another
measurement starts. If a patient's condition changes during the time interval between
measurements, the monitor will not detect it.
• Excessive patient motion may cause inaccurate measurements. Minimize motion to
improve blood pressure measurements.
• Avoid crimping or undue bending, twisting, or entanglement of the NIBP hose.
6.4.1.1. Limitations
The following factors may affect the accuracy of measurement:
• Heart rate extremes of less than 40 bpm or greater than 240 bpm
• A regular arterial pressure pulse is hard to detect
• Cardiac arrhythmias
• Physical movement (patient or imposed)
• Rapid blood pressure changes
• Severe shock or hypothermia that reduces blood flow to the peripheries
• Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming
from the artery
• Edematous extremity
6.4.2.
Understanding the Display





1.
2.
3.
4.
5.
6.
7.



Measurement Unit (mmHg or kPa)
Current Mean Pressure upper and lower alarm limits
NIBP cuff pressure when inflating
Time until next NIBP Measurement (minutes : seconds or manual)
Current Systolic Pressure upper and lower alarm limits
Most recent NIBP reading
Current Diastolic Pressure upper and lower alarm limits
6-25
6.4.3.
NIBP Patient Application
When positioning the patient, routine NIBP measurements (including for the condition
hypertension) require the patient to remain silent, still and relaxed, with legs uncrossed and
arms supported. Note that during MRI procedures, patients are typically lying down with their
legs uncrossed and arms supported as needed for the MRI scan. A five minute waiting period
is recommended before starting readings. Ensure that the cuff is at the level of the right atrium
of the heart.
1. Verify that the patient type is correct. Change it if necessary.
2. Ensure tubing is connected to the 3880 monitor
3. Select a correct sized cuff and then apply it as follows:
a. Determine the patient’s limb circumference.
b. Select an appropriate cuff by referring to the limb circumference marked on the
cuff. The width of the cuff should be 40% (50% for neonates) of the limb
circumference, or 2/3 of the upper arm’s length. The inflatable part of the cuff
should be long enough to encircle at least 50% to 80% of the limb.
c. Apply the cuff to an upper arm or leg of the patient and make sure the marking
on the cuff matches the artery location. Do not wrap the cuff too tightly around
the limb. It may cause discoloration, and ischemia of the extremities. Make sure
that the cuff edge falls within the marked range. If it does not, use a larger or
smaller cuff that will fit better.
4. Connect the cuff to the air tubing and make sure that the bladder inside the cover is not
folded and twisted
5. Press the START/STOP button to initiate a blood pressure reading. Hold TART/STOP
button down for three seconds to initiate a STAT burst of three successive NIBP
readings.
NOTE
• Automatic NIBP readings will not cycle when the monitor is in Standby
6.4.3.1. Setup Checklist
•
•
•
•
The hose is correct.
The connector is firmly pushed inside the cuff tube.
The NIBP hose is properly connected to the module and will not detach if pulled.
The NIBP cuff is correct for the patient’s limb size.
6-26
•
•
•
•
•
•
•
6.4.4.
There are no holes or cracks in the cuff bladder or cuff tube.
All residual air is squeezed out of the cuff before wrapping it around the arm.
The symbol indicating the center of the bladder is over the artery.
The cuff is not loose.
The cuff is at heart level.
The cuff tubes or NIBP tube are not kinked or squeezed together.
Non-invasive blood pressure is selected to be displayed through Monitor Setup patient
parameters menu.
Changing Frequently Used NIBP Settings
6.4.4.1. Manual NIBP Mode
To adjust the NIBP mode between manual and automatic follow these steps:
1. Touch the NIBP vital sign numerical box to bring up the NIBP menu
2. For manual mode set the “Auto Cycle Time” to OFF
3. Touch Back button to close the menu
6.4.4.2. Automatic NIBP Interval Mode
To adjust the NIBP intervals for the Automatic settings follow these steps.
1. Touch the NIBP vital sign numerical box to bring up the NIBP menu
2. Select “Auto Cycle Time” to show drop down: OFF, 3 min, 5 min, 8 min, 10 min, 15 min,
30 min
3. Make your selection
4. Touch Back button to close the menu
6.4.5.
NIBP Alarm Limits
Low Limit
Range
Default
Low
Default
High
High Limit
Range
Off, 30-270
Off, 10-245
Off, 20-255
90
50
60
160
90
110
30-270, Off
10-245, Off
20-255, Off
Off, 30-270
Off, 10-245
Off, 20-255
70
40
50
120
70
90
30-270, Off
10-245, Off
20-255, Off
Off, 30-130
Off, 10-100
Off, 20-120
40
20
25
90
60
70
30-130, Off
10-100, Off
20-120, Off
Adult
systolic
diastolic
mean
Pediatric /Infant
systolic
diastolic
mean
Neonatal
systolic
diastolic
mean
6-27
6.4.6.
NIBP Messages
Message
NIBP Inop
NIBP Over Press
NIBP Time Out
NIBP Leak
Wrong Cuff
NIBP Occlusion
NIBP Cal Error
NIBP Delayed
Trigger Condition
Hardware or software failure detected
Pressure exceeds 300 mmHg for Adult / Ped or 150 mmHg for Neonatal patients
-or15 mmHg remains in the line for Adult / Ped or 5mmHg for Neo for greater than 90 seconds
Pressure remains the same for more than 30 seconds or if measurement exceeds 180 seconds
Air leak is detected
Displayed if the NIBP system detects an incorrect cuff size for the selected patient mode
Occlusion is detected
Calibration error detected
NIBP reading start has been delayed to allow blood flow to resume
6.5. Temperature Monitoring
6.5.1.
Temperature Overview
The 3880 system features a unique and innovative temperature measurement system
supporting surface temperature readings.
6.5.1.1. Temperature Sensor
The fiber-optic temperature sensor is used for the measurement of patient body temperature
using axillary sensing tip placement.
WARNING
• Frequent medical attention to the sensor axilla site for possible pressure tissue necrosis
should be given during longer term monitoring sessions (4 hours or more), especially on
tender skin of neonatal patients.
CAUTION
• The fiber-optic temperature sensors are constructed of fiber-optic glass and must
always be handled with care to prevent damage. Improper handling can result in
inaccurate readings.
6.5.1.2. Limitations
The following factors may influence the accuracy of measurement:
• Sensors access to ambient temperature or drafts
• Do not bend the fiber optic sensor in a radius of less than 15 mm
• Do not expose to temperature above 50○C
• Do not pull or apply tension to the fiber-optic cable
• Do not alter or modify the accessories
6.5.2.
Understanding the Display
6-28


1.
2.
3.
4.
6.5.3.


Measurement Unit
Current Vital Sigh
Alarm Limits
OVR/UND for Temp extended range <30.0 °C or >44.0 °C(<86.0°F or >111.2°F ),
accuracy ± 0.4 °C
Temperature Patient Application
6.5.3.1. Surface Temperature Application
Perform the following procedure to apply the fiber-optic temperature sensor to a patient:
1. Carefully uncoil the sensor, avoid knotting or kinking the fiber optic cable
2. Inspect sensor for damage, including tears or deformations
3. Thoroughly clean and dry the axilla or groin application site
4. Position the sensor tip at the application site
5. Secure sensor with some medical tape
6. Cover application site to block air drafts
WARNING
• Avoid the use of any metalized foil temperature probe covers, or hydrogel backed probe
covers, as excessive RF heating could occur resulting in inaccurate temperature
measurements and/or burns.
NOTE
• There is a temperature difference between surface temperature and patient body (core)
temperature.
• When monitoring temperature during MRI procedures, the radio frequency (RF) energy
may normally increase the patient’s body temperature.
6.5.3.2. Setup Checklist
•
•
•
6.5.4.
Temperature cable is properly inserted into the 3880 system
Temperature sensor is applied and positioned correctly
Temperature sensor is not damaged in any way
Changing the Temperature Settings
6.5.4.1. Units
The temperature format can be in Celsius or Fahrenheit. To adjust the units follow these steps:
1. Touch the Temperature vital sign box
2. Select “Unit”
3. Make your selection
4. Touch Back button to close menu
6-29
6.5.5.
Temperature Alarm Limits, Celsius
Adult Temp
Pediatric Temp
Neonatal Temp
6.5.6.
Default Low
36
36
36
Default
High
39
39
39
High Limit
Range
25-40, Off
25-40, Off
25-40, Off
Temperature Messaging
Message
Temp Inop
Temp Probe Fail
OVR / UND
6.5.7.
Low Limit
Range
Off, 25-40
Off, 25-40
Off, 25-40
Trigger Condition
Hardware or software failure detected
Broken sensor detected or a sensor is not attached properly
Indicating Temp extended range < 30.0 °C or > 44 C°(<86.0°F or
>111.2°F )
accuracy ± 0.4 °C
Connecting the Sensor
The fiber optic temperature sensor utilizes a keyed twist locking connector to securely mate to the
temperature connection port on the right side of the 3880 Monitor unit. Rotate the sensor
connection while gently pushing into the mating connection on the monitor. Once the keyway
has slide into the m ating slot,turn the outer shell≈30°to lock into place.
6.5.8.
Temperature reference measurement
A baseline temperature measurement should be made once the fiber optic temperature sensor is
applied and before starting the MR image scan, which should be used as a reference for the
temperature measured during the scan.
6-30
7. Using the Recorder
The optional 3885-B Base Station recorder provides hard copies of up to two waveforms and
trend information.
NOTE
• The 3880 MRI Patient monitor does not have an internal recorder. Printing can only be
done if the system is communicating with the optional 3885-B Base Station. The Base
station unit houses and drives the strip chart recorder in response to Record or Print
requests from the 3880 Monitor or 3885-T Remote Tablet hard (Record) and soft (Print)
keys.
7.1. Loading Paper
To load paper into the recorder review section 2.2.9 for details.
7.2. Recorder Setup Menu
7.2.1.
Trace 1
The optional recorder can print one or two waveforms of ECG, SpO2, CO2 waveforms. When
Trace 1 and 2 are selected to print, Trace 1 will appear on the top of the paper. To adjust which
waveform you want to print when the Print button is pressed follow these steps:
1. Press the SETTINGS button
2. Select “Recorder Setup”
3. Select “Trace 1”
4. Select desired waveform to print
5. Touch Back button to close the menu
7.2.2.
Trace 2
The optional recorder can print one or two waveforms of ECG, SpO2, CO2 waveforms. When
trace 1 and 2 are selected to print, Trace 2 will appear on the bottom of the paper. To adjust
which waveform you want to print when the Print button is pressed follow these steps:
1. Press the SETTINGS button
2. Select “Recorder Setup”
3. Select “Trace 2”
4. Select desired waveform to print or select OFF to print a single waveform
5. Touch Back button to close the menu
NOTE : Each vital sign parameter must be set ‘ON’ to allow recording of its trace. Also,
with ECG, two leads must be on display (display Trace A and B) and set for recording,
to record ECG Trace 2.
7.2.3.
Waveform Trace delay
Trace delay allows users to set a time delay before the waveform data is sent to the recorder.
This can account for the time delay between when a user decides to print and when they
actually depress the button. The delay options are 0, 4, 8 and 16 seconds.
To adjust the trace delay follow these steps:
1. Press the SETTINGS button
2. Select “Recorder Setup”
7-31
3. Select “Trace Delay”
4. Select desired delay
5. Touch Back button to close the menu
7.2.4.
Auto Strip
Auto strip allows the automatic report feature of the recorder to be switched ON and OFF. The
auto strip will automatically print when a clinical alarm is detected.
To enable the Auto Strip follow these steps:
1. Press the SETTINGS button
2. Select “Recorder Setup”
3. Toggle “Auto Strip” ON and OFF
4. Touch Back button to close the menu
7.2.5.
Run Time
Recorder Run Time allows users to adjust the length of time the recorder prints when activated.
The options are 8, 12, 16, 20 and 30 seconds.
To adjust the waveform Record Run Time follow these steps:
1. Press the SETTINGS button
2. Select” Recorder Setup”
3. Select “Run Time“
4. Select desired time
5. Touch Back button to close the menu
7.2.6.
Recorder Sweep Speed
The Sweep Speed switches the recorder speed between 25 and 50 mm/second.
To adjust recorder Sweep Speed follow these steps:
1. Press the SETTINGS button
2. Select “Recorder Setup”
3. Select “Speed”
4. Select desired speed
5. Touch Back button to close the menu
7.2.7.
To manually start a strip chart recording
Press the front panel “Record” hard key at either the 3880 Monitor or 3885-T Remote Tablet.
7.2.8.
Recorder Output
The strip chart recorder output will be the waveform Trace or Traces selected in the Record
Setup along with the selected delay and run time, with the text printout of all active vital signs
values. The vital signs, such as HR, SpO2, Blood Pressure, GAS measurements, and
Temperature print on the paper in a table at conclusion of the strip run time.
7.3. Printing
7-32
The term “Printing” is used herein to refer to using the strip chart recorder as a printer of text
and numeric information, such as the Tabular Trend table. Strip “Recording” is a specialized
print out of waveform data as described in 7.2.7 and 7.2.8 above. See section 5.5 for instruction
to print Trends.
7-33
8. Pre-Use Operator Verification, Troubleshooting and User
Maintenance
8.1. Overview
Check the following items prior to monitoring to ensure completion of all essential preparations.
Items that are broken, missing, plainly worn, distorted, or contaminated must be replaced
immediately. The 3880 system must not be repaired other than in accordance with written
instructions provided by IRadimed. The device shall not be altered without written approval of
IRadimed. The user has the sole responsibility for any malfunction which results from improper
use, faulty maintenance, improper repair, damage or alteration by anyone other than IRadimed
authorized personnel.
WARNING
• For proper equipment performance, maintenance and service procedures should be
performed at the recommended intervals as described in the monitor’s service manual.
NOTE
• The IRadimed software design controls include performance of a risk analysis using
methods consistent with ISO 14971 Medical devices - Application of risk management to
medical devices. The 3880 system employs watchdog timers, self-monitoring activities
(memory, communication and sensor checks and so on), and power-on self-diagnostics
(for example, memory checksums).
8.1.1.
Battery Life Expectancy
Life expectancy of a battery depends on how frequent and how long it is used. For properly
maintained and stored batteries, the life expectancy is about 2 or 3 years respectively. For more
aggressive and non-traditional use models, the life expectancy maybe less. IRadimed
recommends replacing batteries every 2 to 3 years or when signs of wear or operation are
noticeably different.
To get the most out of your batteries observe the following guidelines:
• The battery performance test must be performed every year, before monitor repairs, or
whenever the battery is suspected as being the source of the problems.
• Take out the battery before the monitor is shipped or will not be used for more than 3
months.
• The shelf-life of a Lithium Polymer battery is about 6 months when the battery is stored
with the battery power being 50% of the total power.
8-1
8.1.2.
Checking a Battery
The user replaceable battery packs utilized in the 3880 patient monitor can be checked outside
of the monitor. This feature allows facilities with multiple batteries to proactively select a battery
that has a desired charge level prior to inserting it into the system. To check a batteries charge
follows these steps:
1. Locate the button on the rear corner of the battery (1)
2. Depress the button and the LED indicators will momentarily show the charge status. (2)


8.2. Performance Checks
8.2.1.
Daily in between tasks
•
•
•
•
•
•
•
•
•
•
•
•
•
8.2.2.
Check that system components and accessories do not have any visual defects such as
cracks or loose parts.
Check that the system components as described in the Care and Cleaning 8.4 part of
this section were cleaned properly after the previous use.
All supplies and accessories are not passed their expired date.
Check that batteries are properly inserted and charged.
Ensure all system components are wirelessly communicated
Wipe the monitor, PODs and accessory surfaces
Change all airway patient accessories.
Ensure that you are using correct accessory sizes for each patient and that they are
properly connected.
Check that all accessories, cables and monitor parts are clean and working properly.
Check that you have selected desired parameters to be displayed in digit and waveform
fields.
Check that the trends of the previous patient are erased.
Monitor patient type mode and alarm limits are suitable for the patient.
Check the compatibility of the 3880 monitor, sensors and cables before use
Regular Inspection and Verification
Wireless Communication
• Place the PODs and 3880 Monitor inside the MRI room suite with the door shut. Place
the 3885-T Remote Tablet in the control room in its desired location and check that the
communication performance is acceptable.
ECG
• Check that the message 'Leads Off' disappears and the waveforms are displayed when
the lead wires are connected to the patient.
Pulse Oximetry
• Check that the Red Light is visible in the sensor
• Check that the SpO2 value is displayed and the message “Probe Off” disappears when
the sensor is connected to the patient
CO2 (CO2 only or 3886 Multi-Gas system)
8-2
•
Occlude the sampling line and check that the message “Occlusion” appears within 30
seconds
NIBP
• Check that the pressure values are displayed for all cuff sizes
Temperature
• Check that the temperature value is displayed when the cable is connected
Recorder
• Check that the strip chart recorder is functional
Alarms
• Turn the monitoring system on and check that the Red, Amber and blue Tri-Color TriColor Alarm Dome Light are lit momentarily
• Check that the speaker gives and audible tones at the desired level
• Use a conventional patient simulator and / or test gasses to verify alarm functionality.
When a problem with the alarm system is suspected, always refer the monitor to a
qualified service personnel.
Battery
• The battery pack should be inspected anytime the battery pack is removed. Look for
signs of physical damage, shock and swelling. Check that the battery pack is holding
sufficient operating capacity.
• Check that the battery is communicating with the monitor by observing the battery icon
on the display.
8.2.3.
CAUTION
• Any failure of the inspection of the battery pack will require discontinuance of use and
replacement will be needed.
• If any cells swollen greater than 8 mm thick or cause the plastic case to bulge
discontinue use and contact your support personnel for proper disposal.
Every Twelve Months
Preventative Maintenance Check
• Calibration check of temperature, NIBP and CO2/ Multi-Gas Agents Unit
NOTE
• The annual check according to detailed instructions of the Service Manual requires
trained service personnel and appropriate testing tools and equipment.
• Verify all calibration / test gas mixture containers are empty before disposal.
• Use only MRI compliant calibration / test gas mixture containers suitable for use in the
MRI environment for verification of gas readings inside of zone IV.
8.3. Service Setup Menu
8.3.1.
Software Version
To check the current revision of software in the 3880 system, PODs and Tablet follow these
steps:
1. Press the SETTINGS Button
2. Select “Service Mode”
3. Enter password
4. Select “Device Information”
5. Check software version
6. Touch Back button to close the menu
8-3
8.4. Care and Cleaning
8.4.1.
Introduction
For safe and reliable function and operation of the monitor, regular care has to be carried out in
accordance with manufactures guidelines. Use only manufactures approved substances and
methods to clean and disinfect your equipment. The warranty does not cover damage caused
by unapproved substances or methods.
IRadimed makes no claims regarding the efficacy of the listed chemicals or methods as a
means for controlling infection.
NOTE
• If the monitoring system does not function as it should and troubleshooting cannot solve
the problem, contact your service representative.
• Detailed cleaning instructions provided with any accessory should be followed.
8.4.2.
General Guidelines
Keep your equipment and accessories free of dust, dirt and contaminants. To avoid damage to
the 3880 monitor follow these rules:
• Always dilute liquid cleaning agents according the manufacturer’s instructions or use
lowest possible concentration.
• Do not immerse part of the 3880 monitor into liquid.
• Do not pour or use pressurized spray liquid onto the 3880 monitor or accessories.
• Do not allow liquid to enter the case.
• Never use abrasive materials, solvent or corrosive cleaners.
• Clean the 3880 monitor in a well-ventilated area before and after each patient use.
• Allow components to dry completely prior to use.
• A soft bristled brush may be used to clean narrow areas.
• Do not use hard or pointed objects to clean any part of the monitor.
WARNING
• Be sure to shut down the system and disconnect all power cables from the outlets
before cleaning the 3880 monitor.
• Do not use unspecified cleaners, materials or methods as they may damage the device,
labels or cause failures.
• Do not use conductive solutions or materials to clean the system.
• Do not reuse sensors intended for single patient use.
CAUTION
• If liquid is spilled on the 3880 monitor or accessories and may have entered the system
immediately contact your service personnel.
• Do not use solvent based cleaning agents as damage to the plastic parts could occur.
NOTE
• Before cleaning any equipment, consult your hospital’s regulations for cleaning
• Refer to any superseding instructions accompanying any accessories or options.
8-4
8.4.3.
Cleaning & Disinfecting
The 3880 system should be cleaned on a regular basis. If there is heavy pollution and/or lots of
dust and sand at/in your facility, the 3880 monitor should be cleaned more frequently.
Recommended cleaning agents are:
• Mild Soap (diluted)
• Ammonia (diluted)
• Isopropanol (70%)
• Chloramine (5%)
• Glutaraldehyde (2%)
• Ethyl Alcohol Based (60-95%)
• Chlorine/Bleach Based (4-6%)
• Iodine Based (0.5-5%)
• Phenols (0.2-3%)
• Quaternary Ammonium Compounds (2%)
• Hydrogen Peroxide (<3%)
To clean the 3880 monitor, follow these rules:
1. Shut down the patient monitor and disconnect it from power.
2. Clean the displays using a soft, clean cloth dampened with glass cleaner.
3. Clean the exterior surface of the 3880 monitor using a soft cloth dampened with an
approved cleaner.
4. Wipe the cleaning solution off the 3880 monitor with a dry cloth.
NOTE
• Disinfection may cause damage to the 3880 monitor and is therefore not recommended
unless otherwise indicated in your hospital’s policy. Cleaning the 3880 monitor prior to
disinfecting is recommended.
8.4.4.
Sterilizing
Sterilization may cause damage to the 3880 monitor and is therefore not recommended. The
decision to sterilize components must be made per your institution’s requirements with an
awareness of the effects on the integrity of the cables and potential hazards that it may cause.
8.4.5.
Cleaning the Recorder Printhead
After the recorder has been used for a long time, deposits of paper debris may collect on the
printhead compromising the print quality and shortening the lifetime of the roller. Follow this
procedure to clean the printhead:
1. Open the Recorder door
2. Gently wipe around the printhead using cotton swaps dampened with alcohol.
3. After the alcohol has complete dried, reload the paper and close the door.
CAUTION
• Do not use anything that may destroy the thermal print head.
• Do not add unnecessary force to the thermal print head.
8-5
8.5. User Maintenance
8.5.1.
Overview
Before every use, a thorough inspection should be performed.
Follow these guidelines when inspecting the 3880 monitor:
• Make sure that the environment and power supply meet the requirements.
• Inspect the 3880 system and its accessories for mechanical damage.
• Inspect all power cords for damage, and make sure that their insulation is in good
condition.
• Make sure that only specified accessories are applied.
• Inspect if the alarm system functions correctly.
• Make sure that the recorder functions correctly and the recorder paper meets the
requirements.
• Make sure that the patient monitor is in good working condition, and batteries have
sufficient charge.
In case of any damage or abnormity, do not use the patient monitor. Contact the hospital’s
biomedical engineers or your authorized IRadimed service personnel immediately.
8.5.2.
Updating Software
As revisions of the software become available, the 3880 can be updated, see service manual
for detail procedure.
8.6. Troubleshooting Problems With No Onscreen Message
The following section is for troubleshooting the 3880 system when there is no corresponding
message displayed on the screen. If a message is displayed on the screen please review Exhibit B of
the operators manual. Please contact IRadimed Technical support at (407) 677-8022 if you need
assistance troubleshooting or are unable to resolve any issues.
8.6.1.
Troubleshooting Power Related Problems
Problem
3880 will not turn on.
Possible Cause
Power dial is not in the
correct position
No AC power/battery
depleted.
1)
1)
2)
3)
Solution
Turn 3880 ON by
rotating the power
dial to the ON
position.
Plug AC Adapter
power cord into a
working AC outlet
immediately.
Plug AC Adapter
into the circular
power receptacle on
the rear of the
device.
Optional Swap low
battery with a fully
charged battery.
8-6
Problem
Possible Cause
Blown Fuse(s).
AC power source has
incorrect voltage.
Screen Damaged.
3885-T will not turn on.
Power ON [ I] key not
pressed.
Battery depleted.
Solution
1) Replace the fuse in
the power supply
box (P/N 1120).
Refer to the service
manual for proper fuse
type and procedure.
1) Switch AC power
cord to a power
receptacle with
sufficient voltage.
Refer to the service
manual for voltage
requirements.
If an audible alarm is
heard and the alarm
dome light changes
when the power ON
button is pressed.
1) Investigate the LCD
display screen for
failure.
2) Contact IRadimed
technical support.
1) Turn 3885-T ON by
firmly pressing the
ON button firmly.
Listen and feel for
the tactile feedback
to confirm the button
has been properly
pressed.
1) Plug AC Adapter
power cord into an
AC outlet
immediately.
2) Plug AC Adapter
into the circular
power receptacle on
the rear of the
device.
3) Optional: Swap low
battery with a fully
charged battery.
8-7
3
Problem
3885-B will not turn on.
Possible Cause
Power ON key not
pressed.
Blown Fuse(s).
No AC power
AC power source has
incorrect voltage.
3886 will not turn on.
Power ON key not
pressed.
Blown Fuse(s).
No AC power
Solution
1) Toggle the power
switch to the ON
position.
Listen and feel for
the tactile feedback
to confirm the button
has been properly
pressed.
1) Replace the fuse in
the rear of the 3885T
Refer to the service
manual for proper fuse
type and procedure.
1) Plug AC Adapter
power cord into a
working AC outlet
immediately.
1) Switch AC power
cord to a power
receptacle with
sufficient voltage.
Refer to the service
manual for voltage
requirements.
1) Toggle the power
switch to the ON
position.
Listen and feel for
the tactile feedback
to confirm the button
has been properly
pressed.
1) Replace the fuse in
the rear of the 3885T
Refer to the service
manual for proper fuse
type and procedure.
1) Plug AC Adapter
power cord into a
working AC outlet
immediately.
8-8
Problem
ePOD or oPOD will not
turn on
Possible Cause
AC power source has
incorrect voltage.
Power ON key not
pressed.
Insufficient battery life
Solution
1) Switch AC power
cord to a power
receptacle with
sufficient voltage.
Refer to the service
manual for voltage
requirements.
1) Toggle the power
switch to the ON
position.
1)
2)
3)
4)
3880 will not operate
on battery.
Battery not properly
charged.
1)
2)
3)
4)
Listen and feel for
the tactile feedback
to confirm the button
has been properly
pressed.
Plug 3880 system
into AC power.
Ensure the POD is
correctly docked and
seated into a
charging bay on the
3880 monitor.
Allow to charge a
minimum of 4 hours.
Contact IRadimed
Technical Support
Plug AC Adapter
power cord into an
AC outlet
immediately.
Plug AC Adapter
into the circular
power receptacle on
the rear of the
device.
Wait until battery is
fully charged.
Press the button on
the exterior of the
battery pack. If no
LED’s illuminate
replace the battery
pack before use.
8-9
Problem
Possible Cause
Aged battery won't hold
charge.
Battery is in sleep
mode.
Short battery run time.
Battery not charged
long enough.
Solution
1) Plug AC Adapter
power cord into an
AC outlet
immediately.
2) Plug AC Adapter
into the circular
power receptacle on
the rear of the
device.
3) Wait until battery is
fully charged.
4) Press the button on
the exterior of the
battery pack. If no
LED’s illuminate
replace the battery
pack before use.
When the battery test
button is pressed and
no lights illuminate.
1) Insert the dead
battery into a 3880
or 3885-B that is
already turned on
and connected to
AC power.
2) If battery doesn’t
wake up after 1 hour
of charge dispose of
it according to
policy.
3) Replace the battery
prior to putting the
3880 back in use.
1) Plug AC Adapter
power cord into an
AC outlet
immediately.
2) Plug AC Adapter
into the circular
power receptacle on
the rear of the
device.
3) Check battery by
pressing the test
button on the battery
(1133 battery only).
Note: The batteries will
charge at a faster rate
when the 3880 is turned
off.
8-10
Problem
Battery is hard to
remove.
8.6.2.
Possible Cause
Aged battery will not
hold charge.
Swollen Battery Cells.
Troubleshooting Alarm Related Problems
Problem
No Audible alarm tone
heard.
Possible Cause
Alarm volume set too low
for the use environment.
Faulty alarm speaker.
Solution
1) Plug AC Adapter
power cord into an
AC outlet
immediately.
2) Plug AC Adapter
into the circular
power receptacle on
the rear of the
device.
3) For 1133 batteries
only. After a few
hours of charge
check battery by
pressing the test
button on the
battery.
4) If problem persists
dispose of the
battery according to
policy.
5) Replace battery or
POD with a new
one.
6) If problem persists,
contact IRadimed
technical support.
Return the device to
IRadimed for battery
removal.
Continuous alarm tone
after alarm silence is
pushed.
Faulty hardware.
Solution
1) Press the Settings
Button.
2) Select Alarms
Function
3) Adjust alarm volume
for the intended use
environment.
1) Contact IRadimed
Technical Support.
1) Note any onscreen
messages.
2) Contact IRadimed
technical support.
8-11
3
Problem
The unit is in Alarm mode
with lights flashing but
no audible alarms can be
heard.
Possible Cause
The 2 minute Alarm
Silence button is
activated.
Audible volume set too
low to be heard.
8.6.3.
Problem
Buttons will not function.
Possible Cause
Key not pressed firmly.
Programmed settings are
restored to default on
power up.
3880 turned off for
longer than 30 seconds
between uses.
Volatile memory may not
store due to internal Coin
cell battery problem.
After two minutes, alarm
tones will automatically
re-engage.
1) Press the Settings
Button.
2) Select Alarms
Function
3) Adjust alarm volume
for the intended use
environment.
Troubleshooting Operation Related Problems
Faulty key panel.
Solution
1) Press the
ALARMSILENCE
button to re-engage
alarm volume.
2) Or wait for two
minutes.
Clock is not correct.
Clock not properly
adjusted to local time
after receipt.
Internal coin cell battery
has become depleted.
Summer/Winter time
change.
Solution
1) Repeat key press
more firmly.
Listen for audible and feel
for the tactile feedback to
confirm the button has
been properly pressed.
If the above 2 solutions
are acceptable contact
IRadimed Technical
Service.
1) Train appropriate
personnel that
turning off the 3880
for more than 30
seconds resets
settings.
1) Replace CR2032
coin cell battery.
2) Contact IRadimed
Technical Service.
1) Adjust clock time as
described in manual.
1) Replace CR2032
coin cell battery.
2) Contact IRadimed
Technical Service.
1) Adjust clock as
described in service
manual.
8-12
4
Problem
3885-T Remote will not
communicate to a
selected 3880 or drops
out.
Possible Cause
3880 is not turned ON.
3880 is not within
wireless range.
1)
1)
2)
Software incompatibility.
1)
Incorrect Channel.
1)
2)
3)
4)
Multiple system
components on the same
wireless network
channel.
1)
Loose or damaged
antenna.
1)
1)
Local radio interference
prevents communication.
1)
Solution
Ensure the 3880 is
turned on and is
operational.
Verify 3880 and
3885-T within 90 ft
(30 m) of 3885-B
and that no other
devices are blocking
the wireless signal.
Reposition 3880 to
establish
communication as
needed.
Ensure the software
revisions for the
3880 and 3885-T are
equal.
Ensure that both the
3885-T, 3885-B and
3880 are operating
on the same
wireless network
channel.
Record wireless
network from the
3880.
Select matching
wireless channel on
3885-T
Select matching
wireless channel on
3885-B.
Ensure that each
3880 in your facility
are on separate,
unique channels (or
not used
simultaneously).
Ensure that the
antennas on the
3885-B are in good
working order and
are attached tightly.
Ensure other
wireless equipment
is greater than 3 feet
away from the 3880
system components.
Try using a different
wireless network
channel for the 3880
system to
communicate on.
8-13
Problem
Possible Cause
MRI Room Attenuation.
1)
2)
3)
4)
ePOD or oPOD will not
communicate with a
3880
3880 is not turned ON.
1)
3880 is not within
wireless range.
1)
2)
Incorrect Channel.
1)
2)
3)
4)
Printer will not print
Multiple system
components on the same
wireless network
channel.
1)
Wireless communication
to the 3885-B
1)
Solution
Ensure the high gain
antenna is attached
to the correct
receptacle on the
3885-B
Position the high
gain antenna so it
has a direct line of
sight to the 3880.
Try a different
wireless channel
Contact IRadimed
Technical Service.
Ensure the 3880 is
turned on and is
operational.
Verify PODS are
within 9 ft (3 m) of
3880 and that no
other devices, walls
or doors are blocking
the wireless signal.
Reposition 3880 to
have a line of sight
to the PODS as
needed
Ensure that the
ePOD, oPOD and
3880 are operating
on the same wireless
network channel.
Record wireless
network from the
3880.
Select matching
wireless channel on
3881 ePOD
Select matching
wireless channel on
3882 oPOD.
Ensure that each
3881 and 3882 in
your facility are on
separate, unique
channels that match
a corresponding
3880 (or not used
simultaneously).
Ensure wireless
connection is
established to a
3885-B equipped
with a recorder
8-14
Problem
8.6.4.
8.6.5.
Solution
1) Review section 7 of
the operators
manual
Troubleshooting MRI Related Problems
Problem
Artifact on MR images.
Possible Cause
Printer out of paper or
paper jam
Possible Cause
Loose connection to cord
when running on AC
power.
Solution
Tighten AC cord connection
to Monitor and power
supply.
Faulty Hardware.
1) Switch to battery
power.
2) Disconnect the power
cable from the 3880
monitor.
3) Disconnect AC power
cord from the AC
outlet in the MRI room.
4) Inspect components
damage.
5) Remove all power
cables from the room.
6) If artifact disappears
then replace faulty
hardware.
7) If artifact is still present
repeat steps for the
3886.
8) If artifact still appears
contact IRadimed
technical service.
Troubleshooting Vital Sign Related Problems
Problem
ECG Vital Signs are not
performing as expected
Possible Cause
Solution
1) Ensure the ePOD is
on the same
wireless network
channel as the 3880.
2) Ensure the ECG
parameter is
enabled.
3) Inspect all ECG
components for
damage and replace
as necessary.
4) Review section 6.1
of the operators
manual
5) Contact your local
representative to
schedule
applications training.
8-15
Problem
Possible Cause
Incompatible lead view
for the MRI scan and/or
electrode placement
Poor skin preparation
Poor electrode
placement
Poor electrode quality
Weak radio link
QRS amplitude is less
than 10 mm/mv
Faulty ECG ePOD
Incorrect ECG Mode
selected
Patient motion
ECG lead not properly
inserted into the ePOD
Damaged ECG lead
Solution
Change the ECG lead view
to select the best
performing view for the
sequence.
Re-prep the patient
according the application
procedure found in
section 6.
Reposition/replace
electrodes according to
the application procedure
found in section 6.
Replace the electrode with
an IRadimed approved
electrode.
Verify radio channel
setting and signal level.
Reposition antenna for
improved reception.
Change the lead view and
/ or reprep and reposition
the electrodes.
Replace ECG module, or
refer to qualified technical
service representative.
Select the appropriate
ECG filter mode for the
application. Refer to
section 6 of the operators
manual.
Ensure that the patient is
not shivering or moving.
Ensure each ECG leadwire
is inserted completely into
the ePOD.
Replace ECG lead with an
IRadimed approved ECG
lead.
8-16
Problem
SpO2 not functioning
Possible Cause
All other issues
SpO2 sensor is not
attached to the patient.
Poor SpO2 sensor
placement
Weak radio link
Faulty SpO2 oPOD
SPO2 readings are
unstable or poor
Sensor positioning
Averaging time
Patients specific anatomy
Cool temperature is
affecting patients
perfusion
Solution
1) Ensure the ePOD is
on the same
wireless network
channel as the 3880.
2) Ensure the ECG
parameter is
enabled.
3) Inspect all ECG
components for
damage and replace
as necessary.
4) Review section 6.1
of the operators
manual
5) Contact your local
representative to
schedule
applications training.
Ensure SpO2 sensor is
securely attached.
Reposition/replace SpO2
sensor according to
section 6.
Verify radio channel
setting and signal level.
Reposition antenna for
improved reception.
Replace SpO2 oPOD, or
refer to qualified technical
service representative.
Check the P.I. value and
try repositioning the
sensor correctly on the
patient according to
section 6.
Ensure the SpO2 cable is
correctly inserted into the
SpO2 applicator / grip.
Try adjusting the SpO2
averaging time.
Skin pigment and certain
anatomy ailments can
cause inconsistent SpO2
readings.
Check that there is no nail
polish on the patients digit
impeding the readings.
Check the P.I. value and
ensure the patient is not
shivering and that their
digits are warm to the
touch.
8-17
Problem
Possible Cause
interference from NIBP
cuff or arterial catheter.
Excessive ambient light
Excessive patient motion
Circulation is reduced
because of excess
pressure
Finger was removed from
the sensor
SpO2 Vital Signs are not
performing as expected
All other issues
CO2 not functioning
Sampling line hose is not
connected
Leaking sampling line
hose
Sampling line filter is wet
or clogged
Values are too low or
unstable
Monitor has an internal
leak
Monitor has an internal
failure
Solution
Move the SpO2 sensor to
an application site and
limb that is not being
utilized for other medical
functions.
Limit the amount of
ambient light entering the
sensors. Cover with a cloth
as needed.
Ensure that the patient is
not shivering or moving.
Position the sensor at a
different site and ensure it
is not applied to tightly to
the patients digit.
Check that the
appropriate sized sensor is
being used and reapply
according to section 6.
1) Ensure the SpO2
parameter is
enabled.
2) Inspect all SpO2
components for
damage and replace
as necessary.
3) Review section 6.2
of the operators
manual.
4) Contact your local
representative to
schedule
applications training.
Attach sampling line hose.
Re-check fittings to ensure
they are tight. Replace
sampling line hose.
Verify proper drying
tubing is in position. Recheck filter to ensure it is
clear. Replace sampling
line hose filter.
Refer to qualified technical
service representative.
Refer to qualified technical
service representative.
8-18
4
Problem
EtCO2 Vital Signs are not
performing as expected
Possible Cause
All other issues
NIBP values seem
unstable
Compromised hose or
cuff
Monitor has an internal
leak
Patients Arm Position
Cuff comes off patient
limb
Inappropriate sized cuff
Cuff applied inside out
NIBP not functioning
NIBP Vital Signs are not
performing as expected
NIBP hose or cuff is
disconnected
Monitor has an internal
failure
All other issues
Solution
1) Ensure the EtCO2
parameter is
enabled.
2) Inspect all EtCO2
components for
damage and leaks
and replace as
necessary.
3) Review section 6.3
of the operators
manual.
4) Contact your local
representative to
schedule
applications training.
Check that tubing is not
stretched, bent,
compressed or loose.
Ensure the patient is not
shivering or moving.
Ensure the correct sized
cuff is being used and
applied correctly.
Replace Hose or cuff if a
leak is suspected.
Refer to qualified technical
service representative.
Ensure that the patients
arm is at heart level.
Determine correct cuff
size and apply to patient
according to section 6.
Reapply cuff according to
section 6.
Ensure NIBP hose is
securely connected.
Refer to qualified technical
service representative.
1) Ensure the NIBP
parameter is
enabled.
2) Inspect all NIBP
components for
damage and leaks
and replace as
necessary.
3) Review section 6.4
of the operators
manual.
4) Contact your local
representative to
schedule
applications training.
8-19
5
Problem
Temperature error or
intermittent function
Temperature Vital Signs
are not performing as
expected
Respiration and Gases
from 3886 are not
performing as expected
Possible Cause
Temperature sensor is
not securely attached to
the patient.
Poor Temperature sensor
placement
Faulty Temperature
sensor
All other issues
Solution
Re-attach Temperature
sensor.
Reposition/replace
Temperature sensor.
Replace Temperature
sensor, or refer to
qualified technical service
representative.
1) Ensure the
Temperature
parameter is
enabled.
2) Inspect all
Temperature cable
for damage or
kinking and replace
as necessary.
3) Review section 6.4
of the operators
manual.
4) Contact your local
representative to
schedule
applications training.
1) Ensure the 3886 is
turned ON
2) Ensure the Gas
parameter is
enabled on the
3880.
3) Inspect all EtCO2
components for
damage and leaks
and replace as
necessary.
4) Review section 6.3.8
of the operators
manual.
5) Contact your local
representative to
schedule
applications training.
8-20
8.7. Repair
8.7.1.
Overview
All repairs on components under warranty must be performed by authorized IRadimed service
personnel. If the 3880 system fails to function properly or requires maintenance, contact your
IRadimed representative.
CAUTION
• Decontaminate all equipment prior to performing any repair or before sending to
IRadimed.
• No repair should ever be attempted by anyone not having a thorough knowledge of the
3880 system.
• Only replace damaged components with parts manufactured and authorized by
IRadimed.
NOTE
• Unauthorized repairs will void the warranty.
• The user of this product shall have sole responsibility for any malfunction which results
from improper use, faulty maintenance, improper repair, damage, or alterations by
anyone other than authorized IRadimed service personnel.
8.7.2.
Changing Fuses
1. Remove the power cord if used.
2. Remove the fuse holder by pulling the holder out with screwdriver.
3. If a fuse is blown, replace it with the IRadimed HE14 fuse which is the correct type and
rating.
8.7.3.
Removing a Paper Jam
If the recorder works incorrectly or produces unusual sounds, check if there is a paper jam. If a
jam is detected follow these steps to remove it:
1. Open the Recorder Door
2. Remove the paper and tear off any damaged paper
3. Reload the paper and close the recorder door.
8-21
8.8. Warranty
IRadimed Corporation warrants the major components of the 3880 system (e.g. 3880, 3885-T
Remote Tablet and 3885-B Base Station) to be free from defects in materials and workmanship
for a period of twelve (12) months from the date of original delivery to the buyer or to buyer's
order, provided that same is properly operated under conditions of normal use, and that periodic
maintenance and service is performed. A ninety (90) day warranty applies to limited-life parts
and accessories (e.g.1133 MRI Compatible Battery Pack, gating cable, SpO2, ECG, NIBP, CO2,
Temperature patient accessories). A thirty (30) day warranty applies to all parts and
accessories not listed above.
This warranty will become null and void if product has been repaired other than by IRadimed
Corporation, or its authorized representative, or if the product has been subject to misuse,
accident, negligence, or abuse.
IRadimed Corporation's sole obligation under this warranty is limited to repairing a product
which has been reported to IRadimed Corporation's Technical Service Center during normal
business hours and shipped transportation prepaid. IRadimed Corporation is not liable for any
damages including, but not limited to, incidental damages, consequential damages or special
damages.
This warranty is in lieu of any other warranties, guarantees or conditions, including
merchantability or fitness for a particular purpose. The remedies under this warranty are
exclusive and IRadimed Corporation neither assumes nor authorizes anyone to assume for it
any other obligation in connection with the sale or repair of its products.
A purchased Maintenance Extension agreement provides for an additional 1, 2, or 3 years of
authorized repair for major products. The maintenance extension period will begin at the end of
the standard warranty period, and continue until the end of the maintenance extension period
purchased. The extended maintenance does not apply to equipment which has been subject to
abuse or neglect.
Maintenance Extensions purchased after the standard warranty has expired shall require a
physical inspection by IRadimed Corporation prior to purchase of any Maintenance Extension.
An additional service fee may also be required to bring the out of warranty product(s) within
specifications before any maintenance extension can be activated. (Cost of such inspection and
possible repair to the product will be communicated to customer at that time). We reserve the
right to refuse the sale of Maintenance Extension to any Product.
IRadimed Corporation warrants any such product subject to a Maintenance Extension
agreement shall, other than its expendable parts, provided that same is properly operated under
conditions of normal use, and that periodic maintenance and service is performed; be repaired
by IRadimed and restored to full operational specification as where applicable at the time of
original manufacture. Any Maintenance Extension will become null and void if product has been
repaired other than by IRadimed Corporation, or its authorized representative, or if the product
has been subject to misuse, accident, negligence or abuse.
Should a unit perform outside of IRadimed specifications and cannot be corrected by on site
technicians with instruction and support from IRadimed and unit must be returned to IRadimed
for repair, a loaner unit, if available, may be provided.
IRADIMED CORPORATION PRODUCTS CONTAIN PROPRIETARY COPY WRITTEN
MATERIAL; ALL RIGHTS ARE RESERVED BY IRADIMED CORPORATION
8-22
9. Accessories
The packaging of the accessories is color coded to help identify which accessories are most
likely appropriate for your particular patient.
• Gray – All patient sizes
• Neonatal (Birth to one month of age) – Purple
• Infant (One month to two years of age) – Orange
• Child (Two to Twelve years of age) – Green
• Adult (Above twelve years of age) – Blue
NOTE
• All materials that come in contact with patients and users comply with ISO 10993-1.
To order replacement parts contact your IRadimed representative or call 1-866-677-8022
9.1. SpO2
Part Number
1171
Description
Image
Multiple Use
Reusable Sensors Grip come in 3 sizes (Grips only)
1821
Fiber Optic oPOD SpO2 Cable
Multiple Use
Fiber optic SpO2 cable for use with IRadimed oPODs.
3882
Use Type
Reusable Sensor Grip Kit (Pack of 3)
8 Channel Wireless oPOD
Multiple Use
Wireless MRI SpO2 module featuring Masimo
technology. For use with the IRadimed 3880.
9.2. NIBP
Part Number
Description
1832LA
Large Adult Reusable Cuff (34-44cm)
1832A
Reusable Non-Invasive blood pressure cuff are
constructed of an extremely soft, easy to clean material
to provide a long usable life and support multiple
patient use.
Adult Reusable Cuff (27-35cm)
1832SA
Reusable Non-Invasive blood pressure cuff are
constructed of an extremely soft, easy to clean material
to provide a long usable life and support multiple
patient use.
Small Adult Reusable Cuff (20.5-28.5cm)
Reusable Non-Invasive blood pressure cuff are
constructed of an extremely soft, easy to clean material
to provide a long usable life and support multiple
patient use.
Image
Use Type
Multiple Use
Multiple Use
Multiple Use
9-1
Part Number
Description
Image
Use Type
1832P
Pediatric Reusable Cuff (14-21.5cm)
1832I
Reusable Non-Invasive blood pressure cuff are
constructed of an extremely soft, easy to clean material
to provide a long usable life and support multiple
patient use.
Infant Reusable Cuff (9-15cm)
1833N4-10
Reusable Non-Invasive blood pressure cuff are
constructed of an extremely soft, easy to clean material
to provide a long usable life and support multiple
patient use.
Neonatal Size 4 Cuff (7-13cm) (Box of 10)
Single Use
1833N3-10
Single Use Non-Invasive blood pressure cuffs are
constructed of soft fabric material that conform to the
tiniest of patients.
Neonatal Size 3 Cuff (6-11cm) (Box of 10)
Single Use
1833N2-10
Single Use Non-Invasive blood pressure cuffs are
constructed of soft fabric material that conform to the
tiniest of patients.
Neonatal Size 2 Cuff (4-8cm) (Box of 10)
Single Use
1833N1-10
Single Use Non-Invasive blood pressure cuffs are
constructed of soft fabric material that conform to the
tiniest of patients.
Neonatal Size 1 Cuff (3-6cm) (Box of 10)
Single Use
1831
Single Use Non-Invasive blood pressure cuffs are
constructed of soft fabric material that conform to the
tiniest of patients.
NIBP Swift Connect NIBP Hose
Multiple Use
Multiple Use
Single lumen non-invasive blood pressure hose
featuring simple connections
Multiple Use
9.3. ECG
Part Number
1813-3
Description
1811
Package of 3 tubes of skin prep gel to prepare patients
skin for MRI ECG electrodes.
9” Five Lead ePOD MRI Leadwire (AAMI)
1811E
ECG leadwire for 3 and 5 lead ECG applications with
AAMI color coding. For Use with IRadimed ePOD only.
9” Five Lead ePOD MRI Leadwire (IEC)
3881
Image
Use Type
ECG Skin Prep Gel (Box of 3)
ECG leadwire for 3 and 5 lead ECG applications with
IEC color coding. For Use with IRadimed ePOD only.
8 Channel Wireless ePOD
Wireless MRI ECG module for use with the IRadimed
3880
Multiple Use
Multiple Use
Multiple Use
Multiple Use
9-2
9.4. CO2/Respiration Monitoring
Part Number
1842A-25
Description
Image
Single Use
Single use standard nasal cannula
1842P-25
Pediatric Nasal Cannula (Pack of 25)
Single Use
Single use standard nasal cannula
1842I-25
Infant Nasal Cannula (Pack of 25)
Single Use
Single use standard nasal cannula
1841-25
Use Type
Adult Nasal Cannula (Pack of 25)
Coextruded Sample Line (Pack of 25)
Single Use
Sample line for use with capnography and anesthetic
agent gas monitoring. For use with P/N 1849.
9.5. Multi-Gas (Agents) Monitoring
Part Number
Description
1849-25
Nomoline Agent Sample Line (2m) (Pack of 25)
1846-25
For use with IRadimed’s 3886 Wireless Multigas
Module only
Scavenge Hose (Pack of 25)
Image
Single Use
For use with IRadimed’s 3886 Wireless Multigas
Module only
1848
Use Type
Single Use
Verification Check Gas
For use with IRadimed’s 3886 Wireless Multigas
Module only
Multiple Use
9.6. Temperature
Part Number
1851
Description
Image
Use Type
Optical Temperature Sensor
Multiple use Fiber Optic temperature sensor
Multiple Use
9-3
9.7. Gating
Part Number
1881
Description
Image
Use Type
Universal Gating Interface
Multiple Use
Non-Magnetic gating interface cable for use with MRI
Systems equipped with cardiac gating leads
9.8. Power Supply
Part Number
Description
1133
3880 Battery
1188
Non-Magnetic battery used with the 3880
3885T Battery
1122
Non-Magnetic battery used with the 3885T
DC Power Cable, 10 feet (3m)
1120
Replacement power cable used to interface the 3880
with the 1120 power supply
Power Supply / Charger
1128
Replacement power cable used with the 1122 cable
North America AC Power Cord, 10 feet (3m)
Image
Use Type
Multiple Use
Multiple Use
Multiple Use
Multiple Use
Multiple Use
Replacement power cable used with 3885 and 3886
1121
North America AC Power Cord, 3 feet (1m)
Multiple Use
Replacement power cable used to interface the 3880
with the 1120 power supply
9.9. Recorder
Part
Number
1882-3
Description
Image
Use Type
3885B Recorder Paper (Pack of 3)
3 Rolls of printer paper for the 3885B recorder
Multiple Use
9-4
10. Exhibits
A.
Specifications
10.1. Overview
Standard System Components
• 3880 MRI Patient Monitor
• Wireless ECG POD
• Wireless SpO2 POD
• Non- Invasive Blood Pressure
• Accessories
Optional System Components
• 3885-T Remote Tablet ‘Extended Range’ Control Room Display
• 3885-B Base Station with recorder
• CO2 and Respiration vital signs
• Temperature vital sign
• 3886 Multi-Gas Anesthetic Agent , 3886 Unit
Clinical Parameters
• Dual Channel, 5 Lead ECG
• Pulse Oximetry
• Perfusion Index
• Non – Invasive Blood Pressure
• Sidestream Capnography, Et CO2 and CO2
• Respiration Rate
• Fiber Optic Temperature
• Dual Anesthetic Agents
• Inspired N20
• Inspired O2
• MAC
10.1.1.
Technical Specifications
10.1.1.1.
Display
Technical Parameters
Type:
Screen Size:
Pixels:
Backlight:
Screen Update Rate
Waveform Display Mode:
Waveform Display Width:
Waveform Display Height:
ECG Single Waveform:
ECG Dual Waveform:
All other Waveforms:
Technical Detail
Color TFT resistive touchscreen
25.7 cm (10.1 inches) diagonal
800 by 480
LED
2 Hz
Moving Waveform
~145 mm
~48mm max
~20mm max
~25mm max
10-1
10.1.1.2.
User Interface
10.1.1.2.1.
Technical Parameters
Power:
Feature Hard Keys:
Setup Hard Keys:
Soft Keys:
Technical Detail
Rotary On, Off
Trends, Print, NIBP Start/Stop and Alarm Silence
Setup and Standby
Touchscreen
10.1.1.2.2.
Technical Parameters
Power:
Feature Hard Keys:
Setup Hard Keys:
Soft Keys:
10.1.1.3.
PODS
Technical Detail
Push Button On, Off
Channel Selection
10.1.1.2.4.
Technical Parameters
Power:
Channel Select:
Tablet
Technical Detail
Push Button On, Off
Trends, Print, NIBP Start/Stop and Alarm Silence
Setup and Standby
Touchscreen
10.1.1.2.3.
Technical Parameters
Power:
Hard Keys:
Monitor
Base Station
Technical Detail
Toggle
Button
Application Features
10.1.1.3.1
Trend Reports
Technical Parameters
Types:
Tabular
Technical Detail
Trend Memory:
Tabular Intervals:
Data Types:
50 readings
3, 5, 8, 10, 15, 30, Auto NIBP
HR, SpO2, NIBP, EtCO2, Resp, Temp, MAC, O2
10.1.1.3.2
Technical Parameters
Indication:
Levels:
Volume:
Silence:
Alarms
Technical Detail
Audible & Visual
High, Medium, Low and Information Messages
User Adjustable, 50 to 85 dba, or OFF
Permanent or 2 minutes timed hold
10-2
10.1.1.4.
Technical Parameters
IEC:
Med Device Directive:
Defibrillator Protection:
Defibrillator Recovery
Time:
10.1.1.5.
Safety Standards
Technical Detail
60601-1, 60601-1-2, 60601-1-8, 60601-2-27, 60601-2-49, 80601-2-30,
80601-2-55, 80601-2-56, 80601-2-61
93/42/EEC, 2007/47/EEC
Up to 5 KV
During a defibrillation procedure, the ECG waveform will saturate then
recover in less than 5 seconds
Physical Specifications
10.1.1.5.1.
Technical Parameters
3880 Monitor:
3885-T Remote Tablet:
3885-B Base Station:
3881/3882 Wireless
PODS:
23 cm (8.8 inches)
19.6 cm (7.7 inches)
18.8 cm (7.4 inches)
9.5 cm (3.8 inches)
3886 Multi-Gas Unit
8 cm (3.13 inches)
Height
Technical Detail
10.1.1.5.2.
Width
Technical Parameters
3880 Monitor:
3885-T Remote Tablet:
3885-B Base Station:
3881/3882 Wireless
PODS:
3886 Multi-Gas Unit
Technical Detail
29 cm (11.4 inches)
26.7 cm (10.5 inches)
38 cm (15 inches)
2.0 cm (0.8 inches)
14.7 cm (5.8 inches)
10.1.1.5.3.
Technical Parameters
3880 Monitor:
3885-T Remote Tablet:
3885-B Base Station:
3881/3882 Wireless
PODS:
3886 Multi-Gas Unit
Technical Detail
12.7 cm (5 inches)
4.5 cm (1.8 inches)
12 cm (4.8 inches)
5.7 cm (2.3 inches)
10.2 cm (4.1 inches)
10.1.1.5.4.
Technical Parameters
3880 Monitor:
3885-T Remote Tablet:
3885-B Base Station:
3881/3882 Wireless
PODS:
3886 Multi-Gas Unit
Depth
Weight
Technical Detail
4 kg (8.9 lbs)
1.6 kg (3.6 lbs)
2.1 kg (4.6 lbs)
73 g (0.16 lbs) (without sensors/leads)
1.04 kg (2.3 lbs)
10-3
10.1.1.6.
Technical Parameters
Voltage Range:
(All 3880 system components)
Frequency Range:
Max Consumption:
3880 Monitor
3885-B Base Station
3886 Multi-Gas Unit
3880 Monitor:
3885-T Remote Tablet:
3881/3882 W ireless PODS:
3880 Monitor:
Power
Requirements
Battery Capacity
Battery Operation
Time
Battery Charge Time
Power On
3885-T Remote Tablet:
3881/3882 Wireless PODS:
3880 Monitor:
3885-T Remote Tablet:
3881/3882 Wireless PODS:
Boot Time:
10.1.1.7.
Operating
Storage
Electrical Specifications
Technical Detail
85 - 264 VAC
50 - 60 Hz
< 40 VA during charging
< 65 VA during charging, 3885-B
< 10 VA
14.8 V at 6 Ah Lithium Polymer
7.4 V at 6 Ah Lithium Polymer
3.7 V at 1200 mAh Lithium Polymer
>8 hours with NIBP readings every 5 minutes
>10 hours
>12 hours
< 5 hours to 90% capacity
< 5 hours to 90% capacity
< 3 hours to 90% capacity
< 4 seconds
Environmental Specifications
Technical Parameters
All 3880 system components
Temperature Range:
Technical Detail
○
○
○
○
+10 to + 40 C (+50 to + 104 F)
Humidity Range:
Altitude Range:
All 3880 system components
Temperature Range:
5% to 85% RH, non-condensing
0 – 5000 meters, Pressure: 1010hPa – 540hPa
Humidity Range:
Altitude Range:
5% to 95% RH, non-condensing
0 – 5000 meters, Pressure 1010hPa – 540hPa
10.1.1.8.
3880 Monitor
3881/3882 Wireless PODS
3885-T Remote Tablet
3885-B Base Station
Accessories
3886 Multi-Gas Unit
○
○
○
○
-20 to + 50 C (-4 to + 122 F)
MRI Conditions
Technical Parameters
MR Environment Safety:
Magnetic Field Limit:
MRI System:
MR Environment Safety:
SAR:
Magnetic Field Limit:
MRI System:
MR Environment Safety:
Magnetic Field Limit:
MR Environment Safety:
MR Environment Safety:
Magnetic Field Limit:
Technical Detail
MRI Conditional
30,000 Gauss
0.5 to 3.0 Tesla MRI Systems
MRI Conditional
≤4 W/kg whole body average SAR
30,000 Gauss
0.5 to 3.0 Tesla MRI Systems
MRI Conditional
15,000 Gauss
MRI Unsafe
MRI Safe as listed in Section 9.1-9.7
MR conditional 600 gauss
10-4
10.1.1.9.
Technical Parameters
Technique:
Data Type:
Paper Speed:
Recorder
Technical Detail
Thermal line recorder at 3885-B Base Station
Single or Dual Waveform; Tabular
12.5 or 25mm/sec continuous
10.1.1.10.
Technical Parameters
Technique:
Digital Pulses:
Gating
Technical Detail
Cardiac or Peripheral
3.3 p-p signal with a pulse duration of 10ms ± 3ms
10.1.1.11.
Vital Signs
10.1.1.11.1.
ECG
Technical Parameters
Lead Set Configuration:
Lead Color:
Lead Configurations:
Lead Fail:
Input Impedance:
Electrode Contact
Impedance:
Technical Detail
3 and 5 lead
AAMI/AHA and IEC
I, II, III, V, AVF, AVR, AVL
Passive, sensing signal imbalance
> 2.5MΩ (according to IEC 60601‐2‐27, 50.102.3)
≤ 20K ohms @ 10 Hz
Heart Rate:
Heart Rate Accuracy:
Heart Rate Resolution:
Heart Rate T-Wave
Rejection:
30 - 250 bpm
± 1% or ± 5 BPM, whichever is greater
1 beat per minute (BPM)
1.3 mV with a 1mV QRS amplitude
Cardiotach Sensitivity:
200 μV minimum
Cardiotach Bandwidth:
Heart Rate (HR)
Averaging Method:
Heart Rate Meter
Accuracy and Response
to
Irregular Rhythm:
Response Time of Heart
Rate Meter to Change
in Heart Rate:
Time to Alarm for
Tachycardia:
0.5 - 40 Hz
Five point Mean filter
A1: Ventricular bigeminy: 40 BPM
A2: Slow alternating ventricular bigeminy: 30 BPM
A3: Rapid alternating ventricular bigeminy: 59 BPM
A4: Bidirectional systoles 90 – 110 BPM
HR change from 80 to 120 BPM: 5 sec
HR change from 80 to 40 BPM: 9 sec
B1 ‐ Vent Tachycardia
1 mVpp, 206 BPM:
Gain 0.5 (12.03, 11.04, 14.1, 11.8, 11.4) Average: 6.25 sec (The
monitoring system may temporarily exit the alarm condition
during the arrhythmia waveform duration.)
Gain 1.0 (11.9, 11.6, 9.2, 9.6, 10.9) Average: 2.59 seconds
Gain 2.0 (8.8, 9.1, 10.3, 9.4, 12.1) Average: 3.93 seconds
B2 ‐ Vent Tachycardia
2 mVpp, 195 BPM:
Gain 0.5 (9.0, 10.4, 12.3, 8.1, 10.4) Average: 3.99 seconds
Gain 1.0 (8.4, 7.7, 12.5, 7.7, 8.3) Average: 1.82 seconds
Gain 2.0 (9.7, 12.6, 8.9, 11.8, 8.3) Average: 4.01 seconds
10-5
10.1.1.11.2.
Technical Parameters
Technique:
Saturation Range:
Saturation Accuracy:
Saturation Resolution:
Pulse Rate Range:
Pulse Rate Accuracy:
Pulse Rate Resolution:
Wavelength Range:
Emitted Light Energy
Calibration Range:
Minimum sensor Bend
Radius
SpO2 averaging time:
SpO2
Technical Detail
®
Masimo SET
1% - 100%
± 2.1% at 70% - 99% (full scale)
< 70% oxygen saturation is unspecified
1%
30 - 240 ppm
± 3 ppm
1 pulse per minute (PPM)
660 nm / 905 nm Note: Wavelength range can be especially useful to
clinicians
< 1.2mW maximum average at 905nm
70 - 100%
4 cm (1.6 inches)
6 seconds
10.1.1.11.3.
NIBP
Technical Parameters
Technique:
Modes:
Measurement Time:
Systolic Measureable
Pressure Range:
Technical Detail
Oscillometric
Manual, Automatic and STAT
< 60 seconds typical; standard adult cuff
Adult/Pediatric: 40 - 270 mmHg (5.3 - 36 kPa)
Neonatal: 30 - 130 mmHg (4 - 17 kPa)
Diastolic Measureable
Pressure Range:
Adult/Pediatric: 25 - 245 mmHg (3.3 - 32 kPa)
Neonatal: 10 - 100 mmHg (1.3 - 13 kPa)
Mean Measureable
Pressure Range:
Adult/Pediatric: 30 - 255 mmHg (4 - 34 kPa)
Neonatal: 15 - 120 mmHg (2 - 16 kPa)
Pressure Accuracy:
Max. Std. Deviation: <8 mmHg (1.1 kPa)
Max. Mean Error: within ± 5mmHg (±0.7 kPa)
Pressure Resolution:
Pulse Rate Range:
Pulse Rate Accuracy:
Max Cuff Inflation
Pressure:
1 mmHg (0.1 kPa)
30-240 ppm
± 1% or ± 5 BPM, whichever is greater
Adult/Pediatric: 270 mmHg
Neonatal: 140 mmHg
Pressure Transducer
Range:
0 - 300 mmHg (0 - 40 kPa)
Transducer Accuracy:
Overpressure Protection:
The greater of ± 2 mmHg or 2% of the reading
Adult: 300 mmHg (40 kPa) < 2 seconds
Pediatric: 300 mmHg (40 kPa) < 2 seconds
Neonatal: 150 mmHg (20 kPa) < 2 seconds
Initial Pressure:
Adult: 165 mmHg (22 kPa)
Pediatric: 165 mmHg (22 kPa)
Neonatal: 100 mmHg (13.3 kPa)
All initial pressures ± 15 mmHg (2 kPa)
STAT Mode:
Minimum Time Between
Readings:
3 consecutive NIBP Readings
Auto: 30 seconds (non STAT)
Manual: 5 seconds
10-6
10.1.1.11.4.
Technical Parameters
Technique:
Range:
Accuracy:
Resolution:
Warmup Time:
Response Time:
Flow Rate:
Calibration:
CO2 Only, Internal System
Technical Detail
Sidestream, Non-dispersive infrared absorption technique
0-15% CO2, or partial pressures at STP: 0-115 mmHg, or 0 - 16 kPa,
± 0.43 Vol% +8%, or ± 3.75 mmHg +8%, or ±0.5kPa +8%
1 mmHg, 0.1%, 0.1 kPa
< 10 seconds (concentrations reported and full accuracy)
< 5 seconds for sample, 150mS waveform response
80 ± 20 ml/min
Automatic
10.1.1.11.5.
Technical Parameters
Source:
Range:
Accuracy:
Resolution:
Respiration
Technical Detail
Capnogram
3 - 120 breaths per minute
1 bpm
1 bpm
10.1.1.11.6.
Technical Parameters
Technique:
Multi-Gas, Agents, P/N 3886
CO2 and Respiration
N2O Range:
N2O Accuracy:
N2O Resolution:
Primary Agent ID
Secondary Agent ID
Multiple Agent (>2) Detect
Sev Range:
ISO, HAL, ENF Range:
Des Range:
Sev, ISO, HAL, ENF, DES Accuracy:
Sev, ISO, HAL, ENF, DES Resolution:
Technical Detail
Sidestream, Non-dispersive infrared (NDIR) absorption
technique
< 20 seconds (concentrations reported and full accuracy)
≤ 5 seconds
50 ± 10 ml/min
Automatic
None
Above 80 RPM, end-tidal agent measurements will
typically decrease below the nominal value in proportion
to the respiration rate as follows: ET=80Et(nom)/RR
Ranges and accuracy same as 10.1.1.11.4 and 5 above
0 - 100 vol%
± 2 vol% + 2%
1%
0.15 vol%
0.20 vol% + 10% of total agent concentration
0.20 vol % +/- 10% of total agents concentration
0 - 10 vol%, accuracy ±0.15vol% +5%
0 - 8%, accuracy ±0.15vol% +5%
0 - 22%, accuracy ±0.15vol% +5%
± 0.15 vol% + 5%
0.1%
Interfering Gas Effects
Tested according to IEC 80601-2-55
Nitrous Oxide
No effect at 60%
Halothane
Enflurane
No effect at 4%
Warmup Time:
Response Time:
Flow Rate:
Calibration:
Drift of Measurement
Accuracy degradation with rate
Isoflurane
Sevoflurane
Xenon
Helium
No effect at 8%
No effect at 8%
No effect at 8%
-10 % of reading @ 80 vol%
-6 % of reading @ 50 vol%
10-7
Desflurane
Ethanol
Isopropanol
+12 % of reading @ 15 vol%
No effect at 0.3 vol%
No effect at 0.5 vol%
Acetone / Metabolic Ketones
Methane
No effect at 1 vol%
No effect at 3 vol%
Carbon Monoxide
Nitrogen Monoxide
No effect at 1 vol%
No effect at 0.02 vol%
Oxygen
No effect at 100 vol%
10.1.1.11.7.
Resolution
Range
Accuracy 0 to 59%
Accuracy 60 to 100%
O2 (Part of 3886)
1%
0 to 100 %
+/- 3%
+/- 5%
10.1.1.11.8. Temperature
Technical Parameters
Technique:
Range:
Technical Detail
Direct Fiber-Optic
○
○
30 - 44 C (86 – 111.2 F)
Accuracy:
± 0.3 C (±0.54 F)
Extended Range:
10 C to 50 C (50 F to 122 F)
○
○
○
○
○
○
Extended Range
Accuracy:
Resolution:
±0.4 C (±0.72 F)
Response Time:
Application Type:
< 20 seconds
Axillary or skin surface
0.1
○
○
○
B. Messages, Alerts, Alarm Priority
Message
Apnea
Agent Unit Connecting
Check Print Door
CO2 Occlusion
CO2 Overscale
CO2 Zeroing
COMM LOSS
Crit Mon Batt
Crit Tab Batt
Data Delay
ECG Batt Crit
ECG Inop
ECG Lead Fail
EtCO2 Cal Error
Trigger Condition
Respiration detection system ( CO2 / Multi-Gas) reports Apnea
Indicates 3880 attempting to make connection with 3886 Multi-gas Unit
Printer door is not fully closed
Gas sampling line is occluded
Co2 measurement exceeds range of the display scale
Performing a Zero reference in gas system
Wireless communication loss with 3885-B for more than 4 seconds
≤ 5% of battery capacity in 3880 monitor
≤ 5% of battery capacity in 3885-T Remote Tablet
Display update error or delay possible
Battery level in ECG transmitter POD at extreme low level
Hardware or software failure detected
Lead wire has no electrical connection to the patient or ECG level overscale
Calibration error detected
Priority
High
N/A
N/A
Med
Low
N/A
Low
Med
Med
High
Med
Med
Low
Med
10-8
Gas System Inop
Gas System Warmup
LAN Conn Error
Low ECG Batt
Low Mon Batt
Low SpO2 Batt
Low Sig IQ
Low Tab Batt
Low Perfusion
Mag Field High
Multi Agent MAC
Mixed Agents
NIBP Cal Error
NIBP Delayed
NIBP Inop
NIBP Leak
NIBP Occlusion
NIBP Over Press
NIBP Time Out
No Sample Line
Out of Paper
POST Fail
Recorder Inop
Recorder Off Line
Radio Inop
SEE MESSAGES!
Sp02 Batt Crit
SpO2 Noisy
SpO2 Hi Light
SpO2 Bad Probe
SpO2 Inop
SpO2 No Probe
SpO2 Probe Off
SpO2 Searching
SW Mismatch
Temp Inop
Temp Probe Fail
Wrong Cuff
Hardware or software failure detected in a gas measurement system
CO2/Multi-Gas unit warming up
LAN connection errors preventing communication
≤ 15% of battery capacity left in ePOD
≤ 15% of battery capacity left in 3880 monitor
≤ 15% of battery capacity left in oPOD
SpO2 unit reports Signal IQ Low
≤ 15% of battery capacity left in 3885-T Remote Tablet
Low perfusion detected by SpO2
Agent bench magnetic field limitations surpassed
The MAC value consists of more than one agent
More than two agents may be present
Calibration error detected
NIBP reading start held for blood flow
Hardware or software failure detected
Air leak is detected
Occlusion is detected
Pressure exceeds 300 mmHg for Adult / Ped or 150 mmHg for Neonatal
patients
-or15 mmHg remains in the line for Adult / Ped or 5mmHg for Neo for
greater than 90 seconds
Pressure remains the same for more than 30 seconds or if
measurement exceeds 180 seconds
CO2 sampling line disconnected, 3886 Only
Recorder paper has run out at Base
Power on self-test failure
Hardware or software failure detected in Base recorder
Print head is too hot or communication loss to the recorder/Base
Radio failure detected with comm to 3885 Base/Tablet
Critical message area full
Battery level in SpO2 transmitter POD at extreme low level
SpO2 unit reports noisy signals from sensor
SpO2 unit reports high ambient light at sensor
SpO2 sensor damaged or not compatible
Hardware or software failure detected
SpO2 sensor is disconnected from the oPOD
SpO2 sensor is not properly attached to the patient
Searching for patient pulse
Software version difference between 3880 components
Hardware or software failure detected
Broken sensor detected or a sensor is not attached properly
NIBP system detects an incorrect cuff size for the selected patient mode
Med
N/A
Low
Low
Low
Low
Low
Low
Low
Med
Med
Med
Med
N/A
Med
Low
Med
Low
Low
Low
Low
Med
Low
Low
Med
High
High
Low
Low
Low
Med
N/A
Med
N/A
Low
Med
Low
Low
All vital signs with alarm limits use high priority indication for violations.
Priority is indicated with visual and audible indications:
Low – Blue, Medium – Yellow, High – Red. See section 4.1.4
10-9
Watch Dog Fail Safe timeout indicated by continuous audio alarm tone and flashing red alarm dome.
C. Repair
All repairs on products under warranty must be performed by Iradimed Corporation personnel, or
an authorized Iradimed Corporation Service and Repair Center.
Unauthorized repairs will void the warranty.
If a device fails to function properly or requires maintenance, contact Iradimed Corporation
Technical Service at 1-407-677-8022 within the U.S., +001-407-677- 8022 from outside the
U.S.(during normal business hours EST), or by E-mail at techsupport@iradimed.com. Iradimed
Corporation Technical Service will advise you of the corrective action required. If you are advised
to return the device to Iradimed Corporation for repair, please do the following:
a.
Obtain a Return Authorization Number. This will ensure proper routing and
facilitate timely repair of your monitoring device.
b.
Clean monitoring device prior to shipment. Do not ship contaminated product
to IRadimed Corporation for repair.
c.
Package the monitoring device with adequate protection. If available, use the
original carton and packing materials in which the monitoring device was
shipped from Iradimed Corporation.
d.
Include a brief description of the problem as well as the name, address and phone
number of the person to be contacted for additional information.
e.
Include a purchase order with the monitoring device being returned if it is out of
warranty; Iradimed Corporation Technical Services can advise you of your
monitoring device’s warranty status if need be. Repairs will be made at
Iradimed Corporation’s current list price for the replacement part(s) plus a
reasonable labor charge.
f.
Ship the monitoring device transportation prepaid, to the location specified by your
Iradimed Corporation Service Representative with the Return Authorization
Number written on the outside of the shipping carton. Repairs will be made,
normally, within two (2) weeks and the monitoring device will be returned to you
prepaid.
To ensure full reliability, it is recommended that all repairs be made by an Iradimed Corporation
Authorized Service and Repair center. For repair at your facility, a competent individual
experienced in the repair of monitoring device can repair the monitoring device only IF it is
authorized by Iradimed Corporation Technical Service prior to the repair.
CAUTION: No repair should ever be attempted by anyone not having a complete
knowledge of the repair of Iradimed Corporation monitoring device. Only replace damaged
parts with components manufactured or sold by Iradimed Corporation. Contact the Iradimed
Corporation Technical Service and Repair Center for service and technical assistance.
10-10
D. Masimo SETTM Technology
D.1. Masimo SET Principles of Operation
The Masimo SET® MS pulse oximeter is based on three principles:
1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light
(spectrophotometry).
2. The volume of arterial blood in tissue and the light absorbed by the blood changes during
the pulse (plethysmography).
3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood
is a major component of noise during the pulse.
The Masimo SET® MS pulse oximeter as well as traditional pulse oximetry determines SpO2 by
passing red and infrared light into a capillary bed and measuring changes in light absorption
during the pulsatile cycle. Red and infrared light-emitting diodes (LEDs) in oximetry sensors
serve as the light sources, a photodiode serves as the photodetector.
Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused
by oscillations in the arterial blood volume. This assumes that the blood flow in the region of the
sensor passes entirely through the capillary bed rather than through any arterio-venous shunts.
The traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean
absorbance (DC) at each of two wavelengths, 660 nm and 905 nm:
• S(660) = AC(660)/DC(660)
• S(905) = AC(905)/DC(905)
The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals:
• R = S(660)/S(905)
This value of R is used to find the saturation SpO2 in a look-up table built into the oximeter’s
software. The values in the look-up table are based upon human blood studies against a
laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.
The Masimo SET® MS board pulse oximeter assumes that arterio-venous shunting is highly
variable and that fluctuating absorbance by venous blood is the major component of noise
during the pulse. MS board decomposes S(660) and S(905) into an arterial signal plus a noise
component and calculates the ratio of the arterial signals without the noise:
• S(660) = S1 + N1
• S(905) = S2 + N2
• R = S1/S2
Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find
the saturation SpO2 in an empirically derived equation into the oximeter’s software. The values
in the empirically derived equation are based upon human blood studies against a laboratory
co-oximeter on healthy adult volunteers in induced hypoxia studies.
The above equations are combined and a noise reference (N’) is determined:
• N’ = S(660) - S(905) x R
If there is no noise N’ = 0: then S(660) = S(905) x R which is the same relationship for the
traditional pulse oximeter.
The equation for the noise reference is based on the value of R, the value being sought to
determine the SpO2. The MS board software sweeps through possible values of R that
correspond to SpO2 values between 1% and 100% and generates an N’ value for each of these
R-values. The S(660) and S(905) signals are processed with each possible N’ noise reference
10-11
through an adaptive correlation canceler (ACC) which yields an output power for each possible
value of R (i.e., each possible SpO2 from 1% to 100%). The result is a Discrete Saturation
Transform (DST™) plot of relative output power versus possibleSpO2 value as shown in the
following figure where R corresponds to SpO2 = 97%:
MEASURED ARMS VALUES
Range
ARMS
90-100 %
1.30 %
80-90 %
1.78 %
70-80 %
2.80 %
Range
ARMS
70-100 %
± 2.1 %
Overall Claimed Accuracy Value
SpO2 Performance information of measured A(rms) accuracy shown in tabular form by range.
Graphic plots below of sampled points from blood study with Iradimed 1170 FO Sensor:
10-12
10-13
E. Internal CO2 Only, and Masimo Multi-Gas Systems Detail Operation
The 3880 MRI Patient monitoring system has two options for gas measurement. There being a
‘built in’ CO2/Respiration only option and an externally packaged Multi-Gas option with full
automatic anesthetic agent identification as well as ‘fast’ parametric O2, known as P/N 3886.
The ‘built in’ CO2 only option is housed within the 3880 monitor unit and operable to the full
magnetic limits of the 3880 monitor unit, 30,000 Gauss. Using the Parameter Setup menu, the
user can select CO2 only which will activate this internal CO2 unit and display CO2 waveform,
Et and Fi CO2 as well as respiration this internal unit measures.
Likewise, from the Parameters Setup menu the operator can select Agents which turns off the
internal CO2 only unit and causes the 3880 monitor unit to communicate with the external 3886
Multi-Gas unit. The 3880 now displays CO2 waveform, Et and Fi CO2, respiration, anesthetic
agents, N2O, and 02 from the 3886 unit. The core of the 3886 is the Masimo/Phasein ISA
sidestream OR+ Multi-Gas system which includes the Servomex Pm1116 Fast Oxygen
transducer. These devices have a long history of successful deployment in various non-MRI
monitors. The 3886 unit, provides magnetic and RF shielding allowing use in MR with magnetic
fields up to 600 Gauss, as such the 3886 is to be mounted on the MR gas machine or other
fixed position below 600 Gauss.
Terms and definitions
Specific terms and definitions used in this manual and explained below:
Term
Explanation
AA
Anesthetic Agent
BTPS
Body Temperature and Pressure Saturated
delay time
The delay time is defined as the time required for
a step function change at the sampling site to
result in 10% of the final value
Et cone.
End-tidal (expired) concentration
Fi cone.
Inspired gas concentration
harmful
substances
Substances introduced in the patient circuit to an
amount that may cause harm to substances
the patient
ICU
Intensive Care Unit
LEG!
Light Emitting Gas Inlet. Status indicator
integrated in the gas sample inlet port
MAC value
1 MAC (Minimum Alveolar Concentration) is the
alveolar concentration (end-tidal) of the agent at
which 50% of individuals fail to move in
response to a noxious or surgical stimulus
MOD
Medical Device Directive
MRI
Magnetic Resonance Imaging
10-14
OR
Operating Room
rise time
Time required to achieve a rise from 1O % to
90 % of final value when a step function
change in concentration occurs at the
sampling site
sampling
line config
A sampling line configuration consists of a
Nomoline Family sampling line connected to
either a patient breathing circuit or
spontaneous breathing patient
STP
Standard Temperature and Pressure:
101.3 ± 4 kPa atmospheric and gas pressure
22 ± 5 °C ambient temperature
Total
system
response
time
Time from a step function change in gas level
at the sampling site to the achievement of
90% of the final gas reading of the gas
monitor.
Total system response time= Delay time+ Rise
time
E.1.1.
USS
Universal Serial Bus
zeroing
Ambient gas reference measurement used to
establish zero concentration levels for CO2,
N2O and Anesthetic Agents, as well as a
calibration point for the oxygen measurements
Warnings and Cautions
To avoid water condensation inside the ISA module and the connecting tubings,
ensure that the surrounding temperature of the ISA module and the connecting tubings
does not fall below the ambient temperature of the Nomoline sampling line.
E.1.2.
3886 Multi-Gas Unit
ISA OR+
The 3886 Multi-Gas Unit contains the Masimo ISA OR+ which is a low-flow sidestream
multigas analyzer designed to monitor respiratory concentrations of CO2, N 2O and gas
mixtures containing any two of the five anesthetic agents Halothane, Enflurane, lsoflurane ,
Sevoflurane and Desflurane in the OR and the ICU. Its low sampling flow and low agent
identification threshold makes the ISA AX+ a perfect choice for adult and pediatric
applications, as well as for the monitoring of infant patients with low tidal volumes and high
respiratory rates .
ISA OR+ sidestream analyzer offers the addition of oxygen measurement capabilities by
means of an integrated paramagnetic O2 sensor.
In the following information regarding the 3886 Multi-Gas Unit, the Masimo term “OR+” is
used interchangeably.
10-15
E.2. Theory and design, 3886 Multi-Gas System
E.2.1.
Gas measurements and identification
The measurement of CO2, N2O and anesthetic agents is based on the fact that different
gases absorb infrared light at specific wavelengths. The analysis of respiratory gases by
the ISA gas analyzers are therefore performed by continuously measuring the infrared
light absorption in the gas flow through an infrared spectrometer. Oxygen, on the other
hand, does not absorb infrared light to the same extent as other breathing gases and is
therefore measured using alternative methods.
The gas analysis
The heart of the ISA gas analyzer is the multi-channel spectrometer which uses a
proprietary broadband infrared radiation source to transmit light through the gas sample.
Before reaching the gas sample, the light path is intersected by narrowband optical filters
that only allow light corresponding to selected wavelength peaks of the measured gases
to pass. At the other end of the light path, a sensor detects the portion of the light that is
not absorbed by the gas. The amplitude of the detector output is an inverse function of
the gas concentration.
Thus, at a concentration of zero, the amplitude is at its maximum.
If the gas sample is a mixture of several components that absorb light at the same
wavelength, such as a mixture of two anesthetic agents, the absorbed radiation will be
the sum of the absorption of the agents. To determine the concentration of each of the
individual gases, several filters have to be used. The ISA gas analyzers therefore uses
the SIGMA spectrometer, which contains up to nine different narrowband filters to
facilitate simultaneous measurement of CO2, N2O and a mixture of any two of the five
anesthetic agents.
JS
Figure 4-1. Gas absorption spectra.
The selection of the optical filters within the spectrometer is crucial to the characteristics
and performance of the gas analyzers. The ISA spectrometer uses the strong absorption
peaks at and 4.5 µm for CO2 and N2O measurements and five wavelengths in the 8 to
10 µm long wave infrared range (LWIR) for the anesthetic agent calculations. The LWIR
contains strong absorption peaks for the anesthetic agents and negligible interference
from other common respiratory gases, such as alcohol and acetone, which could degrade
10-16
measurement accuracy.
In addition to the measurement filters, two optical filters appropriately located within the 4
to 10 µm range are used as references.
E.2.2.
Oxygen measurement, Paramagnetic
Oxygen does not absorb infrared light to the same extent as other breathing gases and is
therefore measured using alternative methods. The ISA OR+ analyzer is fitted with a
paramagnetic oxygen sensor.
Paramagnetic oxygen analysis
Paramagnetic oxygen analysis is based on measurements of the attractive force exerted
by a strong magnetic field applied to the oxygen molecules in a gas mixture. The
paramagnetic analyzer distinguishes oxygen from other gases as a function of their
magnetic susceptibility. Due to its paramagnetic nature, oxygen is attracted into the
magnetic field, while most other gases are not. On a scale, where oxygen is assigned the
value 100, most other gases have a magnetic susceptibility of close to zero.
The Servomex sensors
The oxygen sensor included in the 3886 Multi-Gas system as part of the ISA OR+ gas
analyzer is the Pm1116 paramagnetic oxygen sensor from Servomex. In these sensors, a
symmetrical non­ uniform magnetic field is created. If oxygen is present, it will be attracted
into the strongest part of this field. Two nitrogen-filled glass spheres are mounted on a
rotating suspension within the magnetic field. Centrally on this suspension, a mirror is
mounted. A light beam projected on the_mirror is reflected onto a pair of photocells.
Oxygen attracted into the magnetic field will push the glass spheres from the strongest
part of the magnetic field, causing the suspension to rotate.
When this rotation is detected by the photocells, a signal is generated and passed to a
feedback system. The feedback system will pass a current around a wire mounted on the
suspension, causing a restoring torque that keeps the suspension in its original position.
The current flowing around the wire is measured. This current is directly proportional to
the oxygen concentration.
Figure 4-2. Oxygen measurement with Servomex paramagnetic oxygen sensors.
The most important benefits of the paramagnetic oxygen sensor are:
•
•
•
•
Fast rise time
High stability and accuracy
No chemicals to replace or renew
Low maintenance requirement
10-17
E.2.3.
Sampling
A sidestream gas analyzer continuously removes a gas sample flow from the respiratory
circuit, for example a nasal cannula, a respiratory mask or the Y-piece of an intubated
patient. The gas sample is fed through a sampling line to the gas analyzer. The sampled
gas is usually warm and humid, and cools down in contact with the wall of the sampling
line. Water therefore condenses in form of droplets on the inner wall of the sampling line.
These droplets could potentially occlude the sampling line and interfere with the gas
measurement.
The Nomoline Family
To overcome the shortfalls of current gas sampling solutions, the Nomoline Family
sampling lines have been developed for the ISA sidestream gas analyzers.
Unlike traditional solutions that remove water vapor and collect water in a container, the
Nomoline Family sampling lines incorporates a unique water separation (NO MOisture)
section, which removes condensed water. The NOMO section also has a bacteria filter
which protects the gas analyzer from water intrusion and cross contamination.
Figure 4-3 . The NOMO section.
The Nomoline Family sampling lines are specially designed for 50 sml/min low sample
flow applications. The Nomoline Family sample lines have a very low dead space that
results in an ultra-fast rise time, making measurements of CO2, N2O and anesthetic agents
possible even at high respiratory rates. ISA sidestream gas analyzers are therefore
suitable for adult, pediatric and infant patients.
The Nomoline Family sampling lines are available in a wide variety of versions for both
intubated and spontaneously breathing patients and in both disposable and ReSposable
configurations - intubated patients can for instance be monitored using the disposable
Nomoline Airway adapter Set or a combination of the multiple patient use Nomoline
Adapter and a disposable Nomoline Extension / T-adapter.
The Nomoline Airway Adapter Set with integrated airway adapter can be used with
intubated patients.
The Nomoline with a male Luer Lock type connector is compatible with any normal
configuration that uses a female Luer Lock connector. When connecting to a T-adapter,
10-18
be sure to use a Masimo T-adapter that samples the gas from the center of the T-adapter
(see below). See section 12 for ordering details.
Flow control
During normal operation, a sidestream gas analyzer is continuously fed with a small
sample gas flow. To pull the gas through the sampling line and maintain a steady flo w, a
high-precision flow control system is required. In !SA sidestream gas analyzers, the flow
control system consists of an integrated micro pump, a zero valve and a flow controller.
The pump is fitted with a low-power brushless motor incorporating three miniature ball
bearings to ensure trouble free operation without the need for regular maintenance. Its
balanced shaft design and integrated pneumatic filter virtually eliminates pressure and flow
variations.
System response
In any sidestream gas analyzer, there are three major time parameters characterizing the
system:
• Total system response time
• Delay time
• Rise time
When designing a sidestream gas monitoring system, the physical characterist ics of
several components have to be considered. Parameters such as sampling line volume,
tubing material and the physical design of the sampling interfaces play decisive roles in
determining the responsiveness of the system.
Generally, the total system response time equals the delay time plus the rise time.
The rise time is defined as the time required for a step function change at the sampling
site to bring about a rise from 10% to 90% of the final gas concentration value. The total
numbers of gas fittings together with the physical design of the fittings are examples that
effects the rise time. Fast rise times are important when monitoring infants with high
breathing rates.
The delay time is defined as the time required for a step function change at the sampling
site to result in 10% of the final value. Parameters affecting the delay time are the sample
flow rate, tubing length and tubing inner diameter. In mainstream gas monitoring, where
no tubing exist, the delay time is virtually zero, whereas a sidestream system has a
sample delay time of a few seconds.
Leak test
1. Connect a Nomoline Adapter and a Nomoline Extension sampling line or equivalent to
the ISA gas analyzer, with the analyzer connected to Masimo Gas Master.
2. Tightly block the gas inlet of the Nomoline sampling line.
Check the field "Atm press - cuvette press [kPa]" in Masimo Gas Master - the
pressure value will start to rapidly increase, until the internal pump stops.
When the internal pump stops and while keeping the inlet blocked, quickly block the
exhaust port tightly. When blocked, the "Atm press - cuvette press [kPa]" in Masimo
Gas Master shall be >6 kPa.
3. Stop the pump by sending parameter "Stop pump" under "Installation & maintenance"
10-19
in Masimo Gas Master.
4. Wait about 1O seconds until the "Atm press - cuvette press [kPa]"value as shown by the
Masimo Gas Master is stable. Note the value.
5. Wait additional 10 seconds.
6. Check that the "Atm press - cuvette press [kPa]"value has not changed more than 3 kPa in
10 seconds.
7. If the "Atm press - cuvette press [kPa}" value changes more than 3kPa in 10 seconds,
check tubing and fittings for leakage. If the problem persists, return the analyzer to Masimo
Sweden (see section 9).
Note: In step 5, if the "Atm press - cuvette press [kPa]" is less than 6 kPa, repeat
steps 1 to 3 blocking the exhaust port quicker.
Gas span calibration
Only perform the gas span calibration if the gas span check fails repeatedly.
Before performing the gas span calibration, ensure that the SETO2 and SETN2O values are
set (if applicable for your gas analyzer model) correctly to match the corresponding calibration
gas.
Span calibration can be performed using gases within the ranges:
4.0% ≤ CO2 ≤ 11.0%
45% ≤ O 2
≤
100%
- for ISA Multigas with Servomex only
30% ≤ N2O ≤ 100% - for ISA Multigas only
2.0% ≤ DES ≤ 12.0% - for ISA Multigas only
The accuracy of the individual components of the calibration gas mixture shall each have
an accuracy of at least +/-0.03 vol% or +/-(0.02 vol% +0.1% of reading), whichever is
greater.
Note: DES shall be used for span calibration of all 5 agents (HAL, ENF, ISO, SEV, DES).
Note: Gas span calibration should be performed only for the gas components that failed
in the Gas span check.
1. Warm up the ISA gas analyzer for at least 1 min
2. Send "Pre span calibration zeroing" and make sure that the surrounding gas is normal air
(21% O2 and 0% CO2),
3. For each gas that failed the Gas span check, perform step 4 to 7. Always
perform the span calibration with the gases in order O2, N2O , DES and CO2
Example: Span calibration of O2 and CO2 only, start with O2 then CO2.
4. Supply the calibration gas and wait for at least 30 seconds.
5. Send the corresponding span calibration command.
6. Wait until the gas span calibration is no longer in progress. The calibrationgas can be
turned off when "span calibration is in progress" no longer is set, but the O2 span
calibration continues for about 40 s with a special zeroing during which the Servomex
paramagnetic O2 sensor is sensitive to mechanical movements.
10-20
7. Verify the gas readings
Notes: If the calibration process fails, the flag SPAN_ERR is set, and will stay
active until the next successful calibration is passed.
As long as no sampling line is connected, an ISA gas analyzer stays in a low-power,
sleep mode. Once the sampling line is connected, the ISA gas analyzer switches to
measuring mode and starts delivering gas data.
E.2.4.
Zeroing ·
The infrared gas analyzer needs to establish a zero reference level for the CO2, N20 and
anesthetic agent gas measurement. This zero calibration is here referred to as
"Zeroing".
ISA sidestream gas analyzers perform Zeroing automatically by switching the gas
sampling from the respiratory circuit to ambient air. The automatic Zeroing takes less
than 3 seconds for ISA CO2 gas analyzers and less than 10 seconds for ISA multigas
analyzers. If the ISA sidestream gas analyzer is fitted with an oxygen sensor, the
automatic Zeroing will also include room air calibration of the oxygen sensor. Since a
successful Zeroing requires the presence of ambient air (21% O2 and 0% CO2) , ensure
that the ISA is placed in a well-ventilated place.
During Zeroing, if JSA's exhaust gas is returned to the patient circuit, the returned gas
level will be different from the gas level at the sampling site
ISA OR+ Multigas analyzers normally perform Zeroing directly at startup (with or
without Nomoline attached), when a steady operating temperature is achieved and
thereafter every 8 h from start up. A Zeroing is also performed when the operating mode
is changed from sleep mode to measurement mode.
Additional automatic Zeroing can however be performed if the system consider it
necessary.
E.2.5.
Flow reference zeroing
Addition to the Zeroing the ISA sidestream gas analyzer also perform an automatic flow
reference zeroing 1h from startup and thereafter every 96h. During a flow reference
zeroing the ISA sidestream gas analyzers switch from gas sampling from the respiratory
circuit to ambient air while the pump is switched off. Hence no flow will be drawn from the
reference inlet. During the automatic flow reference zeroing , which takes less than 8
seconds , the LEGI will be blinking with a green light.
10-21
E.2.6.
Gas data considerations
Gas measurement units
Effects of humidity
The partial pressure and the volume percentage of CO2 , N2O , O2 and anesthetic agents
depend on the amount of water vapor in the measured gas. The O2 measurement will be
calibrated to show 20.8 vol% at actual ambient temperature and humidity level, instead of
showing actual partial pressure. 20.8 vol% O2 corresponds to the actual O2 concentration in
room air with 0.7 vol% H20 concentration (at 1013 hPa this equals for example 25°C and
23% RH). The measurement of CO2, N2O, and anesthetic agents (e.g. all gases measured
by the IA-bench) will always show the actual partial pressure at the current humidity level.
In the alveoli of the patient, the breathing gas is saturated with water vapor at body
temperature (BTPS). When the breathing gas flows through the sampling line, the gas
temperature will adapt to ambient before reaching the gas analyzer. As the NOMO
section removes all condensed water, no water will reach the ISA gas analyzer. The
relative humidity of the sampled gas will be about 95%.
If CO2 values at BTPS are required, the following equation can be used:
where :
EtCO2 = EtCO2 value sent from ISA [vol %]
Pamb = Ambient pressure sent from ISA [kPa]
3.8 = Typical partial pressure of water vapor condensed between patient circuit and ISA [kPa)
EtC02(BTPS) = EtCO2 gas concentration at BTPS [vol%]
Spectral broadening
The presence of oxygen and nitrous oxide can cause some interference in the CO2
measurement. This is known as spectral broadening.
Nitrous oxide, N2O:
ISA sidestream analyzers automatically compensates for spectral broadening caused by
nitrous oxide.
Below is the typical effect if using the default value (0 vol% N20) when measuring on gas
mixtures with different N20 concentrations:
N2O concentration
in gas mix
Effect on gas reading
Displayed value if true
concentration is 5.0 vol% CO2
0 vol%
30 vol%
60 vol%
82 vol%
0 % relative
5.17 % relative
10.34 % relative
14.14 % relative
5.0 vol%
5.3 vol%
5.5 vol%
5.7 vol%
10-22
Oxygen, O2:
ISA OR+ sidestream units automatically compensates for spectral
broadening caused by oxygen
Below is the typical effect if using the default value (21 vol% 02) when measuring on gas
mixtures with different O2 concentrations:
O2 concentration in
gas mix
Effect on gas
reading
21 vol%
0 % relative
5.0 vol%
50 vol%
-2.76 % relative
4.9 vol%
70 vol%
-4.67 % relative
4.8 vol%
95 vol%
-7.05 % relative
4.7 vol%
Displayed value if true
concentration is 5.0 vol% CO2
E.3. Specifications
E.3.1.
Intended use
The ISA OR+ product is intended to be connected to other medical backboard devices for
monitoring of breath rate and the following breathing gases:
ISA OR+: CO2, O2, N2O ,Halothane, lsoflurane, Enflurane, Sevoflurane and Desflurane
ISA OR+ is intended to be connected to a patient breathing circuit for monitoring of inspired
/expired gases during anesthesia, recovery and respiratory care. The intended environment
is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be
used in road ambulances. The intended patient population is adult, pediatric and infant
patients.
Nomoline sampling cannulas are intended to be used as accessories to the ISA gas
analyzers. They are connected to the nostrils or to the nostrils and mouth on spontaneously
breathing patients for sampling of CO2• Some models are also used to deliver O2 in parallel
with CO2 sampling. The intended patient population is adult, pediatric and infant patients.
10-23
E.3.2.
Gas Analyzer
Sensor head
2 to 9 channel NDIR type gas analyzer measuring at 4 to 10 µm. Data
acquisition rate 10 kHz(sample rate 20 Hz/channel)
Compensations
ISA OR+:
Calibration
No span calibration is required for the IR bench. An automatic Zeroing is
performed typically 1 to 3 times per day.
Warm-up time
ISA OR+:
Automatic compensation for pressure and temperature.
Manual compensation for broadening effects on CO2
<20 seconds (Concentrations reported, automatic agent
identification enabled and full accuracy)
Rise time1
At 50 sml/min sample flow
ISA OR+
CO2
N2O, O2, ENF, ISO, SEV, DES
HAL
≤ 300 ms
< 400 ms
< 400 ms
Primary agent threshold
(ISA OR+)
0.15 vol% When an agent is identified, concentrations will be reported even
below 0.15 vol% as long as apnea is not detected
Secondary agent threshold
(ISA OR+)
0.2 vol% + 10% of total agent concentration
Agent identification time
(ISA OR+)
< 20 seconds (typically < 10 seconds)
Total system response time ISA OR+
< 4 seconds
(with 2 m Nomoline Airway Adapter Set sampling line)
Measured according to EN ISO 80601-2-55
E.3.3.
Accuracy - standard conditions
The following accuracy specifications are valid for dry single gases at 22 ± 5 'C and 1013 ± 40 hPa:
Gas
Range
Accuracy
CO2
0 to 15 vol%
±(0.2 vol%+ 2% of reading)
N2O
0 to 100 vol%
±(2 vol% + 2% of reading)
HAL, ENF, ISO
0 to 8 vol%
±(0.15 vol% + 5% of reading)
SEV
0 to 10 vol%
±(0.15 vol% + 5% of reading)
DES
0 to 22 vol%
±(0.15 vol% + 5% of reading)
O2
0 to 100 vol%
±(1 vol%+ 2% of reading)
10-24
E.3.4.
Accuracy - all conditions
The following accuracy specifications are valid for all specified environmental conditions
except for interference specified in section E3.5 (effects from water vapor partial pressure on
gas readings) and section E3.6 (interfering gas effects).
Gas
Accuracy
CO2
±(0.5 kPA + 8% of reading)
±(3.75 mmHg + 8% of reading)
N2O
±(2 kPA + 5% of reading)
±(15 mmHg + 5% of reading)
Agents2
±(0.2 kPA + 10% of reading)
±(1.5 mmHg + 10% of reading)
O2
±(2 kPA + 2% of reading)
1 All gas concentrations are
reported in units of volume percent and may be translated into mmHg or kPa by using the
reported atmospheric pressure.
2 The accuracy specification is not valid if more than two agents are present in the gas mixture. If more than two agents
are present, an alarm will be set.
E.3.5. Effects from water vapor partial pressure on gas readings
When the breathing gas through the sampling line, the gas temperature will adapt to the
ambient temperature before reaching the gas analyzer. The measurement of all gases will
always show the actual partial pressure at the current humidity level in the gas sample. As the
NOMO section removes all condensed water, no water will reach the ISA gas analyzer.
However reading will typically be 6% lower than corresponding partial pressure after removal of
all water.
E.3.6. Interfering gas effects
Gas
Gas level
CO2
CO2 only option
3886
ISA OR+
- 1)
- 1)
- 1)
- 1)
Agents
of 3886
N2O of
3886
N2O 4)
HAL 4)
ENF, ISO, SEV 4)
DES 4)
Xe (Xenon) 4)
He (Helium) 4)
Metered dose inhaler
propellants 4)
C2H5OH (Ethanol) 4)
C3H7OH (Isopropanol) 4)
CH3COCH3 (Acetone) 4)
CH4 (Methane) 4)
CO (Carbon monoxide) 5)
60 Vol%
- 2)
- 1)
6)
4 Vol%
- 1)
5 Vol%
- 6)
- 1)
6)
15 Vol%
- 1)
3)
80 Vol%
-10% of reading
- 1)
50 Vol%
-6% of reading 3)
- 1)
Not for use with metered dose inhaler propellants
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
0.3 Vol%
0.5 Vol%
1 Vol%
3 Vol%
1 Vol%
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
- 1)
O2 5)
100 Vol%
- 2)
- 2)
- 1)
- 1)
10-25
Note 1:
Note 2:
Note 3:
Note 4:
Note 5:
Note 6:
Negligible interference, effect included in the specification “Accuracy, all conditions” above.
Negligible interference with N2O / O2 concentrations correctly set, effect included in the
specification “Accuracy, all conditions” above.
Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2
readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50
vol% Helium, the actual measured CO2 concentration will typically be (1-0.06) * 5.0 vol% = 4.7
vol% CO2.
According to the EN ISO 80601-2-55:2011 standard.
In addition to the EN ISO 80601-2-55:2011 standard.
CO2 Only internal option is contra-indicated for use with anesthetic agents, no interfering gas
testing or specification per EN ISO 80601-2-55 standard.
10-26
F.
Symbol Conventions and meanings
Symbol
Used for
or
Symbol
Used For
Manufacturer
CE Mark
Manufacturer/ Date of
Manufacture
Do Not Reuse
Use by date; do not use
after the year (YYYY),
month (MM)
Federal Communications
Commission radio
certification
Consult Instructions for Use
Authorized EU Representative
Non sterile
or
MR Safe: Completely safe
for use with no potential
for interaction with the
MR field.
or
MR Unsafe: Must not be
used in an MRI
environment
MR Conditional: Use in
the MR environment is
restricted to certain
conditions of use to
ensure patient and
operator safety
Fragile
Prescription Only
Atmospheric Pressure Limits
Quantity in Package
Humidity Limits, noncondensing
Part Number
Temperature Limits
Serial Number
QR Code, Unique Device
Identifier
Lot Number
Instructions for Use must be
consulted
Defibrillator-proof type
CF equipment (IEC 606011) protection against
10-27
Shock
–
Radio Source
Not for General Waste
Gas Inlet
Gas Outlet
Power On
Power Off
Battery, negative contact
Direct Current
Universal Serial Bus (USB)
Battery, positive contact
Alternating Current
IPX1
Protected against harmful
effects of dripping water per
IEC 60529
Alarm sound system is
capable of audio sound
triggered by alarms/alerts
Audio Alarms Off; ALARM
conditions can visually
indicate, if ALARM not OFF
Audible Alarms Paused
(includes 120 second
countdown timer adjacent to
symbol)
Alarm condition is occurring
All Alarms Off: Indefinitely
pauses all alarms and
terminates automatic NIBP
measurements
Wireless Signal Strength
Connected to AC mains
3885-T Remote Tablet battery
life
3880 Patient Monitor battery
life
3881 ECG ePOD battery life
3881 SpO2 oPOD battery life
No Battery, or Battery unable
to communicate remaining
life
Heartbeat Detected
Fuse
Settings button: Access
monitor setup menus
Trend button: Trend Screen
access and adjustment
10-28
RECORD button: Starts strip
chart recorder for hard copy
printout at recorder in the
optional 3885-B Base Station
NIBP START/STOP button:
Initiates a NIBP measurement
when one is not in progress,
or stops an NIBP in progress.
Holding START/STOP button
for 3 seconds initiates STAT
readings.
10-29
G. Manufactures Technical Declaration
EMC Information Tables as required by EN 60601-1-2:2007 Clause 5
In accordance with EN 60601-1-2:2007 Medical Electrical Equipment – Part 1-2: General
requirements for safety – Collateral standard: Electromagnetic Compatibility – Requirements and
tests
1. “Medical Electrical Equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided in the
Accompanying Documents” (the following tables).
2. “Portable and Mobile RF Communications Equipment can affect Medical
Electrical Equipment”.
3. “The equipment or system should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the equipment or system
should be observed to verify normal operation in the configuration in which it is used”.
The following tables (as required in EN 60601-1-2:2007) provide information regarding the
Electromagnetic Compatibility (EMC) of this product and its accessories.
Table 201—Guidance and manufacturer’s declaration— electromagnetic emissions—for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration—electromagnetic emissions
The 3880 System is intended for use in the electromagnetic environment specified below.
The customer or the user of the 3880 System should assure that it is used in such an
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions IEC
61000-3-2
Voltage
fluctuations/flicker
emissions IEC
61000-3-3
Compliance Electromagnetic environment - guidance
Group 1
The 3880 System must emit electromagnetic
energy in order to perform its intended function
(remote communications within an specific band for
WLAN; i.e. 2.431 to 2.474 GHz).
Nearby electronic equipment may be affected.
Class B
The 3880 System is suitable for use in all
establishments other than domestic and those
Not applicable
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Not applicable
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3880 System
Table 202—Guidance and manufacturer’s declaration— electromagnetic immunity—for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration—electromagnetic immunity
The 3880 System is intended for use in the electromagnetic environment customer or the user of the 3880 System should
assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic material,
the relative humidity should be at least 30 %.
Electrical fast
transient/burst
±2 kV for power
supply lines
±2 kV for power supply
lines
Mains power quality should be that of a typical
commercial or hospital environment.
IEC 61000-4-4
±1 kV for
input/output lines
±1 kV for input/output
lines
Surge
±1 kV differential
mode
±2 kV common
mode
±1 kV differential mode
<5 % UT (>95 %
dip in UT) for 0.5
cycle
<5 % UT (>95 % dip in
UT) for 0.5 cycle
40 % UT (60 %
dip in UT) for 5
cycles
70 % UT (30 %
40 % UT (60 % dip in
UT) for 5 cycles
Electrostatic discharge
(ESD)
IEC 61000-4-2
IEC 61000-4-5
Voltage dips, short
interruptions, and voltage
variations on power supply
input lines
IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
dip in UT) for 25
cycles
<5 % UT(>95 %
dip in UT) for 5
sec
3 A/m
Compliance level
Electromagnetic environment - guidance
Mains power quality should be that of a typical
commercial or hospital environment.
±2 kV common mode
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the 3880 System requires continued
operation during power mains interruptions, it is
recommended that the 3880 System be
powered from an uninterruptible power supply or
a battery.
70 % UT (30 % dip in
UT) for 25 cycles
<5 % UT(>95 % dip in
UT) for 5 sec
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE—UT is the a.c. mains voltage prior to application of the test level.
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Table 203—Guidance and manufacturer’s declaration— electromagnetic immunity—for LIFE-SUPPORTING EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration—electromagnetic immunity
The 3880 System is intended for use in the electromagnetic environment customer or the user of the 3880 System
should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the 3880 System, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
3 Vrms
150 kHz to 80 MHz
outside ISM bandsa
3V
d = 1.17 ¥ P
10 Vrms
150 kHz to 80 MHz
outside ISM bandsa
10 V
d = 1.20 ¥ P
10 Vrms
80 MHz to 2.5 GHz
10 V/m
d = 1.20 ¥ P
80 MHz to 800 MHz
d = 2.33 ¥ P
800 MHz to 2.5 GHz
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).b
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, c should be less than the compliance
level in each frequency range.d
Interference may occur in the vicinity of equipment marked with
the following symbol:
IEC 60417, No. 417-IEC5140, "Source of Non-Ionizing Radiation"
Symbol
NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects,
and people.
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;
26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to
decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this
reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 3880 System is used
exceeds the applicable RF compliance level above, the 3880 System should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the 3880 System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V 1] V/m
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3880 System
Table 205—Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM—
for LIFE-SUPPORTING EQUIPMENT and SYSTEMS
Recommended separation distances between portable and mobile RF communications equipment and the
3880 System
The 3880 System is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the 3880 System can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the 3880 System as recommended below, according to the maximum output power of the communications
equipment.
Rated
maximum
output power
of transmitter
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
150 kHz to 80 MHz in
80 MHz to 800 MHz
800 MHz to 2.5 GHz
outside ISM bands
ISM bands
d = 1.17 √ P
d = 1.2 √ P
d = 1.2 √ P
d = 2.33 √ P
0.01
0.1
0.12
0.38
0.12
0.38
0.12
0.38
0.23
0.77
10
1.17
3.8
1.2
3.8
1.17
3.8
2.33
7.67
100
11.67
12
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1—At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2—The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
NOTE 3—An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands
between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas.
NOTE 4—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
Recommended separation distances between the 3880 System components and local radio frequency devices, such as WiFi AP devices, for wireless
coexistence: Maintain a 2 meter ( 6’) separation.
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