Iradimed IRM02, IRM01, IRM00 User Manual

• Do not place the NIB P 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 we r e r emoved, or if a shunt is on that arm. This can lea d 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, th e 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, wh ere a thick layer of fat surrounding a limb dampens the oscillations coming

from the artery

• Edematous extremity

6.4.2. Understanding the Display

1. Measurement Unit (mmHg or kPa)

2. Current Mean Pressure upper and lower alarm lim its

3. NIBP cuff pr essure when inflat ing

4. Time until nex t NI BP Measurement (m inutes : seconds or manual)

5. Current Systolic Pressure upper and lower alarm li mits

6. Most recent NIBP reading

7. Current Diastoli c P re ss ure 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 corr ec t . 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 uppe r arm’s length. The i nflatable 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 n ot cy cle when the monit or is i n St andby

6.4.3.1. Setup Checklist

• The hose is correct.

• The connector is fi r mly pushed inside the cuff tube.

• The NIBP hose is pr operly connected to the module and will not detach if pulled.

• The NIBP cuff is correct for the patient’s limb size.

6-26

• There are no hol es or cracks in the cuff bladder or cuff tube.

Range

Low

High

Range

Adult

systolic

Off, 30-270

160

30-270, Off

diastolic

Off, 10-245

10-245, Off

mean

Off, 20-255

110

20-255, Off

Pediatric /Infant

systolic

Off, 30-270

120

30-270, Off

diastolic

Off, 10-245

10-245, Off

mean

Off, 20-255

20-255, Off

Neonatal

systolic

Off, 30-130

30-130, Off

diastolic

Off, 10-100

10-100, Off

mean

Off, 20-120

20-120, Off

• All residua l 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 hear t 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.

6.4.4. Changing Frequently Use d 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 Int e rval 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 sel ection

4. Touch Back button to close the menu

6.4.5. NIBP Alarm Limits

Low Limit

Default

High Limit

6-27

Message

Trigger Condition

NIBP Inop

Hardware or software failure detected

NIBP Over Press

Pressure exceeds 300 mmHg for Adult / Ped or 150 mmHg for Neonatal patients

15 mmHg remains in the line for Adult / Ped or 5mmHg for Neo for greater than 90 seconds

NIBP Time Out

Pressure remains the same for more than 30 seconds or if measurement exceeds 180 seconds

NIBP Leak

Air leak is detected

Wrong Cuff

Displayed if the NIBP system detects an incorrect cuff size for the selected patient mode

NIBP Occlusion

Occlusion is detected

NIBP Cal Error

Calibration error detected

NIBP Delayed

NIBP reading start has been delayed to allow blood flow to resume

6.4.6. NIBP Messages

-or-

6.5. Temperature Monitoring

6.5.1. Temperature Overv i e w

The 3880 system f eatures a unique and in novative temper ature measureme nt 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 tem perature or drafts

• Do not bend the fiber optic sensor in a radius of less than 15 mm

• Do not expose to temperature above 50

• Do not pull or apply tension to the fiber-optic cable

• Do not alter or modify the accessories

○

6.5.2. Underst an d ing the Display

6-28

  



1. Measurement Unit

2. Curren t Vital Sigh

3. Alarm Limits

4. OVR/UND for Temp extended range <30.0 °C or >44.0 °C(<86.0°F or >111.2°F ), accuracy ± 0.4 °C

6.5.3. Temperature Patie nt Application

6.5.3.1. Surface T e m p erature A pp l ication

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

• Temperat ur e c able is properly in s er ted into the 3880 system

• Temperat ur e sensor is applied and positioned correctly

• Temperat ur e sensor is not damaged in any way

6.5.4. Changin g the Temperat ur e 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 sel ection

4. Touch Back button to close menu

6-29

6.5.5. Temperature Alarm Limits, Celsius

Range

Default Low

High

Range

Adult Temp

Off, 25-40

25-40, Off

Pediatric Temp

Off, 25-40

25-40, Off

Neonatal Temp

Off, 25-40

25-40, Off

Message

Trigger Condition

Temp Inop

Hardware or software failure detected

Temp Probe Fail

Broken sensor detected or a sensor is not attached properly

OVR / UND

Indicating Temp extended range < 30.0 °C or > 44 C°(<86.0°F or accuracy ± 0.4 °C

Low Limit

Default

High Limit

6.5.6. Temperature Messaging

>111.2°F )

6.5.7. Connecting the Sensor

The fiber optic temperature sensor utilizes a keyed twist locking connector to securely mate to the temper a ture c o nne c tion port on the right s ide of the 3 8 8 0 M onitor unit. Ro tate the sensor co nne c tion while ge ntly pushing i nto the ma ting co nnec tion on the monitor. O nc e the ke y wa y

h a s s lid e in t o th e m a t in g s lo t , t u r n t h e o u t e r s h e ll ≈3 0 ° t o lo c k in t o p la c e .

6.5.8. Temperature refer en ce measurement

A baseline temperature meas urement sho uld be made once the fi ber o ptic temperat ure s ensor is appl ied and befo re s t arting the MR i mage scan , which s ho uld be used as a reference for t he temperature measured duri ng t he 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 yo u 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, T r ace 2 will appear on the bottom of the paper. To adjust which wavefor m you want to print when the Print button is pressed follow the se 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 displa y (d isplay 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 foll ow these steps:

1. Press the SETTINGS button

2. Select “Recorder Setup”

7-31

3. Select “Trace Delay”

4. Select des ired 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 automatica ll y print when a clinic al alarm is detected.

To enable the Aut o St rip follow thes e st eps:

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 ar e 8, 1 2, 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 sw itches 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 des ired 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. Rec order O utput

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 malfu nc ti on which results fro m imp r oper 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 dev i ces. The 3880 system employs watchdog timers, self-monitoring activities (memory, c om m unication 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 maintain ed and stored batter i es , the life expectancy is about 2 or 3 years res pectively. For more aggressi v e and non-traditional use mo dels, the life expectancy maybe less. recommend s re placing batteries every 2 to 3 years or wh en signs of wear or operation are noticeably different.

To get the most out of your batteries observe the following guidelines:

• The batter y performance test must be performed ever y 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.

IRadimed

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. Thi s feature allows facilities with multiple batteries to proac t ively select a battery that has a desired charge level prior to inserting it into the system. To che c k a batteries charg e 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

• Check that s ystem components and ac cessories do not have any visual defects such as cracks or loo se 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 wir elessly 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 fo r the patient.

• Check the compatibility of the 3880 monitor, sen sors and cables before use

8.2.2. 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 Ta ble t in the control room i n it s desired locat io n and check that the communication performance is acceptab le.

ECG

• Check that the message 'Leads Off' disa ppears and the waveforms are displayed when the lead wires are connected to the patient.

Pulse Oximetry

• Check that the R ed Light is visible in t he s ensor

• Check that the SpO

the sensor is connected to the patient

(CO2 only or 3886 Multi-Gas system)

value is display ed and the message “P ro be O f f” disappears when

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 D om e 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. Che c k 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.

! 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 thi ck or cause the plas tic case to bulge discontinue use and contact your support personnel for proper disposal.

8.2.3. Every Twelve Months

Preventative Maintenance Check

• Calibration check of temperature, NIBP and CO

NOTE

• The annual check a c co rd i n g to detailed instruction s 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 enviro nm ent for verification of gas reading s 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, P OD s 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

/ Multi-Gas Agents Unit

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 y our equipment. The warranty does not cover damage caused by unappro v ed 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 liq uid 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 sp illed 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 instr uc tions accompan y i ng any accessori es 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 monito r 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 pati ent monitor and disconnect it from power .

2. Clean the displays using a soft, clean clo th da m pened with glass clea ne r .

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 indicat ed 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 swa ps dampened with alcohol.

3. After the alcohol has complete dried, reload the paper and close the door.

! CAUTION

• Do not use anythin g t ha t may destroy the thermal print head.

• Do not add unnecessary force to the thermal print head.

8-5

8.5. User Maintenance

Problem

Possible Cause

Solution

3880 will not turn on.

Power dial is not in the

1) Turn 3880 ON by

position.

No AC power/battery

1) Plug AC Adapter

charged battery.

8.5.1. Overview

Before every use, a thorough inspection sho uld be performed. Follow these guidelines when inspecting the 3880 monitor:

• Make sure that the environment and power supply meet the requirements.

• Inspect th e 3880 system and its accessories fo r mechanical dama ge .

• 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 correctl y .

• 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

8.5.2. Updating Software

As revisio ns of the software become available, the 3880 can be updated, see service manual for detail procedure.

IRadimed service personne l imm ediately.

8.6. Troubleshooting Probl ems With No Ons cr e en Mes sag e

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

correct position

depleted.

rotating the power dial to the ON

power cord into a working 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

8-6

Problem

Possible Cause

Solution

Blown Fuse(s).

1) Replace the fuse in

the power supply

type and procedure.

AC power source has

1) Switch AC power

requirements.

Screen Damaged.

If an audible alarm is

technical support.

3885-T will not turn on.

Power ON [ I] key not

1) Turn 3885-T ON by

pressed.

Battery depleted.

1) Plug AC Adapter

charged battery.

box (P/N 1120).

Refer to the service manual for proper fuse

incorrect voltage.

pressed.

cord to a power receptacle with sufficient voltage.

Refer to the service manual for voltage

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

firmly pressing the ON button firmly.

Listen and feel for the tactile feedback to confirm the button has been properly

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

8-7

Problem

Possible Cause

Solution

3885-B will not turn on.

Power ON key not

pressed.

1) Toggle the power

pressed.

Blown Fuse(s).

1) Replace the fuse in

type and procedure.

No AC power

1) Plug AC Adapter

immediately.

AC power source has

1) Switch AC power

requirements.

3886 will not turn on.

Power ON key not

1) Toggle the power

pressed.

Blown Fuse(s).

1) Replace the fuse in

type and procedure.

No AC power

1) Plug AC Adapter

immediately.

switch to the ON position.

Listen and feel for the tactile feedback to confirm the button has been properly

the rear of the 3885T

Refer to the service manual for proper fuse

power cord into a working AC outlet

incorrect voltage.

pressed.

cord to a power receptacle with sufficient voltage.

Refer to the service manual for voltage

switch to the ON position.

Listen and feel for the tactile feedback to confirm the button has been properly

the rear of the 3885T

Refer to the service manual for proper fuse

power cord into a working AC outlet

8-8

Problem

Possible Cause

Solution

AC power source has

incorrect voltage.

1) Switch AC power

requirements.

ePOD or oPOD will not

Power ON key not

1) Toggle the power

pressed.

Insufficient battery life

1) Plug 3880 system

Technical Support

3880 will not operate

Battery not properly

1) Plug AC Adapter

pack before use.

cord to a power receptacle with sufficient voltage.

Refer to the service manual for voltage

turn on

on battery.

pressed.

charged.

switch to the ON position.

Listen and feel for the tactile feedback to confirm the button has been properly

into AC power.

2) Ensure the POD is correctly docked and seated into a charging bay on the 3880 monitor.

3) Allow to charge a minimum of 4 hours.

4) Contact IRadimed

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

8-9

Problem

Possible Cause

Solution

Aged battery won't hold

charge.

1) Plug AC Adapter

pack before use.

Battery is in sleep

When the battery test

3880 back in use.

Short battery run time.

Battery not charged

1) Plug AC Adapter

off.

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

mode.

long enough.

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

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

8-10

Problem

Possible Cause

Solution

Aged battery will not

hold charge.

1) Plug AC Adapter

technical support.

Battery is hard to

Swollen Battery Cells.

Return the device to removal.

Problem

Possible Cause

Solution

No Audible alarm tone

Alarm volume set too low

1) Press the Settings

environment.

Faulty alarm speaker.

1) Contact IRadimed Technical Support.

Continuous alarm tone

Faulty hardware.

1) Note any onscreen

technical support.

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

remove.

8.6.2. Troubleshooting Alarm Related Problems

heard.

after alarm silence is

pushed.

for the use environment.

IRadimed for battery

Button.

2) Select Alarms Function

3) Adjust alarm volume for the intended use

messages.

2) Contact IRadimed

8-11

Problem

Possible Cause

Solution

The unit is in Alarm mode

with lights flashing but

The 2 minute Alarm

1) Press the

re-engage.

Audible volume set too

1) Press the Settings

environment.

Problem

Possible Cause

Solution

Buttons will not function.

Key not pressed firmly.

1) Repeat key press

been properly pressed.

Faulty key panel.

If the above 2 solutions

Service.

Programmed settings are

3880 turned off for

1) Train appropriate

settings.

Volatile memory may not

1) Replace CR2032

Technical Service.

Clock is not correct.

Clock not properly

after receipt.

1) Adjust clock time as

Internal coin cell battery

1) Replace CR2032

Technical Service.

Summer/Winter time

1) Adjust clock as manual.

no audible alarms can be

heard.

Silence button is activated.

ALARMSILENCE button to re-engage alarm volume.

2) Or wait for two minutes.

After two minutes, alarm tones will automatically

low to be heard.

2) Select Alarms

3) Adjust alarm volume

8.6.3. Troubles hooting Operation Related Probl em s

Listen for audible and feel for the tactile feedback to confirm the button has

are acceptable contact IRadimed Technical

Button. Function for the intended use

more firmly.

restored to default on power up.

longer than 30 seconds between uses.

store due to internal Coin cell battery problem.

adjusted to local time

has become depleted.

change.

personnel that turning off the 3880 for more than 30 seconds resets

coin cell battery.

2) Contact IRadimed

described in manual.

coin cell battery.

2) Contact IRadimed

described in service

8-12

Problem

Possible Cause

Solution

4 3885-T Remote will not

3880 is not turned ON.

1) Ensure the 3880 is operational.

3880 is not within

1) Verify 3880 and

needed.

Software incompatibility.

1) Ensure the software

equal.

Incorrect Channel.

1) Ensure that both the

3885-B.

Multiple system

1) Ensure that each

simultaneously).

Loose or damaged

1) Ensure that the

are attached tightly.

Local radio interference

1) Ensure other

system components.

1) Try using a different

communicate on.

communicate to a selected 3880 or drops out.

wireless range.

turned on and is

3885-T within 90 ft (30 m) of 3885-B and that no other devices are blocking the wireless signal.

2) Reposition 3880 to establish communication as

revisions for the 3880 and 3885-T are

3885-T, 3885-B and 3880 are operating on the same wireless network channel.

2) Record wireless network from the

3880.

3) Select matching wireless channel on 3885-T

4) Select matching wireless channel on

components on the same wireless network channel.

antenna.

prevents communication.

3880 in your facility are on separate, unique channels (or not used

antennas on the 3885-B are in good working order and

wireless equipment is greater than 3 feet away from the 3880

wireless network channel for the 3880 system to

8-13

Problem

Possible Cause

Solution

MRI Room Attenuation.

1) Ensure the high gain

antenna is attached

Technical Service.

ePOD or oPOD will not

3880 is not turned ON.

1) Ensure the 3880 is operational.

3880 is not within

1) Verify PODS are

needed

Incorrect Channel.

1) Ensure that the

3882 oPOD.

Multiple system

1) Ensure that each

simultaneously).

Printer will not print

Wireless communication

1) Ensure wireless

with a recorder

to the correct receptacle on the 3885-B

2) Position the high gain antenna so it has a direct line of sight to the 3880.

3) Try a different wireless channel

4) Contact IRadimed

communicate with a 3880

wireless range.

turned on and is

within 9 ft (3 m) of 3880 and that no other devices, walls or doors are blocking the wireless signal.

2) Reposition 3880 to have a line of sight to the PODS as

ePOD, oPOD and 3880 are operating on the same wireless network channel.

2) Record wireless

network from the

3880.

3) Select matching

wireless channel on 3881 ePOD

4) Select matching

wireless channel on

components on the same wireless network channel.

to the 3885-B

3881 and 3882 in your facility are on separate, unique channels that match a corresponding 3880 (or not used

connection is established to a 3885-B equipped

8-14

Problem

Possible Cause

Solution

Printer out of paper or

paper jam

1) Review section 7 of manual

Problem

Possible Cause

Solution

Artifact on MR images.

Loose connection to cord

Tighten AC cord connection

Faulty Hardware.

1) Switch to battery

technica l service.

Problem

Possible Cause

Solution

ECG Vital Signs are not

1) Ensure the ePOD is

applications training.

8.6.4. Troubleshooting MRI Related Problems

the operators

when running on AC power.

to Monitor and power supply.

power.

2) Disconnect the power cable from the 3880 monitor.

3) Disconnect AC power cord from the AC outlet in the MRI r oom.

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

8.6.5. Troubleshooting Vital Sign Related Problems

performing as expected

2) Ensure the ECG

3) Inspect all ECG

4) Review section 6.1

5) Contact your local

on the same wireless network channel as the 3880.

parameter is enabled.

components for damage and replace as necessary.

of the operators manual

representative to schedule

8-15

Problem

Possible Cause

Solution

Incompatible lead view

for the MRI scan and/or

Change the ECG lead view

sequence.

Poor skin preparation

Re-prep the patient

section 6.

Poor electrode

Reposition/replace

found in section 6.

Poor electrode quality

Replace the electrode with

electrode.

Weak radio link

Verify radio channel

improved reception.

QRS amplitude is less

Change the lead view and

the electrodes.

Faulty ECG ePOD

Replace ECG module, or

service representative.

Incorrect ECG Mode

Select the appropriate

manual.

Patient motion

Ensure that the patient is not shivering or moving.

ECG lead not properly

Ensure each ECG leadwire

the ePOD.

Damaged ECG lead

Replace ECG lead with an

lead.

electrode placement

to select the best performing view for the

according the application procedure found in

placement

than 10 mm/mv

selected

electrodes according to the application procedure

an IRadimed approved

setting and signal level. Reposition antenna for

/ or reprep and reposition

refer to qualified technical

ECG filter mode for the application. Refer to section 6 of the operators

inserted into the ePOD

is inserted completely into

IRadimed approved ECG

8-16

Problem

Possible Cause

Solution

All other issues

1) Ensure the ePOD is

on the same

applications training.

SpO2 not functioning

SpO2 sensor is not attached to the patient.

Ensure SpO2 sensor is securely attached.

Poor SpO2 sensor

Reposition/replace SpO2

section 6.

Weak radio link

Verify radio channel

improved reception.

Faulty SpO2 oPOD

Replace SpO2 oPOD, or

service representative.

SPO2 readings are

Sensor positioning

Check the P.I. value and

section 6.

Ensure the SpO2 cable is

SpO2 applicator / grip.

Averaging time

Try adjusting the SpO2 averaging time.

Patients specific anatomy

Skin pigment and certain

readings.

Check that there is no nail

impeding the readings.

Cool temperature is

Check the P.I. value and

touch.

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

unstable or poor

placement

sensor according to

setting and signal level. Reposition antenna for

refer to qualified technical

try repositioning the sensor correctly on the patient according to

correctly inserted into the

anatomy ailments can cause inconsistent SpO2

affecting patients perfusion

polish on the patients digit

ensure the patient is not shivering and that their digits are warm to the

8-17

Problem

Possible Cause

Solution

interference from NIBP

cuff or arterial catheter.

Move the SpO2 sensor to

functions.

Excessive ambient light

Limit the amount of

as needed.

Excessive patient motion

Ensure that the patient is not shivering or moving.

Circulation is reduced

Position the sensor at a

the patients digit.

Finger was removed from

Check that the

according to section 6.

SpO2 Vital Signs are not

All other issues

1) Ensure the SpO2

applications training.

CO2 not functioning

Sampling line hose is not connected

Attach sampling line hose.

Leaking sampling line

Re-check fittings to ensure

sampling line hose.

Sampling line filter is wet

Verify proper drying

line hose filter.

Monitor has an internal leak

Refer to qualified technical service representative.

Values are too low or unstable

Monitor has an internal failure

Refer to qualified technical service representative.

an application site and limb that is not being utilized for other medical

ambient light entering the sensors. Cover with a cloth

performing as expected

because of excess pressure

the sensor

different site and ensure it is not applied to tightly to

appropriate sized sensor is being used and reapply

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

hose

or clogged

they are tight. Replace

tubing is in position. Recheck filter to ensure it is clear. Replace sampling

8-18

Problem

Possible Cause

Solution

EtCO2 Vital Signs are not

performing as expected

All other issues

1) Ensure the EtCO2

applications training.

NIBP values seem

Compromised hose or

Check that tubing is not

compressed or loose.

Ensure the patient is not shivering or moving.

Ensure the correct sized

applied correctly.

Replace Hose or cuff if a leak is suspected.

Monitor has an internal leak

Refer to qualified technical service representative.

Patients Arm Position

Ensure that the patients arm is at heart level.

Cuff comes off patient

Inappropriate sized cuff

Determine correct cuff

according to section 6.

Cuff applied inside out

Reapply cuff according to section 6.

NIBP not functioning

NIBP hose or cuff is disconnected

Ensure NIBP hose is securely connected.

Monitor has an internal failure

Refer to qualified technical service representative.

NIBP Vital Signs are not

All other issues

1) Ensure the NIBP

applications training.

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

unstable

limb

cuff

stretched, bent,

cuff is being used and

size and apply to patient

performing as expected

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

8-19

Problem

Possible Cause

Solution

Temperature error or

intermittent function

Temperature sensor is

the patient.

Re-attach Temperature Poor Temperature sensor placement

Reposition/replace Temperature sensor.

Faulty Temperature

Replace Temperature

representative.

Temperature Vital Signs

All other issues

1) Ensure the

applications training.

Respiration and Gases

1) Ensure the 3886 is

applications training.

not securely attached to

sensor.

are not performing as expected

from 3886 are not performing as expected

sensor

sensor, or refer to qualified technical service

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

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

8-20

8.7. Repair

8.7.1. Overview

All repairs on c omponents under war ranty 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 w arranty.

• The user of this product shall have sole responsibility for any m alfunction which r esults

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 an d rating.

8.7.3. Removing a Paper Jam

If the recorder works incor rectly 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 t he date of original de livery to the buyer or to buyer's order, prov i ded that same is properly operated under conditions of normal use, and that periodic maintenance and service is per formed. A ninety (90 ) day warranty applies to limited-life parts and accessories (e.g.1 133 MRI Compatible Bat tery Pack, gating cable, SpO

, 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 p r od uct has been repaired ot her 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 Servic e Center during norm al 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, guar antees or conditions, includi ng merchantability or fitness for a particular purpose. The remedies under this warranty are exclusive and IRadimed Corporation neither assumes nor authorizes anyon e t o as sume 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 inspec tion 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 th at periodic maint enance and servic e is performed; be repaired by IRadimed and restored to full operational specification as where applicable at the time of original manufacture. Any Ma intenance Ext ension will become null and void if product has been repaired other than by IRad imed Corporatio n, 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.

IRADIME D CORPORAT ION PRODUCT S CONTAIN PRO PRIETARY COPY WRITTEN MATERIAL; ALL RIGHTS ARE RESERVED BY IRADIMED CORPORATION

8-22

9. Accessories

Part Number

Description

Image

Use Type

1171

Reusable Sensor Grip Kit (Pack of 3)

1821

Fiber Optic oPOD SpO2 Cable

3882

8 Channel Wireless oPOD

technology. For use with the IRadimed 3880.

Part Number

Description

Image

Use Type

1832LA

Large Adult Reusable Cuff (34-44cm)

patient use.

1832A

Adult Reusable Cuff (27-35cm)

patient use.

1832SA

Small Adult Reusable Cuff (20.5-28.5cm)

patient use.

The packaging of the accessories is color coded to help identify which access ories are most likely appropriate for your par ticular pati ent.

• 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 twelv e 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. SpO

9.2. NIBP

Reusable Sensors Grip come in 3 sizes (Grips only)

Fiber optic SpO2 cable for use with IRadimed oPODs.

Wireless MRI SpO2 module featuring Masimo

Multiple Use

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

Multiple Use

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

Multiple Use

9-1

Part Number

Description

Image

Use Type

1832P

Pediatric Reusable Cuff (14-21.5cm)

patient use.

1832I

Infant Reusable Cuff (9-15cm)

patient use.

1833N4-10

Neonatal Size 4 Cuff (7-13cm) (Box of 10)

1833N3-10

Neonatal Size 3 Cuff (6-11cm) (Box of 10)

1833N2-10

Neonatal Size 2 Cuff (4-8cm) (Box of 10)

1833N1-10

Neonatal Size 1 Cuff (3-6cm) (Box of 10)

1831

NIBP Swift Connect NIBP Hose

Part Number

Description

Image

Use Type

1813-3

ECG Skin Prep Gel (Box of 3)

skin for MRI ECG electrodes.

1811

9” Five Lead ePOD MRI Leadwire (AAMI)

AAMI color coding. For Use with IRadimed ePOD only.

1811E

9” Five Lead ePOD MRI Leadwire (IEC)

IEC color coding. For Use with IRadimed ePOD only.

3881

8 Channel Wireless ePOD

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

Single Use Non-Invasive blood pressure cuffs are constructed of soft fabric material that conform to the tiniest of patients.

Multiple Use

Single Use

9.3. ECG

Single Use Non-Invasive blood pressure cuffs are constructed of soft fabric material that conform to the tiniest of patients.

Single lumen non-invasive blood pressure hose featuring simple connections

Package of 3 tubes of skin prep gel to prepare patients

ECG leadwire for 3 and 5 lead ECG applications with

Single Use

Multiple Use

Wireless MRI ECG module for use with the IRadimed 3880

Multiple Use

9-2

Part Number

Description

Image

Use Type

1842A-25

Adult Nasal Cannula (Pack of 25)

1842P-25

Pediatric Nasal Cannula (Pack of 25)

1842I-25

Infant Nasal Cannula (Pack of 25)

1841-25

Coextruded Sample Line (Pack of 25)

Part Number

Description

Image

Use Type

1849-25

Nomoline Agent Sample Line (2m) (Pack of 25)

Module only

1846-25

Scavenge Hose (Pack of 25)

1848

Verification Check Gas

Part Number

Description

Image

Use Type

1851

Optical Temperature Sensor

9.4. CO2/Respiration Mo nitoring

Single use standard nasal cannula

Sample line for use with capnography and anesthetic agent gas monitoring. For use with P/N 1849.

9.5. Multi-Gas (Agents) Monitoring

For use with IRadimed’s 3886 Wireless Multigas

Single Use

For use with IRadimed’s 3886 Wireless Multigas Module only

9.6. Temperature

Multiple use Fiber Optic temperature sensor

Single Use

Multiple Use

9-3

Part Number

Description

Image

Use Type

1881

Universal Gating Interface

Systems equipped with cardiac gating leads

Part Number

Description

Image

Use Type

1133

3880 Battery

Non-Magnetic battery used with the 3880

1188

3885T Battery

Non-Magnetic battery used with the 3885T

1122

DC Power Cable, 10 feet (3m)

with the 1120 power supply

1120

Power Supply / Charger Replacement power cable us ed with the 1122 cable

1128

North America AC Power Cord, 10 feet (3m)

1121

North America AC Power Cord, 3 feet (1m)

with the 1120 power supply

Part

Number

Description

Image

Use Type

1882-3

3885B Recorder Paper (Pack of 3)

9.7. Gating

Non-Magnetic gating interface cable for use with MRI

9.8. Power Supply

Replacement power cable used to interface the 3880

Replacement power cable us ed with 3885 and 3886

Multiple Use

Replacement power cable used to interface the 3880

9.9. Recorder

3 Rolls of printer paper for the 3885B recorder

Multiple Use

9-4

10-1

10. Exhibits

Technical Parameters

Technical Detail

Type:

Color TFT resistive touchscreen

Screen Size:

25.7 cm (10.1 inches) diagonal

Pixels:

800 by 480

Backlight:

LED

Screen Update Rate

2 Hz

Waveform Display Mode:

Moving Waveform

Waveform Display Width:

~145 mm

Waveform Display Height:

ECG Single Waveform:

~48mm max

ECG Dual Waveform:

~20mm max

All other Waveforms:

~25mm max

A. Specifications

10.1. Overview

Standard S ystem Components

• 3880 MRI Patient Monitor

• Wireless ECG POD

• Wireless SpO

• Non- Invasive Blood Pressure

• Accessories

Optional System Components

• 3885-T Remote Tablet ‘ Extended Range’ Control Room Display

• 3885-B Base Station with recorder

• CO

• Temperat ur e v i tal 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 CO

• Respirat ion Rate

• Fiber Optic Temperature

• Dual Anesthetic Agents

• Inspired N

• Inspired O

• MAC

POD

and Respiration vital signs

2 2

and CO2

10.1.1. Technical Specifications

10.1.1.1. Display

10-2

Technical Parameters

Technical Detail

Power:

Rotary On, Off

Feature Hard Keys:

Trends, Print, NIBP Start/Stop and Alarm Silence

Setup Hard Keys:

Setup and Standby

Soft Keys:

Touchscreen

Technical Parameters

Technical Detail

Power:

Push Button On, Off

Feature Hard Keys:

Trends, Print, NIBP Start/Stop and Alarm Silence

Setup Hard Keys:

Setup and Standby

Soft Keys:

Touchscreen

Technical Parameters

Technical Detail

Power:

Push Button On, Off

Hard Keys:

Channel Selection

Technical Parameters

Technical Detail

Power:

Toggle

Channel Select:

Button

Technical Parameters

Technical Detail

Types:

Tabular

Trend Memory:

50 readings

Tabular Intervals:

3, 5, 8, 10, 15, 30, Auto NIBP

Data Types:

HR, SpO2, NIBP, EtCO2, Resp, Temp, MAC, O2

Technical Parameters

Technical Detail

Indication:

Audible & Visual

Levels:

High, Medium, Low and Information Messages

Volume:

User Adjustable, 50 to 85 dba, or OFF

Silence:

Permanent or 2 minutes timed hold

10.1.1.2. User Interface

10.1.1.2.1. Monitor

10.1.1.2.2. Tablet

10.1.1.2.3. PODS

10.1.1.2.4. Base Station

10.1.1.3. Application Features

10.1.1.3.1 Trend Reports

10.1.1.3.2 Alarms

10-3

Technical Parameters

Technical Detail

IEC:

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

Med Device Directive:

93/42/EEC, 2007/47/EEC

Defibrillator Protection:

Up to 5 KV

Defibrillator Recovery

Time:

During a defibrillation procedure, the ECG waveform will saturate then recover in less than 5 seconds

Technical Parameters

Technical Detail

3880 Monitor:

23 cm (8.8 inches)

3885-T Remote Tablet:

19.6 cm (7.7 inches)

3885-B Base Station:

18.8 cm (7.4 inches)

3881/3882 Wireless

9.5 cm (3.8 inches) 3886 Multi-Gas Unit

8 cm (3.13 inches)

Technical Parameters

Technical Detail

3880 Monitor:

29 cm (11.4 inches)

3885-T Remote Tablet:

26.7 cm (10.5 inches)

3885-B Base Station:

38 cm (15 inches)

3881/3882 Wireless PODS:

2.0 cm (0.8 inches) 3886 Multi-Gas Unit

14.7 cm (5.8 inches)

Technical Parameters

Technical Detail

3880 Monitor:

12.7 cm (5 inches)

3885-T Remote Tablet:

4.5 cm (1.8 inches)

3885-B Base Station:

12 cm (4.8 inches)

3881/3882 Wireless PODS:

5.7 cm (2.3 inches) 3886 Multi-Gas Unit

10.2 cm (4.1 inches)

Technical Parameters

Technical Detail

3880 Monitor:

4 kg (8.9 lbs)

3885-T Remote Tablet:

1.6 kg (3.6 lbs)

3885-B Base Station:

2.1 kg (4.6 lbs)

3881/3882 Wireless PODS:

73 g (0.16 lbs) (without sensors/leads) 3886 Multi-Gas Unit

1.04 kg (2.3 lbs)

PODS:

10.1.1.4. Safety Standards

10.1.1.5. Physical Specifications

10.1.1.5.1. Height

10.1.1.5.2. Width

10.1.1.5.3. Depth

10.1.1.5.4. Weight

10-4

10.1.1.6. Electrical Specifications

Technical Parameters

Technical Detail

Power Requirements

Voltage Range: (All 3880 system components)

85 - 264 VAC Frequency Range:

50 - 60 Hz

Max Consumption: 3885-B Base Station

< 65 VA during charging, 388 5 -B

3886 Multi-Gas Unit

< 10 VA

Battery Capacity

3880 Monitor:

14.8 V at 6 Ah Lithium Polymer

3885-T Remote Tablet:

7.4 V at 6 Ah Lithium Polymer

3881/3882 W ireless PODS:

3.7 V at 1200 mAh Lithium Polymer

Battery Operation Time

3880 Monitor:

>8 hours with NIBP readings every 5 minutes 3885-T Remote Tablet:

>10 hours

3881/3882 Wireless PODS:

>12 hours

Battery Charge Time

3880 Monitor:

< 5 hours to 90% capacity

3885-T Remote Tablet:

< 5 hours to 90% capacity

3881/3882 Wireless PODS:

< 3 hours to 90% capacity

Power On

Boot Time:

< 4 seconds

Technical Parameters

Technical Detail

Operating

All 3880 system components

Temperature Range:

+10○ to + 40○ C (+50○ to + 104○ F)

Humidity Range:

5% to 85% RH, non-condensing

Altitude Range:

0 – 5000 meters, Pressure: 1010hPa – 540hPa

Storage

All 3880 system components

Temperature Range:

-20○ to + 50○ C (-4○ to + 122○ F)

Humidity Range:

5% to 95% RH, non-condensing

Altitude Range:

0 – 5000 meters, Pressure 1010hPa – 540hPa

Technical Parameters

Technical Detail

3880 Monitor

MR Environment Safety:

MRI Conditional

Magnetic Field Limit:

30,000 Gauss

MRI System:

0.5 to 3.0 Tesla MRI Systems

3881/3882 Wireless PODS

MR Environment Safety:

MRI Conditional

SAR:

≤4 W/kg whole body average SAR

Magnetic Field Limit:

30,000 Gauss

MRI System:

0.5 to 3.0 Tesla MRI Systems

3885-T Remote Tablet

MR Environment Safety:

MRI Conditional

Magnetic Field Limit:

15,000 Gauss

3885-B Base Station

MR Environment Safety:

MRI Unsafe

Accessories

MR Environment Safety:

MRI Safe as listed in Section 9.1-9.7

3886 Multi-Gas Unit

Magnetic Field Limit:

MR conditional 600 gauss

3880 Monitor

< 40 VA during charging

10.1.1.7. Environmental Specifications

10.1.1.8. MRI Conditions

10-5

10.1.1.9. Recorder

Technical Parameters

Technical Detail

Technique:

Thermal line recorder at 3885-B Base Station

Data Type:

Single or Dual Waveform; Tabular

Paper Speed:

12.5 or 25mm/sec continuous

Technical Parameters

Technical Detail

Technique:

Cardiac or Peripheral

Digital Pulses:

3.3 p-p signal with a pulse duration of 10ms ± 3ms

Technical Parameters

Technical Detail

Lead Set Configuration:

3 and 5 lead

Lead Color:

AAMI/AHA and IEC

Lead Configurations:

I, II, III, V, AVF, AVR, AVL

Lead Fail:

Passive, sensing signal imbalance

Input Impedance:

> 2.5MΩ (according to IEC 60601‐2‐27, 50.102.3)

Electrode Contact

≤ 20K ohms @ 10 Hz Heart Rate:

30 - 250 bpm

Heart Rate Accuracy:

± 1% or ± 5 BPM, whichever is greater

Heart Rate Resolution:

1 beat per minute (BPM)

Heart Rate T-Wave

1.3 mV with a 1mV QRS amplitude Cardiotach Sensitivity:

200 μV minimum

Cardiotach Bandwidth:

0.5 - 40 Hz

Heart Rate (HR) Averaging Method:

Five point Mean filter

Heart Rate Meter

Irregular Rhythm:

A1: Ventricular bigeminy: 40 BPM

A4: Bidirectional systoles 90 – 110 BPM

Response Time of Heart in Heart Rate:

HR change from 80 to 120 BPM: 5 sec

Time to Alarm for

B1 ‐ Vent Tachycardia

Gain 2.0 (9.7, 12.6, 8.9, 11.8, 8.3) Average: 4.01 seconds

10.1.1.10. Gating

10.1.1.11. Vital Signs

10.1.1.11.1. ECG

Impedance:

Rejection:

Accuracy and Response to

Rate Meter to Change

Tachycardia:

A2: Slow alternating ventricular bigeminy: 30 BPM A3: Rapid alternating ventricular bigeminy: 59 BPM

HR change from 80 to 40 BPM: 9 sec

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

10-6

10.1.1.11.2. SpO2

Technical Parameters

Technical Detail

Technique:

Masimo SET®

Saturation Range:

1% - 100%

Saturation Accuracy:

± 2.1% at 70% - 99% (full scale) < 70% oxygen saturation is unspecified

Saturation Resolution:

Pulse Rate Range:

30 - 240 ppm

Pulse Rate Accuracy:

± 3 ppm

Pulse Rate Resolution:

1 pulse per minute (PPM)

Wavelength Range:

660 nm / 905 nm Note: Wavelength range can be especially useful to clinicians

Emitted Light Energy

< 1.2mW maximum average at 905nm

Calibration Range:

70 - 100%

Minimum sensor Bend Radius

4 cm (1.6 inches) SpO2 averaging time:

6 seconds

Technical Parameters

Technical Detail

Technique:

Oscillometric

Modes:

Manual, Automatic and STAT

Measurement Time:

< 60 seconds typical; standard adult cuff

Systolic Measureable

Adult/Pediatric: 40 - 270 mmHg (5.3 - 36 kPa)

Diastolic Measureable

Adult/Pediatric: 25 - 245 mmHg (3.3 - 32 kPa) Mean Measureable

Adult/Pediatric: 30 - 255 mmHg (4 - 34 kPa)

Pressure Accuracy:

Max. Std. Deviation: <8 mmHg (1.1 kPa) Pressure Resolution:

1 mmHg (0.1 kPa)

Pulse Rate Range:

30-240 ppm

Pulse Rate Accuracy:

± 1% or ± 5 BPM, whichever is greater

Max Cuff Inflation

Adult/Pediatric: 270 mmHg

Pressure Transducer

0 - 300 mmHg (0 - 40 kPa) Transducer Accuracy:

The greater of ± 2 mmHg or 2% of the reading

Overpressure Protection:

Adult: 300 mmHg (40 kPa) < 2 seconds

Initial Pressure:

Adult: 165 mmHg (22 kPa)

STAT Mode:

3 consecutive NIBP Readings

Minimum Time Between

Auto: 30 seconds (non STAT)

10.1.1.11.3. NIBP

Pressure Range:

Pressure:

Range:

Neonatal: 30 - 130 mmHg (4 - 17 kPa)

Neonatal: 10 - 100 mmHg (1.3 - 13 kPa)

Neonatal: 15 - 120 mmHg (2 - 16 kPa)

Max. Mean Error: within ± 5mmHg (±0.7 kPa)

Neonatal: 140 mmHg

Pediatric: 300 mmHg (40 kPa) < 2 seconds Neonatal: 150 mmHg (20 kPa) < 2 seconds

Pediatric: 165 mmHg (22 kPa) Neonatal: 100 mmHg (13.3 kPa) All initial pressures ± 15 mmHg (2 kPa)

Readings:

Manual: 5 seconds

10-7

10.1.1.11.4. CO2 Only, Internal System

Technical Parameters

Technical Detail

Technique:

Sidestream, Non-dispersive infrared absorption technique

Range:

0-15% CO2, or partial pressures at STP: 0-115 mmHg, or 0 - 16 kPa,

Accuracy:

± 0.43 Vol% +8%, or ± 3.75 mmHg +8%, or ±0.5kPa +8%

Resolution:

1 mmHg, 0.1%, 0.1 kPa

Warmup Ti me:

< 10 seconds (concentrations reported and full accuracy)

Response Time:

< 5 seconds for sample, 150mS waveform response

Flow Rate:

80 ± 20 ml/min

Calibration:

Automatic

Technical Parameters

Technical Detail

Source:

Capnogram

Range:

3 - 120 breaths per minute

Accuracy:

1 bpm

Resolution:

1 bpm

Technical Parameters

Technical Detail

Technique:

Sidestream, Non-dispersive infrared (NDIR) absorption technique

Warmup Ti me:

< 20 seconds (concentrations reported and full accuracy)

Response Time:

≤ 5 seconds

Flow Rate:

50 ± 10 ml/min

Calibration:

Automatic

Drift of Measurement

None

Accuracy degradation wi th rate

Above 80 RPM, end-tidal agent measurements will to the respiration rate as follows: ET=80Et(nom)/RR

CO2 and Respiration

Ranges and accuracy same as 10.1.1.11.4 and 5 above

N2O Range:

0 - 100 vol%

N2O Accuracy:

± 2 vol% + 2%

N2O Resolution:

Primary Agent ID

0.15 vol%

Secondary Agent ID

0.20 vol% + 10% of total agent concentration

Multiple Agent (>2) Detect

0.20 vol % +/- 10% of total agents concentration

Sev Range:

0 - 10 vol%, accuracy ±0.15vol% +5%

ISO, HAL, ENF Range:

0 - 8%, accuracy ±0.15vol% +5%

Des Range:

0 - 22%, accuracy ±0.15vol% +5%

Sev, ISO, HAL, ENF, DES Accuracy:

± 0.15 vol% + 5%

Sev, ISO, HAL, ENF, DES Resolution:

0.1%

Interfering Gas Effects

Tested according to IEC 80601-2-55

Nitrous Oxide

No effect at 60%

Halothane

No effect at 4%

Enflurane

No effect at 8%

Isoflurane

No effect at 8%

Sevoflurane

No effect at 8%

Xenon

-10 % of reading @ 80 vol%

Helium

-6 % of reading @ 50 vol%

10.1.1.11.5. Respiration

10.1.1.11.6. Multi-Gas, Agents, P/N 3886

typically decrease below the nominal value in proportion

10-8

Desflurane

+12 % of reading @ 15 vol%

Ethanol

No effect at 0.3 vol%

Isopropanol

No effect at 0.5 vol%

Acetone / Metabolic Ketones

No effect at 1 vol%

Methane

No effect at 3 vol%

Carbon Monoxide

No effect at 1 vol%

Nitrogen Monoxide

No effect at 0.02 vol%

Oxygen

No effect at 100 vol%

10.1.1.11.7. O2 (Part of 3886)

Resolution

Range

0 to 100 %

Accuracy 0 to 59%

+/- 3%

Accuracy 60 to 100%

+/- 5%

Technical Parameters

Technical Detail

Technique:

Direct Fiber-Optic

Range:

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:

±0.4○ C (±0.72○ F) Resolution:

0.1○

Response Time:

< 20 seconds

Application Type:

Axillary or skin surface

Message

Trigger Condition

Priority

Apnea

Respiration detection system ( CO2 / Multi-Gas) reports Apnea

High

Agent Unit Connecting

Indicates 3880 attempting to make connection with 3886 Multi-gas Unit

N/A

Check Print Door

Printer door is not fully closed

N/A

CO2 Occlusion

Gas sampling line is occluded

Med

CO2 Overscale

Co2 measurement exceeds range of the display scale

Low

CO2 Zeroing

Performing a Zero reference in gas system

N/A

COMM LOSS

Wireless communication loss with 3885-B for more than 4 seconds

Low

Crit Mon Batt

≤ 5% of battery capacity in 3880 monitor

Med

Crit Tab Batt

≤ 5% of battery capacity in 3885-T Remote Tablet

Med

Data Delay

Display update error or delay possible

High

ECG Batt Crit

Battery level in ECG transmitter POD at extreme low level

Med

ECG Inop

Hardware or software failure detected

Med

ECG Lead Fail

Lead wire has no electrical connection to the patient or ECG level overscale

Low

EtCO2 Cal Error

Calibration error detected

Med

10.1.1.11.8. Temperature

B. Messages, Alerts, Alarm Priority

10-9

Gas System Inop

Hardware or software failure detected in a gas measurement system

Med

Gas System Warmup

CO2/Multi-Gas unit warming up

N/A

LAN Conn Error

LAN connection errors preventing communication

Low

Low ECG Batt

≤ 15% of battery capacity left in ePOD

Low

Low Mon Batt

≤ 15% of battery capacity left in 3880 monitor

Low

Low SpO2 Batt

≤ 15% of battery capacity left in oPOD

Low

Low Sig IQ

SpO2 unit reports Signal IQ Low

Low

Low Tab Batt

≤ 15% of battery capacity left in 3885-T Remote Tablet

Low

Low Perfusion

Low perfusion detected by SpO2

Low

Mag Field High

Agent bench magnetic field limitations surpassed

Med

Multi Agent MAC

The MAC value consists of more than one agent

Med

Mixed Agents

More than two agents may be present

Med

NIBP Cal Error

Calibration error detected

Med

NIBP Delayed

NIBP reading start held for blood flow

N/A

NIBP Inop

Hardware or software failure detected

Med

NIBP Leak

Air leak is detected

Low

NIBP Occlusion

Occlusion is detected

Med

NIBP Over Press

Pressure exceeds 300 mmHg for Adult / Ped or 150 mmHg for Neonatal

patients

greater than 90 seconds

Low

NIBP Time Out

Pressure remains the same for more than 30 seconds or if measurement exceeds 180 seconds

Low

No Sample Line

CO2 sampling line disconnected, 3886 Only

Low

Out of Paper

Recorder paper has run out at Base

Low

POST Fail

Power on self-test failure

Med

Recorder Inop

Hardware or software failure detected in Base recorder

Low

Recorder Off Line

Print head is too hot or communication loss to the recorder/Base

Low

Radio Inop

Radio failure detected with comm to 3885 Base/Tablet

Med

SEE MESSAGES!

Critical message area full

High

Sp02 Batt Crit

Battery level in SpO2 transmitter POD at extreme low level

High

SpO2 Noisy

SpO2 unit reports noisy signals from sensor

Low

SpO2 Hi Light

SpO2 unit reports high ambient light at sensor

Low

SpO2 Bad Probe

SpO2 sensor damaged or not compatible

Low

SpO2 Inop

Hardware or software failure detected

Med

SpO2 No Probe

SpO2 sensor is disconnected from the oPOD

N/A

SpO2 Probe Off

SpO2 sensor is not properly attached to the patient

Med

SpO2 Searching

Searching for patient pulse

N/A

SW Mismatch

Software version difference between 3880 components

Low

Temp Inop

Hardware or software failure detected

Med

Temp Probe Fail

Broken sensor detected or a sensor is not attached properly

Low

Wrong Cuff

NIBP system detects an incorrect cuff size for the selected patient mode

Low

-or15 mmHg remains in the line for Adult / Ped or 5mmHg for Neo for

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

10-10

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 Technical Service at 1-407-677-8022 within the U.S., +001-407-677U.S.(during normal business hours EST), or by E-mail at Corporation Technical Service will advise you to return the device to Iradimed

Obtain a Return Authorization Number. This will ensure proper routing and

Corporation for repair, please do the following:

of the corrective action required. If you are advised

techsupport@iradimed.com. Iradimed

8022 from outside the

facilitate timely repair of your monitoring device.

Clean monit o ring device prior to shipment. Do not ship contaminated product to IRadimed Corporation for repair.

Package the monitoring device with adequate protection. If available, use the original carton and packing materials in which the monitoring device was

d. e.

shipped Include a brief description of the problem as well as the name, address and phone

number of the person to be contacted for additional Include a purchase order with the monitoring devic e being returned if it is out of

from Iradimed Corporation.

information.

warranty; Iradimed Corporation Technical Services can advise you of your monitoring devic e’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.

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 prepaid.

To ensure full reliability, it is recommended that all repairs be made by an Iradimed 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 authorized by Iradimed Corporation Technical Service prior to the repair.

CAUTION: No repair should ever be attempted by anyone not having a

knowledge of the repair of Iradimed Corporation monitoring device. Only replace parts with components manufactured or sold by Iradimed Corporation. Corporation Technical Service and Repair Center for service

and technical assistance.

Corporation

be returned to you

Corporation

it is

complete

damaged

Contact the Iradimed

10-11

D. Masimo SETTM Technology

D.1. Masimo SET Principles of Operation

The Masimo SET ® MS pu lse oximeter is based on three princi ples:

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 shunti ng is highly variable and that fluctuating absorban ce by venous blood is a major compo nent of noise during the pulse.

The Masimo SET® MS pulse oximeter as well as traditional pulse oximetry determines SpO passing red a nd infrared light i nto a capillary bed an d m easuring changes in light absorpt ion 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.

Traditio nal pulse oximetry assumes that all pulsations in the light absorbance sig nal 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 wave l engths, 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 SpO software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult vol unteers in induced hy poxia studies.

The Masimo SET ® MS bo ard pulse oximeter assumes that arterio-venous shuntin g 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 t o find the saturation SpO 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 oximet er .

The equation for the noise reference is based on the value of R, the value being sought to determine the SpO correspond to SpO R-values. The S(660) and S(905) signa ls are processed with each possible N’ noise reference

in an empirically derived equation into the oximeter’s software. The values

. The MS board software sweeps through possible values of R that

values between 1% and 100% and gener at es an N’ value for each of th ese

in a look-up table built into the oximeter’s

10-12

through an adaptive correlation canceler (A CC) which yields an output power for each possible

MEASURED A

VALUES

Range

90-100 %

1.30 %

80-90 %

1.78 %

70-80 %

2.80 %

Range

70-100 %

± 2.1 %

Overall Claimed Accuracy Value

value of R (i.e., each possible SpO

from 1% to 100%). The result is a Discrete Saturation

Transform (DST™) plot of relative outpu t power versus possibleSpO2 value as sho wn i n th e following figure w he r e R corresponds to SpO

= 97%:

RMS

SpO2 Performance information of measured A(rms) accuracy shown in tabular form by range.

Graphic plots below of sampled points from blood study w it h Iradimed 1170 FO Se ns or :

10-13

10-14

E. Internal CO2 Only, and Masimo Multi-Gas Systems Detail Operation

Term

Explanation

Anesthetic Agent

BTPS

Body Temperature and Pressure Saturated

delay time

The delay time is defined as the time required for

result

10% of

the

final value

Et cone.

End-tidal (expired) concentration

Fi cone.

Inspired gas concentration

harmful

Substances introduced in the patient circuit to an the patient

ICU

Intensive Care Unit

LEG!

Light Emitting Gas Inlet. Status indicator

integrat ed in the gas sample inlet port

MAC value

1 MAC (Minimum Alveolar Concentration) is the

response to a noxious or surgical stimulus

MOD

Medical Device Directive

MRI

Magnetic Resonance Imaging

The 3880 MRI Patient monitoring system has two options for gas measurement. There being a ‘built in’ CO2/Respi ra ti on 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 in te r nal 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 co m m unicate with the exter nal 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 includ es the Servomex Pm1116 Fast Oxygen transducer. These devices have a long history o f su cc essful 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:

substances

a step function change at the

amount that may cause harm to substances

alveolar concentration (end-tidal) of the agent at which 50% of individuals fail to move in

sampling site

10-15

Operating Room

rise time

Time required to achieve a rise from 1O % to

90 % of final value when a step function

sampling site

sampling

A sampling line configuration consists of a

spontaneous breathing patient

STP

Standard Temperature and Pressure:

Total

Time from a step function change in gas level

time

USS

Universal Serial Bus

zeroing

Ambient gas reference measurement used to

calibration point for the oxygen

measurements

change in concentration occurs at the

line config

system response time

Nomoline Family sampling line connected to either a patient breathing circuit or

101.3 ± 4 kPa atmospheric and gas pressure 22 ± 5 °C ambient temperature

at the sampling site to the ach ievement of 90% of the final gas reading of the gas monitor.

Total s y s tem response time= Delay time+ Ris e

establish zero concentration levels N

and Anesthetic Agents, as well as a

for CO

E.1.1. Warnings an d Cautions

To avoid water conden s ati on inside the ISA module an d the c onnecting tubings, ensure that the surrounding temperatur e of the IS A mo du le a nd th e co nnecting tubings does not fall below the am bi en t t em perature of the Nomoline sa m pl in g line.

E.1.2.

ISA OR+

The 3886 Multi-Gas Unit contains the Masimo ISA OR+ which is a low-flow sidestream multigas analyzer designed to monitor respiratory

mixtures containing any two of the five anesthetic agents 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 m onitoring of infant patients with low tidal volum es and high respiratory rates .

ISA OR+ sidestream analyzer offers the addition of oxygen means of an integrated paramagnetic O

In the following information regarding the 3886 Multi-Gas Unit, the Masimo term “OR+” is used interchangeably.

3886 Multi-Gas Unit

sensor.

concentrations of CO

Halothane, Enflurane, lsoflurane ,

measurement capabilities by

O and gas

10-16

E.2.

Theory and design, 3886 Multi-Gas System E.2.1.

The measurement of CO

gases

Gas measurements and identification

O and anesthetic agents is based on the fact that different

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 mix ture of several components that absorb light at t he s a me

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

O and a mixture of any two of the five

facilitate simultaneous measurement of CO

anesthetic agents.

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 CO

10 µm long

wave infrared range (LWIR) for the anesthetic agent calculations. The LWIR

and N

O measurements and five wavelengths in the 8 to

contains strong absorption peaks for the anesthetic agents and negligible interference from other common respiratory gases, such as alcohol and acetone, which could degrade

10-17

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 measuremen t , 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 passe d t o 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 flowin g ar o und th e wire is measured. This curr e nt i s dire c t l y prop or t ional 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

10-18

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 MO

isture) 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 possible even at

ultra-fast rise time, making measurements of CO

high respiratory rates. ISA sidestream gas analyzers are therefore

suitable for adult, pediatric and infant patients.

N2O and anesthetic agents

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,

10-19

be sure to use a Masimo T-adapter that samples the gas from the center of the T-adapter (see below). See section

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 fil ter 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

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.

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 tightl y. When blocked, the "Atm press - cuvette press [kPa]" in Masimo

Gas Master shall be >6 kPa.

Stop the pump by sending parameter "Stop pump" under "Installation & maintenance"

10-20

in Masimo Gas Master.

in the Gas span check.

Wait about 1O seconds until the "Atm press - cuvette press [kPa]"value as shown by the Masimo Gas Master is stable. Note the value.

Wait additional 10 seconds.

Check that the "Atm press - cuvette press [ kPa]"value has not changed more than 3 kPa in 10 seconds.

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% ≤ CO 45% ≤ O

30% ≤ N2O ≤ 100% - for ISA Multigas only

≤

2.0%

DES ≤ 12.0% - for ISA Multigas only

11.0%

2 ≤

≤ 100% - for ISA Multigas with Servomex 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

Warm up the ISA gas analyzer for at least 1 min

Send "Pre span calibration zeroing" and make sure that the surrounding gas is normal air (21%

For each gas that failed the Gas span check, perform step 4 to 7. Always perform the span

Example:

Supply the calibration gas and wait for at least 30 seconds.

Send the corr esponding span cal ibration command.

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 calibration paramagnetic

and 0%

2),

calibration with the gases in order

Span calibration of O

and CO

, N2O , DES and

only, start with O

then CO

continues for about 40 s with a special zeroing during which the Servomex

sensor is sensitive to mechanical movements.

span

10-21

Notes:

If the calibration process fails, the flag SPAN_ERR is set, and will stay

active until the next successful calibration is passed.

Verify the gas readings

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 CO

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 that the ISA is placed in a well-ventilated place.

During Zeroing, if JSA's level

will

be different from the gas level at the sampling site

ISA OR+ Multigas

exhaust

gas is

returned to the patient circuit, the returned gas

analyzers normally perform Z eroing directly at startup (with or

air (21% O

and 0% CO

ensure

) ,

without Nomoline attached), when a steady operating temperature is achieved and

every

thereafter is changed from sleep mode to measurement mode.

8 h from start up. A Zeroing is also performed when the operating 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

h from startup and thereafter 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.

every

96h. During a flow reference

10-22

N2O concentration

in gas mix

Effect on gas reading

Displayed value if true concentration is 5.0 vol% CO2

0 vol%

0 % relative

5.0 vol%

30 vol%

5.17 % relative

5.3 vol%

60 vol%

10.34 % relative

5.5 vol%

82 vol%

14.14 % relative

5.7 vol%

E.2.6.

Gas data considerations

Gas measurement units

Effects of humidity

N2O , O

The partial pressure and the volume percentage of CO depend

on the amount of water vapor in the measured gas. The

calibrated to show 20.8 vol% at actual ambient temperature and humidit y level, instead of

showing actual room air with 0.7

partial pressure. 20.8 vol%

vol% H

concentration (at 1013 hPa this equals for example 25°C and

20 23% RH). The measurement of CO by the IA-be nch) will

always show the actual partial pressure at the current humidity level.

corresponds to the actual

O, and anesthetic agents (e.g. all gases measured

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%.

values at BTPS are required, the following equation can be used:

and anesthetic agents

2 measurement will be

concentration in

where :

EtCO2

Pamb = Ambient pressure sent from ISA [kPa]

= EtC

value sent from ISA [vol %]

3.8 = Typical partial pressure of water vapor condensed between patient circuit and ISA [kPa) EtC02(BTPS)

Spectral broadening

The presence of oxygen and nitrous oxide can cause some interference in the CO measurement. This is known as spectral broadening.

= EtCO

gas concentration at BTPS [vol%]

Nitrous oxide, N

ISA sidestream analyzers automatically compensates for spectral broadening caused by nitrous oxide.

Below is the typical ef fect if using the default value (0 vol% N20) when measuring on gas mixtures with different N20 concentrations:

10-23

Oxygen, O2:

Effect on gas

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%

ISA OR+ sidestream units automatically compensates for spectral broadening caused by oxygen

Below is the typical effect if using the default value (21 vol% mixtures with different O

concentrations:

)

when measuring on gas

concentration in

gas mix

reading

Displayed value if true

concentration is 5.0 vol% CO

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+: CO

2, O2, N2

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 with CO

patients for sampling of CO

sampling. The intended patient population is adult, pediatric and infant patients.

O ,Halothane, lsoflurane, Enflurane, Sevoflurane and Desflurane

•

Some models are also used to deliver O2 in parallel

10-24

Sensor head

2 to 9 channel NDIR type gas analyzer measuring at 4 to 10 µm. Dat a acquisition rate 10 kHz(sample rate 20 Hz/channel)

Compensations

ISA OR+:

Automatic compensation for pressure and temperature. Manual compensation for broadening effects on CO2

Calibration

No span calibration is required for the IR bench. An automatic Zeroing is performed typically 1 to 3 times per day.

Warm-u p time

ISA OR+: identification enabled and full accuracy)

Rise time1

HAL < 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)

Gas

Range 1

Accuracy

N2O

0 to 100 vol%

±(2 vol% + 2% of reading)

0 to 100 vol%

±(1 vol%+ 2% of reading)

E.3.2. Gas Analyzer

<20 seconds (Concentrations reported, automatic agent

At 50 sml/min sample flow

ISA OR+ CO2 ≤ 300 ms N

O, O2, ENF, ISO, SEV, DES < 400 ms

Measured according to EN ISO 80601-2-55

E.3.3.

Accuracy - standard conditions

The following accu r acy specifications are valid for dry sin gle gases at 22 ± 5 'C and 1013 ± 40 hPa:

CO2 0 to 15 vol%

HAL, ENF, ISO

SEV

DES

0 to 8 vol%

0 to 10 vol%

0 to 22 vol%

±(0.2 vol%+ 2% of reading)

±(0.15 vol% + 5% of reading)

10-25

E.3.4.

Gas

Accuracy

CO2

±(0.5 kPA + 8% of reading)

N2O

±(2 kPA + 5% of reading)

Agents2

±(0.2 kPA + 10% of reading)

±(2 kPA + 2% of reading)

Gas

Gas level

CO2

Agents

N2O of CO2 only option

3886 ISA OR+

N2O

60 Vol%

- 2)

- 1)

HAL

4 Vol%

- 6)

- 1)

ENF, ISO, SEV

5 Vol%

- 6)

- 1)

DES

15 Vol%

- 6)

- 1)

Xe (Xenon)

80 Vol%

-10% of reading 3)

- 1)

He (Helium)

50 Vol%

-6% of reading 3)

- 1)

Metered dose inhaler propellants

Not for use with metered dose inhaler propellants C2H5OH (Ethanol)

0.3 Vol%

- 1)

C3H7OH (Isopropanol)

0.5 Vol%

- 1)

CH3COCH3 (Acetone)

1 Vol%

- 1)

CH4 (Methane)

3 Vol%

- 1)

CO (Carbon monoxide)

1 Vol%

- 1)

100 Vol%

- 2)

- 1)

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).

±(3.75 mmHg + 8% of reading)

±(15 mmHg + 5% of reading)

±(1.5 mmHg + 10% of reading)

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 lin e, the gas temperature will adapt to the ambient temperature before reaching the gas analyzer. The mea s ur e m ent of a ll ga s e s wi ll always show the actu al par t ia l pr e s sur e a t the c ur rent humidity level in t he ga s s am p le. As the NOMO section remo ve s al l co nd en s ed wa t er, 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

of 3886

3886

10-26

Note 1: Negligible interference, effect included in the specification “Accuracy, all conditions” above. Note 2: Negligible interference with N

O / O2 concentrations correctly set, effect included in the

specification “Accuracy, all conditions” above.

Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO

readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO vol% Helium, the actual measured CO vol% CO

concentration will typically be (1-0.06) * 5.0 vol% = 4. 7

Note 4: According to the EN ISO 80601-2-55:2011 standard. Note 5: In addition to the EN ISO 80601-2-55:2011 standard. Note 6: 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.

and 50

10-27

Symbol

Used for

Symbol

Used For

MR Safe: Completely safe

MR field.

MR Conditional: Use in

operator safety

F. Symbol Conventions and meanings

Manufacturer

Manufacturer/ Date of Manufacture

Use by date; do not use after the year (YYYY), month (MM)

Consult Instructions for Use

Non sterile

the MR environment is restricted to certain conditions of use to ensure patient and

CE Mark

Do Not Reuse

Federal Communications Commission radio certification

Authorized EU Representative

for use with no potential for interaction with the

MR Unsafe: Must not be used in an MRI environment

Fragile

Atmospheric Pressure Limits

Humidity Limits, noncondensing

Temperature Limits

QR Code, Unique Device Identifier

Instructions for Use must be consulted

Prescription Only

Quantity in Package

Part Number

Serial Number

Lot Number

Defibrillator-proof type CF equipment (IEC 60601-

1) protection against

10-28

Shock

Radio Source

Protected against harmful

Not for General Waste

–

Gas Inlet

Power On

Battery, negative contact

Direct Current

Universal Serial Bus (USB) IPX1

Alarm sound system is capable of audio sound triggered by alarms/alerts

Gas Outlet

Power Off

Battery, positive contact

Alternating Current

effects of dripping water per IEC 60529

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

Connected to AC mains

3880 Patient Monitor battery life

Wireless Signal Strength

3885-T Remote Tablet battery life

3881 ECG ePOD battery life

No Battery, or Battery unable

3881 SpO2 oPOD battery life

Heartbeat Detected

to communicate remaining life

Fuse

Settings button: Access monitor setup menus

Trend button: Trend Screen access and adjustment

10-29

NIBP START/STOP button:

readings.

RECORD button: Starts strip chart recorder for hard copy printout at recorder in the optional 3885-B Base Station

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

10-30

G. Manufactures Technical Declaration

Guidance and manufacturer’s declaration—electromagnetic emissions

The 3880 System is intended for use in the electromagnetic environment specified below.

Emissions Test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The 3880 System must emit electromagnetic

Nearby electronic equipment may be affected.

RF emissions CISPR 11

Class B

The 3880 System is suitable for use in all

Harmonic

61000-3-2

Not applicable

Voltage

61000-3-3

Not applicable

EMC Information Tables as required by EN 60601-1-2:2007 Clause 5

In accordan ce 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 p ut into servi ce 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 obse rved to verify normal operation in the configuration in which it is used”.

The following tabl es (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

The customer or the user of the 3880 System should assure that it is used in such an

CISPR 11

emissions IEC

fluctuations/flicker emissions IEC

energy in order to perform its intended function (remote communications within an specific band for WLAN; i.e. 2.431 to 2.474 GHz).

establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

10-31

3880 System

Guidance and manufacturer’s declaration—e lectromagnetic immunity

The 3880 System is intended for use in the electromagnetic environment customer or the user of the 3880 System should assure that i t is used in such an

Immunity test

IEC 60601 test

level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC

±6 kV contact

±8 kV air

±6 kV contact

±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

IEC 61000

±2 kV for power supply li nes

input/output lines

±2 kV for power supply lines

lines

Mains powe r quality shoul d be that of a typical commerci al or hospital environment.

Surge

IEC 61000

±1 kV differential mode ±2 kV mode

±1 kV differential mode

±2 kV common mode

Mains powe r quality shoul d be that of a typical commerci al or hospital environment.

Voltage dips, short

<5 % UT (>95 %

<5 % UT (>95 % dip in

Mains powe r quality shoul d be that of a typical

interruptions, and volta ge variations on power supply input lines IEC 61000

dip in UT) for 0.5 cycle

40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 %

UT) for 0.5 cycle

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in

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 uninterru ptible power supply or a

dip in UT) for 25 cycles <5

UT) for 25 cycles

<5 % UT(>95 % dip in

dip in UT) for 5 sec

UT) for 5 sec

Power frequency (50/60 Hz) magnetic field IEC 61000

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical c om mercial or hospital environment.

NOTE—UT is the a.c. mains voltage prior to application of the test level.

Table 202—Guidance and manufacturer’s declaration— electromagnetic immunity—for all EQUIPMENT and SYSTEMS

environment.

61000-4-2

-4-4

-4-5

-4-11

-4-8

±1 kV for

common

% UT(>95 %

±1 kV for input/output

battery.

10-32

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

Immunity test

IEC 60601 test

level

Compliance level

Electromagnetic environment - guidance

Portable and mobile RF communicat i ons equipment should be

used no closer to any part of the 3880 System, including

cables , than the rec om mended separation di stance calculated

from the equation applicable to the frequency of the transmitter.

Recommended separation distance

150 kHz to 80 MHz

outside ISM bands 150 kHz to 80 MHz

outside ISM bands

where P is the maximum output power rating of the transmitter in

watts (W) according to the transmit ter manufacturer and d is the

recommended separation distan ce in me ters (m).b Field strengths from fixed RF transmitters, as determined by an

electromagnetic site survey,

should be less than the compliance

level in each frequency range.d

Interference may occur in the vicinit y of equip men t mar ked wi th

the following symbol:

IEC 60417, No. 417-IEC5140, "Source of Non-Ionizing Radiation"

Symbol

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;

Conducted RF 3 Vrms

IEC 61000-4-6

10 Vrms

Radiated RF 10 Vrms

80 MHz to 2.5 GHz

IEC 61000-4-3

should assure that it is used in such an environment.

3 V d = 1.17 ¥ P

10 V

10 V/m

d = 1.20 ¥ P

d = 2.33 ¥ P

80 MHz to 800 MHz

800 MHz to 2.5 GHz

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,

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.

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

10-33

3880 System

Recommended separation distances between portable and mobile RF communications equipment and the

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 prev 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

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

0.01

0.12

0.23

1.17

1.2

1.17

2.33

3.8

7.67

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined

bands

communications

Table 205—Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM—

for LIFE-SUPPORTING EQUIPMENT and SYSTEMS

3880 System

ent electromagnetic interference by

maximum output power of transmitter

0.1 0.38 0.38 0.38 0.77

100 11.67 12 11.67 23.33

outside ISM bands

d = 1.17 √ P

ISM bands

d = 1.2 √ P

d = 2.33 √ P

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

between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable 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.

10-34

This page is intentionally left blank.

10-35

10-36

10-37

Iradimed IRM02, IRM01, IRM00 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual