2120is Series Operators Manual Addendum Rev A March 2002

Maternal Pulse Oximetry Monitoring Supplement

Introduction The 2120is Series Monitor measures the maternal oxygen saturation and pulse rate using the principles of spectrophotometry and plethysmography. The MSpO2 sensor is comprised of two light-emitting diodes (LEDs) which are the emitters, and one photodiode which is the detector. One LED emits red light and the other infrared into the patient’s skin. The detector receives the amount of light that is not absorbed at the sensor site and the monitor uses the relative absorption of red and infrared to compute the functional percentage of hemoglobin that is combined with oxygen. The heart rate is calculated from the pulses measured at the sensor site. MSpO2 monitoring is done with a Masimo module or a Nellcor module. This supplement provides guidelines for successful MSpO2 monitoring.

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Module and Probe Compatibility 127(Nellcor and Masimo pulse oximetry modules are calibrated to display functional saturation. Other manufacturer’s pulse oximetry monitors may be calibrated to display fractional saturation.

n

2120is Series Monitors with Masimo modules are compatible with Masimo LNOP probes.

n

2120is Series Monitors with Nellcor modules are compatible with Nellcor probes.

127(The MSpO2 cable should plug into the monitor’s MSpO2 connector easily and securely. Do not use excessive force to connect the cable. If the MSpO2 cable does not easily fit into the MSpO2 connector on the monitor, it is likely that you do not have the appropriate cable. The 2120is Series MSpO2 connector is a type BF port.( ). Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment has an F-type applied part.

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Safety :$51,1*6 APNEA-The MSpO2 monitoring feature should NOT be used for apnea monitoring. DEFIBRILLATION-During defibrillation, all personnel must avoid contact with the patient and monitor to avoid a dangerous shock hazard. In addition, proper placement of the paddles in relation to the electrodes is required to minimize harm to the patient. EARLY WARNING-A 2120is Series monitor with builtin MSpO2 monitoring should be considered an early warning device. As a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. EXPLOSION HAZARD-Do not use the 2120is Monitor in the presence of flammable anesthetics or other flammable substance in combination with air, oxygenenriched environments, or nitrous oxide. INTERFERING SUBSTANCES-Carboxyhemoglobin may erroneously increase MSpO2 readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings. MRI INTERFERENCE-Do not use MSpO2 sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The module may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.

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&$87,216 CLEANING AND RE-STERILIZATION-Do no attempt to re-sterilize single-patient use sensors. For re-usable sensors, following the manufacturer’s instructions. Do not immerse the patient cable in water, solvents, or cleaning solutions (the patient cable connectors are not waterproof). Do re-sterilize the patient cable by irradiation, steam, or ethylene oxide. DOUBLE COUNTING-If a patient is receiving tocolytic agents, the bounding effect may cause the pulse wave to have a pronounced dicrotic notch that may occasionally cause double counting of a single beat resulting in a falsely high pulse rate. MEASUREMENT ACCURACY-Inaccurate measurements may result if the sensor is placed on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. Measurements may be compromised if the sensor is placed on a patient wearing dark-colored nail polish. Remove nail polish prior to sensor application. Inaccurate measurements may also result from excessive patient movement, venous pulsations, or electrosurgical interference. PATIENT ASSESSMENT-Do not use a disposable sensor on a patient with known sensitivities or allergic reactions to adhesive tape. Do not use any sensor on a patient who is in shock, has hypotension, severe vasoconstriction or anemia, hypothermia, arterial occlusion proximal to the sensor, or cardiac arrest. SENSOR APPLICATION-Tissue damage can occur through the incorrect application or use of a sensor. Do not wrap the sensor too tightly or apply supplemental tape. SENSOR ENVIRONMENT-Do not use the sensor in environments with excessive illumination such as surgical lamps, especially ones with a xenon light source, bilirubin lights, fluorescent lights, infrared heating lamps, or direct sunlight. Signal loss or inaccurate readings can otherwise result. SENSOR TYPE-Use only Masimo LNOP sensors with Masimo modules; use only Nellcor sensors with Nellcor modules. VISUAL INSPECTION-The MSpO2 waveform generated by the monitor is not intended for true diagnostic interpretation. This waveform should be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

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Measurements If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means, then check the monitor for proper functioning. Inaccurate measurements may be caused by:

n n

Incorrect probe application or use.

n n

Intravascular dyes such as indocyanine green or methylene blue.

Significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or methemoglobin). Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight.

127(Exposure to excessive illumination can be corrected by covering the probe with a dark or opaque material.

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n n n

Excessive patient movement.

n

Excessive environmental motion or electromagnetic interference may prevent tracking of pulse. Measurements may seem inappropriate or the monitor may not seem to operate correctly.

Venous pulsations. Placement of a probe on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.

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Monitoring Patient Preparation Follow these steps to prepare the patient for MSpO2 monitoring. 1. Choose the sensor that is best suited to your patient-disposable, reusable, etc. 2. For re-usable sensor, clean the surface of the sensor before and after each use. 3. Following the instructions provided with the sensor, correctly position and attach the sensor to your patient. Be aware of the following general safety precautions when using MSpO2 sensor: &$87,216 DATA VALIDITY-Do not expose sensor detector to strong ambient light while monitoring a patient. A poor signal may result. Do not allow tape to block the sensor light detector. PATIENT SAFETY -Prolonged monitoring may require changing the sensor site periodically. Move the sensor if there is any sign of skin irritation or impaired circulation. Change the sensor site at least every four hours to prevent ischemic skin necrosis. If required, reduce the application periods to half the times recommended above. PATIENT SAFETY-If a sensor is damaged in any way, discontinue use immediately.

Be sure to read all literature accompanying sensor for specific safety information.

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Modules and Sensors The Masimo and Nellcor modules are used to non-invasively measure the amount of oxygenated hemoglobin and pulse rate. The absorption of selected wavelengths of light is measured with probes. Although these modules process the MSpO2 measurements differently, the function and appearance of MSpO2 on your monitor is the same.

No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Sensors Before use, carefully read the manufacturer’s sensor directions for use. Use only Masimo LNOP oximetry probes with the Masimo module; use only Nellcor probes with the Nellcor module. Other probes (sensors) may cause improper performance.

&$87,21 TISSUE DAMAGE-Tissue damage can be caused by incorrect application or use of a MSpO2 sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor’s directions for use to ensure skin integrity and correct positioning and adhesion of the sensor.

Do not use damaged sensors. Do not use a sensor with exposed optical components. Do not re-sterilize single-patient use sensors. For reusable sensors, refer to the manufacturer’s instructions for cleaning and sterilization. Do not immerse the patient cable in water, solvents, or cleaning solutions (the patient cable connectors are not waterproof). Do re-sterilize the patient cable by irradiation, steam, or ethylene oxide.

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MSpO2 Display Area The MSpO2 display area is summarized by Figure 2 and Table 1. If MSpO2 is selected as the MHR/P source, each pulse beat is indicated with a “beep”: the pitch of the beep will vary according to the saturation value; the pitch rises as the saturation value increases; the pitch lowers as the saturation value decreases. If MECG is selected as the MHR/P source, the MECG audio plink is used instead; it will not vary in pitch. When MSpO2 monitoring is employed, the MSpO2 pulsatile (plethysmograph) waveform can be also be displayed and printed.

C

B

D

MSPO2

97%

A

Figure 2. MSpO2 Display

Table 1. MSpO2 Display Name A

B

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MSpO2 Value

MSpO2 Alarm Setting Indicator

Description Up to three digits indicate the percentage of oxygen in the mother’s blood. This symbol provides information about the MSpO2 audio alarm and the MSpO2 high/low alarm limit settings:

n

: An alarm setting is turned off.

n

: All alarm settings are enabled.

C

MSpO2 Mode Title

Select the mode title to access the MSpO2 Setup window.

D

MSpO2 Pulse Amplitude Indicator

This vertical bar qualitatively indicates pulse amplitude.

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MSpO2 Setup Window Select the MSpO2 mode title hotspot or MSpO2 setup button to access the MSpO2 Setup window (Figure 3 and Figure 4). The available selections and factory default settings are listed in Table 2.

Table 2. MSpO2 Setup Window Summary Field Type

General

Alarms

10

Field Description

Available Selections

Factory Default

MSpO2 Trace

On, Off

Off

Response Time (Nellcor only)

Slow, Normal, Fast

Normal

Averaging Time (sec) (Masimo only)

2, 4, 8, 10, 12, 14, 16

8

Sensitivity (Masimo only)

Normal, Maximum

Normal

MSpO2 Print Interval (min)

Off, 2, 5, 10, 15, 30, 60

5

Audio Alarms

On, Off

On

Alarm Volume

1–9

5

Alarm Limits (%) MSpO2% MSpO2P

Low Off, 80–99 Off, 35–120

High 85–100, Off 100–250, Off

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Low 95 40

High 100 120

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Figure 3. MSpO2 Setup Window-Masimo Module

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Figure 4. MSpO2 Setup Window-Nellcor Module

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%MSpO2 Trace This checkbox enables or disables the trending of the %MSpO2 trend on the bottom grid of the strip chart display and paper.

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On: The %MSpO2 trend displays in blue and prints in grey; both are annotated with %MSpO2 .

n

Off: The %MSpO2 trend is not displayed/printed.

Response Time (Nellcor Module Only) This field only appears when using a Nellcor module and a Nellcor sensor. Choose a response time in order to compensate for different levels of patient activity.

n

Slow: Uses a 10- to 15-second averaging period and is least affected by patient movement. When this setting is selected, dashes “– – –” replace the pulse value displayed in the MHR/P area.

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Normal: Uses a 5- to 7-second averaging period and is recommended in cases where the patient is relatively inactive.

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Fast: Uses a 2- to 3-second averaging period and is most affected by patient movement.

Averaging (Masimo Module Only) This menu option only appears when using a Masimo module and a Masimo sensor. Choose a response time in order to compensate for different levels of patient activity: 2, 4, 6, 8, 10, 12, 14, or 16 seconds. 127(For the 2- and 4-second averaging settings, the actual averaging times may range from 2 to 4 and 4 to 6 seconds, respectively.

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10, 12, 14, or 16 seconds: These averaging settings are least affected by patient movement.

n

8 seconds: This averaging selection is recommended in cases where the patient is relatively inactive.

n

2, 4 or 6 seconds: These averaging selections are most affected by patient movement.

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Sensitivity (Masimo Module Only) This menu option only appears when using a Masimo module and a Masimo sensor.

n

Normal: Use the Normal sensitivity setting for normal patient monitoring purposes.

n

Maximum: Use the Maximum sensitivity setting for improved low perfusion performance and for faster tracking of rapid MSpO2 saturation changes.

Print Interval This setting determines the time interval for displaying and printing the MSpO2 values on the strip chart.

Alarm Limits These fields adjust the high and low alarm limits for %MSpO2, as well as for MHR/P-in increments of 1% or 5 BPM.

Audio Alarm This checkbox enables/disables the audio alarm function for MSpO2.

n

On: Visual and audible indications are provided during an MSpO2 alarm condition.

n

Off: Only a visual indication is provided during an MSpO2 alarm condition.

Master Alarm Volume This field controls the alarm volume for all 2120is alarms.

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Troubleshooting The following is a general checklist to following in troubleshooting operational problems. More specific information is found in Table 3. 1. The MSpO2 sensor is correctly positioned on the patient. (Follow the manufacturer’s instructions provided with the sensor.) 2. The patient cable is connected to the MSpO2 connector on the monitor. 3. The MSpO2 setup window is configured, if necessary. Follow the procedures in this chapter. Table 3. Maternal Pulse Oximetry Troubleshooting Problem COMM message shown in MSpO2 area of

display.

Probable Cause

Possible Solution

Communication error between the built-in MSpO2 module and the remainder of the monitor circuitry.

Contact Biomedical Engineering Department.

n Monitor unable to make a determination

n Check patient. The patient may be

due to insufficient signal.

experiencing shock, hypotension, severe vasoconstriction, severe anemia, hypothermia, arterial occlusion proximal to the sensor, or cardiac arrest. Ensure that the intermediate cable is firmly attached to the monitor and to the sensor assembly.

n Improperly applied sensor.

n Ensure sensor is not too tight. Move sensor to another location.

Dashes (– – –) shown in MSpO2 display area (and possibly in MPR area if MSpO2 is selected as the MPR source).

n Sensor off patient. n Sensor disconnected.

n Re-apply sensor to patient. n Ensure that the intermediate cable is firmly attached to the monitor and to the sensor assembly.

n Excessive maternal movement.

n Talk to the patient about the importance of minimizing limb movement.

n Excessive ambient light. n Damaged sensor. n Pulse rate only: For Nellcor module, SLOW response time selected. REPAIR message shown in MSpO2 area of

display.

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System error or self-test failure.

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n Cover sensor with opaque material. n Replace sensor. n Access MSpO2 Setup window and select NORMAL or FAST mode. Contact Biomedical Engineering Department.

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Product Ordering Information Table 4. Capital Equipment Type

Interconnection Cables

Item

Prod. No.

Ref. No.

Intermediate Cable for Nellcor Sensors

-

1552AAO

Intermediate Cable for Masimo Sensors, 8-foot

-

2002592-002

Intermediate Cable for Masimo Sensors, 12-foot

-

2002592-001

Nellcor Durasensor Adult Reusable Finger Probe

E9004DK

407705-006

Masimo Adult Reusable Finger Probe

E9008JC

2002800-001

Sensors

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Specifications Table 5. MSpO2 Specifications Masimo Module Technique: Sensor Type: Saturation Range: Pulse Rate Range: Saturation Accuracy (with LNOP Sensor): During No Motion Conditionsa: During Motion Conditionsb: Pulse Rate Accuracy: During No Motion Conditions: During Motion Conditions: Wavelengths: Red: Infrared: Response Time: Alarms (audible and visual): Audio: Visual: Limits: Technical: Nellcor Module Technique: Sensor Type: Saturation Range: Pulse Rate Range: Saturation Accuracy: (with Nellcor Puritan Bennett D-25 Sensor)

Pulse Rate Accuracy: Wavelengths: Red: Infrared: Response Time: Alarms (audible and visual): Audio: Visual: Limits: Technical:

Spectrophotometry and plethysmography. Masimo LNOP 1–100 % 25–240 BPM 70–100 % ±2 digits 0–69 % (unspecified) 70–100 % ±3 digits 0–69 % (unspecified) ±3 BPMa ±5 BPMb 660 nm, nominal 940 nm, nominal User-selectable: 2, 4, 6, 8, 10, 12, 14, 16 seconds. Alternating 1.5 second chimes (773 Hz and 523 Hz) Flashing %SpO2 numeric or message User-selectable high and low SpO2; User-selectable high and low pulse rate Sensor errors, connection errors, insufficient signal, excessive motion, communication problem, internal calibration error, or self-test failure. Spectrophotometry and plethysmography. Nellcor Puritan Bennett (D-25 or D-25L recommended) 0–100 % 20–250 BPM %SpO2 ±1 standard deviationc: 70–100 % ±2 digits 50–69 % ±3 digits 0–49 % (unspecified) ±3 BPM 660 nm, nominal 920 nm, nominal User-selectable: slow, normal, and fast averaging modes. Alternating 1.5 second chimes (773 Hz and 523 Hz) Flashing %SpO2 numeric or message User-selectable high and low SpO2; User-selectable high and low pulse rate Sensor errors, connection errors, insufficient signal, excessive motion, communication problem, internal calibration error, or self-test failure.

a

The Masimo SET module, with LNOP adult sensor, has been validated by Masimo for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70–100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±standard deviation. The ±standard deviation encompasses 68% of the population. b The Masimo SET module, with LNOP adult sensor, has been validated by Masimo for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70–100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±standard deviation. The ±standard deviation encompasses 68% of the population. c The accuracy of a given oxygen range is valid for only 68% of the data points taken and the remaining 32% of the data points are not counted in the specification.

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For your notes

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