Panda, iRes and Giraffe Warmers integrated SpO2 Operation and Maintenance Supplement Rev K

© 2007-2019 General Electric Company All rights reserved. General Electric Company reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your GE Representative for the most current information. Panda iRes and Giraffe are registered trademarks owned by Datex-Ohmeda, Inc. GE and GE Monogram are trademarks of General Electric Company. Nellcor™ OxiMax®, Masimo®, and all other company and product names mentioned may be trademarks of the companies with which they are associated. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables that would, alone, or in combination with this device, fall within the scope of one or more of the patents to this device.

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Table of Contents

About this Supplement ... v Scope and Intended Users ... v Organization of this Supplement... v Conventions... vi User Responsibility ... vi Identifying SpO2 Systems... vii

Important Safety Information ... ix Professional Use Only Caution... x Notes... x

Chapter 1: Nellcor SpO2 ...1 Warnings, Cautions, and Notes for Nellcor SpO2... 1 Indications for Use and Operation ... 3 SpO2 Indications for Use ... 3 Oximetry Overview... 4 Automatic Calibration... 4 Functional versus Fractional Saturation... 5 Measured versus Calculated Saturation... 5 Data Update Period, Effect of Data Averaging, and Other Signal Processing ... 5 SpO2 Display... 6 Operation... 7 SpO2 Menus... 8 Nellcor Response Mode ... 9 SatSeconds Display ... 9 Describing SatSeconds ... 10 SatSeconds “Safety Net” ... 11 Performance Considerations ... 11 Oximetry Alarms... 13 Oximetry Indicators and Alerts... 16 SpO2 Alarm Table... 17 Technical Description, Specifications, and Accessories ... 18 Specifications... 18 Nellcor SpO2 Cables and Probes ... 19 Power Fail Recovery ... 19

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Table of Contents

Chapter 2: Masimo SpO2 ... 21 Warnings, Cautions, and Notes for Masimo SpO2 ... 21 General Warnings ... 21 Alarm Warnings... 22 Measurement Warnings ... 22 Loss of Pulse Warnings ... 23 Sensor Warnings ... 23 Indications for Use and Operation ... 24 SpO2 Indications for Use... 24 General Description of Operation ... 24 SpO2 Calibration, Probe Selection and Connection ... 25 SpO2 Display... 25 Operation... 25 SpO2 Menus ... 27 Oximetry Alarms... 29 Oximetry Alerts... 32 SpO2 Alarm Table... 32 Technical Description, Specifications, and Accessories... 33 Accuracy, Tolerance, and Low Perfusion Performance... 33 Specifications... 34 Masimo SpO2 Cables and Probes... 35 Power Fail Recovery ... 35

Chapter 3: Maintenance and Cleaning... 37 Repair Policy ... 37 Maintenance Schedule... 37 Operator Maintenance... 37 Service Maintenance... 38 Functional Testers and Patient Simulators... 38 Cleaning Instructions... 38

Appendix: Conforming with Standards and Directives ... 41 Packaging Material... 41 Disposal ... 41

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About this Supplement

Scope and Intended Users This manual describes the features and operation of the Nellcor or Masimo pulse oximeter, an optional piece of equipment on both the Panda iRes and Giraffe Warmers. The SpO2 system is integral to the Panda iRes and Giraffe Warmers used in hospital delivery rooms and neonatal intensive care units (NICU). The intended users for this manual consist of end users of the equipment, primarily care providers in infant delivery rooms and NICUs, and hospital biological medical engineering services.

Organization of this Supplement This supplement is organized into the following chapters and appendices: •

• • •

“Chapter 1: Nellcor SpO2” and “Chapter 2: Masimo SpO2” Each of these two product-specific chapters: • Provides important information for the safety of both the patient and the care giver. • Provides Information concerning the use and maintenance of the equipment. • Describes the indications for use. • Describes the operation of the equipment. • Provides information on standards, specifications, and operating environment. • Provides information on the cable descriptions and part numbers. “Chapter 3: Maintenance and Cleaning” provides information on performing maintenance and cleaning of the equipment. “Appendix: Conforming with Standards and Directives” provides information on the European Council Directive and the disposal of electrical/electronic equipment. The back cover provides a geographically organized list of GE Healthcare Service Offices.

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About this Supplement

Conventions This section introduces the various types of warnings, cautions, and notes used in this guide to alert you to possible safety hazards and to provide you with additional information.

WARNING: A Warning statement is used when the possibility of injury to the patient or the operator exists. (The warning icon is yellow.) CAUTION: A Caution statement is used when the possibility of damage to the equipment exists. Connector electrostatic discharge sensitive.

NOTE: A Note provides additional information to clarify a point in the text.

User Responsibility This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, GE Healthcare recommends that a telephone or written request for service advice be made to the nearest GE Healthcare Regional Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by GE Healthcare and by GE Healthcare trained personnel. The Product must not be altered without GE Healthcare’s prior written approval. The user of this Product shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than GE Healthcare.

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About this Supplement

Identifying SpO2 Systems

SpO2 probe jack location

If you are uncertain which type of SpO2 system is in use on your unit, refer to the following probe jack photos:

Masimo SET® 1

Masimo SET® 2

Nellcor

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About this Supplement

viii

Important Safety Information

Before using the Nellcor or Masimo pulse oximeter on the Panda iRes and Giraffe Warmers, read through this entire manual.

WARNING: As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury. This device should only be operated by personnel trained in its operation under the direction of qualified medical personnel familiar with the risks and benefits of this type of device. Additional precautions specific to certain procedures are found in the text of this manual. WARNING: Complete the checkout procedures in this manual before putting the unit into operation. If the unit fails any portion of the checkout procedure it must be removed from use and repaired. WARNING: Do not use the warmer in the presence of flammable anesthetics or gases; an explosion hazard exists under these conditions. WARNING: Always disconnect the power before performing service or maintenance procedures detailed in this manual. Apply power only if you are specifically instructed to do so as part of the procedure. WARNING: Thoroughly air dry the warmer after cleaning it with flammable agents. Small amounts of flammable agents, such as ether, alcohol or similar cleaning solvents left on the warmer can cause a fire. WARNING: Only competent individuals trained in the repair of this equipment should attempt to service it as detailed in the Service Manual. WARNING: Detailed information for more extensive repairs is included in the service manual solely for the convenience of users having proper knowledge, tools and test equipment, and for service representatives trained by GE Healthcare. WARNING: To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth.

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Important Safety Information WARNING: Do not touch connectors marked with the electrostatic discharge (ESD) symbol. Marked connectors are sensitive to ESD. To prevent interference, always touch the device rails to neutralize any ESD charge prior to installing any cable into a marked connector. Train all staff that could potentially touch the connector on these precautions.

Professional Use Only Caution This section identifies professional use of the equipment cautions.

CAUTION: U.S. Federal law restricts this device to sale by, or on order of, a licensed medical practitioner.

Notes This section identifies additional information notes. NOTE: Additional copies of this supplement are available on request from the GE Healthcare office listed on the back cover of this supplement manual. Specific warnings, cautions, and notes are provided at the beginning of each chapter.

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Chapter 1: Nellcor SpO2

Warnings, Cautions, and Notes for Nellcor SpO2 This section identifies warnings, cautions, and notes associated with the use of the Nellcor pulse oximetry equipment on the Panda iRes and Giraffe Warmers.

WARNING: Before use, carefully read the sensor directions for use, including all warnings, cautions, and instructions. WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or decreased immunity and inaccurate readings of the pulse oximeter. WARNING: Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements WARNING: The pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Disconnect the pulse oximeter and sensor from the patient during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. WARNING: To ensure accurate performance and prevent device failure, do not subject the pulse oximeter to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. Do not immerse or wet the sensor. WARNING: Periodically inspect extension cables and sensors for damage. Do not use a pulse oximeter, sensor, pulse oximetry cables, or connectors that appear damaged. Do not use an sensor with exposed optical components.

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Chapter 1: Nellcor SpO2 WARNING: The pulse oximeter is not defibrillator-proof. However, it may remain attached to the patient during defibrillation or while an electrosurgical unit is in use, but the readings may be inaccurate during the defibrillation and shortly thereafter. WARNING: If you do not hear the POST pass tone, do not use the pulse oximeter. NOTE: In addition to serving as the POST pass verification, the POST pass tone also functions as an audible confirmation that the speaker is performing properly. If the speaker does not function, the alarm warning sounds cannot be heard. WARNING: Do not block the alarm speaker located on the back of the control panel near the power outlets. Doing so may interfere with audio alarms. WARNING: Do not silence the audible alarm function or decrease the audible alarm volume if patient safety could be compromised. WARNING: Each time the pulse oximeter is used, check alarm limits to ensure that they are appropriate for the patient being monitored. WARNING: Do not attach any cable to the sensor port connector that is intended for computer use. CAUTION: The sensor disconnect error message and associated alarm indicate that the sensor is either disconnected or the wiring is faulty. The user should check the sensor connection and, if necessary, replace the sensor, pulse oximetry cable, or both. WARNING: Inaccurate measurements may be caused by: • • • •

• •

Incorrect sensor application or use. Significant levels of dysfunctional hemoglobin, e.g., carboxyhemoglobin or methemoglobin. Intravascular dyes, such as indocyanine green or methylene blue. Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material). Excessive patient movement. Venous pulsations.

Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. WARNING: If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the pulse oximeter is functioning correctly.

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Chapter 1: Nellcor SpO2 WARNING: The cover should be removed only by qualified service personnel. There are no user-serviceable parts inside. WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. WARNING: Tissue damage can be caused by incorrect application or inappropriate duration of use of an SpO2 sensor. Inspect the sensor site periodically as directed in the sensor directions for use. WARNING: Do not use a pulse oximeter as an apnea monitor. WARNING: Loss of pulse signal can occur in any of the following situations: • • • • • •

The sensor is too tight. There is excessive illumination from the light source, such as a surgical lamp, a bilirubin lamp, or sunlight. A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor attached. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. There is arterial occlusion proximal to the sensor. The patient is in cardiac arrest or is in shock.

WARNING: Do not sterilize by irradiation, steam, or ethylene oxide. For cleaning instructions, refer to “Cleaning Instructions” on page 38.

Indications for Use and Operation SpO2 Indications for Use The Panda iRes and Giraffe Warmers can be configured with optional pulse oximetry, intended for continuous use. The Nellcor Oximeter technology and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 probe). The Nellcor Oximeter technology and accessories are indicated for use with neonatal patients during no motion, and for patients who are well or poorly perfused in hospitals and hospital type facilities.

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Chapter 1: Nellcor SpO2

Oximetry Overview The Nellcor SpO2 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying an sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light source and a photo detector. Nellcor pulse oximetry uses a two-wavelength pulsatile system to distinguish between oxygenated and deoxygenated blood. Nellcor sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm. The total optical output power of the sensor LEDs is less than 15 mW. This information is useful when performing photodynamic therapy. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated into a measurement of functional oxygen saturation (SpO2). Because a measurement of SpO2 is dependent upon light from the sensor, excessive ambient light can interfere with this measurement. Specific information about ambient conditions, sensor application, and patient conditions is contained throughout this manual. Pulse oximetry is based on two principles: that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry), and that the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography). A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LED) in the oximetry sensor serve as light sources; a photo diode serves as the photo detector. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation. To identify the oxygen saturation of arterial hemoglobin, the Nellcor SpO2 uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vascular bed, and blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The pulse oximeter bases its SpO2 measurements on the difference between maximum and minimum absorption (measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous blood.

Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies, an oximeter must know the mean wavelength of the sensor’s red LED to accurately measure SpO2. During monitoring, the Nellcor software selects coefficients that are appropriate for the wavelength of that individual sensor’s red LED; these coefficients are then used to determine SpO2. Additionally, to compensate for differences in tissue thickness, the light intensity of the sensor’s LEDs is adjusted automatically.

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Chapter 1: Nellcor SpO2

Functional versus Fractional Saturation This pulse oximeter measures functional saturation – oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, hemoximeters such as the IL482 report fractional saturation – oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins. To compare functional saturation measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted as follows: fractional saturation functional saturation = --------------------------------------------------------------------------------------------------------------------------  100 100 –  %carboxyhemoglobin + %methemoglobin 

Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the calculated value may differ from the SpO2 measurement of a pulse oximeter. This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO2 and pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. Refer to the following figure.

Saturation (%)

100

pH Temperature PCO2 2,3-DPG Fetal Hb

pH Temperature PCO2 2,3-DPG

50

0 50

100

PO2 (mmHg)

Oxyhemoglobin Dissociation Curve

Data Update Period, Effect of Data Averaging, and Other Signal Processing - OxiMax™ Algorithm The advanced signal processing of the OxiMax algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate, depending on the measurement conditions. During normal measurement conditions in the Normal Mode, the SpO2 averaging time is six (6) to seven (7) seconds or approximately three (3) seconds in Fast Mode. Equivalently, the typical pulse rate averaging time is approximately five seconds, independent of response mode. The OxiMax algorithm automatically extends the dynamic averaging time required beyond seven (7) seconds during degraded or difficult measurement conditions caused by low perfusion, signal artifact, ambient light, electrocautery, other interference, or a combination of these factors, which results in an increase in the dynamic averaging beyond the minimum as set by the response mode. 5

Chapter 1: Nellcor SpO2 If the resulting dynamic averaging time exceeds 20 seconds for SpO2, the algorithm lists the pulse search icon while continuing to update SpO2 and Pulse Rate values every second. As such measurement conditions extend, the amount of data required may continue to increase. If the dynamic averaging time reaches 40 seconds and/or 50 seconds for pulse rate, a low priority alarm state results, and the module reports a zero saturation is displayed indicating a loss-of-pulse condition which results in an audible alarm.

SpO2 Display With plethesmograph waveform: 7

1

2

3

With Blipper bar:

4

6

5 7

8

SpO2 Display

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Screen number 1 2 3

Description

4

SpO2 display

5 6 7 8

Signal strength indicator Plethesmograph waveform SatSeconds Blip bar

Pulse rate display Pulse rate alarm limits SpO2 alarm limits

Chapter 1: Nellcor SpO2

Operation The pulse oximetry (SpO2) option was designed to integrate a Nellcor pulse oximeter into a Giraffe or Panda iRes Warmer. The module can only be used with Nellcor pulse oximeter probes. Illustration

Description 1. Position the probe on the baby. Refer to the manufacturer’s instruction for placement. 2. Plug the probe into the probe jack.

Nellcor probe jack shown. 3. Turn on the SpO2 feature by pressing the button to the left of the SpO2 box. Verify that the patient data appears in the SpO2 display box.

4. Because probe placement is critical*, verify the signal data and data validity: • • • •

The signal strength indicator shows a strong signal. The displays shows a good quality waveform. The SpO2 value is stable. The displayed pulse rate agrees with the baby’s actual heart rate, as confirmed by palpitation, auscultation, or agreement with heart rate displayed on bedside monitor.

* Refer to probe manufacturer’s instructions for specific warnings regarding probe attachment and placement.

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Chapter 1: Nellcor SpO2

SpO2 Menus Screen

Description 1. Access the SpO2 Menu by pressing “Menu” and then “SpO2”.

2. Use the “SpO2 On/Off” key to stop or restart the SpO2 monitor. Press the “Pulse Tone” key to choose from 4 pulse tone volume levels and a tone off setting (the default setting for Giraffe Warmer is “Off”, the default setting for Panda iRes Warmer is “On” at the lowest volume). * * Default setting can be changed on service screen. Refer to the Service Manual.

3. Press the “Alarm Limits” key (as shown for step 2) to access the alarm limit settings for the SpO2 and Pulse Rate.

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Alarm

Default

Range

Low Pulse Rate

100

25-110

High Pulse Rate

200

111-240

Low SpO2

85

20-99

High SpO2

100

86-100

SatSeconds

Off

Off, 10, 25, 50, 100

Chapter 1: Nellcor SpO2 Screen

Description 4. Press the “Settings” key (as shown for step 2) to access the settings menu. •

• •

You may adjust the “Response mode” from Normal to Fast. (Normal is the default.) The response mode setting dictates the response time (two-seconds to four-seconds in fast mode and six-seconds to sevenseconds in normal mode) applied by the Nellcor algorithm in its calculation of SpO2. You may adjust the “View” between Normal and Large. (Normal is the default.) You may adjust the “Display” between Pleth and Blip. (Pleth is the default.)

The plethysmographic waveform is normalized. The signal strength indicator is displayed in the same box as the SpO2 reading. It consists of 0, 1, 2 or 3 (strongest) asterisks (1), depending on the strength of the signal. Pulse rate value is indicated (2), as well as the SpO2 percentage (3). Push the “Exit” key to return to the Home Screen.

Nellcor Response Mode The purpose of the response mode is to set the response time of the Nellcor algorithm calculation of the SpO2. (The response mode does not affect the Nellcor algorithm’s calculation of pulse rate.) The response mode display screen includes the current SpO2 response mode setting and the current measured %SpO2 and pulse rate. Note: When the Nellcor SpO2 is in the fast response mode, the Nellcor SpO2 may produce more SpO2 alarms and pulse rate alarms than the user is accustomed to seeing.

SatSeconds Display When the Nellcor SatSeconds technology detects an SpO2 value outside the alarm limit, the SatSeconds indicator (the circular graph located on the right side of the display, adjacent to the SpO2 reading) begins to “fill” clockwise. When the SpO2 value is within the set limits, the SatSeconds indicator will empty counterclockwise. Refer to “SpO2 Display” item 7 for the location of the SatSeconds Indicator. When the indicator is completely filled, indicating that the SatSeconds setting has been reached, an audible alarm sounds and the displayed %SpO2 rate flashes. As with traditional alarm management, the audible alarm may be silenced by pressing the ALARM SILENCE button or using the Hands Free Alarm silence.

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Chapter 1: Nellcor SpO2

Describing SatSeconds With traditional alarm management, upper and lower alarm limits are set for monitoring oxygen saturation. During monitoring, as soon as an alarm limit is violated by as little as one percentage point, an audible alarm immediately sounds. When the %SpO2 level fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarms can be distracting. The Nellcor pulse oximeter utilizes Nellcor SatSeconds alarm management technique. With the SatSeconds technique, upper and lower alarm limits are set in the same way as with traditional alarm management. The clinician also sets a SatSeconds limit that allows the monitoring of %SpO2 below the selected low alarm limit for a period of time before an audible alarm sounds. The SatSeconds limit controls the time that the %SpO2 level may fall outside the alarm before an audible alarm sounds. The method of calculation is as follows: The number of percentage points that the %SpO2 falls outside of the alarm limit is multiplied by the number of seconds that the %SpO2 level remains outside that limit. This can be stated as an equation: Points x Seconds = SatSeconds Where: Points = %SpO2 percentage points outside of the limit Seconds = number of seconds the %SpO2 remains at that point outside of the limit The alarm response time, assuming a SatSeconds limit set at 50 and a lower alarm limit set at 90, is described and illustrated below. In this example, the %SpO2 level drops to 88 (2 points) and remains there for a period of 2 seconds (2 points x 2 seconds = 4 SatSeconds). The %SpO2 then drops to 86 for 3 seconds and then to 84 for 6 seconds. The resulting SatSeconds are: (2 points x 2 seconds) + (4 points x 3 seconds) + (6 points x 6 seconds) = 52 SatSeconds. After approximately 11 seconds the SatSeconds alarm would sound, because 50 SatSeconds had been exceeded. Refer to the arrow in the following figure.

90 88 %SpO2 86 84 50 Second SatSeconds Alarm Point

0 1 2 3 4 5 6 7 8 9 10 11 SECONDS

Alarm Response with SatSeconds

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