OxiFirst N-400 Operators Manual sw ver 4.6 July 2003

Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor and OxiFirst are trademarks of Nellcor Puritan Bennett. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,700,708; 5,228,440; 5,247,932; 5,377,675; 5,421,329; 5,660,567; 5,782,237; 5,743,260; and Des. 384,643.

Contents

Warnings, Precautions, and System Information... 1 Intended Use/Indications ... 1 Contraindications... 1 Warnings ... 2 Precautions ... 3 Clinical Use Precautions ... 4 Technical Precautions... 5 Alarms ... 6 Inaccurate Measurements ... 7 Loss-of-Pulse Signal ... 7 N-400 and Other Equipment ... 7 Electromagnetic Interference ... 8 Environmental Protection ... 8

Control Buttons, Status Indicators, and System Components... 9 Front Panel ... 9 Description of Front Panel ... 10 Rear Panel ... 11 Description of Rear Panel ... 12 Fetal Patient Module ... 13 Nellcor Fetal Oximetry Sensor ... 13

Features... 15 Overview ... 15 Automatic Self-test And Start-up ... 15 Operator-Selectable Features ... 16 Audible Alarms ... 16

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Contents

Principles of Operation... 17 Hemoglobin and Oxygen Transport ... 17 Principles of Pulse Oximetry and N-400 Operation ... 18 Automatic Calibration... 19 Functional Versus Fractional Saturation ... 19 Measured Versus Calculated Saturation ... 20 FHR and Optical Pulse Rate Determination ... 21 Fetal Heart Rate Measurement ... 21 Optical Pulse Rate Determination ... 21

System Setup... 23 Unpacking and Inspection... 23 List of Components ... 23 Typical Setup ... 23 Setting up the N-400 ... 24 Power Up and Self-test ... 25

Guide to Operation... 27 Basic Operation ... 27 Alarms... 28 Enabling Audio Alarm ... 29 Disabling Audio Alarms ... 29 Silencing the Audio Alarm ... 29 Adjusting Audio Alarm Volume ... 30 Low Saturation Limit Alarm ... 30 Audible Alarms and Visible Indicators for Lost Signal... 31 Setting Low Saturation Alarm Limit... 33 Setting Pulse Tone Volume ... 33 Setting Date/Time ... 34

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N-400 Operator’s Manual

Contents

Connecting to Other Instruments... 37 Connecting Digital Instruments ... 37 Serial Data Connector Pin Assignments ... 37 Setting Baud Rate ... 38 Communication Formats ... 38 Beat-to-Beat Format ... 39 Conversation Format ... 39 Analog Instruments ... 41 Connecting an Analog Device... 41

Maintenance... 43 Service ... 43 Maintenance ... 43 Cleaning ... 43 Technical Assistance... 44 Returning the N-400 ... 44

Troubleshooting Guide... 45 Status Messages ... 45 Troubleshooting Guide ... 49 Potential Problems and Resolutions ... 49

Specifications... 55 Performance ... 55 Controls ... 56 Alarms ... 56 Pulse Tone ... 56 Response Modes ... 56 Switches ... 57 Data I/O ... 57 Connectors ... 58 Electrical ... 58 Classification ... 58 Physical ... 59 Environmental Conditions ... 59 Emissions Compliance ... 60

Index... 61

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Contents

Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6:

Front Panel ... 9 Rear Panel ... 11 Fetal Patient Module ... 13 Nellcor Fetal Oximetry Sensor ... 13 Oxyhemoglobin Dissociation Curve ... 20 Typical OxiFirst System Setup ... 24

Table 1: Table 2: Table 3: Table 4: Table 5:

Lost Signal Conditions... 32 Serial Data Connector Pin Assignments... 37 Baud Rate DIP Switch Settings... 38 Communication Format DIP Switch Settings . 39 Status Messages... 45

Ta b l e s

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N-400 Operator’s Manual

Wa r n i n g s , P r e c a u t i o n s , a n d S y s t e m Information

Carefully read this manual, the Information for Prescribers, the Clinical Use Guide, accessory directions for use, and all warnings, precautions, and specifications before application and use of the OxiFirst System.

Intended Use/ Indications

The OxiFirst Fetal Pulse Oximetry System continuously monitors intrapartum fetal oxygen saturation (FSpO2). Use of the OxiFirst System is indicated as an adjunct to fetal heart rate monitoring in the presence of a nonreassuring fetal heart rate pattern. The OxiFirst System should only be used after amniotic membranes have ruptured, and on a singleton fetus in vertex presentation with a gestational age greater than or equal to 36 weeks.

Contraindications

Use of the OxiFirst Fetal Pulse Oximetry System is contraindicated in patients with one or more of the following conditions: • documented or suspected placenta previa • ominous fetal heart rate (FHR) pattern requiring immediate intervention • need for immediate delivery (unrelated to FHR pattern), such as active uterine bleeding

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Warnings, Precautions, and System Information

Warnings

Warnings in this manual are identified by the WARNING symbol shown above. A warning alerts you to potentially serious outcomes (death, injury, or adverse events) to the user or the patient. WARNING: The OxiFirst System is intended as an adjunct to fetal heart rate monitoring in fetuses with a nonreassuring heart rate pattern. The OxiFirst System must be used in conjunction with clinical signs and symptoms. WARNING: Locate the monitor near the patient in a position that ensures it cannot accidentally fall on the patient. Failure to do so could result in patient injury. WARNING: The OxiFirst System should not be used while using an Electrosurgical Unit (ESU). Remove the fetal oximetry sensor from the mother and fetus before using an ESU. An improperly grounded ESU can cause surface skin burns on the fetus if both the OxiFirst System and an ESU are used together. WARNING: The OxiFirst System should not be used in the presence of flammable anesthetics. Such use may constitute a fire or explosion hazard. WARNING: The OxiFirst System should not be used to monitor patients during water births, in whirlpool or submersion water baths, during showers, or in any other situation where the mother is immersed in water. Doing so may result in electrical shock hazard.

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N-400 Operator’s Manual

Warnings, Precautions, and System Information

WARNING: Do not use the N-400 monitor or fetal oximetry sensor during magnetic resonance imaging (MRI) scanning. Induced current may potentially cause burns or erroneous FSpO2 measurements. WARNING: The OxiFirst System should not be used in women with active genital herpes or other infection precluding internal monitoring. Insertion of the fetal oximetry sensor in these women may result in transmission of pathogens to the fetus. WARNING: The OxiFirst System should not be used in women who are seropositive for human immunodeficiency virus (HIV). Insertion of the fetal oximetry sensor in these patients may result in fetal exposure to the virus. WARNING: Intrauterine insertion of the fetal oximetry sensor in women who are seropositive for Hepatitis B and/or Hepatitis E antigens may result in fetal exposure to these antigens.

Precautions

Precautions are identified by the CAUTION symbol shown above. A caution alerts you to exercise care necessary for the safe and effective use of the OxiFirst system.

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Warnings, Precautions, and System Information

Clinical Use Precautions Caution: Physicians and other licensed practitioners who use the OxiFirst System should have demonstrated expertise in determining fetal presentation and head position, and should be proficient in the placement of fetal scalp electrodes and intrauterine pressure catheters. Caution: Do not attempt to insert the sensor if the patient is dilated less than 2 cm or if the amniotic membranes have not completely ruptured. Doing so may result in erroneous FSpO2 measurements and/or patient injury. Caution: Do not attempt to rupture amniotic membranes with the sensor. Doing so may result in patient injury and/or sensor malfunction. Caution: In situations where an FSpO2 value is not present, and efforts to readjust the sensor fail to restore the displayed value, clinical management should be based on available data, e.g. FHR. No inferences regarding fetal status should be made on the basis of earlier FSpO2 values. Caution: Do not leave the fetal oximetry sensor in place during vacuum extraction, forceps delivery or cesarean delivery. Doing so may result in patient injury. Remove the fetal oximetry sensor before commencing any form of operative delivery. Caution: Application of the Nellcor® Fetal Oximetry Sensor may cause temporary skin indentations, markings, or bruising on the fetus at the sensor site. Caution: If the fetal heart rate slows during vaginal exam or sensor insertion, stop the procedure. Do not proceed with sensor placement as this can cause a reflex bradycardia stimulus. Wait for the fetal heart rate to return to the previous range before proceeding.

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N-400 Operator’s Manual

Warnings, Precautions, and System Information

Technical Precautions Caution: Suboptimal sensor placement, excessive vernix, fetal hair or motion artifact due to uterine contractions or maternal position changes may result in no FSpO2 values being displayed, or erroneous FSpO2 measurements. Caution: The fetal oximetry sensor may be left in place during defibrillation but FSpO2 readings may be inaccurate for a short time. Caution: Do not attempt to use any sensor other than a sterile, single-use Nellcor Fetal Oximetry Sensor with the OxiFirst System. Use of any other Nellcor oximetry sensor or any sensor from another manufacturer may result in system malfunction, erroneous FSpO2 readings, and/or patient injury. Caution: When placing the Nellcor Fetal Oximetry Sensor, exercise caution to avoid interference with other internal probes, such as an intrauterine pressure catheter or a fetal scalp electrode. Caution: Do not use a damaged sensor. Doing so may result in patient injury, sensor malfunction, and/or erroneous FSpO2 measurements. Caution: Do not use the N-400 monitor if the outside monitor cover, or front or rear panels appear to be damaged. Doing so may result in patient injury, instrument malfunction, and/or erroneous FSpO2 measurements. Caution: Never attempt to clean, reprocess, resterilize, or reuse fetal oximetry sensors. Doing so may result in sensor malfunction, erroneous FSpO2 measurements, and/or infection or potential tissue injury to mother and/or fetus. Each fetal oximetry sensor is supplied as a sterile, single-use, disposable device. Caution: Do not remove the outside monitor cover. Doing so may result in electrical shock hazard. There are no userserviceable parts inside.

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Warnings, Precautions, and System Information

Caution: Replace instrument fuses only with those of the same type and rating to protect against fire hazard. Caution: Do not immerse the sensor completely in liquid-the connector is not waterproof. Immersion of the sensor plug in liquid may result in sensor malfunction and/or erroneous FSpO2 measurements. Caution: Do not immerse the Fetal Patient Module completely in liquid– the unit is not waterproof. Fluid damage to the module may result in malfunction and/or erroneous FSpO2 measurements. Caution: Do not reinsert the stylet into the sensor stylet chamber after it has been completely removed from the chamber. Doing so may result in maternal injury. Most sensor adjustments can be accomplished without the stylet being reinserted into the sensor. Caution Do not connect Nellcor sensor extension cables, such as the EC-4 or EC-8, to the OxiFirst System. Unreliable readings may result due to excessive electrical interference. Caution: For optimal clarity of audible indications and alarms, ensure that the speaker is clear of any obstruction.

Alarms

The default state of the audio alarms is OFF. If audio alarms are to be used, they must first be enabled. If audio alarms are enabled, do not set the alarm volume too low to be heard. When the audio alarm off indicator is illuminated, no audio alarm sounds.

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N-400 Operator’s Manual

Warnings, Precautions, and System Information

Inaccurate Measurements

Inaccurate measurements may be caused by: • incorrect application or use of a sensor • significant levels of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin • excessive fetal or maternal patient movement • venous pulsation Note: The user must independently verify that the N-400 pulse rate displayed is the actual fetal heart rate. This can be done by auscultation or by comparison to an independent FHR monitoring device.

Loss-of-Pulse Signal

Loss-of-pulse signal can occur: • during uterine contractions • if the fetus experiences shock, hypotension, severe vasoconstriction, severe anemia, arterial occlusion proximal to the sensor, or cardiac arrest

N-400 and Other Equipment

Turn the N-400 rear-panel AC mains switch OFF before connecting data recording equipment to the N-400 monitor. To ensure patient electrical isolation, connect the N-400 only to other equipment with circuits that are electrically isolated. When connecting the N-400 to accessory equipment, verify proper operation before clinical use. Refer to accessory equipment manual for full instructions on its use. Accessory equipment connected to the N-400's analog and digital outputs must be certified according to the respective IEC standards, that is, IEC 950 for data-processing equipment or IEC 601.1 for electromedical equipment. This equipment must be provided with either an additional protective earth conductor or a medical isolation transformer. The accessory equipment must be powered by separate wall outlets to avoid possible summation of earth leakage currents. If in doubt, consult Nellcor’s Technical Service Department or your local representative.

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Warnings, Precautions, and System Information

Electromagnetic Interference

This device has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN60601-1-2; 1994, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in the health-care environment (for example, cellular phones, mobile two-way radios, televisions), it is possible that high levels of such interference, due to close proximity or strength of a source, may result in disruption of performance of this device. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with these instructions, may cause harmful interference with other devices in the vicinity. Disruption or interference may be evidenced by erratic readings, cessation of operation, or incorrect functioning. If this occurs, the site of use should be surveyed to determine the source of this disruption, and actions taken to eliminate the source. The user is encouraged to try to correct the interference by one or more of the following measures: • Turn equipment in the vicinity off and on to isolate the offending equipment. • Reorient or relocate the other receiving device. • Increase the separation between the interfering equipment and this equipment. • If assistance is required, contact Nellcor’s Technical Service Department.

Environmental Protection

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Nellcor recommends that the institution follow local governing ordinances and recycling instructions regarding disposal or recycling of device components. Fetal oximetry sensors cannot be recycled.

N-400 Operator’s Manual

Control Buttons, Status Indicators, and System Components

Front Panel

Figure 1: Front Panel 1 2 3 4 5 6 7 8 9 10 11

Fetal Patient Module connector On/Standby switch Searching indicator

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FSpO2 display Pulse Amplitude indicator Pulse Rate (bpm) display No function Signal quality indicator

15 16

Control knob Audio Alarm Off indicator Sensor lifted indicator

20 21

13 14

17 18 19

Sensor Unplugged indicator Audio alarm off button Low Saturation Alarm limit button Pull-out card slot No function No function Response Time button Mode 2 Response Time indicator Adjustable feet Attention symbol

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Control Buttons, Status Indicators, and System Components

Description of Front Panel ON/STANDBY switch: Used to turn the N-400 ON and OFF. Searching indicator: Indicator lights when the N-400 is attempting to

locate the fetal pulse. Percent Oxygen Saturation (FSpO2) display: Displays fetal oxygen saturation (FSpO2) level calculated from accepted optical pulses. Pulse amplitude indicator: The number of bars lit indicates the

relative strength of the pulse at the sensor site. Pulse Rate display: Displays fetal pulse rate calculated from accepted

pulses, measured in beats per minute (bpm). Indicator: Feature not available at this time. Signal Quality indicator: Indicates average signal quality of pulses being detected at the sensor site.

Control knob: Adjusts the speaker volume when audible tones or alarms sound, and is used in conjunction with push buttons to set various limits and values. Audio Alarm Off button and indicator: Button used to silence or enable

the audio alarms. Indicator lights when the audio alarm has been silenced. Sensor Lifted indicator: Lights or flashes when sensor is not making

adequate contact with the fetus at the sensor site. Sensor Unplugged indicator: Lights when sensor is disconnected

from patient module or patient module cable is disconnected from N-400. Low Saturation Alarm Limit button: Used in conjunction with the

control knob to set the low saturation alarm limit. Button and indicator: Feature not available at this time.

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N-400 Operator’s Manual

Control Buttons, Status Indicators, and System Components Response Time button: Sets signal averaging time for FSpO2, changing from Mode 1 (default) to Mode 2 operation.

• Mode 1 (default), slow, approximately 50 seconds (at 150 bpm) • Mode 2, fast, approximately 11 seconds (at 150 bpm) Mode 2 rESPONSE tIME indicator: Lights when Mode 2 response

time is selected. Attention symbol: Directs user to see instructions for use or consult accompanying documents.

Rear Panel

Figure 2: Rear Panel 1 2 3 4 5 6 7

Increase (full-scale) 8 button Fuse replacement symbol 9 Decrease (zero) button DIP switches Serial communications port (RS-232) Analog Output jack (not used) FSpO2 analog output jack

10 11 12 13

Analog input jack (not used) Type BF (patient electrically isolated) Equipotential ground Mains (AC) power input Mains (AC) voltage selector and fuse holder Mains (AC) On/Off switch

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Control Buttons, Status Indicators, and System Components

Description of Rear Panel Increase (full-scale) button: Generates full-scale signal at analog

output. Voltage is dependent upon voltage scale switch setting. (See DIP switches below.) Fuse Replacement Symbol: Indicates fuse requirements. Decrease (zero) button: Generates zero-voltage signal at analog

output. DIP switches: 1: Sets analog output voltage scale (DOWN = 0 - 1 V; UP = 0 - 10 V) 2, 5, 9, 10: Not used 3, 4: Sets baud rate for RS-232 output 6, 7, 8: Sets RS-232 communications format Serial Communications Port: Provides RS-232 format digital interface via a standard 9-pin “D” connector pinout. Analog Output jack: Feature not available at this time. FSpO2 Analog Output jack (3/32-inch subminiature): Provides analog output of FSpO2 data with a range of 0 - 100%. Voltage is dependent

upon voltage scale switch setting. (See DIP switches above.) Analog input jack: Feature not available at this time.

Type BF: Patient electrically isolated. Equipotential Ground: Provides an earth ground connection for leakage testing. Mains (AC) Power Input: Connects N-400 to 100/120V~ or 220/ 240V~ via appropriate power cord. Mains (AC) Voltage Selector: Allows selection of the voltage (115 or 230 VAC) Mains (AC) ON/OFF switch: Mains (AC) power switch.

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N-400 Operator’s Manual

Control Buttons, Status Indicators, and System Components

Fetal Patient Module

The Fetal Patient Module amplifies the fetal oximetry signal. The patient module has a connector for the sensor and a cable that connects to the front panel of the N-400 or to an electronic fetal heart rate monitor that uses Nellcor FSpO2 technology.

Figure 3: Fetal Patient Module

Nellcor Fetal Oximetry Sensor

Become familiar with the sensor before using it. Figure 4 shows the Nellcor Fetal Oximetry Sensor, along with descriptive labels. For additional information regarding sensor use, refer to the OxiFirst System Clinical Use Guide.

Figure 4: Nellcor Fetal Oximetry Sensor

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Control Buttons, Status Indicators, and System Components

The sensor is a sterile, single-use sensor that must not be reused. If the sensor is intentionally or accidentally removed from the patient, apply a new, sterile fetal oximetry sensor. Do not attempt to sterilize any sensor after it has been used on a patient. Note: The sensor may be left in place during normal, unassisted vaginal delivery. Caution: Do not leave the fetal oximetry sensor in place during vacuum extraction, forceps delivery or cesarean delivery. Doing so may result in patient injury. Remove the fetal oximetry sensor before commencing any form of operative delivery.

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N-400 Operator’s Manual