Operators Manual
104 Pages
Preview
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This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 Canada. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, OxiBand, Dura-Y, MAX-FAST, SatSeconds, PediCheck, Oxismart and OXIMAX are trademarks of Nellcor Puritan Bennett Inc. 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 Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; Re. 35,122; 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,368,026; 5,485,847; 5,533,507; 5,662,106; 5,853,364, and 6,083,172.
Contents Contents... i Figures... v Tables... vi Safety Information... 1 Warnings ...1 Cautions ...1
Introduction... 3 Intended Use for the N-550 ...3
Description of Controls, Indicators, and Symbols... 5 Identification of Front Panel Buttons and Symbols ...5 Identification of Rear Panel Components ...6 N-550 Symbols ...7 Description of Controls ...8 Description of Displays and Indicators ...9 Description of Audible Indicators ...11
Setting up the Monitor... 13 List of Components ...14 Connecting the N-550 to AC Power ...15 Connecting a Sensor to the N-550 ...16
Battery Operation... 17 Operating the N-550 on Battery Power ...17 Low Battery Indicator ...18
Using the Monitor... 19 Turning on the Monitor ...19 Sensor Attached ...22 No Sensor Attached ...23 Sensor Message ...24
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Contents
Setting the Pulse Beep Volume ... 25 Setting the Alarm Volume ... 26 Setting Alarm Silence Duration ... 26 Disabling Audible Alarms ... 28 Verify Patient Settings ... 29 Alarm Limits Changed Indicator ... 31 Setting Alarm Limits ... 31 Setting SatSeconds Duration ... 33 Setting the Data Port Baud Rate ... 34 Setting the Data Port Protocol ... 35 Clearing Trend Information ... 36
Monitor Trend... 39 Trend Data Operation ... 39 Trend Data ... 40 #1: Trend Print ... 40 #2: Trend Clear ... 40 #3: Not Used ... 40 #4: Baud Rate ... 41 #5: Data Port Printout ... 41 Option 1 ... 41 Option 2 ... 41
Printing... 43 Printing Monitor Real-Time Data ... 43 Trend Data Printout ... 45 Column Headings ... 46 Data Source ... 46 Device/Software Revision Level ... 46 Alarm Limits ... 47 Monitor Mode ... 47 Data Column Headings ... 47 Time ... 48 Patient Data ... 48 Operating Status ... 48
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Contents
Using the Data Port... 51 Overview ...51 Connecting to the Data Port ...51 Data Port Pinouts ...52
Sensors and Accessories... 55 Selecting a Sensor ...55 Biocompatibility Testing ...57 Optional Accessories ...57 Foot Switch ...58 Pole Mount Bracket ...58
Performance Considerations... 59 Performance Verification ...59 N-550 Performance Considerations ...59 Dysfunctional Hemoglobins ...60 Anemia ...60 Saturation ...60 Pulse rates ...60 Sensor Performance Considerations ...60
Operator’s Menu... 63 Troubleshooting... 65 Error Codes ...65 Corrective Action ...65 EMI (Electro-magnetic Interference) ...68 Obtaining Technical Assistance ...69
Maintenance... 71 Returning the N-550 ...71 Service ...71 Periodic Safety Checks ...72 Cleaning ...72
Technical Information... 73 Description of Alarms ...73
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Contents
Factory Defaults ... 73 SatSeconds Display ... 75 Describing SatSeconds ... 75 SatSeconds “Safety Net” ... 77
Principles of Operation... 79 Oximetry Overview ... 79 Automatic Calibration ... 80 Functional versus Fractional Saturation ... 81 Measured versus Calculated Saturation ... 81
Specifications... 83 Performance ... 83 Electrical ... 84 Environmental Conditions ... 85 Physical Characteristics ... 87 Compliance ... 87
Index... 91
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Contents
Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7:
N-550
Front Panel Buttons and Symbols ...5 Rear Panel Symbols ...6 Real-Time Data Printout ...44 Trend Data Printout ...45 Data Port Pin Layout ...53 Alarm Response with SatSeconds ...77 Oxyhemoglobin Dissociation Curve ...82
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Contents
Ta b l e s Table 1: Table 2: Table 3: Table 4:
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Data Port Pinouts ... 52 Sensors by Model Number and Patient Size ... 56 Operator’s Menu ... 63 Factory Default Settings ... 73
Safety Information
Warnings
Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user. WARNING: Explosion hazard. Do not use the N-550 pulse oximeter in the presence of flammable anesthetics or gases. WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information. WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone.
Cautions
Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the N-550 monitor.
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Safety Information
CAUTION: When connecting the N-550 to any instrument, verify proper operation before clinical use. Both the N-550 and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the monitor's data interface must be certified according to IEC Standard 60950 for data-processing equipment or IEC Standard 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port (N-550 data port connector) configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. The N-550 accuracy may degrade if it is connected to secondary I/O devices when the instrument is not connected to earth reference. CAUTION: Do not lift the monitor by the sensor cable or power cord because the cable or cord could disconnect from the monitor, causing damage to the monitor or injuring the patient. CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
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Introduction WARNING: The N-550 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. Do not make any clinical judgments based on the oximeter's measurements only.
Intended Use for the N-550 The N-550 Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-550 is intended for use with neonatal, pediatric, and adult patients during both no-motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only. Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. Use with any particular patient requires the selection of an appropriate oxygen transducer (sensor) as described in this Operator's Manual. Motion performance claims are applicable to models MAX-A, MAX-AL, MAX-P, MAX-N, and MAX-I Nellcor OXIMAXTM oximetry sensors.
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Description of Controls, Indicators, and Symbols Identification of Front Panel Buttons and Symbols
Figure 1: Front Panel Buttons and Symbols 1. SpO2 Sensor Port
11. SatSecondsTM Display
2. Power On/Off Button
12. SatSeconds Alarm Limit Button
3. %SpO2 Display
13. SpO2 Alarm Limit Button
4. Pulse Amplitude Indicator
14. Motion Indicator
5. Pulse Rate Display
15. Sensor Off Indicator
6. Alarm Silence Button
16. Sensor Message Indicator
7. Alarm Silence Indicator
17. Pulse Search Indicator
8. Adjust Up Button
18. Low Battery Indicator
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19. AC Power Indicator
Adjust Down Button
10. Pulse Rate Alarm Limit Button
N-550
20. Speaker
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Description of Controls, Indicators, and Symbols
Identification of Rear Panel Components
1. Data Port Connector
3. AC Power Connector
2. Foot Switch Connector
4. Equipotential Connector (ground)
Figure 2: Rear Panel Symbols
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Description of Controls, Indicators, and Symbols
N-550 Symbols The symbols that are located on the rear panel of the N-550 are as follows:
1. Data Interface
3. Foot Switch
2. Caution - Do not connect while power is on
4. Equipotential Terminal (ground)
The symbols that are located on the front panel of the N-550 are as follows:
N-550
1. Type BF Applied Part - Not Defibrillator Proof
5. Sensor Message
2. Pulse Rate
6. Pulse Search
3. Motion
7. Low Battery
4. Sensor Off
8. AC Power/Battery Charge
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Description of Controls, Indicators, and Symbols
Description of Controls
The Power On/Off button is used to turn the N-550 monitor on or off. Note: Each button press, except the Power On/Off button, should result in either a valid or an invalid button tone. If the button pressed fails to emit a tone, contact qualified service personnel. The Alarm Silence button is used to silence current alarms for the alarm silence duration period. When an alarm has been silenced, pressing the button again reactivates, or “unsilences” the alarm. It is also used to view and adjust alarm silence duration and alarm volume. The Adjust Up button is used to increase alarm limit values, alarm silence duration, pulse beep volume, alarm volume, and data port baud rate. The Adjust Up button is used to select the communication protocol and time settings. The Adjust Down button is used to decrease alarm limit values, alarm silence duration, pulse beep volume, alarm volume, and data port baud rate. The Adjust Down button is used to select the communication protocol, and time settings. The SpO2 Alarm Limit button is used to view the SpO2 alarm limit. When the SpO2 Alarm Limit button is pressed at the same time as the Pulse Rate Alarm Limit button, after three seconds, the menu options are enabled. The Pulse Rate Alarm Limit button is used to view the pulse rate alarm limit. When the Pulse Rate Alarm Limit button is pressed at the same time as the SpO2 Alarm Limit button, after three seconds, the menu options are enabled.
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Description of Controls, Indicators, and Symbols
The SatSeconds Alarm Limit button is used to view the SatSeconds alarm limit. When pressed the menu options are enabled. The Adjust Up and Adjust Down buttons are used to change the SatSeconds limit settings.
Description of Displays and Indicators
The Pulse Amplitude Indicator (blip bar). A 10-segment LED that indicates pulse beat and shows the relative pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse. The %SpO2 Display. Shows the saturation level of oxygenated hemoglobin. The display value flashes zero during loss-of-pulse alarms and flashes the SpO2 value when the SpO2 is outside the alarm limits. During pulse search, the monitor continues to update the display. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the SpO2 value (100.). The Pulse Rate Display. Shows the pulse rate in beats per minute. It flashes zeros during loss-of-pulse alarms and flashes the beats per minute value in red when the pulse rate is outside of the alarm limit. During pulse search, the monitor continues to update the display. Pulse rates outside of the pulse rate range (20 to 250 bpm) are displayed as the closest value within the range. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the pulse rate value (112.). The AC Power Indicator. Lights continuously when the N-550 is connected to AC power. It also indicates that the battery is charging. It is off when the monitor is being powered by its internal battery. The Low Battery Indicator. Lights continuously to indicate that 15 or fewer minutes of battery capacity remain. The Low Battery indicator flashes when the battery is critically low.
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Description of Controls, Indicators, and Symbols
The Alarm Silence Indicator. Lights continuously when an audible alarm has been silenced. It flashes when the alarm silence duration has been set to OFF. The Motion Indicator. Lights continuously whenever the OxiSmart® XL algorithm detects the presence of artifact independent of its severity or the impact on the SpO2 or pulse rate values. Whenever the motion indicator and the pulse search indicator are simultaneously lit, it is an indication that the artifact is significant and/or has been persistent. The Pulse Search Indicator. Lights continuously prior to initial acquisition of a pulse signal and during prolonged and challenging monitoring conditions. It flashes during a loss-of-pulse signal. The Sensor Off/Signal Loss Indicator is lit when either the sensor is invalid, or no longer on the patient’s finger. It usually indicates that the sensor is not on the patient. The Sensor Message Indicator. Lights when the monitor cannot determine an SpO2 level or a pulse rate. The Sensor Message recommendations for improving the signal are:
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Reposition sensor
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Check or change adhesive wrap
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Choose alternate site
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Warm site
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Cover sensor
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Use forehead, nasal, or ear sensor (adult patients only)
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Use OXIMAX adhesive sensor
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Secure cable
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Secure with headband (MAX-FAST)
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Remove nail polish
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Loosen sensor (too tight)
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Isolate external interference (electrosurgical device, cell phone)
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Clean site (MAX-R)
Description of Controls, Indicators, and Symbols
The SatSecondsTM Indicator. Fills in clockwise as the SatSeconds alarm management approaches the SatSeconds alarm limit threshold. When a SatSeconds setting other than OFF is selected, the green LED at the top of the SatSeconds indicator will light. The green LED at the 12-o'clock position indicates that SatSeconds are engaged.
Description of Audible Indicators Following are descriptions of N-550 audible indicators.
N-550
Power-On Self-Test Pass
A 1-second tone indicating that the N-550 has been turned on and has successfully completed the power-on self-test
Valid Button Press
A short, medium-pitched tone indicating that an appropriate button has been pressed
Invalid Button Press
A short, low-pitched tone indicating that a button has been pressed that is not appropriate for the current state of the monitor
High Priority Alarm
A high-pitched, fast-pulsating tone indicating loss of pulse with no patient motion
Medium Priority Alarm
A medium-pitched, normal-pulsating tone indicating an SpO2 or pulse rate limit violation
Low Priority Alarm
A low-pitched, slow-pulsating tone indicating a sensor disconnect, low battery, or monitor failure
Alarm Silence Reminder
Three beeps that sound approximately every 3 minutes when alarms are silenced with the alarm silence duration set to OFF
Pulse Beep
A single beep sounds for each detected pulse. The pitch changes as monitored SpO2 values increase or decrease.
Volume Setting Tone
A continuous tone that is used to adjust the alarm volume
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Description of Controls, Indicators, and Symbols
Confirmation Tone
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Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been deleted
Setting up the Monitor WARNING: Explosion hazard. Do not use the N-550 pulse oximeter in the presence of flammable anesthetics or gases. WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information. WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Disconnect the N-550 and Nellcor sensor from the patient during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The N-550 may affect the MRI image; the MRI unit may affect the accuracy of oximeter measurements. WARNING: To ensure accurate performance and prevent device failure, do not subject the N-550 to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. WARNING: Do not use an N-550 monitor, sensor, cables, or connectors that appear to be damaged.
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