Nellcor OxiMax N-550 Скачать руководство пользователя

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Specifications

N-550

Electromagnetic
Compatibility

IEC 60601

1, sub clause 36, IEC/EN

60601

2 (second edition)

Radiated and conducted
emissions

EN 55011, Group 1, Class B

Harmonic emissions

IEC 61000

Voltage fluctuations/
flicker emissions

IEC 61000

Electrostatic discharge
immunity

EN 61000

2, level 3 table top

equipment

Radiated radio

frequency

electromagnetic field
immunity

IEC 61000

3, level 2

Electrical fast transient/
burst immunity

IEC 61000

4, level 3

Surge immunity

IEC 61000

5, level 3; FDA

Reviewer’s Guide

Conducted EMI
susceptibility

IEC 61000

Power frequency
magnetic fields

IEC 61000

Operation with line
voltage variations

IEC 61000

11 for Table 7

FDA Reviewer’s Guide

Item

Compliant With

Содержание OxiMax N-550

Страница 1: ...N 550 Pulse Oximeter Operator s Manual min min SpO2 N 550 SatSeconds SpO2...

Страница 2: ...nty 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 us...

Страница 3: ...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 Conne...

Страница 4: ...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 Po...

Страница 5: ...erations 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...

Страница 6: ...ety 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...

Страница 7: ...Panel Buttons and Symbols 5 Figure 2 Rear Panel Symbols 6 Figure 3 Real Time Data Printout 44 Figure 4 Trend Data Printout 45 Figure 5 Data Port Pin Layout 53 Figure 6 Alarm Response with SatSeconds 7...

Страница 8: ...Contents vi Ta b l e s Table 1 Data Port Pinouts 52 Table 2 Sensors by Model Number and Patient Size 56 Table 3 Operator s Menu 63 Table 4 Factory Default Settings 73...

Страница 9: ...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 t...

Страница 10: ...tional 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 requir...

Страница 11: ...spitals 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 p...

Страница 12: ...Blank Page...

Страница 13: ...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 Si...

Страница 14: ...ion of Controls Indicators and Symbols 6 Identification of Rear Panel Components Figure 2 Rear Panel Symbols 1 Data Port Connector 3 AC Power Connector 2 Foot Switch Connector 4 Equipotential Connecto...

Страница 15: ...ows The symbols that are located on the front 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 1 Type BF Appl...

Страница 16: ...arm 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 butto...

Страница 17: ...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 al...

Страница 18: ...al 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...

Страница 19: ...g 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...

Страница 20: ...Description of Controls Indicators and Symbols 12 Confirmation Tone Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been deleted...

Страница 21: ...n 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 f...

Страница 22: ...accidentally turned off WARNING Use only the DOC 10 pulse oximetry cable with the N 550 monitor Use of another sensor cable will have an adverse effect on performance Do not attach any cable that is i...

Страница 23: ...e N 550 to AC Power 1 Power Connector 1 Plug the female connector of the power cord into the monitor AC power connector 1 2 Plug the male connector of the power cord into a properly grounded AC outlet...

Страница 24: ...ch any cable that is intended for computer use to the sensor port Do not connect any device other than a Nellcor approved sensor to the sensor connector 1 SpO2 Sensor Port 1 Connect a DOC 10 pulse oxi...

Страница 25: ...will make a fully charged battery available for use at any time The monitor cannot operate with a dead battery even when plugged in Before attempting to turn on an N 550 with a depleted battery first...

Страница 26: ...ected to AC power within approximately 15 minutes it will shut down Note As the battery is used and recharged over a period of time the amount of time between the onset of the low battery alarm and th...

Страница 27: ...bserved to verify normal operation in the configuration in which it is used CAUTION If any indicator or display element does not light or the speaker does not sound do not use the monitor Instead cont...

Страница 28: ...at all display segments and indicators light and the speaker sounds a 1 second pass tone 4 While performing POST the self test display appears for approximately 2 to 4 seconds During this time All ind...

Страница 29: ...presentative for technical assistance Write down the numbers and have them available prior to requesting technical assistance 6 If the N 550 detects an internal problem during the self test an alarm t...

Страница 30: ...ys dashes in the SpO2 and Pulse Rate displays while the N 550 is searching for a valid pulse 1 Sensor Off 2 Pulse Search Indicator When a valid pulse is detected the monitor enters the Monitoring Mode...

Страница 31: ...sing the Monitor N 550 23 No Sensor Attached When the sensor is not attached the monitor displays dashes and the Pulse Search indicator is not lit indicating that the monitor failed to detect a sensor...

Страница 32: ...or a pulse rate The Sensor Message recommendations for improving the signal are Reposition sensor Check or change adhesive wrap Choose alternate site Warm site Cover sensor Use forehead nasal or ear s...

Страница 33: ...nect a DOC 10 pulse oximetry cable to the SpO2 Sensor Port 1 on the front of the monitor 2 Connect an SpO2 Sensor to the other end of the DOC 10 pulse oximetry cable 3 Place the SpO2 Sensor on the pat...

Страница 34: ...or a preset period called alarm silence duration To view the current setting press and hold the Alarm Silence button until 30 SEC 60 SEC 120 SEC or OFF is displayed To adjust the settings press and ho...

Страница 35: ...e personnel as described in the N 550 service manual With the monitor in the normal monitoring mode 1 Press the Alarm Silence button until XX SEC is displayed Durations are OFF 30 60 90 and 120 second...

Страница 36: ...he alarm silence duration to OFF can be enabled or disabled by qualified service personnel as described in the service manual WARNING Do not silence the audible alarm or decrease its volume if patient...

Страница 37: ...three beeps approximately every three minutes to warn the user that the alarm sound has been silenced Verify Patient Settings With the monitor in the normal monitoring mode 1 Press the SpO2 Alarm Limi...

Страница 38: ...ate Alarm Limit button twice to view the current Pulse Rate lower alarm limit 5 Press the SatSeconds Alarm Limit button to view the current SatSeconds setting Note The SatSeconds 12 O clock indicator...

Страница 39: ...he display until the N 550 is turned off or the limit is returned to the default value Alarm limits that have been changed from the default setting are identified by a decimal point after the displaye...

Страница 40: ...power on default the N 550 displays a decimal point after the changed parameter 3 Press the SpO2 Alarm Limit button twice to view the current SpO2 lower alarm limit 4 Press the Adjust Up button or Ad...

Страница 41: ...current lower alarm limit for Pulse Rate 8 Press Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting Setting SatSeconds Duration Refer to Describing SatSeconds on p...

Страница 42: ...rate determines the speed at which the N 550 sends data to the attached equipment printer or portable computer The baud rate is determined by the capabilities of the attached equipment With the monito...

Страница 43: ...the desired baud rate Possible settings are 24 2 400 96 9 600 and 192 default 19 200 Setting the Data Port Protocol With the monitor in the normal monitoring mode 1 Simultaneously press the SpO2 Alarm...

Страница 44: ...protocol Possible settings are 1 ASCII 2 External equipment communications Refer to the external equipment manuals for the interfacing instructions Clearing Trend Information With the monitor in the n...

Страница 45: ...Using the Monitor N 550 37 2 Press the Adjust Up button to select Option 2 3 Press the SatSeconds Alarm Limit button to clear the trend data 4 The monitor emits 3 beeps indicating that data is cleared...

Страница 46: ...Blank Page...

Страница 47: ...ontains the most recent 24 hours of data with newly collected data overwriting the oldest data on a rolling basis The N 550 continues to record data points as long as the monitor is powered on and an...

Страница 48: ...s on the display Then using the Adjust Up button and Adjust Down button you may scroll through the available menu options as follows 1 Trend Print Allows printing of the existing trend data The output...

Страница 49: ...on page 34 The baud rate selections are 24 2 400 baud rate 96 9 600 baud rate 192 default 19 200 baud rate 5 Data Port Printout Selections are as follows Option 1 Printout in real time ASCII character...

Страница 50: ...Blank Page...

Страница 51: ...k on When connecting the N 550 to a printer or computer verify proper operation before clinical use Both the N 550 and the printer or PC must be connected to a grounded AC outlet Any printer or comput...

Страница 52: ...ter 3 Connect the N 550 to an AC outlet 4 Turn on the N 550 The printer will start printing real time trend data or the PC will start displaying real time data at a rate of one line every 2 seconds Fi...

Страница 53: ...lumn Readings are displayed in 4 second intervals The values on each row are an average for the 4 second period At the end of the printout an Output Complete line indicates that the transmission was s...

Страница 54: ...ighted box above represents the model number of the monitor in this case the N 550 Device Software Revision Level The next data field tells the user the software level Version 1 00 00 and a software v...

Страница 55: ...is 85 and the upper alarm limit is 100 Pulse Rate alarm limits are 40 to 170 BPM SatSeconds alarm limit is set to off Monitor Mode The monitor mode is ADULT Data Column Headings Actual column headings...

Страница 56: ...arameter In this example the SpO2 is 100 and the pulse rate is 190 beats per minute An asterisk indicates that the parameter is outside the set limits If no data for a parameter is available three das...

Страница 57: ...at one time in the Status column Note A sensor disconnect and sensor off will also cause three dashes to be displayed in the patient data section of the printout Code Meaning AO Alarm Off AS Alarm Si...

Страница 58: ...Blank Page...

Страница 59: ...nts of system standard IEC Standard 60601 1 1 and the electromagnetic compatibility system standard IEC Standard 60601 1 2 Connecting to the Data Port The N 550 data port may be connected to the print...

Страница 60: ...trated in Figure 5 The conductive shell is connected to earth ground when connected to a PC or printer Table 1 Data Port Pinouts Pin Signal Name 1 Not connected 2 RxD_232 RS 232 input 3 TxD_232 RS 232...

Страница 61: ...Using the Data Port N 550 53 Figure 5 Data Port Pin Layout Pins 2 3 and 5 provide data in RS 232 format No hardware flow control is used...

Страница 62: ...Blank Page...

Страница 63: ...550 performance WARNING Use only one pulse oximetry cable to increase the length of the sensor Use of more than one pulse oximetry cable may have an adverse effect on performance Do not attach any ca...

Страница 64: ...ls html Follow the sensor sterilization procedures in the applicable sensor directions for use DFU Table 2 Sensors by Model Number and Patient Size Sensor Model Patient Size OXIMAX MAX FAST adhesive r...

Страница 65: ...Contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative for information about these accessories Foot switch Pole Mount Bracket Accessories for the N 550 are...

Страница 66: ...e foot switch is connected to the rear of the N 550 CAUTION The N 550 must be turned off when connecting or disconnecting the foot switch Pole Mount Bracket An optional pole mount bracket is available...

Страница 67: ...0 can be verified by following the procedures outlined in the Performance Verification section of the N 550 service manual Qualified service personnel should perform these procedures before using the...

Страница 68: ...e oximeter may fail to provide an SpO2 if hemoglobin levels fall below 5 gm dl Saturation The N 550 will only measure saturation levels between 1 and 100 Pulse rates The N 550 will only measure pulse...

Страница 69: ...e accompanying the sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the sensor remains properly positioned on the patient WARNING...

Страница 70: ...r to a less active site use an adhesive sensor that tolerates some patient motion use a new sensor with fresh adhesive backing If poor perfusion affects performance consider using the OXIMAX MAX R sen...

Страница 71: ...ta Printout on page 45 2 Trend clear Clearing Trend Information on page 36 3 Language selection Not Used English only 4 Baud rate Setting the Data Port Baud Rate on page 34 24 2400 baud 96 9600 baud 1...

Страница 72: ...Blank Page...

Страница 73: ...nnectors switches or openings in the chassis Error Codes When the N 550 detects an error condition it may display the letters EEE followed by an error code When an error code is displayed turn the ins...

Страница 74: ...ellcor representative 3 The monitor does not sound a tone indicating successful completion of the Power On Self Test POST The monitor has failed the power on self test Do not use the monitor This tone...

Страница 75: ...indicator lights after successful measurements have been made Check the patient Perfusion may be too low for the N 550 to track the pulse Test the instrument on someone else Change the sensor site Tr...

Страница 76: ...listing of error codes EMI Electro magnetic Interference CAUTION This device has been tested and found to comply with the limits for medical devices to the IEC 60601 1 2 EN60601 1 2 and the Medical D...

Страница 77: ...ent 1 800 635 5267 or your local Nellcor representative Obtaining Technical Assistance For technical information and assistance or to order parts or a service manual contact Nellcor s Technical Servic...

Страница 78: ...Blank Page...

Страница 79: ...r other accessory items with the monitor Pack the N 550 in its original shipping carton If the original carton is not available use a suitable carton with appropriate packing material to protect it du...

Страница 80: ...r surface cleaning and disinfecting the monitor follow your institution s procedures or The N 550 may be surface cleaned by using a soft cloth dampened with either a commercial nonabrasive cleaner or...

Страница 81: ...conds alarm the SatSeconds indicator clock will flash 3 Low priority alarm A low pitched slow pulsating tone indicating a sensor disconnect low battery or monitor failure During a low battery alarm th...

Страница 82: ...60 seconds Alarm Silence Restrictions Allow Off as a choice for alarm silence duration reminder will sound Allow Off as a choice for alarm silence duration reminder will not sound Not allow Off as a c...

Страница 83: ...e Alarm Silence button Note When a SatSeconds setting other than OFF is selected the green LED at the top of the SatSeconds indicator will light The green LED indicates that SatSeconds have been engag...

Страница 84: ...imit 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...

Страница 85: ...ates the number of SpO2 points both positive and negative until either the SatSeconds limit SatSeconds setting is reached or the SpO2 level returns within a normal range and remains there SatSeconds S...

Страница 86: ...Blank Page...

Страница 87: ...ased 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 abs...

Страница 88: ...these conditions become even more challenging the amount of data required continues to extend If the dynamic averaging time reaches 40 seconds the pulse search indicator begins flashing the SpO2 and...

Страница 89: ...o compare functional saturation measurements to those from an instrument that measures fractional saturation fractional measurements must be converted as follows Measured versus Calculated Saturation...

Страница 90: ...Principles of Operation 82 Figure 7 Oxyhemoglobin Dissociation Curve...

Страница 91: ...Accuracy and Motion Tolerance Saturation Without Motion Adults1 70 to 100 2 digits Without Motion Neonate1 70 to 100 3 digits With Motion Adults and Neonates2 70 to 100 3 digits Low Perfusion3 70 to...

Страница 92: ...trument Power Requirements 100 to 240 volts AC 18 to 26 volt amps to be compliant with IEC 60601 1 sub clause 10 2 2 Fuses qty 2 2 A 250 volts slow blow IEC 5 x 20 mm Battery The battery provides at l...

Страница 93: ...kPa to 106 kPa 20 6 in Hg to 31 3 in Hg Relative Humidity 10 to 95 non condensing to be compliant with IEC 60601 1 sub clause 44 5 Transport and Storage not in shipping container Temperature 20 C to...

Страница 94: ...AX MAX I 52 5 mW OXIMAX MAX P 52 5 mW OXIMAX MAX A 52 5 mW OXIMAX MAX AL 52 5 mW OXIMAX MAX R 52 5 mW OXIMAX Oxiband OXI A N 52 5 mW OXIMAX Oxiband OXI P I 52 5 mW OXIMAX Durasensor DS 100A 52 5 mW OX...

Страница 95: ...r Degree of protection Type BF Applied part Mode of operation Continuous N 550 resistant to liquid ingress IEC 60601 1 sub clause 44 6 for class IPX1 Drip Proof equipment Degree of Safety in presence...

Страница 96: ...5 clause 4 Environmental IEC 60601 1 sub clause 44 5 Operation during physical shock IEC 60068 2 27 Operation during vibration IEC 60068 2 6 and IEC 60068 2 34 Cleaning IEC 60601 1 sub clause 44 7 Cas...

Страница 97: ...ostatic discharge immunity EN 61000 4 2 level 3 table top equipment Radiated radio frequency electromagnetic field immunity IEC 61000 4 3 level 2 Electrical fast transient burst immunity IEC 61000 4 4...

Страница 98: ...Blank Page...

Страница 99: ...Battery Use 17 Baud Rate 41 BlipBar 9 C Calculated Saturation 81 Calibration Automatic 80 Cleaning 72 Components List of 14 Connecting a Sensor 16 Connecting to the Data Port 51 Corrective Action 65...

Страница 100: ...lse Rate Low Limit Alarm 49 Pulse Search 49 Pulse Search Indicator 10 R Rear Panel 6 Returning the N 550 71 S Safety Checks 72 Safety Information 1 SatSeconds Duration Setting 33 Saturation High Limit...

Страница 101: ...Index N 550 93 T Technical Assistance 69 Transport Relative Humidity 85 Temperature 85 Trend Clear 40 Trend Data Operation 39 Trend Print 40...

Страница 102: ...Blank Page...

Страница 103: ...Blank Page...

Страница 104: ...ivision 4280 Hacienda Drive Pleasanton CA 94588 U S A Telephone Toll Free 1 800 563 5267 Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS U K Rx ONLY 2002 Nellcor Pur...

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