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Specifications

N-560 Operator’s Manual

103

Manufacturer’s Declaration

This product complies with EN/IEC 60601-1-2:2001.

WARNING: The use of accessories, sensors, and cables other than
those specified may result in increased emission and/or create invalid
readings of the N-560.

EMC

EN 55011, Class B/
Group 1

EMC Disturbance
Characteristics — Limits and
Methods of Measurement,
Industrial Scientific and
Medical (ISM) RF Equipment,
Edition 3.1,1999-08

Safety Alarms

EN 60601-1-8: 2004

General Application of Alarms
in Medical Electric Equipment

Front panel and case
labeling

IEC 60878, EN 980,
ISO 7000, EN 60417-1,
EN 60417-2

Button spacing

ISO 7250

Year of manufacture
symbol

EN 980

Operation during
physical shock

IEC 60068-2-27

Operation during
vibration

IEC 60068-2-6, IEC
60068-2-34

Item

Standard

Description

Содержание OXIMAX N-560

Страница 1: ...C M Y CM MY CY CMY K Ops ai 1 24 06 9 31 41 AM Ops ai 1 24 06 9 31 41 AM...

Страница 2: ...ranty 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...

Страница 3: ...bols 5 Identification of Rear Panel Components 6 N 560 Symbols 6 Description of Controls 7 Description of Displays and Indicators 9 Interference Explained 11 Description of Audible Indicators 13 Setti...

Страница 4: ...Limits Changed Indicator 34 Setting Alarm Limits 34 Discussion 34 Procedure 34 Setting SatSeconds Duration 37 Discussion 37 Procedure 37 Setting the Data Port Baud Rate 37 Discussion 37 Procedure 38 S...

Страница 5: ...Column Headings 58 Data Source 58 Device Software Revision Level 58 Alarm Limits 58 N 560 Mode 59 Data Column Headings 59 Time 59 Patient Data 60 Operating Status 60 Sensors and Accessories 63 Selecti...

Страница 6: ...iption of Alarms 85 Factory Defaults 86 SatSeconds Display 87 Describing SatSeconds 87 SatSeconds Safety Net 89 Principles of Operation 91 Oximetry Overview 91 Automatic Calibration 92 Functional vers...

Страница 7: ...ttons and Symbols 5 Figure 2 Rear Panel Symbols 6 Figure 3 Data Port Pin Layout 49 Figure 4 Real Time Data Printout 56 Figure 5 Trend Data Printout 57 Figure 6 Alarm Response with SatSeconds 89 Figure...

Страница 8: ...tor s Menu 73 Table 4 Error Codes 76 Table 5 Factory Default Settings 86 Table 6 Tone Definition 96 Table 7 Cable Compliance 104 Table 8 Electromagnetic Emissions 105 Table 9 Electromagnetic Immunity...

Страница 9: ...ics 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...

Страница 10: ...em 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...

Страница 11: ...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 faciliti...

Страница 12: ...Introduction 4...

Страница 13: ...conds Alarm Limit Button 2 Power On Off Button 13 SpO2 Alarm Limit Button 3 SpO2 Display 14 Interference Indicator 4 Pulse Amplitude Indicator 15 Sensor Off Indicator 5 Pulse Rate Display 16 Sensor Me...

Страница 14: ...mbols that are located on the rear panel of the N 560 are as follows The symbols that are located on the front panel of the N 560 are as follows 1 Data Port Connector 3 AC Power Connector 2 Visual Ala...

Страница 15: ...er On Off button is used to turn the N 560 on or off The Alarm Silence button is used to silence current alarms for the alarm silence duration period When an alarm has been silenced pressing the butto...

Страница 16: ...ettings Press the Adjust Down button one time to decrease the display by one digit Holding the Adjust Down button down for more than one second cause the display digits to scroll The SpO2 Alarm Limit...

Страница 17: ...pO2 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...

Страница 18: ...and Pulse Rate and consequently fidelity in tracking rapid changes in these values may be reduced see Description of Displays and Indicators on page 9 The Pulse Search Indicator Lights continuously pr...

Страница 19: ...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 alarm management...

Страница 20: ...s such as nail polish dye or pigmented cream failure to cover the sensor with opaque material in high ambient light conditions for example conditions created from one or more of the following sources...

Страница 21: ...A high pitched fast pulsating tone indicating loss of pulse Medium Priority Alarm A medium pitched normal pulsating tone indicating an SpO2 or pulse rate limit violation Low Priority Alarm A low pitch...

Страница 22: ...Description of Controls Indicators and Symbols 14...

Страница 23: ...lace the N 560 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 str...

Страница 24: ...rolled by a wall switch because the N 560 may be accidentally turned off WARNING Use only the DOC 10 pulse oximetry cable with the N 560 Use of another sensor cable will have an adverse effect on perf...

Страница 25: ...erly grounded AC outlet 3 Verify that the AC Power Indicator is lit Connecting a Sensor to the N 560 WARNING Use only the DOC 10 pulse oximetry cable with the N 560 Use of another sensor cable will ha...

Страница 26: ...0 pulse oximetry cable to the SpO2 Sensor Port 1 on the front of the N 560 2 Connect an SpO2 Sensor to the other end of the DOC 10 pulse oximetry cable Plug the sensor connector firmly into the DOC 10...

Страница 27: ...d Therefore it is recommended that the N 560 remain connected to AC power when not in use This will make a fully charged battery available for use at any time The N 560 cannot operate with a dead batt...

Страница 28: ...ime between the onset of the low battery alarm and the N 560 shutoff may become shorter It is recommended that qualified service personnel replace the internal battery every 24 months CAUTION If the N...

Страница 29: ...section WARNING The N 560 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the N 560 should be observed to verify normal operation in the configur...

Страница 30: ...s CAUTION During POST immediately after power up confirm that all display segments and indicators light and the speaker sounds a 1 second pass tone 4 While performing POST the self test display appear...

Страница 31: ...evice version illustrated is only a sample The device version identifies the hardware configuration and the software revision Device version numbers are often needed when calling Nellcor s Technical S...

Страница 32: ...ilure to do so could result in an inaudible alarm tone Note In addition to serving as the POST pass verification the POST pass tone also functions as an audible confirmation that the speaker is perfor...

Страница 33: ...r movement of the blip bar and if the pulse beep volume is not 0 listen for pulse beeps to verify that displayed measurement values are current and accurate When a sensor is connected to the N 560 and...

Страница 34: ...d The Sensor Message indicator lights when the N 560 cannot determine an SpO2 level or a pulse rate The Sensor Message recommendations for improving the signal are Reposition sensor Check or change ad...

Страница 35: ...10 pulse oximetry cable to the SpO2 Sensor Port 1 on the front of the N 560 2 Connect an SpO2 Sensor to the other end of the DOC 10 pulse oximetry cable 3 Place the SpO2 Sensor on the patient or your...

Страница 36: ...se its volume if patient safety could be compromised Alarms can be silenced for a preset period called alarm silence duration To view the current setting press and hold the Alarm Silence button until...

Страница 37: ...ence duration has elapsed the alarm will sound The power on default setting for audible alarm silence duration is set at the factory to 60 seconds The default setting can be adjusted by service person...

Страница 38: ...Audible Alarms Discussion Setting the alarm silence duration to OFF means that the N 560 will produce no audible alarms Visual indications of an alarm condition are not affected by disabling the audib...

Страница 39: ...C is displayed 2 While pressing the Alarm Silence button press and hold the Adjust Up button until OFF is displayed Release buttons 3 The Alarm Silence indicator will flash indicating that the alarm s...

Страница 40: ...monitoring mode 1 Press the SpO2 Alarm Limit button to view the current SpO2 upper alarm limit 2 Press the SpO2 Alarm Limit button twice to view the current SpO2 lower alarm limit 3 Press the Pulse R...

Страница 41: ...w 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 lights indicating that SatSeconds u...

Страница 42: ...ntil the N 560 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 displayed reading Sp...

Страница 43: ...larm limit setting Note When an alarm limit is changed from power on default the N 560 displays a decimal point after the changed parameter 3 Press the SpO2 Alarm Limit button twice to view the curren...

Страница 44: ...ulse Rate 6 Press the Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting 7 Press the Pulse Rate Alarm Limit button twice to view the current lower alarm limit for P...

Страница 45: ...Limit button The current SatSeconds setting is displayed Note The possible settings for SatSeconds are Off 10 25 50 and 100 seconds 2 Press the Adjust Up button or Adjust Down button to select the de...

Страница 46: ...e 1 Simultaneously press the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for 3 seconds Menu option 1 will be displayed 2 Press the Adjust Up button until menu item option 4 is displayed...

Страница 47: ...tings are 24 2 400 bps 96 9 600 bps 192 default 19 200 bps Setting the Data Port Protocol With the N 560 in the normal monitoring mode 1 Simultaneously press the SpO2 Alarm Limit button and Pulse Rate...

Страница 48: ...otocol Possible settings are 1 ASCII 2 External equipment communications Refer to the external equip ment manuals for the interfacing instructions Clearing Trend Information With the N 560 in the norm...

Страница 49: ...he N 560 N 560 Operator s Manual 41 2 Press the Adjust Up button to select Option 2 3 Press the SatSeconds Alarm Limit button to clear the trend data 4 The N 560 emits 3 beeps indicating that data is...

Страница 50: ...Using the N 560 42...

Страница 51: ...e alarm limits only as needed Note Trend memory always contains the most recent 24 hours of data with newly collected data overwriting the oldest data on a rolling basis The N 560 continues to record...

Страница 52: ...you may scroll through the available menu options as follows 1 Trend Print Allows printing of the existing trend data The output may be viewed on a PC using the Hyper Terminal program You must press...

Страница 53: ...rate 96 9 600 baud rate 192 default 19 200 baud rate 5 Data Port Printout Selections are as follows Option 1 Printout in ASCII characters Option 2 External equipment communications Refer to the extern...

Страница 54: ...N 560 Trend 46...

Страница 55: ...ponsible 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 Connecting t...

Страница 56: ...ive shell is connected to earth ground when connected to a PC or printer Table 1 Data Port Pinouts Pin Signal Name 1 RXD RS 422 positive input 2 RXD RS 232 input 3 TXD RS 232 output 4 TXD RS 422 posit...

Страница 57: ...differential transmit data pair RXD and RXD are the differential receive pair Data Port Setup Discussion Use the Data Port Setup procedure to configure the N 560 data port baud rate and protocol Proce...

Страница 58: ...Button to select Option 4 The selected baud rate will be displayed Note The available selections are 24 2400 baud rate 96 9600 baud rate 192 19200 baud rate 4 Press the Adjust Up button or the Adjust...

Страница 59: ...hold the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for at least 3 seconds Option 1 will be displayed 7 Press the Adjust Up button until Option 5 is displayed 8 Press the SatSeconds Ala...

Страница 60: ...CII 2 External equipment communications Refer to the external equipment manuals for the interfacing instructions 9 Press the Adjust Up button or the Adjust Down button to display the desired protocol...

Страница 61: ...ed from the patient the N 560 remains in the Pulse Search Mode for awhile then the N 560 displays 3 dashes in the SpO2 and pulse rate display One way to test the nurse call function is to create an al...

Страница 62: ...and 15 provide a relay that opens when an alarm is sounding Pin 15 is a common lead for both relays Note When the relay is closed there is approximately 27 ohms of resistance Setting Nurse Call RS 23...

Страница 63: ...the N 560 must be turned off and then turned back on When connecting the N 560 to a printer or computer verify proper operation before clinical use Both the N 560 and the printer or PC must be connect...

Страница 64: ...rt connector 1 2 Turn on the printer 3 Connect the N 560 to an AC outlet 4 Turn on the N 560 The printer will start printing real time trend data or the PC will start displaying real time data at a ra...

Страница 65: ...Status column 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 transmiss...

Страница 66: ...ed box above represents the model number of the N 560 in this case the N 560 Device Software Revision Level The next data field tells the user the software level Version 1 00 00 and a software verific...

Страница 67: ...mits are 40 to 170 bpm SatSeconds alarm limit is set to off N 560 Mode The N 560 mode is ADULT Data Column Headings Actual column headings are in the third row of the column heading line Patient data...

Страница 68: ...isplayed PA represents pulse amplitude The number can range from 0 to 254 There are no alarm parameters for this value It can be used for trending information as an indication of a change in pulse vol...

Страница 69: ...ta section of the printout Code Meaning AO Alarm Off AS Alarm Silence LB Low Battery LM Loss of Pulse w Interference LP Loss of Pulse MO Interference Detected PH Pulse Rate Upper Limit Alarm PL Pulse...

Страница 70: ...Printing 62...

Страница 71: ...may cause improper N 560 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...

Страница 72: ...sor Models and Patient Weights OXIMAX Sensor Model Patient Size1 OXIMAX MAX FAST adhesive forehead sensor single patient use MAX FAST 10 kg 22 lbs OXIMAX Softcare nonadhesive sensor single patient use...

Страница 73: ...t use infant reusable cable OxiCliq I 3 to 20 kg 6 6 to 44 lbs OXIMAX Durasensor finger clip sensor reusable adult DS 100A 40 kg 88 lbs OXIMAX Oxiband sensor reusable neonatal adult OXI A N 3 kg or 40...

Страница 74: ...ct Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative for information about these accessories Visual alarm indicator Pole mount bracket Accessories for the N 5...

Страница 75: ...Manual 67 Pole Mount Bracket An optional pole mount bracket is available for the N 560 The pole mount bracket may be used to attach the N 560 to an IV pole The pole mount bracket is attached to the re...

Страница 76: ...Sensors and Accessories 68...

Страница 77: ...service personnel should perform these procedures before using the N 560 for the first time in a clinical setting N 560 Performance Considerations Certain patient conditions can affect the measuremen...

Страница 78: ...50 beats per minute Detected pulse rates outside the range of 20 to 250 beats per minute are displayed as the closest value within the range Sensor Performance Considerations WARNING Pulse oximetry re...

Страница 79: ...ge can be caused by incorrect application or inappropriate duration of use of an SpO2 sensor Inspect the sensor site as directed in the sensor directions for use High ambient light sources such as sur...

Страница 80: ...r perfusion affects performance consider using the OXIMAX MAX R sensor it obtains measurements from the nasal septal anterior ethmoid artery an artery supplied by the internal carotid artery This sens...

Страница 81: ...u Function Reference Paragraph 1 Trend print tabular N 560 trend only Trend Data Printout on page 57 2 Trend clear Clearing Trend Information on page 40 3 Language English 4 Baud rate Setting the Data...

Страница 82: ...Operator s Menu 74...

Страница 83: ...nnectors switches or openings in the chassis Error Codes When the N 560 detects an error condition it may display the letters EEE followed by an error code When an error code is displayed turn the N 5...

Страница 84: ...qualified service personnel provides additional troubleshooting information Following is a list of possible problems and suggestions for correcting them Table 4 Error Codes Error Code Action 513 1 Cha...

Страница 85: ...560 contact qualified service personnel or your local Nellcor representative 3 The N 560 does not sound a tone indicating successful completion of the Power On Self Test POST The N 560 has failed the...

Страница 86: ...ight or the sensor may be on an extremity with a blood pressure cuff arterial catheter or intravascular line Reposition the sensor as necessary 5 The Pulse Search indicator lights after successful mea...

Страница 87: ...rror code is still present turn the N 560 off and let it continue to charge If the N 560 has been charged for 30 minutes and the error code is still present notify service personnel Refer to the N 560...

Страница 88: ...installed and used in accordance with these instructions may cause harmful interference with other devices in the vicinity If assistance is required contact Nellcor s Technical Services Department 1...

Страница 89: ...eshooting N 560 Operator s Manual 81 The most recent revision of this manual and the service manual are available on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals...

Страница 90: ...Troubleshooting 82...

Страница 91: ...N 560 Pack the N 560 in its original shipping carton If the original carton is not available use a suitable carton with appropriate packing material to protect it during shipping Return the N 560 by...

Страница 92: ...follow your institution s procedures or The N 560 may be surface cleaned by using a soft cloth dampened with either a commercial nonabrasive cleaner or a solution of 70 alcohol in water and lightly wi...

Страница 93: ...cating an SpO2 or pulse rate limit violation During a medium priority alarm the green display turns red and flashes with the patient parameter that violated the limit SpO2 or Pulse Rate If the alarm i...

Страница 94: ...m Limit plus 1 to 250 bpm 170 bpm Pulse Rate Lower Alarm Limit 30 bpm to Upper Alarm Limit minus 1 40 bpm Alarm Silence Reminder On or Off On Alarm Silence Duration Off 30 60 90 120 seconds 60 seconds...

Страница 95: ...atSeconds 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...

Страница 96: ...s 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 d...

Страница 97: ...0 integrates 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 SatS...

Страница 98: ...Technical Information 90...

Страница 99: ...hout 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...

Страница 100: ...During normal measurement conditions in the Normal response mode the averaging time is 6 to 7 seconds If the resulting dynamic averaging time exceeds 20 seconds the Pulse Search indicator is continuou...

Страница 101: ...re functional saturation measurements to those from an instrument that measures fractional saturation fractional measurements must be converted as follows Measured versus Calculated Saturation When sa...

Страница 102: ...optical interaction of the sensor and the patient s tissue These capabilities are beyond the scope of known bench top testers SpO2 measurement accuracy can only be evaluated in vivo by comparing puls...

Страница 103: ...nsors with the N 560 Neonate specifications are shown for OXIMAX MAX N sensors with the N 560 Saturation accuracy will vary by sensor type Refer to the Sensor Accuracy Grid The Sensory Accuracy Grid i...

Страница 104: ...mation of Button Pressed Volume level Not changeable Pitch 30 Hz 784 Hz Pulse width 20 ms 150 ms Pulse repetition interval 20 ms double burst 150 ms Repetitions 3 High Priority Alarm Volume level Adju...

Страница 105: ...30 Hz 500 Hz Pulse width 20 ms 200 ms Pulse repetition interval 20 ms double burst 15000 ms Repetitions Continually Medium Priority Alarm Volume level Adjustable alarm volume Pitch 30 Hz 752 Hz Pulse...

Страница 106: ...th 20 ms 40 ms Pulse repetition interval ms 20 ms double burst N A Repetitions 1 Valid Button Press Volume level Not changeable Pitch 30 Hz 784 Hz Pulse width 20 ms 30 ms Pulse repetition interval 20...

Страница 107: ...pm high light and low modulation Type Nickel metal hydride Voltage 9 6 volts DC 3 8 AH Recharge 6 hours Shelf Life 3 months new fully charged battery After 3 months storage the N 560 will run for 50 o...

Страница 108: ...re 4 F to 140 F 20 C to 60 C Altitude Barometric Pressure 390 m to 5 574 m 1 280 ft to 18 288 ft 50 kPa to 106 kPa 14 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing over temperature ran...

Страница 109: ...X Durasensor DS 100A 52 5 mW OXIMAX OxiCliq P 52 5 mW OXIMAX OxiCliq N 52 5 mW OXIMAX OxiCliq I 52 5 mW OXIMAX OxiCliq A 52 5 mW OXIMAX Dura Y D YS 52 5 mW OXIMAX MAX FAST 52 5 mW OXIMAX Softcare SC P...

Страница 110: ...trical System Safety Canada CSA C22 2 No 601 1 M90 1998 Safety Medical Electrical Sys Requires NRTL Listing Electric Shock Classification EN 60601 1 Class I or Internally powered Battery mode Type BF...

Страница 111: ...p 1 EMC Disturbance Characteristics Limits and Methods of Measurement Industrial Scientific and Medical ISM RF Equipment Edition 3 1 1999 08 Safety Alarms EN 60601 1 8 2004 General Application of Alar...

Страница 112: ...et hardwire cable 10 ft 3 m Printer cable RS 232 15 to 9 pin D 10 ft 3 m Oxinet II data cable 10 ft 3 m HP Agilent interface cable 3 ft 0 9 m GE Marquette interface cable 3 ft 0 9 m Datex Ohmeda inter...

Страница 113: ...for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The N 560 is suitable for u...

Страница 114: ...1 kV for input output lines Complies Mains power should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Complies Mains power quality...

Страница 115: ...rtable and mobile RF communications equipment should be used no closer to any part of the N 560 including cables than the recommended separation distance calculated from the equation applicable to the...

Страница 116: ...cel lular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment...

Страница 117: ...r of the Transmitter W Separation Distance according to Frequency of Transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3...

Страница 118: ...Specifications 110...

Страница 119: ...g 19 Battery disposal 19 Battery use 19 Baud rate 44 Blipbar 9 C Calculated saturation 93 Calibration automatic 92 Components list of 16 Connecting a sensor 17 Connecting to the data port 47 Correctiv...

Страница 120: ...verview 91 P Patient settings verifying 32 Performance considerations 69 Performance verification 69 PH 61 PL 61 Print trend 44 Printing trend information 55 PS 61 Pulse amplitude indicator 9 Pulse be...

Страница 121: ...19 SL 61 SO 61 Specifications 95 performance 95 specifications battery 99 compliance 103 electrical 99 electrical instrument 99 environmental 100 physical 101 storage altitude 100 barometric pressure...

Страница 122: ...Index 114...

Страница 123: ......

Страница 124: ...ivision 4280 Hacienda Drive Pleasanton CA 94588 U S A Telephone Toll Free 1 800 NELLCOR Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS U K 2007 Nellcor Puritan Benn...

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