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.

Nonin

®

 reserves the right to make changes and improvements to this manual and the products it 

describes at any time, without notice or obligation.

Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, Minnesota 55441-5443 USA

+1 (763) 553-9968 

(800) 356-8874 (USA and Canada)

Fax: +1 (763) 553-7807

E-mail: [email protected]

Nonin Medical B.V.

 Prins Hendriklaan 26

 1075 BD Amsterdam, Netherlands

+31 (0)13 - 79 99 040 (Europe)

Fax: +31 (0)13 - 79 99 042
E-mail: [email protected]

nonin.com

Authorized EC Representative:

MPS, Medical Product Service GmbH

Borngasse 20

D-35619 Braunfels, Germany

References to

 

“Nonin”

 

in this manual shall imply Nonin Medical, Inc.

Nonin,

 

PureLight and nVISION are registered trademarks or trademarks of Nonin Medical, Inc.

Microsoft

®

 and Windows

®

 are registered trademarks of Microsoft Corporation.

© 2013 Nonin Medical, Inc.

6130-001-02

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a 
licensed practitioner.

Consult Instructions for Use.

0123

0123 

EC REP

Summary of Contents for 8500

Page 1: ...Operator s Manual Models 8500 and 8500M Handheld Pulse Oximeters 0123 0123 English ...

Page 2: ...79 99 040 Europe Fax 31 0 13 79 99 042 E mail infointl nonin com nonin com Authorized EC Representative MPS Medical Product Service GmbH Borngasse 20 D 35619 Braunfels Germany References to Nonin in this manual shall imply Nonin Medical Inc Nonin PureLight and nVISION are registered trademarks or trademarks of Nonin Medical Inc Microsoft and Windows are registered trademarks of Microsoft Corporati...

Page 3: ...Batteries 7 Important Notes about Battery Use 8 With AA Batteries 9 Connecting the Sensor 9 Turn On Off 9 Startup Self Test 10 Detailed Operation 11 Setup Mode 11 Entering Setup Mode 11 Care and Maintenance 12 Visual Indicators 13 Memory Functions 8500M only 14 Memory Download 8500M only 14 Downloading the Data Stored in Memory 14 Communications 15 Serial Output 15 Service Support and Warranty 16 ...

Page 4: ...ii Contents Continued SpO2 Accuracy Testing 26 Pulse Rate Motion Testing 26 Low Perfusion Testing 26 Principles of Operation 27 Specifications 27 ...

Page 5: ...iii Figures Figure 1 Front View 6 Figure 2 Installing Batteries in the 8500 8 Figure 3 Connecting a Sensor 9 ...

Page 6: ...2 Pulse Oximeter Sensor Connector Pin Assignments 15 Table 3 Electromagnetic Emissions 22 Table 4 Electromagnetic Immunity 23 Table 5 Guidance and Manufacturer s Declaration Electromagnetic Immunity 24 Table 6 Recommended Separation Distances 25 ...

Page 7: ... Using other manufacturers sensors may cause improper pulse oximeter performance Using other manufacturers sensors can result in improper pulse oximeter performance Do not use a damaged sensor If the sensor is damaged in any way discontinue use immediately and replace the sensor As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or stran...

Page 8: ...ng the batteries before 3 minutes have elapsed most likely will result in corrupt data Always replace the batteries with fully charged batteries Do not use fully charged and partially charged batteries at the same time as this may cause the batteries to leak Use only Nonin specified battery types with this device Do not remove any covers other than the battery cover when replacing batteries There ...

Page 9: ...d must be repaired by trained Nonin personnel only Field repair of the device is not possible Do not attempt to open the case or repair the electronics Opening the case may damage the device and void the warranty Any sign or evidence of opening the system field service by non Nonin personnel tampering or any kind of misuse or abuse of the system shall void the warranty in its entirety Cautions Con...

Page 10: ...E Marking indicating conformance to EC directive No 93 42 EEC concerning medical devices SN Serial Number located on the back cover IPX2 Protected against vertically falling water drops when enclosure is tilted up to 15 degrees per IEC 60529 IP32 Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and ingress of solid foreign objects greater than or equal to ...

Page 11: ... are replaced with dashes indicating that readings are not possible Low Battery Indicator When battery capacity is low the display will blink once each second If the batteries are not replaced they will reach critically low capacity and the display will blink dashes The Pulse Quality LED will blink red or amber not green After 10 minutes of critically low battery capacity the display will go blank...

Page 12: ...icators Figure 1 Front View Oxygen Saturation Heart Rate Pulse Quality Indicator On Button Off Button Advance Dimmer Button Off Button On Button Pulse Rate Pulse Quality Indicator Advance Dimmer Button Oxygen Saturation ...

Page 13: ...cover on the back of the device 2 Insert six new AA size alkaline batteries Insert the batteries as indicated inside the battery compartment Proper battery positioning is essential for correct operation 3 Replace the battery cover and turn the device on If the device does not turn on see Troubleshooting WARNING Before changing the batteries make sure the device is off and the sensor is not applied...

Page 14: ...e lower settings will conserve battery life Clock calendar settings can affect battery storage life Batteries drain during storage but they drain much more quickly when the unit s clock calendar functions are set Refer to Clock and Calendar Settings for more information WARNING The device turns off after approximately 10 minutes when at critically low battery capacity CAUTION Replace the batteries...

Page 15: ...g a Sensor Turn On Off Turn on the device by pressing the ON button Turn off the device by pressing the OFF Ø button To conserve battery life the device automatically powers off after 10 minutes of inactivity Inactivity is indicated by dashes on the displays and may result from an improperly connected or positioned sensor or from an inadequate patient pulse signal The Advance Dimmer button control...

Page 16: ...ars briefly in the displays the software revision numbers display in the following order Main revision r 3 numbers 8500 8500M Memory revision n n for m 3 numbers for Model 8500M the 8500 will display n n and no for Model 8500 a dash appears for Model 8500 in the displays until a valid pulse signal is detected Apply the pulse oximeter sensor to the patient s finger ensure the system is obtaining an...

Page 17: ...ent settings press the Advance Dimmer button until the calendar or clock entry to be changed appears in the display Dashes appear in the SpO2 and Pulse Rate displays when Set Up is complete The device is ready for use To review settings Press and release the ON button until all settings are reviewed To change settings when set up mode is entered The year y 07 or user set year automatically appears...

Page 18: ...ened with isopropyl alcohol or a mild detergent Do not pour or spray any liquids onto the device and do not allow any liquid to enter any openings in the device Allow the device to dry thoroughly before reusing CAUTION Do not autoclave or immerse the device or sensors in liquid Do not expose the device or components to excessive moisture or liquids CAUTION Do not use caustic or abrasive cleaning a...

Page 19: ...equate Signal Sensor misalignment ambient light nail polish artificial nails etc Pulse Quality LED blinks Dash appears in the leftmost position of the SpO2 display SpO2 and Pulse Rate numeric displays freeze for 10 seconds After 10 seconds a dash replaces the SpO2 and Pulse Rate numeric displays Inadequate SpO2 or pulse rate data excessive motion or erratic heart rate etc more than 20 seconds Dash...

Page 20: ...re sampled and stored every 4 seconds Oxygen saturation values are stored in 1 increments in the range of 0 to 100 The stored pulse rate ranges from 18 to 300 pulses per minute The stored values are in increments of 1 pulse per minute in the interval from 18 to 200 pulses per minute and increments of 2 pulses per minute in the interval from 201 to 300 pulses per minute Memory Download 8500M only N...

Page 21: ...e data may be read as 8 data bits no parity Real time data may be printed or displayed by devices other than the pulse oximeter At start up a header is sent identifying the format and the date and time as HH MM SS where HH represents the hour MM represents the minutes and SS represents the seconds The data are sent once per second in the following format SPO2 XXX HR YYY where XXX represents the Sp...

Page 22: ... 1 763 553 7807 E mail technicalservice nonin com Nonin Medical B V Prins Hendriklaan 26 1075 BD Amsterdam Netherlands 31 0 13 79 99 040 Europe Fax 31 0 13 79 99 042 E mail technicalserviceintl nonin com nonin com All non warranty work shall be done according to Nonin standard rates and charges in effect at the time of delivery to Nonin All repairs include a complete retest of Models 8500 and 8500...

Page 23: ... reserves the right to charge a fee for a warranty repair request on any device that is found to be within specifications The Model 8500 or 8500M is a precision electronic instrument and must be repaired by knowledgeable and specially trained Nonin personnel only Accordingly any sign or evidence of opening the Model 8500 or 8500M field service by non Nonin personnel tampering or any kind of misuse...

Page 24: ...ion can be found in the respective sensor Instructions for Use WARNING The use of accessories sensors and cables other than those specified in the Parts and Accessories List may result in increased electromagnetic emission and or decreased immunity of this device WARNING Use only with Nonin branded PureLight pulse oximeter sensors These sensors are manufactured to meet the accuracy specifications ...

Page 25: ...onin Technical Service A dash appears in the leftmost position of the SpO2 display A sensor fault exists disconnect failure misalignment or incompatibility with the monitor Verify that the sensor is correctly connected to the device and the patient replace sensor if the condition persists Dashes are displayed in both the SpO2 and Pulse Rate displays No signal is detected because the sensor is not ...

Page 26: ...e ECG monitor may not be functioning properly Assess the patient An inconsistent Pulse Rate or an amber Pulse Quality display during the use with electrosurgical unit ESU The ESU may be interfering with the pulse oximeter performance Assess the patient Move the device cables and sensors as far away from the ESU as possible The Pulse Quality LED is blinking amber with each pulse The quality of the ...

Page 27: ...cial nails Performance degradation from arterial catheter blood pressure cuff infusion line Reduce or eliminate the source The Pulse Quality display is blinking red and the SpO2 and or Pulse Rate displays are dashes Inadequate signal at sensor site Assess the patient Reposition sensor or select an alternate sensor site Inadequate pulse signal due to excessive motion Reduce patient motion Repositio...

Page 28: ...ipment can affect medical electrical equipment Table 3 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance This device is intended for use in the electromagnetic environment specified below The user of this device should ensure that it is used in such an environment RF Emissions CISPR 11 Group 1 This device uses RF energy only for its internal function Therefor...

Page 29: ...nt Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode N A N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec N A Mains power qualit...

Page 30: ...lectromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically wit...

Page 31: ...er W 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 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitte...

Page 32: ...mples measured over the SpO2 range of 70 100 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 9919 2005 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use Pulse Rate Motion Testing This test measures pulse rate oximeter accuracy with motion artifact simulation int...

Page 33: ...r Red 660 nanometers 0 8 mW max avg Infrared 910 nanometers 1 2 mW max avg Indicators Pulse Quality Indicator LED tricolor Numeric Displays 3 digit 7 segment LEDs red Temperature Operating 20 to 50 C 4 to 122 F Temperature Storage Transportation 30 to 50 C 22 to 122 F Humidity Operating 10 to 90 noncondensing Humidity Storage Transportation 10 to 95 noncondensing Altitude Operating Up to 12 000 me...

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