Nonin Medical Onyx II 9560
Contents
1. ll Notes Byte number 1 in each frame is greater than 127 Reserved bytes are undefined range of 0 to 255 12 LINONIN Byte 1 STATUS BYTE This byte provides status information at a rate of 1 75 of a second Range 128 to 255 Byte 1 Status BIT7 BIT BITS BIT4 BIT3 BIT2 BIT BITO 1 R YPRF RPRF_ GPRF an ARTF oor SNSF Note Bit 7 is always set The following are all active high R Reserved Reserved for future use ARTF Artifact Indicates artifact condition of each pulse occurs only during pulse OOT Out Of Track An absence of consecutive good pulse signals Indicates sustained period of Artifact SNSA Sensor Alarm Device is providing unusable data for analysis set when the finger is removed RPRF Red Perfusion Amplitude representation of low no pulse signal occurs only during pulse YPRF Yellow Perfusion Amplitude representation of low marginal signal quality occurs only during pulse GPRF Green Perfusion Amplitude representation of high signal quality occurs only during pulse SYNC Frame Sync 1 to Frame 1 0 on frames 2 through 25 The oximeter reports each pulse by setting clearing the RPRF and GPRF bits for a period of 12 frames 160mS The table below describes the condition and state of the pulse perfusion bits Condition RPRF Bit 22. The 9560 includes 6 bytes of header information a minimum of 14 bytes of spot check data and 2 bytes of footer information To determine the total length for the expandable Spot check data the host must capture the data length from bytes 5 and 6 of the header With the minimum data length of 14 the data length defined in bytes 5 and 6 will be 0x00 OxOE 14 bytes decimal The Spot check data consists of time of spot check SpO2 Pulse Rate and status Header expandable Spot check data Footer This data section is expandable As new parameters are available the data length will increase The minimum length of the Spot check Data is 14 bytes Ox0E ETX end of transmission Byte Data Information Format 1 00 NULL start sync Hex 2 02 STX start of packet Hex 3 00 Packet type MSB Hex 4 0D Packet type LSB Hex 5 00 Data Length MSB variable Hex 6 0E Data Length LSB variable Hex 7 20 Hundredths place of Year default to 20 BCD 8 Year of Measurement Year of Measurement 00 99 BCD 9 Month of Measurement Month of Measurement 01 12 BCD 10 Day of Measurement Day of Measurement 01 31 depending on the BCD month 11 Hour of Measurement Hour of Measurement 00 23 BCD e e a pace 13 Second of Measurement Second of Measurement 00 59 BCD 14 pp nro tgs 15 STATUS MSB See STATUS specification below Hex 7 wro
3. LINONIN Serial Date Format 2 This data format provides continuous data transmission of a 5 byte data packet sent 75 times per second The data packet includes real time data of 8 bit waveform value beat to beat SpOz2 value SpO2 and Pulse Rates values formatted for both recording and display purposes status of the measurement and battery Packet Description A frame consists of 5 bytes a packet consists of 25 frames Three packets 75 frames are transmitted each second ne a a 01 STATUS PLETH HR MSB CHK p STATUS PLETH HR LSB CHK j01 STATUS PLETH SpO2 CHK a STATUS PLETH SREV CHK 01 STATUS PLETH reserved CHK lot STATUS PLETH TMR MSB CHK p STATUS PLETH TMR LSB CHK 01 STATUS PLETH ISTAT2 CHK p STATUS PLETH SpO2 D CHK 01 STATUS PLETH SpO gt Fast CHK pe lo1 STATUS PLETH SpO2 B B CHK 2 p STATUS PLETH reserved CHK 01 STATUS PLETH reserved CHK as 01 STATUS PLETH E HR MSB CHK a STATUS PLETH IE HR LSB CHK 01 STATUS PLETH E SpO2 CHK 01 STATUS PLETH E SpO2 D CHK 01 STATUS PLETH reserved CHK p STATUS PLETH reserved CHK 01 STATUS PLETH IHR D MSB CHK p STATUS PLETH HR D LSB CHK 01 STATUS PLETH E HR D MSB__ CHK lot ISTATUS PLETH IE HR DLSB__ CHK 01 STATUS PLETH reserved CHK 01 STATUS PLETH reserved CHK Notes Byte number 1 in each frame is set to a value of 1 Reserved bytes are undefined range of 0 to 255 LI
4. 11 LINONIN Serial Data Format 7 This data format provides the same information as Data Format 2 except that the waveform value provides the full resolution of 16 bits instead of 8 bits Packet Description A frame consists of 5 bytes a packet consists of 25 frames Three packets 75 frames are transmitted each second Frame Byte 1 Byte 2 Byte 3 Byte 4 STATUS PLETH MSB PLETH LSB IHR MSB CHK i STATUS PLETH MSB PLETH LSB HR LSB CHK STATUS PLETH MSB _ PLETH LSB SpO2 CHK STATUS _ PLETH MSB PLETHLSB SREV CHK pare PLETHMSB__ PLETHLSB reserved CHK STATUS PLETHMSB PLETHLSB TMR MSB CHK STATUS PLETHMSB PLETHLSB_ _ TMR LSB CHK STATUS PLETH MSB PLETH LSB STAT2 CHK STATUS _ PLETH MSB PLETHLSB SpO D CHK mak PLETHMSB__ PLETHLSB SpO gt Fast CHK STATUS PLETHMSB _ PLETHLSB__ SpO2B B CHK B pane PLETHMSB__ PLETHLSB reserved CHK oS JSTATUS PLETH MSB PLETH LSB reserved CHK amp ISTATUS PLETHMSB _ PLETHLSB__ E HRMSB CHK pare PLETHMSB__ PLETHLSB E HR LSB CHK STATUS PLETHMSB PLETHLSB E SpO2 CHK eae PLETHMSB__ PLETHLSB E SpO2 D CHK STATUS PLETHMSB PLETHLSB reserved CHK STATUS PLETHMSB PLETH LSB reserved CHK STATUS PLETH MSB _ PLETH LSB HR D MSB CHK STATUS PLETH MSB PLETHLSB HR D LSB CHK aar PLETH MSB PLETH LSB E HR D MSB CHK STATUS PLETHMSB PLETH LSB E HR D LSB CHK a IPLETH MSB IPLETH LSB reserved CHK STATUS PLETHMSB PLETH LSB reserved CHK
5. and pulse rate of patients who are well or poorly perfused It is intended for spot checking of adult and pediatric patients on fingers other than the thumb between 0 3 1 0 inch 0 8 2 5 cm thick Caution Federal law USA restricts this device to sale by or on the order of a licensed practitioner Contraindications Do not use this module in a Magnetic Resonance MR environment Do not use this device in an explosive atmosphere or in the presence of flammable anesthetics or gases This device is not defibrillation proof per IEC 60601 1 1990 clause 17h Warnings Use the Model 9560 within its designated range approximately 328 feet 100 meters spherical radius line of sight when connected to a class device from patient module to the display Moving outside this range may cause missing lost and or inaccurate data This device is intended only as an adjunct in patient assessment It must be used in conjunction with other methods of assessing Clinical signs and symptoms The device must be able to measure the pulse properly to obtain an accurate SpO2 measurement Verify that nothing is hindering the pulse measurement before relying on the SoO2 measurement Operation of this device below the minimum amplitude of 0 3 modulation may cause inaccurate results General operation of the device may be affected by the use of an electrosurgical unit ESU The use of batteries other than those
6. into the Model 9560 until the fingertip touches the built in stop guide 2 Make sure the finger is lying flat not on its side and is centered within the device For best results keep the Model 9560 at the patient s heart or chest level 3 If the device does not turn on remove the finger and wait a few seconds before reinserting it When a finger is inserted the Model 9560 performs a brief startup sequence Verify that all LEDs illuminate during the startup sequence If any LED is not lit do not use the Model 9560 contact NONIN Technical Service for repair or replacement In the factory default mode after the startup sequence the two flashing red bars will appear on the left hand side of the Model 9560 display Wait until these bars disappear before removing the finger A minus sign appears in the left most digit of the SpOz display when the Model 9560 senses that the finger has been removed The last measured SpOz2 and pulse rate values freeze for 10 seconds and then the displays go blank The device will automatically shut off to conserve battery life approximately 20 seconds after the finger is removed or after a 2 minute period of inadequate pulse signal Using the Lanyard and Carrying Case A lanyard and carrying case are provided for convenience The Model 9560 will function with or without the lanyard If lanyard use is desired thread the lanyard as shown below 22 LINONIN Model 9560 Care Maintenance an
7. by absorption and reflection from structures objects and people 26 LINONIN Testing Summary SpOo2 accuracy motion and low perfusion testing was conducted by NONIN Medical Incorporated as described below SpO Accuracy Testing SpO accuracy testing is conducted during induced hypoxia studies on healthy non smoking light to dark skinned subjects during motion and no motion conditions in an independent research laboratory The measured arterial hemoglobin saturation value SpOz of the sensors is compared to arterial hemoglobin oxygen SaOz value determined from blood samples with a laboratory co oximeter The accuracy of the sensors in comparison to the co oximeter samples measured over the SpOs range of 70 100 Accuracy data is calculated using the root mean squared Arms Value for all subjects per ISO 9919 2005 Standard Specification for Pulse Oximeters for Accuracy Low Perfusion Testing This test uses an SpO Simulator to provide a simulated pulse rate with adjustable amplitude settings at various SpO levels The module must maintain accuracy in accordance with ISO 9919 2005 for pulse rate and SpO at the lowest obtainable pulse amplitude 0 3 modulation 27
8. specified in these instructions may result in increased electromagnetic emission and or decreased immunity of this device This device should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the device should be observed carefully to verify normal operation A Cautions This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin Significant levels of dysfunctional hemoglobin may affect measurement accuracy This device has no audible alarms and is intended only for spot checking This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following e Do not apply the pulse oximeter on the same arm as a blood pressure cuff arterial catheter or infusion line s IVs excessive light such as sunlight or direct home lighting excessive motion moisture in the device improperly applied device finger is outside recommended size range poor pulse quality venous pulsations anemia or low hemoglobin concentrations cardiogreen or other intravascular dyes carboxyhemoglobin methemoglobin dysfunctional hemoglobin 18 LINONIN A Cautions e artificial nails or fingernail polish The device may not work when circulation is reduced Warm or rub the fing
9. 00 to 255 CHK Checksum Byte 1 Byte 2 Byte 3 Byte 4 modulo 256 15 LINONIN Serial Data Format 8 This data format provides continuous data transmission of a 4 byte data packet sent once per second The data packet includes real time data of SoO2 and Pulse Rate formatted for display status information of the measurement and status of the battery Packet Description Three bytes of data are transmitted 1 once per second Byte 1 Status BIT7 Bite BITS BiT4 BiT3 BIT2 Bm1 BITO 1 R OOT LPRF_ MPRF ARTF HR8 HR7 Note Bit7 is always set Byte 2 Heart Rate HR D BIT7 BIT6 BIT5 BIT4 BIT3 BIT2 BIT1 BITO 0 HR6 HR5 HR4 HR3 HR2 HR1 HRO Note Bit 7 is always clear Byte 3 SpO2 D BIT7 BIT6 BIT5 BIT4 BIT3 BIT2 BIT1 BITO 0 SP6 SP5 SP4 SP3 SP2 SP1 SPO Note Bit 7 is always clear Byte 4 Status2 BIT7 Bite BITS BIT4 BIT3 BIT2 BITI BITO 0 R SPA R SNSF R R LOW BAT Note Bit7 is always clear The following are all active high ARTF Artifact Indicated artifact condition on each pulse OOT Out Of Track An absence of consecutive good pulse signals Indicates sustained period of Artifact LPRF Low Perfusion Amplitude representation of low no signal quality holds for entire duration MPRF Marginal Perfusion Amplitude representat
10. 0MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Q Notes e At 80 MHz and 800MHz the separation distance for the higher frequency range applies e These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the module b Over the frequency range 150 kHz to 80 MHz field strengths should be less th
11. 9560 The date and time must conform to the ranges defined below The date and time will be lost when replacing the batteries Name Dec Range Comments YY year 00 99 MM month 1 12 DD day 1 31 Depends on leap year and month for accurate range hh hour 0 23 mm minute 0 59 ss second 0 59 Setting the Time To set the time in the 9560 the host must send the 9560 a 10 byte command Byte 1 Byte2 Byte3 Byte4 Byte5 Byte6 Byte7 Byte8 Byte9 Byte10 Start STX Op Code Data Size Year Month Day Hour Minute Second ETX 0x02 0x72 0x06 YY MM DD hh mm ss 0x03 Example Date 12 31 2050 amp Time 14 30 15 Hours Minutes Seconds Byte 1 Byte2 Byte3 Byte4 Byte5 Byte6 Byte7 Byte8 Byte9 Byte10 Start STX Op Code Data Size Year Month Day Hour Minute Second I EIX 0x02 0x72 0x06 0x32 0x0C Ox1F Ox0E Ox1E OxOF 0x03 Response None 4 LINONIN Retrieving Time from the 9560 To retrieve the time from the 9560 the host must send a 4 byte command string Byte 1 Byte 2 Byte 3 Byte 4 Start STX Op Code Data size End ETX 02 hex 72 hex 00 03 hex Response The 9560 sends the date and time as part of the following 10 byte string Byte 1 Byte2 Byte3 Byte4 Byte5 Byte6 Byte7 Byte8 Byte9 Byte10 Start STX Op Code Data Size Year Month D
12. Canada Safety Code 6 standards include a substantial safety margin designed to ensure the safety of all persons regardless of age and health The exposure standard for wireless mobile phones employs a unit of measurement known as the Specific Absorption Rate or SAR The SAR limit set by the FCC is 1 6W kg Federal Communications Commission FCC Notice This equipment has been tested and found to comply with the limits for a class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with the instructions it may cause harmful interference to radio or television reception which can be determined by turning the equipment off and on The user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the distance between the equipment and the receiver e Connect the equipment to an outlet on a circuit different from the outlet where the receiver is connected e Consult the dealer or an experienced radio TV technician for assistance e RF Exposure For body worn operation to maintain compliance with FCC RF exposure guidelines use only accessories that contain no metallic components and provide a separation distance of 15mm 0 6 in
13. LINONIN Onyx II Model 9560 Bluetooth Fingertip Oximeter OEM Specification and Technical Information NONIN Medical Inc 13700 1st Avenue North Plymouth Minnesota 55441 5443 USA 763 553 9968 800 356 8874 USA and Canada Fax 763 553 7807 E mail info nonin com www nonin com 2008 NONIN Medical Inc 6470 000 01 LINONIN Table of Contents NONIN Onyx II Model 9560 Bluetooth Fingertip Oximeter Technology Specifications 1 Input Output Formatting Options ccccccsseeeseeeeeseeeeneeseneeeeneeeeeeaeeesaesneneeeneeeescaesaseaeenseeeseesessaesaseenenenees 3 Data Format SOMOS eso ictasactcudsseandecis netieauss n A E EEE E R ER 3 Communications Interface amare Der ene r ameere MEER Pe EPerT P UPEEPCEONEPOE TE MEET ACE REERET Pr Un rrar unter emer rr Foren 3 Selecting the Data FOrIMt ccccccccccessccesseceesseceseeeesaeceeaceceeceecsaeeseaaeceeaeeceaceesaaeceeauecseaeectaeeeeaeeseaaesaes 4 Setting Retrieving Time in the 9560 c ccccccccscceesseceenseceeseeeeeceeaaeceeaeeceeeeeeaeceeaaeceeneeseaeeeeaeeeeaaeeaes 4 Data Format 13 SmartPoint AIGONUINT zsess2bcotceseatactehettaseentdeceashetiasteiadatideGitaneatedasiadGass 5 Data Packet Descriptio hercuriorisiriicernin iinr iian E 6 Serial Date Format 2 cis denna ccg tin vt daetneytuxcuu el E EE EE EEA RE E E E 8 Packet Descriph onssa E EEEE ESE ERES TEETE E EEEa 8 Formatted for Recording Purposes cscccscccsccesscesscesscessceeneeeneecsceceeeasecsaecse
14. NONIN Byte 1 START BYTE Always set to a 01 value Byte 2 STATUS BYTE This byte provides status information at a rate of 1 75 of second Range 128 to 255 Byte 2 Status BIT7 BiT BITS BIT4 BIT3 BIT2 BIT BITO YPRF 1 R ARTF OOT SNSF RPRE GPRF SYNC Note Bit7 is always set The following are all active high R Reserved Reserved for future use ARTF Artifact short term Indicates artifact condition of each pulse occurs only during pulse OOT Out Of Track An absence of consecutive good pulse signals Indicates sustained periods of Artifact SNSA Sensor Alarm Device is providing unusable data for analysis set when the finger is removed RPRF Red Perfusion Amplitude representation of low poor signal quality occurs only during pulse YPRF Yellow Perfusion Amplitude representation of low marginal signal quality occurs only during pulse GPRF Green Perfusion Amplitude representation of high signal quality occurs only during pulse SYNC Frame Sync 1 on Frame 1 0 on frames 2 through 25 The oximeter reports each pulse by setting clearing the RPRF and GPRF bits for a period of 12 frames 160mS The table below describes the condition and state of the pulse perfusion bits Condition RPRF Bit 2 of GPRF Bit 1 of Status Byte Status Byte Green high pulse signal 0 1 Yellow low marginal pul
15. an 3 V m 25 LINONIN The following table describes the recommended separation distances between portable and mobile RF communications equipment and this module Table 4 Recommended Separation Distances This module is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled Customers or users of this module can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the module as recommended below according to maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter Rated Maximum Output Power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Transmitter d 1 17 P d 1 17 P d 2 33 P W 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 transmitter in watts W according to the transmitter manufacturer Notes e At 80 MHz and 800MHz the separation distance for the higher frequency range applies e These guidelines may not apply in all situations Electromagnetic propagation is affected
16. and pushing inward slightly to re secure the battery cover Do not force it into place it fits only when properly positioned E 4 5 Visually inspect to ensure that the battery cover is properly placed 6 Insert your finger into the device to verify operation Using Model 9560 and Verifying Operation The Model 9560 contains numeric LEDs that display oxygen saturation and pulse rate A tricolor LED display provides a visual indication of the pulse signal quality while blinking at the corresponding pulse rate This display changes colors to alert you to changes in pulse quality that may affect the readings green indicates a good pulse signal yellow indicates a marginal pulse signal and red indicates an inadequate pulse signal Activate the Model 9560 by inserting the patient s finger into the unit The Model 9560 detects the inserted finger and automatically illuminates the displays Correct positioning of the light emitter and photodetector on the finger is critical for accurate measurements All emitted light must pass through the fingertip A While on the finger do not press the Model 9560 against any surface and do not squeeze or hold it together The internal spring provides the correct pressure additional pressure may cause inaccurate readings Caution Do not apply the pulse oximeter on the same arm as a blood pressure cuff arterial catheter or infusion line s IVs 1 Insert the patient s finger nail side up
17. at of a typical interruptions and commercial or hospital environment If the user of the voltage variations N A N A module requires continued operation during power on power supply mains interruptions it is recommended that the input lines device be powered from an uninterruptible power IEC 61000 4 11 supply or battery pack Power Frequency cat 50 60 Hz Power frequency magnetic fields should be at levels na 3 A m 3 A m characteristic of a typical location in a typical Magnetic Field A commercial or hospital environment IEC 61000 4 8 Note Ur is the AC mains voltage before application of the test level 24 LINONIN Table 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity IEC 60601 Test Level Compliance Level Electromagnetic Immunity Test Environment Guidance This module is intended for use in the electromagnetic environment specified below The customer and or user of this module should ensure that it is used in such an environment Portable and mobile RF communications equipment should be used no closer to any part of the module including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF 3 Vrms 3V d 1 17 JP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m d 1 17 JP 80 MHz to 800MHz IEC 61000 4 3 80MHzto2 5GHz V d 2 33 JP 80
18. ay Hour Minute Second l ETX 02 hex F2 hex 06 hex YY MM DD hh mm ss 03 hex Data Format 13 SmartPoint Algorithm Data format 13 uses a SmartPoint Algorithm to determine a reliable single point measurement The 9560 will acquire a SmartPoint measurement within 40 seconds from power on An indicator on the 9560 display flashes while acquiring the measurement and stops flashing after the SmartPoint value is transmitted or stored into memory when a wireless transmission is not possible If after 40 seconds a high quality measurement is not possible the SmartPoint Algorithm will send the current measurement and mark the measurement as not completing the algorithm Low perfusion weak pulse signal conditions or artifact pulse conditions may affect the ability to obtain the high quality measurement indication If the 9560 is unable to establish a wireless connection the SmartPoint measurement will be stored into memory The 9560 has memory capacity to store a minimum of 20 SmartPoint measurements When a wireless connection is made the 9560 oximeter will forward the oldest stored measurements prior to sending the new measurement After stored measurements are sent they are removed from memory Notes If the finger is removed before 40 seconds and a high quality measurement is not available no data will be sent or stored in memory Stored measurements will be lost after battery replacement LINONIN Data Packet Description
19. ches to the body Use of other accessories may violate FCC RF exposure guidelines and should be avoided e The Model 9560 is designed and manufactured not to exceed the emission limits for exposure to radio frequency RF energy set by the United States FCC These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population The guidelines are based on the safety standards previously set by both U S and international standards bodies This EUT has been shown to be capable of compliance for localized specific absorption rate SAR for uncontrolled environment general population exposure limits specified in ANSI IEEE Std C95 1 1992 and has been tested in accordance with the measurement procedures specified in FCC OET Bulletin 65 Supplement C 2001 and IEEE Std 1528 200X Draft 6 5 January 2002 e The FCC requires the user to be notified that any changes or modifications to this device that are not expressly approved by Nonin Medical Inc may void the user s authority to operate the equipment 20 LINONIN Using the Model 9560 Guide to Symbols on the Module ey Consult Instructions for Use Caution Type BF Applied Part Patient isolation from electrical shock ope O UL Mark for Canada and the United States with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 30EM and CAN CSA C22 2 No 601 1 cE CE Marking
20. csaecssecsaeesseeessesseeseneesas 10 Formatted for Display Purposes cccccsccsssesscesscesscesscssseesseeeneeeseeeseeescecsaecsaecsaecusecsaeesseeeseesseeesneeeas 10 Sonal pata FONAL RI rs a a a eee Te PET E O N 12 Packet DESCriIPU OM cise co seessbecsscusts Gaxeease cectossedtecedas eeu sa a a ie a a aiai 12 Formatted for Recording Purposes scccsccesccesscesscesscesseesseeeseeeseeeeececaecaecsaecssecsseeseeeeeesseeenneesas 14 Formatted for Display PUrpOSes sscccsccescesscesscesscessceseeesseeeseeeaeeeaeecacecauecsaecaecnseceaeeeaeeeeeeeeeeeneeeeas 15 Serial Data Formal Ho oreeson E e r EE Er ET ert 16 Packet DescriptiOn sise cotdesscusseannativersaniadere aasian EE EERE EEE EEEE A REER 16 indications tor USC cnerenenin S 18 CCOMEPAINGI CATIONS a Ea EEEE A E A EE E ETE 18 WADII S e A E R A 18 G tiohS soni a aa pa a ae aeaa tect aea a a e a 18 Regulatory Information sssssnneennnnnnnunnennnnnnnnnnnnnnnnnn nunne nnnnnnnnnnnnnnnnnn anunn nnnm nnmnnn nnmnnn nnana nannamamma nnmnnn 20 Declaration of Conformity with FCC and Canadian Ministry of Health Rules for Electromagnetic Compatibility sa osscndebeSauducpvenndvaussendetpascnaveueesyadhpaoondmemessvaveedednseeeenmavegasin 20 Federal Communications Commission FCC Notice ccccccccceeeseseseeeeeeeeeeesessneeeeeeeees 20 Using the Model 9560 on cicccie ccc cecectsccedeccnecttectnccetectiecate ete cevesteeciie chic svi ctteciiecttecvvectueciveciecvieetecivecttecvies 21 Guide t
21. ction indicator is not available on the 9560 product Once the Bluetooth connection is established the 9560 receives and transmits data using the SPP protocol using the following settings Data bits 8 Bits per second Parity Stop bits Flow Control 9600 None 1 None Note Throughout this document all values are in decimal unless otherwise noted The decimal number must be converted to 8 bit hex for data transmission A hex value will be described with this format 0xZZ where ZZ is the hex value with a range of 0 to FF LINONIN Selecting the Data Format To select the data format the host must send the 9560 the following 6 byte command string Byte 1 Byte2 Byte3 Byte4 Byte5 Byte6 Start STX Op Code Data Size Data Type Data Format TEX 0x02 0x70 0x02 0x02 OxZZ where ZZ is 0x03 OD 08 07 or 02 Response During the first five seconds from connection after the 9560 receives a command it will respond with an ACK 0x06 for a supported command or NAK 0x15 for an unsupported command Once the data format is changed the 9560 will retain the new data format until changed to a different data format Because the data format is retained in non volatile memory the data format will be retained after a battery change If the data format is not changed the 9560 will default to data format 13 Setting Retrieving Time in the 9560 The host can set and retrieve the time from the
22. d Cleaning The advanced digital circuitry within the Model 9560 requires no calibration or periodic maintenance other than battery replacement Field repair of the Model 9560 circuitry is not possible Do not attempt to open the Model 9560 case or repair the electronics Opening the case will damage the Model 9560 and void the warranty Do not open the Model 9560 more the 90 and do not twist or pull on the device when cleaning Cleaning the Inner Surfaces of the Model 9560 1 Wipe the surfaces with a soft cloth dampened with isopropyl alcohol or a mild detergent see CAUTION below If low level disinfection is required a cloth dampened with 10 bleach 90 water solution may also be used Do not use undiluted bleach or andy cleaning solution other than those recommended here as permanent damage could result 2 Dry with a soft cloth or allow to air dry Ensure that all surfaces are completely dry A Caution Do not sterilize autoclave or immerse this device in liquid Do not use caustic or abrasive cleaning agents or any cleaning products containing ammonium chloride 23 LINONIN Manufacturer s Declaration See the following tables for specific information regarding this module s compliance to IEC 60601 1 2 2001 Table 1 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance This module is intended for use in the electromagnetic environment specified below The cust
23. de is used or disposed of improperly Remove batteries if the device will be stored for more than 30 days Do not use different types of batteries at the same time Do not mix fully charged and partially charged batteries at the same time These actions may cause the batteries to leak Follow local state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries In compliance with the European Directive on Waste Electrical and Electronic Equipment WEEE 2002 96 EC do not dispose of this product as unsorted municipal waste This device contains WEEE materials please contact your distributor regarding take back or recycling of the device If you are unsure how to reach your distributor please call NONIN for your distributor s contact information 19 LINONIN Regulatory Information Declaration of Conformity with FCC and Canadian Ministry of Health Rules for Electromagnetic Compatibility e Nonin Medical Inc of 18700 1st Avenue North Plymouth Minnesota 55441 declares under its sole responsibility that Model 9560 to which this declaration relates comply with part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation e Ministry of Health
24. eat SpOz2 Average E SpOz 8 beat SpO2 Extended Average SpO gt Fast 4 beat Average optimized for fast responding SpOz B B Beat to Beat value No Average When SpOz and HR cannot be computed the system will send a missing data indicator For missing data the HR equals 511 and the SpOz equals 127 14 LINONIN Formatted for Display Purposes These values are formatted for display purposes every 1 5 seconds They provide the most reliable reading possible during periods of artifact When the device is removed from the finger the last SoO2 and Pulse Rate reading will be reported for 10 seconds before changing to the missing data value During this 10 second period the sensor alarm bit SNSA is set indicating that the finger has been removed This feature is useful for spot check measurements HR D 4 beat Pulse Rate Average E HR D 8 beat Pulse Rate Extended Average SpO2 D 4 beat SpO2 Average E SpOz2 D 8 beat SpO Extended Average When SpOz and HR cannot be computed the system will send a missing data indicator For missing data the HR equals 511 and the SpOz equals 127 HR Format 7 6 5 4 3 2 1 0 _HR MSB 0 R R R R _ R HRs HP7 7 6 5 4 3 2 1 0 HRLSB 0 HR6 HR5 HR4 HR3 HR2 HRI HRO SpO Format 4 3 2 1 SpO 0 SP6 SP5 SP4 SP3 SP2 SP1 SPO R Reserved range 0 or 1 Byte 5 CHK This byte is used for the checksum of bytes 1 through 4 Range
25. er or re position the device This device s display will go blank after 30 seconds of no readings or poor readings Do not sterilize autoclave or immerse this device in liquid Do not use caustic or abrasive cleaning agents or any cleaning products containing ammonium chloride A flexible circuit connects the two halves Do not twist or pull the flexible circuit or overextend the device s spring Do not hang the lanyard from the device s flexible circuit strain relief A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor This equipment complies with IEC EN 60601 1 2 2001 for electromagnetic compatibility for medical electrical equipment and or systems This standard is 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 healthcare and other environments it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device Medical electrical equipment needs special precautions regarding EMC and all equipment must be installed and put into service according to the EMC information specified in this manual Portable and mobile RF communications equipment can affect medical electrical equipment Batteries may leak or explo
26. er to a master device the master device must initiate the connection by first pairing with the 9560 The 9560 has a six digit identification number printed on the battery door To complete the pairing process the six digit number must be provided to the master as the Bluetooth PassKey Bluetooth PIN Once the pairing is complete the 9560 will automatically reconnect to the master device when possible The six digit Bluetooth PassKey on the 9560 must be entered only during the pairing to a new master Note To connect to a new device new master the 9560 must be out of range from the previous master or unpaired from that master Specific to Data format 13 after the 9560 turns on and a measurement is available to wirelessly send the 9560 will send a Bluetooth Page message to reestablish the connection with the master with which it is paired If the master is not available the 9560 will become discoverable for pairing to a new master For backwards compatibility when using data formats 2 7 or 8 the 9560 will not initiate the Bluetooth Page The master must initiate the Bluetooth Page Scan to automatically reestablish the connection to the 9560 Once the Bluetooth connection is made the 9560 will automatically send continuous data to the master as defined in the data format sections For greater detail on establishing a Bluetooth wireless connection refer to Nonin s Bluetooth Connection Brief Note A Bluetooth conne
27. imized for fast responding SpOz B B Beat to Beat value No Average When SpOz and HR cannot be computed the system will send a missing data indicator For missing data the HR equals 511 and the SpOz equals 127 Formatted for Display Purposes These values are formatted for display purposes every 1 5 seconds They provide the most reliable readings possible during periods of artifact When the device is removed from the finger the last SpO2 and Pulse Rate reading will be reported for 10 seconds before changing to the missing data value During this 10 second period the sensor alarm bit SNSA is set indicating that the finger has been removed This feature is useful for spot check measurements HR D 4 beat Pulse Rate Average E HR D 8 beat Pulse Rate Extended Average SpO2 D 4 beat SpO2 Average E SpO2 D 8 beat SpO2 Extended Average When SpOz and HR cannot be computed the system will send a missing data indicator For missing data the HR equals 511 and the SpOz equals 127 10 LINONIN HR Format 7 6 5 4 3 2 1 0 _HR MSB 0 R R R R R HRs HR7 7 6 5 4 3 2 1 0 HRLSB 0 HR6 HR5 HR4 HR3 HR2 HRI HRO SpO gt Format 6 5 4 3 SpO gt 0 SP6 SP5 SP4 SP3 SP2 SP1 SPO R Reserved range 0 or 1 Byte 5 CHK This byte is used for the checksum of bytes 1 through 4 Range 00 to 255 CHK Checksum Byte 1 Byte 2 Byte 3 Byte 4 modulo 256
28. indicating conformance to EC directive No 93 42 EEC concerning medical devices SN Serial Number i Battery Orientation Co Non ionizing electromagnetic radiation Equipment includes RF transmitters interference may A occur in the vicinity of equipment marked with this symbol WN Remote Alarms Not for Continuous Monitoring Sp02 K Indicates separate collection for electrical and electronic equipment WEEE Bluetooth Installing Batteries Two 1 5 volt AAA size batteries power the Model 9560 for approximately 600 spot checks NONIN recommends using alkaline batteries included with each new Model 9560 When batteries are low the numeric displays flash once per second Remove batteries if the device will be stored for more than 30 days Replace low batteries as soon as possible using the instructions below Note Rechargeable batteries may be used however they require more frequent replacement toop 1 Hold the Model 9560 as shown above pressing upward and then pulling outward slightly with the thumb to release the device s battery tray Remove the battery cover and the depleted batteries disposing of the batteries properly Insert two new 1 5 volt AAA size batteries Follow the polarity markings and as illustrated Proper positioning of the batteries is essential for operation 21 LINONIN 4 Carefully guide the battery cover back onto the Model 9560 pressing downward
29. ion of low marginal signal quality holds for entire duration SNSA Sensor Alarm Device is providing unusable data for analysis set when the finger is removed SPA SmartPoint High quality SmartPoint measurement Algorithm LOW BAT Low Battery Low Batteries Replace batteries as soon as possible condition HR8 HRO Heart Rate HR D 4 beat Pulse Rate average formatted for display SP6 SPO SpOz SpOz D 4 beat SpO2 average formatted for display R Reserved range Reserved for future use 0 or 1 16 LINONIN The SpOz and Pulse Rate values are formatted for display purposes every 1 5 seconds They provide the most reliable reading possible during periods of artifact When the device is removed from the finger the last SpO2 and Pulse Rate reading will be reported for 10 seconds before changing to the missing data value During this 10 second period the sensor alarm bit SNSA is set indicating that the finger has been removed This feature is useful for spot check measurements HR D 4 beat Pulse Rate Average SpO2 D 4 beat SpO2 Average When SpOz and HR cannot be computed the system will send a missing data indicator For missing data the HR equals 511 and the SpOz equals 127 17 LINONIN Indications for Use The NONIN Model 9560 Finger Pulse Oximeter is a small lightweight portable wireless device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin SpOz
30. nfrared using NONIN PureLight Sensor 910 nanometers 1 2 mW maximum average 4 SpOs Accuracy Arms 70 100 Oxygen Saturation Accuracy 2 digits Low Perfusion Oxygen Saturation 2 digits Accuracy 5 Pulse Rate Accuracy Arms Pulse Rate Accuracy 20 250 BPM 3 digits Low Perfusion Pulse Rate Accuracy ess 40 240 BPM 3 digits 6 Internal Power Battery Two 1 5 volt AAA batteries Operating Life 600 spot checks 30 secs spot check in a 6 month period Storage Life 12 months 7 Weight 63 grams with batteries installed 8 Temperature Operating 5 C to 40 C Storage Transportation 40 C to 70 C 9 Operating Altitude Up to 40 000 feet 12 192 meters 10 Hyperbaric Pressure Up to 4 atmospheres 11 Humidity Operating 10 to 95 relative humidity non condensing Storage Transportation 10 to 95 relative humidity non condensing Allow to stabilize 12 Enclosure Degree of Ingress Protection IP32 This information is especially useful for clinicians performing photodynamic therapy 1 Ams represents approximately 68 of measurements When the Model 9560 is transferred from a non operating temperature humidity condition allow one hour of stabilization to operating temperature humidity specifications prior to use LINONIN 13 Bluetooth Information Bluetooth Compliance Operating Frequency Output Power Operating Range Network Topology Operation Antenna Type Mod
31. o Symbols on the Module sec ccisscvstssscensezenseesceeavaussucnioesenusvevasendbeuaacentevdvavaburedeentenes 21 Installing Batteries Saas sceescazecetsiee aac ceececeaveeeeaceueacbieacavetaestaecetereasatancxacebtee EE EREE E EEEE 21 Using Model 9560 and Verifying OP ratiOn ccsssssccceceeeseeennnaaeeeeeeesesesenaaaeeseeesenseeneaaa 22 Using the Lanyard and Carrying Case ix secscecctvstcvesteanenacdessevereuaedpastesecuaedpsadbaeteseenseaececuauaee 22 Model 9560 Care Maintenance and Cleaning 11 ccccccceceeeeeeeeeeeeeeseeseeeseeeeeeseeeeseeeeeeeeeeees 23 Cleaning the Inner Surfaces of the Model 9560 csccccscccssssceesseceeseeeeseeeeaeceeaeeceeneesseeseaeceeaeeenaes 23 Manufacturer s Declaration cccccseeccsseseeeeeeeeeeeeeeeeneeeeeeeneeseeeeneesesennenseseeneeseseenenseseeneesasesnaesesesnensasesnenens 24 Testing SUMMARY Aidee Seca ac es fac ck cee at ae ah cae ay cca ra ct veda ed ec ee ese ee teased aa EEE a aE aaa 27 POs ACCULACY ToStNg issie eiee aee ee stee sete asra Ee EES E EET TER EAEE EESE EEE 27 Low Perfusion Testing sssrssesissp ipren soens aen ere aE ER OS r REE E PATETAS ERRER E 27 LINONIN NONIN Onyx II Model 9560 Bluetooth Fingertip Oximeter Technology Specifications Oxygen Saturation Range SpOz 0 to 100 2 Pulse Rate Range 18 to 321 beats per minute BPM 3 Measurement Wavelengths and Output Power Red 660 nanometers 0 8 mW maximum average I
32. of GPRF Bit 1 of Status Byte Status Byte Green high pulse signal 0 1 Yellow low marginal pulse signal 1 1 Red low no pulse signal 1 0 Byte 2 amp 3 PLETH BYTE These two bytes consist of a 16 bit plethsmographic waveform pulse waveform Range 0 to 65535 MSB LSB Byte 2 MSB Pulse Waveform Byte 3 LSB Pulse Waveform Pulse waveform value Byte 2 decimal value 256 Byte 3 decimal value 13 LINONIN Byte 4 FLOAT BYTE This byte is used for SpOz Pulse Rate and information that can be processed at a rate of 1 3 of second Range 00 to 127 SREV Oximeter Firmware Revision Level TMR 1 3 Second Timer LSB least significant 7 bits MSB most significant 7 bits STAT2 Status Byte 2 occurs 1 of 25 description given below Byte 4 STAT2 BIT7 BIT6 BITS BIT4 BIT3 BIT2 BIT1 BITO 0 SPA R R R LOW BAT LOW BAT 1 Low Batteries Replace batteries as soon as possible SPA 1 High quality SmartPoint Measurement R Reserved range 0 or 1 Formatted for Recording Purposes These values are formatted for recording purposes every 1 3 of second When the finger is removed from the device these values will immediately be formatted with the missing data value These values are retained for legacy purposes and are formatted with the missing data values during periods of sustained artifact HR 4 beat Pulse Rate Average E HR 8 beat Pulse Rate Extended Average SpOz 4 b
33. omer and or user of this device should ensure that it is used in such an environment RF Emissions This module uses RF energy only for its internal function CISPR 11 Group 1 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Giese Harmonic Emissions N A This module is suitable for use in all establishments including IEC 61000 3 2 domestic and those directly connected to the public low Voltage voltage power supply network that supplies buildings used for Fluctuations Flicker 1 9 domestic purposes Emissions IEC 61000 3 3 Table 2 Electromagnetic Immunity IEC 60601 Compliance Electromagnetic immunity Tesi Test Level Level Environment Guidance This module is intended for use in the electromagnetic environment specified below The customer and or user of this device should ensure that it is used in such an environment Electrostatic Floors should be wood concrete or ceramic tile If 6 kV contact 6 kV contact Discharge ESD 48 Kai 8 KV ai floors are covered with synthetic material the relative IEC 61000 4 2 ape ale ila humidity should be at least 30 Electrical Fast F TransientBurst N A NA oe IEC 61000 4 4 p Surge N A N A Mains power quality should be that of a typical IEC 61000 4 5 commercial or hospital environment Voltage dips short Mains power quality should be th
34. se signal 1 1 Red low no pulse signal 1 0 Byte 3 PLETH BYTE This byte consists of an 8 bit plethsmographic waveform pulse waveform The pulse oximeter infra red signal is filtered and then compressed into an 8 bit value The compression provides good detail for low to large pulse signals For uncompressed waveform refer to Data Format 7 Range 00 to 255 LINONIN Byte 4 FLOAT BYTE This byte is used for SpOz Pulse Rate and information that can be processed at a rate of 1 3 of second Range 00 to 127 SREV Oximeter Firmware Revision Level TMR 1 3 Second Timer LSB least significant 7 bits MSB most significant 7 bits STAT2 Status Byte 2 occurs 1 of 25 description given below Byte 4 STAT2 BIT6 BIT5 BIT4 BIT3 BIT2 BIT1 0 R SPA R R R R LOW BAT LOW BAT 1 Low Batteries Replace batteries as soon as possible SPA 1 High Quality SmartPoint Measurement R Reserved range 0 or 1 Formatted for Recording Purposes These values are formatted for recording purposes every 1 3 of second When the finger is removed from the device these values will be formatted with the missing data value These values are retained for legacy purposes and are formatted with the missing data values during periods of sustained artifact HR 4 beat Pulse Rate Average E HR 8 beat Pulse Rate Extended Average SpOz 4 beat SpOz2 Average E SpOz 8 beat SpO2 Extended Average SpO gt Fast 4 beat Average opt
35. te a e 17 Pulse Rate MSB See HR format below Hex 18 Pulse Rate LSB See HR format below Hex 19 00 to FF Reserved for future use Hex 20 SpO2 See SpO gt 2 format below Hex 22 03 LINONIN Data Format 13 Data Packet Description continued Status MSB BIT7 BIT6 BITS BiIT4 BIT3 BIT2 BITI BITO R R R R R R SPA NOMS Status LSB BIT7 Bite BIT5S BIT4 BIT3 BIT2 BIT1 BITO R R R MEM R R R LOW BAT The following are all active high SPA SmartPoint High Quality SmartPoint Measurement Algorithm NOMS No Measurement No measurement for SpOz or Pulse Rate MEM From Memory Stored measurement from memory LOW BAT Low Battery Low Batteries Replace batteries as soon as possible condition R Reserved Reserved for future use 16 Bit HR Format 7 6 5 4 3 2 1 0 HRMSB R R R R R R R HRB 7 6 5 4 3 2 1 0 HRLSB HR7 HRe HRS HR4 HR3 HR2 HRI HRO 8 Bit SpO Format 7 6 5 4 3 2 SpO R_ spe sP5 sP4 SP3 SP2 SP1 SPO When SpOz and HR cannot be computed the system will send a missing data indicator For missing data the HR equals 511 and the SpOz equals 127 The missing data could be result of these conditions 1 Device is positioned improperly on finger 2 Device was removed from the finger prior to a reading 3 Signal at the finger is not discernable warm the hand
36. ulation Type Band Width Bluetooth Profiles Supported Antenna Type Antenna Gain Version 2 0 2 4 to 2 4835 GHz lt 20dBm 100 meter radius indoors Point to Point Slave Model 9560 L shaped PWB whip type antenna Frequency Shift Keying Frequency Hopping Spread Spectrum 1 MHz Serial Port Profile Inverted F type antenna 2 dB typ 3 dB max 14 Dimensions 3 23cm x 6 40cm x 3 78cm W x H x D 15 Ruggedness Shock IEC 60068 2 27 Vibration Sinusoidal IEC 60068 2 6 Random IEC 60068 2 64 IEC 60068 2 36 Bump IEC 60068 2 29 17 Warranty Two years from the date of purchase Line of sight when connected to a class 1 device LINONIN Input Output Formatting Options Data Format Solutions The 9560 features four data format solutions They are e Data format 13 provides easy spot check measurements with the storage and forwarding of measurements e Data format 8 provides real time oximetry measurements every second e Data format 2 provides real time oximetry measurements with compressed waveform 8 bit waveform every 1 75 of a second e Data format 7 provides real time oximetry measurements with full resolution waveform 16 bit waveform every 1 75 of a second For greater detail see the appropriate data format section in this document Communications Interface Using Bluetooth communications terms the 9560 oximeter is a slave device To connect the 9560 oximet
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