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1. 81 Oximetry Overview 81 Functional versus Fractional Saturation 82 Measured versus Calculated 82 OXIMAX Technology 83 ii OxIMAx N 65 Service Manual Contents Block Diagram Theory 84 SpO2 Printed Circuit Board 85 Patient Interface 85 Power Supply eed ea hua add OE dear do 85 Power Monitoring 85 User Interface Printed Circuit Board 85 Keypad Cp 86 Backlight EE EEE EEE rds dde EEE VEE isis 86 CPU and Flash 86 Real Time 86 PME ae Sikre eee ee 86 LCD eg Ar aa aasawa EE aka C c ee CR 87 FDA EA Goes 87 Power Supply 0 1 87 Power Supply Monitoring 87 ir RES EN EE 109 OxIMAx N 65 Service Manual Contents Blank Page N 65 Service Manual Introduction Warnings
2. S 22 General Operation 26 Operation with a Live 26 Pulse Oximetry Functional Tests 28 Test SUID r Lidal seer STR GE a B aca a hop duett 31 Tes BPM EEE 32 TESt 2 SPOZ site uri y pumas a oe AE VE 33 Test 3 Modulation Level 34 N 65 Service Manual Contents Test 4 Light Level acus ea Wed cede RRS REO Re 36 cou NI ARR TERT 37 Troubleshooting 39 Introduction RR cnr 39 How To Use This Section 39 Who Should Perform Repairs 39 Troubleshooting Guide 39 Error Codes C 42 Disassembly Guide 47 Introduction narr 47 Tools Required 47 Replacement Level Supported 47 Prior to 5 lt 48 Separating the Front and Back Cases
3. 8 Rear Panel Symbols 8 Label Symbols RE SE 9 Menu Parameters 10 Set Menu Parameters 11 Set Time Date Parameters 12 Related Documents 14 Routine Maintenance 15 TT EROR Add ene RE Rew eee ke Ene Rees 15 Periodic Safety lt 15 Functional Checks duke bare Saeed ead RENERE a Wie Es 15 Battery Installation b se bek eee ske pe karse dd 16 Performance Verification 17 sa sa p uz D u has ERE ORE hab as oan eRe bene PEODRAS 17 Equipment Needed 17 Performance Tests 17 Power On Self Test 17 DISCUSSION AE EV b iB aca q ls 17 Procedur EE 18 Operational 22 Setting the Time and Date 22 DISCUSSION PENE quad a aut 22 PIOGSQUIO
4. E n Action Explanation 585 Q 24 24 539 1 2 I Restart the monitor Erroneous key press detected at start 2 Replace membrane switch pad 540 x Replace UI board Fatal system error reading memory 541 X Return monitor for repair Fatal software error 542 1 2 1 Replace UI board RAM corruption detected during 2 Return monitor for repair background check 543 X Set time and date Invalid time Cannot snapshot 544 X Replace UI board Invalid register value 545 X Replace SpO2 board SpO2 board in unexpected state 546 X Replace UI board IrDA failure 997 X Replace UI board RAM error 998 X Replace UI board Spurious Interrupt 999 X Replace UI board Watchdog protection activated OxIMAx N 65 Service Manual Disassembly Guide Introduction Tools Required The N 65 be disassembled into all major component parts including Front case with front panel keypad Rear bottom User Interface PCB SpO2 PCB Battery compartment door Note Some spare parts have a business reply card attached Please fill out and return the business reply card Caution Observe ESD electrostatic discharge precautions when disassembling and reassembling the monitor and when handling any components of it The tools required to disassemble and reassemble the monitor are Number one medium Phillips screwdriver Torque driver four inch pounds 10 cm kg
5. VIN 1 69 RUN 10UH 47 cg 4 DIGICAL OUT 1 2 awn 625 SYNC bas m 10U 10U 6 5KHz 5y D SYNC 768K 22 10V 4v 4 DIGICAL_PGM gt PIC CLKY gt 100 8 LPF ITH v79 GND 407 0 01U 1878 R53 a 280K 173 WA Board Edge Test Points C65 C60 R61 220P T101 T105 T103 T107 0 10 L 10 0K x 125 N 65 1 RXD5V RXDSV T109 T113 T115 T117 T119 s o EE T102 T104 1106 T108 7110 T127 111 T112 7114 7116 1118 Technical Discussion 5ANALOG PIC RXSV 6 TLC3702C 3V to SV LEVEL C50 SHIFTERS sizes IXDSV rxpsv 1 TLC3702C 12 5 AN R69 4 99K Q 6 RP13 AN NJ MBT3906DW RAP Q8B Q8A rd MBT3906DW s 47K gt gt DIGICAL 6 D7 T66 RP21 4 4 AAN AA Ta BAT54SWT1 T67 Q9B MBT3904DW TOK NY Notes Resistors are 1 1 16W unless otherwise noted R Packs are 5 1 32W unless otherwise noted CB junction of Q8B is used as a diode Figure 33 SpO2 Schematic Diagram Sheet 7 of 7 101 Blank Page N 65 VON C27 0 1uF 4 1 Z gt 1V21B 2 8 C10 w 1V8 C67 C9 2 0 1uF C68 0 1uF T21 Internal 1 on PBRST Open Drain Outputs U2 DS1832S R1 5 11K 3V0 U19 WD STB 2 RAGS SK UC RSTN2 VCHK OK 2 TOL 5 2 GOOD 2 J1 PB
6. J 100R 66 2 LCD 2 LCD 10uF 5 D MUX26 60 28 MUX27 61 SEG21 58 MUXZI 7 SEG28 30 MUX29 63 I 31 MUX39 64 C56 1 ohm 18 1 8w T26 0 1uF T29 R57 C55 10K 0 1uF SEG30 SEG gg es 9 9 30 segaz ures ee a Q RESET 8 SEG33 A gt an MUX34 88 38 2 IR BRD7 CS BRD SEG34 EI 2 IR RX H RD 232 40 2 IR TX gt TD 232 SEG37 48 RH S J8 X 4 x LCD_CONN R58 100k 4 T41 T40 T38 T36 T37 55541144 T39 T14 R59 C57 71 5K 470pF J u13 TFDU4100 U14 TOIM4232 96864MH C58 C59 N SEGA lag 22pF 22pF lt gt gt gt LCD1 TEST 1 comi 83 gt LCD1_COM1 1 HS LCD1 COM2 T32 T34 12 0 131 J9 Backlight U T Y4 Audio Transducer 16 LE2021 SO0R 10K 2 BK_LIGHT gt c70 C71 BZ SDAT 22pF 22pF BZ SCLK NNN BZ CSN 3 41050 1 5 C64 Figure 36 User Interface PCB INSTALL Schematic Diagram Sheet 3 of 3 107 Blank Page Index Symbols SpO2 high limit 11 SpO2 low limit 11 A accessories on internet 14 accuracy 69 alarm volume 11 arterial dyes 17 audible indicator 70 B battery compartment door replacement 59 battery installation 16 block diagram theory 84 bpm high limit 11 bpm low limit 11 business reply card 47 C calculated saturation 82
7. 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 at 100 g Alarm requirements EN 60601 1 8 Pulse oximeters EN 865 and ISO 9919 with Transport Boot Part number 10007434 Operation during vibration IEC 60068 2 6 and IEC 60068 2 34 Radiated and conducted emissions EN 55011 Group 1 Class B Manufacturer s Declaration A OxIMAx N 65 Service Manual WARNING The use of accessories sensors and cables other than those specified may result in increased emission and or create invalid readings of the OXIMAX N 65 75 Specifications 76 The N 65 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the monitor can help prevent electromagnetic interference by maintaining minimum distance between portable and mobile RF communications equipment transmitters and the monitor as recommended below according to the maximum output of the communications equipment Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the N 65 IEC 60601 1 2 Frequency of 150 kHz to 80 MHz to 800 MHz to Transmitter 80 MHz 800 MHz 2 5 GHz Equation 35 35 PIA E y x EP 4 Rated Maxi
8. Note The longer screws install at the top of the case See Figure 12 AY items and 4 8 Align the front and rear cases See Figure 12 Figure 12 Installing The Case Screws 9 Install the four screws Figure 12 items 1 through 4 10 Install the batteries and battery cover See Figure 13 1 Batteries 2 Battery cover 3 Battery cover latch Figure 13 Battery Installation OxIMAx N 65 Service Manual 53 Disassembly Guide 11 Perform the performance verification tests before placing the monitor into service See Pulse Oximetry Functional Tests on page 28 Front Case Assembly Replacement The front case assembly contains the keypad To replace the front case assembly 1 Remove the batteries from the monitor See Prior to Disassembly on page 48 2 Separate the front and rear case assemblies See Separating the Front and Back Cases on page 48 3 Dispose of the front case assembly in accordance with local regulations 4 Connect the new front case assembly ribbon cable to the SpO2 PCB connector J4 See Figure 14 Figure 14 Front Case Ribbon Cable Connection 54 N 65 Service Manual Disassembly Guide 5 Lock the ribbon cable connector See Figure 15 1 2 3 2 1 SpO2 2 J4 lock 3 Lock direction 4 Unlock direction Figure 15 Locking SpOz PCB Connection to J4 6 Place the front and rear cases together and insta
9. 48 SpO2 PCB or User Interface PCB Replacement 50 Front Case Assembly Replacement 54 Rear Case Assembly Replacement 57 Battery Compartment Door 59 Spare oe tees bacs 61 2226 Are agere 1 Sa ee 61 Obtaining Replacement 61 Parts List and Accessories 61 Packing Tor Shipment 65 Introduction s u eee eee 65 Returning the 65 Repacking in Original Carton 65 Packing in a Different Carton 67 Specifications 69 PertormarCce uuu ske kva uba kede Ge ed adi aoe Ge osa 69 aeg TE 73 Environmental 74 Physical Characteristics 75 Compliance TGN 75 Manufacturer s Declaration 75 Technical
10. Replacement Level Supported The replacement level supported for the monitor is at the printed circuit board PCB and major subassembly level When a PCB problem is identified follow the procedures in Disassembly Guide on page 47 to replace the PCB Check to ensure the symptom disappears and that the monitor passes all performance tests If the symptom persists swap the replacement PCB with the malfunctioning PCB the original PCB that was installed when you started troubleshooting and continue troubleshooting OxIMAx N 65 Service Manual 47 Disassembly Guide Prior to Disassembly The monitor batteries must be removed prior to disassembly To remove the batteries Press the Power button to turn the monitor off Remove the battery cover Pull the battery cover latch downward toward the bottom of the monitor case and lift the battery cover See Figure 4 item 1 Remove the batteries 1 Batteries 2 Battery cover 3 Battery cover latch Figure 4 Removing Batteries Separating the Front and Back Cases To separate the monitor front and back cases 1 48 Do the procedure in paragraph Prior to Disassembly on page 48 N 65 Service Manual Disassembly Guide 2 Remove the four screws holding the monitor front and rear cases together See Figure 5 items 1 through 4 Figure 5 Monitor Case Screws assemblies Use care when separating the cases Do not appl
11. 2 sec Priority 6 Pulse Beep Volume level Adjustable 42 to 52 dB A at one meter Pitch 30 Hz 1500 Hz On pulse width 50 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause N A 2 sec Priority 7 Alarm Silence Reminder OxIMAx N 65 Service Manual Volume level Adjustable 42 to 52 dB A at one meter Pitch 30 Hz 500 Hz On pulse width 130 msec 20 msec Off Interval 20 msec 130 msec Number of pulses in burst 3 Repetition Pause 179 27 sec 2 sec Priority 8 71 Specifications 72 Audible Indicators Continued Audible Val Indicator Parameter ue High Priority Volume level Adjustable 42 to 52 Alarm dB A at one meter Pitch 30 Hz 1200 Hz On pulse width 250 msec 20 msec Off Interval 20 msec 80 msec Number of pulses in burst 1 Repetition Pause 0 sec 2 sec Priority 9 Medium Priority Volume level Adjustable 42 to 52 Alarm dB A at one meter Pitch 230 Hz 752 Hz On pulse width 400 msec 20 msec Off Interval 20 msec 300 msec Number of pulses in burst 1 Repetition Pause 0 sec 2 sec Priority 10 Low priority Alarm Volume level Adjustable 42 to 52 dB A at one meter Pitch 30 Hz 500 Hz On pulse width 400 msec 20 mse
12. Return the monitor by any shipping method that provides proof of delivery Repacking in Original Carton If available use the original carton and packing materials See Figure 24 Pack the monitor as follows OxIMAx N 65 Service Manual 65 Packing for Shipment To repackage the monitor in the original carton 1 Place the monitor in original packaging Figure 24 Packing 2 Place in shipping carton and seal carton with packing tape 3 Label carton with shipping address return address and RGA number 66 OxIMAx N 65 Service Manual Packing for Shipment Packing in Different Carton If the original carton is not available repackage the monitor in a different carton To repackage the monitor in a different carton 1 Place the monitor in a plastic bag 2 Locate a corrugated cardboard shipping carton with a bursting strength of at least 200 pounds per square inch psi 3 Fill the bottom of the carton with at least two inches of packing material 4 Place the bagged unit on the layer of packing material and fill the box completely with packing material 5 Seal the carton with packing tape 6 Label the carton with the shipping address return address and RGA number OxIMAx N 65 Service Manual 67 Packing for Shipment 68 Blank Page OxIMAx N 65 Service Manual Specifications Performance Measurement Range SpO2 196 to 100 Pulse Rate 20 beats per minute bpm to 250 bpm Per
13. oxygenated hemoglobin expressed as percentage of the hemoglobin that can transport oxygen It does not detect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin In contrast hemoximeters such as the 482 report fractional saturation oxygenated hemoglobin expressed as percentage of all measured hemoglobin including measured dysfunctional hemoglobins To compare functional saturation measurements to those from an instrument that measures fractional saturation fractional measurements must be converted as follows fractional saturation functional saturation e FT O lt x100 100 carboxyhemoglobin methemoglobin Measured versus Calculated Saturation 82 When saturation is calculated from a blood gas partial pressure of oxygen PO2 the calculated value may differ from the SpO2 measurement of a pulse oximeter This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO2 and pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin See Figure 25 t pH Temperature 2 ot 2 3 DPG d 1 Fetal Hb fm 100 d t 2 3 DPG 5 pH t Temperature 537 t 2 5 6 o 50 100 PO mmHg Figure 25 Oxyhemoglobin Dissociation Curve N 65 Service Manu
14. DLW31SN222SQ2B gt gt DET 5 Sensor el T97 D5 C43 Cable LED 47P C44 T62 a C BAV99LT1 ZIR s E U12 D4 5ANALOG 5 TPS77025 PERDER 10 N BAV99LT1 x gt 16 C29 0 01U N 65 Technical Discission P gt 5ANALOG BAT54SWT1 gt gt PIC_RED_IR5V 7 PIC_RA1 PIC RAO an PIC_RB3 3 C PIC_RB4 RB5 12 PIC_RB5 gn oe RBS RB7 PIC_RB7 PIC RB1 PIC RB2 1 a PIC RCO gt gt PIC_RC3 m PIC TX5V 7 PIC RX5V 7 PIC RD6 5 RD7 5 PIC RE1 5 PIC REO 5 PIC CLK 7 5ANALOG R11 n 20 0K Notes Resistors are 1 1 16W unless otherwise noted Q2 R Packs are 596 1 32W unless otherwise noted MMBF2201 Figure 32 SpO2 PCB Schematic Diagram Sheet 6 of 7 99 Blank Page SPO2 Side 12 5DIG 5ANALOG T950 O T91 L5 L6 SV to LEVEL SHIFTER 2512063017Y0 2512063017Y0 T93 RP17 100 U18 gt gt RXD3V 4 6 PIC_TX5V gt y gt gt PIC TX3V 4 6 PIC RED IRSV NEU DIGICAL IN5V PIC RED IR3V 4 de PIC SYNCSV 7 PIC RED 5VDIG lt gt gt DIGICAL_IN3V 4 5VANALOG lt lt gt gt gt PIC_SYNC3V 4 2 74LVC244APW 3 C45 4 gt gt RST L5V 4 0 1U g 5 6 7 N 8 re 9 10 11 T92 1794 T130 HEADER 7X2 DO NOT INSTALL gt 1124 T98 DIGICAL INSV 5DIG MAIN BOARD A SIDE P S SIDE ces 3V Voltage T2 3V 2 994V 5DIG 10U 100 U21 L4 9 0 105v U20 10v_ 10V
15. On pulse width 500 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause N A 2 sec Priority 1 Beep Volume Volume level Adjustable 42 to 52 setting dB A at one meter Pitch 30 Hz 1500 Hz On pulse width 500 msec 20 msec Off Interval 420 msec 10 msec Number of pulses in burst 1 Repetition Pause N A 2 sec Priority 2 POST Pass Volume level Fixed at 45 dB A at one meter Pitch 30 Hz 600 Hz On pulse width 1000 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause N A 2 sec Priority 3 Invalid Key Press Volume level Fixed at 45 dB A at one meter Pitch 30 Hz 200 Hz On pulse width 50 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause N A 2 sec Priority 4 70 N 65 Service Manual Audible Indicators Continued Specifications audible Parameter Value Indicator Confirmation Volume level Fixed at 45 dB A at one meter Pitch 30 Hz 700 Hz On pulse width 130 msec 20 msec Off Interval 20 msec 130 msec Number of pulses in burst 3 Repetition Pause N A 2 sec Priority 5 Valid Key Press Volume level Fixed at 45 dB A at one meter Pitch 30 Hz 800 Hz On pulse width 10 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause N A
16. P26 NCS2 i oy NCSS 3V Reset Trip Point 2 780V 0 078V R43 __NRD NOE_ 178K NWRO NWE T76 2 NWR1 NUB R44 NWAIT P24 BMS U23 100K s lt 5V Reset Trip Point R72 4 599V 0 120V NRST 155 15 0K NWDOVF O R73 30 9K BAT54SWT1 x P25 MCLKO L gt 5DIG LTC1728 5 Y2 T82 pn 3 our en LI D6 0 10 2 vec 4 3V A B 32 000MHZ TDI 5 JTAG TEST PORT C61 gt 3V 3 NOT POPULATED 0 01U 4 DURING Notes VY 5 PRODUCTION Resistors are 1 1 16W unless otherwise noted s Packs 5 1 32W unless otherwise noted IVA N 65 L5V 1 7 Figure 30 SpO2 Schematic Diagram Sheet 4 of 7 95 Blank Page 5 R4 1 00M 5 A 2 5 5 R6 010 40530 A 140K MAX970Q MAX970Q 6 PIC RB2 Y 5 14 42 5 NZ Fi 6 PIC Ros YHH NG R10 24 9K 5 I OT32 T21 U1D O T1 R17 MAX970Q 24 9K 49 9K 2 5 x C11 470P 2 5 6 A T25 T27 R19 D R21 R22 1 OQ 25 100 24 9K 126 24 9K T125 25 C12 C73 5 0 1U 470P 6 PIC_RD7 6 PIC_RD6 6 PIC_RB3 TLC2262PW 2 5 R40 10 0K To PIC RC3 6 PIC RB1 6 PIC RB26 C24 C25 10U 0 01U 0 01U 10V 32 5 5 C46 U13 10U 10V T46 PIC 6 LMC7211BIM5 MAX4053Q N N 65 RP11 47K 3 PIC RB56 PIC 46 T28 TLC2262PW 1312 N MAX4053Q V C17 c19 R39 lt R41 22P 0 022U 15 0K LED IDRV6 R29 1
17. 1 P9 IRQO E m i Bg U20 3 LCD GQ p12 F1a 752125 50 23 3 LED DAT rag ON 3 BZ SDAT a P13 SCKO FEN BB bi4 TXDO Ds 2 99 lt gt 1SQw_OUT gt 3 IR RX gt 69 p 5 RXDO D6 SAN 1SPO2V GOOD P20 SCK1 EN ilu 4 D 8585 23 NE 2 90 XB rss p OUT EN P25 MCLKq BI KKEYPD1 1 9 GND VCC 11 0592MHz T10 1 UC RSTN gt C43 lt gt 0 1uF JTAG TEST PORT NOT POPULATED DURING PRODUCTION For Pins 10A and 4240 only A RP10 C45 C46 CONN ASY DSUB P P 9 4 0M 0 1uF 0 1uF 30K Z J5 a 1 KEYPD7 K SPO2 RSTN HANN 1 x lt VCMP 1 1 VSDIG T20 1 PWR ON PWR_OFF 1 VCHK_OK lt PA gt VON 24 23 C47 C48 4 7uF 0 1uF Mfg Test gt Figure 35 User Interface PCB Schematic Diagram Sheet 2 of 3 105 Blank Page N 65 141143 3V0 42 NJU6432BF 1 1LCD1 COM1 MUXDI SS LCD1 COM2 C53 Technical Discussion Q2 T22 T23 IRLML6401 9 R53 9 47 5 onm 1 8w 47uF gt C54 10v 0 1uF R78 294K 7 MUXOZ 41111 muxog 42 IM EGB MUX09 43 743 SEG9 1 MUXiO dd SEG10 MUX11 45 15 49 muxi2 46 C C i 2 PWR_IRDAN 5j SEG1275 MUX13 47 7 R75 SEG13 44
18. 2003 to 2099 Q 13 Introduction 14 Related Documents To perform test and troubleshooting procedures and to understand the principles of operation and circuit analysis sections of this manual you must know how to operate the N 65 Refer to the OxIMAX N 65 Operator s Manual To understand the various Nellcor approved OxiMAx sensors that work with the monitor refer to the individual Ox1Max sensor s Directions For Use The latest version of the operator s manual and the service manual are posted on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html Spare Parts and Accessories are posted on the Internet at http www mallinckrodt com respiratory resp Serv_Supp Apartweb main PartAcceMenu html OxIMAx N 65 Service Manual Routine Maintenance Cleaning WARNING Do not spray pour or spill any liquid on the OxIMAX N 65 its accessories connectors switches or openings in the enclosure as this may damage the monitor For surface cleaning and disinfecting follow your institution s procedures or The OXIMAX N 65 may be surface cleaned by using a soft cloth dampened with either commercial nonabrasive cleaner or solution of 70 percent alcohol in water and lightly wiping the surfaces of the monitor The monitor may be disinfected using a soft cloth saturated with a ten percent solution of chlorine bleach in tap water Before cleaning an SpO
19. 24 hour format Successful completion of POST is announced by a POST pass tone A failed POST is announced by a high priority alarm tone Procedure To run POST 1 Press the Power button to turn on the monitor 2 Note Do not have a sensor connected to the monitor The backlight remains on during POST All display numbers and icons are shown for three seconds The backlight is turned on SpO2 min 18 N 65 Service Manual Performance Verification 2 The display goes blank for one second SpO2 Q min AA o o 0 3 The software version number displays The software version is identified by two dashes in the SpO2 area of the display the software version installed Write down the software version number 2 Note The software version 001 is an example Check the monitor for and have it available prior to requests for technical assistance 4 The current time displays in a 24 hour format OxIMAx N 65 Service Manual 19 Performance Verification Note If the time has never been set do not continue until you set the BY time See Operator 5 Manual SpO2 Q min 13 4S o 0 5 Ifthe monitor detects a problem an error tone sounds and an error code Er and the error number display See Troubleshooting on page 39 SpO2 Q min Er 123 6 Upon successful completion of POST the monitor sounds a one second tone to indicate it has
20. 52 5 mW Oxiband OXI A N 52 5 mW OxIMAx N 65 Service Manual 73 Specifications Environmental Conditions Operation Temperature 5 C to 40 C 41 F to 104 F Altitude 390 m to 3 012 m 1 254 ft to 9 882 ft Atmospheric Pressure 70 kPa to 106 kPa 20 6 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Transport and Storage not in shipping container Temperature 20 C to 60 C 4 F to 140 F Altitude 390 m to 5 574 m 1 280 ft to 18 288 ft Atmospheric Pressure 50 kPa to 106 kPa 14 7 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Transport and Storage in shipping container Temperature 20 C to 70 C 4 F to 158 F Altitude 390 m to 5 574 m 1 280 ft to 18 288 ft Atmospheric Pressure 50 kPa to 106 kPa 14 7 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing 74 OxIMAx N 65 Service Manual Physical Characteristics Compliance Specifications Weight 0 62 Ibs 0 28 kg Dimensions 2 875 in x 6 25 in x 1 375 in 7 3 cm x 15 9 cm x 3 5 cm Item Compliant With Equipment classification Safety Standards EN 60601 1 1990 1 A2 EN 60601 1 2 2001 UL 60601 1 CAN CSA C22 2 No 601 1 Type of protection Internally powered equipment on battery power Degree of protection Type BF Applied part Mode of operation Continuous
21. OxIMAx N 65 Service Manual PP PP PP P Warnings are identified by the WARNING symbol shown above Warnings alert the user to potential serious outcomes death injury or adverse events to the patient or user WARNING The sensor uses the date and time provided by the N 65 handheld pulse oximeter when the sensor event record is recorded by the sensor The accuracy of the date time is dependent on the date time already set in and provided by the monitor WARNING Explosion hazard Do not use the OxIMAX N 65 in the presence of flammable anesthetics mixed with air oxygen or nitrous oxide WARNING Do not spray pour or spill any liquid on the OXIMAX N 65 its accessories connectors switches or openings in the enclosure as this may damage the monitor WARNING Chemicals from broken LCD display panel are toxic when ingested Use caution when the OX1MAX N 65 has a broken display panel WARNING The use of accessories sensors and cables other than those specified may result in increased emission and or create invalid readings of the OXIMAX N 65 WARNING Do not silence the OxIMAX N 65 audible alarm or decrease its volume if patient safety could be compromised WARNING To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient Introduction Cautions Notes 99 WARNING As with all medical equipment carefully route patient cabling to red
22. Q 24 24 257 X Replace SpO2 board SpO2 back end reports packet start ID SID missing 258 X Replace SpO2 board SpO2 back end reports packet length error 259 X Replace SpO2 board SpO2 back end reports message length error 260 X Replace SpO2 board SpO2 back end reports packet contains unsupported key 261 X Replace SpO2 board SpO2 back end reports packet CRC error 262 X Replace SpO2 board SpO2 back end reports end of packet missing 263 X Replace SpO2 board SpO2 back end reports packet contains unidentified key 264 X Replace SpO2 board SpO2 back end reports corrupted variable 265 X Replace SpO2 board SpO2 back end reports memory overflow 266 X Replace SpO2 board SpO2 back end reports bad pointer 267 X Replace SpO2 board SpO2 back end reports parameter value out of range 268 X Replace SpO2 board SpO2 back end reports reset detected 269 X Replace SpO2 board SpO2 back end reports unexpected value 270 X Replace SpO2 board SpO2 back end reports time out 271 X Replace SpO2 board SpO2 back end reports not ready not initialized 272 Replace SpO2 board SpO2 back end reports double fault 273 1 2 3 Restart the monitor SpO2 back end reports date out of 2 Set the time and date range error 3 Replace UI board 274 X Return monitor for SpO2 back end reports incompatible reprogramming software version 275 X Check replace sensor SpO2 back end reports incorrect extension cable registration number 276 X Replace
23. sensor The accuracy of the date time used for patient alarm events depends on the date time set in the monitor Note When the monitor times out in 30 seconds the parameter is set and the monitor display returns to the normal operation Normal operation means the monitor is turned on e a sensor is connected to the monitor sensor is applied to the patient the patient s SpO2 oxygen saturation percentage and pulse rate readings BPM are being reported e no error conditions exist Procedure To set the time and date 1 With the monitor in normal operation press the Power button to turn the monitor off 2 Press the Power button to turn the monitor on N 65 Service Manual Performance Verification 3 Press the Menu button during the POST operation until the set hours window appears with the hours indication 13 flashing SpO2 min 4 Pressthe Up Arrow button or the Down Arrow button until the desired hours appear 5 Press the Menu button to set the hours and show the minutes set display The minutes indication 45 flashes SpO2 74 Press the Arrow button or the Down Arrow button until the desired minutes appear Q Q OxIMAx N 65 Service Manual 23 Performance Verification 7 Press the Menu button to set the minutes and show the day set display The day indication 29 flashes SpOz Q min 8 Press the Up Arrow button or the Dow
24. with OXIMAX sensor SpO2 back end reports sensor read extension cable failure 2T X Check replace sensor SpO2 back end reports sensor extension cable signature verification fails 280 X Check replace sensor SpO2 back end reports does not extension cable support feature required by sensor 281 X Check replace sensor SpO2 back end reports overflow extension cable underflow 282 X Check replace sensor SpO2 back end reports sensor extension cable activation failure OxIMAx N 65 Service Manual Scope of Action Troubleshooting Table 5 Error Codes Continued 2 E n Action Explanation a O 512 X Replace UI board Communication failure with real time clock 513 X Replace UI board Real time clock oscillator control problem 514 X Replace UI board Real time clock failed timing test 515 X Replace UI board LCD failed feedback test 516 X Replace UI board LCD failed feedback test 518 X Return monitor for repair Various system faults 519 X Return monitor for repair Unrecoverable software error 520 X Replace UI board Unrecoverable error verify real time clock 521 X Replace batteries Battery power is critically low 522 X Replace batteries System power levels unacceptable for continued operation 523 1 2 3 Restart the monitor NVRAM failed consistency check 2 Set the time and date 3 Replace UI boar
25. 11 Introduction WARNING Do not silence the N 65 audible alarm or decrease its volume if patient safety could be compromised Set Time Date Parameters To access the Time Date settings menu press the Menu button during start up Power On Self Test POST Press the Menu button repeatedly to display the time date parameters to set Use the Up Arrow button and Down Arrow button to adjust time date settings Press the Menu button to return to the POST display When the month entry is made the monitor checks the day selection to see if it is valid If the day selection is not valid for the month selected the menu display returns to the day selection display When the year entry is made the monitor checks the day and month selections to see if they are valid If the day or month selection is not valid for the year selected the menu display returns to the day selection display Examples of invalid dates are 30 February 31 February 31 April 31 June 31 September 31 November 29 February on non leap year 12 N 65 Service Manual OxIMAx N 65 Service Manual Introduction Table 2 Time Set Menu of Presses Parameter Press Function The Menu button must be pressed during the POST 1 Hour Adjust I to 23 Q 2 Minute Adjust I to 59 Q 3 Adjust 1 to 31 Q 4 Month Adjust I to 12 Q 5 Year Adjust
26. 2 OxIMAx sensor read the Directions For Use enclosed with the OxiMAx sensor Each sensor model has cleaning instructions specific to that sensor Periodic Safety Checks The N 65 does not require calibration A qualified service technician should perform the following safety checks every 24 months To perform periodic safety checks 1 Inspect the equipment for mechanical and functional damage 2 Inspect safety labels for legibility If the labels are damaged contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative Functional Checks If the monitor has been visibly damaged or subjected to mechanical shock for example if dropped immediately perform the performance tests See Performance Tests on page 17 Every two years a qualified service technician should perform the electrical safety tests detailed in Safety Tests on page 37 If the unit fails these electrical safety tests refer to Troubleshooting on page 39 OxIMAx N 65 Service Manual 15 Routine Maintenance Battery Installation Caution The monitor does not operate with dead batteries Install new batteries To install new batteries 1 Press the Power button to turn the monitor off 2 Pull the battery compartment latch downward toward the bottom of the monitor and remove the battery access door See Figure 1 3 Install four size batteries orientated as shown in Figure 1 4 Repl
27. 50 T29 Q R34 249K Technical Discussion 2 5 T17 5 Q A 0 022U R7 175 c 2 5 2 5 A U25A LT1013S ce R1 220P 95 3K 9723 R2 T14 c2 712 O O O O RP25 47K 49 9K 0 01U 0 01U 5 R3 5 A 5ANALOG U3A NI 100K U3B MAX4066 S TLC2262PW x C5 c6 2 5 TLC3702C 0 047U 0 047U PIC RAO 6 N 5 2 5 U6 T7 MAX4066S Q PIC RA1 6 2 5 2 5 C23 20P R78 499K 740 T30 c14 T34 T35 C16 136 R28 O O RP23 PIC RE1 6 49 9K 47K 5 A 5 R33 5ANALOG U11A A U11B 100K TLC2262PW x 2 5 TLC3702C A q V4 U25B LT1013S Notes 1126 j Resistors are 1 1 16W unless otherwise noted R Packs are 5 1 32W unless otherwise noted 30 1K U4A gt gt PIC RB7 6 u U4B ae gt gt PIC RB6 6 Figure 31 SpO2 PCB Schematic Diagram Sheet 5 of 7 97 Blank Page 5ANALOG RP24 Ei 47K SENSOR DISCONNECT T121 R51 PIC RA2 0 O U14B LT1013S WY R75 58 475 R R54 Q 153 200 5ANALOG 5ANALOG Q6 5 065 T58 O 5 LED_IDRV amp R66 10 T84 T856 x Y1 10 000MHZ 100 T86 D3A O Q 7 DIGICALY 41206ESD D3B C41 C40 33P 33P Q7A MBT3904DW 41206ESD D3C 41206ESDV T61 T96 9 E L1 2512063017Y0 R94 511 3 DET 5 2 12 2512063017Y0 yet C42 4 PIC n 4 Sa R95 511 PI sL 4
28. 8 Figure 8 User Interface PCB and SpO2 PCB Removal Caution Do not force the User Interface PCB and SpO2 PCB apart This may damage the boards To separate the User Interface PCB from the SpO2 PCB grasp the User Interface PCB in one hand and the SpO2 PCB in the other Rotate the ends of the two PCBs as shown in Figure 9 until the two PCBs separate at the connection points Gently work the boards apart 4 Separate the User Interface PCB from the SpO2 PCB See the Caution above and Figure 9 as follows 1 Left Connection J8 on SpO2 J4 on User Interface 2 User Interface PCB 3 Right Connection 11 on SpO2 J5 on User Interface 4 SpO2 PCB Figure 9 Separating the User Interface PCB SpO2 PCB OxIMAx N 65 Service Manual 51 Disassembly Guide 5 Place the defective PCB to the side 6 Align the replacement PCB with the other PCB at the connectors When both rows of the connectors are aligned gently press the PCBs together See Figure 10 1 Left Connection 78 on SpO2 14 on User Interface 2 User Interface PCB 3 Right Connection 71 on SpO2 JS on User Interface 4 SpO2 PCB Figure 10 Connecting PCBs 7 Install the User Interface PCB and SpO2 PCB into the monitor case Ensure that the battery springs are aligned properly in their slots See Figure 11 Figure 11 Battery Spring Alignment 52 OxiMAX N 65 Service Manual Disassembly Guide
29. AX N 65 Operator s low for the monitor to operate Manual and the SpO2 PCB is damaged or not remove and reinsert the flex cable The flex circuit between the front panel 0 Caution Unlock J4 before attempting to making good connection Inspect the flex cable for damage Inspect the connection to J4 If there is damage to the flex cable replace the front case Otherwise remove the cable from J4 and reconnect it Reassemble the monitor and retest Refer to Separating the Front and Back Cases on page 48 and Front Case Assembly Replacement on page 54 remove the flex circuit cable The front panel keypad is defective 0 Caution Unlock J4 before attempting to Replace the Front Case Refer to Front Case Assembly Replacement on page 54 OxIMAx N 65 Service Manual Troubleshooting Table 4 Troubleshooting Guide Continued Condition Recommended Action Replacing the front case does not fix the problem Replace the 2 PCB See SpO2 PCB or User Interface PCB Replacement on page 50 Replacing the SpO2 PCB does not fix the problem Replace the User Interface PCB See SpO2 PCB or User Interface PCB Replacement on page 50 If this does not fix the problem return the monitor to Nellcor One or more keys on the front panel keypad does not work The flex circuit between the front panel and the SpO2 PCB is damaged or not making a good connection Caution Unlock J4 before
30. RLML6401 4 7U SMCJ7 0C 7 221 aiz 4 2 1 Q 100K N IRLML6401 T166 T167 O 1 R101 1 VBATTERY lt 3 BAT54SWT1 301K 2 T170 O T175 Q10 MPSAO6S T168 T169 BSS138 013 R107 49 9K C103 47P N V4 V T172 Q 2 R108 4 PWRON gt 100R Figure 28 SpO2 Schematic Diagram Sheet 2 of 7 N S A Blank Page T133 T135 T136 Q Q Q VOU T134 R81 2 1 0 R82 274K 1 2 VON gt R83 97 6K R84 845K Technical Discussion 5VDIG gt J6 pin 13 PIS ique U31 MP506 sheet 7 R99 5VRDIG gt RP14 pin 2 this sheet IN OUT 5VRDIG gt 232 level shifters sheet 1 ms 108 5VRDIG gt R99 sheet 1 SDN G BYP C87 4 7U E 0 01U LT1761ES5 5 7 T139 5VANALOG 5 5VANALOG gt J6 pin 10 506 sheet 7 User OO MN R413 5VRANA gt RP14 pin 1 this sheet IN OUT je 2 10R SDN BYP C88 C90 LT1761ES5 5 BUTS 12VR 12VR gt J2 pin 1 UI board pg1 12VR gt RP14 pin 3 4 this page R89 10uH 12V gt J6 pin 6 MP506 10R MBRO520L connector pg7 U35 1 VCMP gt 605 s 5 C117 5 9 me T g gt gt N 19 Te T TT 12VR T145 U26 gt L R117 gt R116 gt R92 2 R114 me 22VGHK_OK 1 1 0M gt 1 0M 1 0M gt 100K ie T142 me T132 O VSDTP Q SSE ners Bik ug 294K 15 8K 1 VCMP gt 0 1uF N N 65 Figure 29 SpO2 PCB Schematic Diagram Sh
31. absorption of red and infrared light i e spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse 1 plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LED in the oximetry sensor serve as light sources a photo diode serves as the photo detector Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the pulse oximeter uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The pulse oximeter bases its SpO2 measurements on the difference between maximum and minimum absorption i e measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of nonpulsatile absorbers such as tissue bone and venous blood OxIMAx N 65 Service Manual 81 Technical Discussion Functional versus Fractional Saturation This pulse oximeter measures functional saturation
32. ace the battery access door 1 Battery compartment latch Figure 1 Installing Batteries WARNING Explosion hazard Do not use the OxIMAX N 65 in the presence of flammable anesthetics mixed with air oxygen or nitrous oxide 16 OxIMAx N 65 Service Manual Performance Verification Introduction This section discusses the tests used to verify performance following repairs or during routine maintenance All tests can be performed without removing the N 65 cover All tests except the battery charge and battery performance tests must be performed as the last operation before the monitor is returned to the If the monitor fails to perform as specified in any test repairs must be made to correct the problem before the monitor is returned to the user Equipment Needed Equipment Description Durasensor OXIMAx oxygen sensor DS 100A OXIMAX oxygen sensor MAX A Extension cable DEC 4 Nellcor model SRC MAX Tester Provides testing for compatible monitors Performance Tests The Power On Self Test POST performance test verifies that the OxiMAx N 65 is ready for patient monitoring Power On Self Test Discussion Before using the monitor you must verify that it is working properly and is safe to use Proper working conditions are verified each time the monitor is turned on as described in the following procedure The POST verification procedure takes approxim
33. al Technical Discussion Technology The monitor is designed to use Nellcor brand OxiMAx sensors containing technology These OxiMAx sensors can be identified by the deep blue color of their plug All OxiMAxsensors contain a memory chip carrying information about the sensor which the monitor needs for correct operation including the sensor s calibration data model type troubleshooting codes and error detection data This unique oximetry architecture enables several new features with the monitor When sensor is connected to the monitor the monitor first reads the information in the OxiMAx sensor memory chip checks it to make sure that there are no errors and then loads the data to begin monitoring As the monitor reads the information it flashes the Data In Sensor icon This process takes a couple of seconds Once the reading process is complete the monitor begins monitoring Pulse Oximeters containing OxiMAx technology including the monitor use calibration data contained in the OxiMAx sensor in calculating the patient s SpO2 OxIMAx N 65 Service Manual 83 Technical Discussion Block Diagram Theory This section provides an explanation of OxiMAX N 65 block diagram theory of operation Schematic diagrams and are provided at the end of this section The monitor consists of two printed circuit boards PCB the user interface PCB and the SpO PCB The relationship b
34. ately 10 seconds to complete Caution If any indicator or display element does not light when the monitor is turned on do not use it Instead contact qualified service personnel your local Nellcor representative or Nellcor s Technical Services Department Note Physiological conditions medical procedures or external agents that may interfere with the monitor s ability to detect and display accurate measurements include dysfunctional hemoglobin arterial dyes low perfusion dark pigment and externally applied coloring agents such as nail polish dye or pigmented cream Note Ox1Max N 65 automatically starts POST which tests the monitor circuitry and functions OxIMAx N 65 Service Manual 17 Performance Verification display segments and icons are shown and the monitor speaker sounds lt gt Caution During POST immediately after power up confirm that all one second tone When the monitor is turned on the backlight remains on The display displays the following sequence in order as POST takes place All display graphics are shown for three seconds and the backlight is turned on display goes blank all display elements off for one second The software version number displays for three seconds as a three digit number in the right number field with leading zeros if the version number is less than 100 and two dashes in the left number field current time of day is shown in
35. ator 20 Pulse Beep Tone Volume Adjust indicator 21 BPM Lower Alarm Limit indicator 22 Print indicator 23 Interference indicator 24 Pulse Search indicator 25 Data indicator 26 Alarm Silenced indicator 6 N 65 Service Manual Introduction SpOz 9 2 gt 33 32 31 30 29 28 27 27 Power button 28 Up Arrow button 29 Backlight button 30 Menu button 31 Data Record Print button 32 Down Arrow button 33 Alarm Silence button OxIMAx N 65 Service Manual 7 Introduction Front Panel Symbols The follow two symbols are located on the front panel of the monitor SpOz2 of lo gt 5 Displays the measured percent of oxygen saturation Q min Displays the measured pulse beats per minute Rear Panel Symbols The following symbols are located on the rear panel of the monitor 1 Label 2 Battery Cover See Instructions for Use Type BF Applied Part Not defibrillator proof IPX1 Resistant to liquid ingress Prescription only 8 OxIMAx N 65 Service Manual Date of Manufacture European union approval 0123 oF US OG Russian regulatory approval WM04 S N Serial number Canadian USA certification mark electrical safety Label Symbols These symbols display on the monito
36. attempting to remove and reinsert the flex cable Inspect the flex cable for damage Inspect the connection to J4 If there is damage to the flex cable replace the front case Otherwise remove the cable from 14 and reconnect it Reassemble the monitor and retest Refer to Separating the Front and Back Cases on page 48 and Front Case Assembly Replacement on page 54 front panel keypad is defective Caution Unlock J4 before attempting to remove the flex circuit cable Replace the front case Refer to Front Case Assembly Replacement on page 54 Replacing the front case does not fix the problem Replace the SpO2 PCB SpO2 PCB or User Interface PCB Replacement on page 50 Replacing the SpO2 PCB does not fix the problem Replace the User Interface PCB See SpO2 PCB or User Interface PCB Replacement on page 50 If this does not fix the problem return the monitor to Nellcor One or more display segments does not work A User Interface PCB component has failed Inspect the User Interface PCB for cracking burning or damage If damage is found replace the User Interface PCB See SpO2 PCB or User Interface PCB Replacement on page 50 The User Interface PCB is defective If damage is found replace the User Interface PCB See SpO2 PCB or User Interface PCB Replacement on page 50 Pulse rate and SpO 2 value does not dis play when the monitor is turned on The SpO
37. brief description of each test OxIMAx N 65 Service Manual 29 Performance Verification Table 3 shows the Pulse Oximetry Functional Tests you must perform and description of each Table 3 Pulse Oximetry Functional Tests Test Description Test Setup This procedure establishes the baseline for all the other tests Test Setup must be performed before performing any or all of the SRC MAX tests See Test Setup on page 31 Test 1 BPM This procedure simulates an OXIMAX sensor attached to a patient indicating 60 bpm and 200 bpm The test sets up Test 1 for 60 bpm See Test 1 BPM on page 32 Test 2 SpO2 This procedure simulates an OXIMAX sensor attached to a patient indicating 75 percent blood oxygen saturation and 90 percent blood oxygen saturation The test sets up Test 2 for 75 percent blood oxygen saturation See Test 2 SpO2 on page 33 Test 3 Modulation This procedure simulates an OXIMAX sensor attached to a patient indicating low and high pulse strength The test sets up Test 3 for low pulse strength See Test 3 Modulation Level on page 34 Test 4 Light This procedure simulates an OXIMAX sensor attached to a patient indicating low and high light level passing through the patient at the sensor site The test sets up Test 4 for low light level See Test 4 Light Level on page 36 30 OxiMAX N 65 Service Manual Performance Verification Test Setup You must complete Test Set
38. c Off Interval 20 msec 3200 msec Number of pulses in burst 1 Repetition Pause 0 sec 2 sec Priority 11 OxiMAX N 65 Service Manual Specifications Electrical Batteries Type Voltage 4 AA alkaline 6 Volts DC as per 4 AA batteries Battery life is typically Alkaline 15 hours Lithium 40 hours Sensors Wavelength Nellcor pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm The total optical output power of the sensor LEDs is less than 15 mW This information may be useful to clinicians such as those performing photodynamic therapy Note Sensor LED light emissions fall within Class 1 level according to IEC 60825 1 2001 No special safety precautions are required Sensor Power Dissipation Sensor Dissipation 52 5 mW MAX I 52 5 mW 52 5 mW 52 5 mW MAX AL 52 5 mW 52 5 mW Durasensor DS 100A 52 5 mW OXIMAX OxiCliq 52 5 mW OXIMAX OxiCliq N 52 5 mW OXIMAX OxiCliq I 52 5 mW OXIMAX OxiCliq 52 5 mW OxiMAx Dura Y D YS 52 5 mW OxIMAX MAX FAST 52 5 mW Softcare SC PR 52 5 mW Softcare SC NEO 52 5 mW OXIMAX Softcare SC A
39. calibration 15 cautions 2 cleaning 15 D date and time 22 day 13 description of OxiMax N 65 4 disassembly guide 47 disinfecting 15 display update interval 69 DS 100A 17 dysfunctional hemoglobin 17 E equipment needed for performance checks 17 error codes 42 exploded view 63 explosion hazard I extension cable 17 external agents 17 OxIMAx N 65 Service Manual F fractional saturation 82 front case assembly replacement 54 front panel description 4 front panel symbols 8 function menu 10 functional checks 15 functional saturation 82 functional tests 28 H hour 13 L label symbols 9 low perfusion 17 M manufacturer s declaration 75 measured saturation 82 medical procedures 17 menu set time and date 12 minute 13 monitor measurement range 69 returning the monitor 65 month 13 N nitrous oxide 16 O obtaining replacement parts 61 obtaining spare parts 61 operating altitude 74 relative humidity 74 temperature 74 operation with a live subject 26 operational setup 22 109 Index operator s manual 14 OXIMAX technology 83 oximetry overview 81 P packing for shipment 65 packing in a different carton 67 parts list 61 performance verification 17 periodic safety checks 15 physiological conditions 17 POST pass tone 20 power on self test 17 print data 11 pulse beep volume 11 R rear case assembly replacement 57 rear panel symbols 8 related documents 14 repacking in
40. cienda Drive Pleasanton CA 94588 U S A Telephone 1 800 635 5267 Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 OAS U K 2006 Nellcor Puritan Bennett Inc All rights reserved Rx ONLY 0123 10006573 0306 tyco Healthcare
41. d 524 X Replace UI board NVRAM failed read after write verification 525 X X Restart replace UI board Time base discrepancy writing error entry 526 1 2 Replace SpO2 board Fatal error for SpO2 communication 2 Replace UI board 527 1 2 Replace SpO2 board Communication failure with SpO2 2 Replace UI board board 528 1 2 1 Replace UI board Fatal error creating parser 2 Return monitor for repair 529 1 2 1 Replace UI board Fatal error creating parser 2 Return monitor for repair 530 1 2 1 Replace SpO2 board Unrecoverable error with SpO2 2 Replace UI board communication 531 1 2 1 Replace SpO2 board Unrecoverable error with SpO2 2 Replace UI board communication 532 1 2 1 Replace SpO2 board Unrecoverable error with SpO2 2 Replace UI board communication 533 1 2 1 Replace SpO2 board Unrecoverable error with SpO2 2 Replace UI board communication 534 1 2 1 Replace SpO2 board Unrecoverable error with SpO2 2 Replace UI board communication 535 1 2 1 Replace SpO2 board Unrecoverable error with SpO2 2 Replace UI board communication 536 X Replace UI board Flash memory failed CRC check 537 X Replace UI board Fatal system error 538 Set the monitor time and date Real time clock value bad OxIMAx N 65 Service Manual 45 Troubleshooting 46 Scope of Action Table 5 Error Codes Continued
42. e equation applicable to the frequency of the transmitter 35 where is the maximum output d power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m 78 N 65 Service Manual Specifications Table 8 Electromagnetic Immunity Continued The monitor is intended for use in the electromagnetic environment specified below The customer or user of the monitor should assure that it is used in such an environment Field strengths from fixed RF transmitters as determined by an 3 5 electromagnetic site survey should d be less than the compliance level in 1 80 MHz to 800 b MHz each frequency range 7 d XR 800 MHz to 2 5 GHz 14 Interference may occur the vicinity of equipment marked with this symbol 2 Note 1 At 80 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strength 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 t
43. eet 3 of 7 93 Blank Page 3V 022 AT91R40807 RET DE Ki Place caps as close as practical to U22 two per side ANA 4 VDD AO NLB 6 AN n p VNAV ETEN c52 c53 c54 55 c56 57 68 cs 281 yop AN RP2 100 Y Y Y ET VDD 6 4 NN AS FLASH PROGRAM MEMORY 82 vpp Te AN von NAA 24 9 8 95 voo V 100 s 4 AA A9 DQ2 E H q er PO TCLKO DQ4 50 p4 t10A0 E48 AA AN DQ5 7 PIC SYNC3V gt vn 100 Y Y Y DQ6 7 PIC RED IR3V Ed HELL La 8 DQ7 A15 LLL cM 8 4 16 L 7 DIGICAL 55 partiom 16 7 bag R112 56 P5 TIOB1 A17 AM 2 1 DQ10 RP20 gun A18 RP5 100 100 P6 TCLK2 A19 DQ12 100K cg DIGICAL OUT L L 58 2 P28 A20 CS7 DQ13 _ 59 P8 TIOB2 P29 A21 CS6 DQ14 UNUSED inputs 7 DIGICAL INSVY B 51 DQ15 A 1 1740 P9 IRQO DO 79 RP6 a P10 IRQ1 PIC RX3V P1t IRQ2 1 PIC RST lt A P13 SCKO 7 TXD3V lt lt OG p14 TXD0 P15 RXDO 7 RXD3V gt 7 TX3V2 LE T79 T81 T78 T80 O 0 BAUD1 Is BAUD2 72 CHIP SHIP i a 29LV400B C62 3V Technical Discussion U24 IS HARDWARE COMPATABLE WITH 2MBIT TO 16MBIT BOOT BLOCK FLASH FROM AMD ATMEL INTEL MICRON SHARP AND STM U24 must be 120nS or faster NCS1
44. en the battery voltage is critically low The circuit provides the low battery signal OxIMAx N 65 Service Manual 87 Blank Page 5VRDIG A R23 T177 698K 5VRDIG A C105 0 1uF R50 301K 1176 L10 1 toj U33 lt gt 1178 Vec 4 O 4 OWYWYN 2 7 RXD5V lt lt 3 SPO2 TXD 2506033017Y0 lis C1065 MAX9100 100pF a s 5VRDIG 182 R110 i 49 9K 1181 O R97 T180 D13 845K o X amp Y 5VANALOG lt L11 BAT54A 2 N SPO2_RXD 5VRDIG 7 TXD5V gt m 2506033017Y0 C81 ins LIS 0 1uF 100pF R11 ias R85 75 0K 698K T x 5VRDIG V T XN R86 J5 SAL 301K Engineering Mode 4 Mfg Test du 112 12 2 1 3 SPO2 RSTN 2506033017Y0 C114 g 100pF MAX9100 al SU T185 1187 T189 1191 T190 o Q KEYPD3 WRITE TO MEMORY KEYPD4 KEYPD7 Down ARROW 3 J KEYPD6 MENU SC 5 up arrow Er 5 iake Hn KEYPD2 N 65 8 ARROW 100K 3 VCHK Technical Discussion 12VR T131 Q N lt VBATTERY2 C108 092 2 470 HEADER 12XP 8 MENU Q Er SS VCMP 3 PWR OFF 2 PWR gt VON2 3 115 109 4 70 pu Jj J7 J8 N N N Figure 27 SpO2 Schematic Diagram sheet 1 of 7 89 Blank Page Technical Discussion T164 T165 T173 R109 O Q O Q11 Ei B1 O BAT_POS 3 2 2 3 VON 1 3 PTC7812 R93 C104 TVS1 IRLML6401 R102 1K C101 I
45. entative OxIMAx N 65 Service Manual 39 Troubleshooting 40 If an error code is shown on the monitor front panel display see Figure 3 Turn the monitor off wait ten seconds then turn it back on This clears recoverable errors encountered by the monitor If the error code persists refer to Table 5 Error Codes on page 43 for an explanation of the error code Apply the action specified SpO gt Q min Er 123 8 0 Figure 3 Typical Error Code Display Once you have performed the recommended action reassemble the monitor refer to Performance Verification on page 17 and conduct a performance verification before returning the monitor to service If the symptom persists continue troubleshooting Table 4 Troubleshooting Guide Condition Recommended Action The monitor does not turn on when you press the Power button Power button was not fully Fully press the Power button depressed The batteries are missing Open the battery compartment If the batteries are missing install new batteries Refer to the OxIMAX N 65 Operator s Manual batteries are installed incorrectly Open the battery compartment If the batteries are not installed correctly remove and reinstall them Make sure the batteries are not installed backwards Refer to the N 65 Operator s Manual The batteries are at or near a voltage too Install new batteries Refer to the OXxIM
46. etween these two components and their interconnections is shown in the block diagram See Figure 26 SpO2 BOARD USER INTERFACE BOARD Batteries Power LCD 4 X AA Supply 3 2 6 4 Vdc 3 2 6 4 Vdc Power Watchdog Monitoring Reset Power SpO2 Power Good Backlight Monitoring Serial Patient Interface Interface Patient Sensor External Printer Figure 26 Block Diagram 84 N 65 Service Manual Technical Discussion SpO Printed Circuit Board The SpO2 PCB provides patient interface and monitor operating power Patient Interface The patient interface receives signals from the sensor These signal are converted and supplied to the user interface PCB central processing unit CPU The patient interface receives control signals from the CPU These control signals are used to control the light emitting diodes in the OxiMAx sensor Power Supply The power supply provides operating voltages to the SpO2 PCB and the user interface PCB These voltages are supplied to the SpO2 PCB power monitoring function SpO2 PCB circuits e user interface PCB power supply user interface PCB CPU user interface PCB audio circuits Power Monitoring The SpO2 power monitoring function monitors and controls the outputs of the SpO2 power supply The SpO2 power monitoring function provides the user interface CPU and SpO2 patient interface with status information on the power supp
47. fusion Range 0 03 to 20 Accuracy Tolerance Saturation Adult 70 to 100 2 digits Neonate 70 to 100 3 digits Low Perfusion 70 to 100 2 digits Pulse Rate Adult and Neonate 20 to 250 bpm 3 digits Low Perfusion 2 20 to 250 bpm 3 digits Adult specifications are shown for MA X A and MAX N sensors with the N 65 Neonate specifications are shown for MAX N sensors with the N 65 Saturation accuracy will vary by sensor type Refer to the Sensor Accuracy Grid The Sensor Accuracy Grid is shipped with the N 65 The latest version of the Sensor Accuracy Grid is available on the Internet at http www mallinckrodt com respiratory resp Serv Supp ProductManuals html Reading accuracy in the presence of low perfusion detected IR pulse modulation amplitude 1 596 was validated using signals supplied by a patient simulator SpO2 and pulse rate values were varied across the monitoring range over a range of weak signal conditions and compared to the known true saturation and pulse rate of the input signals Display Update Interval 100 millisecond OxIMAx N 65 Service Manual Specifications Audible Indicators Aung Parameter Value Indicator Alarm Volume Volume level Adjustable 40 to 52 Setting dB A at one meter Pitch 30 Hz 752 Hz
48. he measured field strength in which the monitor is used exceeds the applicable RF compliance level above the monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the monitor P Over the frequency range 150 kHz to 80 MHz field strength should be less than V V m OxIMAx N 65 Service Manual 79 Specifications Blank Page 80 OxIMAx N 65 Service Manual Technical Discussion Oximetry Overview The N 65 uses pulse oximetry to measure functional oxygen saturation in the blood Pulse oximetry works by applying an sensor to a pulsating arteriolar vascular bed such as a finger or toe The OxrMax sensor contains a dual light source and a photo detector Bone tissue pigmentation and venous vessels normally absorb a constant amount of light over time The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations The ratio of light absorbed is translated into a measurement of functional oxygen saturation SpO2 Because a measurement of SpO is dependent upon light from the OxiMAx sensor ambient light can interfere with this measurement Specific information about ambient conditions OxiMAx sensor application and patient conditions is contained throughout this manual Pulse oximetry is based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their
49. inuous or spot check monitoring of functional arterial oxygen saturation SpO2 and pulse rate of adult pediatric and neonatal patients in hospital hospital type facilities transport and mobile environments as well as in the homecare environment Front Panel Description This section identifies the symbols controls displays and indicators on the OXIMAX N 65 Refer to the OxIMAx N 65 Operator s Manual for a complete description of all buttons symbols controls displays and indicators 1 SpO2 area of display 2 Measured SpO2 3 Pulse beats per minute BPM area of display 4 Measured BPM 4 OxIMAx N 65 Service Manual OxIMAx N 65 Service Manual Introduction 5 6789 101112 16 15 1413 5 5 2 Lower Alarm Limit indicator 6 Sp02 Upper Alarm Limit indicator 7 Pulse Amplitude indicator Blip bar 8 Time Colon time date field separator 9 Adjust Time mode indicator 10 Adjust Volume mode indicator 11 Set Limit mode indicator 12 BPM Upper Alarm Limit indicator 13 BPM Limit Changed indicator 14 Sensor Off Patient indicator 15 Sensor Disconnected indicator 16 SpO2 Limit Changed indicator Introduction N N b 26 25 24 23 22 17 Low Battery indicator 18 Data In Sensor indicator 19 Alarm Volume Adjust indic
50. ll the four screws See Figure 16 items 1 through 4 Figure 16 Installing The Case Screws OxIMAx N 65 Service Manual 55 Disassembly Guide 7 Install the batteries and battery cover as shown in Figure 17 1 Batteries 2 Battery cover 3 Battery cover latch Figure 17 Battery Installation 8 Perform the performance verification tests before placing the monitor into service See Pulse Oximetry Functional Tests on page 28 56 N 65 Service Manual Disassembly Guide Rear Case Assembly Replacement To replace the rear case assembly 1 Remove the batteries from the monitor See Prior to Disassembly on page 48 2 Separate the front and rear case assemblies See Separating the Front and Back Cases on page 48 of the SpO2 PCB are held in slots in the battery compartment Observe how these connectors are engaged in these slots when you remove the SpO2 PCB and User Interface PCB and ensure that the battery connectors are inserted back in these slots when you reassemble the monitor 0 Caution The battery connectors spring assemblies at the bottom 3 Lift the SpO2 PCB and User Interface from the case 18 Figure 18 User Interface PCB and SpO2 PCB Removal 4 Discard the rear case assembly in accordance with local regulations OxIMAx N 65 Service Manual 57 Disassembly Guide 5 Install the User Interface PCB and SpO2 PCB into the monitor case Ensure that the batter
51. ly output signals User Interface Printed Circuit Board The user interface PCB provides User setup of the monitor via the keypad Patient SpO2 and pulse rate via the display Monitor status via the display and audio function Printed reports via the IrDA Infrared Data Association and external printer Display readability in dark environments via the display backlight Operating voltages for the user interface circuits Operating voltage monitoring OxIMAx N 65 Service Manual 85 Technical Discussion Keypad The user interface PCB keypad contains seven push buttons These buttons allow the user to setup and control of the monitor The buttons are I Alarm Silence 5 Backlight 2 Down Arrow 6 Up Arrow 3 Data 7 Power 4 Menu The signals from the buttons pass directly through the SpO2 PCB and are applied to the user interface PCB CPU The Power button signal is applied to the SpO2 power supply turning the monitor on or off Backlight The backlight illuminates the display for better viewing CPU and Flash The CPU controls all functions and timing for the monitor The CPU communicates with the SpO2 PCB patient interface The patient interface signal are sent to the CPU for processing The CPU sends signals to the patient sensor via the patient interface for controlling the sensor light levels Real Time Clock The real time clock and non volatile random access me
52. monitor pulse rate decreases to 60 and stabilize at 60 bpm The test pass criteria is 57 to 63 bpm inclusive The monitor displays 75 SpO2 displays 60 bpm test pass criteria is 57 to 63 bpm inclusive alarms Pulse Amplitude indicator displays low level modulation Test 2 SpO2 To perform Test 2 SpOz 1 Press the SRC MAX SpO2 select button The SRC MAX 8 2 90 LED lights The monitor displays three dashes until the SRC MAX stabilizes at 90 5 2 The test pass criteria is 88 to 92 SpO2 inclusive The monitor displays 90 SpO2 pass criteria is 88 to 92 SpO2 inclusive displays 60 bpm no alarms Pulse Amplitude indicator displays low level modulation SpO2 74 on dU amp bU JE o OxIMAx N 65 Service Manual 33 Performance Verification 2 Press the SRC MAX SpO2 select button 34 The SRC MAX SpO2 75 LED lights The monitor displays two dashes until the SRC MAX stabilizes at 75 SpO2 The test pass criteria is 73 to 77 SpO2 inclusive The monitor displays 75 SpO2 pass criteria is 73 to 77 SpO2 inclusive displays 60 bpm alarms Pulse Amplitude indicator displays low level modulation Test 3 Modulation Level To perform Test 3 Modulation Level wor Press the SRC MAX Modulation selection button The SRC MAX Modulation LED lights The monitor pulse blip bar initially increases in amplitude and then stabili
53. mory RAM chip maintain time and date used in the monitor These circuits utilize a gold electrolytic super capacitor for power when the monitor is turned off Audio The audio circuit drives a transducer to provide the monitor tones 86 N 65 Service Manual Technical Discussion LCD The liquid crystal display LCD is driven by the CPU The LCD displays the patient s SpO2 and pulse rate The LCD also displays icons indicating the status and functions of the monitor Refer to the N 65 Operator s Manual for a description of the icons CoO a Col mA Y D XH gt IrDA The IrDA Infrared Data Association is an industry standard for infrared communications The IrDA receives information from the CPU converts it and sends it to an external printer The external printer communicates with the IrDA Refer to the printer manual for more information Power Supply The user interface PCB power supply receives power from the SpO2 PCB power supply The power supply provides a regulated 3 0 volts DC to the CPU Power Supply Monitoring The power supply outputs are monitored by the power monitoring function to ensure stability The power supply monitoring circuit sends reset signal to the watchdog circuits to shut down the monitor when voltages are out of tolerance The power supply monitoring circuit monitors the battery output voltage and shuts down the monitor wh
54. mum Separation Separation Separation Output Power of Distance in Distance in Distance in Transmitter in Meters Meters Meters Watts 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 8 7 3 100 12 12 23 For transmitters rated at maximum output power not listed above the separation distance can be estimated using the equation in the corresponding column where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 2 2 Note At 80 MHz to 800 MHz the separation distance for the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people OxiMAX N 65 Service Manual Table 7 Electronic Emissions The monitor is intended for use in the electromagnetic environment specified below The customer or user of the monitor should assure that it is used in such an environment Electromagnetic Emission Test Compliance Environment Guidance RF emissions Group I The monitor uses RF energy only for its CISPR 11 internal function Therefore the RF emissions are very low and not likely to cause interference in nearby electronic equipment RF emissions Class B The monitor is suitable for use in CISPR 11 establishments including diagnostic establishments and those directly connected to the public low
55. n Arrow button until the desired day appears OG 9 Press the Menu button to set the day and show the month set display The month indication 7 flashes SpO2 ON min 10 Press the Up Arrow button or the Down Arrow button until the desired month appears Q 24 N 65 Service Manual Performance Verification 11 Press the Menu button to set the month and show the year set display The year indication 2004 flashes Q min Jn Cu dy 50 0 0 12 Press the Up Arrow button or the Down Arrow button until desired year appears OG 13 Press the Menu button to set the year and return to normal operation OxIMAx N 65 Service Manual 25 Performance Verification General Operation The Operation with Live Subject test is an overall performance check of the system Operation with Live Subject Patient monitoring involves connecting the OxiMAx sensor to a live subject for qualitative test 1 Sensor Port To connect the OxIMAX sensor to a live subject for a qualitative test 1 26 Connect a Nellcor Oxi Max MAX A oxygen OxIMAx sensor to the monitor Clip the MAX A to the subject as recommended the OxiMAx sensor s Directions For Use Press the Power button to turn the monitor on and verify that it is operating The monitor should stabilize on the subject s physiological signal in approximately 30 seconds Verify that the oxygen saturati
56. not fix the problem Replace the SpO2 PCB See SpO2 PCB or User Interface PCB Replacement on page 50 Replacing the SpO2 PCB does not fix the problem Replace the User Interface PCB See SpO2 PCB or User Interface PCB Replacement on page 50 If this does not fix the problem return the monitor to Nellcor The Backlight LEDs on the User Interface PCB have failed Replace the User Interface PCB See SpO2 PCB or User Interface PCB Replacement on page 50 The monitor shuts off when you press the Backlight button The batteries are at or near a voltage too low for the monitor to operate Install new batteries See the N 65 Operator s Manual The printer does not print The IrDA between the printer and the monitor is not properly aligned Align the printer and the monitor See the N 65 Operator s Manual for instructions The printer is turned off Turn the printer on See the printer documentation The printer batteries are at or near a voltage too low to operate Install new batteries in the printer See the printer documentation The Data button on the front panel keypad is defective Caution Unlock J4 before attempting to remove the flex circuit cable Replace the Front Case See Front Case Assembly Replacement on page 54 Replacing the Front Case does not fix the problem Replace the User Interface PCB See SpO2 PCB or User I
57. nterface PCB Replacement on page 50 If this does not fix the problem return the monitor to Nellcor The printer is defective See the printer documentation or replace the printer Error Codes An error code displays when the monitor detects a non correctable failure Table 5 provides a list of error codes for the monitor However you can turn the Power off and on once called cycling the power to try removing the error code if one of the following occurs monitor sounds a low priority alarm measurements stop is shown in the 6SpO2 numeric display area Error code is shown in the right numeric display If the error code remains see Error Codes on page 43 N 65 Service Manual Troubleshooting Table 5 provides a list of error codes for the monitor Scope of Action Table 5 Error Codes E n E Action Explanation N Q 24 24 1 X Replace SpO2 board SpO2 front end RAM error 2 X Replace SpO2 board SpO2 front end ROM code integrity error 3 X Replace SpO2 board SpO2 front end reported a bad CRC 4 X Replace SpO2 board SpO2 front end reported FSP message not allowed 5 X Replace SpO2 board SpO2 front end reported illegal value sent in FSP message 6 X Replace SpO2 board SpO2 front end reports calibration offset failure 9 X Replace SpO2 board SpO2 front end reported syntax err
58. on and pulse rate values are reasonable for the subject Press the Data button N 65 Service Manual Performance Verification The monitor records snap shot data SpO2 74 6 Turn off the monitor OxIMAx N 65 Service Manual 27 Performance Verification Pulse Oximetry Functional Tests The Pulse Oximetry Functional Tests utilize the pulse oximetry functional tester Nellcor model SRC MAX to verify the performance of the monitor See Figure 2 1 OxiMAx N 65 Cable Connector 6 Modulation Select Button 2 RED LED Drive Indicator 7 SpO2 Select Button 3 Not Used For OxIMax N 65 8 Light Level Selection Button 4 Not Used For OxiMAx N 65 9 Pulse Rate Selection Button 5 Battery Low Indicator 10 INFRARED LED Drive Indicator Figure 2 SRC MAX OxiMAx Oximetry Tester 28 OxiMAX N 65 Service Manual Performance Verification The SRC MAX functional tester allows qualified technicians to functionally test Nellcor OxiMAx technology based pulse oximeters and OEM OxiMAx technology based monitors The Pulse Oximetry Functional tests should be completed in the order shown Test Setup Note The technician must complete Test Setup before performing tests Ap 1 through 4 as follows Test 1 BPM Test 2 SpO2 Test 3 Modulation Test 4 Light See Table 3 Pulse Oximetry Functional Tests on page 30 for a
59. or in FSP message 10 1 2 1 Check replace sensor SpO2 front end reports over current extension cable failure 2 Replace SpO2 board 11 1 2 1 Replace batteries SpO2 front end reports incorrect 2 Replace SpO2 board system voltage 12 X Replace SpO2 board SpO2 front end reports other hardware problem 14 X Replace SpO2 board SpO2 front end reports communication channel overflow 16 X Replace SpO2 board SpO2 front end reports watchdog time out 17 X Check replace sensor SpO2 front end reports that sensor extension cable appears defective 18 X Replace SpO2 board SpO2 front end reports internal register appears modified from expected value 19 X Check replace sensor SpO2 front end reports signal out of extension cable range 48 X Replace SpO2 board SpO2 front end reports spurious interrupt 49 X Replace SpO2 board SpO2 front end reports internal buffer overflow 50 X Replace SpO2 board SpO2 front end reports intermittent error 51 X Replace SpO2 board SpO2 front end reports digital communication error 53 X Replace SpO2 board SpO2 front end data not received 256 X Replace SpO2 board SpO2 back end reports beginning of packet missing OxIMAx N 65 Service Manual 43 Troubleshooting 44 Scope of Action Table 5 Error Codes Continued Action Explanation Code 2 E E D
60. original carton 65 replacement battery compartment door 59 front case assembly 54 rear case assembly 57 user interface pcb 50 replacement level supported 47 Returned Goods Authorization RGA number 65 RGA number 65 routine maintenance 15 S safety tests 37 sensors 73 separating the front and back cases 48 service manual 14 spare parts 61 spare parts on Internet 14 specifications 69 battery 73 compliance 75 electrical 73 environmental 74 performance 69 physical 75 SRC MAX 28 SRC MAX tester 17 storage 110 altitude 74 relative humidity 74 temperature 74 strangulation 2 surface cleaning 15 symbols Canadian ICES 001 approval 9 date of manufacture 9 European union approval 9 fragile 9 keep away from heat 9 keep upright 9 label 9 protect from moisture 9 rear panel 8 resistant to liquid ingress 8 Russian regulatory approval 9 see instructions for use 8 serial number 9 temperature limitation 9 type BF applied part 8 T technical discussion 81 test H1 SpO2 33 test 2 bpm 32 test 3 modulation level 34 test 4 light level 36 time set menu 13 transport altitude 74 relative humidity 74 temperature 74 troubleshooting guide 39 V verify performance 17 W wavelength 73 wavelength sensor 73 who should perform repairs 39 OxiMAXx N 65 Service Manual Index year 13 OxIMAx N 65 Service Manual 111 NELLCOR Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Ha
61. passed the test WARNING If you do not hear the POST pass tone do not use the monitor WARNING Ensure that the speaker is clear of any obstructions and that the speaker holes are not covered Failure to do so could result in an inaudible alarm tone 20 OxiMAX N 65 Service Manual Performance Verification pass tone also functions as audible confirmation that the speaker is performing properly If the speaker does not function the alarm warning sounds cannot be heard 2 Note In addition to serving as the POST pass verification the POST 7 Press the Alarm Silence button The Alarm Silenced indicator displays SpO2 74 8 Press Alarm Silence button The Alarm Silenced indicator does not display o 0o 0 9 Press the Backlight button The backlight turns on 10 Press the Backlight button The backlight turns off OxIMAx N 65 Service Manual 21 Performance Verification Operational Setup The operational setup procedure sets the time and date into the monitor Refer to the OxiMAx N 65 Operator s Manual for individual parameter settings The monitor returns to the factory default settings when it is powered on therefore individual parameter settings need to be set at that time Setting the Time and Date 22 Discussion WARNING The OxIMAX sensor uses the date and time provided by the OXIMAX N 65 when the patient alarm events are recorded to the memory chip in the
62. r s labels H R Keep away from heat y Temperature limitation Protect from moisture Fragile Humidity limitation Keep upright 15 95 RH OxIMAx N 65 Service Manual Introduction Introduction Menu Parameters This section contains information on how to set monitor parameters and limits using the menu structure See Set Menu Parameters on page 11 to set the following parameters high and low SpO2 limits high and low BPM limits alarm volume pulse beep volume dataprinting See Set Time Date Parameters on page 12 to set the following parameters Hour Minute Day Month Year 10 OxIMAx N 65 Service Manual Set Menu Parameters Introduction To set menu parameters press the Menu button repeatedly during normal operation to display the parameters to set Use the Up Arrow button or Down Arrow button to adjust the parameter limit Press the Menu button to return to the default monitoring display Table 1 Menu Structure stored snap shot and sensor event data Parameter Press Function Presses 1 SpO2 Low Adjust limit e Limit 2 SpO High Adjust limit e Limit 3 BPM Low Adjust limit Limit 4 BPM High Adjust limit e Limit 5 Pulse Beep Adjust volume Indications e Volume on blip bar 6 Alarm Adjust volume Indications Volume on blip bar 7 Print Data Print summary and or OxIMAx N 65 Service Manual
63. rator s manual German Operator s manual Greek Operator s manual Hungarian Operator s manual Italian Operator s manual Japanese Operator s manual Norwegian Operator s manual Polish Operator s manual Portuguese Brazilian Operator s manual Russian Operator s manual Spanish Latin American Operator s manual Swedish Operator s manual Turkish 62 OxiMAX N 65 Service Manual Spare Parts Figure 23 shows the monitor exploded view with numbers relating to the spare parts list 1 top enclosure 2 SpO PCB 3 user interface Ul 7 4 bottom enclosure 5 battery cover Figure 23 Exploded View OxIMAx N 65 Service Manual 63 Spare Parts Blank Page 64 OxIMAx N 65 Service Manual Packing for Shipment Introduction To ship the OxIMAX N 65 follow the instructions in this section Returning the Monitor Contact Nellcor s Technical Services Department for shipping instructions including Returned Goods Authorization RGA number Unless otherwise instructed by Nellcor s Technical Services Department it 15 not necessary to return the OxiMAx sensor or other accessory items with the monitor Pack the monitor 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
64. s contact Nellcor s Technical Services or your local Nellcor representative Refer to parts by the part names and part numbers Spare parts and accessories for the N 65 are listed on the Internet at http mallinckrodt com respiratory resp Serv_Supp Apartweb main PartAcceMenu html Parts List and Accessories Table 6 Parts and Accessories List Figure 23 D soa Reference escription Spare Parts 1 Top enclosure with membrane panel 2 SpO2 PCB 3 User interface UI 4 Bottom enclosure 5 Battery cover Membrane switch panel LCD assembly Battery alkaline 1 5V type AA Screw PH 4 X 16 inch Screw PH 4 X 3 16 inch OxIMAx N 65 Service Manual 61 Spare Parts Table 6 Parts and Accessories List Description Product data label Quick guide label Accessories Boot protective silicone yellow Case carry fabric black with shoulder strap DEC 4 sensor extension cable Jacket water resistant clear plastic Transport Boot CD operator and service manuals Home Use Guide English Operator s manual Arabic Operator s manual Chinese Operator s manual Czechoslovakian Operator s manual Danish Operator s manual Dutch Operator s manual English Operator s manual Finnish Operator s manual French Ope
65. sensor is not connected properly Reconnect the SpO2 sensor to the monitor Connect the SpO2 sensor to the patient See the sensor Directions for Use The SpO sensor has failed Replace the SpO2 sensor The User Interface PCB is defective Replace the User Interface PCB See SpO2 PCB or User Interface PCB Replacement on page 50 SpO2 PCB is defective Replace the SpO2 PCB See SpO2 PCB or User Interface PCB Replacement on page 50 The display backlight does not come on when you press the Backlight button flex circuit between the front panel and the SpO2 PCB is damaged or not making a good connection Caution Unlock J4 before attempting to remove and reinsert the flex cable Inspect the flex cable for damage Inspect the connection to J4 If there is damage to the flex cable replace the front case Otherwise remove the cable from J4 and reconnect it Reassemble the monitor and retest See Separating the Front and Back Cases on page 48 and Front Case Assembly Replacement on page 54 OxIMAx N 65 Service Manual 41 Troubleshooting Table 4 Troubleshooting Guide Continued Condition Recommended Action The Backlight button on the front panel keypad is defective Caution Unlock J4 before attempting to remove the flex circuit cable Replace the front case See Front Case Assembly Replacement on page 54 Replacing the SpO2 PCB does
66. t pass criteria is 73 to 77 SpO2 inclusive displays 60 bpm test pass criteria is 57 to 63 bpm inclusive alarms pulse amplitude indicator displays low level modulation 2 Perform Test 1 BPM on page 32 The pulse amplitude should indicate low level modulation 3 Perform Test 2 SpO2 on page 33 The pulse amplitude should indicate low level modulation 36 N 65 Service Manual Performance Verification 4 Press SRC MAX Light Level selection button The SRC MAX Light Level V LED lights The monitor pulse blip bar initially increases in amplitude and then reduces and stabilizes at 3 5 bars The monitor displays 75 SpO2 displays 60 bpm alarms pulse amplitude indicator displays low level modulation 5 Perform Test 1 BPM on page 32 The pulse amplitude indicator should indicate low level modulation 6 Perform Test 2 SpO2 on page 33 The pulse amplitude indicator should indicate low level modulation 7 Disconnect all equipment and turn off the monitor Safety Tests The monitor safety tests meet the standards of and are performed in accordance with EN 60601 1 1990 A1 and A2 IEC 60601 1 UL 60601 1 and CAN CSA C22 2 No 601 1 This product is categorized as internally powered type BF equipment OxIMAx N 65 Service Manual 37 Performance Verification Blank Page 38 OxiMAX N 65 Service Manual Troubleshooting Introduction This section explains how to tro
67. ubleshoot the OxiMAX N 65 Tables list possible monitor difficulties along with probable causes and recommended actions to correct the difficulty How To Use This Section Use this section in conjunction with Performance Verification on page 17 and Spare Parts on page 61 To remove and replace a part suspected of being defective follow the instructions in Disassembly Guide on page 47 The circuit analysis section in the Technical Discussion on page 81 offers information on how the monitor functions Who Should Perform Repairs Only qualified service personnel should open the monitor housing remove and replace components or make adjustments If your medical facility does not have qualified service personnel contact Nellcor s Technical Services or your local Nellcor representative Troubleshooting Guide Note Follow the recommended actions discussed in this section to correct the majority of problems you may encounter However problems not covered here can be resolved by calling Nellcor s Technical Services or your local Nellcor representative If you encounter a problem that cannot be resolved through a visual inspection refer to Table 4 Troubleshooting Guide on page 40 In the table find the condition that describes the problem and follow the corrective actions in the order presented For a symptom that is not listed in Table 4 contact the Nellcor Technical Services Department at 1 800 635 5267 or your local Nellcor repres
68. uce the possibility of patient entanglement or strangulation WARNING To ensure accurate performance and prevent device failure do not expose the monitor to extreme moisture such as rain Cautions are identified by the CAUTION symbol shown above Cautions alert the user to exercise care necessary for the safe and effective use of the N 65 Caution Observe ESD electrostatic discharge precautions when working within the unit Caution Observe ESD electrostatic discharge precautions when disassembling and reassembling the N 65 and when handling any of the components of the monitor Caution When reassembling the OXIMAX N 65 tighten the screws that hold the cases together to a maximum of ten inch pounds Over tightening could strip out the screw holes in the front case rendering it unusable Notes are identified by the Note symbol shown above Notes provide useful helpful information OxIMAx N 65 Service Manual Introduction Manual Overview This manual contains information for service personnel who will service the Nellcor model OxiMAx N 65 handheld pulse oximeter herein referred to as the monitor Only qualified service personnel should service this product Read the operator s manual carefully and thoroughly understand the operation of the monitor OxIMAx N 65 Service Manual 3 Introduction Description of OxIMAx N 65 The OxIMAX M N 65 handheld pulse oximeter is indicated for cont
69. up before performing any other pulse oximetry functional tests To perform test setup 1 Press the Power button to turn on the monitor 2 After the monitor presents the monitoring screen connect the SRC MAX tester to the monitor sensor port as shown Note Use a DEC 4 extension cable between the SRC MAX and the LA monitor Sensor Port The SRC MAX panel lights and in a few seconds the monitor tracks the simulator After the monitor completes POST the monitor is in SpO2 alarm displays an SpO2 of 75 pass criteria is 73 to 77 SpO2 inclusive displays a pulse rate of 60 pass criteria is 57 to 63 bpm inclusive OxIMAx N 65 Service Manual 31 Performance Verification Test 1 BPM Pulse Amplitude indicator displays low level modulation low amplitude pulse amplitude indicator SpOz Q min IC I3a b A A o o 0 To perform Test 1 BPM 1 Press the SRC MAX Pulse Rate selection button The SRC MAX Pulse Rate 200 LED lights The monitor bpm increases to 200 and stabilize at 200 bpm The test pass criteria is 197 to 203 bpm inclusive The monitor 32 displays 75 SpO2 displays 200 bpm pass criteria is 197 to 203 bpm inclusive alarms Pulse Amplitude indicator displays low level modulation SpO2 Q min N 65 Service Manual Performance Verification 2 Press the SRC MAX Pulse Rate select button The SRC MAX Pulse Rate 60 LED lights The
70. utton C1 0 1UFY7 V4 3V0 7 T l 339 A 1 0M 21V21B gt al 2 R2 RE N gt 1 0M R3 1 0M R77 1 0M P 30 1K LJ ytt see LHP keveni 2 R73 C23 s62K 2PWR_CMPN2 VCMPN 2 100pF C24 RTA 649K VON 12 100pF 100pF lt Lp4V8 gt BAT LOWN 2 GRITN 2 gt LCD SEGTIN 2 0 1uF 1uF 1 gt U6 Technical Discussion IN SDN amp BYP z OUH MBR0520L R24 C17 c18 22 9 R26 82 5K R6 R8 10 30 1K DS1338Z 3 SQW_OUT amp 7 RTC SDAT SCLK VBATTERY Y1 32 768KHz C3 3V0 VCMP Figure 34 User Interface PCB Schematic Diagram Sheet 1 of 3 103 Blank Page N 65 3V0 T15 c33 c34 c35 c36 38 1 40008 0 1uF 0 1uF 0 1uF 0 1uF 0 1uF 0 1uF 10 1Meg x 16 FLASH PROGRAM MEMORY vppio A A U18 1V8 1 62 5 A3 AM29LV400 5048 A 5 05 C39 C40 C41 VDDCORE VDDCORE 3V0 o tur o tuF aaa VERGGRE A 1RTC SDAT 42 POTCLKO 4 SCLK 20 1 1 J6A Technical Discussion BiU gt 3V0 kors R76 1WD STB 5 211 p2 71080 3 BK LIGHT Pe P3 TCLK1 Mfg Test gt 3 BZ FRQ BA PA TIOA1 3V0 3 PWR_BZN P5 TIOB1 T Pe TCLK2 A19 1 BWE EN N 2G P7ITIOA2 P28 A20 CS7 58 KEYPD4 PWR_OFF PB TIOB2 P29 A21 CS6 59 KEYED otur KEYPD7 3 PWR_IRDAN 8
71. voltage power supply network that supplies buildings used for domestic purposes OxIMAx N 65 Service Manual Specifications TT Specifications Table 8 Electromagnetic Immunity The monitor is intended for use in the electromagnetic environment specified below The customer or user of the monitor should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Test Level Level Electrostatic 6 contact Complies Discharge ESD 8 air 61000 4 2 Electrical fast 2 power Complies transient burst supply lines IEC 61000 4 4 I kV for input output lines Power 3 A m Complies Frequency 50 60 Hz magnetic field Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 Vrms IEC 61000 4 3 80 MHz to 2 5 GHz Recommended Separation Distance Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Main power should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the Monitor including the cables than the recommended separation distance calculated from th
72. x O Q x 2 OXIMAX N 65 Handheld Pulse Oximeter Service Manual NELLCOR Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare Nellcor Oxiband Durasensor OxiCliq Dura Y MAX FAST and Ox1M ax are trademarks of Nellcor Puritan Bennett Incorporated or an affiliate Cet appareil ISM est conforme la norme NMB 001 Canada To obtain information about warranty if any contact Nellcor s Technical Services Department or your local representative Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett Covered by one or more of the following U S Patents and foreign equivalents 4 802 486 4 869 254 4 928 692 4 934 372 4 960 126 5 078 136 5 485 847 5 743 263 5 865 736 6 035 223 6 298 252 6 463 310 6 591 123 6 675 031 6 708 049 6 801 797 and Re 35 122 Contents Introduction ee 1 Ido fM C kn dessa ce 1 CAUTIONS ce 2 NORS 22222262 2506 EE 2 Manual Overview 3 Description of 65 2 4 Front Panel Description 4 Front Panel 5
73. y springs slip into place See Figure 19 Figure 19 Battery Spring Alignment Note The longer screws install at the top of the case See Figure 20 AY items I and 4 6 Place the front and rear cases together and install the four screws See Figure 20 Figure 20 Installing The Case Screws 58 N 65 Service Manual Disassembly Guide 7 Install the batteries and battery cover See Figure 21 Figure 21 Battery Installation 8 Perform the performance verification tests before placing the monitor into service See Pulse Oximetry Functional Tests on page 28 Battery Compartment Door Replacement To replace the battery compartment door 1 Press the battery door latch Figure 22 item 1 and lift the batter door from the monitor rear case Figure 22 Battery Compartment Door Latch 2 Insert the new battery compartment door in the case and close until the battery door latch snaps in place OxIMAx N 65 Service Manual 59 Disassembly Guide 60 Blank Page OxIMAx N 65 Service Manual Spare Parts Introduction The latest version of this manual is available on the Internet at http www mallinckrodt com respiratory resp Serv Supp ProductManuals html Spare parts are shown in Table 6 Item numbers correspond to the callout numbers in Figure 23 Obtaining Replacement Parts Nellcor s Technical Services provides technical assistance information and replacement parts To obtain replacement part
74. y stress 0 Caution flex cable runs between the monitor front and rear case to the flex cable 3 Separate the monitor front and rear case assemblies See Figure 6 1 Connector J4 Figure 6 Cases Separated Caution Failure to unlock connector J4 on the SpO2 PCB before removing the front case flex circuit could damage the flex circuit OxIMAx N 65 Service Manual 49 Disassembly Guide 4 Unlock connector J4 on the SpO2 PCB See Figure 6 and Figure 7 1 SpO2 PCB 2 J4 lock 3 Lock direction 4 Unlock direction Figure 7 SpOz PCB Connector J4 Lock 5 Disconnect the ribbon cable from SpO2 PCB connector J4 SpO2 PCB or User Interface PCB Replacement To replace the SpO2 PCB or the User Interface PCB 1 Complete the procedure in Prior to Disassembly on page 48 2 Complete the procedure in Separating the Front and Back Cases on page 48 of the SpO2 PCB are held in slots in the battery compartment Observe how the connectors are engaged in the slots when you remove the SpO2 PCB and User Interface PCB Ensure that the battery connectors are inserted back into these slots when you reassemble the monitor 0 Caution The battery connectors spring assemblies at the bottom 50 OxiMAX N 65 Service Manual Disassembly Guide 3 Pull the SpO2 PCB and User Interface PCB to the left to free the case from the DB 9 connector Lift the combined SpO2 and User Interface PCBs from the case See
75. zes at the higher level The monitor displays 75 SpO2 test pass criteria is 73 to 77 SpO2 inclusive displays 60 bpm test pass criteria is 57 to 63 bpm inclusive alarms Pulse Amplitude indicator displays high level modulation N 65 Service Manual 2 OxIMAx N 65 Service Manual Performance Verification Perform Test 1 BPM on page 32 The Pulse Amplitude indicator should indicate high level modulation Perform Test 2 SpO2 on page 33 The Pulse Amplitude indicator should indicate high level modulation Press the SRC MAX Modulation selection button The SRC MAX Modulation W LED lights The monitor pulse blip bar decreases in amplitude SpO2 G 74 IJa b eee The monitor displays 75 SpO2 displays 60 bpm alarms Pulse Amplitude indicator displays low level modulation Perform Test 1 BPM on page 32 The pulse amplitude indicator should indicate low level modulation Perform Test 2 SpO2 on page 33 The pulse amplitude indicator should indicate low level modulation 35 Performance Verification Test 4 Light Level To perform Test 4 Light Level 1 Press the SRC MAX Light Level selection button The SRC MAX Light Level amp LED lights The monitor pulse blip bar initially increases in amplitude and then reduces and stabilizes at 3 5 bars 96 SpO2 QD min IL 15 b The monitor displays 75 SpO2 tes

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