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Specification

78 N5500 Service Manual

Technical

Information, N5500

9.9 Compliance

Item

Compliant with

Classification

Class I (on AC power) Internally powered (on battery power)

Type of protection

Type CF – Applied part

Mode of operation

Continuous

Resistant to liquid

Class IPX1 Drip-proof equipment

General Safety

IEC60601-1:1998+A1:1991+A2:1995

General requirements for Safety and Essential Performance

IEC60601-2-49:2001

Particular requirements for the Safety of Multifunction patient equipment

IEC60601-1-1:2000 Safety requirements for medical electrical systems

Alarms

EN475:1995 Electrically – generated alarm signals

IEC60601-1-8:2001 Draft

Alarm systems requirements, tests and guidances in medical electrical

equipments systems

Electrocardiograph

IEC60601-2-27:1994

Particular requirements for the safety of Electrocardiographic monitoring

equipment

AAMI EC53:1995+A1:1998 ECG cables and leadwires

Non-invasive

Blood Pressure

AAMI SP10:1992+A1:1996

Electronic or Automated Sphygmomanometers

EN1060-1:1995 Non-invasive sphygmomanometers

EN1060-3:1997

Supplementary requirements for electrical-mechanical blood pressure

measuring systems

IEC60601-2-30:1999

Particular requirements for the Safety, including essential performance, of

automatic cycling indirect blood pressure monitoring equipment

Oxygen saturation

EN865:1997 Pulse oximeters, Particular requirements

ASTM F 1415:1992 Standard specification for Pulse oximeters

ISO9919:1992 Pulse oximeters for medical use-requirements

ISO/W 9919:2001 Draft

Basic safety & essential performance of Pulse oximeter for medical use

Temperature

monitoring

EN12470-4:2001

Performance of Electrical Thermometers for continuous Measurement

Содержание OxiMax N 5500

Страница 1: ...Service Manual Patient Monitor...

Страница 2: ...ealthcare UK Ltd 154 Fareham Road Gosport PO13 OAS U K EU Representative Tyco Healthcare UK Ltd 154 Fareham Road Gosport PO13 OAS U K Tel 44 1 329 224 114 Fax 44 1 329 224 390 Manufactured for Tyco He...

Страница 3: ...rranties or merchantability and fitness for a particular purpose Tyco Healthcare shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furni...

Страница 4: ...ult Settings Troubleshooting Service Menu and Factory Default Settings 29 4 1 Introduction 29 4 2 Service Menu 29 4 3 Demo Mode 34 4 4 Factory Default Settings 34 Troubleshooting 37 5 1 Introduction 3...

Страница 5: ...a Different Carton 72 Technical Information Specifications 73 9 1 Display 73 9 2 Controls 73 9 3 Alarms 73 9 4 Physical 73 9 5 Electrical 74 9 6 Environmental Conditions 74 9 7 Measurement Parameters...

Страница 6: ...nit Block Diagram 85 Figure 21 Respiration Unit Block Diagram 85 Figure 22 SpO2 Unit Block Diagram 85 Figure 23 Temperature Unit Block Diagram 86 Figure 24 Analog Control Unit Block Diagram 86 Figure...

Страница 7: ......

Страница 8: ...r openings in the chassis WARNING Do not immerse the N5500 or its accessories in liquid or clean with caustic or abrasive cleaners WARNING Ensure that conductive portions of the electrodes leads and c...

Страница 9: ...sembling the N5500 patient monitor and when handling any of the components of the N5500 patient monitor CAUTION When reassembling the N5500 over tightening could strip out the screw holes in the cases...

Страница 10: ...e that accompany these accessories 1 3 Description of the N5500 Patient Monitor The purpose and function of the Nellcor N5500 patient monitor is to monitor ECG heart rate noninvasive blood pressure sy...

Страница 11: ...b Switch 5 Alarm Limits Icon 18 Low Battery Indicator 6 Big Numbers Icon 19 Battery Charging AC Power Indicator 7 NIBP Start Stop Switch 20 Pulse Amplitude Indicator 8 Power On Off Icon 21 Numeric Val...

Страница 12: ...er Connector 12 Heat Sink Figure 2 N5500 Rear Panel The N5500 patient monitor has a color liquid crystal display LCD The Numeric frames on the screen contain five numeric values are displayed The Grap...

Страница 13: ...ce N5500 1 ECG Respiration Connector 2 SpO2 Connector 3 NIBP Connector 4 Temperature Connector T2 5 Temperature Connector T1 Figure 3 N5500 Right Side Panel 1 Optional thermal printer or Printer cover...

Страница 14: ...spilled on the monitor clean and dry thoroughly before reuse Note If in doubt about monitor safety refer the unit to qualified service personnel For surface cleaning follow your institution s procedu...

Страница 15: ...4 Batteries If the N5500 has not been used for a long period of time the battery will need charging To charge the battery connect the N5500 to an AC outlet as described in Paragraph 3 3 1 in this ser...

Страница 16: ...ble 1 lists the equipment required for performance verification Table 1 Required Test Equipments Equipment Description Digital multimeter DMM Fluke Model 87 or equivalent ECG cable for 3 leadwires MDE...

Страница 17: ...ery may require a complete charge discharge cycle to restore its normal capacity depending on its previous usage 3 3 2 Battery Performance Test 1 The N5500 monitor is specified to typically operate on...

Страница 18: ...recharge battery 3 3 1 Battery Charge 3 3 3 Power On Self Test 1 Connect monitor to AC power source and verify AC Power indicator is lit 2 Observe monitor front panel With monitor off press Power On O...

Страница 19: ...e icon appears in each numeric frame on display c SpO2 display continues flashing d Audible alarm returns in approximately 60 seconds 3 3 4 2 QRS Volume Control 1 Press monitor Power On Off switch to...

Страница 20: ...ess the Power On Off switch to turn the monitor on 3 Connect DOC 10 pulse oximetry cable to the monitor 4 Connect a MAX A sensor to the pulse oximetry cable 5 Leave the sensor open with the LEDs and p...

Страница 21: ...160 BPM 200 BPM Heart Rate Alarm Lower Limits 50 BPM 75 BPM 100 BPM NIBP SYS Alarm Upper Limits 160 mmHg 120 mmHg 90 mmHg NIBP SYS Alarm Lower Limits 90 mmHg 70 mmHg 40 mmHg NIBP DIA Alarm Upper Limi...

Страница 22: ...when all the parameter signals display normally iii Verify the parameter values and waveforms are printed out with 25 mm s iv Verify printing stops with pressing Record switch again v Set Print speed...

Страница 23: ...tem CMS mode 7 Verify that first two transferred numbers are 55 and 01 8 Press the CLOSE button to exit the program 9 Enter the service code 900 in order to exit CMS mode 3 3 4 7 Network Test Perform...

Страница 24: ...d heart rate display will flash indicating heart rate is below default low alarm limit medium priority alarm 7 Increase heart rate setting on ECG simulator to 240 bpm a After about 15 seconds verify m...

Страница 25: ...f the N5500 pneumatic system The Bio Tek simulator or any equivalent NIBP simulator is required to perform these tests Each of the tests must be performed to verify pneumatic system functionality The...

Страница 26: ...ver is greater to successfully complete the test 3 3 5 2 2 Over Pressure Test The over pressure test verifies the functionality of the over pressure relief system 1 Ensure Bio Tek simulator is in Pres...

Страница 27: ...he knob 3 The N5500 displays pressure of approximately 290 mmHg automatically and measures inflation time in seconds 4 The test result displays at the test completion Note The test will have been succ...

Страница 28: ...light ii The monitor will display three dashes until the SRC MAX stabilizes at 90 SpO2 The test pass criteria is 88 to 92 SpO2 iii The monitor will display 90 SpO2 60 bpm no alarm 7 Test 2 Pulse rate...

Страница 29: ...equence verify the following monitor reactions a Monitor displays respiration rate of 120 3 breaths per minute b Audible alarm will sound High respiration rate limits violated message will display and...

Страница 30: ...Class I and Type CF 3 4 1 Protective Earth Continuity This test checks the integrity of the power cord ground wire from the AC plug to the instrument chassis ground The current used for this test is l...

Страница 31: ...perating instructions 2 Place a 200 cm2 foil in contact with the instrument case making sure the foil is not in contact with any metal parts of the enclosure that may be grounded 3 Measure the leakage...

Страница 32: ...lar manner by wrapping each sensor end individually with aluminum foil filled with conductive gel only enough gel to ensure conductivity Attach a wire to the foil that is connected to a test lead from...

Страница 33: ...ition the measured leakage current must not exceed that indicated in Table 6 Table 6 Patient Leakage Current Values Mains Voltage on Applied Part Test Condition Allowable Leakage Current microamps Nor...

Страница 34: ...combination as listed in Table 7 and measure each patient auxiliary current Table 7 Test Lead Combinations First Test Lead Second Test Lead ECG 1 LA ECG 3 RA ECG 1 LA ECG 2 LL ECG 2 LL ECG 3 RA ECG 1...

Страница 35: ......

Страница 36: ...or each setting in the N5500 Power on defaults are the settings in effect each time the N5500 is powered on Once the Service menu is entered physiological monitoring is terminated The screen layouts d...

Страница 37: ...s then press the knob 7 Repeat step 5 6 to enter all the access code 4 0 2 Figure 6 Service Menu 8 The Service Menu will now be present The available Service Menu items are explained in Figure 6 and T...

Страница 38: ...h Dutch English Finnish French German Greek Italian Norwegian Polish Portuguese Russian Spanish Swedish NIBP Test Mode Activate NIBP Test Mode screen see Table 11 System Information Activate System In...

Страница 39: ...nd it difficult to operate the monitor NIBP Test Mode WARNING A blood pressure cuff connected to the monitor should never be applied to a human subject while the monitor is in NIBP test Mode as injury...

Страница 40: ...ervice Menu System Information This screen displays several system related items Table 11 System Information System Information Description Monitor On Time Displays the number of hours rounded to the...

Страница 41: ...lt settings are divided into three groups adult pediatric and neonatal as described in Table 12 The parameters of the N5500 monitor are preset to Adult monitoring mode Alarm limits settings will be au...

Страница 42: ...39 0 C 102 2 F T1 Alarm Lower Limits 36 0 C 96 8 F 36 0 C 96 8 F 36 0 C 96 8 F T2 Alarm Upper Limits 39 0 C 102 2 F 39 0 C 102 2 F 39 0 C 102 2 F T2 Alarm Lower Limits 36 0 C 96 8 F 36 0 C 96 8 F 36...

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Страница 44: ...medical facility does not have qualified service personnel contact Nellcor Technical Services or your local Nellcor representative 5 4 Replacement Level Supported The replacement level supported for t...

Страница 45: ...f the categories in Table 13 are discussed in the following paragraphs Table 13 Problem Categories Problem Area Refer to Paragraph 1 Power No power up Fails power on self test Powers down without appa...

Страница 46: ...4 Inside monitor check SMPS to Rear communication board DC wire connected to SMPS and Rear communication PCB 5 Ensure Power Switch PCB is plugged into Main PCB assembly If connection is good replace P...

Страница 47: ...oblem persists replace LCD cable 4 If the problem persists replace Main PCB assembly 5 If the problem persists replace backlight inverter 6 If the problem persists replace LCD panel 3 LCD screen has d...

Страница 48: ...address problems with the display and audible tones Table 17 Alarms Audible Tones Problems Symptom Recommended Action 1 Alarm sounds for no apparent reason 1 Moisture or spilt liquids can cause an ala...

Страница 49: ...ce 1 Open printer door and check paper is present 2 If problem persists ensure printer wire is connected to SpO2 PCB assembly 3 If problem persists replace printer 3 Printer paper will advance but pap...

Страница 50: ...ror EEE260 SpO2 module Packet contains unsupported Key EEE261 SpO2 module Packet CRC error EEE262 SpO2 module End of Packet missing EEE263 SpO2 module Packet contains undefined Key EEE267 SpO2 module...

Страница 51: ...IBP module Busy response EEE705 NIBP module Single failure message EEE706 NIBP module Zero pressurization message EEE707 NIBP module No initialization EEE708 NIBP module error EEE801 Analog system ECG...

Страница 52: ...SD electrostatic discharge precautions when working within the unit Note Some spare parts have a business reply card attached When you receive these spare parts please fill out and return the card 6 1...

Страница 53: ...rinter or Printer Cover Main PCB Backlight Inverter Alarm LED PCB TFT LCD Panel Function Switch PCB Power Switch PCB Encoder Knob Alarm Indicator Window SMPS Rear Communication PCB NIBP Module Cooling...

Страница 54: ...persists swap back the replacement PCB with the suspected malfunctioning PCB the original PCB that was installed when you started trouble shooting and continue troubleshooting as detected in this sec...

Страница 55: ...then replace a new fuse 250V 4A Battery Fuse or External DC Fuse Replacement a Step B2 1 SMPS disassembly b Ensure a blown fuse F1 External DC Fuse 250V 6 3A F2 Battery Fuse 250V 6 3A c Replace a new...

Страница 56: ...scribes the steps to remove the battery from the N5500 for replacement without disassembling the main case of the monitor R Battery Disassembly a Remove 2 screws on the lower part of the rear case hol...

Страница 57: ...steps to separate the front and rear case assemblies Before the steps A and B a Remove the monitor s 6 screws b Separate the front case from the rear case c Turn down the grabbers of the Main board ca...

Страница 58: ...acket from the front case a Disconnect the Encoder wire the Function switch board wire and the Power switch board wire from the Main PCB b Remove 4 corner screws on the LCD Bracket c Remove the LCD Br...

Страница 59: ...Parts N5500 CAUTION Be careful of disconnecting the LCD cable because the LCD connector cover is weak A1 2 TFT LCD Panel Disassembly a Remove the LCD window from the LCD panel b Disconnect the LCD bac...

Страница 60: ...cklight Inverter Disassembly a Disconnect the LCD backlight wire and the Inverter wire from the Backlight inverter b Remove 3 screws on the Backlight inverter A1 4 Alarm LED PCB Disassembly a Disconne...

Страница 61: ...sassembly a Pull the Knob straight out from the front case CAUTION Be careful when pulling the Knob because the Encoder may be damaged b Turn the Encoder to the left in order to remove the Encoder fro...

Страница 62: ...ce Manual 55 Disassembly Guide Spare Parts N5500 A2 3 Power Switch PCB Disassembly a Remove 3 screws on the Power switch PCB A2 4 Alarm Indicator Window Disassembly a Push the latches slightly to remo...

Страница 63: ...the rear case assembly B Rear Case Disassembly B1 SMPS Bracket Disassembly a Remove 4 screws and washers on the rear case b Separate the rear case from the rear case assembly B1 1 SMPS Disassembly a...

Страница 64: ...Communication PCB Disassembly a Remove 6 screws on the Rear communication PCB b Disconnect the Main board cable the SMPS to Rear board DC wire the Speaker wires and the Fan wire from the Rear communi...

Страница 65: ...e left in order to remove it A nut is firmly on the back of the GND terminal Turn the nut to the left in order to remove it c Push both side of the latches on the AC inlet slightly to remove the AC in...

Страница 66: ...Guide Spare Parts N5500 B1 5 Cooling Fan Disassembly a Remove 4 corner screws on the cooling fan b Remove the cooling fan from the SMPS bracket B2 Analog Bracket Disassembly B2 1 SpO2 module and SpO2...

Страница 67: ...rom the SpO2 module c Remove 3 PCB supporters on the SpO2 module d Remove the PI cable from the SpO2 module e Remove the SpO2 module f Turn down the grabbers of the Main board cable connector and the...

Страница 68: ...e the SpO2 PCB B2 2 ECG PCB Disassembly a Disconnect the ECG wire and the Temperature wires from the ECG PCB b Remove 4 corner screws on the ECG PCB c Remove the PCB supporters on the ECG PCB d Remove...

Страница 69: ...nnectors Wall Disassembly a After the SMPS bracket and the Analog Boards are disassembled as described in B1 and B2 remove 4 corner screws fastening the Side connectors wall to the SMPS bracket b Remo...

Страница 70: ...rom the Side connectors wall C 2 ECG Connector Disassembly a Remove 4 corner screws on the ECG connector b Remove the ECG connector from the Side connectors wall C 3 Temperature Connector Disassembly...

Страница 71: ...Manual Disassembly Guide Spare Parts N5500 C 4 NIBP Connector Disassembly a Remove the NIBP hose from the NIBP connector b Turn to the left a nut fastening the NIBP connector c Remove the NIBP connec...

Страница 72: ...ction describes the steps that may remove an optional printer in the N5500 If you would like to install a printer follow the reverse sequence of the procedures B3 Printer Disassembly The rear case sep...

Страница 73: ...Disassembly Guide 66 N5500 Service Manual Disassembly Guide Spare Parts N5500 B3 Printer Disassembly c Remove 2 screws inside the Printer door d Remove the Printer...

Страница 74: ...ble 20 Item No corresponds to the circled callout numbers in Figure 8 7 2 Obtaining Replacement Parts Nellcor Technical Service provides technical assistance information and replacement parts To obtai...

Страница 75: ...Spare Parts 68 N5500 Service Manual Disassembly Guide Spare Parts N5500 Figure 8 N5500 Exploded View...

Страница 76: ...ule 13 M2005 0 SMPS 14 M4012 0 LCD 6 4 TFT 15 M4014 0 Printer 16 M6005 0 Battery 17 M8001 0 Backlight Inverter 18 P1016 0 Main Board 19 P1017 0 ECG Board 20 P1018 0 SpO2 Board 21 P1019 0 Rear Communic...

Страница 77: ...e 46 W0064 0 Main BD Cable 47 W0065 0 NIBP Cable 48 W0066 0 Analog BD Cable 49 W0067 0 Function SW BD Wire 50 W0068 0 Backlight Inverter Wire 51 W0069 0 LED BD Wire 52 W0071 0 Power SW BD Wire 53 W007...

Страница 78: ...pplier or local Nellcor office Technical Services Department for a returned goods authorization number Mark the shipping carton and any shipping documents with the returned goods authorization RGA num...

Страница 79: ...lastic bag 2 Locate a corrugated cardboard shipping carton with at least 200 pounds per square inch psi bursting strength 3 Fill the bottom of the carton with at least 2 inches of packing material 4 P...

Страница 80: ...Waveforms Maximum 9 2 Controls Standard Trim Knob control 5 soft switches Power On Off NIBP start stop Record Home Alarm Silence Suspend 9 3 Alarms Categories Patient Status and System Status Prioriti...

Страница 81: ...ating Shelf Life 2 months new fully charged battery Complies with 91 157 EEC 9 6 Environmental Conditions Operation Temperature 5 C to 40 C Humidity 15 RH to 95 RH non condensing Altitude 0 ft to 10 0...

Страница 82: ...S ECG Electrocardiograph Output Frequency Response Bandwidth Low Extend 0 05 Hz to 40 Hz Filter 0 5 Hz to 30 Hz Monitor 0 5 Hz to 40 Hz ECG Size sensitivity 1 25 1 7 2 5 5 0 7 5 10 0 15 0 20 0 mm per...

Страница 83: ...mmHg Neonatal 5 mmHg to 150 mmHg Pressure Display Accuracy Mean error and standard deviation per ANSI AAMI SP10 1992 A1 1996 Pressure Sensor Accuracy 3 mmHg or 2 of reading whichever is greater per AN...

Страница 84: ...N5500 Neonate specifications are shown for OxiMax MAX N sensors with the N5500 Saturation accuracy will vary by sensor type 2 Applicability accuracy with motion OxiMax sensors 3 Specification applies...

Страница 85: ...diograph IEC60601 2 27 1994 Particular requirements for the safety of Electrocardiographic monitoring equipment AAMI EC53 1995 A1 1998 ECG cables and leadwires Non invasive Blood Pressure AAMI SP10 19...

Страница 86: ...ission IEC61000 4 2 Electrostatic Discharge IEC61000 4 3 Radiated RF electromagnetic field IEC61000 4 4 Electrical fast transient burst IEC61000 4 5 Surge current CISPR 11 EN55011 RF Emissions Group 1...

Страница 87: ......

Страница 88: ...arious microprocessor programmed analytical functions l Creating both visual and audible alarm signals when settable limits are violated l Creating and displaying warning error messages when condition...

Страница 89: ...ort Interface Serial Interface Serial Interface General Purpose Port Interface Figure 10 N5500 System Block Diagram 2 ECG UNIT Respiration UNIT SpO2 UNIT Temperature UNIT IOP UNIT Analog Control UNIT...

Страница 90: ...ROM and Flash S3C44B0X SDRAM Boot Memory Selection Signal FLASH Boot ROM Boot Memory Selector UART RTC Watch Dog Timer GPIO SDRAM Data Source Program Source Program Selection Switch SpO2 Unit IOP Unit...

Страница 91: ...IBP UNIT Asyncronous Serial Communication with Analog Control Unit Asyncronous Serial Communication with TCP IP UNIT Asyncronous Serial Communication with Printer UNIT Figure 16 Communication Unit Blo...

Страница 92: ...Sat Detector Lead off detector RL Driver Signal Sat Detector Instrument AMP Gain AMP Filter Instrument AMP Gain AMP Filter Instrument AMP Gain AMP Filter MUX Level Conversion Patient Cable Lead Selec...

Страница 93: ...unit analog circuit control PIC16C65 selection of ECG channels and filter size adjustment verification of lead off QRS heart rate etc Asyncronous Serial Communication with Communication UNIT PIC16C65...

Страница 94: ...tions l They detect a lead off condition if one of the electrode connections is disrupted l They detect the presence of pacemaker signals within the QRS waveform complex of the ECG 10 4 NIBP Processin...

Страница 95: ...could not represent the MAP point exactly On clinical trial perspective overall system accuracy is not easy to be determined The clinical trial test protocols have been tried and have been described i...

Страница 96: ...works by applying a sensor to a pulsating arteriolar vascular bed The sensor contains a dual light source and photodetector Bone tissue pigmentation and venous vessels normally absorb a constant amou...

Страница 97: ...sorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies an oximeter must know the mean wavelength of the sensor s red LED to accurately measure SpO2 During manufa...

Страница 98: ...the sensor memory chip check it to make sure that there are no errors and then load the data to begin monitoring The monitor containing OxiMax Technology uses calibration data contained in the sensor...

Страница 99: ...ce in amplifying at the definite level of signal This extracted thoracic impedance signal is used to measure the respiration by digital signal processing 10 7 Temperature Processing Measurement of pat...

Страница 100: ......

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