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Manufacturer’s Declaration and Guidance

Service Manual

2-13

Enclosure Leakage Current

Condition

AC Line Polarity

Neutral

Line Cord

Power Line

Ground

IEC 60601-1

ANSI/AAMI 60601-1

Normal

Closed

100 μA

Single Fault

Open

Closed

500 μA

Closed

Open

Normal

Reversed

Closed

100 μA

Single Fault

Open

Closed

500 μA

Closed

Open

Table 2-10.

Earth and Enclosure Leakage Current Specifications (Continued)

Table 2-11.

Patient Applied and Patient Isolation Risk Current

Patient Applied Risk Current

Condition

AC Line Polarity

Neutral Line

Power Line

Ground Cable

IEC 60601-1

ANSI/AAMI 60601-1

Normal

Closed

100 μA

Single Fault

Open

Closed

500 μA

Closed

Open

Normal

Reversed

Closed

100 μA

Single Fault

Open

Closed

500 μA

Closed

Open

Patient Isolation Risk Current

Condition

AC Line Polarity

Neutral Line

Power Line

Ground Cable

IEC 60601-1

UL 60601-1

Single Fault

Normal

Closed

5000 μA

Reversed

Closed

Содержание Nellcor GR101704

Страница 1: ...Service Manual Nellcor Bedside Respiratory Patient Monitoring System...

Страница 2: ...able version of this manual If in doubt contact Covidien Technical Services While the information set forth herein is believed to be accurate it is not a substitute for the exercise of professional ju...

Страница 3: ...2 2 Physical Characteristics 2 1 2 3 Electrical Requirements 2 1 2 3 1 Power 2 1 2 3 2 Battery 2 2 2 3 3 Rating of Nurse Call Relay 2 2 2 4 Environmental Conditions 2 3 2 4 1 Operating 2 3 2 4 2 Trans...

Страница 4: ...gement Parameter 3 13 4 Product Overview 4 1 Overview 4 1 4 2 Product Description 4 1 4 3 Indications for Use 4 1 4 4 List of Components 4 2 4 5 Synopsis 4 2 4 6 Product Views 4 3 4 6 1 Front Panel 4...

Страница 5: ...Service Mode 6 16 6 5 1 Settings Menu 6 19 6 5 2 Service Menu 6 31 6 5 3 Logs Menu 6 31 6 5 4 Covidien Service Menu 6 32 6 5 5 Parameter Activation Menu 6 33 6 5 6 About Monitor Menu 6 33 7 Trend Dat...

Страница 6: ...onal Defaults 10 5 10 3 Performance Verification 10 8 10 3 1 Overview 10 8 10 3 2 Required Equipment 10 8 10 4 Safety Testing Standards 10 9 10 5 Battery Check 10 10 10 5 1 Battery Power 10 10 10 5 2...

Страница 7: ...r Battery Access Door Replacement 12 7 12 4 3 Rubber Feet Replacement 12 8 12 5 Chassis Disassembly and Reassembly 12 10 12 5 1 Parameter Module Replacement 12 10 12 5 2 Monitoring System Chassis Disa...

Страница 8: ...Page Left Intentionally Blank vi...

Страница 9: ...e 6 2 Possible User Interface Settings 6 16 Table 6 3 Possible Alarm Management Settings 6 17 Table 6 4 Possible Data Interface Settings 6 18 Table 6 5 Possible Service Functions 6 18 Table 7 1 Input...

Страница 10: ...1 7 Common Prompts and Error Messages 11 16 Table 11 8 Common Operational Performance Issues 11 17 Table 11 9 Common Prompts and Error Messages 11 17 Table 12 1 Available Spare Parts 12 1 Table 12 2 R...

Страница 11: ...ITORING 6 11 Figure 6 6 High priority alarm BATTERY CRITICALLY LOW 6 11 Figure 6 7 Medium priority alarm SpO2 LOW 6 11 Figure 6 8 Low priority alarm SENSOR OFF 6 12 Figure 6 9 Sample Alarm Limit Viola...

Страница 12: ...vable Components 12 3 Figure 12 2 Exploded View of Internal Components 12 4 Figure 12 3 External Fuse Removal 12 7 Figure 12 4 Battery Removal 12 8 Figure 12 5 Rubber Feet Replacement 12 9 Figure 12 6...

Страница 13: ...Audience This manual provides information to professionals acting as trained and quali fied service technicians in a hospital or hospital type setting for maintenance and service or repair of the mon...

Страница 14: ...njury WARNING Use only Covidien approved internal batteries WARNING The monitoring system is not defibrillator proof It may remain attached to the patient during defibrillation or during use of an ele...

Страница 15: ...em is clear of any obstructions that prevent awareness of visual or audible alarms Failure to do so may result in inadvertently missing a visual alarm or an inaudible alarm tone WARNING Do not use any...

Страница 16: ...e instrument connected to it must utilize a grounded outlet Any equipment connected to the data interface must be certified according to the latest IEC EN 60950 1 standard for data processing equipmen...

Страница 17: ...le using the monitoring system to order parts or to order an Operator s or Service Manual contact Covidien or a local Covidien representative When calling Covidien or a local Covidien representative h...

Страница 18: ...ting the monitoring system and troubleshooting errors or malfunctions Before using the monitoring system thor oughly read this manual Nellcor Sensor Instructions for Use Guides sensor selection and us...

Страница 19: ...re all product requirements are met prior to installation 2 2 Physical Characteristics 2 3 Electrical Requirements 2 3 1 Power Weight 7 5 lbs 3 4 kg Dimensions 10 in x 6 5 in x 5 in 252 mm x 163 mm x...

Страница 20: ...Lithium Ion Voltage 7 2 Volts DC 11 6 Ah 83 Wh Recharge 8 hours with monitoring system turned off 12 hours with monitoring system turned on Shelf Life Four months if monitoring system runs on new full...

Страница 21: ...t to 15 000 ft Atmospheric Pressure 105 kPa to 57 2 kPa 31 0 in Hg to 16 89 in Hg Relative Humidity 15 to 95 non condensing Not in shipping container In shipping container Temperature 20 C to 60 C 4 F...

Страница 22: ...expressed as 1 SD Because pulse oximeter equipment measurements are statistically distributed about two thirds of the measurements can be expected to fall in this accuracy ARMS range refer to the Sen...

Страница 23: ...rity 88 1 dB 85 5 dB 80 6 dB 71 5 dB Medium Priority 78 3 dB 75 4 dB 70 2 dB 61 2 dB Low Priority 74 4 dB 71 1 dB 66 4 dB 57 6 dB SPD Alarm Low Priority 74 4 dB 70 7 dB 65 7 dB 57 5 dB Equipment Class...

Страница 24: ...ult in inaccurate readings of the monitoring system and increased EMI emissions of the monitoring system The monitoring system is suitable for prescription use only in the specified electro magnetic e...

Страница 25: ...the monitoring system should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 EN 55011 Group 1 Class A Not intended for...

Страница 26: ...at of a typical commercial and or hospital environment Surge IEC EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a ty...

Страница 27: ...ommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb I...

Страница 28: ...Rated Maximum Output Power P of Transmitter in Watts Separation Distance According to Frequency of Transmitter in Meters 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1...

Страница 29: ...X N 1 5 ft 0 5 m Nellcor Infant SpO2 Sensor Sterile single use only MAX I Nellcor Pediatric SpO2 Sensor Sterile single use only MAX P Nellcor Adult SpO2 Sensor Sterile single use only MAX A Nellcor Ad...

Страница 30: ...og 15 pin D 3 3 ft 1 m Printer cable RS 232 15 to 9 pin D 10 0 ft 3 m Philips interface cable M1943 NL 3 3 ft 1 m Oxinet III hardwire cable 10 0 ft 3 m Oxinet III data cable Table 2 9 Sensor and Cable...

Страница 31: ...Leakage Current Specifications Continued Table 2 11 Patient Applied and Patient Isolation Risk Current Patient Applied Risk Current Condition AC Line Polarity Neutral Line Power Line Ground Cable IEC...

Страница 32: ...Page Left Intentionally Blank 2 14 Service Manual Product Specifications...

Страница 33: ...his chapter explains the theory behind operations of the Nellcor Bedside Respiratory Patient Monitoring System 3 2 Block Diagram The functional block diagram provides a quick visual overview of the mo...

Страница 34: ...ial blood in tissue and hence light absorption by that blood changes during the pulse registered using plethys mography A monitoring system determines SpO2 by passing red and infrared light into an ar...

Страница 35: ...vidien Nellcor monitoring systems sensors and cables Reference the individual testing device s operator s manual for the procedures specific to the model of tester used While such devices may be usefu...

Страница 36: ...in or methemoglobin In contrast hemoximeters such as the IL482 report fractional saturation where oxygenated hemoglobin is expressed as a percentage of all measured hemoglobin including measured dysfu...

Страница 37: ...terference or a combination of these factors which results in an increase in the dynamic averaging If the resulting dynamic averaging time exceeds 20 seconds for SpO2 the monitoring system displays th...

Страница 38: ...sor data prior to monitoring for new information As the monitoring system reads sensor information it sends the sensor model number to the monitoring screen This process may take a few seconds The sen...

Страница 39: ...ach time it violates the alarm threshold SatSeconds monitors both degree and duration of desaturation as an index of desaturation severity Thus the SatSeconds parameter helps dis tinguish clinically s...

Страница 40: ...of the event is two 2 seconds before saturation again exceeds the lower alarm threshold of 85 Because the SatSeconds alarm limit is set to 25 and the actual number of SatSeconds equals 12 there is no...

Страница 41: ...ion of the event is 15 seconds before saturation again exceeds the lower alarm threshold of 85 Because the SatSeconds alarm limit is set to 25 and the actual number of SatSeconds equals 15 there is no...

Страница 42: ...hreshold of 85 Since the patient s saturation does not return to a value over the lower alarm threshold within 2 5 seconds an alarm sounds At this level of saturation the event cannot exceed 2 5 secon...

Страница 43: ...uration A patient s respiratory compromise can be proportionally more severe before patterns appear in the saturation trend Remain vigilant when monitoring a patient on supplemental oxygen Caution Do...

Страница 44: ...that may increase in acuity if left untreated Patterns of desaturation are multiple sequential occurrences of a desaturation followed by a resaturation The SPD parameter qualifies patterns of desatura...

Страница 45: ...lts indicate SPD is a sensitive marker in detecting repetitive reductions in airflow 3 7 4 Pulse Rate Delay Alarm Management Parameter The monitoring system also monitors pulse rate by determining the...

Страница 46: ...Page Left Intentionally Blank 3 14 Service Manual Theory of Operations...

Страница 47: ...2 and pulse rate of adult pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused The monitoring system is intended for use in hosp...

Страница 48: ...r to a patient When the monitoring system detects a valid pulse it enters monitoring mode and displays patient parameters The movement of the blip bar or the plethysmographic waveform and the flashing...

Страница 49: ...nection to alternating current power source 7 Data port Houses DB 15 serial connector 3 Battery condition indicator Indicates battery is charging 8 Ethernet port Houses RJ 45 ethernet receptacle 4 Spe...

Страница 50: ...e sensor signals reflecting relative pulsatile strength 5 Trend data time scale Contains time period for graphed trend data Press or to change the time period 6 Battery fuel gauge Indicates remaining...

Страница 51: ...o bottom as the patterns become less severe If the icon fills completely an alarm sounds 15 Pulse rate BPM upper and lower limits Displays current upper and lower alarm limit settings to the right of...

Страница 52: ...ce duration not shown counts down on screen Pulse amplitude blip bar Not shown in figure Indicates pulse beat and the relative non normalized pulse amplitude in numbers only view As the detect ed puls...

Страница 53: ...unications Commission Compliance with FCC Protection against fluid ingress This side up Atmospheric pressure limitations Keep dry Temperature limitations Fragile Humidity limitations Do not use during...

Страница 54: ...Page Left Intentionally Blank 4 8 Service Manual Product Overview...

Страница 55: ...ian install and set up the monitoring system after performing functional tests per the Service Manual 5 2 Safety Reminders WARNING Explosion hazard Do not use the monitoring system in the presence of...

Страница 56: ...C power to the monitoring system WARNING Use only Covidien approved sensors and interface cables when connecting to the sensor connector Connecting any other cable or sensor influences the accuracy of...

Страница 57: ...power is not available The monitoring system commu nicates the transition from AC power to battery power or from battery power to AC power via the AC power or battery indicator on the front panel A ne...

Страница 58: ...the monitoring system Reference Rear Panel p 4 6 2 Plug the male connector of the power cord into a properly grounded AC outlet 3 Verify the monitoring system s AC power indicator lights Note If the A...

Страница 59: ...excessive tem peratures may trigger the thermal fuse which permanently shuts down the battery Should this occur replace the battery pack To fully charge the battery 1 Connect the monitoring system to...

Страница 60: ...e power from the internal battery than others Duration of operation depends on the battery charge status Avoid power intensive conditions for ideal battery usage The following condi tions will help ac...

Страница 61: ...ical procedures or external agents such as dysfunctional hemoglobin arterial dyes low perfusion dark pigment and externally applied coloring agents such as nail polish dye or pigmented cream may inter...

Страница 62: ...he patient after reading the Instructions for Use accompanying the sensor 6 When the monitoring system detects a valid pulse it enters the monitoring mode and displays real time patient data 7 Detach...

Страница 63: ...orm regular maintenance and safety checks every 24 months In the case of mechanical or functional damage contact Covidien or a local Covidien rep resentative 6 2 Power WARNING Explosion hazard Do not...

Страница 64: ...voltage condition Battery Status Reference Battery Power Usage p 5 6 for details on initial internal battery setup information The yellow BATTERY LOW warning flashes and a medium priority alarm sound...

Страница 65: ...able Do not dispose of the battery by placing it in the regular trash Dispose of the battery in accordance with local guidelines and regulations or contact Covidien to arrange for disposal Note As the...

Страница 66: ...so carefully view the splash screen during power on Verify there are no black gaps on the monitoring screen during power on self test POST or when every pixel on the screen is completely lit Should u...

Страница 67: ...ition to serving as the POST pass verification the POST pass tone also functions as an audible confirmation that the speaker is performing properly If the speaker does not function the alarm warning s...

Страница 68: ...such as nail polish dye or pigmented cream may interfere with the monitoring system s ability to detect and display measurements 6 2 4 System Resets If the monitoring system issues a system reset bas...

Страница 69: ...ch any cable intended for computer use to the sensor port WARNING Use only Covidien approved sensors and interface cables when connecting to the sensor connector Connecting any other cable or sensor i...

Страница 70: ...icon are visual indicators of real time data The pulse beep tone is an audible indicator of the real time patient data When users first apply a recommended sensor to a patient the monitoring system m...

Страница 71: ...nate default Institutional default settings require changes to the available options in Service Mode by a qualified service technician Figure 6 3 Default Monitoring Screen Layout 6 4 2 Status Messages...

Страница 72: ...Management and Status Messages The status field at the top of the monitoring screen contains information describ ing overall monitoring system status and any active alarms If multiple alarms occur du...

Страница 73: ...MONITORING status message is the most common of this type Figure 6 4 Sample user prompt message READY Figure 6 5 Sample status message MONITORING High priority alarm messages High priority alarms take...

Страница 74: ...recommended action 4 Clear the alarm message by pressing the EXIT or DISMISS ALARM button Limit Threshold Violation Indicators The monitoring system reports real time patient data If that data falls o...

Страница 75: ...iority of the alarm Caregivers may choose to silence alarms by pressing ALARM SILENCE For any alarm condition still active for more than two 2 minutes the monitoring system will increase the urgency l...

Страница 76: ...Mode SILENCE ALARM remains available at all times Not active If SILENCE ALARM is not active the SILENCE ALARM icon remains white on a grey background Active If SILENCE ALARM is active the SILENCE ALA...

Страница 77: ...s Institutions may choose to allow caregivers to turn off or dim the backlight thus also dimming visual alarms The factory default is to enable the WAKE DISPLAY ON ALARM option The monitoring system t...

Страница 78: ...8 12 24 or 48 hours 1 hour Monitoring history trend scale 15 or 30 minutes 1 2 4 8 12 24 or 48 hours 1 hour Screen Brightness 0 25 50 75 100 75 Allow backlight OFF Yes No No Wake display on alarm Yes...

Страница 79: ...Alarm Yes No time remaining No no time displayed ALARM SILENCE Duration OFF 30 60 90 120 seconds 120 seconds Sensor Alarm Priorities Sensor Disconnect Sensor Off Sensor Failure Note Each alarm can be...

Страница 80: ...sible Setting Factory Default Remote settings Wireless LAN ASCII SPDOut Disconnected LAN ASCII SPDOut Disconnected Nurse call priority RS 232 Normally normally Normally Serial connection ASCII 9600 or...

Страница 81: ...rompt Figure 6 10 Prompt to Enter SERVICE MODE 5 Enter 62907 as the service mode password at the prompt using the onscreen number pad 6 Press ENTER SERVICE MODE 7 Select the desired menu option and an...

Страница 82: ...SpO2 and pulse rate alarm limit thresholds as well as SatSeconds Pulse Rate Delay and SPD parameter default settings To set SatSeconds Pulse Rate Delay and SPD Alert parameter defaults 1 Access the se...

Страница 83: ...t ALARM DISABLED REMINDER to set permissions for the alarm disabled reminder 5 Select the desired default a Select NO if the institution does not permit caregivers using the parameter b Leave it YES i...

Страница 84: ...slide bars up or down to set upper and lower alarm limits c Select SATSECONDS and set to 10 25 50 or 100 SatSeconds or OFF d Select SPD and set the sensitivity to 1 2 or 3 or OFF e Select PULSE RATE D...

Страница 85: ...he default trend scale when viewing trend information Default is one 1 hour Monitoring History Scale Use to set the default trend scale when viewing the monitoring history Default is one 1 hour Backli...

Страница 86: ...set the default main trend parameters 1 Access the service function menu Reference To access service function menus p 6 18 2 Select SETTINGS 3 Select DISPLAY SETTINGS 4 Select MAIN SCREEN TREND PARAM...

Страница 87: ...the change b Press CANCEL to leave the default as it was To adjust default backlight brightness 1 Access the service function menu Reference To access service function menus p 6 18 2 Select SETTINGS 3...

Страница 88: ...t SETTINGS 3 Select DISPLAY SETTINGS 4 Select WAKE DISPLAY ON ALARM 5 Select the desired default YES or NO 6 Select the desired option a Press SAVE CHANGES to retain the change b Press CANCEL to leave...

Страница 89: ...iguring a medical system and therefore is responsible for ensuring the system complies with the Require ments for Medical Electrical Systems IEC Standard 60601 1 2007 and the electro magnetic compatib...

Страница 90: ...the change b Press CANCEL to leave the default as it was To set default WLAN or LAN network connectivity 1 Access the service function menu Reference To access service function menus p 6 18 2 Select...

Страница 91: ...oring Settings Alarm Mode Use to set the default alarm mode to adult settings or neonate settings Date and Time Use to set the default display for date and time or after a soft ware update Response Mo...

Страница 92: ...y or year a Press the desired month day or year b Press decrement to decrease the month day or year c Press increment to increase the month day or year 7 Adjust to the desired date format a Press DATE...

Страница 93: ...Press BACK to return to the previous submenu b Press EXIT MENU 6 5 2 Service Menu Reference Monitoring Screen Calibration p 10 44 for monitoring screen cal ibration instructions Reference Software and...

Страница 94: ...s such as FIRST PREVIOUS NEXT or LAST 5 Press CANCEL To export logs 1 Access the service function menu Reference To access service function menus p 6 18 2 Select LOGS 3 Select the desired option a Sel...

Страница 95: ...llow instructions per the activation instructions in the upgrade kit b Press CANCEL 5 If continuing press NEXT 6 If continuing press FINISH 7 Select the desired option a Press BACK to return to the pr...

Страница 96: ...Operation 6 34 Service Manual a Press an alternate menu option b Press EXIT AND RESTART to exit SERVICE MODE...

Страница 97: ...ient or not and retains this information even during total loss of power It can store up to 48 hours of trend data which is available for download when desired Users may view real time and historical...

Страница 98: ...nd two antennae Each data port has a different intended use 1 Serial DB 15 data port This female DB 15 port provides RS 232 RS 422 and differential transmission data connectivity Use for sending histo...

Страница 99: ...result in bad or missing data WARNING Only use Covidien approved hardware or remote monitoring software for data port connectivity Table 7 2 Sample Equipment Types Type Description Serial connection...

Страница 100: ...Accuracy may degrade if it is connected to secondary I O devices when equipment is not connected to earth reference Use the appropriate configuration information to ensure proper connectivity When co...

Страница 101: ...120 ohms 1 2 watt 5 between pin 1 and pin 9 of the cable and keep cable length to a maximum of 4 000 feet Plug the end of the cable with the resistor added into the monitoring system Table 7 3 DB 15...

Страница 102: ...ector on the equipment No hardware flow control is used However support exists for XON XOFF flow control in ASCII mode 100base T RJ 45 Requirements Caution Do not create sharp bends in the cable Bend...

Страница 103: ...Layout 1 LED 1 Indicates data exchange 2 LED 2 Indicates a valid 100base T TCP IP link Table 7 4 RJ 45 Signal Pinouts Pin Signal Name Description Pin Signal Name Description 1 TX_D1 output 5 Not used...

Страница 104: ...t Covidien or a qualified service technician for upgrade support The pin layout illustrates the pins viewed from the left to the right of the USB connector beginning with pin 4 The data lines are shie...

Страница 105: ...ork can only be performed through the Service Menu connectivity options Reference Connectivity Settings p 6 27 The wireless configuration supports either ASCII or SPDout options and will both transmit...

Страница 106: ...ess the NETWORK PROPERTIES icon 3 Attach a USB keyboard to enter any alphanumeric information 4 Detach the USB keyboard 5 Press FINISH Delete network configuration Secured network Types of security su...

Страница 107: ...nnection Windows 3 Attach a USB keyboard to enter any alphanumeric information 4 Type in the assigned network name 5 Select the network type 6 Select the security type 7 Input the security key 8 Selec...

Страница 108: ...ion Windows 4 Press the available desired option from broadband dial up or VPN 5 Attach a USB keyboard to enter any alphanumeric information 6 Input the assigned user name 7 Input the assigned passwor...

Страница 109: ...tings 5 Press the NETWORK PROPERTIES icon next to the desired network 6 Press IP properties 7 Press Static in the upper right corner 8 Attach a USB keyboard 9 Input the IP address and subnet mask 10 P...

Страница 110: ...ONNECTIVITY SETTINGS 3 Select the desired protocol for data exchange 4 Press SAVE CHANGES to save the selected setting 7 4 Using the Nurse Call Interface 7 4 1 Nurse Call Feature WARNING Do not use th...

Страница 111: ...DC depending on the option chosen either NORM or NORM With an audible alarm the output between pins 5 and 11 will reverse polarity Pins 7 and 15 provide a relay that closes when an alarm is sounding o...

Страница 112: ...The nurse call polarity can be set to a positive signal or a negative signal during an alarm condition To set nurse call polarity 1 While in normal monitoring mode press MENU 2 Press CONNECTIVITY SET...

Страница 113: ...cific measured parameter s current value The voltage differential varies proportionally from 0 0 to 1 0 VDC as the pin s parameter varies over its full range of values For example as the current value...

Страница 114: ...Page Left Intentionally Blank 7 18 Service Manual Trend Data Access...

Страница 115: ...250 bpm appear as 250 Detected pulse rates below 20 appear as a zero 0 Saturation The monitoring system displays saturation levels between 1 and 100 8 2 2 Nellcor Sensor Performance Considerations WA...

Страница 116: ...o cover the sensor site with opaque material when operating under high ambient light conditions Excessive patient movement Dark skin pigment Intravascular dyes or externally applied coloring such as n...

Страница 117: ...orehead SpO2 sensors work particularly well on supine patients and mechanically ventilated patients During low perfusion con ditions Nellcor forehead SpO2 sensors reflect changes to SpO2 values up to...

Страница 118: ...2 2007 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation Because of the proliferation of radio frequency transmitting equipment...

Страница 119: ...on to isolate the interfering equipment Reorient or relocate the interfering equipment Increase the separation between the interfering equipment and the monitoring system The monitoring system genera...

Страница 120: ...Page Left Intentionally Blank 8 6 Service Manual Performance Considerations...

Страница 121: ...Disinfection Use a soft cloth saturated with a solution of 10 chlorine bleach in tap water lightly wiping the surface of the monitoring system Before attempting to clean a Nellcor sensor read the Inst...

Страница 122: ...in the regular trash Dispose of the battery in accordance with local guidelines and regulations or contact Covidien to arrange for disposal 9 5 Storage 9 5 1 Monitoring System Transport and Storage Th...

Страница 123: ...silence duration alarm disabled reminder alarm silence duration and sensor alarm priorities Import and export settings Transfer of default settings from one monitoring system to another Data Interfac...

Страница 124: ...oring history trend scale 15 or 30 minutes 1 2 4 8 12 24 or 48 hours 1 hour Screen Brightness 0 25 50 75 100 75 Allow backlight OFF Yes No No Wake display on alarm Yes No Yes Language Croatian Czech D...

Страница 125: ...Alarm Yes No time remaining No no time displayed ALARM SILENCE Duration OFF 30 60 90 120 seconds 120 seconds Sensor Alarm Priorities Sensor Disconnect Sensor Off Sensor Failure Note Each alarm can be...

Страница 126: ...ssing the POWER ON key 4 Touch the monitoring screen at the prompt to enter Service Mode Note The monitoring system will eventually continue to boot if the user does not touch the monitoring screen at...

Страница 127: ...ing Institutional Defaults Change power on default values to institutional power on default values using the monitoring system s service mode WARNING Audible alarms should not be silenced if patient s...

Страница 128: ...ning the master institutional default settings 6 Press NEXT To export master institutional defaults Note Network settings are not included in the export 1 Access the service function menu Reference To...

Страница 129: ...ce function menus p 10 4 2 Select SETTINGS 3 Select IMPORT AND EXPORT SETTINGS 4 Select IMPORT SETTINGS 5 Insert a USB flash drive containing the master institutional default settings 6 Press NEXT 7 P...

Страница 130: ...m all tests before the battery charge and battery performance checks then perform both battery checks as the last oper ation before returning the monitoring system to the caregiver If the monitoring s...

Страница 131: ...y with the applicable stan dards Reference Ground Integrity p 2 12 for test values Reference Safety Tests p 2 12 for test values Note For testing the patient applied risk current the leakage test lead...

Страница 132: ...specting the Battery Fuel Gauge Indica tor which should be completely full and check the Low Battery Indicator which should be off If the fuel gauge is not completely full or if the Low Battery Indi c...

Страница 133: ...to neonate alarm settings for any of these tests Note This section uses factory defaults If the institution or caregiver using the monitoring system customized the defaults the monitoring system displ...

Страница 134: ...c Slide the bar down to a value of 86 using arrow keys as necessary d Press SAVE CHANGES e Repeat steps two through four to view SpO2 Upper and Lower Alarm Limits f Select SpO2 g Ensure the selected...

Страница 135: ...lse Rate Upper Alarm Limit which should be set at a value of 170 c Slide the bar up until it will not slide any further Ensure the selected number for Pulse Rate Upper Alarm Limit increases to a value...

Страница 136: ...r Alarm Limit is set at a value of 249 6 Turn off the monitoring system by pressing the POWER ON key clearing all changes 7 Turn on the monitoring system by pressing the POWER ON key 8 Verify return t...

Страница 137: ...ain monitor ing screen 4 Test the Pulse Rate Delay setting a Press MENU b Press ALARM LIMITS c Select PULSE RATE DELAY d Ensure the delay is set to OFF e Select a delay of 10 seconds f Press SAVE CHAN...

Страница 138: ...all changes To test alarm mode 1 Turn on the monitoring system by pressing the POWER ON key 2 Press MENU 3 Press MONITORING SETTINGS 4 Select ALARM MODE 5 Ensure the alarm mode is ADULT ALARM SETTING...

Страница 139: ...hreshold settings 10 Ensure the silence timer counts down from 0 30 to 0 00 10 6 2 Operational Setup Operational Setup procedures confirm settings for and allow configuration of the listed parameters...

Страница 140: ...VE CHANGES 9 Press MENU 10 Select ALARM LIMITS 11 Select PULSE RATE 12 Slide the Pulse Rate Lower Alarm Limit up until it indicates 160 13 Confirm the following results a The waveform tracks the pulse...

Страница 141: ...by yellow e Pulse tone is audible f Audible alarm returns in approximately two 2 minutes Figure 10 3 Sample Configuring Alarms with Silenced Alarm To configure alarm volume Configure the desired volu...

Страница 142: ...lume icon with increment and decrement buttons 5 Press decrement until the pulse beep volume setting displays 25 Verify the volume of the alarm decreases 6 Press increment to increase the pulse beep v...

Страница 143: ...s an automatic three step calibration signal The calibration signal begins at 0 0 VDC and holds that point for 60 seconds It increases to 1 0 VDC and holds that value for 60 seconds The third part of...

Страница 144: ...s normal system components to test circuit oper ation Use a Max A sensor to examine LED intensity control The test uses the red sensor LED to verify intensity modulation controlled by the LED intensit...

Страница 145: ...for a qualitative test To test using a live subject 1 Ensure the monitoring system is connected to an AC power source 2 Connect a DOC 10 interface cable to the sensor port 3 Connect the DS 100A senso...

Страница 146: ...l Figure 10 4 Sensor Identification 7 Verify the oxygen saturation and pulse rate values are reasonable for the subject 10 6 4 Pulse Oximetry Functional Tests Use the SRC MAX functional tester to veri...

Страница 147: ...ied technicians to functionally test Nellcor and OEM OxiMax technology based pulse oximeters and monitor 1 DOC 10 Interface Cable Connector 5 SpO2 Select Button 2 Infrared LED Drive Indicator 6 Modula...

Страница 148: ...he BPM Test 1 Ensure the monitoring system is connected to an AC power source 2 Connect a DOC 10 interface cable to the sensor port 3 Turn on the monitoring system by pressing the POWER ON key 4 Verif...

Страница 149: ...73 and 77 inclusive creating an SpO2 LOW alarm condition c BPM indication between 57 and 63 inclusive d Pulse waveform of approximately 1 2 inch peak to peak P T P amplitude Actual amplitude may vary...

Страница 150: ...pulse amplitude low light patients 9 Press PULSE RATE 10 Verify the 60 BPM LED lights The monitoring system registers pulse rate decreases and stabilizes to a value between 57 to 63 BPM inclusive a A...

Страница 151: ...the interface cable 6 Verify the listed system behaviors Figure 10 8 SpO2 Test SpO2 75 BPM 60 a Active visual and audio alarms b Saturation indication between 73 and 77 inclusive creating an SpO2 LOW...

Страница 152: ...patients 9 Press SpO2 10 Verify the 75 LED lights The monitoring system registers SpO2 decreases and stabilizes to a value between 73 and 77 inclusive a Active visual and audio alarms b Saturation ind...

Страница 153: ...ble 6 Verify the listed system behaviors Figure 10 10 MOD Test BPM 60 SpO2 75 and MOD Low a Active visual and audio alarms b Saturation indication between 73 and 77 inclusive creating an SpO2 LOW alar...

Страница 154: ...nd 77 inclusive c BPM indication between 57 and 63 inclusive d Pulse waveform of approximately one inch P T P amplitude Actual amplitude may vary but references high pulse amplitude low light patients...

Страница 155: ...Press PULSE RATE 12 Verify the 60 BPM LED lights The monitoring system registers pulse rate decreases and stabilizes to a value between 57 to 63 BPM inclusive a Active visual and audio alarms b Satur...

Страница 156: ...nd stabilizes to a value between 73 and 77 inclusive a Active visual and audio alarms b Saturation indication between 73 and 77 inclusive creating an SpO2 LOW alarm condition c BPM indication between...

Страница 157: ...onnected to an AC power source 2 Connect a DOC 10 interface cable to the sensor port 3 Turn on the monitoring system by pressing the POWER ON key 4 Verify the word PLETH appears at the top left corner...

Страница 158: ...ange at the measurement site If the monitoring system recovers and displays normally this is an indication of proper operation with light changes Figure 10 15 LIGHT Test BPM 60 SpO2 75 MOD low Light H...

Страница 159: ...ons 11 Press PULSE RATE 12 Verify the 60 BPM LED lights The monitoring system registers pulse rate decreases and stabilizes to a value between 57 to 63 BPM inclusive a Active visual and audio alarms b...

Страница 160: ...he monitoring system registers SpO2 decreases and stabilizes to a value between 73 and 77 inclusive a Active visual and audio alarms b Saturation indication between 73 and 77 inclusive creating an SpO...

Страница 161: ...OD decrease LED lights The pulse amplitude waveform initially decreases in amplitude and then stabilizes at P T P amplitude of approximately half inch a Active visual and audio alarms b Saturation ind...

Страница 162: ...ower source 2 Connect a DOC 10 interface cable to the sensor port 3 Locate the DB 15 connector on the side of the monitoring system 4 Review the DB 15 pinouts Reference DB 15 Pin Layout p 7 5 5 Ensure...

Страница 163: ...nce Tests Service Manual 10 41 13 Change the SpO2 to 90 on the SRC MAX 14 Use the DVM to verify continuity between pins 8 and 15 and no continuity between pins 7 and 15 thus verifying the Nurse Call f...

Страница 164: ...rm management SatSeconds SPD and pulse rate delay Pass Fail Monitoring settings Pass Fail Operational setup Pass Fail Nurse call Pass Fail Monitoring screen calibration Pass Fail Overall Performance C...

Страница 165: ...ail Value A Enclosure leakage current SFC OERM 500 Pass Fail Value A Patient leakage current NC 10 Pass Fail Value A Patient leakage current OS 50 Pass Fail Value A Patient leakage current SFC OE 50 P...

Страница 166: ...Do not use the pointed tip of a pencil or pen To calibrate the monitoring screen 1 Access the service function menu Reference To access service function menus p 10 4 2 Select the SERVICE menu 3 Select...

Страница 167: ...data If desired export all trend data prior to upgrade Reference To export trend data p 7 8 To upgrade platform software or firmware 1 Remove from monitoring 2 Access the service function menu Refere...

Страница 168: ...Page Left Intentionally Blank 10 46 Service Manual Modification and Testing...

Страница 169: ...failure reset the monitoring system and ensure it is functioning correctly prior to usage WARNING Only qualified service personnel should remove the monitoring system cover There are no user serviceab...

Страница 170: ...eriod of up to two 2 minutes A countdown timer reflects any silence time remaining Prompts Prompts require a response For example the READY ATTACH SENSOR TO PATIENT AND MONITOR prompt reminds users to...

Страница 171: ...old 7 SatSeconds Alarm Icon Icon remains black on a yellow background until the error condition clears 3 SPD ALERT Alarm Patient is experiencing mul tiple sequential occurrences of a desaturation 8 Sa...

Страница 172: ...larm or status If it is an alarm it offers users a MORE INFO button which when pressed provides detailed data and a means to correct the situation or clear the alarm Press DISMISS ALARM to clear the a...

Страница 173: ...abled or set to OFF patient pulse rate violates the lower pulse rate limit threshold Pulse rate is below the alarm limit Check patient immedi ately No Med Pulse Rate High 1 If Pulse Rate Delay is enab...

Страница 174: ...power usage AND battery level critical Connect to AC power No Med Battery Low Battery power usage AND battery level low Connect to AC power Yes HIgh Battery Failure Battery missing OR battery charger...

Страница 175: ...error occurred Reference Communication Issues p 11 16 Reference Hardware Issues p 11 17 No Serial Communications system failure Serial communication error occurred Reference Com munication Issues p 11...

Страница 176: ...an alarm message 1 Press MORE INFO or VIEW ALL to continue depending on which is available A description of the error and any recommended action appears This particular alarm cannot be cleared Figure...

Страница 177: ...No power even though attached to AC and or DC power source Power membrane switch panel LEDs do not light at appropriate times Powers down or resets without apparent cause Battery failure Reference Pow...

Страница 178: ...ce Operational Performance Issues p 11 17 Hardware1 Over temperature condition Patient data appears suspect Intermittent or corrupt patient data Nurse call failure Invalid date during start up Primary...

Страница 179: ...e battery is completely depleted and the unit shuts down it may not charge after connection to AC and the battery charge indicator will not light Power cycle once and retry charging the battery while...

Страница 180: ...replace the SBC PCB After confirming it is not a hardware issue contact Technical Services BATTERY MISSING message occurs even though a battery is present The battery charger system is not functionin...

Страница 181: ...er on self test POST Remove from active service Reset and power back on Check connectivity between the MAIN PCB and the LCD ASSEMBLY Replace the MAIN PCB and or the LCD ASSEMBLY Power indicator is ON...

Страница 182: ...er patient and or try another sensor or inter face cable Perfusion may be too low for the monitoring system to track the pulse Check the patient Test the monitoring system on someone else Change the s...

Страница 183: ...t movement for example an Nellcor adhesive sensor Electro magnetic interference may be preventing the monitoring system from tracking the pulse Remove the source of interference and or try to stabiliz...

Страница 184: ...les Fiber is not always visibly damaged Contact an IT specialist to review the network connection Return to a qualified service technician Unable to connect to the wireless net work Unable to establis...

Страница 185: ...r products Check the for the loss of pulse indicator If lit ensure Nellcor sensor is firmly connected Ref erence Nellcor Sensor Performance Consider ations p 8 1 Check the monitoring screen for the ja...

Страница 186: ...lure Analog output system failure Cooling fan failure Check fan Replace if needed Check the Main PCB Replace if needed Thermal control system is above thermal limit Power down and allow to cool Remove...

Страница 187: ...correctable Failures Contact Covidien or a local Covidien representative should the monitoring system detect a non correctable failure When a non correctable error occurs several events also occur Th...

Страница 188: ...erwise instructed by Covidien it is not necessary to return the sensor or other acces sory items with the monitoring system Pack the monitoring system in its orig inal shipping carton If the original...

Страница 189: ...Battery Cables Chassis enclosures Obtain part numbers for spare parts by contacting Covidien or accessing http www covidien com 12 2 Spare Parts List Table 12 1 Available Spare Parts Description Part...

Страница 190: ...5 Parameter Interface Board with SpO2 PCB Item Reference p 12 15 Parameter Board PCBA Assembly Reference p 12 15 Parameter Module Assembly Reference p 12 10 Parameter Module Case Bottom Item Reference...

Страница 191: ...y Access Door 4 Parameter Module Case Front 1 Single Board Computer SBC PCB 10 Battery Cradle Carrier 2 Main PCB 11 Fan Cooling 3 Flex Circuit Cable J2 12 Rear Enclosure 4 Antenna Set 2 13 Power Suppl...

Страница 192: ...Repair 12 4 Service Manual Figure 12 2 Exploded View of Internal Components...

Страница 193: ...fore attempting to open or disassemble disconnect the power cord to avoid possible injury Caution Observe electrostatic discharge ESD precautions prior to opening the chassis or handling any internal...

Страница 194: ...cedure should be performed before repairs when possible 12 4 Basic Preventive Maintenance Replace the battery at least every two years More frequent battery replacement may be required depending on us...

Страница 195: ...ll outward 2 Remove both 5 x 20 mm slow blow 1 5 amp 250 volt fuses Figure 12 3 External Fuse Removal 3 Replace with two 2 new 5 x 20 mm slow blow 1 5 amp 250 volt fuses 4 Reinsert the fuse drawer unt...

Страница 196: ...ck chassis 3 Place and tighten the T 15 torx battery cover screw to 10 inch pounds 4 Connect to AC power 5 Press the ON STANDBY button to power on the monitoring system 6 Verify battery charge and AC...

Страница 197: ...the monitoring system is clean and dry 2 Peel away the protective release liner on the rubber foot to expose the adhesive 3 Gently align the rubber foot to the indented area 4 Press down firmly on th...

Страница 198: ...Parameter Module Replacement p 12 10 to remove and then replace the parameter module or its subassemblies 2 Reference Monitoring System Chassis Disassembly p 12 17 for chassis disassembly 3 Reference...

Страница 199: ...bottom of the chassis is up Figure 12 6 Parameter Module Screw Removal 2 Remove T 15 screw located between the slots at the rear of the bottom chassis 3 Using a flat blade screwdriver release the face...

Страница 200: ...inst the parameter module assembly through the two openings releasing it from the backplane Expect minor resistance until it releases Figure 12 8 Parameter Module Assembly Removal 5 Remove and set asi...

Страница 201: ...y pressing the ON STANDBY button 2 Disconnect from AC power 3 Remove the parameter module Reference To remove the parameter module p 12 11 4 Set it face down on a static free work surface Caution Ensu...

Страница 202: ...bottom enclosure in an alter nate location To replace a parameter module case component 1 Select the new parameter module case component top cover faceplate or bottom enclosure and place with the stil...

Страница 203: ...interface board PCB and the oximetry module PCB To remove the parameter board assembly 1 Turn off the monitoring system by pressing the ON STANDBY button 2 Disconnect from AC power 3 Remove the param...

Страница 204: ...rx screws Figure 12 10 Parameter Board PCB and Oximetry Module Removal 14 Gently lift upward removing the oximetry module PCB off the parameter board assembly standoffs ensuring all pins fully disconn...

Страница 205: ...tandouts to the left of the bottom enclosure 8 Replace and tighten the four T 10 torx screws to a maximum of 10 inch pounds 9 Replace the top cover ensuring the tabs slip down into the mating slots of...

Страница 206: ...ace is clean and free of debris 5 Remove the battery Reference To remove the battery access door and battery p 12 7 6 Remove and set aside all four T 15 torx screws one from each corner of the rear ch...

Страница 207: ...B 12 Disconnect the five pin battery connector from the J23 receptacle on the Main PCB 13 Disconnect the four pin power connector from the J22 receptacle on the Main PCB 14 Disconnect the three pin fa...

Страница 208: ...D to the J21 mating blade on the Main PCB 3 Firmly connect the five pin battery connector to the J23 receptacle on the Main PCB 4 Firmly connect the four pin power connector to the J22 receptacle on t...

Страница 209: ...WARNING Before attempting to open or disassemble disconnect the power cord to avoid possible injury Caution Observe ESD electrostatic discharge precautions when disassembling and reassembling the mon...

Страница 210: ...module until completing power entry module replacement To replace the power entry module 1 Properly orient the new power entry module so the single blade is to the top and the dual blades are to the b...

Страница 211: ...ower Cable Assembly Replacement 6 Remove the blue N brown L and green GND power cables connected to the power entry module noting their current positions 7 Remove all sets of M6 lug nuts and ground wi...

Страница 212: ...To reassemble the monitor ing system chassis p 12 20 12 6 3 Battery Components Replacement The battery cradle assembly consists of several subassemblies and PCBs For suc cessful battery cradle replac...

Страница 213: ...rx screws two on top and two deep underneath using a long reach driver Figure 12 14 Battery Cradle Removal 4 Lift out the battery cradle supporting both the battery cradle and still connected wires No...

Страница 214: ...eference Power Supply PCB Replacement p 12 26 3 Replace the cooling fan Reference Cooling Fan Replacement p 12 29 4 Gently align and replace the battery cradle 5 Tighten all four T 10 torx screws two...

Страница 215: ...into the battery cradle retaining slots and onto the battery cradle standoffs ensuring the fan cable remains free of the battery cradle 3 Route the fan cable up under the battery cradle so it rests o...

Страница 216: ...t PCB Replacement To remove the Battery Interconnect PCB 1 Follow all previous steps for removing the battery cradle Reference Battery Cradle Replacement p 12 25 It is not necessary to remove the powe...

Страница 217: ...ews to 10 inch pounds 3 Rotate the battery cradle 4 Reconnect the five pin J2 connector 5 Replace the cooling fan Reference Cooling Fan Replacement p 12 29 6 Replace the battery cradle in the back cha...

Страница 218: ...he wiring harness 4 Remove the fan from its enclosure Figure 12 17 Cooling Fan Removal To replace the cooling fan 1 Place the new fan down in its enclosure 2 Replace the battery cradle in the back cha...

Страница 219: ...nt chassis off to the side 3 Identify the proper cables under the battery cradle They are the cables to the opposite side of the enclosure from the power entry module 4 Remove the five pin Mini mate b...

Страница 220: ...n PCB 5 Firmly connect the three pin black fan cable and connector to the J2 black recep tacle on the Main PCB 6 Firmly connect the five pin Mini mate black cable and connector to its J2 white recepta...

Страница 221: ...r details Main PCB Replacement To remove the Main PCB 1 Disassemble the monitoring system chassis Reference Monitoring System Chassis Disassembly p 12 17 2 Move the rear enclosure off to the side reta...

Страница 222: ...PCB Reference To replace the Single Board Computer SBC PCB p 12 37 2 Route all four flex cables through their appropriate slots in the Main PCB J15 Main flex cable Gold J5 Two pin speaker cable Red an...

Страница 223: ...nd unpinched 4 Replace and tighten the two T 15 torx screws to 10 inch pounds 5 Firmly connect the J5 speaker connector 6 Reconnect all flex cables into their connectors based on the same method as re...

Страница 224: ...olden UFL antennae connectors onto the SBC PCB 3 Wire tie ferrite bead to the Main PCB capturing right antenna PCB wire under neath the wire tie while ensuring the wire remains free under the Main PCB...

Страница 225: ...ct both golden UFL antennae connectors for the antennae from the board 5 Gently remove the SBC board exerting even pressure on both sides Figure 12 21 Single Board Computer SBC Removal To replace the...

Страница 226: ...sposal of the original speaker assembly To remove the alarm speaker 1 Disassemble the monitoring system chassis Reference Monitoring System Chassis Disassembly p 12 17 2 Move the rear enclosure off to...

Страница 227: ...12 17 2 Move the rear enclosure off to the side retaining the front panel on a static free working surface 3 Follow the steps for disconnecting the speaker Reference To remove the alarm speaker p 12 3...

Страница 228: ...ead the large right hand flex cable through the plastic LCD clamp plate ensur ing the smaller top flex cable is free above the plastic LCD clamp plate and the dog leg flex cable threads through the pl...

Страница 229: ...on the plate Reference To replace the alarm speaker p 12 38 7 Reassemble the monitoring system chassis Reference Monitoring System Chassis Reassembly p 12 20 12 8 Return Authorization and Shipment 12...

Страница 230: ...ference Battery or Battery Access Door Replacement p 12 7 3 Remove the battery access door and battery 4 Place the battery in a plastic bag 5 Fold the plastic bag around the battery 6 Insert in the or...

Страница 231: ...tabs of the bottom carton insert 15 Lock the carton flap by folding downwards 16 Completely fill the carton with packing material to ensure nothing will shift during shipment 17 Close the monitoring s...

Страница 232: ...Page Left Intentionally Blank 12 44 Service Manual Repair...

Страница 233: ...7 10 22 10 24 Error Messages 11 5 External Fuse Removal 12 7 F Firmware Version 6 5 Fractional Saturation 3 4 Front Panel 4 3 Functional Saturation 3 4 Fuse Replacement 12 7 G Ground Integrity Specifi...

Страница 234: ...a Valid Pulse 6 8 Sensor Alarm Priorities 6 22 Performance Considerations 8 1 Service Functions 10 10 Service Returning for 11 20 Setting Institutional Defaults 6 13 Specifications 2 4 Electrical 2 5...

Страница 235: ......

Страница 236: ...t No 10104356 Rev B 2013 11 2013 Covidien Covidien Ireland Limited IDA Business Technology ParkTullamore Covidien llc 1 800 635 5267 www covidien com 15 Hampshire Street 1 800 635 5267 Mansfield MA 02...

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