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To obtain information about a 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.
I n t r o d u c t i o n Warnings 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 O N-65 handheld pulse oximeter when the sensor event record is recorded by the...
Introduction WARNING: As with all medical equipment, carefully route patient cabling to reduce 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 Cautions are identified by the CAUTION symbol shown above.
Introduction Manual Overview This manual contains information for service personnel who will service the Nellcor model O 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.
Introduction Description of O N-65 The O ™ N-65 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO ) 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.
Introduction Front Panel Symbols The follow two symbols are located on the front panel of the monitor. Displays the measured percent of oxygen saturation. Displays the measured pulse beats per minute. Rear Panel Symbols The following symbols are located on the rear panel of the monitor. 1 —...
Introduction Date of Manufacture European union approval Canadian/USA certification mark (electrical safety) Russian regulatory approval Serial number Label Symbols These symbols display on the monitor’s labels. Keep away from heat Temperature limitation Protect from moisture Fragile Keep upright Humidity limitation N-65 Service Manual...
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 SpO limits • high and low BPM limits •...
Introduction Set Menu Parameters 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.
Introduction WARNING: Do not silence the O 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.
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Introduction Table 2: Time Set Menu # of Parameter Press Function Presses The Menu button must be pressed during the POST. Hour Adjust 1 to 23 Minute Adjust 1 to 59 Adjust 1 to 31 Month Adjust 1 to 12 Year Adjust 2003 to 2099 N-65 Service Manual...
O N-65. Refer to the O N-65 Operator's Manual. To understand the various Nellcor approved O sensors that work with the monitor, refer to the individual O sensor's Directions For Use.
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.
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.
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...
Performance Verification Caution: During POST (immediately after power-up), confirm that all display segments and icons are shown, and the monitor speaker sounds a 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: •...
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Performance Verification 2. The display goes blank for one second. 3. The software version number displays. The software version is identified by two dashes in the %SpO area of the display. Note: The software version 001 is an example. Check the monitor for the software version installed.
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Performance Verification Note: If the time has never been set, do not continue until you set the time. See Operator’s Manual. 5. If the monitor detects a problem, an error tone sounds and an error code (Er) and the error number display. See Troubleshooting on page 39. 6.
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Performance Verification Note: In addition to serving as the POST pass verification, the POST 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. 7.
Performance Verification Operational Setup The operational setup procedure sets the time and date into the monitor. Refer to the O 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.
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Performance Verification 3. Press the Menu button during the POST operation until the set hours window appears with the hours indication (13) flashing. 4. Press the 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.
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Performance Verification 7. Press the Menu button to set the minutes and show the day set display. The day indication (29) flashes. 8. Press the Up Arrow button or the Down Arrow button until the desired day appears. 9. Press the Menu button to set the day and show the month set display. The month indication (7) flashes.
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Performance Verification 11. Press the Menu button to set the month and show the year set display. The year indication (2004) flashes. 12. Press the Up Arrow button or the Down Arrow button until the desired year appears. 13. Press the Menu button to set the year and return to normal operation. N-65 Service Manual...
Sensor Port — To connect the O sensor to a live subject for a qualitative test: 1. Connect a Nellcor O MAX-A oxygen O sensor to the monitor. 2. Clip the MAX-A to the subject as recommended in the O sensor's Directions For Use.
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Performance Verification The monitor records snap-shot data. 6. Turn off the monitor. N-65 Service Manual...
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 —O N-65 Cable Connector 6 — % Modulation Select Button 2 —...
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Performance Verification The SRC-MAX functional tester allows qualified technicians to functionally test Nellcor O technology-based pulse oximeters and OEM O 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 1 through 4 as follows.
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Performance Verification Table 3 shows the Pulse Oximetry Functional Tests you must perform and a 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.
Performance Verification Test Setup You must complete Test Setup 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.
Performance Verification • Pulse Amplitude indicator - displays low level modulation (low amplitude pulse amplitude indicator) Test 1: BPM 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.
Performance Verification 2. Press the SRC-MAX Pulse Rate select button. The SRC-MAX Pulse Rate 60 LED lights. The monitor pulse rate decreases to 60 and stabilize at 60 bpm. The test pass criteria is 57 to 63 bpm inclusive. The monitor: •...
Performance Verification 2. Press the SRC-MAX %SpO select button. The SRC-MAX %SpO 75 LED lights. The monitor displays two dashes until the SRC-MAX stabilizes at 75 %SpO The test pass criteria is 73 to 77 %SpO inclusive. The monitor: • displays 75 %SpO (pass criteria is 73 to 77 %SpO inclusive)
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Performance Verification 2. Perform Test 1: BPM on page 32. The Pulse Amplitude indicator should indicate high level modulation. 3. Perform Test 2: SpO2 on page 33. The Pulse Amplitude indicator should indicate high level modulation. 4. Press the SRC-MAX % Modulation selection button. The SRC-MAX % Modulation LED lights.
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 LED lights. The monitor pulse blip bar initially increases in amplitude and then reduces and stabilizes at 3-5 bars. The monitor: •...
Performance Verification 4. Press the SRC-MAX Light Level selection button. The SRC-MAX Light Level LED lights. The monitor pulse blip bar initially increases in amplitude and then reduces and stabilizes at 3-5 bars. The monitor: • displays 75 %SpO • displays 60 bpm •...
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Performance Verification N-65 Service Manual...
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 representative.
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Troubleshooting 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.
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Replace the User Interface PCB. See SpO2 PCB or User problem. 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...
Replace the User Interface PCB. See SpO2 PCB or User problem. Interface PCB Replacement on page 50. If this does not fix the problem, return the monitor to Nellcor. • The Backlight LEDs on the User Replace the User Interface PCB. See SpO2 PCB or User Interface PCB have failed.
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Troubleshooting Table 5 provides a list of error codes for the monitor. Table 5: Error Codes Scope of Action Error Action Explanation Code Replace SpO board. front end RAM error. Replace SpO board. front end ROM/code integrity error. Replace SpO board.
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Troubleshooting Table 5: Error Codes (Continued) Scope of Action Error Action Explanation Code Replace SpO board. back end reports packet start ID (SID) missing. Replace SpO board. back end reports packet length error. Replace SpO board. back end reports message length error.
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Troubleshooting Table 5: Error Codes (Continued) Scope of Action Error Action Explanation Code Replace UI board. Communication failure with real time clock. Replace UI board. Real time clock oscillator control problem. Replace UI board. Real time clock failed timing test. Replace UI board.
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Troubleshooting Table 5: Error Codes (Continued) Scope of Action Error Action Explanation Code 1 — Restart the monitor. Erroneous key press detected at start. 2 — Replace membrane switch pad. Replace UI board. Fatal system error reading memory. Return monitor for repair. Fatal software error.
D i s a s s e m b l y G u i d e Introduction The O N-65 can be disassembled into all major component parts, including: • Front case with front panel keypad • Rear bottom • User Interface PCB •...
Disassembly Guide Prior to Disassembly The monitor batteries must be removed prior to disassembly. To remove the batteries: 1. Press the Power button to turn the monitor off. 2. Remove the battery cover. 3. Pull the battery cover latch downward toward the bottom of the monitor case and lift the battery cover.
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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 Caution: A flex cable runs between the monitor front and rear case assemblies. Use care when separating the cases. Do not apply stress to the flex cable.
Disassembly Guide 4. Unlock connector J4 on the SpO PCB. See Figure 6 and Figure 7. 1 — SpO PCB . 2 — J4 lock 3 — Lock direction 4 — Unlock direction Figure 7: SpO PCB Connector J4 Lock 5.
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Disassembly Guide 3. Pull the SpO PCB and User Interface PCB to the left to free the case from the DB-9 connector. Lift the combined SpO and User Interface PCBs from the case. See 8. Figure 8: User Interface PCB and SpO PCB Removal Caution: Do not force the User Interface PCB and SpO PCB apart.
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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 (J8 on SpO , J4 on User Interface) 2 —...
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Disassembly Guide Note: The longer screws install at the top of the case. See Figure 12, items 1 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.
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.
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Disassembly Guide 5. Lock the ribbon cable connector. See Figure 15. 1 — SpO 2 — J4 lock 3 — Lock direction 4 — Unlock direction Figure 15: Locking SpO PCB Connection to J4 6. Place the front and rear cases together and install the four screws. See Figure 16, items 1 through 4.
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Disassembly Guide 7. Install the batteries and battery cover as shown in Figure 17. Batteries 1 — Battery cover 2 — Battery cover latch 3 — Figure 17: Battery Installation 8. Perform the performance verification tests before placing the monitor into service.
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. Caution: The battery connectors (spring assemblies) at the bottom of the SpO PCB are held in slots in the battery compartment.
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Disassembly Guide 5. Install the User Interface PCB and SpO PCB into the monitor case. Ensure that the battery 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, items 1 and 4.
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.
Nellcor's Technical Services provides technical assistance information and replacement parts. To obtain replacement parts, 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 O N-65 are listed on the Internet at: http://mallinckrodt.com/respiratory/resp/Serv_Supp/Apartweb/main/PartAcceMenu.html...
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Spare Parts Table 6: Parts and Accessories List Figure 23 Description Reference 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...
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Spare Parts Figure 23 shows the monitor exploded view with numbers relating to the spare parts list. Figure 23: Exploded View N-65 Service Manual...
Contact Nellcor’s Technical Services Department for shipping instructions, including a Returned Goods Authorization (RGA) number. Unless otherwise instructed by Nellcor's Technical Services Department, it is not necessary to return the O sensor or other accessory items with the monitor. Pack the monitor in its original shipping carton.
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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. N-65 Service Manual...
Packing for Shipment Packing in a 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).
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Packing for Shipment N-65 Service Manual...
S p e c i f i c a t i o n s Performance Measurement Range 1% to 100% Pulse Rate 20 beats per minute (bpm) to 250 Perfusion Range 0.03% to 20% Accuracy Tolerance Saturation 70 to 100% ±2 digits Adult 70 to 100% ±3 digits Neonate...
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Specifications Audible Indicators Audible Parameter Value Indicator Alarm Volume Volume level Adjustable, 40 to 52 Setting dB(A), at one meter Pitch (±30 Hz) 752 Hz On pulse width 500 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst 1 Repetition Pause (±2 sec.) Priority...
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Specifications Audible Indicators (Continued) 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 (±2 sec.) Priority...
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Specifications Audible Indicators (Continued) Audible Parameter Value Indicator 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.
• 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.
Specifications Environmental Conditions Operation Temperature 5 ºC to 40 ºC (41 ºF to 104 ºF) 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...
Specifications Physical Characteristics Weight 0.62 lbs. (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) Compliance Item Compliant With Equipment classification Safety Standards: EN 60601-1: 1990 (A1 + A2), EN 60601-1-2: 2001, UL 60601-1, CAN/CSA C22.2 No.
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Specifications The O 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 a 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.
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Specifications 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 1...
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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 Electromagnetic Test Level Level Environment...
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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 electromagnetic site survey , should...
T e c h n i c a l D i s c u s s i o n Oximetry Overview The O N-65 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying an O sensor to a pulsating arteriolar vascular bed, such as a finger or toe.
Technical Discussion Functional versus Fractional Saturation This pulse oximeter measures functional saturation -- oxygenated hemoglobin expressed as a 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 IL482 report fractional saturation -- oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins.
Technical Discussion Technology The monitor is designed to use Nellcor brand O sensors containing O technology. These O sensors can be identified by the deep blue color of their plug. All O sensors contain a memory chip carrying information about...
Technical Discussion Block Diagram Theory This section provides an explanation of O 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.
Technical Discussion Printed Circuit Board The SpO PCB provides patient interface and monitor operating power. Patient Interface The patient interface receives signals from the O 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.
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: 1 — Alarm Silence 5 — Backlight 2 — Down Arrow 6 — Up Arrow 3 —...
Technical Discussion The liquid crystal display (LCD) is driven by the CPU. The LCD displays the patient’s %SpO and pulse rate. The LCD also displays icons indicating the status and functions of the monitor. Refer to the O N-65 Operator’s Manual for a description of the icons.
12 cleaning minute monitor measurement range 69 returning the monitor 65 date and time month description of OxiMax N-65 disassembly guide disinfecting nitrous oxide display update interval DS-100A dysfunctional hemoglobin obtaining replacement parts obtaining spare parts...
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Index operator’s manual altitude 74 OXIMAX technology relative humidity 74 oximetry overview temperature 74 strangulation surface-cleaning symbols packing for shipment Canadian ICES-001 approval 9 packing in a different carton date of manufacture 9 parts list European union approval 9 performance verification fragile 9 periodic safety checks keep away from heat 9...
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