Operator’s Manual Model Model 7500FO 7500FO Digital Pulse Oximeter 0123 1 English
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Consult Instructions for Use. NONIN® reserves the right to make changes and improvements to this manual and the products it describes at any time, without notice or obligation. Nonin Medical, Inc. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA +1 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax +1 (763) 553-7807 mail@nonin.com www.nonin.
Contents Guide to Symbols ...............................................................1 Indications for Use .............................................................3 Contraindications ...................................................................... 3 Warnings ................................................................................... 3 Cautions .................................................................................... 4 Displays, Indicators and Controls .....................
Technical Information ......................................................38 Manufacturer’s Declaration .....................................................38 Equipment Response Time .....................................................42 Testing Summary ....................................................................43 Specifications ..........................................................................
Guide to Symbols This table describes the symbols that are found on the Model 7500FO. Detailed information about functional symbols can be found in “Operating the Model 7500FO.” Symbol Description Caution! ! Consult Instructions for Use. Type BF Applied Part (Patient isolation from electrical shock).
Symbol Description Alarm Bar LED. Pulse Quality LED. Sensor Alarm LED. Pulse Strength Bargraph LED. Alarm Silence LED. AC Power Adapter LED. Low Battery LED. ON/STANDBY button. Alarm Silence button. Limits button. Plus button. Minus button. Non-ionizing electromagnetic radiation. Equipment includes RF transmitters; interference may occur in the vicinity of equipment marked with this symbol.
Indications for Use The NONIN® Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and infant patients in an Magnetic Resonance (MR) environment while operating on battery power alone. Testing was performed in MR conditional environments at 1.5T and 3T.
Warnings (Continued) • The use of accessories, sensors, and cables other than those listed in this manual may result in increased electromagnetic emission and/or decreased immunity of this device. • To comply with relevant product safety standards, ensure that all alarm volumes are set appropriately and are audible in all situations. Do not cover or otherwise obstruct any speaker openings. • This device is a precision electronic instrument and must be repaired by qualified technical professionals.
! Cautions (Continued) • Do not gas sterilize or autoclave this device. • Batteries might leak or explode if used or disposed of improperly. • This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality. • Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity.
! Cautions (Continued) • This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following: - excessive ambient light - excessive motion - electrosurgical interference - blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.
Displays, Indicators and Controls This section describes the displays, indicators, and controls for the Model 7500FO. On/Standby Alarm Silence Sensor Connector %SpO2 Display Plus (+) Pulse Rate Display Minus (-) Alarm Bar Speaker Limits %SpO2 Display The %SpO2 display is located on the left-hand side of the Model 7500FO front panel and is identified by the %SpO2 symbol. This display shows blood oxygen saturation, from 0 to 100 percent. The numeric displays blink during SpO2 alarm conditions.
Pulse Rate Display The pulse rate display is located on the right-hand side of the Model symbol. This display 7500FO front panel and is identified by the shows the pulse rate in beats per minute, from 18 to 321. The numeric displays blink during pulse rate alarm conditions. See “Specifications” for sensor accuracy information. NOTE: LED means “light-emitting diode.” Numeric LEDs Green numeric LEDs display %SpO2 and pulse rate values.
Pulse Strength Bargraph LED This 8-segment tricolor bargraph indicates pulse strength as determined by the oximeter. The height of the Pulse Strength Bargraph LED is proportional to the pulse signal, and the color is determined by pulse strength: Green = a good pulse strength Amber = a marginal pulse strength Red = a low pulse strength, high priority alarm Alarm Silence LED This amber LED indicates that the audible alarm is silenced for two minutes when it blinks.
! CAUTION: The two-minute alarm silence is automatically engaged at startup. Limits Button This button displays the upper and lower limits for alarm indications for SpO2 and heart rate measurements. Pressing the Limits button allows users to access advanced menu options, including adjusting alarm settings, alarm volume, and date and time settings. All adjustments can be made using the Plus (+) and Minus (-) buttons.
Operating the Model 7500FO NOTES: • • • Before using the Model 7500FO, please review all contraindications, warnings and cautions. Before using the Model 7500FO, the battery must be charged for four (4) hours. When the Model 7500FO reaches critical battery, a medium priority alarm will sound. To clear the alarm: charge the battery and turn the device off and back on. Press the ON/STANDBY button. When the unit is first turned on, the Model 7500FO performs a brief initialization sequence.
Operating Instructions Operating in the MR Environment When operating the 7500FO in the MR (magnetic resonance) environment, observe the following safety considerations: MR MR Use only NONIN-branded 8000FC or 8000FI Fiber Optic Sensors. Do not use cables or sensors that contain conductive wires. The 7500FO and the connectors for the fiber optic contain ferrous material and must be kept as far away from the magnet as possible at all times.
• Install the 7500FO in the MR environment near the observation window or outside the MR environment so the displayed values on the pulse oximeter may be clearly viewed. The 7500FO monitor must also be firmly attached to a fixed object using the mounting hole (1/4-20 thread) on the bottom of the device. • If interference is suspected to the MR image or to the 7500FO, contact NONIN Technical Service at (800) 356-8874 or (763) 553-9968 for assistance.
Operating Modes and Defaults The Model 7500FO features Setup mode, Factory Defaults, User-Defined Defaults and Patient Security modes. NOTE: Patient Security mode overrides any default settings. Setup Mode, Viewing Limits and Setting Time In Setup mode, users can adjust alarm limits and volumes, set clock and calendar information and clear the device’s memory. Pressing the Limits button activates Setup mode, and all adjustments can be made using the Plus (+) or Minus (-) buttons.
User-Defined Defaults In User-Defined Defaults, alarm limit and volume settings must be adjusted. To set the User-Defined Defaults, set the alarm limits, hold the Alarm Silence button and then press the Limits button. This sets the UserDefined Defaults to be the same as the current alarm limits. The Model 7500FO recalls User-Defined Default settings at startup whenever this option is selected. Once activated, User-Defined Defaults have priority over Factory Defaults.
When the Patient Security mode is enabled, operators cannot change SpO2, or Pulse Rate limits or Alarm Volume—though it is still possible to view those settings. In Patient Security mode, operators cannot view or set the time and date. When the Model 7500FO is turned on in Patient Security mode, “SEC on” is displayed in the display area, and three informational tones sound. The upper alarm limits are then displayed, followed by the lower alarm limits.
Operator Functions The Model 7500FO has several easy-to-use basic functions. Most involve pressing only a single button. Function Button Instruction Turn the Model 7500FO on and off. Press the ON/STANDBY button to turn on the Model 7500FO. Press and hold the button for at least one second to turn off the Model 7500FO. In Patient Security mode, hold the ON/STANDBY button for three seconds to turn off the Model 7500FO. Initiate an event marker.
Table 1: Limits Display Sequence Display Initial Setting (Pulse Rate Display) Recall Alarm Settings “rCL” “no” “yES” or “no” Low %SpO2 Alarm Limit “02L” 2,3 “85” “Off”, 50 to 95 by 1 Pulse High Alarm Limit “HH” 2 “200” “Off”, 75 to 275 by 5 Pulse Low Alarm Limit “HL” 2 “50” “Off”, 30 to 110 by 5 High %SpO2 Alarm Limit “02H” 2 “Off” “Off”, 80 to 100 by 1 Alarm Volume “adb” 2 “Hi” “Off” or “Lo” or “Hi” Clear Memory “Clr” 1 “no” “yES” or “no” Confirm Memory Clear “del” 1 “no”
The Model 7500FO features a number of advanced options, which are intentionally more difficult to activate. These functions are recommended only for trained operators and require multiple button presses to prevent accidental activation. Function Button Instruction Recall Previous Alarm Limit Settings Press the Limits button while the unit is on. “rCL” appears, indicating that previous alarm limit settings may be recalled. To recall the settings, press the Plus button and select “yES.
Function Button Instruction Make Current Alarm Values User-defined Defaults To set the User-Defined Defaults to the current alarm settings, hold the Alarm Silence button and then press the Limits button. Revert to Factory Defaults To revert to the factory defaults, from the User-Defined Defaults alarm limits, hold the alarm Silence button and then press the Minus (-) button. + NOTE: User-defined default values will be lost when factory defaults are made active.
Care and Maintenance The advanced digital circuitry within the pulse oximeter of the Model 7500FO requires no calibration or periodic maintenance other than battery replacement by qualified technical professionals. Field repair of the Model 7500FO circuitry is not possible. Do not attempt to open the Model 7500FO case or repair the electronics. Opening the case may damage the Model 7500FO and void the warranty. If the Model 7500FO is not functioning properly, see “Troubleshooting.
Alarms and Limits The Model 7500FO is equipped with audio and visual alarm indicators to alert the operator to provide immediate patient attention or to abnormal device conditions. High Priority Alarms High priority alarms require immediate attention to the patient. They include SpO2, pulse rate, and low perfusion alarms. On the Model 7500FO, high priority alarms are indicated by a rapidly blinking red Alarm Bar LED when the value is equal to or greater than the alarm limit.
Alarm Summary The Model 7500FO detects both patient and equipment alarms. In general, patient alarms are identified as high priority, while equipment alarms are identified as medium priority. High priority alarms always take priority over medium priority alarms. Alarm indicators remain active for as long as the alarm condition is present.
Reviewing and Setting Volume and Alarm Limits NOTE: Alarm limits reset themselves to default values each time the unit is powered up—unless the unit is in Patient Security mode. In Patient Security mode, alarm limits and volumes cannot be adjusted; they can only be viewed. WARNING: To comply with relevant product safety standards, ensure that all alarm volumes are set appropriately and are audible in all situations. Do not cover or otherwise obstruct any speaker openings.
Recalling Previous Settings The digital pulse oximeter includes a feature that allows recall of the operator-adjusted settings in use when the device was last turned off. The following settings are recalled when this feature is activated: • SpO2 high and low alarm limits • Pulse rate high and low alarm limits • Alarm volume settings Previous operator-adjusted settings can be recalled by pressing the Limits button while the unit is on.
Memory and Data Output Features The Model 7500FO provides real-time (serial) patient data output, as well as analog output signals for SpO2, pulse rate and event markers. Serial Patient Data Output This device features real-time data output capabilities. The serial format includes an ASCII header containing model number, time, and date information. The device provides real-time data output capability via the serial connector port.
Analog Output The Model 7500FO provides analog output signals for SpO2, pulse rate, and event markers. Each output level conforms to the specifications shown below: Output Specification SpO2 Output Analog Range 0 - 1.0 VDC (representing 0-100%) Pulse Rate Output Analog Range 0 - 1.0 VDC (representing 0-300 BPM) 1.27 VDC (out of track) 1.27 VDC (out of track) Event Marker 0 VDC or 1.0 VDC nominal (representing an event). Event marker high for SpO2 less than low alarm limit.
Memory Features The Model 7500FO can collect and store 70 hours of continuous SpO2 and pulse rate information. Data may be played back with data retrieval software (NONIN’s nVISION software is recommended). If you wish to create your own software, contact NONIN for the data format. The memory in the Model 7500FO functions much like an “endless loop” tape. When the memory is full, the unit begins overwriting the oldest data with new data.
Playing Back Memory Data The Model 7500FO has a Memory Playback feature, allowing stored data to be output through an external serial connection. Playing back the data does not clear the data from memory. 1. 2. 3. 4. With the unit off, connect the serial connector port of the Model 7500FO to the back of your computer using the 7500 SC cable, which is available from NONIN. Press and hold the Plus (+) button while briefly pressing the ON/STANDBY button. Release the Plus (+) button.
Parts and Accessories The following NONIN accessories function with the Model 7500FO. Detailed information regarding specified sensor use (patient population, body/tissue, and application) can be found in the respective sensor instructions.
For more information about NONIN parts and accessories, contact your distributor, or contact NONIN at (800) 356-8874 (USA and Canada) or (763) 553-9968. This information is also available on the NONIN website: www.nonin.com. WARNING: The use of accessories, sensors, and cables other than those listed in this manual may result in increased electromagnetic emission and/or decreased immunity of this device. WARNING: Use only NONIN-branded PureLight pulse oximeter sensors.
Service, Support, and Warranty A return authorization number is required before returning any product to NONIN. To obtain this return authorization number, contact NONIN Technical Service: Nonin Medical, Inc. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA (800) 356-8874 (USA and Canada) +1 (763) 553-9968 (outside USA & Canada) Fax +1 (763) 553-7807 E-mail: mail@nonin.com www.nonin.
Warranty NONIN MEDICAL, INCORPORATED, (NONIN) warrants to the purchaser, for a period of one year from the date of purchase, each Model 7500FO battery pack. NONIN warrants the pulse oximetry module of the Model 7500FO for a period of three years from the date of purchase. Extended warranties are available on most NONIN pulse oximeter models. Please consult your local NONIN distributor for additional information.
Troubleshooting Problem Possible Cause Possible Solution Model 7500FO will The unit has no power. Plug in the AC adapter. not activate. Model 7500FO will The battery pack is not not operate on charged. batteries. The battery pack is inoperable. Plug in the Model 7500FO AC Adapter to charge the battery pack. Unable to obtain a green pulse display on the bargraph. Reposition the finger or insert a different finger, and keep the sensor motionless for at least 10 seconds.
Problem Possible Cause Unable to obtain a green pulse display on the bargraph, cont’d. The sensor is applied incorrectly. Possible Solution Apply the sensor correctly. There is possible interference from one of the following sources: • • • • Reduce or eliminate any interference. Make sure that the sensor is not placed on the same arm being used for other patient therapies or diagnostics (e.g., arterial catheter blood pressure cuff blood pressure cuff).
Problem Possible Cause Possible Solution Reposition finger or insert a A dash (-) appears An inadequate signal from the finger is being different finger, keeping sensor in the %SpO2 detected. motionless for at least 10 seconds. display. Position sensor at different site. The finger was removed from the sensor. Reinsert the finger and keep the sensor motionless for at least 10 seconds. The Model 7500FO is not functioning. Turn the unit off, check all connections, and retry.
Problem The unit is in Alarm mode, but no audible alarms can be heard. Possible Cause The 2-minute Alarm Silence button is activated. Possible Solution Press the Alarm Silence button to re-engage alarm volume, or wait for two minutes. After two minutes, alarm tones will automatically reengage. Audible volume set to Adjust volume through setup mode “oFF” in alarm limits. The Model 7500FO does not record data. The battery is low. Recharge the battery. The battery is missing.
Technical Information NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. ! CAUTION: A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. ! CAUTION: All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard EN 60950 or UL 1950 for data-processing equipment.
Table 3: Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment— Guidance This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is used in such an environment. Electrostatic Discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete, or ceramic tile.
Table 4: Guidance and Manufacturer’s Declaration— Electromagnetic Immunity Immunity Test IEC 60601 Compliance Test Level Level Electromagnetic Environment—Guidance This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is used in such an environment.
Table 5: Recommended Separation Distances This table details the recommended separation distances between portable and mobile RF communications equipment and this device. This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Equipment Response Time SpO2 Values Standard/Fast Averaged SpO2 Average Latency 4 beat exponential 2 beats Response Latency 4 beat exponential 2 beats Pulse Rate Values Standard/Fast Averaged Pulse Rate Example - SpO2 Exponential Averaging SpO2 decreases 0.75% per second (7.5% over 10 seconds) Pulse Rate = 75 BPM SaO2 Reference 4 Beat Average 100 95 90 SpO2 85 80 75 70 65 • The response of the 4-beat average is 1.5 seconds. 42 80.0 Specific to this example: 72.0 Tim e in seconds 64.
Testing Summary SpO2 accuracy, and low perfusion testing were conducted by NONIN Medical, Inc., as described below: SpO2 Accuracy Testing SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to dark-skinned subjects during motion and no-motion conditions in an independent research laboratory.
Specifications Oxygen Saturation Display Range: Pulse Rate Display Range 0 to 100% SpO2 18 to 321 pulses per minute (BPM) Displays: Pulse Quality: Sensor Alarm: Pulse Strength Bargraph: Alarm Indicator: Alarm Silenced: Numeric Displays: Low Battery: LED, amber LED, amber LED, bargraph, tri-color segments LED, bi-color LED, amber 3-digit, 7-segment LEDs, green LED, amber SpO2 Accuracy (Arms)a: FO Sensor 70-100% ± 2 digits Pulse Rate Accuracy (Arms)a: No Motion Low Perfusion ±3 digits, 18-300 BPM ±3 di
Dimensions Approximately 219 mm (8.6”) W x 92 mm (3.6”) H x 142 mm (5.6”) D Weight Approximately 900 grams (2 lbs) with battery Warranty 3 years Classification per IEC 60601-1/CSA601.1/UL60601-1 30EM: Type of Protection: Internally powered (on battery power). Class I with AC adapter. Degree of Protection: Type BF-Applied Part Mode of Operation: Continuous Enclosure Degree of Ingress Protection: IPX2 Analog Outputs: SpO2 Output Range: 0-1 VDC (0-100% SpO2, 1.
