Operator’s Manual Model Model 7500 7500 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 ..........................................................................................
Guide to Symbols This table describes the symbols that are found on the Model 7500. Detailed information about functional symbols can be found in “Operating the Model 7500.” Symbol Description Caution! ! Consult instructions for use. C SSIFIE LA UL D C Type BF Applied Part (Patient isolation from electrical shock). US 0123 SN UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1.
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 7500 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, infant, and neonatal patients. It is intended for spot-checking and/or continuous monitoring of patients during both motion and no-motion conditions, and for patients who are well or poorly perfused.
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 hinder any speaker openings. • This device is a precision electronic instrument and must be repaired by qualified technical professionals.
! Cautions (Continued) • Do not immerse this device or sensors in any liquids. • Do not use caustic or abrasive cleaning agents on the unit or sensors. • Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. Use only NONIN-approved battery packs. • When using the 300PS-UNIV battery charger, ensure that the AC cord is plugged into a grounded outlet.
! Cautions (Continued) • A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. • 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 dataprocessing equipment. • Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
Displays, Indicators and Controls This section describes the displays, indicators, and controls for the Model 7500. On/Standby Alarm Silence Sensor Connector %SpO2 Display Pulse Rate Display Plus (+) Minus (-) Alarm Bar Speaker Limits %SpO2 Display The %SpO2 display is located on the left-hand side of the Model 7500 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.
Numeric LEDs Green numeric LEDs display %SpO2 and pulse rate values. When setting the device, these LEDs also display values for alarm limits, volume, and date and time settings. Indicators and Icons Alarm Bar LED This LED indicates all alarm conditions. For high priority (patient) alarms, the indicator is displayed in red, blinking fast. For medium priority alarms, the indicator is displayed in amber, blinking slowly. Pulse Quality LED This amber LED blinks to indicate a poor pulse signal.
Low Battery LED This amber LED indicates a low battery charge when blinking, and a critical battery charge when lit solidly. This LED does not indicate that the Model 7500 is running on battery power. WARNING: This device turns off after approximately 30 minutes when in low battery mode. Model 7500 Front Panel Buttons ON/STANDBY Button Pressing this button once turns on the Model 7500. Holding this button for at least 1 second shuts down the 7500, putting it into Standby mode.
Operating the Model 7500 NOTES: • • • Before using the Model 7500, please review all contraindications, warnings and cautions. Before using the Model 7500, the battery must be charged for four (4) hours. When the Model 7500 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 7500 performs a brief initialization sequence.
Operating Modes and Defaults The Model 7500 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 7500 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 7500 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 7500 has several easy-to-use basic functions. Most involve pressing only a single button. Function Button Instruction Turn the Model 7500 on and off. Press the ON/STANDBY button to turn on the Model 7500. Press and hold the button for at least one second to turn off the Model 7500. In Patient Security mode, hold the ON/STANDBY button for three seconds to turn off the Model 7500. Initiate an event marker. Momentarily press the ON/STANDBY button while the unit is on.
Table 1: Limits Display Sequence Parameter (SpO2) Parameter Display Recall Alarm Settings “rCL” Low %SpO2 Alarm Limit Pulse High Alarm Limit Pulse Low Alarm Limit High %SpO2 Alarm Limit Alarm Volume Clear Memory Confirm Memory Clear 2,3 Initial Setting (Pulse Rate Display) Adjustment Range “no” “yES” or “no” “85” “Off”, 50 to 95 by 1 “HH” 2 “200” “Off”, 75 to 275 by 5 “HL” 2 “02L” “50” “Off”, 30 to 110 by 5 “02H” 2 “Off” “Off”, 80 to 100 by 1 “adb” 2 “Hi” “Off” or “Lo” or “Hi” “
The Model 7500 features a number of advanced options, which are intentionally more difficult to activate. These functions are recommended only for trained operators and they 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 7500 requires no calibration or periodic maintenance other than battery replacement by qualified technical professionals. Field repair of the Model 7500 circuitry is not possible. Do not attempt to open the Model 7500 case or repair the electronics. Opening the case may damage the Model 7500 and void the warranty. If the Model 7500 is not functioning properly, see “Troubleshooting.
Alarms and Limits The Model 7500 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 7500, 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 7500 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 hinder 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 7500 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 7500 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) Event Marker 0 VDC or 1.0 VDC nominal (representing an event). 1.27 VDC (out of track) Event marker high for SpO2 less than low alarm limit.
Memory Features The Model 7500 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 7500 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 7500 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. With the unit off, connect the serial connector port of the Model 7500 to the back of your computer using the 7500 SC cable, which is available from NONIN. 2. Press and hold the Plus (+) button while briefly pressing the ON/STANDBY button. 3. Release the Plus (+) button.
Service, Support, and Warranty A return authorization number is required before returning any product to NONIN. To obtain this return authorization number, contact NONIN Customer Support: 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 7500 battery pack. NONIN warrants the pulse oximetry module of the Model 7500 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.
Parts and Accessories The following NONIN accessories function with the Model 7500. Detailed information regarding specified sensor use (patient population, body/ tissue, and application) can be found in the respective sensor instructions.
Model Number Description External Cables UNI-RA-0 UNI-EXT-X 7500 SC 7500A 7.
Troubleshooting Problem Possible Cause Possible Solution Model 7500 will not activate. The unit has no power. Plug in the AC adapter. Model 7500 will not operate on batteries. The battery pack is not Plug in the Model 7500 AC Adapter charged. to charge the battery pack. The battery pack is inoperable. Contact NONIN Customer Support for repair or replacement. Unable to obtain a green pulse display on the bargraph. The patient pulse strength is indiscernable or perfused poorly.
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 7500 is not functioning. Turn the unit off, check all connections, and retry.
Technical Information NOTE: This product complies with ISO 10993, 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 Response 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. 38 80.0 Specific to this example: 72.0 Time in seconds 64.
Testing Summary SpO2 accuracy, motion, 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: 0 to 100% SpO2 18 to 321 pulses per minute (BPM) Pulse Rate Display Range 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 70-100% SpO2 Accuracy (Arms)a: Adults/ Pediatrics Neonates Finger Clip: Flex: Soft Sensor: Reflectance: ±2 digits ±2 digits ±2 digi
LOW PERFUSION Reusable: Disposable: Finger Clip: Flex: Soft Sensor: Reflectance: 6000 Series: 7000 Series: ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits ±3 digits Alarm Volume: High: 75dBA Informational Tone Volume: Low: High: 64dBA 67dBA Low: 55dBA Measurement Wavelengths and Output Power:c Red: 660 nm @ 0.8 mW maximum average power Infrared: 910 nm @ 1.
Analog Outputs: SpO2 Output Range: 0-1 VDC (0-100% SpO2, 1.27 VDC (out of track) Pulse Rate Output Range: 0-1 VDC (0-300 BPM), 1.
