Model 7500FO Operators Manual 5934-001-04

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 E-mail: [email protected] Nonin Medical B.V. Prins Hendriklaan 26 1075 BD Amsterdam, Netherlands +31 (0)13 - 79 99 040 (Europe) Fax: +31 (0)13 - 79 99 042 E-mail: [email protected] nonin.com 0123

EC

REP

MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany References to “Nonin” in this manual shall imply Nonin Medical, Inc. Nonin, PureLight and nVISION are registered trademarks or trademarks of Nonin Medical, Inc. Microsoft® and Windows® are registered trademarks of Microsoft Corporation. © 2014 Nonin Medical, Inc. 5934-001-04

Contents Indications for Use ... 1 Contraindications... 1 Warnings ... 1 Cautions ... 2

Guide to Symbols ... 4 Displays, Indicators and Controls... 6 %SpO2 Display... 6 Pulse Rate Display ... 6 Numeric LEDs ... 6 Indicators and Icons ... 7 Model 7500FO Front Panel Buttons ... 8

Operating the Model 7500FO ... 10 Operating Instructions ... 11 Operating in the MR Environment ... 11

Operating Modes and Defaults... 12 Setup Mode, Viewing Limits and Setting Time ... 12 Factory Defaults ... 12 User-Defined Defaults ... 13 Patient Security Mode ... 13 Viewing and Changing Patient Security Mode... 14

Operator Functions ... 15 Care and Maintenance... 18 Cleaning the Model 7500FO... 18

Alarms and Limits... 19 High Priority Alarms... 19 Medium Priority Alarms ... 19 Watchdog Alarms ... 19 Informational Tones... 19 Alarm Summary... 20 Patient Alarms... 20 Equipment Alarms... 20

Reviewing and Setting Volume and Alarm Limits ... 21 Reviewing, Setting, or Changing Volumes and Alarm Limits ... 21 Silencing Alarms... 21 Recalling Previous Settings... 22 Error Codes ... 22

Memory and Data Output Features ... 23 Serial Patient Data Output... 23

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Contents (Continued) Analog Output ...24 Analog Output Calibration...24 Memory Features ...25 Clearing Patient Memory ...25 Playing Back Memory Data ...25 Connecting the Device into a Medical System ...26

Parts and Accessories...27 Service, Support, and Warranty...28 Warranty...28

Troubleshooting ...30 Technical Information ...33 Manufacturer’s Declaration ...33 Equipment Response Time...36 Testing Summary ...37 SpO2 Accuracy Testing ...37 Low Perfusion Testing ...37 Principles of Operation...38 Specifications ...38

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Tables Table 1. Symbols ... 4 Table 2. Factory Default Settings... 12 Table 3. Basic Functions... 15 Table 4. Limits Display Sequence... 15 Table 5. Advanced Functions ... 16 Table 6. Electromagnetic Emissions... 33 Table 7. Electromagnetic Immunity... 34 Table 8. Guidance and Manufacturer’s Declaration-Electromagnetic Immunity... 35 Table 9. Recommended Separation Distances ... 36

iv

Indications for Use

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. It is intended for spot checking and/or continuous monitoring of patients who are well or poorly perfused.

Contraindications Explosion Hazard: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses. This device is not defibrillation proof per IEC 60601-1. The battery charger cannot be used in the MR environment.

Warnings This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors and/or double-backed adhesive strips may vary due to medical status or skin condition. Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor. Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU). To avoid patient injury, use only Nonin-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for Nonin pulse oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance. To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories before use. No modifications to this device are allowed as it may affect device performance. Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor. Verify all alarm settings and limits during system startup to ensure that they are set as intended. Do not use this device in or around water or any other liquid, with or without AC power. As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement, strangulation, or injury to the patient. Use this device only with power adapters supplied by Nonin Medical. This device turns off after approximately 30 minutes when in low battery mode. This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed carefully to verify normal operation.

1

Indications for Use

Warnings (Continued) The battery pack must be installed at all times while the device is operating-even when operating on AC power. Do NOT use the device without batteries. 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. When operating in an MR environment, securely fasten this device to a non-movable pole mount or other large object, and keep it as far from the magnetic field as possible. For magnetic equipment with a magnetic strength of 1.5T or less, the device must be a minimum of 2 meters away from the magnet. The fiber cable for this device is extremely sensitive and must be handled with caution at all times. Do not use a damaged sensor. To avoid injury or potential equipment damage, always keep the oximeter, battery charger and metal end of fiber optic cable beyond the distance of magnetic attraction. To ensure safe operation of the 7500FO in the MR environment, the monitor must be located outside the 200 Gauss line of the MR room and must be firmly attached to a fixed object. When audible alarms cannot be heard due to ambient noise, visible alarms must be used.

Cautions This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in this manual. Portable and mobile RF communications equipment can affect medical electrical equipment. When mounting the monitor to a mobile pole, mounting the monitor higher than 1.5 meters (5 feet) or mounting more than 2 kilograms (4.5 pounds) of equipment onto the pole may result in tipping, damage to the equipment, or injury. If the device does not beep during the initialization sequence, the speaker may not be functioning properly. Discontinue use until the situation is corrected by qualified technical personnel. Review all limits to ensure they are appropriate for the patient. Setting alarm limits to extremes can render the alarm system useless. This device is a precision electronic instrument and must be repaired by qualified technical professionals. Field repair of the device is not possible. Do not attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty. If this device fails to respond as described, discontinue use until the situation is corrected by qualified technical professionals. The sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation, or reposition the sensor. Do not gas sterilize or autoclave this device.

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Indications for Use

Cautions (Continued) 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. Do not place liquids on top of this device. 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. In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor’s contact information. To prevent potential loss of monitoring or inaccurate data, remove any objects that might hinder pulse detection and measurement (e.g., blood pressure cuffs). Data is written in four-minute intervals-so if the entire memory is filled, portions of the oldest record will be overwritten when a new record begins. 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 - venous pulsations - excessive motion - anemia or low hemoglobin concentrations - electrosurgical interference - cardiogreen and other intravascular dyes - blood flow restrictors (arterial catheters, blood - carboxyhemoglobin pressure cuffs, infusion lines, etc.) - methemoglobin - moisture in the sensor - dysfunctional hemoglobin - improperly applied sensor - artificial nails or fingernail polish - incorrect sensor type - a sensor not at heart level. - poor pulse quality 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 data-processing equipment. Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results. The two-minute alarm silence is automatically engaged at startup. Radios and cell phones or similar devices can affect the equipment and must be kept at least 2 meters (6.5 feet) away from equipment. Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data transfer.

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Guide to Symbols

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.” Table 1: Symbols Symbol

Description Caution!

!

Consult Instructions for Use. Follow Instructions for Use. Type BF Applied Part (Patient isolation from electrical shock). MR

MR

Magnetic Resonance (MR) Conditional Magnetic Resonance (MR) Unsafe 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.

0123

CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices.

D

C

C UL US

SSIFIE LA

SN

Serial Number Indicates separate collection for electrical and electronic equipment (WEEE).

EC

REP

Authorized Representative in the European Community. Manufacturer

IPX2 %SpO2

Protected against vertically falling water drops when enclosure is tilted up to 15 degrees, per IEC 60529. %SpO2 display. Pulse Rate Display. Numeric LEDs.

Alarm Bar LED.

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Guide to Symbols

Table 1: Symbols (Continued) Symbol

Description 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.

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Displays, Indicators and Controls

Displays, Indicators and Controls This section describes the displays, indicators, and controls for the Model 7500FO.

On/Standby

Alarm Silence

%SpO2 Display

Sensor Connector

Pulse Rate Alarm Bar Display Speaker

Plus (+) Minus (-) Limits

Figure 1: Model 7500FO Front View

%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. See “Specifications” for sensor accuracy information.

Pulse Rate Display The pulse rate display is located on the right-hand side of the Model 7500FO front panel and is identified by the symbol. This display 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. When setting the device, these LEDs also display values for alarm limits, volume, and date and time settings.

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Displays, Indicators and Controls

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 an inadequate pulse signal. If there is a sustained period of poor quality signals, this LED will display a steady, constant light.

Sensor Alarm LED This amber LED indicates when a sensor has become disconnected, has failed, or is not compatible with this monitor. NOTE: In the 7500FO, the Sensor Alarm LED latches. Sensor must be properly attached to patient and alarm silence button must be toggled to clear LED. WARNING: Do not use a damaged sensor.

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. When alarms are active, this LED blinks in time with the alarm bar. If no alarms are active, this LED flashes at the medium priority alarm rate. When lit solid, the Alarm Silence LED indicates that audible alarm volumes are set to less than 45 dB.

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Displays, Indicators and Controls

AC Power Adapter LED This green LED is displayed when an external power supply is providing power to the Model 7500FO. NOTE: When the external power supply is disconnected, the device automatically switches to battery power without loss of functionality.

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 7500FO is running on battery power. WARNING: This device turns off after approximately 30 minutes when in low battery mode.

Model 7500FO Front Panel Buttons ON/STANDBY Button Pressing this button once turns on the Model 7500FO. Holding this button for at least 1 second shuts down the unit, putting it into Standby mode. In Standby mode, all device functions are shut off, with the following exceptions: • The AC Power Adapter LED is lit whenever the device is plugged in. • Batteries are charged whenever the device is plugged in. Momentarily pressing this button while the unit is on initiates an event marker.

Alarm Silence Button This button toggles alarms between silenced and audible. Pressing the Alarm Silence button silences the alarm for two minutes. Pressing it again (while alarms are silenced) returns the alarms to their audible mode.

!

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. 8

Displays, Indicators and Controls

Plus (+) and Minus (-) Buttons These buttons adjust values for many Model 7500FO functions. The Plus (+) and Minus (-) buttons are used to adjust time, date, volume and upper and lower alarm limits, except in Patient Security mode.

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Operating the Model 7500FO

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.

!

CAUTION: If the device does not beep during the initialization sequence, the speaker may not be functioning properly. Discontinue use until the situation is corrected by qualified technical personnel.

Verify that all LEDs illuminate and the unit beeps three times during the first phase of the initialization sequence. If any LED is not lit (except the AC Power Adapter LED), do not use the Model 7500FO. Contact Nonin Technical Service for assistance. To verify that the Model 7500FO is functioning properly, it is important to monitor SpO2 and pulse rate readings. Use the following procedure to verify that the sensor is working properly. 1. Ensure that the Model 7500FO is on, with the sensor connected. 2. Apply the pulse oximeter sensor (see sensor instructions for use). 3. Verify that a good SpO2 reading is displayed, that a pulse rate value appears, and that the pulse strength bargraph LED is active. WARNING: This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. WARNING: As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement, strangulation, or injury to the patient. WARNING: Verify all alarm settings and limits during system startup to ensure that they are set as intended.

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Operating Instructions

Operating Instructions Operating in the MR Environment When operating the 7500FO in the MR (magnetic resonance) environment, observe the following safety considerations:

MR

Use only Nonin-branded 8000FC or 8000FI Fiber Optic Sensors. Do not use cables or sensors that contain conductive wires.

MR

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.

WARNING: To avoid injury or potential equipment damage, always keep the oximeter and metal end of fiber optic cable beyond the distance of magnetic attraction. To ensure safe operation of the 7500FO in the MR environment, the monitor must be located outside the 200 Gauss line of the MR room and must be firmly attached to a fixed object.

MR Conditions MR OPERATIONS:

MR

USE ONLY NONIN Fiber Optic Sensors. (Sensors containing electrical conductors will cause patient burns). The Model 7500FO must be kept outside the 200 Gauss line of the MR field and affixed to an immovable object. Do not place on MR bed! 5682-000-04

MR

Contraindication: The battery charger cannot be used in the MR environment.

When operating the 7500FO in the MR environment, observe the following installation recommendations: • 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, +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe) for assistance.

MR

When operating the 7500FO inside the MR environment, operate the 7500FO on battery power only. Remove the 7500FO from the MR environment to recharge the batteries when the pulse oximeter is not in use.

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Operating Modes and Defaults

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. Setup mode is available when the device is operating, or during the startup/initialization process. Time is set by adjusting each of the last five options in setup mode: year, month, day, hour and minute. Setup mode is not available in Patient Security mode. In Patient Security mode, pressing the Limits button scrolls through the limits on the displays, allowing the operator to view the current limits. Pressing and holding the Plus (+) button also reviews the limits, regardless of operating mode.

Factory Defaults In Factory Defaults, all adjustable parameters are set as indicated in the table below. This is the Model 7500FO’s default operating setting. The Model 7500FO is shipped with factory defaults active. To revert to factory default alarm limits from the user-defined default alarm limits, simultaneously press the alarm silence and minus (-) buttons. NOTE: User-Defined Default values are lost when Factory Defaults are set active. Table 2: Factory Default Settings Alarm Limit

Factory Default Adjustment Options

Increment

SpO2 High Alarm Limit

Off

Off, 80-100

1%

SpO2 Low Alarm Limit

85%

Off, 50-95

1%

Pulse Rate High Alarm Limit

200 BPM

Off, 75-275

5 BPM

Pulse Rate Low Alarm Limit

50 BPM

Off, 30-110

5 BPM

Alarm Volume

High

Off, Low, High

N/A

Default alarm and volume settings are automatically selected for every operating session in which the parameters were not recalled or changed within the setup menu.

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Operating Modes and Defaults

User-Defined Defaults In User-Defined Defaults, alarm limit and volume settings must be adjusted. To set the UserDefined Defaults, set the alarm limits, hold the Alarm Silence button and then press the Limits button. This sets the User-Defined 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. NOTE: All user-defined default settings are retained even when both external and battery power are lost.

Patient Security Mode Alarm limits cannot be changed when the Model 7500FO is in Patient Security mode. Patient Security mode prevents accidental changes to critical parameters. The Model 7500FO allows users to lock and unlock alarm limits, volume settings, and time settings through the use of Patient Security mode. Operators will notice several operating differences with Patient Security mode: • Default and other previous device settings cannot be recalled. • Clock and calendar data cannot be changed. • SpO2 and pulse rate alarm limits and volumes cannot be changed. Pressing the Limits button allows the operator to review the limits. • Patient memory cannot be cleared. • To put the device into Standby mode, the ON/STANDBY button must be held for at least 3 seconds. • Memory playback not available. Patient Security mode remains active when the device is turned off and then turned back on. Patient Security mode is retained even when both external and battery power are lost. NOTE: Turn on the device and verify Patient Security mode and settings after initiating Patient Security mode. 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. NOTE: Patient memory cannot be cleared when this device is in Patient Security mode. In addition, Patient Security mode is not disabled when the unit is turned off.

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Operating Modes and Defaults

Viewing and Changing Patient Security Mode To enter Patient Security mode, press and hold the Alarm Silence button while turning on the device. To exit Patient Security mode, press and hold the Alarm Silence and Limits buttons while turning on the device. When the device is restarted, the Patient Security mode status is displayed on the Numeric LEDs for 1 second: • “SEC on” is displayed when Patient Security mode is enabled. • “SEC 0FF” is displayed when Patient Security mode is disabled.

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Operator Functions

Operator Functions The Model 7500FO has several easy-to-use basic functions. Most involve pressing only a single button. Table 3: Basic Functions 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.

Momentarily press the ON/STANDBY button while the unit is on.

Mute the audible alarms (2 minutes).

Momentarily press the Alarm Silence button.

Change Pulse tone volume.

Momentarily press the Plus (+) button while the unit is in operating mode. Press again to sequence through volume options for pulse tones.

Set alarm limits or alarm volumes, clear memory or set clock.

Momentarily press the Limits button to step through the Limits menu. Use the Plus or Minus buttons to adjust alarm limits or selected volumes as desired. When pressing Limits button, settings will appear in the order shown in Table 4.

then

or

!

CAUTION: Review all limits to ensure they are appropriate for the patient.

!

CAUTION: Setting alarm limits to extremes can render the alarm system useless. Table 4: Limits Display Sequence Parameter (SpO2) Display

Initial Setting (Pulse Rate Display)

Recall Alarm Settings

“rCL”

“no”

“yES” or “no”

Low %SpO2 Alarm Limit

“02L” 2,3

“85”

“0FF”, 50 to 95 by 1

Pulse High Alarm Limit

“HH” 2

“200”

“0FF”, 75 to 275 by 5

Parameter

Adjustment Range

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