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36

Technical Information

Table 4: Guidance and Manufacturer’s Declaration—

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.

Portable and mobile RF communications equipment should be used no closer to any part of
the device, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.

Recommended Separation Distance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to

80 MHz

3 V

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to

2.5 GHz

3 V/m

where

P

is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter
manufacturer and

d

is the recommended

separation distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey

a

, should be

less than the compliance level in each
frequency range.

b

Interference may occur in the vicinity of
equipment marked with the following
symbol:

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/

cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field
strength in the location in which the device is used exceeds the applicable RF
compliance level above, the device should be observed to verify normal opera-
tion. If abnormal performance is observed, additional measures may be neces-
sary, such as reorienting or relocating the device.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less

than [3]V/m.

NOTES:

•

At 80 MHz and 800 MHz, the higher frequency range applies.

•

These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.

d

1.17

P

=

d

1.17

P

=

d

2.33

P

=

80 MHz to 800MHz

800MHz to 2.5 GHz

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Содержание 7500

Страница 1: ...Operator s Manual Digital Pulse Oximeter Model 7500 Model 7500 1 0123 English ...

Страница 2: ...orth 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 com Authorized EC Representative MPS Medical Product Service GmbH Borngasse 20 D 35619 Braunfels Germany References to NONIN in this manual shall imply Nonin Medical Inc Nonin is a registered trademark of Nonin Medical Inc 2007 Nonin Medical Inc 5676 001 01 CAUTION Federal ...

Страница 3: ...he Model 7500 18 Alarms and Limits 19 High Priority Alarms 19 Medium Priority Alarms 19 Watchdog Alarms 19 Informational Tones 19 Alarm Summary 20 Reviewing and Setting Volume 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 Analog Output 24 Memory Features 25 Service Support and Warranty 27 Warra...

Страница 4: ...respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 and CAN CSA C22 2 No 601 1 CE Marking indicating conformance to EC directive No 93 42 EEC concerning medical devices Serial Number Indicates separate collection for electrical and electronic equipment WEEE Authorized Representative in the European Community Lot Number IPX2 Protected against vertically falling ...

Страница 5: ...arm 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 Symbol Description ...

Страница 6: ... signs and symptoms Oximeter readings of this device may be affected by the use of an electrosurgical unit ESU 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 Do not use a damaged sensor Do not use this device in or...

Страница 7: ...els 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 If this dev...

Страница 8: ...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 ...

Страница 9: ...tor 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 Cautions Continued ...

Страница 10: ...splays 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 7500 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...

Страница 11: ...s failed or is not compatible with this monitor 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 pu...

Страница 12: ...ntarily 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 b...

Страница 13: ...7500 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 7500 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 bargrap...

Страница 14: ...ts 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 7500 s default operating setting The Model 7500 is shipped with factory defaults active To revert to Factory Default alar...

Страница 15: ...idental changes to critical parameters The Model 7500 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 volume...

Страница 16: ...wer alarm limits NOTE Patient memory cannot be cleared when the Model 7500 is in Patient Security mode In addition Patient Security mode is not disabled when the unit is turned off 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 but...

Страница 17: ...nitiate 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 th...

Страница 18: ... yES or no Confirm Memory Clear del 1 no yES or no Year y 00 0 to 99 by 1 Month nn 00 0 to 12 by 1 Day d 00 1 to 31 by 1 Hour h 00 0 to 23 by 1 Minutes nn 00 0 to 59 by 1 Notes 1 Both of these menu options are part of the memory clear command del will be displayed only if yES was selected as the setting for the Clr parameter 2 These parameters are restored when Recall Alarm Settings is set to yES ...

Страница 19: ... Memory Playback Press and hold the Plus button while turning on the Model 7500 This functions with the NONIN nVISION software Select the Model 2500 option in nVISION software the Model 2500 option also applies to the Model 7500FO NOTE Alarm limits cannot be changed when the Model 7500 is in Patient Security mode Patient Security mode prevents accidental changes to critical parameters The Model 75...

Страница 20: ...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 CAUTION Review all limits to ensure they are appropriate for the patient Function Button Instruction ...

Страница 21: ...ids onto the Model 7500 and do not allow any liquid to enter any openings in the device Allow the unit to dry thoroughly before reusing it Clean the Model 7500 separately from its associated sensors For instructions regarding cleaning pulse oximeter sensors refer to the appropriate pulse oximeter sensor package inserts CAUTION Follow local state and national governing ordinances and recycling inst...

Страница 22: ...s On the Model 7500 medium priority alarms are indicated with a slowly blinking amber Alarm Bar LED Medium priority alarms are illuminated amber on the Alarm Bar LED and on the appropriate indicator s or numeric displays sometimes displaying an error code to help the user identify the source of the error Medium priority alarms are sounded as three beeps and a 25 second pause Watchdog Alarms Watchd...

Страница 23: ...rm Bar LED Equipment Alarms Alarm Description 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 Low Perfusion Alarm Red segment on Pulse Strength Bargraph indicates low patient perfusion Alarm Description Visual Indicator Low ...

Страница 24: ...lue press the Plus or Minus buttons as desired 4 Continue to press the Limits button until the unit returns to normal operation Silencing Alarms Press the Alarm Silence button to silence alarms for two minutes The Alarm Silence LED blinks at the medium priority alarm rate while alarms are temporarily silenced If alarms are silenced during active alarm conditions the Alarm Silence LED blinks in tim...

Страница 25: ...t yES Press the Limits button again to accept the recall and return to normal operation NOTE The recalled value for the SpO2 low alarm will not be less than the current default Error Codes This device includes error codes that indicate problems with the unit Error codes are indicated by Err in the SpO2 display and a capital E followed by a 2 digit code in the pulse rate display To correct error co...

Страница 26: ...or port The 7500 SC cable available from NONIN may be used to connect the Model 7500 to the receiving computer The information from the Model 7500 is sent in an ASCII serial format at 9600 baud with 8 data bits 1 start bit and 2 stop bits Each line is terminated by CR LF Data from the device are sent once per second in the following format SPO2 XXX HR YYY NOTE Pressing the ON STANDBY button will i...

Страница 27: ...gnal sequence is as follows Output Specification SpO2 Output Analog Range 0 1 0 VDC representing 0 100 1 27 VDC out of track 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 Event marker high for SpO2 less than low alarm limit Analog Output Load Current 2 mA maximum SpO2 Analog Output Accuracy 2 Pulse ...

Страница 28: ...lue of the 4 second sample period is stored Oxygen saturation values are stored in 1 increments in the range of 0 to 100 The stored pulse rate ranges from 18 to 300 pulses per minute The stored values are in increments of one pulse per minute in the interval from 18 to 200 pulses per minute and in increments of 2 pulses per minute in the interval from 201 to 300 pulses per minute Patient data is r...

Страница 29: ...r 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 Playback mode will be shown on the SpO2 and Pulse Rate displays until memory playback is completed 4 When Memory Playback is complete the device will return to normal operation NOTES Patient memory cannot be cleared when the Model 7500 is i...

Страница 30: ...t 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 com WARNING 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 m...

Страница 31: ...d to be defective in any manner whether such remedies be in contract tort or by law This warranty excludes cost of delivery to and from NONIN All repaired units shall be received by the purchaser at NONIN s place of business NONIN reserves the right to charge a fee for a warranty repair request on any Model 7500 that is found to be within specifications The Model 7500 is a precision electronic ins...

Страница 32: ...inger Clip Sensor 1 meter 8000AP 3 Pediatric Finger Clip Sensor 3 meters 8000J Adult Flex Sensor 1 meter 8000J 3 Adult Flex Sensor 3 meters 8008J Infant Flex Sensor 8001J Neonatal Flex Sensor 8000R Reflectance Sensor 8000SL Reusable Pulse Oximeter Sensor Large 8000SM Reusable Pulse Oximeter Sensor Medium 8000SS Reusable Pulse Oximeter Sensor Small Pulse Oximeter Disposable Sensors 6000A Disposable...

Страница 33: ...mulator Other Accessories nVISION nVISION software for Microsoft Windows 95 98 2000 NT 4 0 XP operating systems Avant RS Rolling Stand available in standard or deluxe Avant PC Pole Mount Clamp CAUTION Use the Model 7500 only with power adapters supplied by Nonin Medical When using the 300PS UNIV battery charger ensure that the AC cord is plugged into a grounded outlet WARNING The use of accessorie...

Страница 34: ...discernable or perfused poorly Reposition the finger or insert a different finger and keep the sensor motionless for at least 10 seconds Warm the patient s finger by rubbing or covering with a blanket Position the sensor at a different site NOTE In some instances patient perfusion may be inadequate for pulse detection Circulation is reduced because of excess pressure on the sensor between the sens...

Страница 35: ...ure the sensor is securely attached to the Model 7500 Check the sensor for any visible signs of deterioration Contact NONIN Customer Support Frequent or steady pulse quality indication There is excessive ambient light Shield the sensor from the light source The Model 7500 is applied to a polished or artificial fingernail Apply the sensor to a finger without artificial or polished nails Position th...

Страница 36: ...isplay area The Model 7500 encountered an error Turn the unit off and then back on again to remove the error code If the error persists disconnect all power and then reconnect the power and turn the unit back on If the error still persists note the error code and contact NONIN Customer Support The unit is in Alarm mode but no audible alarms can be heard The 2 minute Alarm Silence button is activat...

Страница 37: ...pment can affect medical electrical equipment Table 2 Electromagnetic Emissions Emissions Test Compliance 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 RF Emissions CISPR 11 Group 1 This device uses RF energy only for its internal function Therefore...

Страница 38: ...mmon mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 di...

Страница 39: ... surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To asses...

Страница 40: ...According to Frequency of Transmitter Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of...

Страница 41: ...d 7 5 over 10 seconds Pulse Rate 75 BPM Specific to this example The response of the 4 beat average is 1 5 seconds The response of the 8 beat average is 3 seconds Pulse Rate Values Response Latency Standard Fast Averaged Pulse Rate 4 beat exponential 2 beats Extended Averaged Pulse Rate 8 beat exponential 2 beats ...

Страница 42: ...Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 9919 2005 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use Pulse Rate Motion Testing This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse oximeter tester This test ...

Страница 43: ...igits Soft Sensor 2 digits N A Reflectance 2 digits N A Disposable 6000 Series 2 digits 3 digits 7000 Series 3 digits 4 digits MOTION Reusable Finger Clip 2 digits 3 digits Flex 4 digits 5 digits Soft Sensor 3 digits 4 digits Pulse Rate Accuracy 18 to 300 BPM no motion 40 to 240 BPM motion 40 to 240 BPM low perfusion NO MOTION Adults Pediatrics Neonates Reusable Finger Clip 3 digits 3 digits Flex ...

Страница 44: ...atmospheres Power Requirements Mains 100 240 VAC 50 60 Hz Internal Power Battery 7 2 volt NiMH battery pack Operating Life fully charged battery 16 hours minimum Storage Life 21 days minimum Recharge Rate 4 hours maximum 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 UL606...

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