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Nonin 2500 PalmSAT, Руководство оператора

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Technical Information

Technical Information

NOTE: 

This product complies with ISO 10993-1, Biological Evaluation of Medical Devices 

Part 1: Evaluation and Testing.

Manufacturer’s Declaration

Refer to the following table for specific information regarding this device’s compliance to 
IEC 60601-1-2.

 

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.

CAUTION: 

Portable and mobile RF communications equipment can affect medical 

electrical equipment.

Table 4: 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, its RF emissions are very low 
and are not likely to cause any interference in 
nearby electronic equipment.

RF Emissions
CISPR 11

Class B

This device is suitable for use in all 
establishments, including domestic and those 
directly connected to the public low-voltage power 
supply network that supplies buildings used for 
domestic purposes.

Harmonic Emissions
IEC 61000-3-2

N/A

Voltage Fluctuations/Flicker 
Emissions
IEC 61000-3-3

N/A

!

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Содержание 2500 PalmSAT

Страница 1: ...Operator s Manual Model 2500 PalmSAT Pulse Oximeter 0123 0123 English...

Страница 2: ...040 Europe Fax 31 0 13 79 99 042 E mail infointl nonin com nonin com Authorized EC Representative MPS Medical Product Service GmbH Borngasse 20 D 35619 Braunfels Germany References to Nonin in this ma...

Страница 3: ...ery Use 9 With AA Batteries 9 With Rechargeable NiMH Battery Pack 9 Recharging Batteries NiMH Battery Pack only 9 Connecting the Sensor 10 Power On Off 10 Power On Self Test 10 Monitoring 11 Detailed...

Страница 4: ...1 Troubleshooting 22 Technical Information 24 Manufacturer s Declaration 24 Equipment Response Time 27 Testing Summary 28 SpO2 Accuracy Testing 28 Pulse Rate Motion Testing 28 Low Perfusion Testing 28...

Страница 5: ...iii Figures Figure 1 Displays Indicators and Buttons 6 Figure 2 Rear View 7 Figure 3 Installing Batteries 8 Figure 4 Connecting a Sensor 10...

Страница 6: ...and Settings 12 Table 3 Pulse Oximeter Sensor Connector Pin Assignments 18 Table 4 Electromagnetic Emissions 24 Table 5 Electromagnetic Immunity 25 Table 6 Guidance and Manufacturer s Declaration Elec...

Страница 7: ...se sensors are manufactured to meet the accuracy specifications for Nonin Pulse Oximeters Using other manufacturers sensors may cause improper pulse oximeter performance Using other manufacturers sens...

Страница 8: ...ties due to reduced circulation Warm or rub the finger to increase circulation or reposition the sensor Replace the batteries as soon as possible after a low battery indication Always replace the batt...

Страница 9: ...ries connected to the serial port of this device must be certified according to at least IEC 60950 or UL1950 for data processing equipment This device is a precision electronic instrument and must be...

Страница 10: ...ndicating conformance to EC directive No 93 42 EEC concerning medical devices Serial Number located under the back cover IPX2 Protected against vertically falling water drops when enclosure is tilted...

Страница 11: ...splay is red SpO2 and pulse rate values are not updated After about 10 seconds the values are replaced with dashes indicating that readings are not possible Low Battery Indicator When batteries are cr...

Страница 12: ...moglobin SpO2 by measuring the absorption of red and infrared light passing through perfused tissue Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxy...

Страница 13: ...des the following items 1 Model 2500 Pulse Oximeter 1 Model 2500 Operator s Manual on CD 1 Nonin Pulse Oximeter Sensor 4 AA Size Alkaline Batteries Confirm that the items listed are packed with the sy...

Страница 14: ...attery compartment Proper battery positioning is essential for correct operation 3 Replace the battery cover and turn on the device If the unit does not turn on see Troubleshooting Figure 3 Installing...

Страница 15: ...re replacement in about 6 weeks Using the oximeter will shorten the required replacement time With Rechargeable NiMH Battery Pack If the clock calendar is not set when the unit is stored and if the un...

Страница 16: ...500 is turned on for normal operation the unit will cycle through a startup initialization sequence before displaying valid data During startup always check for any missing indicators or LED display s...

Страница 17: ...s are displaying readings and verifying that blinking of the Pulse Quality display is in time with the pulse rate for at least 10 seconds If the Pulse Quality display is blinking red or amber or is bl...

Страница 18: ...in the displays and then CLr no appears Making Selections in Setup Mode 1 When entering Setup mode CLr no is displayed This indicates the memory clear setting is being adjusted and that the default v...

Страница 19: ...e nn 00 59 00 a Choosing yes for both the CLr and dEL settings the memory clear function will clear the memory and exit setup mode Table 2 Adjustable Parameters and Settings Continued Setting Appears...

Страница 20: ...loth dampened with isopropyl alcohol Do not pour or spray any liquids onto the device and do not allow any liquid to enter any openings in the device Allow the device to dry thoroughly before reusing...

Страница 21: ...ignal Sensor misalignment ambient light nail polish artificial nails etc Pulse Quality LED is blank Dash appears in the leftmost position of the SpO2 display SpO2 and Heart Rate numeric displays freez...

Страница 22: ...inute The stored values are in increments of 1 pulse per minute in the interval from 18 to 200 pulses per minute and increments of 2 pulses per minute in the interval from 201 to 300 pulses per minute...

Страница 23: ...setup mode will continue directly to the calendar and clock settings Refer to Choosing Calendar and Clock Settings If yES is entered in response to dEL confirming that you do want to clear the memory...

Страница 24: ...dition Therefore real time data may be read as 8 data bits no parity Real time data may be printed or displayed by devices other than the pulse oximeter On power up a header is sent identifying the fo...

Страница 25: ...rth Plymouth Minnesota 55441 5443 USA 800 356 8874 USA and Canada 1 763 553 9968 Fax 1 763 553 7807 E mail technicalservice nonin com Nonin Medical B V Prins Hendriklaan 26 1075 BD Amsterdam Netherlan...

Страница 26: ...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 c...

Страница 27: ...e found in the respective sensor Instructions for Use WARNING The use of accessories sensors cables and power supplies other than those specified in the Parts and Accessories List may result in increa...

Страница 28: ...al is detected because the sensor is not plugged in Verify the sensor connections Sensor failure Replace the sensor The displayed pulse rate does not correlate to the pulse rate displayed on the ECG m...

Страница 29: ...elocate the sensor Excessive ambient light Reduce ambient light Excessive patient motion Reduce patient motion The patient is wearing nail polish or artificial nails Remove nail polish or artificial n...

Страница 30: ...pment can affect medical electrical equipment Table 4 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance This device is intended for use in the electromagnetic en...

Страница 31: ...mon 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 sup...

Страница 32: ...from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment mark...

Страница 33: ...r 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...

Страница 34: ...ples measured over the SpO2 range of 70 100 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 9919 2005 Medical Electrical Equipment Particular requirements f...

Страница 35: ...ers 1 2 mW max avg Indicators Pulse Quality Display LED tricolor Numeric Displays 3 digit 7 segment LEDs red Low Battery Indicator LED amber Temperature Operating 20 to 50 C 4 to 122 F Temperature Sto...

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