ADC Diagnostix 2100 Manuals

ADC ® DiagnostixTM 2100 Fingertip Pulse Oximeter ® Directions for Use ADC 55 Commerce Drive Hauppauge, NY 11788 ADC (UK) Ltd. Unit 6, PO14 1TH United Kingdom Made in China. tel: 631-273-9600 toll free: 1-800-232-2670 fax: 631-273-9659 www.adctoday.com [email protected] IB p/n 93-2100-00 rev 4 Printed in China Warranty American Diagnostic Corporation (ADC®) warrants its products against defects in ma- terials and workmanship under normal use and service as follows: 1. Warranty service extends to the original retail purchaser only and commences with the date of delivery. 2. Your Pulse Oximeter is warranted for two (2) years from date of purchase (all parts). What is Covered: Replacement of parts, and labor. What is Not Covered: Transportation charges to and from ADC®. Damages caused by abuse, misuse, accident, or negligence. Incidental, special, or consequential dam- ages. Some states do not allow the exclusion or limitation of incidental, special, or consequential damages, so this limitation may not apply to you. To Obtain Warranty Service: Send item(s) postage paid to ADC®, Attn: Repair Dept., 55 Commerce Dr., Hauppauge, NY 11788. Please include your name and ad- dress, phone no., proof of purchase, and a brief note explaining the problem. Implied Warranty: Any implied warranty shall be limited in duration to the terms of this warranty and in no case beyond the original selling price (except where prohibited by law). This warranty gives you specific legal rights and you may have other rights which vary from state to state. This manual is available online in a variety of languages, follow the links for language options. www.adctoday.com/care To register your product visit us at www.adctoday.com/register FOR QUESTIONS, COMMENTS, OR SUGGESTIONS CALL TOLL FREE: 1-800-ADC-2670 OR VISIT www.adctoday.com/feedback 0197 Troubleshooting Possible Problems Problem Possible Reason Solution 1. Finger is not inserted correctly. 2. Patient SpO2 value is too low to be measured. 1. Finger might not be inserted deep enough. 2. Excessive patient movement. 1. No battery or low battery power. 2. Battery not installed correctly. 3. The monitor may be damaged. 1. The Oximeter is automatically powered off, when no signal was detected after 8 seconds. 2. The battery power is too low to operate. 1. ERR 3 means the red emission LED is damaged. 2. Err 4 means the infra-red emission LED is damaged. Err 6 means crystal damage. Err 7 means all the emission LED or reception dioxide is damaged. SpO2% or pulse rate do not display normally. SpO2% or pulse rate is shown unstably. The monitor cannot be powered on. Indication is suddenly off. “Err 3” or “Err 4” “Err 6” “Err 7” 1. Retry inserting the finger. 2. There is excessive illumination. 3. Measure more times. If you determine the product is working correctly, see your healthcare provider for an exact diagnosis. 1. Retry inserting the finger. 2. Sit calmly and retry. 1. Replace battery. 2. Remove and reinstall battery. 3. Contact customer service center. 1. Normal. 2. Replace batteries. 1. Check the red emission LED. 2. Check the infra-red emission LED. 3. Return to Service Center 1. Return to Service Center 1. Return to Service Center Display Type: OLED Display SPO2 display range: 0-100% PR Display Range: 30-235 BPM PR Display Mode: Bargraph Data Update Time: < 15 s LED Wavelengths Red: 660nm Infrared: 940nm Measurement range: SPO2: 70-99% - 100% ±3%; s ≤70% no definition Pulse Rate: 30-235 BPM, ±2 bpm during the pulse rate range of 30-99 bpm and 2% during the pulse rate range of 100-235 bpm. Accuracy: ±2% on the stage of 80%-99%; ±3% on the stage of 70%-80%; Accuracy: ±2 BPM or ±2% (larger) Pulse Intensity: Bargraph Indicator Power Requirements: Two AAA alkaline Batteries Power consumption: Less than 40mA Declaration: EMC of this product comply with IEC60601-1-2 standard. Measurement Performance in Low Perfusion Condition: required the test equipment (BIO-TEK INDEX Pulse Oximeter tester) the pulse wave is available without failure when the simulation pulse wave amplitude is at 6%. Interference Resistance Capacity against Ambient Light: Device work normally when mixed noise produced by BIO-TEK INDEX Pulse Oximeter tester. Guidance and Manufacturer’s Declaration Electromagnetic Emissions Guidance and Manufacturer’s declaration - electromagnetic environment specified below. The customer or the user of the PULSE OXIMETER should assure that it is used in such an environment. Emission Test Compliance Level Electronic Environment Guidance RF Emissions CISPR11 Group 1 The PULSE OXIMETER uses very low RF energy only and is not likely to cause interference to nearby electronic equipment. RF Emissions CISPR11 Class B The PULSE OXIMETER is suitable for use in all establishments,including domestic and Harmonic emissions Not applicable those directly connected to the public IEC 61000-3-2 low-voltage power supply which powers buildings used for domestic purposes. Voltage fluctuations/ Flicker emissions Not applicable IEC 61000-3-2 Recommended Separation Distance Between Portable and Mobile RF communication equipment and the Equipment or Systems For all equipment and Systems that are not Life-Supporting Recommended separation distances between portable and mobile RF communications equipment and Pulse Oximeter The Pulse Oximeter is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter can help prevent electromagnetic intereference by maintaining a minimum distance between portable and recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter (m) Output power of transmitter (W) 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.1167 0.2334 0.1 0.3689 0.7378 1 1.1667 2.3334 10 3.6893 7.3786 100 11.6667 23.3334 For transmitters rated at a maximum output power not listed above, the recommended separtaion distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where (p) is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity For all Equipment and Systems Guidance and Manufacturer’s declaration - electromagnetic environment specified below. The customer or the user of the PULSE OXIMETER should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electronic Test Test Level Level Environment Guidance Electrostatic Discharge +/- kV contact +/- kV Contact Floors should be wood, concrete, or ceramic tile. (ESD) +/- 8kV air +/- 8kV air If floor is covered with synthetic material, the IEC 61000-4-2 relative humidity should be at least 30%. Power Frequency Power frequency magnetic fields should be at (50/60 Hz) Magnetic Field 3A/m 3A/m levels characteristic of a typical location in a typical IEC 61000-4-8 commercial or hospital environment. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity For all Equipment and Systems that are not Life-Supporting Guidance and Manufacturer’s declaration - electromagnetic environment specified below. The customer or the user of the PULSE OXIMETER should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electronic Test Test Level Level Environment Guidance Radiated RF 3 V/m 3 V/m Portable and mobile RF communications equipment should not be IEC 61000-4-3 80 MHz to 2.5 GHz used close to any part of the Pulse Oximeter, including cables. The recommended separation distance should be calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80MHZ to 800MHZ 800MHZ to 2.5GHz Where P is 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). 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. should be less than the compliance level in each frequency range. NOTE 1: At 80MHz and 800MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection structures, objects and people. A. Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones, and land mobile radios, amateur radio, AM/FM radio, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic en- vironment due to fixed RF transmitters, an electromagnetic site survey should be considered. If measured field strength in the location in which the Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measurements may be necessary, such as reorienting the location of the Pulse Oximeter. B.Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. Symbol Definition Important Warning/Caution Latex-Free Equipment type is BF Hemoglobin Saturation Heart Rate (BPM) Low Power Indication Symbol Definition Not for Continuous Monitoring Conforms to EU Standards Authorized European Represenative’s Information Manufacturer’s Information Serial Number Symbol Definitions Low power indication: Battery Life: (2) ”AAA” 1.5V, 600mAh alkaline batteries Can operate as long as 30 hours (continious). Dimension: Length: 2.3” (58mm) Width: 1.3” (32mm) Height: 1.3” (34mm) Weight: 1.8oz. (50g) (including two AAA batteries) Environment: Operation Temperature: 41°F - 104°F (5°C - 40°C) Storage Temperature: 14°F - 104°F (-10°C - 40°C) Relative Humidty: 15%-80% in operation / 10%-80% in storage Finger Range: .31” - .98” (.8cm-2.5cm) Minimum Weight: 20lbs. (13kg) Technical Specifications

1 ADC ® DiagnostixTM 2100 Fingertip Pulse Oximeter Directions for Use

ADC ® Diagnostix™ 2100 Fingertip Pulse Oximeter Directions for use ® guid com