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Summary of Contents for Hopkins Newborn & Mom Pulse OX 594020

  • Page 2 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Instructions to User Dear Hopkins Customer, Thank you very much for purchasing our product. Please read the manual very carefully before using this device. Failure to follow these instructions can cause abnormal readings or damage to the oximeter.
  • Page 3 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Warnings! • Check the device, sensors and probes to make sure that there is no visible damage that may affect user’s safety or measurement performance with regard to sensors and clips. It is recommended that the device should be inspected once a week.
  • Page 4 ® User Manual for the Hopkins Newborn & Mom Pulse Ox • The light (the infrared light is invisible) emitted by the device is harmful to the eyes, so service technicians and patients should not stare at the light. •...
  • Page 5 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Important! • Existence of high intensive light sources, such as fluorescence light, ruby lamp, infrared heater or strong sunshine, etc. may cause inaccurate measurement. Please put an opaque cover on the sensor or change the patient’s location.
  • Page 6: Table Of Contents

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox Content 1 Overview ............... 1 1.1 Appearance ............. 1 1.2 Name and Model ............ 2 1.3 Intended Use ............2 1.4 Structure and Conformation ........ 2 1.5 Features ............... 2-3 2 Battery Installation ............
  • Page 7 ® User Manual for the Hopkins Newborn & Mom Pulse Ox 6.1 Oximeter Maintenance ........20-21 6.2 Cleaning and Disinfecting Instruction ....22 6.3 Replacement Parts .......... 22-23 7. Troubleshooting ............24 Appendix ................ 25 A Key of Symbols ............25 B SpO Common Knowledge .......
  • Page 8: Overview

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox 1 Overview 1.1 Appearance Figure 1 Front/Rear View...
  • Page 9: Name And Model

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox 1.2 Name and Model ® Name: Hopkins Newborn and Mom Pulse OX Kit Model: #716266 1.3 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO through a patient’s...
  • Page 10: Battery Installation

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox • Shift parameter display between PR and PI • 2AAA alkaline batteries with low power consumption • Low battery voltage indication 2 Battery Installation Figure 2 Battery Installation 1. Refer to Figure 2; insert two AAA size batteries into the battery compartment properly.
  • Page 11: Operation

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox Operation 3.1 Direct Measurement 1. Open the clip as shown in Figure 3. Figure 3 Put finger into the Oximeter 2. Put finger into the rubber cushions of the clip (make sure the finger is in the correct position with OLED display facing up), and then clip the finger.
  • Page 12 ® User Manual for the Hopkins Newborn & Mom Pulse Ox in 4D). Shifting parameter display between PR and PI is under the condition of the screen tilting to a side, as shown in 4B and 4E. After 20 seconds without operation,...
  • Page 13 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Screen Description:  “%SpO ”: SpO symbol; “99”: SpO value;  “PR”: Pulse rate icon; “65”: Pulse rate value;  “ ”: Pulse beat symbol;  “ ”: Pulse intensity histogram.
  • Page 14: Alarm And Alarm Silence

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox 3.2 Alarm When measuring, if SpO value or pulse rate value exceeds the preset alarm limit, the device will alarm automatically and the value which exceeds limit on the screen will flash.
  • Page 15: Menu Screen

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox 3.3 Menu Screen Figure 5 Menu Screen Press and hold the display key to enter the menu screen. Menu screen description: “SpO alm Lo” : SpO alarm Lower limit. The user can modify the value of 85~99, the step is “1”, the default is 90.
  • Page 16: Menu Screen

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox user can modify the value of 30~60, the step is “1”, the default is 50. “Pulse beep”:Pulse beep button. When SpO value (90~99) changes, the pitch tone changes accordingly.
  • Page 17: Hopkins Y-Probe Sensor

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox ® 3.4 Hopkins Y-Probe Sensor ® 1. Connect the Hopkins Y-Probe Sensor to SpO sensor connector as shown below. Make sure the side with “Arrow” faces upward. Figure 6 Probe Connection ®...
  • Page 18: Proper Application Of Hopkins Y-Probe

    4. Other operation is similar to chapter 3.1 direct measurement. 3.5 Proper Application of Hopkins Y-Probe Your Newborn and Mom Pulse OX Kit, Model: #716266 comes with a package of 10 hook-and-loop non-stick sensor wraps which are provided to secure ®...
  • Page 19 Secure the sensor with the Hopkins Adjustable Y-Probe Sensor Latex Free Belt and tighten gently. Apply a Hopkins® Y-Probe wrap on top to prevent ambient light interference. A secure wrap with the probe sensor centered in the middle of it will minimize any effects from ambient light sources.
  • Page 20 Secure the sensor with the Hopkins Adjustable Y-Probe Sensor Latex Free Belt and tighten gently. Apply a Hopkins® Y-Probe wrap on top to prevent ambient light interference. A secure wrap with the probe sensor centered in the middle of it will minimize any effects from ambient light sources.
  • Page 21: Warnings And Precautions

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox ® Cleaning and Disinfecting the Hopkins Adjustable Y-Probe Sensor after each use: Unplug the sensor from the monitor before cleaning or disinfecting. Clean the sensors and contact surfaces with a soft cloth moistened in water or a mild soap solution.
  • Page 22 User Manual for the Hopkins Newborn & Mom Pulse Ox ® The Hopkins Adjustable Y-Probe Sensor is only intended to be used with the Hopkins Neonatal ® Pulse Oximeter #716266. Use of the Hopkins Adjustable Y-Probe Sensor with incompatible devices may result in inaccurate performance or damage to the sensor or monitor.
  • Page 23: Safe Operation In A Neonatal Incubator

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox towel if necessary. Important! During prolonged use, check and reposition the sensor to an alternate location every 4 hours. Intravascular dyes interfere with performance of the sensor and monitor and may cause inaccurate measurements.
  • Page 24: Technical Specifications

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox Neonate SpO sensor: 4. Technical Specifications A. Technique: dual-wavelength LED sensor, LED sensor wavelength: Red light: 663 nanometers, Infrared light: 890 nanometers. Maximal optical output power: less than 1.5mW maximum average.
  • Page 25 ® User Manual for the Hopkins Newborn & Mom Pulse Ox C. Pulse Rate measurement Measuring range: 30bpm~240bpm Measuring accuracy: ±2bpm or ±2% (whichever is greater) Pulse Rate alarm range: high limit: 100~240bpm (default 120bpm) low limit: 30~60bpm (default 50bpm) Perfusion Index(PI) Display Range: 0.2%~20%...
  • Page 26 ±1%. When using the Hopkins Wrap, ensure the probe is centered in the wrap to prevent interference from ambient light. Dimensions: 60 mm (L) × 33 mm (W) × 30 mm (H) Net Weight: 35g (including battery) M.
  • Page 27: Accessories

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox 5. Accessories A. Lanyard B. Two batteries C. Pouch D. External SpO Probe (optional) E. User Manual F. Quality Certificate Note: The accessories are subject to change. For detailed items and quantity see the Packing List.
  • Page 28 ® User Manual for the Hopkins Newborn & Mom Pulse Ox not be used for an extended period of time. • The recommended storage environment of the device:  Ambient temperature: -4ºF~140ºF,-20ºC~60ºC  Relative humidity 10%~95%,  Atmospheric pressure: 50kPa~107.4kPa.
  • Page 29: Cleaning And Disinfecting Instruction

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox 6.2 Cleaning and Disinfecting Instruction • Surface-clean the sensor with a soft cloth dampened with a 75% isopropyl alcohol solution. If low-level disinfection is required, use a 1:10 bleach solution.
  • Page 30 ® User Manual for the Hopkins Newborn & Mom Pulse Ox • ® Hopkins Y-probe wraps #592012BG is a bag of 100.
  • Page 31: Troubleshooting

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox 7. Troubleshooting Trouble Possible Reason Solution 1. Place the 1. The finger is finger correctly The SpO not placed far inside and try and Pulse enough inside. Rate display 2.
  • Page 32: Appendix

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox Appendix A Key of Symbols Symbol Description With Type BF applied part Warning ─ See User Manual %SpO The pulse oxygen saturation Pulse rate (beats per minute) Pulse rate icon...
  • Page 33 ® User Manual for the Hopkins Newborn & Mom Pulse Ox hemoglobin of the arterial blood. SpO is an important physiological parameter to reflect the respiration function; it is calculated by the following method: = HbO / (HbO +Hb) ×100%...
  • Page 34 ® User Manual for the Hopkins Newborn & Mom Pulse Ox fractional oxygen saturation – a percentage of all measured hemoglobin, including dysfunctional hemoglobin, such carboxyhemoglobin metahemoglobin. 3. Clinical application of pulse oximeters is an important physiological parameter to analyze a patient’s respiration and blood oxygenation levels.
  • Page 35 • Insufficient coverage of the y probe can interfere with readings. Make sure to have the Y-Probe centered in the middle of the Hopkins Wrap. • Vascular dyes or externally used products such as nail enamel or tinted skin care •...
  • Page 36 ® User Manual for the Hopkins Newborn & Mom Pulse Ox • Blood vessel contraction caused by peripheral vessel hyperkinesia body temperature decreasing...
  • Page 37 ® User Manual for the Hopkins Newborn & Mom Pulse Ox 4. Pathological Factors causing low SpO Measuring value • Hypoxemia disease, functional lack of HbO • Pigmentation or abnormal oxyhemoglobin level • Abnormal oxyhemoglobin variation • Methemoglobin disease • Sulfhemoglobinemia or arterial occlusion exists near sensor •...
  • Page 38: C Electromagnetic Interference Data

    ® User Manual for the Hopkins Newborn & Mom Pulse Ox C Guidance and Electromagnetic Interference Data The following tables (Table 1 to 4) provide the specific information regarding this device's compliance to IEC 60601-1-2.
  • Page 39 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The user of this device should assure that it is used in such an environment.
  • Page 40 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Table 2 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of this device should assure that it is used in such an electromagnetic environment.
  • Page 41 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Surge ±1 kV line (s) to line(s) 61000-4-5 ±2 kV line(s) to earth Voltage dips, <5 % U short (>95 % dip interruptions in U and voltage for 0.5 cycle...
  • Page 42 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of this device should assure that it is used in such an electromagnetic environment.
  • Page 43 ® User Manual for the Hopkins Newborn & Mom Pulse Ox 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 .
  • Page 44 ® User Manual for the Hopkins Newborn & Mom Pulse Ox Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of this...
  • Page 45 ® User Manual for the Hopkins Newborn & Mom Pulse Ox For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.

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