Hopkins Newborn & Mom Pulse OX 594020, Instruction And Service Manual

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Page 2: ...d reproduced or translated into another language without the prior written consent We reserve the right to improve and amend it at any time without prior notice This device complies with Part 15 of th...

Page 3: ...e when ambient temperature exceeds 98 6 F 37 C Injury may occur due to overheating of the sensor Discomfort may occur if the oximeter is used on the same finger for an extended period of time especial...

Page 4: ...the sensor in the correct position The patient s finger should remain still during measurement Do not put wet finger directly into sensor Do not let anything block the emitting light from device Vigor...

Page 5: ...eater or strong sunshine etc may cause inaccurate measurement Please put an opaque cover on the sensor or change the patient s location If the first reading shows unstable waveform the measurement may...

Page 6: ...tion 2 1 5 Features 2 3 2 Battery Installation 3 3 Operation 4 3 1 Direct measurement 4 6 3 2 Alarm and alarm silence 7 3 3 Menu Screen 8 9 3 4 Hopkins Y Probe Sensor 10 11 3 5 Proper application of H...

Page 7: ...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 SpO2 Common Knowledge 25 30 C El...

Page 8: ...User Manual for the Hopkins Newborn Mom Pulse Ox 1 Overview 1 1 Appearance Figure 1 Front Rear View 1...

Page 9: ...patient s finger It is applicable for spot checking SpO2 and pulse rate of adult and pediatric patients in homes and clinics 1 4 Structure and Conformation It consists of main unit and photoelectric...

Page 10: ...Battery Installation Figure 2 Battery Installation 1 Refer to Figure 2 insert two AAA size batteries into the battery compartment properly 2 Replace the cover Please make sure that the batteries are c...

Page 11: ...ower on automatically in 2 seconds and start to display software version number 4 The user can read the values and view the waveform on the display screen as seen in figures 4A 4F below Shift paramete...

Page 12: ...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 the PI will automatically shift to PR as shown in 4C...

Page 13: ...he Hopkins Newborn Mom Pulse Ox Screen Description SpO2 SpO2 symbol 99 SpO2 value PR Pulse rate icon 65 Pulse rate value Pulse beat symbol Pulse intensity histogram PI Perfusion index icon 1 4 Perfusi...

Page 14: ...on the screen will flash The detailed information refers to chapter 4 To silence the alarm or re set the pulse ox 1 Press Display Key to mute If this alarm event continues the pulse ox will resume al...

Page 15: ...o enter the menu screen Menu screen description 1 SpO2 alm Lo SpO2 alarm Lower limit The user can modify the value of 85 99 the step is 1 the default is 90 2 PR alm Hi Pulse Rate alarm Upper limit The...

Page 16: ...isplay screen 6 Restore default Restore default setting Refer to Figure 5 for each default value On setup menu screen 1 Press the Display Key to choose the setting item 2 Press and hold the Display Ke...

Page 17: ...gure 6 Probe Connection Important Note When the Hopkins Y Probe Sensor is connected properly the built in finger clip sensor will be disabled The measurement is detected from the external SpO2 probe 2...

Page 18: ...ls in the patient The recommended application site for infant and pediatric patients is on the finger foot or hand The recommended application for adult patients is on the finger Using the Hopkins Y P...

Page 19: ...sensor centered in the middle of it will minimize any effects from ambient light sources Other wraps can be used to secure lead wires to minimize the movement of the sensor itself IMPORTANT LED Senso...

Page 20: ...x Free Belt and tighten gently 5 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 fr...

Page 21: ...in water or a mild soap solution 3 To disinfect wipe the sensor and patient contact surfaces with disinfecting solution Isopropyl alcohol is recommended If using Sanizide follow the manufacturer s re...

Page 22: ...t 3 Important Batteries are not to be stored in the oximeter for an extended period of time and battery failure due to prolonged storage in the oximeter is not covered under the 3 year product warrant...

Page 23: ...l Incubator Continuous use of fingertip SpO2 sensor may result in discomfort or pain so we suggest inspecting the monitoring site for skin integrity every 2 hours for an adult patient every 1 hour for...

Page 24: ...sensor wavelength Red light 663 nanometers Infrared light 890 nanometers Maximal optical output power less than 1 5mW maximum average B SpO2 measurement Measuring range 70 100 Measuring accuracy 70 99...

Page 25: ...Display Range 0 2 20 E Audible visual alarm function When measuring if SpO2 value or pulse rate value exceeds the preset alarm limit the device will alarm automatically and the value which exceeds li...

Page 26: ...between the SpO2 value measured in the condition of indoor natural light and that of darkroom is less than 1 When using the Hopkins Wrap ensure the probe is centered in the wrap to prevent interferenc...

Page 27: ...6 Maintenance Replacement Parts 6 1 Oximeter Maintenance The service life not a warranty of this device is 5 years In order to ensure its long service life please adhere to the use of maintenance Plea...

Page 28: ...he factory prior to sale there is no need to calibrate the device during use However if it is necessary to verify its accuracy routinely the user can obtain verification by means of SpO2 simulator or...

Page 29: ...soft cloth wet with clean water and let air dry or wipe it dry You may use Sanizide to clean the unit Caution Do not sterilize by irradiation steam or ethylene oxide Do not use the sensor if it is da...

Page 30: ...User Manual for the Hopkins Newborn Mom Pulse Ox Hopkins Y probe wraps 592012BG is a bag of 100 23...

Page 31: ...r correctly inside and try again 2 Keep the patient calm Cannot turn the device on 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The device is malfunctionin...

Page 32: ...g See User Manual SpO2 The pulse oxygen saturation PR Pulse rate beats per minute Pulse rate icon Low battery voltage B SpO2 Common Knowledge 1 Meaning of SpO2 SpO2 is the saturation percentage of oxy...

Page 33: ...al with its density or concentration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect the...

Page 34: ...gical parameter to analyze a patient s respiration and blood oxygenation levels Some examples where SpO2 monitoring is important are monitoring patients with serious respiratory disease patients under...

Page 35: ...g lamps or direct sunlight 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 pr...

Page 36: ...User Manual for the Hopkins Newborn Mom Pulse Ox Blood vessel contraction caused by peripheral vessel hyperkinesia or body temperature decreasing 29...

Page 37: ...Hypoxemia disease functional lack of HbO2 Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sens...

Page 38: ...l 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 606...

Page 39: ...idance 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...

Page 40: ...uch an electromagnetic environment Immunity test IEC 60601 test level Compli ance level Electromagnetic environment guidance Electrostati c discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV conta...

Page 41: ...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 s N A N A Power frequency 50 60Hz magnetic field IEC61000 4 8 3 A m 3 A m...

Page 42: ...ce level Electromagnetic environment guidance Conduct ed RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 N A 3 V m Portable and mobile RF communications equipment should...

Page 43: ...ects and people 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 c...

Page 44: ...device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below accordi...

Page 45: ...pplicable 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 separa...