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Summary of Contents for Hopkins 594810
- Page 1 594810 Hopkins Handheld Pulse Oximeter Instructions for Use Hopkins Medical Products...
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Page 2: Product Information
PRODUCT INFORMATION Product Name: Hopkins Handheld Pulse Oximeter Product Model: 594810 Manufacturer: Hopkins Medical Products Address: 6850 Southbelt Drive Caledonia, MI 49316 USA REVISION HISTORY This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. - Page 3 PREFACE MANUAL PURPOSE This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
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Page 4: Table Of Contents
4. 2 Low battery indicator..........4. 3 Install the Batteries..........594810 operation............Introduction............Turn on the 594810..........Set up the 594810........... 5.3.1 Adjust pulse Beep Volume......... 5.3.2 Select Patient Type........... 5.3.3 Set alarm Limit..........5.3.3.1 PR High/Low alarm Limit........ 5.3.3.2 Set SPO2 Low alarm Limit...... - Page 5 Measurement Limitations........Summary of Spo2 & pulse rate accuracy testing..Maintenance............. Cleaning............... Safety Checks............Disposal............... Accessories............. Specifications............10 EMC information............11 Warranty..............30...
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Page 6: Safety Information
1 Safety information ！ WARNING WARNING: Explosion hazard. Do not use the 594810 in the presence of ！ flammable anesthetics mixture with air, oxygen, or nitrous oxide. WARNING: Chemicals from a broken LCD display panel are toxic when ！ ingested. Use caution when the 594810 has a broken display panel. - Page 7 Hopkins Medical Products. Do not connect any device other than a Hopkins-approved SPO2 sensor to the sensor connector. WARNING: The 594810 should not be used adjacent to or stacked with ！ other equipment. If adjacent or stacked use is necessary, the 594810 should be observed to verify normal operation using the configuration...
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Page 8: Symbols
2 Symbols Direct Current (DC) Attention: Consult accompanying documents (this manual). Auxiliary output connector Power supply connector Alarm silence Setting button Power button Up button Down button Date of manufacture Serial number Safety Class II equipment Type BF applied part, defibrillation protected IPX1 Resistant to liquid ingress European community representative... -
Page 9: Introduction
WARNING: Do not make any clinical judgments based solely on the 594810. The 594810 is intended only as an adjunct in patient ！ assessment. It must be used in conjunction with clinical signs and symptoms. -
Page 10: Product Description
3.4 Product Description Display screen Power on/off Up/Down Speaker Alarm silence Lamp Sensor connector Cord hole Battery door High level Alarm : the lamp flashes red. Medium level Alarm : the lamp flashes yellow. NOTE Low level Alarm : the lamp lights yellow without flashing. 3.5 Display Screen Elements %SPO2 area of display Measured %SPO2... -
Page 11: Battery Installation
15 minutes of operation is available. The batteries should be replaced. Caution: If the 594810 is to be stored for a period of three ！ months or longer, remove the batteries from the device before storage.Warranty is void if batteries are stored in the device. -
Page 12: 594810 Operation
WARNING: Explosion hazard. Do not use the 594810 in the presence ！ of flammable anesthetics mixed with air, oxygen, or nitrous oxide. WARNING: To ensure patient safety, do not place the 594810 in any ！ position that might cause it to fall on the patient. -
Page 13: Turn On The 594810
5.2 Turn on the 594810 1) Press and hold the Power button to turn on the 594810. 2) The alarm lamp flashes, and then goes out. 3) The system gives a beep and displays the startup screen. 4) The startup screen disappears and the pulse oximeter enters the main screen. -
Page 14: Set Spo2 Low Alarm Limit
The alarm will stay silent for 60 seconds. WARNING：The 594810 will only keep the last setting. When the ！ 594810 is turned on, user should check whether the current setting meet conditions of patient. 5.3.4 When an Alarm Occurs When an alarm occurs, observe the following steps to take proper actions: 1) Check the patient's condition. -
Page 15: Reset To Default
1) Select an appropriate SpO2 sensor according to the person category and weight. 2) Wear the sensor into the measurement part of patient. 3) Connect an approved SpO2 sensor or extension cable to the 594810 SpO2 sensor port. 5.4.2 Display description... - Page 16 Caution: Use only Hopkins-approved sensors and extension cables ！ Note: Physiological conditions, medical procedures, or external agents that may interfere with the 594810's ability to detect and display measurements include: Dysfunctional hemoglobin Arterial dyes...
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Page 17: Alarms
Prolonged and/or excessive patient movement Intravascular dyes or externally applied coloring, such as nail polish or pigmented cream failure to cover the sensor site with opaque material in high ambient light conditions Loss-of-pulse signal can occur for the following reasons: The sensor is applied too tightly A blood pressure cuff is inflated on the same extremity as the one with the sensor attached... -
Page 18: Alarm Indicators
3) Low level alarms Indicate that the patient's vital signs appear abnormal and an immediate treatment may be required. 5.5.3 Alarm Indicators When an alarm occurs, the pulse oximeter will indicate it through the following indications: Alarm lamp Alarm tone Alarm message For different alarm levels, the alarm lamp, alarm tone and alarm messages presented are different. -
Page 19: Physiological Alarm Messages
Physiological Alarm Messages Alarm Alarm Message Alarm Cause and actions Level SpO2 Too High SPO2 reading will flash. A measurement has risen Alarm lamp is red and above the high alarm limit or flashing. fallen below the low alarm limit. Check the patient's SpO2 Too Low SPO2 reading will flash. -
Page 20: Measurement Limitations
Arms Pulse SPO2 Oximeter Sensor 100%-70% 100% – 90% 90% - 80% 80% - 70% 594810 Adult 1.3910 1.2555 1.3774 1.5687 2) The data from the hypoxia breathe-down trials for each of the 12 volunteers is summarized in Figures 1&2:... - Page 21 -21-...
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Page 23: Maintenance
ISO80601-2-61. 7 Maintenance 7.1 Cleaning WARNING: Do not spray, pour, or spill any liquid on the 594810, its ！ accessories, connectors, switches, or openings in the chassis as this may damage the pulse oximeter. -
Page 24: Disposal
It should change the measurement part per 2 hours when user continuing using for detecting. Do not immerse or wet the sensor. Do not lift the 594810 by the sensor l cable because it could become disconnected and damage the oximeter. -24-... - Page 25 3) Secure the sensor with the Hopkins® Adjustable Y-Probe Sensor Latex Free Belt and tighten gently. (Recommended) . 4) Apply a Hopkins® Y-Probe Wrap (#592012) 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.
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Page 26: Specifications
IMPORTANT! LED Sensors are light sensitive. Use Hopkins® Y-Probe wrap on top of the Adjustable Y-Probe Sensor with belt to better secure the probe. Inspect the sensor site every 2 hours for skin integrity and relocate the sensor every 2 hours according to steps 1-4 . -
Page 27: Emc Information
CISPR 11 cause any interference in nearby electronic equipment. Radio frequency Class A The 594810 is suitable for use in (RF) emissions all establishments other than domestic and CISPR 11 those directly connected to the public low-voltage power supply network that... - Page 28 IEC 70 % UT (30 % dip is recommended that the 61000-4-11 in UT) for 25 cycles 594810 be powered from an uninterruptible power supply <5 % UT (>95 % or a battery. dip in UT) for 5 s...
- Page 29 Guidance and Declaration - Electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity tests IEC 60601 test level Compliance level Conduced RF IEC 3 Vrms 61000-4-6...
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Page 30: Warranty
Please remove the batteries during prolonged periods of non-use or storage (longer than 5 days). If a material or manufacturing defect is discovered during the warranty period, Hopkins Medical Products® will repair or replace, at no charge, the device. -30-... - Page 31 Disclaimer of Warranties THE FOREGOING EXPRESS WARRANTY, AS CONDITIONED AND LIMITED, IS IN LIEU AND EXCLUDES ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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