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Hopkins 594030 User Manual

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Hopkins Wave Plus Fingertip
Oximeter
594030
User Manual

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Summary of Contents for Hopkins 594030

  • Page 1 Hopkins Wave Plus Fingertip Oximeter 594030 User Manual...
  • Page 2 Instructions to User Dear Customers, Thank you for purchasing this quality pulse Oximeter from Hopkins Medical Products. Please read the manual very carefully before using this device. Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter.
  • Page 3 Instructions for Safe Operation Check the device 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 before each use. If there is obvious damage, stop using the device.
  • Page 4 Caution: DO NOT use the Oximeter while the patient is under MRI or CT scanning. This device is NOT MRI Compatible. Explosive hazard—DO NOT use the Oximeter in environment with inflammable gas such as some ignitable anesthetic agents. Discomfort or pain may appear if using the Oximeter continuously on the same location for a long time, especially for patient with poor microcirculation.
  • Page 5 The light (the infrared light is invisible) emitted from the device is harmful to the eyes. Do not stare at the light. The Oximeter is not a treatment device. Local laws and Regulations must be followed when disposing of the device. Attention: ...
  • Page 6 steam disinfection on the Oximeter. Refer to Chapter 7 for instructions regarding cleaning and disinfection.  The equipment is IP32 with protection against harmful solid foreign objects and ingress of liquid. So that means the equipment is protected against solid foreign objects of 12.5mm and greater, and protected against vertically falling water drops when enclosure tilted up to 15°.
  • Page 7 Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards: 60601-1: 2005 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance; BS/EN/ISO 9919:2009 or the equivalent ISO 80601-2-61:2011 - Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse Oximeter equipment.

  • Page 8: Table Of Contents

    Table of Contents 1 OVERVIEW............... 1 ............1 1.1 A PPEARANCE ..........2 1.2 N AME AND ODEL ............2 1.3 I NTENDED ............2 1.4 F EATURE 2 BATTERY INSTALLATION ......... 5 3 OPERATION..............6 4 TECHNICAL SPECIFICATIONS........ 11 5 PACKING LIST ............14 6 REPAIR AND MAINTENANCE.......
  • Page 9 7 TROUBLESHOOTING..........17 8 KEY OF SYMBOLS..........18 9 FREQUENTLY ASKED QUESTIONS ......19 10 WARRANTY............22 APPENDIX I RESULT DESCRIPTION......26 APPENDIX II EMC ............. 26 VIII...

  • Page 10: Overview

    1 Overview 1.1 Appearance Display Screen Display Key Figure 1 Front View Battery Cover Nameplate Lanyard Hole Figure 2 Rear View...

  • Page 11: Name And Model

    Note: the appearance is for demonstration only, please refer to the Oximeter you purchased. 1.2 Name and Model Name: Hopkins Wave Plus Fingertip Oximeter Model: 594030 1.3 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO ) through a patient’s finger.
  • Page 12 √ Plethysmogram √ Auto on/off √ PR and PI shifts √ Over-limits indication √ Over-limits indication sound Manual Indication sound mute Four direction display √ √ Setting menu √ Over-limits setting √ Pulse beep Wireless function Continuous, Measuring mode Spot check Record list √...
  • Page 13  Measuring mode  Spot check mode: the measurement starts automatically when the finger is inserted into the finger clip properly, the measuring time lasts 30 seconds with a countdown indication. The SpO PR readings will freeze at the end of 30 seconds, the analysis result for the pulse rhythm will be displayed on the screen as well.

  • Page 14: Battery Installation

    measurement is less than 5 seconds, then no recording will be created.  Up to 12 groups of records can be stored in the record list, the newest record is marked as M1, and the oldest record is marked as M12. The new record will override the previous record.

  • Page 15: Operation

    Figure 3 Battery Installation 2. Replace the cover.  Please make sure that the batteries are correctly installed. Incorrect installation may cause the device not to work.  Please remove batteries if the device is not being used for more than 7 days to prevent and avoid potential damage from the battery leaking.
  • Page 16 Figure 4 2. Next enter into data display screen:  Press the Display Key to change display direction, the four display directions are as shown in figure 5A, 5B, 5C, & 5D. For display screens of figure 5B and 5D, the PI% display value will be replaced with PR display value after 20 seconds if the Display Key is not pressed again.
  • Page 17  Icon “ ” on display screen is the countdown timer if the Oximeter is operating in Spot check mode. The total measuring time for Spot check mode is 30 seconds. Figure 5E Figure 6  When the measurement ends up for Spot check mode, the measured SpO , PR value and the analysis result of pulse rhythm will be displayed...
  • Page 18 Display Key to enter the setup menu screen. “Beep” ： Pulse beep option. If it is set to on, every pulse beat makes a beep. “Mode”: to set the measuring mode. “Continuous” and “Spot check” for optional, the default is “Spot check”.
  • Page 19 Using the Oximeter  The finger should be put into the sensor correctly.  Do not shake the finger and relax during measurement.  Do not put a wet finger directly into sensor.  Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion.

  • Page 20: Technical Specifications

    sunshine, etc. may cause inaccuracy of measurement result. Please put an opaque cover on the sensor or change the measuring site if necessary.  If the first reading appears with poor waveform (irregular or not smooth), then the reading is unlikely accurate, the more stable value is expected by waiting for a while, or a restart and select another finger if needed.
  • Page 21 C. Perfusion Index(PI) Display range 0%~20% D. Preset over-limits low limit: 90% Pulse Rate: high limit: 120bpm low limit: 50bpm E. Over-limit settings for 594030 Low limit setting range: 85%~99%, step: 1% Default setting: 90% Pulse Rate: Low limit setting range: 30~60bpm, step: 1bpm;...
  • Page 22 alert with beep automatically and the value which exceeds limit will flash on the screen. G. Power supply requirement: 2 x LR03 (AAA) alkaline batteries Supply voltage: 3.0VDC Operating current: ≤40mA H. Environmental Conditions: Operating Temperature: 41°F ~104°F Operating Humidity: 30%~80% Atmospheric pressure: 70kPa~106kPa...

  • Page 23: Packing List

    L. Classification The type of protection against electric shock: Internally powered equipment. The degree of protection against electric shock: Type BF applied parts. The degree of protection against harmful solid foreign objects and ingress of liquid: The equipment is IP32 with protection against harmful solid foreign objects and ingress of liquid.
  • Page 24 The expected service life (not a warranty) of this device is 5 years. In order to ensure its long service life, please pay attention to the maintenance.  Please change batteries when low-voltage indicator lightens.  Please clean the surface of the device before using, with 75% alcohol wipes, then let it air dry or wipe it dry.
  • Page 25 claimed in this manual is supported by the clinical study conducted by inducing hypoxia on healthy, non-smoking, light-to-dark skinned subjects in an independent research laboratory  If it is necessary to verify the precision of the Oximeter routinely, the user can do the verification by means of SpO simulator, or it can be done by the local third party test...

  • Page 26: Cleaning And Disinfecting Instruction

    Do not immerse the device in liquid. It is recommended that the device should be kept in a dry environment. Humidity may reduce the life of the device, or even damage 6.2 Cleaning and Disinfecting Instruction  Surface-clean sensor with a soft cloth damped with a solution such as 75% isopropyl alcohol, if low-level disinfection is required, use a mild bleach solution.

  • Page 27: Key Of Symbols

    1. Place the finger correctly inside and try again. 2. Try an alternate set of batteries. 3. Ensure the patient is not moving erratically. 4. If the above problem still exists, please contact Hopkins customer service at 1-800-835-1995 or customerservice@hopkinsmedical.net 8 Key of Symbols Symbol...

  • Page 28: Frequently Asked Questions

    Authorized representative in the European community Manufacturer (including address) BF type applied part Attention ─ refer to User Manual Follow WEEE regulations for disposal Warning ─ indicates a potential hazard or unsafe practice that, if not avoided, could result in serious injury.
  • Page 29 2. Q: What's the normal range of SpO value for healthy people? A: The normal range varies by individual, but usually over 95%, otherwise, please consult your physician. 3. Q: What's the normal range of PR value for healthy people? A: Usually, the normal range is 60bpm~100bpm.
  • Page 30 6. Q: How to confirm that the SpO reading is true or accurate? A: Hold breath for a while (50 seconds or more), if the SpO value significantly decreases, it means that reading truly reflects physiological condition change. 7. Q: When to replace the batteries? A: The icon of low battery will appear on the screen when the battery voltages are low.

  • Page 31: Warranty

    Blood vessel contraction caused by peripheral vessel hyperkinesia body temperature decreasing; i) Low perfusion condition (Perfusion Index is small). 10 Warranty Your Hopkins® 594030 Wave Plus Fingertip Oximeter is guaranteed for 3 years against manufacturer’s defects material workmanship for the original purchaser only, from...
  • Page 32 Battery corrosion is not covered by 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 the oximeter at no charge.
  • Page 33 Disclaimer of Warranties THE FOREGOING EXPRESS WARRANTY, AS CONDITIONED AND LIMITED, IS IN LIEU EXCLUDES OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
  • Page 34 Register your product online: www.hopkinsmedicalproducts.com/registration For questions or concerns, please contact customer service: customerservice@hopkinsmedical.net www.hopkinsmedicalproducts.com 1-800-835-1995...

  • Page 35: Appendix I Result Description

    Appendix I Result Description Description No irregularity found Suspected a little fast pulse Suspected fast pulse Suspected short run of fast pulse Suspected a little slow pulse Suspected slow pulse Suspected occasional short pulse interval Suspected irregular pulse interval Suspected fast pulse with short pulse interval Suspected slow pulse with short pulse interval Suspected slow pulse with irregular pulse interval...
  • Page 36 Guidance and manufacturer’s declaration-electromagnetic emission The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Fingertip Oximeter should assure that it is used in such an environment. Emissions Complianc Electromagnetic environment-guidance test The Fingertip Oximeter uses...
  • Page 37 IEC61000-3-3 Table 2 Guidance and manufacturer’s declaration-electromagnetic emission The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Fingertip Oximeter should assure that it is used in such an environment. Electromagne Compli IEC60601 test...
  • Page 38 least 30% ±2kV for power Electrical fast Supply lines transient/ ±1 kV for burst input/output IEC61000-4-4 lines ±1kV line (s) to Surge line(s) ±2kV line(s) to IEC 61000-4-5 earth <5% U Voltage dips, (>95% dip in U short for 0.5 cycle <40% U interruptions (60% dip in U...
  • Page 39 Power frequency magnetic fields should Power be at levels frequency( characteristic 50Hz/60Hz) 3A/m 3A/m of a typical magnetic field location in a IEC61000-4-8 typical commercial or hospital environment. NOTE: U is the a.c. mains voltage prior to application of the test level. Table 3 Guidance and manufacturer’s declaration –...
  • Page 40 Electromagnetic Immunity IEC60601 Compliance environment test test level level -guidance Portable and mobile RF communications equipment should be used no closer to any part of The Fingertip Conducted 3 Vrms Oximeter, 150 kHz to including cables, IEC61000- 80 MHz than the recommended separation distance...
  • Page 41 Recommended separation distance d=1.2 P d=1.2 P 80MHz to 800MHz d=2.3 P 800MHz to 2.5GHz 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 metres (m).
  • Page 42 from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in each frequency range . Interference may occur in the vicinity of equipment marked with the following symbol.
  • Page 43 NOTE 1: At 80 MHz and 800 MHz, 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. 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 cannot be predicted...
  • Page 44 Table 4 Recommended separation distances between portable and mobile RF communication the equipment The Fingertip Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user Fingertip Oximeter help prevent electromagnetic interference maintaining...
  • Page 45 0.38 0.73 For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter watts according transmitter...
  • Page 47 Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, PEOPLE’S REPUBLIC OF CHINA Distributed By Shanghai International Holding Corp. GmbH (Europe) Hopkins Uniform Company Eiffestrasse 80, 20537 Hamburg Germany 6850 Southbelt Drive Caledonia, MI 49316 USA Tel: 1-800-835-1995 E-mail:customerservice@hopkinsmedical.net Website:www.hopkinsmedicalproducts.com...

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