Hopkins 594030 Скачать руководство пользователя страница 7 | Manualshive

Страница: 7 / 47

Hopkins 594030 Скачать руководство пользователя страница 7

VI

Declaration of Conformity

The manufacturer hereby declares that this device

complies with the following standards:

IEC

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.

And it also follows the provisions of the council

directive MDD 93/42/EEC.

«
...
5
6
7
8
9
...
»

Содержание 594030

Страница 1: ...Hopkins Wave Plus Fingertip Oximeter 594030 User Manual...

Страница 2: ...g abnormality or damage to the Oximeter Version of the Manual Ver 1 0 Revised date August 1st 2019 All rights reserved 3502 1290169 Note The contents contained in this manual are subject to change wit...

Страница 3: ...each use If there is obvious damage stop using the device Special attention should be paid while the Oximeter is used constantly at ambient temperature above 98 F burns may occur because of over heati...

Страница 4: ...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 It is recommended th...

Страница 5: ...erials high temperature and moisture The device should be kept out of the reach of children If the Oximeter gets wet please stop using it and do not resume operation until it is dry and checked for co...

Страница 6: ...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 verticall...

Страница 7: ...al 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 requirem...

Страница 8: ...ANCE 1 1 2 NAME AND MODEL 2 1 3 INTENDED USE 2 1 4 FEATURE LIST 2 2 BATTERY INSTALLATION 5 3 OPERATION 6 4 TECHNICAL SPECIFICATIONS 11 5 PACKING LIST 14 6 REPAIR AND MAINTENANCE 14 6 1 MAINTENANCE 14...

Страница 9: ...VIII 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...

Страница 10: ...1 1 Overview 1 1 Appearance Figure 1 Front View Figure 2 Rear View Display Key Nameplate Lanyard Hole Battery Cover Display Screen...

Страница 11: ...Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO2 through a patient s finger It is applicable for spot checking SpO2 and pulse rate of adult and pediatr...

Страница 12: ...e beep Wireless function Measuring mode Continuous Spot check Record list Description Indication sound mute For the model with both over limits indication function and pulse beep function when beep is...

Страница 13: ...is out the display will be cleared and the Oximeter shuts down automatically Continuous mode measurement will start automatically when finger is inserted into the Oximeter SpO2 and PR readings will be...

Страница 14: ...batteries are removed from the device all readings will be deleted When the Oximeter is powered off press and hold the Display keep to bring up the record recall screen On the record recall screen pr...

Страница 15: ...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 Any such damage is not covered under the product wa...

Страница 16: ...e 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...

Страница 17: ...lue and the analysis result of pulse rhythm will be displayed on the screen as shown in figure 5E Other result descriptions see Appendix I Recording recall functions are available when the Oximeter is...

Страница 18: ...check Menu setup Press the Display Key to choose the setting item press and hold the Display Key to activate the setting item then press it to modify the setting parameter Next press and hold the Dis...

Страница 19: ...ressure measurement or during venous infusion Do not let anything block the emitting light from device i e do not use finger nail polish paints Vigorous exercise and electrosurgical device interferenc...

Страница 20: ...reading is unlikely accurate the more stable value is expected by waiting for a while or a restart and select another finger if needed 4 Technical Specifications A SpO2 Measurement Transducer dual wa...

Страница 21: ...imit 120bpm low limit 50bpm E Over limit settings for 594030 SpO2 Low limit setting range 85 99 step 1 Default setting 90 Pulse Rate Low limit setting range 30 60bpm step 1bpm High limit setting range...

Страница 22: ...ure 41 F 104 F Operating Humidity 30 80 Atmospheric pressure 70kPa 106kPa I Low Perfusion Performance The accuracy of SpO2 and PR measurement still meet the precision described above when the modulati...

Страница 23: ...ign objects and ingress of liquid The equipment is IP32 with protection against harmful solid foreign objects and ingress of liquid Electro Magnetic Compatibility Group I Class B 5 Packing List 1 Fing...

Страница 24: ...ow liquid to enter the device Please take out the batteries if the Oximeter will not be used any more than 7 days The recommended storage environment of the device ambient temperature 4 F 140 F relati...

Страница 25: ...e by the local third party test company Please note that the specific calibration curve so called R curve should be selected when use of SpO2 simulator e g for Index 2 series SpO2 simulator from Fluke...

Страница 26: ...oft cloth damped with a solution such as 75 isopropyl alcohol if low level disinfection is required use a mild bleach solution Then surface clean with a cloth damped ONLY with clean water and dry with...

Страница 27: ...y 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 Description SpO2 Pulse oxygen saturation B...

Страница 28: ...for disposal Warning indicates a potential hazard or unsafe practice that if not avoided could result in serious injury Attention indicates a potential hazard or unsafe practice that if not avoided c...

Страница 29: ...ge is 60bpm 100bpm 4 Q Why do the display value of SpO2 and PR vary with time A The measured SpO2 and PR value changes in correspondence with the change of patient s physiological conditions 5 Q What...

Страница 30: ...ll appear on the screen when the battery voltages are low By then batteries need to be replaced 8 Q What to do if the Oximeter is moistened or sprayed by water A Remove the batteries immediately and d...

Страница 31: ...sure to the chamber with High pressure oxygen g There is an arterial occlusion proximal to the sensor h Blood vessel contraction caused by peripheral vessel hyperkinesia or body temperature decreasing...

Страница 32: ...ormal wear or alterations made to the instrument 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 materia...

Страница 33: ...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 MER...

Страница 34: ...ster your product online www hopkinsmedicalproducts com registration For questions or concerns please contact customer service customerservice hopkinsmedical net www hopkinsmedicalproducts com 1 800 8...

Страница 35: ...e slow pulse 6 Suspected slow pulse 7 Suspected occasional short pulse interval 8 Suspected irregular pulse interval 9 Suspected fast pulse with short pulse interval 10 Suspected slow pulse with short...

Страница 36: ...onment guidance RF emissions CISPR 11 Group 1 The Fingertip Oximeter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference...

Страница 37: ...or the user of the Fingertip Oximeter should assure that it is used in such an environment Immunity test IEC60601 test level Compli ance level Electromagne tic environment guidance Electrostatic disc...

Страница 38: ...es N A N A Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth N A N A Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 1 1 5 UT 95 dip in UT for...

Страница 39: ...r hospital environment NOTE UT is the a c mains voltage prior to application of the test level Table 3 Guidance and manufacturer s declaration electromagnetic immunity The Fingertip Oximeter is intend...

Страница 40: ...ated RF IEC61000 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz N A 3 V m Portable and mobile RF communications equipment should be used no closer to any part of The Fingertip Oximeter including cab...

Страница 41: ...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 separat...

Страница 42: ...transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the f...

Страница 43: ...oadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured fiel...

Страница 44: ...er can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Fingertip Oximeter as recommended below...

Страница 45: ...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 sepa...

Страница 46: ...37...

Страница 47: ...518110 Shenzhen PEOPLE S REPUBLIC OF CHINA Distributed By Made in China Hopkins Uniform Company 6850 Southbelt Drive Caledonia MI 49316 USA Tel 1 800 835 1995 E mail customerservice hopkinsmedical ne...

Отзывы:

Нет отзывов