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Without our company or other approved maintenance organizations trained service personnel should not try to 

maintain the product.

This device can only be used for one test object at a time.

If the small parts on the device are inhaled or swallowed, please consult a doctor promptly.

The device and accessories are processed with allergenic materials. If you are allergic to it , stop using this product.

After pressing the power button, if the device has display fault such as white screen, blurred screen or no display 

content, please contact our company.

The device shall comply with the standard IEC 80601-2-30:Particular requirements for basic safety and essential perfor-

mance of automated non-invasive sphygmomanometers.

1.1 Operation for AC Adapter (Separate Sale)

 Note  

The device can be powered by a power adapter that is a part of the medical electrical system.

Be sure to use the dedicated medical grade power adapter of this device.

Otherwise it may cause trouble

Dedicated power adapter must use AC 100 V~240 V

Otherwise it may cause fire or electric shock.

When there is breakage of dedicated power adapter plug or wire, please do not use it.

Otherwise it may cause fire or electric shock.

Please do not plug or unplug the adapter on the socket with wet hands.

Otherwise it may cause electric shock or injury.

1.2 Operation for Battery

 Note  

Please use 4 “AA” size manganese or alkaline batteries, do not use batteries of other types.

Otherwise it may cause fire.

ENGLISH

Summary of Contents for 32902

Page 1: ...E LEO BLOOD PRESSURE MONITOR WITH SOFTWARE TENSIOM TRE LEO AVEC LOGICIEL DE LEO MEDIDOR DE PRESI N CON SOFTWARE MEDIDOR DA TENS O LEO COM SOFTWARE PROFESSIONAL MEDICAL PRODUCTS 0123 Shanghai Internati...

Page 2: ...tions and software upgrades the information contained in this document is subject to change without notice The warning items Before using this product you should consider the safety and efficacy of th...

Page 3: ...Setting the Date and Time 65 Chapter 7 About Unit 66 Chapter 8 User Switch 66 Chapter 9 Over limit Prompt Function 67 9 1 Physiological parameter over limit prompt 67 9 2 Technical parameter over limi...

Page 4: ...itor 78 14 2 Installation of Software 78 Chapter 15 Error Message 79 Chapter 16 Troubleshooting 80 Chapter 17 Keys and Symbols 82 Chapter 18 Maintenance Cleaning and Keeping 83 Chapter 19 NIBP Specifi...

Page 5: ...of blood coagulation whether automatically measure the blood pressure should be based on the clinical evaluation because limb friction with the cuff may cause the risk of hematoma For severe blood ci...

Page 6: ...patient is in severe shock or hypothermia measurements will be unreliable since reduced blood flow to the peripher ies will cause reduced pulsation of the arteries Heart Rate Extremes Measurements can...

Page 7: ...ventilated place for a period of time to dissipate moisture Otherwise the device may be damaged due to moisture Do not store and transport the device outside the specified environment Otherwise it may...

Page 8: ...for basic safety and essential perfor mance of automated non invasive sphygmomanometers 1 1 Operation for AC Adapter Separate Sale Note The device can be powered by a power adapter that is a part of t...

Page 9: ...r apply to measure the non invasive blood pressure and SpO2 of human adult children neonate uses three user mode each user can store 100 items records of measurement results at most Each record includ...

Page 10: ...the reference for the health care professional Chapter 2 MAIN UNIT The production is in the package Open the package and confirm whether the production is whole ENGLISH Cuff plug Cuff air plug jack Di...

Page 11: ...ata Line Software CD User Manual Optional Accessories AC adapter Input voltage AC 100 V 240 V Frequency 50 Hz 60 HZ Rated current AC 150 mA Output DC 6 0 V 0 2 V 1 0 A or DC5 0 V 0 2 V 1 0 A SpO2 prob...

Page 12: ...m optical therapy D Error in weak filling condition SpO2 and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO2 error is 4 when measuring range is 30 bpm 100 bpm pulse rate error i...

Page 13: ...ot include the airway tube plug When replacing please do not throw the airway tube plug away install it on the new cuff Note When the product and accessories described in this manual are about to exce...

Page 14: ...EC standards such as IEC60950 Information technology equipment Safety and IEC60601 1 Medical electrical equipment Safety and all equip ment should be connected to in accordance with the requirement of...

Page 15: ...ies power will exhaust Replace with four new batteries the same sort at the same time Test while low power may cause data deviation and other problems Turn the unit off before replacing the batteries...

Page 16: ...ed medical grade power adapter Note When regulated power supply and batteries are both used at the same time the battery power will not be con sumed Switch regulated power supply and battery as power...

Page 17: ...and time when measuring will be correct in the memory otherwise it may not be correct The results can be uploaded to PC via USB and processed with the PC software 1 There are two modes of time setting...

Page 18: ...select UNIT option to switch units be tween mmHg and kPa Chapter 8 USER SWITCH The Electronic Sphygmomanometer stores the measure results of three users automatically and up to 100 items for every us...

Page 19: ...rompt the user can press MENU button to enter system menu select PROMPT SETUP option to enter its interface then set the limit value of blood pressure When the BP measurement result is higher than the...

Page 20: ...ower replaced Chapter 10 THE USAGE METHOD OF SPHYGMOMANOMETER 10 1 Accurate Measurement Way Measurement in quiet and relaxing state 1 Adopt a comfortable sitting position use back and arms to support...

Page 21: ...e When measurement a patient it is necessary to frequently check the color warmth and sensitivity of the distal of the limb Once any abnormalities are observed place the cuff in another position or st...

Page 22: ...he patient speak or move his body during measurement When measuring the patient is nervous excited emotional instability The room temperature rise or fall sharply or the environment of measurement oft...

Page 23: ...r tube of the cuff will pass the top of your palm 4 Wrap the cuff to your upper arm Make the air tube inside the forearm and aligned with your middle finger 5 The bottom of the cuff should be approxim...

Page 24: ...ructions of your physician Note Wait at least 4 5 minutes between measurements When repeatedly measuring the accurate blood pressure value may not be measured due to congestion in the arm Please measu...

Page 25: ...igure shows that there is no measurement result can be displayed 3 Press LIST button to display the data list interface 4 Press TREND button to display trend interface End to display the measurement v...

Page 26: ...less than 30 seconds when signal attenuation weak perfusion or other interference appears it will result in time increasing of dynamic data averaging which depends on the PR value The PLETH waveforms...

Page 27: ...is distributed from dark to light including 3 dark black skins 2 medium black skins 5 light skins 2 white skins When using the device please keep it away from the instruments that can generate strong...

Page 28: ...rillation proof function The person who is allergic to silicone PVC TPU TPE or ABS can not use this device For some special patients it should be a more prudent inspecting in the measurement part The...

Page 29: ...pean Union market 1 Attach the SpO2 probe to the appropriate site of the patient finger as the following figure Place SpO2 probe 2 Plug the connector of the SpO2 probe cable into the USB socket in the...

Page 30: ...ular staining agents such as indocyanine green or methylene blue skin pigmentation It is required to use SpO2 probe which is provided by our company contact with our sale department when necessary Cha...

Page 31: ...are shown as follows ENGLISH Error Message Causes Solutions Self test failure System failure Function abnormal Please contact us Loose cuff Cuff is not connected correctly Correctly connect cuff refe...

Page 32: ...y connect cuff refer to Chapter 10 Talk or move arms when measuring Keep quiet and restart a measurement The turnup clothing presses the arm Take off the clothing which presses the arm and restart a m...

Page 33: ...surement button or never stop inflating when measuring Pull out the cuff to deflate Stop using the device and contact us Cuff never deflation Pull out the cuff to deflate Stop using the device and con...

Page 34: ...Close the Prompt sound indication Low power Full power 1 No NIBP data to review 2 No finger inserted to SpO2 probe This item is only suitable for European Union market 3 An indicator of signal inadeq...

Page 35: ...ries and main unit must be separated for cleaning Maintenance is not allowed during device using Do not squeeze the rubber tube on the cuff Manufacturer Date of manufacture Keep away from sunlight Kee...

Page 36: ...ing out then use the cloth for cleaning The device should be inspected and calibrated periodically or obey the requirements of the hospital It is available to inspect in the state specified inspection...

Page 37: ...he device where there is water Do not place the device where with slope vibration or impact Take the batteries out if the device is not to be used for three months or longer Chapter 19 NIBP SPECIFICAT...

Page 38: ...ue of Stethosco py The error meets the requests in the ANSI AAMI SP 10 2002 A1 2003 A2 2006 Operating temperature humidity 5 C 40 C 15 RH 85 RH Non condensing Transport Transport by general vehicle or...

Page 39: ...s Standard Configure Adult Cuff limb circumference 22 32 cm middle of upper arm Software CD User Manual USB data line four AA alkaline batteries Separate Sale Adult Cuff limb circumference 32 43 cm mi...

Page 40: ...cy SpO2 70 100 2 0 69 undefined PR 2 bpm or 2 select larger Measurement Performance In Weak Filling Condition Pulse filling ratio 0 4 SpO2 error 4 Pulse rate error 2 bpm or 2 select larger Optical Sen...

Page 41: ...unction There fore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establi...

Page 42: ...common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typi cal commercial or hospital environment Voltage dips short interruptions and voltage variations on power...

Page 43: ...the recom mended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Where P is the maximum output power rating of the tran...

Page 44: ...dcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the...

Page 45: ...0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d...

Page 46: ...device should not contact the pins of connectors marked with an ESD warning symbol unless electrostatic discharge precautions are used the device should not connect to these connectors In order to avo...

Page 47: ...able types must be used to ensure that they comply with interference radiation and immunity standards Disposal The product must not be disposed of along with other domestic waste The users must dispos...

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