Omron Gentle Temp 521 MC-521-E Page 9 Product Information Sheet Download

Page: 9 / 15

PM-1157-01-07/2013

Materials Used

Component Material

CAP Polycarbonates

Plastic

Battery Cover

Acrylonitrile - Butadiene - Styrene Plastic

Cosmetic cover

Acrylonitrile - Butadiene - Styrene Plastic

Rear Cover

Acrylonitrile - Butadiene - Styrene Plastic

Action Key

Polypropylene Plastic

Front Cover

Acrylonitrile - Butadiene - Styrene Plastic

Power Button

Silicone Rubber

Probe cover

ZIP Lock Bags_ LLDPE Film + HDPE Ring

Probe cover Detect

Polyoxymethylene, polyacetal

Summary of Contents for Gentle Temp 521 MC-521-E

Page 1: ...entle Temp 521 Item Number MC 521 E Table of Contents Page General Information Sales name and Item number of product 1 Model Category of the product 1 Legal Manufacturer Production Facilities 1 Photo of Product 1 Packaging Content including accessories 2 List of Harmonized EN standards 2 Intended Use 3 Particularity s How it works 4 Efficiency of the medial product 5 Description of the design and ...

Page 2: ...ang Development Zone YuShan Town KunShan City Jiang Su China Phone Fax 31 23 5544700 31 23 5544 701 e mail info omronhealthcare eu omron com Ear Thermometer Omron Gentle Temp 521 is a medical device meant for measurement of temperature The thermometer detects the infrared heat given off by the eardrum and surrounding tissues and it converts this heat into an equivalent ear temperature The Gentle T...

Page 3: ... 7 Warranty card The complete set of the medical device is specified in the Instruction Manual in the Technical Data section The above mentioned medical device belongs to a IIa MDD Annex IX Rule 10 potential risk class Applicable Directives Medical Device Directive MDD 93 42 EEC Standards EN980 2008 EN1041 2008 EN60601 1 2006 EN60601 1 2 2007 EN60601 1 6 2007 EN ISO14971 2012 EN ISO 10993 1 2009 E...

Page 4: ... adult on themselves or children The device is intended for use on adults and children as well as babies Intended Use of the Probe Covers Medical product s intended use as determined by the manufacturer The probe cover is designed to be used on the Omron Gentle Temp 520 digital ear thermometer It protects the sensor from dirt and ear wax to ensure accurate measurements Application field This devic...

Page 5: ... supplement to our current EFT portfolio Key features 3 in 1 measurement ear surface room temp measurement Fast 1 second measurement 25 memories Backlight function 21 probe covers Selectable Celsius Fahrenheit New ergonomic design Large display Automatic shut off How it works The digital ear thermometer Omron Gentle Temp 521 measures the infrared heat given off by the eardrum and surrounding tissu...

Page 6: ...e Instruction Manual for the full details on the application of this product 1 Chose which temperature indication C and F 2 Set the buzzer to turn the buzzer on or off 3 Attach the probe cover 4 Press ON MEM button 5 Insert probe comfortably into the ear in the direction of the eardrum 6 Press START button 7 At the long beep the thermometer can be removed 8 Read the temperature measurement 9 Press...

Page 7: ...ared sensor with tissue paper or a paper towel Do not use more than one probe cover at a time If there is any temperature difference between the places where the unit is stored and where you are going to measure leave the unit in the room where you are going to use it for more than 30 minutes to allow it to reach room temperature first then measure If the ear is cold wait until the ear is warmed u...

Page 8: ...nts Measurement Accuracy Ear Measurement Mode 0 2 C 0 4 F within 35 5 C to 42 0 C 95 9 F to 107 6 F 0 3 C 0 5 F for other range Surface Mode 0 3 C 0 5 F within 22 0 C to 42 2 C 71 6 F to 108 0 F for other range it is 2 C 3 6 F or 4 whichever is greater Measurement Range 34 0 C 93 2 F to 42 2 C 108 0 F Power Supply 3 0V DC 1 CR2032 Lithium Button Battery Power Consumption 0 015 W Battery Life With ...

Page 9: ...ene Plastic Cosmetic cover Acrylonitrile Butadiene Styrene Plastic Rear Cover Acrylonitrile Butadiene Styrene Plastic Action Key Polypropylene Plastic Front Cover Acrylonitrile Butadiene Styrene Plastic Power Button Silicone Rubber Probe cover ZIP Lock Bags_ LLDPE Film HDPE Ring Probe cover Detect Polyoxymethylene polyacetal ...

Page 10: ...10 PM 1157 01 07 2013 Title page of Instruction Manual 9 languages English French German Italian Spanish Dutch Russian Turkish Arabic ...

Page 11: ...M 1157 01 07 2013 OMRON Gentle Temp 521 MC 521 E Package Design Packaging specifications Dimensions WxDxH Qty Weight Main Unit 36x56x161mm 85g Package 115x59 5x197mm 1 343g Master Carton 497x420x340 40 15KG ...

Page 12: ...ine service other than cleaning and visually checking for damage Repair In case of malfunction of the device the user must turn to the OMRON retail outlet or distributor to test the device and repair the failure The user shall not repair the device by themselves Warranty card text as included in the product This product is guaranteed by OMRON for a period of 3 years after the date of purchase The ...

Page 13: ...ions regarding disposal or recycling of this equipment and batteries The main constituents of each part are listed in the table Materials List on page 9 Warranty Warranty term for the ear thermometer 3 years Warranty term for probe cover None as this is a single use item Lifetime Lifetime of the ear thermometer 5 years Life of the probe cover no lifetime as these are considered disposable items Wa...

Page 14: ...ns lifetime operating and storage conditions safety functional peculiarities efficiency and other parameters Comparative table of the product with the Previous Model Medical device under registration Earlier registered analogue Pictures of the devices Product Description Digital Ear Thermometer Digital Ear Thermometer Model OMRON Gentle Temp 521 MC 521 E Omron Gentle Temp 510 MC 510 E2 Sensing Uni...

Page 15: ...ally powered ME equipment Applied Part Type BF Type BF Weight Approx 85 g including battery installed Approx 50 g including battery installed Outer Dimensions 36 mm w x 161 mm h x 56 mm d 46 mm w x 93 mm h x 57 mm d Package Contents Test Battery Lithium Button Battery CR2032 probe cap 21 probe covers connection ring instruction manual warranty card Main unit Storage case 10 probe covers instructio...

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