Viatom OxySmart PC-60F User Manual Download

Page: 43 / 43

Version: A

Shenzhen Viatom Technology Co., Ltd.
Website: www.getwellue.com
Email: [email protected]

Manufacturer

：

Shenzhen Crea/ve Industry Co., Ltd.

Shanghai Interna/onal Holding Corp.

GmbH (Europe)

Eiﬀestrasse 80, 20537 Hamburg Germany

Summary of Contents for OxySmart PC-60F

Page 1: ...I OxySmart Finger p Oximeter User Manual Model PC 60F ...

Page 2: ...sponsibility is assumed by us for its use or any infringements of pa9ents or other rights of third par9es that may result from its use Instruc ons for Safe Opera on 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 minimally before each use If t...

Page 3: ... Manual Cau ons Explosive hazard DO NOT use the Oximeter in environment with inﬂammable gas such as some ignitable anesthe9c agents DO NOT use the Oximeter while the pa9ent is under MRI or CT scanning This device is NOT MRI Compa9ble Warnings Discomfort or pain may appear if using the Oximeter con9nuously on the same loca9on for a long 9me especially for pa9ent with poor microcircula9on It is reco...

Page 4: ...d when disposing of the device A en ons Keep the Oximeter away from dust vibra9on corrosive substances explosive materials 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 opera9on un9l it is dry and checked for correct opera9on When it is carried from a cold environment to a warm and humid environm...

Page 5: ...se pay aGen9on to the eﬀects of lint dust light including sunlight etc Declara on of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essen9al performance ISO 80601 2 61 2017 Medical electrical equipment Part 2 61 Par9cular requirements for basic safety a...

Page 6: ...VI Cau on U S federal law restricts this device to sale or use by or on the order of a physician Table of Contents 1 OVERVIEW 1 3 OPERATION 4 5 PACKING LIST 13 ...

Page 7: ...VII 7 TROUBLESHOOTING 16 8 KEY OF SYMBOLS 17 9 FREQUENTLY ASKED QUESTIONS 19 APPENDIX EMC 23 ...

Page 8: ... Overview 1 1 Appearance Figure 1 Front View Note the appearance is for demonstra9on only please refer to the oximeter you purchased Display Key Lanyard Hole BaGery Cover Display Screen Figure 2 Rear View ...

Page 9: ...pO2 through a pa9ent s ﬁnger It is applicable for checking SpO2 and pulse rate of adult and pediatric pa9ents in homes and medical clinics 1 3 Conﬁgura on SpO2 PR PI Plethysmogram Auto on oﬀ PR and PI shiks Pulse bar Over limits selng Pulse beep Measuring Mode Con9nuous Spot Check Record list 2 Battery Installation ...

Page 10: ... markings 2 Replace the cover Please make sure that the baGeries are correctly installed Incorrect installa9on may cause the device not to work Please remove baGeries if the device is not being used for more than 7 days to prevent and avoid poten9al damage from the baGery leaking Any such damage is not covered under the product warranty ...

Page 11: ...ﬁnger is in the correct posi9on and then clip the ﬁnger as shown in ﬁgure 4 Figure 4 Put ﬁnger into the Oximeter Wait 2 seconds the Oximeter will power on automa9cally and start to measure 2 END When ﬁnger is out the Oximeter shuts down automa9cally 3 Readings display screen The screen displays as below ...

Page 12: ...t Spot check mode The total measuring me for Spot check mode is 30 seconds 4 Recording recall Recording recall func ons are available At power oﬀ status pressing Display key can bring up record list display screen as shown in ﬁgure 7 In record list screen press Display key to shiP the records page ...

Page 13: ...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 If the baVeries are removed from the device then the records will be not kept or vola le 5 Menu When ﬁnger is in oximeter long 9me pressing display key can enter the setup menu screen ...

Page 14: ... conﬁrm the modiﬁca9on and exit from this selng item At last move the selng item to Save exit menu and long 9me pressing Display Key to store the modiﬁca9on and exit from the setup menu Mode to set the measuring mode Con nuous or Spot check Beep Pulse beep op9on If it is set to on every pulse beat makes a beep when beep is on and over limits indica9on sound is ac9vated then Display key will work a...

Page 15: ...t or during venous infusion Do not let anything block the emilng light from device i e do not use ﬁnger nail polish paints Vigorous exercise and electrosurgical device interference may aﬀect the measuring accuracy Nail polish may aﬀect the measuring accuracy and too long ﬁngernail may cause failure of measurement or inaccurate result Existence of high intensive light sources such as ﬂuorescence li...

Page 16: ...cessary If the ﬁrst reading appears with poor waveform irregular or not smooth then the reading is unlikely true the more stable value is expected by wai9ng for a while or a restart is needed when necessary ...

Page 17: ... cal output power 2mW SpO2 display range 35 100 SpO2 measuring accuracy 2 for SpO2 range from 70 to 100 B Pulse Rate measurement PR display range 30bpm 240bpm PR measuring accuracy 2bpm or 2 whichever is greater C Perfusion Index PI Display range 0 20 D Preset over limits SpO2 low limit 90 Pulse Rate high limit 120bpm low limit 50bpm E Over limit seBngs SpO2 ...

Page 18: ...alert func on When measuring if SpO2 value or pulse rate value exceeds the preset limit the device will alert with beep automa9cally and the value which exceeds limit will ﬂash on the screen G Power supply requirement 2 x LR03 AAA alkaline baGeries Supply voltage 3 0VDC Opera9ng current 40mA H Environmental Condi ons Opera9ng Temperature 5 C 40 C Opera9ng Humidity 30 80 Atmospheric pressure 70kPa ...

Page 19: ... SpO2 value measured in the condi9on of indoor natural light and that of darkroom is less than 1 K Dimensions 56 mm L 34 mm W 30 mm H Net Weight approx 60g L Display OLED M Classiﬁca on The type of protec on against electric shock Internally powered equipment The degree of protec on against electric shock Type BF applied parts The degree of protec on against harmful solid foreign objects and ingre...

Page 20: ...ms and its quan9ty are subject to change please refer to your subject in hand 6 Repair and Maintenance 6 1 Maintenance The expected service life not a warranty of this device is 5 years In order to ensure its long service life please pay aGen9on to the maintenance Please change the baGeries when the low voltage indicator lightens Please clean the surface of the device before using with 75 alcohol ...

Page 21: ... SpO2 simulators should not be used to validate the accuracy of the Oximeter they can only be used as func9onal testers to verify its precision The SpO2 accuracy 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...

Page 22: ...iza on cannot be used on the device 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 it 6 2 Cleaning and Disinfec ng Instruc on Surface clean sensor with a sok cloth damped with a solu9on such as 75 isopropyl alcohol if low level disinfec9on is required use a mild bleach solu9on Then ...

Page 23: ...he ﬁnger correctly inside and try again 2 Changing baGeries 3 Let the pa9ent keep calm 4 Please shake the Oximeter with a certain force to make the movable metal ball move freely If the problem s9ll exists maybe the orienta9on sensor is not working properly 5 If the above problem s9ll exists please contact the local service center ...

Page 24: ...17 8 Key of Symbols ...

Page 25: ...18 Symbol Descrip on SpO2 Pulse oxygen satura9on Pulse rate beats per minute PI Perfusion Index Pulse Strength Bar Graph Low baGery voltage CE mark SN Serial number Date of manufacture BPM PR ...

Page 26: ...ura9on percentage of oxygen in the blood 2 Q What s the normal range of SpO2 value for healthy people Authorised representa9ve in the European community Manufacturer including address BF type applied part AGen9on refer to User Manual Follow WEEE regula9ons for disposal ...

Page 27: ...ue of SpO2 and PR vary with 9me A The measured SpO2 and PR value changes in correspondence with the change of pa9ent s physiological condi9ons 5 Q What to do if there is no SpO2 and PR reading A Do not shake the ﬁnger and keep calm during the measurement Please also avoid the Oximeter and the cuﬀ on the same limb for blood pressure and oxygen satura9on measurement simultaneously 6 Q How to conﬁrm ...

Page 28: ...e the baGeries A The icon of low baGery will appear on the screen when the baGery voltages are low By then baGeries need to be replaced 8 Q What to do if the Oximeter is moistened or sprayed by water A Remove the baGeries immediately and dry the Oximeter completely with a hair dryer 9 Q What factors will aﬀect the SpO2 accuracy A a Intravascular dyes such as indocyanine green or methylene blue ...

Page 29: ...ive pa9ent movement e Placement of a sensor on an extremity with a blood pressure cuﬀ arterial catheter or intravascular line f Exposure to the chamber with High pressure oxygen g There is an arterial occlusion proximal to the sensor h Blood vessel contrac9on caused by peripheral vessel hyperkinesias or body temperature decreasing i Low perfusion condi9on Perfusion Index is small Please contact th...

Page 30: ...d manufacturer s declara on electromagne c emission The Finger9p Oximeter is intended for use in the electromagne9c environment speciﬁed below The customer or the user of the Finger9p Oximeter should assure that it is used in such an environment Emissions test Complia nce Electromagne c environment guidance ...

Page 31: ... to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Finger9p Oximeter suitable for use in all establishments including domes9c establishments and those directly network that supplies buildings used for domes9c purposes H a r m o n i c emissions IEC61000 3 2 N A V o l t a g e ﬂuctua9ons ﬂicker emissions IEC61000 3 3 N A ...

Page 32: ...Finger9p Oximeter is intended for use in the electromagne9c environment speciﬁed below the customer or the user of the Finger9p Oximeter should assure that it is used in such an environment Immunity test IEC60601 test level Compl iance level Electromagn e c environmen t guidance ...

Page 33: ...r 8 kV contac t 15kV air Floors should be wood concrete or ceramic 9le if ﬂoors are covered with synthe9c material the rela9ve humidity should be at least 30 Electrical fast transient burst IEC61000 4 4 2kV for power Supply lines 1 kV for input output lines N A N A ...

Page 34: ...ine s to earth N A N A Voltage dips short interrup9 ons and voltage varia9ons on power supply input lines IEC61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s N A N A ...

Page 35: ...A m Power frequency magne9c ﬁelds should be at levels characteris9 c of a typical loca9on in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to applica9on of the test level Guidance and manufacturer s declara on electromagne c immunity ...

Page 36: ...e electromagne9c environment speciﬁed below The customer or the user of The Finger9p Oximeter should assure that it is used in such an electromagne9c environment Immunit y test IEC6060 1 test level Complian ce level Electromagne c environment guidance ...

Page 37: ...Hz to 2 5 GHz N A 3 V m Portable and mobile RF communica9ons equipment should be used no closer to any part of The Finger9p Oximeter including cables than the recommended separa9on distance calculated from the equa9on applicable to the frequency of the transmiGer Recommended separa on distance ...

Page 38: ... At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situa9ons Electromagne9c propaga9on is aﬀected by absorp9on and reﬂec9on from structures objects and people ...

Page 39: ...o ﬁxed RF transmiGers and electromagne9c site survey should be considered If the measured ﬁeld strength in the loca9on in which The Finger9p Oximeter is used exceeds the applicable RF compliance level above The Finger9p Oximeter should be observed to verify normal opera9on If abnormal performance is observed addi9onal measures may be necessary such as re orien9ng or reloca9ng The Finger9p Oximeter...

Page 40: ...re controlled The customer or the user of The Finger9p Oximeter can help prevent electromagne9c interference by maintaining a minimum distance between portable and mobile RF communica9ons equipment transmiGers and the Finger9p Oximeter as recommended below according to the maximum output power of the communica9ons equipment Rated maximum Separa on distance according to frequency of transmi er M Me...

Page 41: ...34 maximum output power of transmi e r W Wa s 0 01 N A 0 12 0 23 0 1 N A 0 38 0 73 1 N A 1 2 2 3 10 N A 3 8 7 3 100 N A 12 23 150kHz to 80MHz d 1 2 P 80MHz to 2 5GHz d 2 3 P 80MHz to 800MHz d 1 2 P ...

Page 42: ...ency of the transmiGer where P is the maximum output power ra9ng of the transmiGer in waGs W according to the transmiGer manufacturer NOTE 1 At 80 MHz and 800 MHz the separa9on distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situa9ons Electromagne9c propaga9on is aﬀected by absorp9on and reﬂec9on from structures objects and people ...

Page 43: ...enzhen Viatom Technology Co Ltd Website www getwellue com Email service getwellue com Manufacturer Shenzhen Crea ve Industry Co Ltd Shanghai Interna onal Holding Corp GmbH Europe Eiﬀestrasse 80 20537 Hamburg Germany ...

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