Creative Medical PC-60F User Manual
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Creative Medical PC-60F User Manual

Fingertip oximeter
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Fingertip Oximeter
User Manual
Shenzhen Creative Industry Co., Ltd.

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Summary of Contents for Creative Medical PC-60F

  • Page 1 Fingertip Oximeter User Manual Shenzhen Creative Industry Co., Ltd.
  • Page 2 Instructions to User Dear Customers, Thank you for purchasing this quality product. Please read the manual very carefully before using this device. Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter. The manual is published in English and we have the ultimate right to explain the Manual.
  • Page 3 For user's convenience, we share the latest version analysis software of the Oximeter on our website, the user can enter into our website (www.creative-sz.com) to download the corresponding latest version data manager software. Please contact the manufacturer or your local distributor if anything about software downloading.
  • Page 4 Notes  The contents contained in this manual are subject to change without notice.  Information furnished by our company is believed to be accurate and reliable. However, no responsibility is assumed by us for its use, or any infringements of patients or other rights of third parties that may result from its use.
  • Page 5 recommended that the device should be inspected minimally before 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 37°C, burns may occur because of over-heating of the sensor at this situation.
  • Page 6 Cautions  Explosive hazard—DO NOT use the Oximeter in environment with inflammable gas such as some ignitable anesthetic agents.  DO NOT use the Oximeter while the patient is under MRI or CT scanning. This device is NOT MRI Compatible. Warnings ...
  • Page 7 applied to the same location for longer than 2 hours. If any abnormal condition is found, please change the position of Oximeter.  DO NOT clip this device on edema or tender tissue.  The light (the infrared light is invisible) emitted from the device is harmful to the eyes.
  • Page 8  Keep the Oximeter away from dust, vibration, 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 operation until it is dry and checked for correct operation.
  • Page 9  DO NOT use high temperature or high pressure steam disinfection on the Oximeter. Refer to Chapter 7 for instructions regarding cleaning and disinfection.  The equipment is IP22 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...
  • Page 10 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 equivalent 80601-2-61:2011 - Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse Oximeter equipment.
  • Page 11 Caution: U.S. federal law restricts this device to sale or use by or on the order of a physician. FCC Rules are specifically for PC-60FW This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including...
  • Page 12 Table of Contents 1 OVERVIEW ............... 1 ..............1 1.1 A PPEARANCE ............3 1.2 N AME AND ODEL ............... 3 1.3 I NTENDED ..............3 1.4 F EATURE 2 BATTERY INSTALLATION ..........9 3 OPERATION ..............10 4 DOWNLOAD THE APP SOFTWARE ....... 22...
  • Page 13 5 TECHNICAL SPECIFICATIONS ......... 24 6 PACKING LIST ..............29 7 REPAIR AND MAINTENANCE ........29 ............. 30 7.1 M AINTENANCE ....33 7.2 C LEANING AND ISINFECTING NSTRUCTION 8 TROUBLESHOOTING ............34 9 KEY OF SYMBOLS ............35 10 FREQUENTLY ASKED QUESTIONS ......37 APPENDIX I RESULT DESCRIPTION ........
  • Page 14 1 Overview 1.1 Appearance Display Screen Display Key Figure 1 Front View...
  • Page 15 Nameplate Battery Cover Figure 2 Rear View Note: the appearance is for demonstration only, please refer to the oximeter you purchased.
  • Page 16 1.2 Name and Model Name: Fingertip Oximeter Model: PC-60F/PC-60FW/PC-60A 1.3 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO through a patient’s finger. It is applicable for spot-checking and pulse rate of adult and pediatric patients in homes and medical clinics.
  • Page 17 "√" this function is available, " " without this function. × Display type: D-O-D means dot-matrix dual color OLED Model PC-60FW PC-60A PC-60F Function OLED OLED Display type √ √ √ , PR, PI √ √ Plethysmogram × √ √...
  • Page 18 √ √ Over-limits indication × sound Indication sound mute Manual Manual Manual Four directions display √ √ √ √ Setting menu × √ √ Over-limits setting × √ √ Pulse beep × Wireless function √ × × Continuous, Continuous, × Measuring mode Spot check Spot check...
  • Page 19  Indication sound mute For the model with both over-limits indication function and pulse beep function, when beep is on and over-limits indication sound is activated, then Display key will work as the Mute key, and short time pressing it can mute the over-limits indication sound and pulse beep for 90 seconds.
  • Page 20 pulse rhythm will be displayed on the screen as well. Once the finger 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, and PR readings will be displayed until the finger is removed from the oximeter.
  • Page 21 the time from displaying valid readings to the end of measurement is less than 5 seconds, then no recording will be done.  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.
  • Page 22 display, and if there is no key operation for 6 seconds, then the Oximeter will power off automatically again. 2 Battery Installation 1. Refer to Figure 3, insert two AAA size batteries into the battery compartment properly, and note the polarity markings. 2.
  • Page 23 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. Any such damage is not covered under the product warranty.
  • Page 24 position), and then clip the finger, as shown in figure 4. 2. Next enter into data display screen:  A short time press of the Display Key can 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 no key operation.
  • Page 25 Figure 5A Figure 5B Figure 5C Figure 5D  For PC-60A, the display screen is as shown in below figure.
  • Page 26  For PC-60F and PC-60FW, the display direction is remembered at each startup, it will display the screen layout (display direction) from the last time it was used. The only difference between PC-60F and PC-60FW is...
  • Page 27 PC-60F has no wireless function and thus no wireless icon “ ” on the screen.  Icon “ ” on display screen means the counting-down time if the Oximeter works at Spot check mode. The total measuring time for Spot check mode is 30 seconds.
  • Page 28 5E. Other result descriptions see Appendix I.  Recording & recall functions are available for PC-60F and PC-60FW. At power off status, long time pressing Display key can bring up record list display screen, as shown in figure 6.
  • Page 29 PC-60F and PC-60FW “Wireless” ： the wireless on-off button. Transmitting data to PC when it is on. “on” and “off” can be optional. The factory default is “on”. “Beep” ： Pulse beep option. If it is set to on, every pulse...
  • Page 30 beat makes a beep. “Mode”: to set the measuring mode. “Continuous” and “Spot check” for optional, the default is “Spot check”. Menu setup Short time press Display Key to choose the setting item; Longtime press Display Key to active the setting item, then short time press it to modify the setting parameter;...
  • Page 31 if wireless connection is setup, the icon " " will be Note: displayed on the screen. 4. Wireless icon“ ”/" ": The icon of Definition “ ” The device is being to establish a “ ” flashes wireless connection with blue surrounding host.
  • Page 32 1. "Wireless" function is disabled; display“ ” 2. The device fails to setup a wireless icon connection with the surrounding host within 3 minutes; Hardware failure wireless transmission function while “Wireless” function is enabled. Data transmission The user could effectively transmit the data to computer through the wireless function.
  • Page 33  Do not shake the finger and relax during measurement.  Do not put wet finger directly into sensor.  Avoid placing the device on the same limb which is wrapped with cuff blood pressure measurement or during venous infusion. ...
  • Page 34 Oximeter. When you want to change the Oximeter’s display direction, if you move the Oximeter too slowly, the movable metal ball will also move slowly because of not enough acceleration. Consequently the response of orientation detection would be delayed. Acceleration needs provided orientation-sensor for quick sensing the orientation...
  • Page 35 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 true, the more stable value is expected by waiting for a while, or a restart is needed when necessary.
  • Page 36 Downloading the APP software for iOS system  For smart phone or Pad with iOS system (such as iPhone, iPad), please follow this procedure to download: 1. On Apple App Store, enter "Shenzhen Creative" into the search box. Note: if you use an iPad to search, please select "iPhone only"...
  • Page 37 5 Technical Specifications A. SpO Measurement Transducer: dual-wavelength LED sensor with wavelength: Red light: 663 nm, Infrared light: 890 nm. Maximal average optical output power: ≤2mW display range: 35%~100% measuring accuracy: ≤ 2% for SpO range from 70% to 100% B.
  • Page 38 PR measuring accuracy: ±2bpm or ±2% (whichever is greater) Perfusion Index(PI) Display range 0%~20% Preset over-limits for PC-60A low limit: 90% Pulse Rate: high limit: 120bpm low limit: 50bpm Over-limit settings for PC-60F, PC-60FW Low limit setting range: 85%~99%, step: 1% Default setting: 90%...
  • Page 39 Pulse Rate: Low limit setting range: 30~60bpm, step: 1bpm; High limit setting range: 100~240bpm, step: 5bpm; Default setting: high: 120bpm; low: 50bpm Audible & visual alert function When measuring, if SpO value or pulse rate value exceeds the preset limit, the device will alert with beep automatically and the value which exceeds limit will flash on the screen.
  • Page 40 Operating current: ≤40mA I. Environmental Conditions: Operating Temperature: 5°C ~40°C Operating Humidity: 30%~80% Atmospheric pressure: 70kPa~106kPa J. Low Perfusion Performance: The accuracy of SpO and PR measurement still meet the precision described above when the modulation amplitude is as low as 0.6%. K.
  • Page 41 the condition of indoor natural light and that of darkroom is less than ±1%. L. Dimensions: 56 mm (L) × 34 mm (W) × 30 mm (H) Net Weight: approx. 60g (including batteries) M. Classification The type of protection against electric shock: Internally powered equipment.
  • Page 42 harmful solid foreign objects and ingress of liquid. Electro-Magnetic Compatibility: Group I, Class B 6 Packing List 1) Fingertip Oximeter 2) User Manual 3) Batteries 4) Pouch (optional) 5) Lanyard (optional) Note: the items and its quantity are subject to change, please refer to your subject in hand.
  • Page 43 7.1 Maintenance The expected service life (not a warranty) of this device is 5 years. In order to ensure its long service life, please pay attention to the maintenance. Please change the batteries when the low-voltage  indicator lightens. Please clean the surface of the device before using, ...
  • Page 44 device: ambient temperature: -20ºC ~60ºC, relative humidity 10%~95%, atmospheric pressure: 50kPa~107.4kPa. The Oximeter is calibrated in the factory before sale,  so there is no need to calibrate it during its life cycle. Any SpO simulators should not be used to validate the accuracy of the Oximeter, they can only be used as functional testers to verify its precision.
  • Page 45 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 house. Please note that the specific calibration curve (so called R-curve) should be selected when use of SpO simulator, e.g.
  • Page 46 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. 7.2 Cleaning and Disinfecting Instruction Surface-clean sensor with a soft cloth damped with a ...
  • Page 47 Do not use the Oximeter if it is damaged. 8 Troubleshooting Problem: 1. The SpO and Pulse Rate display instable 2. Cannot turn on the device 3. No display direction doesn’t change or changes insensitively. Display 5. No display of the wireless icon “...
  • Page 48 4. Please shake the Oximeter with a certain force to make the movable metal ball move freely. If the problem still exists, maybe the orientation-sensor is not working properly. 5. Hardware failure of wireless transmission function. 6. If the above problem still exists please contact the local service center.
  • Page 49 Perfusion Index (%) Pulse Strength Bar Graph Low battery voltage CE mark Serial number Date of manufacture Authorised representative European community Manufacturer (including address)
  • Page 50 BF type applied part Attention ─ refer to User Manual Wireless icon Follow WEEE regulations for disposal 10 Frequently Asked Questions 1. Q: What's SpO A: SpO means the saturation percentage of oxygen in the blood. 2. Q: What's the normal range of SpO value for healthy...
  • Page 51 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. 4. Q: Why do the display value of SpO and PR vary with time? A: The measured SpO...
  • Page 52 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 saturation measurement simultaneously. 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...
  • Page 53 to be replaced. 8. Q: What to do if the Oximeter is moistened or sprayed by water? A: Remove the batteries immediately and dry the Oximeter completely with a hair dryer. 9. Q: What factors will affect the SpO accuracy? A:a) Intravascular dyes such as indocyanine green or methylene blue;...
  • Page 54 as nail enamel or color skin care; d) Excessive patient 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 contraction caused by peripheral vessel hyperkinesias or body temperature decreasing;...
  • Page 55 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...
  • Page 56 Suspected fast pulse with short pulse interval Suspected slow pulse with short pulse interval Suspected slow pulse with irregular pulse interval Poor signal. Measure again Appendix II EMC The equipment meets the requirements of IEC 60601-1-2:2014. Table 1 Guidance and manufacturer’s declaration-electromagnetic emission The Fingertip Oximeter is intended for use in the electromagnetic...
  • Page 57 assure that it is used in such an environment. Complianc Electromagnetic Emissions test environment-guidance The Fingertip Oximeter uses RF energy only for its internal function. Therefore, its RF RF emissions Group 1 emissions are very low and are CISPR 11 not likely to cause any interference in nearby electronic equipment.
  • Page 58 including domestic Harmonic establishments and those emissions directly network that supplies IEC61000-3-2 buildings used for domestic Voltage fluctuations/fli purposes. cker emissions 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...
  • Page 59 used in such an environment. Compli Electromagneti IEC60601 test Immunity test ance c environment level level -guidance Floors should be wood, concrete or ceramic tile. ±8 kV Electrostatic if floors are ±8 kV contact contact discharge(ESD) covered with ±15kV air ±15kV IEC61000-4-2 synthetic...
  • Page 60 be at least 30% Electrical fast ±2kV for power transient/ Supply lines burst ±1 kV for IEC61000-4-4 input/output lines ±1kV line (s) to Surge line(s) ±2kV line(s) to IEC 61000-4-5 earth...
  • Page 61 <5% U (>95% dip in U Voltage dips, for 0.5 cycle short <40% U interruptions (60% dip in U ) for and voltage 5 cycles <70% U variations on (30% dip in U ) for power supply 25 cycles input lines <5% U IEC61000-4-11 (>95% dip in U...
  • Page 62 magnetic fields 50Hz/60Hz) should be at magnetic field levels IEC61000-4-8 characteristic of a typical location in a typical commercial or hospital environment. NOTE: U is the a.c. mains voltage prior to application of the test level. Table 3...
  • Page 63 Guidance and manufacturer’s declaration – electromagnetic immunity 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 electromagnetic environment. Electromagnetic Immunity IEC60601...
  • Page 64 be used no closer to any part of The Fingertip Oximeter, including cables, Conducted 3 Vrms than the 150 kHz to recommended IEC61000-4- 80 MHz separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended...
  • Page 65 Radiated RF 3 V/m separation distance IEC61000-4- 80 MHz to 3 V/m d=1.2 P 2.5 GHz 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...
  • Page 66 manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in...
  • Page 67 each frequency range . Interference may occur in the vicinity of equipment marked with the following symbol. 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.
  • Page 68 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 theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered.
  • Page 69 Oximeter. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. Table 4 Recommended separation distances between portable and mobile RF communication the equipment The Fingertip Oximeter is intended for use in an electromagnetic environment which...
  • Page 70 interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Fingertip Oximeter as recommended below, according to the maximum output power of the communications equipment. Rated Separation distance according to frequency maximum of transmitter M(Meters)
  • Page 71 output power 150kHz to 80MHz to 80MHz to of transmitter 80MHz 800MHz 2,5GHz W(Watts) d=1.2 d=1.2 d=2.3 0,01 0.12 0.23 0.38 0.73 For transmitters rated at a maximum output power not...
  • Page 72 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 in watts (W) according to the transmitter manufacturer. NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
  • Page 74 Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China Tel: +86-755-2643 3514 Fax: +86-755-2643 0930 E-mail: info@creative-sz.com Website: www.creative-sz.com Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg Germany...

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