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Creative OXY-11 Operator's Manual
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Creative OXY-11 Operator's Manual

Creative OXY-11 Operator's Manual

Fingertip oximeter
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OXY-11
Fingertip Oximeter
Operator's Manual
Shenzhen Creative Industry Co., Ltd.

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Summary of Contents for Creative OXY-11

  • Page 1 OXY-11 Fingertip Oximeter Operator’s Manual Shenzhen Creative Industry Co., Ltd.
  • Page 2 Instruction for User Dear users, thanks you very much for purchasing the Oximeter. This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
  • Page 3 Safety Contraindications Do not use oximeter in a magnetic resonance (MR or CT) environment. Warnings Keep the oximeter away from young children. Small parts such as the battery door, battery and lanyard may trigger choking hazards.
  • Page 4 Cautions ● Do not use oximeter in the present of flammable anesthetics. ● The oximeter needs to be used according to information provided in the user manual. ● The equipment is NOT intended for neonate and infant. ● Do not use a damaged oximeter which may affect measurement performance.
  • Page 5 relocating the device to another finger. ● Do not place the oximeter on edema or fragile tissues. ● Do not use the oximeter as the only basis for making medical decision,it is intended only to be used as addtional information that you can give to your licensed health care professional.
  • Page 6 its components,including the battery. ● Do not stare the light(the infrared is invisible) which emitted from the oximeter is harmful to the eyes. ● For clinical limitations and contraindications, please carefully review the medical literature ● The equipment is just a clinical diagnosis of auxiliary equipment.
  • Page 7 Low perfusion (PI <0.3) / finger trembling. ● Not suitable for the users with large finger size or exceeding oximeter's finger measurement cavity size. ● Please don't use the thumb and tail finger to measure . ● Discomfort or pain may appear if using the equipment ceaselessly,especially for microcirculation barrier patients, it recommended that the equipment should not be used on the same finger more than 5 minutes.
  • Page 8 Any of the following conditions may reduce the performance of the oximeter. ◆ Flicking or very bright light ◆ Moisture in the oximeter ◆ The individual weight less than 20kgs ◆ Week pulse quality(low perfusion) ◆ Venous pulsations ◆ Low hemoglobin ◆...
  • Page 9 ◆ Methemoglobin ◆ Dysfunctional hemoglobin ◆ Artificial nails or fingernail polish ◆ The Finger is too cold ◆ Patients with abnormal circulation of finger endings caused by cop...
  • Page 10 The Basics The oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood .It is an important bio-parameter for respiration. A number of diseases relating to respiratory system may cause the decrease of SpO2 in the blood, furthermore, some other causes such as the malfunction of human body’s self-adjustment, damages during surgery, and the injuries caused by some medical...
  • Page 11 as a consequence, such as vertigo, impotence, vomit etc. Serious symptoms might bring danger to human’s life . therefore, prompt information of patients SpO2 is of greats help for the doctor to discover the potential danger, and is of great importance in the clinical of medical field. Principle Principle of the oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer Law...
  • Page 12 according to Spectrunm Absorprtion characteristic of Reductive hemoglobin(Hb) and oxyhemoglobin(HbO2)in glow&near-infrared zones. Opertation Principle of the device is:Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning Recording Technology,So that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger-type sensor.Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic...
  • Page 13 circuits and microprocessor. Figure 1 Oximeter‘s schematic illustration...
  • Page 14 Introduction 2.2.1 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 SpO pulse rate of adult and pediatric patients in homes and medical clinics.
  • Page 15 adults and children,it recommended that the finger thickness should between 8-25.4mm. NOTES: ·The probe is the hole in the middle of the equipment to which the finger insert. ·The Probe is the Applied part of the equipment. 2.2.2 Features · The oximeter is small in volumes, light in weight and easy to carry,...
  • Page 16 · One button and easy to operate. · There are three modes: power off , sleep and measure. · Automatically turning into sleep mode within 8 seconds after there is no signal. Notes: ·Press the operating button to activate oximeter(measure mode) from sleep mode.
  • Page 17 Front View Figure 2 Front view...
  • Page 18 Functions Display OLED Spo2 parameter measurement Pulse rate parameter measurement Bar graph display Battery display Automatically enters sleep mode Pulse waveform display Four direction display...
  • Page 19 Symbols Symbol Definition %SpO Pulse Oxygen Saturation (%) Pulse Rate (BPM) Battery positive/ cathode electrode This item is compliant with Medical Device Directive 93/42/EEC Caution, Consult Accompanying Documents...
  • Page 20 Serial Number Federal law restricts this device to sale by or on Rx Only the order of a licensed healthcare practitioner Power indication(some models have no battery capacity indicator, but have low battery indicator) Date of Manufacturer Manufacturer...
  • Page 21 BF Type Applied Part The device has no Alarm System The product is protected against harmful effects IPX2 of dripping water per IEC 60529. Federal law restricts this device to sale by or on Rx Only the order of a licensed healthcare practitioner Power indication(some models have no battery capacity indicator, but have low battery indicator)
  • Page 22 Battery Installation A.Put the two AAA batteries into battery compartment in correct polarities. B.Push the battery cover horizontally along the arrow shown as figure 3. Figure 3 Battery installation...
  • Page 23 WARNINGS ● Battery polarities should correctly installed,otherwise,damag may be caused to the equiment. ● Please remove the batteries if the oximeter will be stored for mo than 30 days. ● Please remove the batteries if you want to turn off the oximeter.
  • Page 24 Operating Guide Application Method A.Remove the battery cover,and insert the two AAA batteries following polarity markings indicated inside of the battery compartment,then reposition the cover. B.Hold the oximeter with the display facing toward you,slide your finger into the opening probe of the device,as shown below(Figure 4),until the fingertip touches the built-in stop guide.For best results,make sure the finger is centered with in...
  • Page 25 the finger guide. C.Press the button to activate the oximeter from sleep mode, and then measurement interface will appear in 3 seconds. D.The measurement result will be read directly from the screen. E.The oximeter will turn into sleep mode automatically within 8 seconds after the finger left the probe.
  • Page 26 Attention for Operation A. Ring finger, middle finger index finger recommended as suitable monitor position B. Excessive or rapid movement may affect measurement...
  • Page 27 accuracy C. Improper sensor placement may affect the measurement accuracy D. The oximeter can be reused after cleaning and disinfection E. The measurement comes to the best when the oximeter and the heart are at the same level. F. The plethysmogram can be used as pulse intensity indicator. The displayed parameters G.
  • Page 28 I. The displayed parameters will show invalid indicator as '---' if signal quality is very low. J. The displayed parameters will show invalid indicator as '---' if oximeter fault occur. K. The maximum continuous test time does not exceed 5 minutes.
  • Page 29 Specifications Classification Type of protection against electric shock: Internally powered equipment. Degree of protection against electric shock: Type BF-Applied part (non-defibrillation proof) Operating mode: Spot checking The degree of protection against harmful solid foreign objects and ingress of liquid: IPX2...
  • Page 30 Measurement Specifications declared accuracy Display range: 70% to 99% ±2 digits; 0% to 69% Unspecified Resolution: 1% Update Period: 1s Averaging Time: 8s PR declared accuracy Display range: 25 to 250±3 digits Resolution: 1 bpm...
  • Page 31 Update Period: 1s Averaging Time: 8s Power Requirements Specification……………………………Two 1.5V(AAA) Operating Voltage…………………… DC 2.3-3V Environmental Specifications Temperature (ºC) Operating…………………………………+41º to +104 ºF / 5º to 40 ºC Storage/transportation…………….-4º to +140 ºF / -20º to 60 ºC...
  • Page 32 Humidity Operating…………………………………10 % to 95% non-condensing Storage/transportation……………10 % to 95% non-condensing Atmosphere Pressure Operating…………………………………70 to 106 kpa Storage/transportation……………50 to 107.4 kpa Physical Specifications Width*Height*Depth………About 33x36x58mm Weight………………………………About 60 g (including the batteries)
  • Page 33 Display Specifications Display type OLED, 0.96", 128×64 pixel SpO2%, PR, battery indicator, Pulse Display content rate bar graph, pulse waveform. LED Wavelength Wavelength Radiant Power 660±6nm 1.8mW 905±10nm 2.0mW...
  • Page 34 Maintenance Maintenance The equipment’s design life expectancy is about 2 years, keep your equipment and accessories free of dust and dirt, and follow these rules: A. Please clean the equipment before use according to chapter 6.2; Remove the batteries inside the battery cassette if the equipment will not be operated for a long time;...
  • Page 35 indicate lamps were empty; C. It is recommended that the equipment should be kept in a dry environment with no corrosive gases and good ventilation anytime. The moisture and high-light environments will affect its lifetime and even might damage the equipment. D.
  • Page 36 transported mixed with toxic, harmful, corrosive materials. WARNING No modification of this equipment is allowed.  Disposal Dispose of the oximeter in accordance with local environment and waste disposal laws and regulations.
  • Page 37 Cleaning/Disinfection Cautions ● Never immerse or soak the oximeter. ●We recommend that the oximeter be cleaned and disinfected after use every time or determined by your hospital’s policy,to avoid long term damage to the oximeter. ● Never use cleaning agents/disinfectants other than the recommended.
  • Page 38 Cleaning The recommended cleaning agents include: water Shut down the oximeter and remove the battery. Clean the oximeter with cotton or soft cloth moistened with water. After cleaning, wipe off the water with a soft cloth. Allow the oximeter to air dry. Disinfection recommended disinfectants...
  • Page 39 70%,isopropanol 70%. A. Shut down the oximeter and remove the battery. B. Clean the oximeter as instructed above. C. Disinfect the oximeter with cotton or soft cloth moistened with one of the recommended disinfectants. D. After disinfection, be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with water.
  • Page 40 Accessories One lanyard Two AAA batteries One user manual One certificate card Note: For particular configuration of accessories please refer to the product package list.
  • Page 41 Troubleshooting Troubleshooting WARNINGS : ●Necessary maintenance must be performed by qualified service personal ONLY. ●Users are NOT permitted to maintain the equipment by themselves. ●There are NO replaceable components in the equipment...
  • Page 42 Appendix equipment meets requirements 60601-1-2:2014. 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 used in such an environment. Electromagnetic Emissions test Compliance...
  • Page 43 The Fingertip Oximeter uses RF energy only for its internal function. RF emissions Therefore, its RF Group 1 CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions The Fingertip Oximeter Class B CISPR 11 suitable for use in all...
  • Page 44 Voltage and those directly fluctuations/flicker network that supplies emissions buildings used for IEC61000-3-3 domestic purposes. 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 used in such an environment.
  • Page 45 Electromagnetic IEC60601 test Complian Immunity test environment level ce level -guidance Floors should be wood, concrete or ceramic tile. if Electrostatic floors are ±8 kV discharge(ESD ±8 kV contact covered with contact ±15kV air synthetic ±15kV air IEC61000-4-2 material, the relative humidity should be at least...
  • Page 46 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 47 <5% U Voltage dips, (>95% dip in U short for 0.5 cycle <40% U interruptions (60% dip in U ) for and voltage 5 cycles variations on <70% U power supply (30% dip in U ) for 25 cycles input lines <5% U IEC61000-4-1 (>95% dip in U...
  • Page 48 Power frequency magnetic fields should be at Power levels frequency( characteristic of 50Hz/60Hz) 3A/m 3A/m a typical location magnetic field in a typical IEC61000-4-8 commercial or hospital environment. NOTE : U is the a.c. mains voltage prior to application of the test level.
  • Page 49 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 50 Portable and mobile RF communications equipment should be used no closer to any part of The Fingertip Oximeter, including cables, than the Conducted 3 Vrms recommended 150 kHz to separation distance IEC61000-4- 80 MHz calculated from the equation applicable to the frequency of...
  • Page 51 the transmitter. Recommended separation distance Radiated RF 3 V/m d=1.2 P IEC61000-4- 80 MHz to 3 V/m d=1.2 P 80MHz to 2.5 GHz 800MHz d=2.3 P 800MHz to 2.5GHz Where P is the maximum output power rating of the...
  • Page 52 transmitter in watts (W) according to the transmitter 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...
  • Page 53 less than the compliance level in each frequency range . Interference may occur in the vicinity of equipment marked with the following symbol.
  • Page 54 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. 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.
  • Page 55 which The Fingertip Oximeter is used exceeds the applicable RF compliance level above, The Fingertip Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The Fingertip Oximeter. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
  • Page 56 Fingertip Oximeter intended electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The Fingertip Oximeter 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, according to the maximum output power of the communications equipment.
  • Page 57 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...
  • Page 58 For transmitters rated at a maximum output power not listed above, the recommended separation distance d 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.
  • Page 59 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)