Pulse Oximeter AP-10 User Manual Shenzhen Creative Industry Co., Ltd User Manual for Pulse Oximeter Instructions to User Dear Customer, 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 Pulse Oximeter. No part of this manual may be photocopied, reproduced or translated into another language without the prior written consent. We reserve the right to revise and amend it at any time without prior notice. Version of the Manual: Ver 1.2 Issued Date: June18th, 2019 All rights reserved.
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3502-1290162 User Manual for Pulse Oximeter Notes:
The contents contained in this manual are subject to change without prior notice. Information furnished by Creative is believed to be accurate and reliable. However, no responsibility is assumed by Creative its use, or any infringements of patents or other rights of third parties that may result from its use. for Instructions for Safe Operation Check the device to make sure that there is no visible damage that may affect users safety and measurement performance. It is recommended that the device should be inspected minimally before each use. If there is obvious damage, stop using the device.
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User Manual for Pulse Oximeter service must only be Necessary qualified performed technicians. Users are not permitted to service this device. by The Pulse Oximeter must not be and used with accessories not specified in User Manual. devices the Cautions Explosive hazardDO NOT use the Pulse Oximeter in environment with inflammable gas such as some ignitable anesthetic agents. DO NOT use the Pulse Oximeter while the Patient is under MRI or CT scanning. This device is NOT MRI Compatible. Warnings Discomfort or pain may occur if using the sensor of this device
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User Manual for Pulse Oximeter continuously on the same location for a long time, especially for the patients with poor microcirculation. Misapplication of a SpO2 probe with excessive pressure for prolonged periods can induce pressure injury. Place the SpO2 probe on the finger tightly will cause venous pulse and effect blood circulation, and lead to interstitial edema, hypoxia and inaccurate measurement. Biocompatibility tests have been performed on all the applied parts, some exceptional allergic patients may still have anaphylaxis. Do not apply have anaphylaxis. those who to be For the individual patients, there prudent should inspecting in the placing process. The sensor cannot be placed on the edema and tender tissue. a more
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User Manual for Pulse Oximeter The local law should be followed when disposing of the expired device or its accessories. strong DO NOT operate in the environment electro-magnetic where as interference radiogram, television, radiophone, etc. exists, such Please pay attention to the SpO2 probe cable while using to avoid strangulating patient. The functional tester cannot be used to assess the accuracy of the device. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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
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User Manual for Pulse Oximeter any accept interference, and (2) this device must interference received, including interference that may cause undesired operation. FCC RF Radiation Exposure Statement:
1. This Transmitter must not be co-located in conjunction with any other antenna or transmitter. 2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment. operating or Attentions corrosive Keep the Oximeter away from dust, substances, vibration, materials, explosive high temperature and moisture. If the Oximeter gets wet, please stop operating it and do not resume
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User Manual for Pulse Oximeter operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for the Oximeter ambient temperature. reach to DO NOT operate the button on the front panel with sharp materials or sharp point. DO NOT use high temperature or high pressure steam disinfection on the Oximeter and probes. Refer to related instructions regarding cleaning and disinfection. The intended use of this device is not for therapy purpose. The equipment IP22 with protection against harmful solid foreign objects and ingress of liquid. So that means the equipment is chapter for is
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User Manual for Pulse Oximeter solid against protected foreign objects of 12.5mm and greater, and protected against vertically falling water drops when enclosure tilted up to 15. Please pay attention to the effects of lint, dust, light (including sunlight), etc. Declaration of Conformity 60601-1:2005+A1:
The manufacturer hereby declares that this device complies with the following standards:
IEC 2012, IEC60601-1-2:2014, IEC60601-1-11:2010, ISO 80601-2-61:2011 and follows the provisions of the council directive MDD93/42/EEC.
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User Manual for Pulse Oximeter Table of Contents 1 Overview ........................................................ 1 1.1 Appearance .................................................. 1 1.2 Product Name and Model ............................ 3 1.3 Structure ...................................................... 3 1.4 Features ....................................................... 3 1.5 Intended Use ................................................ 4 1.6 Working Environment .................................. 4 2 Preparation ..................................................... 5 2.1 Power Supply ............................................... 5 2.2 Connection ................................................... 5 3 Make measurement ........................................ 7 3.1 Starting Measurement ................................. 7 3.2 SpO2 Measurement ...................................... 7 3.3 Setting Menu .............................................. 13 3.4 Body Movement Detection ........................ 16 3.5 Additional Information ............................... 17
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User Manual for Pulse Oximeter 4 Technical Specification ................................... 19 5 Classification ................................................. 22 6 Packing List ................................................... 22 7 Repair and Maintenance................................ 23 7.1 Maintenance .............................................. 23 7.2 Cleaning and Disinfection ........................... 24 7.3 Storage and Transportation ........................ 25 8 Troubleshooting ............................................ 26 Appendix ......................................................... 27 A Common Knowledge for SpO2 Measurement 27 B Wristband Installation and Disassembly ........ 32 C Key of Symbol ................................................ 35
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User Manual for Pulse Oximeter 1 Overview 1.1 Appearance 1 2 Figure 1A Front view 1. Working status indicator. 2. LCD display screen: Display measurement result, waveform. Note: Two kinds of appearance for optional, please refer to the device youve purchased. 1 User Manual for Pulse Oximeter 1 3 5 2 4 Figure 1B Front view Figure 2 Right side view Figure 3 Left side view 3. Power on/off key: Power on/off the device by 2 User Manual for Pulse Oximeter long pressing. 4. SpO2 probe connector. 5. Data interface: For charging and data uploading. 1.2 Product Name and Model Name: Pulse Oximeter Model: AP-10 1.3 Structure It consists of main unit, SpO2 probe, data interface as well as the bluetooth module (optional). 1.4 Features Its a smart wearable Pulse Oximeter, lightweight, small in size and easy to wear;
1.44 inch color LCD to display parameters and plethysmogram;
Body activity recording and analysis function is available;
Setting menu is available;
3 User Manual for Pulse Oximeter Over-limit alert by vibration of the device. The over limits can be adjusted via the provided PC software . Convenient to measure and record SpO2, pulse rate in long-term while sleeping;
Up to 72 hours data storage (500 pieces of record at most). Data can be uploaded to PC for review and analysis. 1.5 Intended Use This Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR). Its applicable for long-term tracking of SpO2, PR of adult or pediatric while sleeping in hospital, clinics or home. This device is not intended for continuous monitoring. 1.6 Working Environment Operating temperature: 0~40 Operating humidity:
4 User Manual for Pulse Oximeter 10%~90% (non-condensing) Atmospheric pressure: 70kPa~106kPa 2 Preparation 2.1 Power Supply Internal power supply: built-in lithium battery 3.7V/500mAh. External power supply for charging via USB cable: the power source from USB cable should produce the capacity of 5V DC/1.2A. 2.2 Connection The illustration of connection among SpO2 probe and Pulse Oximeter is shown in figure 2.1. 5 User Manual for Pulse Oximeter Pulse Oximeter SpO2 sensor
(finger rubber) Figure 2.1 Device and accessories connection
----- Finger rubber SpO2 sensor 6 User Manual for Pulse Oximeter 3 Make measurement 3.1 Starting Measurement 1) Connect the required cables and probe. 2) Check that the cables and probe are correctly connected. 3) Long press power on/off key to turn on the device. 3.2 SpO2 Measurement 1. Long press power on/off key to turn on the device. 2. Connect the SpO2 probe to the connector on the side of the device, the red blinking light from successful connection. (Note: When disconnecting the connector, be sure to hold the head of the connector firmly and pull). indicates a the probe 7 User Manual for Pulse Oximeter SpO2 probe connector Finger rubber SpO2 sensor Figure 3.1 SpO2 probe connection 3. Wear the Oximeter on your left hand. 4. For Finger rubber SpO2 sensor: Insert the finger
(index finger is preferred, the nail should be not too long) into the probe until the fingernail tip rests against the stop at the end of the probe (figure3.2). Adjust the finger to be placed evenly on the middle base of the sensor
(make sure the finger is in the right position). Note: If the index finger cannot be positioned correctly, or is not available, other finger can be 8 User Manual for Pulse Oximeter used. Fingertip sign Figure 3.2 Placement illustration
--- For Finger rubber SpO2 sensor The right placement of probe is as shown in figure3.3A. Figure 3.3A The wrong placement of probe is as shown in figure3.33B/3.3C. Figure 3.3B Figure out Figure 3.3C Not deep enough 9 User Manual for Pulse Oximeter 5. The Oximeter will automatically start measurement in 2 seconds, and then recording the measured data automatically. The display screen is as shown in figure 3.4. User can read the values and view the waveform form the display screen. Figure 3.4 SpO2 measuring screen display Screen description:
%SpO2: SpO2 label; 99: current SpO2 value. PR: Pulse rate label; 68current PR 10 User Manual for Pulse Oximeter value.
%PI: Perfusion index label; 2.0: current PI value.
: Pulse beat icon.
: Pulse strength bar-graph. The displayed waveform is plethysmogram.
: Battery voltage icon. link
: Wireless icon. If the wireless is setup
(bluetooth communication) successfully, the icon will be displayed on the screen; if the icon is flashing, it means a failure connection. If there is no wireless icon, it means the device is not configured withe wireless function.
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icon. During measurement, if the memory is full, then Full memory icon will appear on the screen for prompt; if the memory is fail to store (eg. the Oximeter is unexpected power off), then icon will be displayed on screen. If the memory is full, its recommended that the 11 User Manual for Pulse Oximeter user export the stored data from the device then delete the data, and the device can continue storing data. Key Operation:
Long press: press and hold the key for over 1 second. Short press: press the key for less than 1 second Description for Power indicator:
1) The power indicator is always on during charging. 2) When the screen display is on, the indicator is off. 3) During measuring, short press the power on/off key, then the device enter into power saving mode
(backlight is off), and the power indicator keeps on. Short press the power on/off key again, the power indicator off and device screen display is on. Activate the device during standby status:
12 User Manual for Pulse Oximeter 1). Short press power on/off key
. 2). Insert the air-flow module into the Oximeter. 3.3 Setting Menu Double short time press the power on/off key to enter into Menu Setting Screen, as shown in figure 3.5. 13 User Manual for Pulse Oximeter Figure 3.5 Date: set current date;
Time: set current time;
SpO2 alm Lo: set SpO2 low limit; Setting range:
85%~100%, default setting: 85%;
PR alm Lo: set pulse rate low limit; Setting range: 25bpm~99bpm, default setting: 50bpm;
PR alm Hi: set pulse rate high limit; Setting range: 100bpm~250bpm, default setting:
14 User Manual for Pulse Oximeter 120bpm;
Alert: enable/disable the function of over-limit indication by vibration of the Oximeter, factory default is off. Power saving: turn on/off the power saving mode, factory default is on. Delete record: select Delete record and long press key to enter into Deletion Confirmation screen. Then, select Yes with key (short time press), and long pressing key to carry out the deleting action. Default: select Default and long press key to enter into Default Setting screen. Then select Yes with key (short time press), and long pressing key to carry out the action of resuming all items to factory setting. 15 User Manual for Pulse Oximeter Menu setting operation:
Short time press to move the cursor to the item you need to set, and longtime press to activate the setting item, then short time press it to modify the setting parameter; Next, longtime press to confirm the modification and exit from this setting item. At last, move the setting item to Exit setting to exit from the setup menu. 3.4 Body Movement Detection Wearing the Oximeter and making measurement, if you rotate your wrist, then the screen enter into the time indicating screen, as shown in figure 3.6. 16 User Manual for Pulse Oximeter Figure 3.6 14:52:48: the current time. 00:23:45: the measuring duration up to now. V1.0.7.5: the software version. UID 00125: unique ID for the device. 3.5 Additional Information During measurement, if the memory is full, then icon appears on the screen, and the device will not store the following measured data again. 17 User Manual for Pulse Oximeter If appears on the screen, it indicates that battery power is not enough, please charge for the battery. If you keep on using it, after a while the Oximeter will be off. Do not make measurement when the Oximeter is charging. Avoid shaking finger as possible as you can during measurement. Do not wrap wet finger or put wet finger directly into sensor. Do not let anything block the emitting light from device. Using enamel or other makeup on the nail may affect the measuring accuracy. If the first readings appear with poor plethysmogram (irregular or not smooth), then the readings are unlikely true, the more stable values are expected by waiting for a while. The measurement records will not be lost, and the settings will not be changed if the power supply of the Oximeter is interrupted. After 18 User Manual for Pulse Oximeter connecting the power again and turn on the Oximeter, it will resume to normal working and the setting for the Oximeter remains unchanged. 4 Technical Specification A. Display Mode: 1.44 inch color LED display B. SpO2 measurement Transducer: dual-wavelength LED LED wavelength:
Red light: 660nm, Infrared light: 905nm Maximal optical output power: less than 2mW maximum average Measuring range: 0~100%
Display range: 0~100%
Measuring accuracy: Arms value (defined in ISO 80601-2-61) is not greater than 3% for SpO2 range from 70% to 100%. Data update: <10s C. Pulse Rate measurement Measuring range: 30bpm~250bpm 19 User Manual for Pulse Oximeter Measuring accuracy:
2bpm or 2%
(whichever is greater) Resolution: 1bpm D. Perfusion Index Display Range: 0.2%~20%
E. Preset alert limits SpO2 Low alert limit: 85%
PR high alert limit: 120bpm PR low alert limit: 50bpm F. Power Supply:
Built-in lithium battery: 3.70V/500mAh Operating current: 90mA Continues working time (display is off and measuring SpO2 Only): about 13 hours G. Operating environment Operating temperature: 5~40 Operating humidity:
15%~93% (non-condensing) Atmospheric pressure: 70kPa~106kPa H. Performance under low perfusion condition 20 User Manual for Pulse Oximeter The accuracy of SpO2 and PR measurement still meets the specification described above when the modulation amplitude is as low as 0.6%. I. Resistance to ambient light interference:
The accuracy of SpO2 and PR measurement still meets the specification described above when the device is tested by SpO2 simulator
(Fluke Biomedical Index 2 series) while setting the emulating interference of sun light and 50Hz/60Hz fluorescent light. J. Over-limit alert by visible display:
If the measured SpO2, PR exceeds the preset alert limit value, then visible alert should be available. K. Dimensions: D 56mm W 44mmH 16mm Net Weight: about 45g L. Bluetooth function Frequency band: 2.4GHz Working profile: BLE V4.0 21 User Manual for Pulse Oximeter 5 Classification The type of protection against electric shock:
Internally powered equipment. The degree of protection against electric shock: Type BF applied part. The degree of protection against harmful ingress of liquids: IP22. Electro-Magnetic Compatibility:
Group I, Class B 6 Packing List 1. SpO2 probe................One 2. Wristband ............................One 3. AC power adapter..........OneOptional 4. Data cable ..............OneOptional Note: the accessories are subject to change, please refer to the items in your package. 22 User Manual for Pulse Oximeter 7 Repair and Maintenance 7.1 Maintenance The 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 charge the device when low battery voltage indicator lightens. Please clean the surface of the device before using. Use cloth with alcohol to wipe the device first, and then let it dry in air or wipe it dry. The recommended storage environment of the device:
ambient temperature: -20C ~60C, relative humidity 10%~95%, atmospheric pressure:
50kPa~107.4kPa. The oximeter is calibrated in the factory before sale, there is no need to calibrate it during its life cycle. However, if it is necessary to verify its precision routinely, the user can 23 User Manual for Pulse Oximeter do the verification by means of SpO2 simulator, or it can be done by the local third party test house. High-pressure /high temperature sterilization cannot be used on the device. Do not immerse the device in liquid. 7.2 Cleaning and Disinfection Surface-clean sensor with a soft gauze by wetting with a solution such as 75%
isopropyl alcohol, if low-level disinfection is required, use a 1:10 bleach solution. Then surface-clean with a damp cloth and dry with a piece of cloth. Clean the wristband with soapy water. Please detach the wristband from the oximeter firstly.(Refer to Appendix for detailed disassembly method) Caution: Do not sterilize by irradiation steam, or ethylene oxide. Do not use the sensor if it is damaged. 24 User Manual for Pulse Oximeter 7.3 Storage and Transportation If the device will not be used for long period of time, wipe it clean and keep it in the packaging, which shall be kept in a dry and good ventilation place free from dust and corrosive gases. Storage environment:
Ambient temperature: -20~60 Relative humidity: 10%~95% (non-condensing) Atmospheric pressure: 50kPa~107.4kPa Transportation:
The device should be transported by land (vehicle or railway) or air in accordance with the contractual terms. Do not hit or drop it with force. 25 User Manual for Pulse Oximeter 8 Troubleshooting Trouble Possible Reason Solution The SpO2 and Pulse Rate display instable 1. The finger is not placed far enough inside. 2. The finger is not wrapped correctly Can not turn on the device 1. Low battery voltage 2. The device is malfunctioning. Fragmental SpO2 waveform 1. Your finger is out of proper location in the probe. 2. Blood flow in the finger blocked. 3. Extreme movement 1. Place the finger correctly inside and try again. 2. Wrap the finger properly and make the emitter focus on receiver 1. Please charging. 2. Please contact the local service center. 1. Adjust your finger location properly. 2. Make sure there is no object may occlude the blood flow. 3. Extreme movement may cause invalid measuring result. 26 User Manual for Pulse Oximeter Appendix A Common Knowledge for SpO2 Measurement 1 Meaning of SpO2 SpO2 is the saturation percentage of oxygen in the blood, so called O2 concentration in the blood; it is defined by the percentage of oxyhemoglobin
(HbO2) in the total hemoglobin of the arterial blood. SpO2 is an important physiological parameter to reflect the respiration function; it is calculated by the following method:
SpO2 = HbO2/ (HbO2 +Hb)100%
HbO2 are the oxyhemoglobins
(oxygenized hemoglobin), Hb are those hemoglobins which release oxygen. 2 Principle of Measurement Based on Lamber-Beer law, the light absorbance of a given substance is directly proportional with its density or concentration. When the light with 27 User Manual for Pulse Oximeter certain wavelength emits on human tissue, the measured intensity of light after absorption, reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes. Due to that oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different absorption character in the spectrum range from red to infrared light (600nm~1000nm wavelength), by using these characteristics, SpO2 can be determined. SpO2 measured by this oximeter is the functional oxygen saturation -- a percentage of the hemoglobin that can transport oxygen. In contrast, hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin. Clinical application of pulse oximeters: SpO2 is an important physiological parameter to reflect the respiration and ventilation function, so SpO2 measurement used in clinical becomes more popularly, such as monitoring the patient with 28 User Manual for Pulse Oximeter serious respiratory disease, the patient under anesthesia during operation, premature and neonate. The status of SpO2 can be determined in time by measurement and find the hypoxemia patient earlier, thereby preventing or reducing accidental death caused by hypoxia effectively. 3 Factors affecting SpO2 measuring accuracy
(interference reason) Intravascular dyes such as indocyanine green or methylene blue. Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight. Vascular dyes or external used color-up product such as nail enamel or color skin care Excessive patient movement Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or 29 User Manual for Pulse Oximeter intravascular line Exposure to the chamber with High pressure oxygen There is an arterial occlusion proximal to the sensor Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing 30 User Manual for Pulse Oximeter 4 Factors causing low SpO2 Measuring value
(pathology reason) Hypoxemia disease, functional lack of HbO2 Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough 31 User Manual for Pulse Oximeter B Wristband Installation and Disassembly Introduction:
Velcro Buckle Wristband Velcro The other side of Oximeter Fig. A One side of Oximeter Fig. B Pulse Oximeter Installation Procedure:
Step 1: Insert the wristband to the Oximeter from one side to the other side, as shown in Fig.C. Step 2: Put the Oximeter on the wrist, and stick the Fig. C 32 User Manual for Pulse Oximeter Velcro to the inner side of wristband, press the wristband to make the Velcro stick to the inner side of wristband firmly, as shown in Fig.D. Fig. D Step 3: Bring the wristband out from the buckle, and fold back the wristband, as shown in Fig.E. Then press the Velcro to make it stick to the outer side of wristband firmly, as shown in Fig.F. Fig. E 33 User Manual for Pulse Oximeter Fig.F The Disassembly:
of wristband disassembly is similar to the installation method, but with reverse procedure. process Note: Please detach the wristband from the Oximeter before cleaning the wristband. 34 User Manual for Pulse Oximeter C Key of Symbol Symbol Description With Type BF applied part Symbols on the enclosure See User Manual Data interface SN Serial number No alarm Do not litter at will Life span Symbols on the screen
%SpO2 The oxygen saturation
%PI Perfusion Index PR RR Pulse rate Respiration rate 35 User Manual for Pulse Oximeter Pulse beat Wireless Pulse strength bar-graph Low battery voltage Memory full Memory error Note: the above symbol may appear on your device. 36 User Manual for Pulse Oximeter Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, PEOPLES REPUBLIC OF CHINA Tel: +86-755-2643 3514 Fax: +86-755-2643 0930 E-mail: info@creative-sz.com Website: www.creactive-sz.com EC-Representative:
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg Germany