Creative Medical AP-20 User Manual

Creative Medical AP-20 User Manual

Sleep screener

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Sleep Screener
AP-20
User Manual
Shenzhen Creative Industry Co., Ltd

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Summary of Contents for Creative Medical AP-20

  • Page 1 Sleep Screener AP-20 User Manual Shenzhen Creative Industry Co., Ltd...
  • Page 2 User Manual for Sleep Screener 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 Sleep Screener.
  • Page 3 User Manual for Sleep Screener 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 for its use, or any infringements of patents or other rights of third parties that may result from its use.
  • Page 4 User Manual for Sleep Screener  Necessary service must performed only qualified technicians. Users are not permitted to service this device.  The Sleep Screener must not be used with devices accessories not specified in User Manual. Cautions  Explosive hazard—DO NOT use the Sleep Screener in environment with inflammable gas such as some ignitable anesthetic agents.
  • Page 5 User Manual for Sleep Screener continuously on the same location for a long time, especially for the patients with poor microcirculation.  Misapplication of a SpO probe with excessive pressure for prolonged periods can induce pressure injury.  Place the SpO probe on the finger tightly will cause venous pulse and effect blood circulation, and lead to...
  • Page 6 User Manual for Sleep Screener The sensor can not be placed on the edema and tender tissue.  The local law should be followed when disposing of the expired device or its accessories.  DO NOT operate in the environment where strong electro-magnetic...
  • Page 7 User Manual for Sleep Screener operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm humid environment, please do not use it immediately. Allow at least 15 minutes for the Screener reach ambient...
  • Page 8 User Manual for Sleep Screener 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 tilted up to 15°. Please pay attention to the effects of ...
  • Page 9: Table Of Contents

    User Manual for Sleep Screener 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 ........5 2 Preparation .............
  • Page 10 User Manual for Sleep Screener 4 Technical Specification ........23 5 Classification ............26 6 Packing List ............27 7 Repair and Maintenance ........28 7.1 Maintenance ..........28 7.2 Cleaning and Disinfection ......29 7.3 Storage and Transportation ......30 8 Troubleshooting ...........
  • Page 11: Overview

    User Manual for Sleep Screener 1 Overview 1.1 Appearance 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 you’ve purchased.
  • Page 12 User Manual for Sleep Screener 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...
  • Page 13: Product Name And Model

    Data interface: For charging, data uploading and connecting air-flow measuring module. 1.2 Product Name and Model Name: Sleep Screener Model: AP-20 1.3 Structure It consists of main unit, SpO probe, air-flow module, acceleration sensor, oral-nasal cannula, data interface as well as the bluetooth module (optional).
  • Page 14: Intended Use

    User Manual for Sleep Screener snore waveform; Body activity recording analysis  function is available; Setting menu is available;  Over-limit alert by vibration of the device.  The over limits can be adjusted via the provided PC software . Convenient to measure and record SpO ...
  • Page 15: Working Environment

    User Manual for Sleep Screener long-term tracking of SpO , PR, RR, oral/nasal air flow and snoring 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: 10%~90% (non-condensing) Atmospheric pressure: 70kPa~106kPa...
  • Page 16: Connection

    User Manual for Sleep Screener 2.2 Connection The illustration of connection among SpO probe, oral-nasal cannula, air-flow module and Sleep Screener is shown in figure 2.1. Note: Two kinds of SpO probes are for optional (L-type with wrapper and finger rubber), please refer to the probe you’ve optioned.
  • Page 17 User Manual for Sleep Screener Oral mask Open-ended Air-flow branches for nostrils module Sleep Screener sensor (L-type with wrapper ) Oral-nasal cannula Figure 2.1A Device and accessories connection ----- L-type SpO sensor with wrapper...
  • Page 18 User Manual for Sleep Screener sensor (finger rubber) Figure 2.1B Device and accessories connection ----- Finger rubber SpO sensor...
  • Page 19: Make Measurement

    User Manual for Sleep Screener 3 Make measurement 3.1 SpO Measurement 1. Long press power on/off key to turn on the device. 2. Connect the SpO probe to the connector “ ” on the side of the device, the red blinking light from probe indicates...
  • Page 20 User Manual for Sleep Screener Figure 3.1 SpO probe connection 3. Wear the Screener on your left hand. 4.  For L-type SpO sensor with wrapper: Wrap it upon the finger (index finger is preferred) with the disposable wrapper (the light emitter should aim at the light receiver), refer to figure 3.2A for placement illustration.
  • Page 21 User Manual for Sleep Screener Note: If the index finger cannot be positioned correctly, or is not available, other finger can be used. Fingertip sign Figure 3.2B Placement illustration For Finger rubber SpO sensor The right placement of probe is as shown in figure3.3A.
  • Page 22 User Manual for Sleep Screener 5. The Screener 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.
  • Page 23 User Manual for Sleep Screener “%PI”: Perfusion index label; “2.0”: current  PI value. “ ”: Pulse beat icon.  “ ”: Pulse strength bar-graph.  The displayed waveform is plethysmogram.  “ ”: Battery voltage icon.  “ ”: Wireless icon. If the wireless ...
  • Page 24: Oral-Nasal Air Flow Monitoring

    User Manual for Sleep Screener then delete the data, and the device can continue storing data. 3.2 Oral-nasal Air Flow Monitoring 1. Connect the oral-nasal cannula to one end of the air-flow module, and insert the cable of air-flow module to the connector “ ”...
  • Page 25 User Manual for Sleep Screener Figure 3.5...
  • Page 26 User Manual for Sleep Screener Figure 3.6 Oral-nasal air flow monitoring screen Screen description: RR : Respiration rate icon; “22”: current  respiration rate. FL:Oral-nasal air flow waveform.  SN:Snore waveform.  Key Operation: Long press: press and hold the key for over 1 second.
  • Page 27: Setting Menu

    User Manual for Sleep Screener Short press the power on/off key again, the power indicator off and device screen display is on. Activate the device during standby status: 1). Short press power on/off key “ ”. 2). Insert the air-flow module into the Screener. 3.3 Setting Menu Double short time press the power on/off key “...
  • Page 28 User Manual for Sleep Screener Figure 3.7...
  • Page 29 User Manual for Sleep Screener  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; ...
  • Page 30 User Manual for Sleep Screener “ ” 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”...
  • Page 31: Body Movement Detection

    User Manual for Sleep Screener 3.4 Body Movement Detection Wearing the Screener and making measurement, if you rotate your wrist, then the screen enter into the time indicating screen, as shown in figure 3.8. Figure 3.8  “14:52:48”: the current time. ...
  • Page 32: Additional Information

    User Manual for Sleep Screener 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.  If “ ” appears on the screen, it indicates that battery power is not enough, please charge for the battery.
  • Page 33: Technical Specification

    User Manual for Sleep Screener then the readings are unlikely true, the more stable values are expected by waiting for a while. 4 Technical Specification A. Display Mode: 1.44 inch color LED display B. SpO measurement Transducer: dual-wavelength LED LED wavelength: Red light: 660nm, Infrared light: 905nm Maximal optical output power: less than 2mW maximum average...
  • Page 34 User Manual for Sleep Screener (whichever is greater) Resolution: 1bpm D. Perfusion Index Display Range: 0.2%~20% E. Preset alert limits Low alert limit: 85% PR high alert limit: 120bpm PR low alert limit: 50bpm F. Oral-nasal air flow measurement (with air-flow module) Measuring principle: Oral/nasal air flow pressure measuring method.
  • Page 35 User Manual for Sleep Screener Operating current: ≤90mA Continues working time (display is off and measuring SpO Only): about 13 hours H. Operating environment Operating temperature: 5~40℃ Operating humidity: 15%~93% (non-condensing) Atmospheric pressure: 70kPa~106kPa I. Performance under low perfusion condition The accuracy of SpO and PR measurement still meets the specification described above...
  • Page 36: Classification

    User Manual for Sleep Screener K. Over-limit alert by visible display: If the measured SpO , PR, RR exceeds the preset alert limit value, then visible alert should be available. L. Dimensions: D 56mm× W 44mm×H 16mm Net Weight: about 45g M.
  • Page 37: Packing List

    User Manual for Sleep Screener 6 Packing List probe………………….....One (L-type with wrapper or Finger Rubber) Air-flow module………......One Oral-nasal cannula....……One Wristband ………......…One AC power adapter……………....One Data cable… ……....…One ( Optional ) Note: the accessories are subject to change, please refer to the items in your package.
  • Page 38: Repair And Maintenance

    User Manual for Sleep Screener 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.
  • Page 39: Cleaning And Disinfection

    User Manual for Sleep Screener user can do the verification by means of 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 ...
  • Page 40: Storage And Transportation

    User Manual for Sleep Screener 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.
  • Page 41: Troubleshooting

    User Manual for Sleep Screener 8 Troubleshooting Trouble Possible Reason Solution 1. Place the finger 1. The finger is correctly inside and The SpO not placed far try again. and Pulse enough inside. Rate 2. Wrap the finger 2. The finger is display properly and make not wrapped...
  • Page 42: Appendix

    User Manual for Sleep Screener Appendix Common Knowledge Measurement 1 Meaning of SpO is the saturation percentage of oxygen in the blood, so called O concentration in the blood; it is defined by the percentage of oxyhemoglobin (HbO ) in the total hemoglobin of the arterial blood.
  • Page 43 User Manual for Sleep Screener 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 (HbO and deoxygenated hemoglobin (Hb) have different absorption character in the spectrum range from red to infrared light (600nm~1000nm wavelength),...
  • Page 44 User Manual for Sleep Screener serious respiratory disease, the patient under anesthesia during operation, premature and neonate. The status of SpO 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 SpO measuring accuracy (interference reason)
  • Page 45 User Manual for Sleep Screener intravascular line  Exposure to the chamber with High pressure oxygen  There is an arterial occlusion proximal to the sensor  Blood vessel contraction caused peripheral vessel hyperkinesias or body temperature decreasing...
  • Page 46 User Manual for Sleep Screener 4 Factors causing low SpO Measuring value (pathology reason)  Hypoxemia disease, functional lack of HbO  Pigmentation or abnormal oxyhemoglobin level  Abnormal oxyhemoglobin variation  Methemoglobin disease  Sulfhemoglobinemia or arterial occlusion exists near sensor ...
  • Page 47: B Knowledge For Oral-Nasal Air Flow And Snoring

    User Manual for Sleep Screener B Knowledge for Oral-nasal Air flow and Snoring detection The principle of measurement for oral-nasal air flow and snoring is by means of the air flow pressure sensor within the measuring module to detect the pressure variation of the air flow which comes from patient’s mouth/nose via the cannula.
  • Page 48: C Wristband Installation And Disassembly

    User Manual for Sleep Screener and stenocardia. Seriously, if breath suspending for over 120 seconds at night, sudden death may occur in the early morning. C Wristband Installation and Disassembly Introduction: Velcro Wristband Velcro  Buckle Fig. A One side The other side of Screener...
  • Page 49 User Manual for Sleep Screener Step 2: Put the Screener on the wrist, and stick the 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.
  • Page 50 User Manual for Sleep Screener Disassembly: process wristband disassembly is similar to the installation method, but with reverse procedure. Note: Please detach the wristband from the Screener before cleaning the wristband.
  • Page 51: D Key Of Symbol

    User Manual for Sleep Screener D Key of Symbol Symbol Description With Type BF applied part See User Manual Symbols Data interface Serial number enclosure No alarm Do not litter at will Life span %SpO The oxygen saturation Symbols Perfusion Index Pulse rate screen Respiration rate...
  • Page 52 User Manual for Sleep Screener Pulse beat Wireless Pulse strength bar-graph Low battery voltage Memory full Memory error Note: the above symbol may appear on your device.
  • Page 53 User Manual for Sleep Screener...
  • Page 54 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.creactive-sz.com EC-Representative: Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg Germany...

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