Acare AH-TX Series Instruction Manual

Acare AH-TX Series Instruction Manual

Handheld pulse oximeter
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AH-TX Series Handheld Pulse Oximeter Instruction Manual
Handheld Pulse Oximeter
Model: AH-TX Series
(AH-TA)
(AH-TB)
Instruction Manual
Issued Date: July. 01, 2019
Ver.1.0

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  • Page 1 AH-TX Series Handheld Pulse Oximeter Instruction Manual Handheld Pulse Oximeter Model: AH-TX Series (AH-TA) (AH-TB) Instruction Manual Issued Date: July. 01, 2019 Ver.1.0...
  • Page 2 Contents of this manual are subject to change without prior notice. Revision number: 1.0 Release time: 2018-07 Copyright © 2016 Acare Technology Co., Ltd. All rights reserve.
  • Page 3 This manual contains exclusive information protected by copyright laws and we, Acare, reserve its copyright. No parts of this manual shall be photocopied, Xeroxed or translated into other languages without written approval from the manufacturer.
  • Page 4 AH-TX Series Handheld Pulse Oximeter Instruction Manual Manufacturer's Responsibility The manufacturer will be responsible for the safety, reliability and performance of the instrument under the following circumstances only:  All installation, expansion, readjustment, renovation or repairs of the instrument are conducted by personnel certified by the manufacturer.
  • Page 5 AH-TX Series Handheld Pulse Oximeter Instruction Manual  【】is used to signify text as it appears on the product screen. → is used to indicate operational procedures.  Warning: Indicates a potential hazard or unsafe practice that, if not avoided, will result in serious injury.
  • Page 6 AH-TX Series Handheld Pulse Oximeter Instruction Manual Compliance regulations This product complies with the relevant medical equipment regulations as follows:  IEC 60601-1 (Edition 3.1)  IEC 60601-1-2 (4 Ed.)  IEC 60601-1-8  ISO 80601-2-61  EN 301489-1 ...
  • Page 7: Table Of Contents

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Contents Chapter 1 General Introduction … … … … … … … … . . . … … … … 1 1.1 Intended Use … … … … … … … … … … … … … … … … 1 1.2 Main Unit...
  • Page 8 AH-TX Series Handheld Pulse Oximeter Instruction Manual 3.4.7 Time Setup … … … … … … … … … … … … … … … 1 3 3.4.8 Language Setup ……………………………………...13 3.5 Selecting the Work Mode … … … … … … … … … … … … … 1 3 3.5.1 Continuous Monitoring Mode …...
  • Page 9 AH-TX Series Handheld Pulse Oximeter Instruction Manual 5.5.3 Adjusting the Alarm Limit …………………………..28 5.6 HR Alarm Setup ……………………………………………..28 5.6.1 Switching HR Alarm On/Off … … … … … … … … 2 8 5.6.2 Setting the Alarm Level … … … … … … … … … … 2 8 5.6.3 Adjusting the Alarm Limit...
  • Page 10 AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 9 Maintenance and Cleaning … … … … … … … … … … . 3 9 9.1 Introduction …………………………………………………….39 9.2 Maintenance … … … … … … … … … … … … … … … … … … 4 0 9.3 Cleaning the Oximeter...
  • Page 11 AH-TX Series Handheld Pulse Oximeter Instruction Manual Appendix B EMC …………………………………………………..50 Appendix C Factory Defaults ……………………………………….52 C.1 Alarm Setup … … … … … … … … … … … … … … … … … . . . 5 2 C.2 Alarm Type Setup …...
  • Page 12: Chapter 1 General Introduction

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 1 General Introduction 1.1 Intended Use The AH-TX handheld pulse oximeter is intended for continuously monitoring or spot checking peripheral oxygen saturation (SpO2) and pulse rate (PR) for adult, pediatric or neonatal patients.
  • Page 13: Side View

    AH-TX Series Handheld Pulse Oximeter Instruction Manual function. Users can operate all functions through the touch interface. Speaker Battery case 1.2.2 Side View Fig 1-3 Side view of the oximeter 1.3 Display Views SpO2 probe connector Charger connector / Data download connector...
  • Page 14 AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 1-4 Big numeric display mode PA: It is show the pulse amplitude, similar the PI. (%): Display the SpO unit. parameter area: Current SpO value and its high and low alarm are displayed in this area.
  • Page 15: Spo2 Waveform Display Mode

    AH-TX Series Handheld Pulse Oximeter Instruction Manual electrical charge in the batteries. HR parameter area: Current heart rate (HR) value and its high and low alarm are displayed in this area. HR(bpm): Display the heart rate unit. System time: Current time is shown in the area.
  • Page 16: Chapter 2 Safety

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 2 Safety 2.1 Safety Information Warning:  Explosion hazard: Do not use the oximeter in an environment with flammable gases.  Do not use the product in the presence of high power appliances such as high voltage cables, X-ray machines, ultrasound equipment or defibrillator.
  • Page 17: Explanation Of Interface Symbols

    AH-TX Series Handheld Pulse Oximeter Instruction Manual monitor are for reference only and cannot be directly used for diagnostic interpretation.  The use of accessories, probes, and cables other than those specified may result in increased emission, low anti-disturbance and/or may lead to the oximeter producing invalid readings. It is advisable to check the oximeter at least once a month.
  • Page 18 AH-TX Series Handheld Pulse Oximeter Instruction Manual Symbol Symbol Note Increase/Up button Decrease/Down button Back to previous page Next page Previous page Battery indicator Battery in charge Bluetooth connection indicator (AH-TB only) Cancel selection Conform selection Information button, show the manufacturer information...
  • Page 19: Chapter 3 Basic Operations

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 3 Basic Operations 3.1 Unpacking and Checking Open the package. Take out the oximeter and its accessories. The following parts are provided in the package: Parts Standard Quantity √ probes √ User’s manual √...
  • Page 20: Starting The Oximeter

    AH-TX Series Handheld Pulse Oximeter Instruction Manual  To avoid the risk of explosions, do not use the oximeter in the presence of flammable anesthetics, vapors or liquids. 3.3 Starting the oximeter Press the power button to turn on the pulse oximeter, the startup screen appears and show the software version at the bottom right.
  • Page 21 AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 3-1 Menu window Fig 3-2(a) System setup window...
  • Page 22: Alarm Volume Setup

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 3-2(b) System setup window 3.4.1 Alarm Volume Setup Press the Alarm Vol to select the item, then adjust its value using the “ ” or “ “ icon. You can select from 1 to 5. The volume will be minimum when select is 1.
  • Page 23: Scan Speed Setup

    AH-TX Series Handheld Pulse Oximeter Instruction Manual 3.4.5 Scan Speed Setup Press the Scan Speed to select the item, then adjust its value using the “ ” or “ “ icon. You can select from 12mm/s or 25mm/s. 3.4.6 Date Setup Press the Year / Month / Day to select the item, then adjust its value using the “...
  • Page 24: Continuous Monitoring Mode

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 3-3 Type select window 3.5.1 Continuous Monitoring Mode The continuous monitoring mode is intended for long-term monitoring of a patient. This mode is normally selected when the patient is in hospital or under transport.
  • Page 25: Selecting Patient Type

    AH-TX Series Handheld Pulse Oximeter Instruction Manual 3.6 Selecting Patient Type To select the different patient type can set the different alarm limit value. Fig 3-3 Patient Type select window Select【Menu】→【Alarm Setup】→【 Next page】→ 【Type】. Using the “ ” or “...
  • Page 26: Shutting Off The Oximeter

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 3-3 Load Default window If you have made changes to the system’s configuration and want to restore the original factory settings, follow this procedure: Select【Menu】→【Load Default】. A window will appear, asking you to confirm that you want to return to 】to restore the factory...
  • Page 27 AH-TX Series Handheld Pulse Oximeter Instruction Manual Caution: If the oximeter is not in use and there has been no button operation for more than 1 minutes, the oximeter will shut down automatically.
  • Page 28: Chapter 4 Alarm

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 4 Alarm The oximeter generates all audible and visual alarms through a speaker and visual alarm on the screen. "Alarm" refers to a prompt that is given by the oximeter through visual, audible and other means, to alert medical personnel when a vital sign appears abnormal or the oximeter experiences a technical problem.
  • Page 29: Alarm Indicators

    AH-TX Series Handheld Pulse Oximeter Instruction Manual emergency treatment is required.  Medium level alarms(!!) Indicate that the patient’s vital signs appear abnormal and immediate treatment is required.  Low level alarms(!) Indicate that the patient’s vital signs appear abnormal and immediate treatment may be required.
  • Page 30: Alarm Message

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Low(!) “DO-DO” Caution:  When multiple alarms of different levels occur at the same time, the oximeter will select the highest warning level and give the highest visual and audible alarm indications. ...
  • Page 31: Pausing The Alarm Tones

    AH-TX Series Handheld Pulse Oximeter Instruction Manual When an alarm occurs, the alarm message will be displayed in the alarm area.  The system uses the following symbols to match the alarm level of physiological alarm messages:  High level alarms: !!! ...
  • Page 32 AH-TX Series Handheld Pulse Oximeter Instruction Manual system for patient monitoring. Adjusting the alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance.  General personnel should not arbitrarily modify the alarm conditions, and only those who have professional knowledge or relevant training can adjust the alarm setting.
  • Page 33 AH-TX Series Handheld Pulse Oximeter Instruction Manual 4.6 Alarm Delay The alarm condition delay and alarm signal generation delay is under 0.5 sencond.
  • Page 34: Chapter 5 Measuring Spo2

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 5 Measuring SpO2 5.1 Introduction The measurement of oxygen saturation of arterial blood (also known as peripheral oxygen saturation, usually shortened to SpO2) relies on the principles of light spectra and volume tracing. An LED in the oximeter emits light rays through the body, wherever the probe is used, e.g.
  • Page 35 AH-TX Series Handheld Pulse Oximeter Instruction Manual  Do not use the oximeter and the SpO probe during magnetic resonance imaging (MRI). The induced current could cause burns to the patient.  Prolonged continuous monitoring may increase the risk of unexpected changes in skin characteristics of the patient, such as irritation, reddening, blistering or burns.
  • Page 36: Monitoring Procedure

    AH-TX Series Handheld Pulse Oximeter Instruction Manual 5.3 Monitoring Procedure Selecting the SpO2 Probe Depending on the patient category, weight and application site, you can select a different SpO2 probe as required. Connecting the SpO2 Probe Plug the SpO2 probe cable into the SpO2 connector on the oximeter.
  • Page 37: Spo2 Alarm Setup

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 5-1 Parameter and PPG Waveform SpO2 parameter area: Current SpO2 value and its upper and lower alarm are displayed in this area. The data average is done with an average of ten data and the data update by every second.
  • Page 38: Adjusting The Alarm Limit

    AH-TX Series Handheld Pulse Oximeter Instruction Manual 5.5.2 Adjusting the Alarm Limit Select【Menu】→【Alarm Setup】. Adjust【High】:If an SpO2 measurement is higher than the high alarm limit, the “SpO2 High” alarm will be triggered. Adjust【Low】:If an SpO2 measurement is lower than the low alarm limit, the “SpO2 Low”...
  • Page 39: Chapter 6 Reviewing

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 6 Reviewing 6.1 Introduction Select【Menu】→【Trend】→【Report】to enter the trend reviewing window. You can review previously stored SpO2 and HR data in this window. Fig 6-1 SpO2/HR reviewing window 6.2 Reviewing Screen The above screen shows the SpO2/HR reviewing window. You can review SpO2/PR values measured at different time intervals in this window.
  • Page 40: Export Data

    AH-TX Series Handheld Pulse Oximeter Instruction Manual window. The user can click on any column then the delete icon and cancel icon will appear at the bottom. If you want to delete the data, press the “ ” icon, if not, press the “...
  • Page 41: Delete All Data

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 6-3 Data export window The screen will display "Data exporting..." in the data transfer process, and "Completed" will be displayed after the transfer is completed. Fig 6-3 Data export completed window 6.3.3 Delete all data...
  • Page 42 AH-TX Series Handheld Pulse Oximeter Instruction Manual If you want to delete all the data, please follow the steps as below: Select【Menu】→【Trend】→【Delete all】to enter the “Delete all” window. If you want to delete all records, press the “ ” to delete all records data.
  • Page 43: Chapter 7 Data Transmission

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 7 Data transmission 7.1 Wired transmission 7.1.1 USB cable Users can download data through the general USB cable. Select【Menu】→【Trend】→【Export】to enter the data export mode.  Connection the PC or NB through a general USB cable.
  • Page 44: Chapter 8 Battery

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 8 Battery 8.1 Introduction The oximeter is designed to operate on a Li-ION rechargeable battery. Under normal circumstances, no special battery maintenance is necessary. The battery status as follows: Indicates that the power of the battery is full;...
  • Page 45: Charging Lithium Ion Battery

    AH-TX Series Handheld Pulse Oximeter Instruction Manual should be removed. Dispose of used batteries in accordance with local ordinances and regulations.  If removed the battery from oximeter, keep the batteries out of the reach of children. 8.2 Charging Lithium Ion Battery Only Lithium-Ion rechargeable battery can be recharged by the charger with this pulse oximeter.
  • Page 46: Checking The Lithium-Ion Battery

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 8-2 Connect the AC-DC adapter Warning:  Disconnect the oximeter from the patient and stop all monitoring before charging the battery.  Please use the adapter provided by the original manufacturer to charge.
  • Page 47: Disposing Of The Batteries

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Caution:  The service life of battery depends on the length and frequency of use. Lithium-Ion batteries can generally be charged and discharged 300 times.  The operating time of a battery depends on the configuration and operation of the pulse oximeter.
  • Page 48: Chapter 9 Maintenance And Cleaning

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 9 Maintenance and Cleaning 9.1 Introduction Keep your equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these rules: When cleaning the oximeter, always dilute cleaning products according the manufacturer’s instructions, and use the lowest possible...
  • Page 49: Maintenance

    AH-TX Series Handheld Pulse Oximeter Instruction Manual 9.2 Maintenance Note: In order to ensure the performance and safety of the equipment, it is recommended to do regular inspection and maintenance, at least must be checked after 1 year of use. Check the equipment through a professional technical engineer.
  • Page 50: Cleaning The Oximeter

    AH-TX Series Handheld Pulse Oximeter Instruction Manual 9.3 Cleaning the Oximeter Common detergent and non-corrosive disinfectant used in hospitals can be used to clean the oximeter; be aware that many kinds of detergents must be diluted prior to utilization. Use cleaning fluids according to the instruction of the detergent manufacturer.
  • Page 51: Disposal

    AH-TX Series Handheld Pulse Oximeter Instruction Manual never put the probe directly in liquid. Warning: Do not reuse or disinfect disposable SpO2 probe. 9.5 Disposal Dispose of the oximeter in accordance with local environment and waste disposal laws and regulations. For the disposal of SpO2 probe, follow local...
  • Page 52: Chapter 10 Accessories Of Probe

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 10 Accessories of Probe Nellcor compete SpO probe (Applied parts) Type Model Patient Category ASDNR-A1 Adult finger (patient size>30kg) Disposable ASDNR-P2 Pediatric foot/hand (patient size 10-50kg) Adult finger or neonatal foot/hand ASDNR-N3 Single patient (patient size >40 kg or <3 kg)
  • Page 53 AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 11 Symbol Definitions Refer to user manual before Manufacturer information application Keep away from sunlight Date of Manufacture Dispose the waste according Use by date to the national law. Do not use if package Type BF Applied Part.
  • Page 54: Appendix A Product Specifications

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Appendix A Product Specifications A.1 Safety Specifications SFDA classification CE classification Type of protection against II, with internal power device. electric shock Degree of protection against electric shock Degree of protection against Ordinary equipment, without protection hazards of explosion against hazards of explosion.
  • Page 55: Charging Specifications

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Storage/Transportation: -20℃ to +70℃; Operating: 860hPa to 1060hPa; Atmospheric Storage: 500hPa to 1060hPa; pressure Operating: 10% to 95% (non-condensing) Humidity Storage/Transportation: 10% to 95% (non- condensing) A.4 Charging Specifications A.4.1 AC-DC Adapter (MPU15-102) Sinpro Electronics Co.
  • Page 56: Hardware Specifications

    AH-TX Series Handheld Pulse Oximeter Instruction Manual With SpO monitored continuously, Audio indicators off and backlight brightness set to minimum and using new, full power batteries at ambient temperature 25℃. Charge time 3 hours to 90% 4 hours to 100% A.5 Hardware Specifications...
  • Page 57: Sensors

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Quantity Functions Power button. A.5.4 Sensors Pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 905 Wavelength This information may be useful to clinicians, such as those performing photodynamic therapy.
  • Page 58: Digital Spo2

    AH-TX Series Handheld Pulse Oximeter Instruction Manual A.6 Specifications A.6.1 Digital SpO2 Technic Digital SpO technic Range 0~100% Resolution Oxygen Saturation Declared 70 – 100% SpO2 ±2 digits, Below Accuracy Range 70% unspecified Low Perfusion Oxygen Saturation 70 – 100% SpO2 ±3 digits, Below...
  • Page 59 AH-TX Series Handheld Pulse Oximeter Instruction Manual low limit 85% to (high limit -1) Alarm limits Range (bpm) Step (bpm) PR high limit (low limit +1) to 250 PR low limit 25 to (high limit -1)
  • Page 60: Appendix B Emc

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Appendix B EMC Guidance and manufacturer’s declaration – electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should make certain that they are in such an environment when operating it.
  • Page 61 AH-TX Series Handheld Pulse Oximeter Instruction Manual Guidance and Declaration – Electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below. The customer or the user of the device should make certain that they are in such an environment when operating it.
  • Page 62 AH-TX Series Handheld Pulse Oximeter Instruction Manual IEC 61000-4-11 Power frequency Power frequency magnetic (50/60 Hz) 3 A/m 3 A/m The power frequency of magnetic field magnetic fields should be at IEC 61000-4-8 levels characteristic of a typical location in a typical commercial or hospital environment.
  • Page 63 AH-TX Series Handheld Pulse Oximeter Instruction Manual Portable and mobile RF communications equipment should not be used closer to any part of the device, including cables, than the recommended separation distance. This is calculated from the equation applicable to the frequency of the transmitter.
  • Page 64 AH-TX Series Handheld Pulse Oximeter Instruction Manual 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 65: Appendix C Factory Defaults

    AH-TX Series Handheld Pulse Oximeter Instruction Manual output power of 150 kHz to 80 80 MHz to 800 800 MHz to 2.5 transmitter(W)                 ...
  • Page 66: Alarm Setup

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Alarm Setup Factory Default Alarm Level High PR Alarm Level Medium C.1.2 Alarm Type Setup Setup Adult Pediatric Neonate SpO2 High Limit SpO2 Low Limit PR Setup Adult Pediatric Neonate PR High Limit PR Low Limit C.3 System Setup...
  • Page 67 AH-TX Series Handheld Pulse Oximeter Instruction Manual continues mode.
  • Page 68: Appendix D Alarm Message

    AH-TX Series Handheld Pulse Oximeter Instruction Manual Appendix D Alarm Message This section lists some important alarm message. In the tables below, “*” means the alarm level is user-adjustable. D.1 Physiological alarm Messages Cause Level too High* A measurement has risen above the high...
  • Page 69 AH-TX Series Handheld Pulse Oximeter Instruction Manual D.3 Symbols on marking Symbol Title (informative) Description for ALARM SYSTEMS (normative) No Sensor The SpO probe detached the oximeter. Medium No Finger The SpO probe detached the patient. Medium LowBatt The battery power is low.
  • Page 70 AH-TX Series Handheld Pulse Oximeter Instruction Manual 國家通訊傳播委員會(NCC)警告 根據「低功率電波輻射性電機管理辦法」第十條: 製造、輸入或販賣低功率射頻電機者,應於低功率射頻電機使用說明書 內加印第十二條及第十四條之規定內容。 根據「低功率電波輻射性電機管理辦法」第十二條: 經型式認證合格之低功率射頻電機,非經許可,公司、商號或使用者均 不得擅自變更頻率、加大功率或變更原設計之特性及功能。 根據「低功率電波輻射性電機管理辦法」第十四條: 低功率射頻電機之使用不得影響飛航安全及干擾合法通信;經發現有干 擾現象時,應立即停用,並改善至無干擾時方得繼續使用。 前項合法通信,指依電信法規定作業之無線電通信。 低功率射頻電機須忍受合法通信或工業、科學及醫療用電波輻射性電機 設備之干擾。...
  • Page 71 AH-TX Series Handheld Pulse Oximeter Instruction Manual FCC Warning This device complies with part 15 of the fcc rules. Operationis subject to the following two conditions: (1) this device maynot cause harmful interference, and (2) this device mustaccept any interference received, including interference thatmay cause undesired operation.
  • Page 72 Acare Technology Co., Ltd. Address: 6F.-6, No.5, Wuquan 1st Rd., Xinzhuang Dist., New Taipei City 242, Taiwan...
  • Page 73 AH-TX Series Handheld Pulse Oximeter Instruction Manual TEL : +886-2-2298-8170 FAX : +886-2-2298-8560 Email: info@acaretech.com Website: http://www.acaretech.com...

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