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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 AH-TX Series Handheld Pulse Oximeter Instruction Manual Product Information Product Model: AH-TX Series Product Name: Handheld pulse oximeter Manufacturer: Acare Technology Co., Ltd. After Service Contact Information:
Address: 6F.-3, No.24, Wuquan 2st Rd., Xinzhuang Dist., New Taipei City 242, Taiwan TEL: +886-2-2298-8170 FAX: +886-2-2298-8560 Email: service@acaretech.com Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. 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. i AH-TX Series Handheld Pulse Oximeter Instruction Manual CE Mark EC Representative Name:
COMPAIA EUROPEA DE PROSUCTOS MEDICOS, S.L. Villapark Business Park, Av Quitapesares 8, Building 8, Villaviciosa de Odon
(MEDIPRO)
(Madrid) 28670, Spain Statement The manufacturer, Acare, holds the copyright to this manual, and is entitled to treat it as a proprietary file. This manual is only to be used for supporting the operation, maintenance and service of the AH-TX product, and it cannot be resold or republished by any other party. 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. The contents of this manual are subject to amendment without notification. ii 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. The storage conditions, operating conditions and electrical status of the instrument conform to the product specification. The instrument is used in accordance with the user manual. About this manual 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 of the product, and ensures patient and operator safety. This manual is based on the maximum potential configuration of the product, and therefore some contents may not apply to your device. If you have any questions, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be referred to when needed. All illustrations in this manual serve only as examples. They may not necessarily reflect the setup or data displayed on your product. Key:
Bold Italic text is used in this manual to quote the referenced chapter or sections. iii 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. Caution: Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property Note: Provides application tips or other useful information to ensure that you get the most from your product. Note: The oximeter is calibrated in the factory before sale, there is no need to calibrate it during its life cycle. damage. iv AH-TX Series Handheld Pulse Oximeter Instruction Manual This product complies with the relevant medical equipment regulations Compliance regulations as follows:
IEC 60601-1 (Edition 3.1) IEC 60601-1-2 (4th Ed.) IEC 60601-1-8 ISO 80601-2-61 EN 301489-1 EN 301489-17 FCC Part15B FCC Part15C NCC (Taiwan Only) v AH-TX Series Handheld Pulse Oximeter Instruction Manual Contents Chapter 1 General Introduction . 1 1.1 Intended Use 1 1.2 Main Unit . 1 1.2.1 Front & Rear View 1 1.2.2 Side View
. 2 1.3 Display Views 2 1.3.1 Large Numeric Display Mode
. 3 1.3.2 SpO2 Waveform Display Mode
. 4 Chapter 2 Safety 6 2.1 Safety Information . 6 2.2 Explanation of interface Symbols 7 Chapter 3 Basic Operations . 9 3.1 Unpacking and Checking . 9 3.2 Getting Started .9 3.3 Starting the oximeter .10 3.4 General Setup . 1 0 3.4.1 Alarm Volume Setup ........12 3.4.2 Beep Volume Setup ........12 3.4.3 Key Volume Setup ..........................12 3.4.4 Adjust the Screen Brightness . . 1 2 3.4.5 Scan Speed Setup . 1 3 3.4.6 Date Setup ...............................14 vi 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 1 4 3.5.2 Spot-checking Mode 15 3.6 Selecting Patient Type ....15 3.7 Load Default Configuration . 16 3.8 Shutting off the Oximeter 1 6 Chapter 4 Alarm
.18 4.1 Alarm Categories ..18 4.2 Alarm Levels . 1 8 4.3 Alarm Indicators .. 19 4.3.1 Alarm tone . 2 0 4.3.2 Alarm Message 20 4.4 Pausing the Alarm Tones 2 1 4.5 Shutting off the Alarm Volume 2 1 Chapter 5 Measuring SpO2 2 4 5.1 Introduction .24 5.2 Safety Information . 2 4 5.3 Monitoring Procedure 26 5.4 Parameter Display 2 7 5.5 SpO2 Alarm Setup . 2 7 5.5.1 Switching SpO2 Alarm On/Off . 2 7 5.5.2 Setting the Alarm Levels .28 vii 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 ..28 Chapter 6 Reviewing . 2 9 6.1 Introduction .29 6.2 Reviewing Screen . 2 9 6.3 Delete Record
.29 6.3.1 Delete single data 3 0 6.3.2 Export data 3 0 6.3.3 Delete all data 32 Chapter 7 Data transmission .33 7.1 Wired transmission . 3 3 7.1.1 USB cable . 3 3 7.2 Wireless transmission (AH-TB only) .33 7.2.1 Bluetooth Low Energy . 3 3 Chapter 8 Battery .35 8.1 Introduction .35 8.2 Charging Lithium Ion Battery 36 8.3 Checking the Lithium-Ion Battery .37 8.4 Disposing of the Batteries 3 8 viii 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 41 9.4 Cleaning SpO2 Probe 41 9.5 Disposal .42 Chapter 10 Accessories of Probe . 4 3 Appendix A Product Specifications 44 A.1 Safety Specifications ..44 A.2 Physical Specifications 44 A.3 Environmental Specifications . 4 4 A.4 Charging Specifications 4 5 A.4.1 AC-DC Adapter ..45 A.4.2 Battery Specification .45 A.5 Hardware Specifications 4 6 A.5.1 Display ..46 A.5.2 Audio Indicating 4 6 A.5.3 Button ..46 A.5.4 Sensors ..47 A.6 Specifications .47 A.6.1 Digital SpO2 48 A.6.2 Alarm limit specifications ..48 ix 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 . 5 2 C.3 System Setup . 5 2 C.4 Work Type Setup ...53 Appendix D Alarm Message . 5 4 D.1 Physiological alarm 54 D.2 Technical alarm 54 x 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. This device can be used in professional institutions or units with health care capability. This includes outpatient departments, emergency rooms and departments of internal medicine in hospitals, ordinary departments in clinics, nursing hospitals and community medical institutions. 1.2 Main Unit 1.2.1 Front & Rear View Fig 1-1 Front & rear view of the oximeter 1. Display screen The Display screen is a 4.3 inch TFT LCD with touch 1 AH-TX Series Handheld Pulse Oximeter Instruction Manual function. Users can operate all functions through the touch interface. 2. 3. 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 Power button 1. 2. 3. visibility. This device features an automatic display rotation, which allows vertical and horizontal positioning of the screen, to maximize space utilization and 1.3.1 Large Numeric Display Mode 2 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. SpO2 (%): Display the SpO2 unit. SpO2 parameter area: Current SpO2 value and its high and low alarm are displayed in this area. visible. displayed in this area. 4. Plath bar: Pulse intensity is indicated by the number of stacked blocks 5. Alarm status area: Alarm status symbols and alarm pause time are 6. Menu: Directly after startup, Menu shown here is the function controlled by the left hand button. When appropriate, press the left button to enter Menu. Information: Its show the manufacturer information. PPG wave: Its show the PPG waveform while press the symbol. Heart icon: It will flash with the heartbeat. 10. Battery symbol: This symbol indicates the remaining quantity of 1. 2. 3. 7. 8. 9. 3 AH-TX Series Handheld Pulse Oximeter Instruction Manual electrical charge in the batteries. 11. HR parameter area: Current heart rate (HR) value and its high and low alarm are displayed in this area. 12. HR(bpm): Display the heart rate unit. 13. System time: Current time is shown in the area. 1.3.2 SpO2 Waveform Display Mode Fig 1-5 SpO2 waveform display mode 1. SpO2 parameter area: Current SpO2 value and its upper and lower alarm are displayed in this area. 2. PPG waveform area: The waveform shown in this area illustrates the current PPG curve of the patient being monitored. 3. PR parameter area: Current PR value and its upper and lower alarm are displayed in this area. 4 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. Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture. The device is not designed for use in a sterile field. The oximeter should be handled with care so as to avoid it getting knocked or falling. Do not use this device during defibrillation. When the device is in use, ensure that the batteries have sufficient charge remaining; otherwise start-up abnormalities may occur or the measurement data may be inaccurate. Patients must not wear nail varnish while using the pulse oximeter as this will lead to unreliable SpO2 measurements. Measurements and pulse signals can be affected by certain environmental conditions, errors in applying the probe, and certain patient conditions. See the appropriate sections of this manual for specific safety information. The physiological data and alarm messages displayed on the 5 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. Do not use to measure the patient while charging the battery. The battery should only be replaced by a service technician with a screwdriver and keep the hands dry. Inserting a specific type of battery that is not supplied by the manufacturer or replacement of lithium batteries by inadequately trained personnel could result damage to device. Do not open the monitor housings; electric shock hazard may exist. All servicing and future upgrades must be carried out by the personnel trained and authorized by manufacturer only. Caution: In order to obtain accurate results, the oximeter should be used in a quiet and comfortable environment. 2.2 Explanation of Interface Symbols Symbol Symbol Note Alarm volume pause Menu button Wave enable/disenable Home button, back to the main page 6 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 Cancel selection Conform selection Bluetooth connection indicator (AH-TB only) Information button, show the manufacturer information 7 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 SpO2 probes Users manual AC-DC Class II adapter (MPU15-102) Standard Quantity 1 1 1 3.2 Getting Started 1. Before using the oximeter to take measurements for the first time, carry out the following checks on the oximeter and all connected modules:
Check for any mechanical damage;
Check for correct connection between of all the external cables and 2. Make sure that the battery has sufficient power. For the first time use, you must charge the battery, first, following the instructions given in accessories. the Battery chapter. Warning:
If the oximeter is mechanically damaged, or if it is not working properly, do not use it on a patient for any monitoring procedure. Contact your service personnel. 8 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. Enter the main screen, the alarm indication should light up and system should give a beep. After starting the oximeter you can change the settings for more convenient use, as shown in section 3.4. Enter the main screen, the alarm indication should light up and system should give a beep. After starting the oximeter you can change the settings for more convenient use, as shown in section 3.4. 3.4 General Setup Press the menu button to enterMenu, then selectSystem Setupto enter the system setup menu shown as follows. You can set parameters for the following functions:
9 AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 3-1 Menu window Fig 3-2(a) System setup window 10 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. 3.4.2 Beep Volume Setup Press the Beep Vol to select the item, then adjust its value using the icon. You can select from 0 to 4. The volume will off when select 3.4.3 Key Volume Setup Press the Key Vol to select the item, then adjust the value using the icon. You can select from 0 to 4. The volume will off when select 3.4.4 Adjust the Screen Brightness Press the Brightness to select the item, then adjust the value using the or icon. You can select from 1 to 5. Selecting the minimum brightness can save power. or is 0. or is 0. Caution: If the oximeter is used outdoors, or if the ambient light is strong, set the screen brightness to a higher level. If the user to turn off the physiological alarms totally, which may cause the emergency event of the patient not be discovered in time. When the alarm is completely turned off, this device should be used accompanied by the professionals. 11 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 Press the Hour / Minute to select the item, then adjust its value using the the or icon. 3.4.7 Time Setup or icon. 3.4.8 Language Setup Press the Language to select the item, then adjust the language type using or icon. the 3.5 Selecting the Work Type The oximeter is designed to operate in two types: continuous monitoring and spot-checking. You can choose the oximeters work type through the following steps:
1. SelectSystem SetupType, then adjust the type using the or icon. Spot: Work in spot check type, only record the measurement data after removing the probe from your finger. 10sec, 30sec, 1min, 5min, 10min, 30min: Work in continuous type, every 10sec or 30sec or 1min or 5min or 10min or 30min record the measurement data. 12 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. When the oximeters memory reaches full capacity, it will stay in the last column. Caution: Users should periodically clear the data manually. 3.5.2 Spot-checking Mode Spot-checking mode is intended for short-term, on-site measurement. This mode is normally selected to check up on the condition of a patient by doctors making rounds of a ward. 13 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 SelectMenuAlarm Setup Next page 1. Type. 2. Using the PedPediatric orNeoNeonate. The default isNone. icon set theTypetoAduAdult, or 3.7 Load Default Configuration 14 AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 3-3 Load Default window If you have made changes to the systems configuration and want to restore the original factory settings, follow this procedure:
1. SelectMenuLoad Default. 2. A window will appear, asking you to confirm that you want to return to the original configuration. Select to restore the factory configuration. If not, press the or to back to the previous page , also can press the 3.8 Shutting off the Oximeter to back the main page. To shut off the oximeter, follow the steps below:
1. Confirm that patient monitoring is complete. 2. Disconnect the SpO2 probe form the oximeter. 3. Press the power button to turn off the oximeter. 15 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. 16 AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 4 Alarm visual alarm on the screen. The oximeter generates all audible and visual alarms through a speaker and
"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. 4.1 Alarm Categories The oximeters alarms fall into two categories:
1. Physiological alarms A physiological alarm is triggered when the monitored parameter exceeds the set alarm limit or the patient condition is abnormal. 2. Technical alarms A technical alarm is triggered a device malfunction or incorrect operation of the oximeter or system problems. Caution: The technical alarms cannot be changed by the user. 4.2 Alarm Level 1. The oximeters physiological alarms fall into three categories of increasing severity: low level alarms, medium level alarms, and high level alarms. High level alarms(!!!) Indicate that the patient is in a life-threatening situation and 17 AH-TX Series Handheld Pulse Oximeter Instruction Manual emergency treatment is required. Medium level alarms(!!) immediate treatment is required. Low level alarms(!) Indicate that the patients vital signs appear abnormal and Indicate that the patients vital signs appear abnormal and immediate treatment may be required. 2. The oximeters technical alarms can be classified into two categories of severity: medium level alarms and low level alarms. 4.3 Alarm Indicators signals:
When an alarm occurs, the oximeter will indicate it through the following Alarm tone: The speaker on the rear panel of the oximeter will sound the alarm in different tones, according to the severity of the alarm. Alarm message: Alarm messages are displayed on the front screen. Caution: Alarm tone and alarm messages will according to the level of The different level alarms are indicated by the system in the following High(!!!) DO-DO-DO------DO-DO, DO-DO-DO------DO-DO severity of the alarm. 4.3.1 Alarm tone audio tones:
Alarm level Audible prompt Medium(!!) DO-DO-DO 18 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. When multiple alarms occur at the same time, the alarm messages will be displayed in the respective alarm area. Test the alarm system when turning on the device:
1. Do not insert your finger into the probe while turning on the device in order to enter and test the alarm sound. 2. By adjusting the SpO2 and HR settings to an abnormal value to enter and test the alarm system, you can check for visual and audible alarms. When an alarm occurs, the alarm levels are indicated in the following 4.3.2 Alarm Background color different visual ways:
Alarm level Visual prompt Low(!) flashing. 4.3.3 Alarm Message 19 High(!!!) Red background color flashes in red with 2.5 Hz. Medium(!!) Yellow background color flashes in yellow with 0.5 Hz. Yellow background color lights on in yellow without 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: !!!
Medium level alarms: !!
The system uses the following background colors to indicate different Low level alarms: !
messages and match the alarm level:
High level alarms(!!!): Red Medium level alarms(!!): Yellow Low level alarms(!): Yellow 4.4 Pausing the Alarm Tones Press the alarm pause icon to keep the alarm paused for 120 seconds and the pause time will be displayed in red numeric. When the audible alarm is paused, the alarm background color remains lit, and the alarm message remains displayed. Pressing the icon again will restart the audible alarm. The audible alarm automatically starts again once the alarm pause period expires. Warning:
When the alarm sound is switched off, the monitor will give no audible alarm tones even if a new alarm occurs. Therefore, the user should be very carefully about whether to switch off the alarm sound or not.Users should not rely exclusively on the audible alarm 20 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. 1. 2. 3. 4. 4.5 When an Alarm Occurs Warning:
condition first. alarm system useless. When an alarm occurs, you should always check the patients Do not setting alarm limits to extreme values that can render the Check the alarm message appeared on screen. It is needed to identify the alarm and action appropriately, according to the cause of the alarm. Check the patients condition. Identify alarming parameter and alarm category. Identify the cause of the alarm. Silence the alarm, if necessary. 5. When cause of alarm has been over, check that the alarm system is working properly. Alarm messages for individual parameters can be found in Appendix D Alarm message. 21 AH-TX Series Handheld Pulse Oximeter Instruction Manual The alarm condition delay and alarm signal generation delay is under 0.5 4.6 Alarm Delay sencond. 22 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. through the finger, at two different specific wavelengths. Each of these is selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin in the blood. An optical receptor measures the changes in the light intensity after the light passes through the capillary network and estimates the ratio of oxygenated hemoglobin and the total hemoglobin. 5.2 Safety Information Warning:
cautions. Only use the SpO 2 probes specified in this manual. Follow the SpO2 probe instructions for use and adhere to all warnings and When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter for a full diagnosis of the patients condition. 23 AH-TX Series Handheld Pulse Oximeter Instruction Manual Do not use the oximeter and the SpO 2 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. Inspect the probe site every two hours and move the probe if the skin quality changes. For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the probe site more frequently. Check the SpO 2 probe and its package for any sign of damage before use. Do not use the probe if any damage is detected. When discarding a disposable or broken SpO 2 probe, please observe all local, state, and federal regulations relating to the disposal of this products or similar products. If using a disposable probe, do not reuse it on different patients. Caution: In cases where it is necessary to add a clip to fix the fingertip probe, clip the cable and not the probe itself. Please note that the probe cable should not be pulled with force. Note:
The pleth wave is not equal to the intensity of PR signal. The oximeter does not provide an automatic self-check alarm signal; the operator should use an SpO2 simulator or use the oximeter on themselves to check the oximeter is working correctly. 24 AH-TX Series Handheld Pulse Oximeter Instruction Manual 5.3 Monitoring Procedure 1. Selecting the SpO2 Probe Depending on the patient category, weight and application site, you can select a different SpO2 probe as required. 2. Connecting the SpO2 Probe Plug the SpO2 probe cable into the SpO2 connector on the oximeter. 3. Applying the SpO2 Probe to the patient Clean the application site, removing barriers such as colored nail polish, and apply the probe to the patient. Warning:
inflation. Do not use the SpO2 c on a limb where a NIBP cuff has been applied. This may result in inaccurate SpO 2 readings during cuff Do not attempt to monitor SpO 2 levels on a finger that has been painted with nail polish, as this may result in unreliable measurements. 5.4 Parameter Display 25 AH-TX Series Handheld Pulse Oximeter Instruction Manual Fig 5-1 Parameter and PPG Waveform 1. 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. 2. PPG waveform area: The waveform shown in this area illustrates the current PPG curve of the patient being monitored. 3. PR parameter area: Current PR 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. 5.5 SpO2 Alarm Setup 1. SelectMenuAlarm Setup. 2. Set theSpO2 LeveltoOffto shut off SpO2 alarm. 5.5.1 Setting the Alarm Levels SelectMenuAlarm Setup. 1. 2. Set theSpO2 Levelto MedorHigh. 26 AH-TX Series Handheld Pulse Oximeter Instruction Manual 5.5.2 Adjusting the Alarm Limit 1. SelectMenuAlarm Setup. 2. AdjustHigh:If an SpO2 measurement is higher than the high alarm limit, the SpO2 High alarm will be triggered. 3. AdjustLow:If an SpO2 measurement is lower than the low alarm limit, the SpO2 Low alarm will be triggered. 5.6 HR Alarm Setup 5.6.1 Setting the Alarm Level SelectMenuAlarm Setup. Set theHR Levelto LoworMedorHigh. 5.6.2 Adjusting the Alarm Limit 1. SelectMenuAlarm Setup. 2. AdjustHigh: If a HR measurement is higher than the high alarm limit, the HR High alarm will be triggered. 3. AdjustLow: If a PR measurement is lower than the low alarm limit, the HR Low alarm will be triggered. 1. 2. 27 AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 6 Reviewing 6.1 Introduction SelectMenuTrendReportto 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. If the report data spreads across more than one page, you can turn pages by using the Next pageor Previous page. Users can delete single data or delete all data at once, as shown below:
6.3 Delete Record 6.3.1 Delete single data SelectMenuTrendReportto enter the trend reviewing 28 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 or icon to back. Fig 6-2 Single data delete window 6.3.2 Export data SelectMenuTrendExportto enter the data export mode. Connection the PC or NB through a USB cable. Use the SpO2Reader software to download the record data. 29 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 30 AH-TX Series Handheld Pulse Oximeter Instruction Manual If you want to delete all the data, please follow the steps as below:
SelectMenuTrendDelete allto enter the Delete all window. If you want to delete all records, press the to delete all records data. If not, press the or icon to back. Fig 6-3 Delete all data windowc The window will show the Completed when data deleted. 31 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. SelectMenuTrendExportto enter the data export mode. Connection the PC or NB through a general USB cable. Use the SpO2Reader software to download the record data. Fig 7-1 Connection PC or NB by a USB cable 7.2 Wireless transmission (AH-TB only) 7.2.1 Bluetooth Low Energy Users can also wirelessly transmit data via Bluetooth. AH-TB provides a Bluetooth Low Energy(V4.2) wireless transmission interface that allows you to develop your own software or mobile app to receive data. 32 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:
1 2 3 4 5 left(2/3 full);
left(1/3 full);
Indicates that the power of the battery is full;
Indicates that the power of the battery has 2 grids Indicates that the power of the battery has 1 grids Indicates that the battery is almost depleted. Indicates that the battery is in charge. Under normal conditions, the battery can be used for about 14 hours. If the battery is too low, it will trigger a low battery warning and show the Low Battery icon on screen. In this case, please connect the charger to charge the battery. Warning:
Do not attempt to replace the battery yourself, take it to an authorized representative or manufacturer. Use only batteries specified in this manual. When the oximeter is not in use for a long time, the batteries 33 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. To charge the Lithium Ion battery:
1. Take out the adapter(MPU15-102) provided by the manufacturer. 2. Open the silicone protective plug. 3. Connect the AC-DC adapter and plug the adapter into the AC mains. 4. The indicating icon on the oximeter will light up, to show that the battery is charging. 5. When the battery charge icon on the oximeter become to battery full icon, the battery is fully charged. Fig 8-1 Open the silicone protective plug 34 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. If you use an adapter that is not supplied form the original manufacturer, it may cause damage to the product. When using this adapter for charging, please ensure that there is enough space in the AC socket installation area to install or remove the AC power cord, and avoid obstacles in the vicinity of the AC power cord to affect the power cord installation. The user can disconnect the power by unplugging the AC power cord. 8.3 Checking the Lithium-Ion Battery The performance of a battery may deteriorate over time. To check the performance of a battery, follow this procedure:
1. Disconnect the oximeter from the patient and stop all monitoring and measuring procedures. 2. Plug the adapter into the oximeter and connect it to the AC mains. Allow the battery to charge uninterrupted for more than 4 hours. 3. Disconnect the oximeter from the AC mains and allow the oximeter to run on the battery until it shuts off. Make a note of how long this takes. 4. The operating time of a battery directly reflects its performance. 35 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. 8.4 Disposing of the Batteries Batteries that are damaged or depleted should be replaced and discarded properly. Dispose of used batteries according to local regulations. Do not disassemble batteries, dispose of them in fire, or cause them to short circuit. They may leak, ignite, or explode, causing personal Warning:
injury. 36 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:
1. When cleaning the oximeter, always dilute cleaning products according the manufacturers instructions, and use the lowest possible concentration. Do not immerse any part of the equipment in the liquid. Do not pour liquid on to the equipment or the accessories. Do not allow liquid to enter the case. Never use abrasive materials (such as steel wool or silver polish), or erosive cleaners (such as acetone or acetone-based cleaners) to clean the oximeter. Warning:
Be sure to shut down the system and disconnect all power cables from the outlets before cleaning the equipment. For optimal performance, product service should be performed only by qualified service personnels. Do not serviced or maintained while in use with the patient. Caution:
If you spill liquid onto the equipment or accessories caused any damage, contact your service personnel. 37 2. 3. 4. 5. 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. Clean the plug connected to the power cord at least once a year. Too much dust on the plug may cause a fire. The following safety checks and tests should be performed at least every 12 months by a qualified person with adequate training, knowledge, and practical experience. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the following tests, the device must be Inspect the equipment and accessories for mechanical and functional repaired. damage. Inspect the relevant safety labels for legibility. Verify that the device functions properly, as described in the instructions for use. Warning: Do not attempt to service the device yourself, take it to an authorized representative or manufacturer. 38 AH-TX Series Handheld Pulse Oximeter Instruction Manual 9.3 Cleaning the Oximeter 1. 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. 2. Avoid the use of alcohols, amino or acetonyl detergents when cleaning the oximeter. 3. The oximeter case and screen must be kept free of dust. It can be wiped with a lint-free soft cloth or a sponge soaked in detergent. While cleaning the oximeter, be careful not to spill liquid onto the instrument, and do not allow any liquid to spill inside the oximeter. When wiping the side panel of the oximeter, be especially careful to keep liquid away from the cable and the outlet. 4. Do not use abrasive materials such as wire brushes or metal brighteners when cleaning the oximeter, as they will damage the panel and the oximeter screen. Do not submerge the oximeter in liquid. 5. 6. If the cable or plug accidentally gets wet, rinse them with distilled or deionized water and dry them in an environment with a temperature between 40C and 80 C for at least one hour. 9.4 Cleaning SpO2 Probe 1. The casing of the probe and light tube can be cleaned with a swab, or a non-velvet soft cloth dipped in medical alcohol. 2. The probe cable can be cleaned with hydrogen peroxide 3%, or isopropyl alcohol 70%. 3. Never put the oximeter and probe in a high-pressure container, and 39 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 regulations regarding the disposal of hospital waste. 40 AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 10 Accessories of Probe Nellcor compete SpO 2 probe (Applied parts) Type Model Patient Category Disposable ASDNR-A1 Adult finger (patient size>30kg) ASDNR-P2 Pediatric foot/hand (patient size 10-50kg) Single patient use only Adult finger or neonatal foot/hand
(patient size >40 kg or <3 kg) ASDNR-N3 ASANR-D1 ASANR-D3 ASWNR-D1 ASWNR-D3 ASYNR-D1 ASYNR-D3 Adult Adult / Neonatal Neonatal Reusable ASWNR-D3 Adult / Neonatal ASPNR-D1 Pediatric / Neonatal ASPNR-D3 Pediatric / Neonatal Adult ASSNR-D1 ASSNR-D3 ASVNR-D1 ASVNR-D3 Adult / Pediatric / Neonatal 41 AH-TX Series Handheld Pulse Oximeter Instruction Manual Chapter 11 Symbol Definitions Refer to user manual before application Manufacturer information Keep away from sunlight Date of Manufacture Use by date Dispose the waste according to the national law. Do not use if package damaged. Type BF Applied Part. CE mark SN Serial number Attention: Consult accompanying documents (this manual). IP22 Degree of protection against ingress of dust and liquid. Single patient use only Contains no Latex FCC certification mark NCC certification mark This side up Handle With Care Fragile Keep dry Keep away from heat Direct CurrentDC 42 AH-TX Series Handheld Pulse Oximeter Instruction Manual Appendix A Product Specifications A.1 Safety Specifications SFDA classification CE classification Type of protection against electric shock Degree of protection against electric shock II IIb BF II, with internal power device. Degree of protection against Ordinary equipment, without protection hazards of explosion against hazards of explosion. Degree of protection against ingress of liquid Equipment type IP22 Handheld A.2 Physical Specifications Mainframe weight 320g Mainframe size 84mm(W)165mm(H)26mm(D) AC-DC adapter weight 150g AC-DC adapter size 43.5mm(W)60mm(H)40.2mm(D) A.3 Environmental Specifications Temperature Operating: 0 to +35 43 AH-TX Series Handheld Pulse Oximeter Instruction Manual Storage/Transportation: -20 to +70 Atmospheric Operating: 860hPa to 1060hPa pressure Storage: 500hPa to 1060hPa 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. Ltd MPU15-102 100240VAC50/60Hz 5V 2.4A A.4.2 Battery Specification Input Output Standard Type Size Weight Quantity Rated Voltage Rated Capacity Run time NCA596080 Lithium-ion rechargeable 5.85mm60 mm80mm battery 67g 1 3.6 VDC 3950 mAh 14 hours 44 AH-TX Series Handheld Pulse Oximeter Instruction Manual With SpO2 monitored continuously, Audio indicators off and backlight brightness set to minimum and using new, full power batteries at ambient temperature 25. 3 hours to 90%
4 hours to 100%
Charge time A.5 Hardware Specifications A.5.1 Display Type Sizediagonal TFT LCD 4.3 inch Resolution 480272 pixels A.5.2 Audio Indicating Speaker Gives audible alarm, button tone and beep tone Supports Pitch Tone and multi-
Alarm tones meet the requirement of IEC Alarm sound pressure 60~90 dB, Testing place is 1 meter from A.5.3 Button level volume;
60601-1-8. the tone. 45 AH-TX Series Handheld Pulse Oximeter Instruction Manual Quantity Functions A.5.4 Sensors 1 Power button. Wavelength nm. 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 This information may be useful to clinicians, such as those performing photodynamic therapy. A.5.5 Bluetooth L.E Specifications Specifications BGM121/BGM123 SiP Module with a standard 2.14 dBi dipole antenna. Bluetooth 4.2 Low Energy compliant. The BGM121/BGM123 has Bluetooth, CE, partial FCC, ISED Canada and Japan certifications The BGM121/BGM123 Bluetooth Declaration ID is: D033250. FCC ID: QOQBGM12LMA ISED: 5123A-BGM12LMA Japan certification number 209-J00226. NCC ID: CCAB19LP1110T9 46 AH-TX Series Handheld Pulse Oximeter Instruction Manual A.6 Specifications A.6.1 Digital SpO2 SpO2 Technic Range Resolution Refreshing rate Pitch Tone Heart Rate Range Resolution Accuracy Range Refreshing rate Digital SpO2 technic 0~100%
1%
1 second with 25 bpm to 250 bpm 1 bpm
(select larger)
(select larger) 1 second Oxygen Saturation Declared 70 100% SpO2 2 digits, Below Accuracy Range 70% unspecified Low Perfusion Oxygen Saturation 70 100% SpO2 3 digits, Below Declared Accuracy Range 70% unspecified Pulse Rate Declared Accuracy Range 25250 bpm 2bpm or 2%
Low Perfusion Pulse Rate Declared 25250 bpm 3bpm or 2%
A.6.2 Alarm Limit Specifications Alarm limits Range (%) Step (%) SpO2 high limit
(low limit +1) to 100 1 47 AH-TX Series Handheld Pulse Oximeter Instruction Manual SpO2 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) 1 48 AH-TX Series Handheld Pulse Oximeter Instruction Manual Appendix B EMC Guidance and manufacturers 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. Emissions test Compliance guidance Electromagnetic environment -
The device only uses RF energy for its Radio frequency internal function. Therefore, its RF
(RF) emissions Group 1 emissions are very low and are not CISPR 11 likely to cause any interference in nearby electronic equipment. Class B The device is suitable for use in all Radio frequency RF emissions Harmonic emissions IEC 61000-3-2 N/A fluctuations/flicker N/A Voltage emissions establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 49 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. Immunity test IEC 60601 test Compliance Electromagnetic level level environment -guidance Electrostatic Floors should be wood, discharge (ESD) 8 kV contact 8 kV contact concrete or ceramic tile. If IEC 61000-4-2 15 kV air 15 kV air floors are covered with synthetic material, the relative humidity should be at least 30 %. transient / burst N/A N/A N/A N/A N/A N/A interruptions and N/A N/A N/A Electrical fast
(EFT) IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short voltage variations on power supply input lines 50 AH-TX Series Handheld Pulse Oximeter Instruction Manual Power frequency Power frequency magnetic
(50/60 Hz) 3 A/m 3 A/m The power frequency of IEC 61000-4-11 magnetic field IEC 61000-4-8 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the AC mains voltage prior to application of the test level. Guidance and Declaration electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below. The customer or the user of device should make certain that they are in such an environment when operating it. Immunity test IEC 60601 test level Compliance level Conducted RF IEC 61000-4-6 N/A Radiated RF 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz Electromagnetic environment - guidance N/A 3 V/m 51 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. d
5.3 V 1 d
5.3 E 1 d
7 E 1 P P P 80 MHz to 800 MHz 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. following symbol:
Interference may occur in the vicinity of equipment marked with the 52 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. 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, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Mattress Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the SL-F SL Series Anti-decubitus The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of 53 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) MHz MHz GHz d
5.3 V 1 P d
5.3 E 1 P d
7 E 1 P 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 0.01 0.1 1 10 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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. higher frequency range applies. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Appendix C Factory Defaults This section lists the most important factory default settings. These settings can be adjusted and you can load the factory defaults if you need. C.1.1 Alarm Setup 54 AH-TX Series Handheld Pulse Oximeter Instruction Manual Alarm Setup Factory Default SpO2 Alarm Level PR Alarm Level High Medium C.1.2 Alarm Type Setup SpO2 Setup SpO2 High Limit SpO2 Low Limit PR Setup PR High Limit PR Low Limit Adult 100 90 Adult 120 50 Pediatric Neonate Pediatric Neonate 100 90 160 75 95 90 200 100 C.3 System Setup System Setup Alarm Volume Beep Volume Key Volume Brightness Scan Speed Factory Default 1 0 0 1 25mm/s C.4 Work Type Setup Work Type Setup Factory Default Interval 10s Hint: The Work Type is mean the work is in the spot check mode or 55 AH-TX Series Handheld Pulse Oximeter Instruction Manual continues mode. 56 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 SpO2 too High* A measurement has risen above the high High alarm limit or fallen below the low alarm Medium SpO2 too Low*
limit. PR too High*
A measurement has risen above the high High alarm limit or fallen below the low alarm Medium PR too Low*
limit. The signal was too weak or poor to be No Pulse analyzed. Low Perf The signal detected is weak. Medium Level Low High D.2 Technical alarm Messages Cause Level No Sensor The SpO2 probe detached the oximeter. Medium No Finger The SpO2 probe detached the patient. LowBatt The battery power is low. Medium Medium 57 AH-TX Series Handheld Pulse Oximeter Instruction Manual D.3 Symbols on marking Symbol Title (informative) Description for ALARM SYSTEMS
(normative) No Sensor The SpO2 probe detached the oximeter. Medium No Finger The SpO2 probe detached the patient. Medium LowBatt The battery power is low. Medium 58 AH-TX Series Handheld Pulse Oximeter Instruction Manual
(NCC) 59 AH-TX Series Handheld Pulse Oximeter Instruction Manual FCC Warning 1. 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. 2. NOTE: the grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. Such modifications could void the users authority to operate the equipment. 3. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 60 Acare Technology Co., Ltd. Address: 6F.-6, No.5, Wuquan 1st Rd., Xinzhuang Dist., New Taipei City 242, Taiwan 61 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 62
1 | Agents Letter | Cover Letter(s) | 247.54 KiB | January 13 2020 |
ACARE Example of Agents letter (for TCB TCB approval):
COMPANY LETTERHEAD Date (18/11/2019) TUV SUD BABT TCB/FCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Dear Sir or Madam, We, Acare Technology Co., Ltd. (5F.-4, No.24, Wuquan 2nd Rd., Xinzhuang Dist.,New Taipei City 242, Taiwan (R.O.C), hereby authorize Electronics Testing Center, Taiwan(Kevin Lin, 886 3 3280026 #578) to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. This authorization expires on least 6 months duration. Sincerely, Company Officer: a Huang Telephone Number: 886 2 2298 8170#502 Email: cara@acarecorp.com
1 | Confidentiality Letter | Cover Letter(s) | 320.70 KiB | January 13 2020 |
ACARE Date (18/11/2019) COMPANY LETTERHEAD TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Confidentiality Request FCC ID: 2ATBR-AHTB Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules, Acare Technology Co., Ltd. hereby requests permanent confidential treatment of information accompanying this application as outlined below:
Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation Acare Technology Co., Ltd. also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of 180 days:
Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, ONH. Name: Cara Huang Title: | Product Specialist
1 | Test Setup Photos | Test Setup Photos | 670.09 KiB | January 13 2020 / July 10 2020 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2020-01-13 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2020-01-13
|
||||
1 | Applicant's complete, legal business name |
Acare Technology Co., Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0028478634
|
||||
1 | Physical Address |
5F-4, No.24, Wuquan 2nd Rd., Xinzhuang Dist.
|
||||
1 |
New Taipei Cit, N/A
|
|||||
1 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
v******@tuvsud.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ATBR
|
||||
1 | Equipment Product Code |
AHTB
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
L****** C****
|
||||
1 | Telephone Number |
+886-********
|
||||
1 | Fax Number |
+886-********
|
||||
1 |
i******@acarecorp.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 07/10/2020 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Handheld Pulse Oximeter | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Electronics Testing Center, Taiwan
|
||||
1 | Name |
W******** T******
|
||||
1 | Telephone Number |
886-3******** Extension:
|
||||
1 | Fax Number |
886-3********
|
||||
1 |
w******@etc.org.tw
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0046700 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC