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Handheld pulse oximeter user’s manual

A.7 Measurement Specifications

A.7.1 Digital SpO2

SpO

Technic

Digital

SpO

technic

Range

0~100%

Resolution

Accuracy

70% to 100%: ±2%

0% to 69%: unspecified

Refreshing rate

<13 seconds

Pitch Tone

with

Range

25 bpm to 250 bpm

Resolution

1 bpm

Accuracy

±2% or ±1 bpm, whichever is the greater

Refreshing rate

<13 seconds

Summary of Contents for AH-M1

Page 1: ...Handheld Pulse Oximeter Model AH M1 Instruction Manual Issued Date Jul 12 2011 Ver 1 0 ...

Page 2: ... 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 z Document No P2000040 1 z Revision number 1 0 z Release time 2011 07 Copyright ...

Page 3: ...y file This manual is only to be used for supporting the operation maintenance and service of the AH M1 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 ma...

Page 4: ...l certified by the manufacturer z The storage conditions operating conditions and electrical status of the instrument conform to the product specification z 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 prere...

Page 5: ...al 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 z Bold Italic text is used in this manual to quote the referenced chapter or sections z is used to signify text as it appears on the product screen z ...

Page 6: ...f not avoided will result in death or serious injury Caution Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage Note Provides application tips or other useful information to ensure that you get the most from your product V 0 ...

Page 7: ...Mode 7 1 3 2 SpO2 Waveform Display Mode 9 Chapter 2 Safety 1 2 1 Safety Information 1 2 2 Explanation of Symbols 3 Chapter 3 Basic Operations 1 3 1 Unpacking and Checking 1 3 2 Getting Started 2 3 3 Starting the oximeter 3 3 4 General Setup 3 3 4 1 Beep Volume Setup 3 3 4 2 Key Volume Setup 4 3 4 3 Adjust the Screen Brightness 4 3 4 4 Scan Speed Setup 4 3 5 Date and Time Setup 5 ...

Page 8: ...g the Factory Configuration 9 3 12 Shutting off the Oximeter 10 Chapter 4 Alarm 1 4 1 Alarm Categories 1 4 2 Alarm Levels 2 4 3 Alarm Indicators 3 4 3 1 Alarm tone 4 4 3 2 Alarm Lamp 5 4 3 3 Alarm Message 6 4 3 4 Flashing Numeric 6 4 4 Alarm Status Symbol 6 4 5 Alarm Tone Configuration 7 4 5 1 Setting the minimum Alarm Volume 7 4 5 2 Changing the Alarm Volume 7 4 6 Pausing the Alarm Tones 7 4 7 Sh...

Page 9: ...g SpO2 Alarm On Off 6 5 6 2 Setting the Alarm Level 6 5 6 3 Adjusting the Alarm Limit 6 5 6 4 Altering the Desaturation Limit 7 5 7 PR Alarm Setup 7 5 7 1 Switching PR Alarm On Off 7 5 7 2 Setting the Alarm Level 7 5 7 3 Adjusting the Alarm Limit 8 Chapter 6 Reviewing 1 6 1 Introduction 1 6 2 Reviewing Screen 1 6 3 Reviewing Setup 2 Chapter 7 Battery 1 7 1 Introduction 1 7 2 Installing Batteries 3...

Page 10: ...f the Batteries 9 Chapter 8 Maintenance and Cleaning 1 8 1 Introduction 1 8 2 Annual Safety Checks 2 8 3 Cleaning the Oximeter 4 8 4 Cleaning SpO2 Sensor 5 8 5 Disposal 6 Chapter 9 Accessories 1 Appendix A Product Specifications 1 A 1 Safety Specifications 1 A 2 Physical Specifications 1 A 3 Environmental Specifications 2 A 4 Charging Specifications 2 A 4 1 AC DC Adapter Optional 2 A 4 2 Battery S...

Page 11: ...6 A 7 Measurement Specifications 7 A 7 1 Digital SpO2 7 A 7 2 Nellcor SpO2 8 A 7 3 Alarm limit specifications 8 Appendix B EMC 10 Appendix C Factory Defaults 15 C 1 Alarm Setup 15 C 2 System Setup 15 C 3 SpO2 Setup 16 C 4 Trend Setup 16 Appendix D Alarm Message 17 D 1 Physiological alarm 17 D 2 Technical alarm 18 ...

Page 12: ...tion SpO2 and pulse rate PR for adult pediatric or neonatal patients This device can be used in 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 It may also be used in the home ...

Page 13: ...imeter 1 Alarm indication lamp When an alarm occurs this lamp will light up as defined below z High level alarm the lamp quickly flashes red z Medium level alarm the lamp slowly flashes yel low z Low level alarm the lamp lights yellow without 6 4 5 3 9 1 2 7 8 ...

Page 14: ... screen display between large numeric mode and SpO2 waveform mode under the monitoring screen z Exit current menu under the menu screen 5 Alarm pause button Pressing this button z Will not work when the alarm volume is off z Can pause the alarm for 120 seconds when the alarm volume is on z Changes the alarm message to prompt message when Sensor off alarm is activated z Note the alarm can not be pe...

Page 15: ...eat displayed z Move the cursor upwards or increase the value of a selected menu item under the menu screen 8 Down button Press this button to z Lower the volume of the heart beat displayed z Move the cursor downwards or decrease the value of a selected menu item 9 Battery charging indicating lamp z Lights orange when the battery is being charged z Will show no light when the battery is fully char...

Page 16: ...1 2 2 Rear View Fig 1 2 Rear view of the oximeter 1 Speaker 2 Battery door 1 2 ...

Page 17: ... 3 Side view of the oximeter 1 SpO2 probe connector 2 Cord hold 3 Power supply connector Used to connect the charger stand 4 Infrared port A port through which a personal computer can communicate with the product to export data in real time 1 3 4 2 ...

Page 18: ...ows vertical and horizontal positioning of the screen to maximize space utilization and visibility 1 3 1 Large Numeric Display Mode Fig 1 4 Big numerics display mode 1 Menu Directly after startup Menu shown here is the function controlled by the left hand button When 1 3 4 5 6 10 11 9 2 8 120 s 7 ...

Page 19: ...in this area 5 SpO2 parameter area Current SpO2 value and its high and low alarm limits are displayed in this area 6 Technical alarm and prompt information area Current technical alarm and prompt information is shown in this area 7 Alarm status area Alarm status symbols and alarm pause time are displayed in this area 8 Pleth bar Pulse intensity is indicated by the number of stacked blocks visible ...

Page 20: ...veform display mode 1 SpO2 waveform area The waveform shown in this area illustrates the current SpO2 volume curve of the patient being monitored 2 SpO2 parameter area Current SpO2 value and its upper and lower alarm limits are displayed in this area 3 PR parameter area Current PR value and its upper and lower alarm limits are displayed in this area 2 1 3 ...

Page 21: ...Do not use the product in the presence of high power appliances such as high voltage cables X ray machines ultrasound equipment or a 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...

Page 22: ...imeter as this will lead to unreliable SpO2 measurements Measurements and pulse signals can be affected by certain environmental conditions errors in applying the sensor and certain patient conditions See the appropriate sections of this manual for specific safety information The use of accessories sensors and cables other than those specified may result in increased emission low anti disturbance ...

Page 23: ...in a quiet and comfortable environment 2 2 Explanation of Symbols Symbol Symbol Note Type BF applied part defibrillation protected Attention Consult accompanying documents this manual Direct Current DC IPX1 Degree of protection against ingress of liquid Alarm volume off Alarm volume pause parameter alarm off 3 ...

Page 24: ... Note Beep volume off Power supply connector Left right button Up button Down button Date of manufacture Manufacturer CE mark SN Serial number Power button Symbol for the marking of electrical and electronics devices according to Directive 2002 96 EC 4 ...

Page 25: ...t the oximeter and its accessories The following parts are provided in the package Parts Standard Optional Quantity SpO2 probes DB9 plugs 1 User s manual this manual Lithium battery 1 AC DC adapter 1 Battery charger stand 1 Protective cover 1 Clip with lanyard 1 QuickStart 1 CDROM 1 Check list 1 Alkaline battery 3 1 ...

Page 26: ...nsert batteries into the battery compartment Make sure that the battery has sufficient power When using rechargeable batteries for the first time you must charge them first following the instructions given in 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 To ...

Page 27: ...settings for more convenient use as shown in section 3 4 3 4 General Setup Press the Left button to enter Menu then select General Setup to enter the general setup menu shown as follows You can set parameters for the following functions Fig 3 1 General setup window 3 4 1 Beep Volume Setup Press the Left button to select the item then adjust its value using the Up or Down button You can select from...

Page 28: ...tness Press the Left button to select the item then adjust the value using the Up or Down button You can select from 1 to 5 Selecting the minimum brightness can save power Caution If the oximeter is used outdoors or if the ambient light is strong set the screen brightness to a higher level 3 4 4 Scan Speed Setup Press the Left button to select the item then adjust its value using the Up or Down bu...

Page 29: ...m menu as shown below Fig 3 2 System setup window 2 Select the year month and day to the right of Date and set them to the current date at your location 3 Select the hour and minute to the right of Time and set them to the current time at your location 3 6 Selecting the Work Mode The oximeter is designed to operate in two modes continuous monitoring and spot checking The work mode 5 ...

Page 30: ...will pop up and ask for your password Input the password and select OK to enter the maintenance window shown as follows Fig 3 3 Maintenance window 2 Select Work Mode and then set the oximeter s work mode to Continuous or Spot Check 3 6 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 ...

Page 31: ... from 1 to 99 with each patient Details are as follows Apply the SpO2 sensor to the patient After valid SpO2 signals are detected 1 The patient ID flashes and after 8 seconds will automat ically increase by 1 number to admit a new patient 2 Pressing the Left hand button when the current patient ID is flashing will make the patient ID stop flashing and the ID number will remain unchanged The new pa...

Page 32: ... To enter the demo mode 1 Select Menu System Maintenance enter the required password 2 Set Screen to Demo and the message Demo Mode will appear in the technical alarm area To exit the demo mode 1 Select Menu System Maintenance enter the required password 2 Set Screen to Normal Caution The Demo mode is for demonstration purpose only Do not enter the Demo Mode when a patient is being monitored to av...

Page 33: ...e 3 10 Checking the Version Select Menu System Maintenance enter the required password Select Factory Setup to check the version of the oximeter 3 11 Restoring the Factory Configuration If you have made changes to the system s configuration and want to restore the original factory settings follow this procedure 1 Select Menu System 2 Select Load Default Conf A pop up window will appear asking you ...

Page 34: ...oximeter follow the steps below 1 Confirm that patient monitoring is complete 2 Disconnect the SpO2 sensors form the oximeter 3 Press the power button and hold it for 2 seconds to turn off the oximeter Caution Under the Spot check mode if the oximeter is not in use and there has been no button operation for more than 5 minutes the oximeter will shut down automatically 10 ...

Page 35: ...nical problem Note The oximeter generates all audible and visual alarms through a speaker a visual alarm lamp and the screen 4 1 Alarm Categories The oximeter s alarms fall into three categories 1 Physiological alarms Physiological alarms are triggered when a monitored parameter moves outside of set alarm limits or by an abnormal patient condition Physiological alarm messages are displayed in the ...

Page 36: ...es updating the user on the system status separate from the physiological and technical alarm messages Prompt messages are displayed in the technical alarm area 4 2 Alarm Levels 1 The oximeter s 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 situat...

Page 37: ...s and low level alarms Caution The technical alarms cannot be changed by the user 4 3 Alarm Indicators When an alarm occurs the oximeter will indicate it through the following signals 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 lamp The alarm lamp on the front of the oximeter will flash a different co...

Page 38: ...as been breached to cause the alarm to sound will flash Caution Alarm lamp alarm tone and alarm messages will vary according to the level of severity of the alarm 4 3 1 Alarm tone The different level alarms are indicated by the system in the following audio tones Alarm level Audible prompt High DO DO DO DO DO DO DO DO DO DO Medium DO DO DO Low DO 4 ...

Page 39: ...es in red at 2 Hz Medium Alarm lamp flashes in yellow at 0 5 Hz Low Alarm lamp is yellow but does not flash 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 alarm area in turn 5 ...

Page 40: ...arms The system uses the following background colors to indicate different messages and match the alarm level High level alarms red Medium level alarms yellow Low level alarms yellow 4 3 4 Flashing Numeric When a physiological alarm occurs the flashing numeric indicates the parameter that has been breached 4 4 Alarm Status Symbol Indicates that the alarm sound is turned off Indicates that the alar...

Page 41: ...select a value between X and 4 X is the minimum volume The value of X depends on the setting of the minimum alarm volume 4 6 Pausing the Alarm Tones Press the alarm pause button to keep the alarm paused for 120 seconds An alarm paused symbol will indicate that the alarm is paused and the pause time will be displayed in the alarm status area z When the audible alarm is paused the alarm lamp remains...

Page 42: ... off the alarm volume This symbol will show in the alarm status area The alarm lamp and alarm messages remain active even when the alarm volume is off The audible alarm is reactivated automatically when z The factory configuration is selected z The alarm volume is set to a nonzero value When a factory configuration is selected the alarm volume of the oximeter may be lower than the minimum alarm vo...

Page 43: ...ly exclusively on the audible alarm 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 4 8 When an Alarm Occurs Note When an alarm occurs always check the patient s condition first Check which alarm message has appeared on the screen This is necessary to identify the alarm and the appropriat...

Page 44: ...d identify the alarm category 3 Identify the cause of the alarm 4 Silence the alarm if necessary 5 When the cause of the alarm has been identified and addressed check that the alarm system is working properly Alarm messages for individual parameters can be found in Appendix D Alarm message 10 ...

Page 45: ...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...

Page 46: ...s of the patient s condition Do not use the oximeter and the SpO2 sensor 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 sensor site every two hours and move the sensor if the skin ...

Page 47: ... disposal of this products or similar products Caution In cases where it is necessary to add a clip to fix the fingertip sensor clip the cable and not the sensor itself Please note that the sensor 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 sim...

Page 48: ... to the patient Clean the application site removing barriers such as colored nail polish and apply the sensor to the patient Warning Do not use the SpO2 sensor on a limb where a NIBP cuff has been applied This may result in inaccurate SpO2 readings during cuff inflation Do not attempt to monitor SpO2 levels on a finger that has been painted with nail polish as this may result in unreliable measure...

Page 49: ...SpO2 parameter 1 SpO2 label 2 High alarm limit of SpO2 3 Low alarm limit of SpO2 4 SpO2 value 5 SpO2 unit z Waveform Display Fig 5 2 SpO2 waveform 5 5 PR Display Fig 5 3 PR parameter 1 PR label 2 High alarm limit of PR 3 Low alarm limit of PR 4 PR value 5 PR unit 5 1 5 2 4 3 1 5 2 3 4 ...

Page 50: ...in the visible SpO2 parameter display area 5 6 2 Setting the Alarm Level 1 Select Menu Alarm Setup 2 Set the Alarm of SpO2 to Med or High 5 6 3 Adjusting the Alarm Limit 1 Select Menu Alarm Setup 2 Adjust High If an SpO2 measurement is higher than the high alarm limit the SpO2 Too High alarm will be triggered 3 Adjust Low If an SpO2 measurement is lower than the low alarm limit the SpO2 Too Low al...

Page 51: ... a pop up window will appear requiring a password 2 Input the password and select OK to enter the maintenance window Select Desat Lim and then set its value through the Up and Down button 5 7 PR Alarm Setup 5 7 1 Switching PR Alarm On Off 1 Select Menu Alarm Setup 2 Set the Alarm of PR to Off to shut off PR alarm When the PR alarm is off this symbol will be in the visible PR parameter display area...

Page 52: ...e Alarm Limit 1 Select Menu Alarm Setup 2 Adjust High If a PR measurement is higher than the high alarm limit the PR Too High alarm will be triggered 3 Adjust Low If a PR measurement is lower than the low alarm limit the PR Too Low alarm will be triggered 8 ...

Page 53: ...dow 6 2 Reviewing Screen Fig 6 1 SpO2 PR reviewing window The above screen shows the SpO2 PR reviewing window You can review SpO2 PR values measured at different time intervals in this window When SpO2or PR values are over the alarm limit that has been set their values will appear in red If the trend data spreads across more than one page you can turn pages by using the Up or Down button 1 ...

Page 54: ... set Interval Select ID Delete Selected Delete All and Export Trend z Interval The time interval between recordings can be adjusted to take regular readings within the range of 2 seconds to 30 minutes z Select ID This selects the desired patient ID No The user may change ID Nos to browse the trend data of corresponding patients z Delete Selected This deletes the stored trend data of the selected I...

Page 55: ...nd data from every stored ID No z Export Trend This allows the user to send trend data from a selected ID No to a computer Before this can be done the relevant computer software must be opened and the infrared interfaces of the instrument and the computer must be aligned 3 ...

Page 56: ... battery are used the battery icon indicates the battery status as follows 1 Indicates that the power of the battery is full 2 Indicates that the power of the battery has 3 grids left 3 4 full 3 Indicates that the power of the battery has 2 grids left half full 4 Indicates that the power of the battery has 1 grid left 1 4 full 5 Indicates that the battery is almost depleted The battery power suppl...

Page 57: ...e the battery The oximeter will switch off automatically 10 minutes after the first Battery Low alarm is given Caution Remove the batteries prior to shipping or if the oximeter is not likely to be used for an extended period of time Warning Use only batteries specified in this manual Keep the batteries out of the reach of children When the oximeter is not in use for a long time the batteries shoul...

Page 58: ...ice follow the steps below to install or change the batteries 7 2 1 Opening the Battery Door 1 Turn the oximeter off first 2 Use a screw driver to remove the screw that secures the battery door to the oximeter Fig 7 1 Loose the screw 3 Press the battery door pushing it downwards to remove the battery door 3 screw ...

Page 59: ...artment aligning the on each battery with the shown inside the battery compartment 2 Close the battery door and push it upwards 3 Use a screw driver to tighten the screw that secures the battery door to the pulse oximeter Caution Check the batteries periodically for corrosion Replace batteries if corrosion is present otherwise damage to the oximeter may occur 4 ...

Page 60: ...hium Ion Battery 1 Insert the lithium ion battery in the battery compartment following shown as follows Fig 7 3 Install the Li battery 2 Close the battery door and push it upwards 3 Tighten the screw that secures the battery door to the pulse oximeter Warning Disconnect the oximeter from the patient and stop all monitoring before charging the battery 5 0 Press the battery in ...

Page 61: ...se oximeter Fig 7 4 Charging device To charge the Lithium Ion battery 1 Place the oximeter in the charger stand 2 Connect the AC DC adapter and plug the adapter into the AC mains 3 The indicating lamp on the battery charger and the indicating lamp on the oximeter will light up to show that the battery is charging 6 Handheld oximeter AC DC adapter Charger stand ...

Page 62: ...harge of the battery A battery should be conditioned with this method regularly to maintain its useful life Condition a battery once when it has been used or stored for two months or when its run time becomes noticeably shorter To optimize a battery follow this procedure 1 Disconnect the oximeter from the patient and stop all monitoring and measuring procedures 2 Place the battery in need of optim...

Page 63: ...attery 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 Place the oximeter in the charger stand 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 a...

Page 64: ... time of a battery depends on the configuration and operation of the pulse oximeter 7 6 Disposing of the Batteries Batteries that are damaged or depleted should be replaced and discarded properly Dispose of used batteries according to local regulations Warning Do not disassemble batteries dispose of them in fire or cause them to short circuit They may leak ignite or explode causing personal injury...

Page 65: ... s instructions and use the lowest possible concentration 2 Do not immerse any part of the equipment in the liquid 3 Do not pour liquid on to the equipment or the accessories 4 Do not allow liquid to enter the case 5 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 s...

Page 66: ...fety Checks Note To ensure the ongoing performance and safety of your equipment the device must be checked after 1 year of use Use professional technology engineers to check the device 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 wit...

Page 67: ...ions properly as described in the instructions for use Test the earth leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit NC 500μA SFC 1000μA Test the enclosure leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit NC 100μA SFC 500μA Test the patient leakage current normal operation according IEC 60601 1 1988 A1 1991 A2 1995 Limit type BF for a c 100μA for d c 100μA T...

Page 68: ...rosive 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...

Page 69: ...ot submerge the oximeter in liquid 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 40 C and 80 C for at least one hour 8 4 Cleaning SpO2 Sensor 1 The casing of the sensor and light tube can be cleaned with a swab or a non velvet soft cloth dipped in medical alcohol 2 The sensor cable can be cleaned ...

Page 70: ...use or disinfect disposable SpO2 sensors 8 5 Disposal Dispose of the oximeter in accordance with local environment and waste disposal laws and regulations For the disposal of SpO2 sensors follow local regulations regarding the disposal of hospital waste 6 0 ...

Page 71: ...r Type Model Patient Category Disposable ASDNR A1 Adult finger patient size 30kg ASDNR P2 Pediatric foot hand patient size 10 50kg ASDNR N3 Adult finger or neonatal foot hand patient size 40 kg or 3 kg Reusable ASANR D3 Adult ASYNR D3 Adult neonatal ASPNR D3 Pediatric neonatal 1 ...

Page 72: ...r internal power device Degree of protection against electric shock BF Degree of protection against hazards of explosion Ordinary equipment without protection against hazards of explosion Degree of protection against ingress of liquid IPX1 Equipment type Handheld A 2 Physical Specifications Mainframe weight 200g Mainframe size 58 5mm W 123mm H 28mm D Charger weight 100g Charger size 96mm W 66mm H ...

Page 73: ...40 Storage 20 to 50 Atmospheric pressure Operating 860hPa to 1060hPa Storage 500hPa to 1060hPa Humidity Operating 15 to 85 non condensing Storage 10 to 93 non condensing A 4 Charging Specifications A 4 1 AC DC Adapter Optional Input 100 240VAC 50 60Hz Output 5V 1 5A A 4 2 Battery Specification Standard Type Lithium ion rechargeable battery Size 50mm 46 5 mm 13 5mm 2 ...

Page 74: ...ower batteries at ambient temperature 25 Charge time 3 hours to 90 4 hours to 100 Shutdown delay 10min After the first low battery alarm Optional Type 1 5V AA alkaline battery Capacity 2000mAh Quantity 3 Run time 14 hours With SpO2 monitored continuously Audio indicators off and backlight brightness set to minimum and using new full power batteries at ambient temperature 25 Shutdown delay 10 min A...

Page 75: ...Indicating LED Mainframe LED Alarm indicating lamp 1 Yellow Red Battery charging indicating lamp 1 Orange When charged it lights orange When fully charged or not charged it does not light Charger LED AC power indicating lamp 1 Green When connecting to the AC DC adapter it lights green When disconnecting from the AC DC adapter it does not light 4 ...

Page 76: ...one and beep tone Supports Pitch Tone and multi level volume Alarm tones meet the requirement of IEC 60601 1 8 Alarm pressure 45 dB to 85 dB Testing place is 1 meter from the tone A 5 4 Buttons Quantity 6 Functions Power button Up button Down button Left button Right button and Alarm pause button 5 ...

Page 77: ...put power of the sensor LEDs is less than 15 mW This information may be useful to clinicians such as those performing photodynamic therapy A 6 Data Storage The changing trends of SpO2 and PR data will be shown in the oximeter Displaying way Trend tabular Trend interval 2 seconds to 30 minutes Trend parameter PR SpO2 Trend data Spot check ID from 1 to 99 300 groups can be stored for each ID Continu...

Page 78: ...1 Digital SpO2 SpO2 Technic Digital SpO2 technic Range 0 100 Resolution 1 Accuracy 70 to 100 2 0 to 69 unspecified Refreshing rate 13 seconds Pitch Tone with PR Range 25 bpm to 250 bpm Resolution 1 bpm Accuracy 2 or 1 bpm whichever is the greater Refreshing rate 13 seconds 7 ...

Page 79: ...ediatric 70 to 100 3 neonate 70 to 100 2 low perfusion 0 to 69 unspecified Refreshing rate 7s Pitch Tone with PR Range 25 bpm to 250 bpm Resolution 1 bpm Accuracy 3 bpm Refreshing rate 7s A 7 3 Alarm Limit Specifications Alarm limits Range Step SpO2 high limit low limit 1 to 100 1 SpO2 low limit Desat to high limit 1 8 ...

Page 80: ...Handheld pulse oximeter user s manual Alarm limits Range bpm Step bpm PR high limit low limit 1 to 250 1 PR low limit 20 to high limit 1 9 ...

Page 81: ...ance Radio frequency RF emissions CISPR 11 Group 1 The device only uses RF energy for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Radio frequency RF emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public ...

Page 82: ...d concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst EFT IEC 61000 4 4 N A N A N A Surge IEC 61000 4 5 N A N A N A Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 N A N A N A Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power freque...

Page 83: ...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 P V d 1 5 3 P E d 1 5 3 80 MHz to 800 MHz P E d 1 7 800 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 separa...

Page 84: ...vice 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 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the SL F SL Series Anti decubitus Mattress The devi...

Page 85: ...transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for 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 Appendix C Factory De...

Page 86: ...el Med PR Alarm Level Med C 2 System Setup System Setup Factory Default Beep Vol 2 Key Vol 2 Brightness 3 Scan Speed 25mm s C 3 SpO2 Setup SpO2 Setup Adult Pediatric Neonate SpO2 High Limit 100 100 95 SpO2 Low Limit 90 90 90 PR Setup Adult Pediatric Neonate PR High Limit 120 160 200 PR Low Limit 50 75 100 15 ...

Page 87: ...Handheld pulse oximeter user s manual C 4 Trend Setup Trend Setup Factory Default Interval 30s 16 ...

Page 88: ...rm Messages Cause Level SpO2 Too High A measurement has risen above the high alarm limit or fallen below the low alarm limit Medium SpO2 Too Low SpO2 Desat SpO2 measurement has fallen below the SpO2 desat limit High PR Too High A measurement has risen above the high alarm limit or fallen below the low alarm limit Medium PR Too Low No Pulse The pulse signal was too weak to be analyzed High 17 ...

Page 89: ...r user s manual D 2 Technical alarm Messages Cause Level Sensor Off The SpO2 sensor detached the patient or the oximeter Medium Battery Low The battery power is low Medium SpO2 Low Perf The signal detected is weak Medium 18 ...

Page 90: ...Acare Technology Co Ltd Address 6F 6 No 5 Wuquan 1st Rd Xinzhuang Dist New Taipei City 242 Taiwan TEL 886 2 2298 8170 FAX 886 2 2298 8560 Email info acaretech com Website http www acaretech com ...

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