PocketSigns PS8x - Digicare Biomedical
Contents
1. Press the battery in Fig 8 3 Install the battery 2 Close the battery door and push it upwards 3 Tighten the screw that secures the battery door to the pulse monitor Ye Warning Do not use the charger stand when the alkaline batteries is depleted or no battery is installed Disconnect the monitor from the patient and stop monitoring before charging the battery When connecting the running monitor to the AC DC adapter to charge its battery there will be a message displayed on the screen and the monitor will shut down after 10 seconds PocketSigns PS8x Monitor User s Manual rev1 8 3 Charging the Lithium Ion Battery Handheld monitor Battery charger AC DC adapter Fig 8 4 Charging device To charge the lithium ion battery 1 Place the pulse monitor 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 monitor are on to indicate that the battery is in charge 4 When the battery charging indicating lamp on the monitor turns off the battery is fully charged PocketSigns PS8x Monitor User s Manual revl 8 4 Optimizing Battery Performance A battery needs at least two optimizing cycles when it is put into use for the first time A battery cycle is one complete uninterrupted charge of the battery followed by a complete uninterrupted discharge of the battery A battery should be2. 3 It is forbidden to put the monitor in high pressure containers and put the sensor directly in liquid Ye Warning Do not reuse or disinfect the disposable SpO sensor 9 4 Cleaning ECG Cable The recommended disinfectors include glutaric dialdehyde solution and 10 decolourant solution a Please clean cable prior to sterilization b Clean the cable surface with soft cloth bedewed with some fresh water or neutral soapy water c Scrub cable with soft cloth bedewed with some disinfector d Wipe off the disinfector remaining on cable with a soft cloth bedewed with fresh water e Put cable in a shady and cool environment for airing 9 3 PocketSigns PS8x Monitor User s Manual revl Attention e Do not sterilize lead wires with high pressure radioactive or steam devices e Do not directly submerge lead wires in liquid To avoid long time harm to cable it is suggested that the product be sterilized only when necessary according to the regulation of your hospital e Do not clean and reuse disposable electrodes 9 5 Disposal Dispose of the monitor in accordance with local environment and waste disposal laws and regulations For the disposal of SpO2 sensor and ECG cable follow local regulations regarding disposal of hospital waste 9 4 PocketSigns PS8x Monitor User s Manual revl Chapter 10 Accessories 10 1 SpO Nellcor SpO sensor Type Model Patient Category MAX A Adult finger patient si
3. 3 7 PocketSigns PS8x Monitor User s Manual rev1 3 Press the power button and hold it for 2s to turn off the monitor a Caution Under the Spot check mode if the monitor is not in use and there is no button operation for more than 5 minutes the monitor will shut down automatically PocketSigns PS8x Monitor User s Manual revl Chapter 4 Alarm Alarm refers to a prompt that is given by the monitor for medical personnel through visual audible and other means when a vital sign appears abnormal or the monitor faces technical problem e Note The monitor generates all the audible and visual alarms through speaker alarm lamp and screen 4 1 Alarm Categories By nature the pulse monitor s alarms can be classified into three categories 1 Physiological alarms Physiological alarms are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition Physiological alarm messages are displayed in the physiological alarm area 2 Technical alarms Technical alarms are triggered by a device malfunction or a patient data distortion due to improper operation or system problems Technical alarm messages are displayed in the technical alarm area 4 1 PocketSigns PS8x Monitor User s Manual revl 3 Prompt messages As a matter of fact prompt messages are not alarm messages Apart from the physiological and technical alarm messages the pulse monitor will show some messa
4. 7 2 PocketSigns PS8x Monitor User s Manual rev1 Chapter 8 Battery 8 1 Introduction The handheld monitor is designed to operate on three 1 5V alkaline AA batteries or a rechargeable lithium ion battery Under normal circumstances no special maintenance is needed When alkaline batteries or a lithium ion battery is used the battery icon indicates the battery status as follows Indicates that the power of the battery is full Indicates that the power of the battery is 3 grids left Indicates that the power of the battery is 1 grid left MN gt ME 3 E Indicates that the power of the battery is 2 grids left Zz s MM Indicates that the battery is almost depleted Battery power supply can only last for a period of time If the voltage of batteries is too low an alarm of Battery Low will be triggered If alkaline AA batteries are used please change them timely if a rechargeable battery is used please insert the monitor to battery 8 1 PocketSigns PS8x Monitor User s Manual rev1 charger and connect the charger with commercial power to charge the battery The monitor will be switched off automatically 10 minutes after the first Battery Low alarm is given a Caution Remove the batteries prior to shipping or if the monitor is not likely to be used for an extended period of time Ye Warning E Use only batteries specified in this manual E Keep the batteries out of children s reach
5. 10mm mV x1 Input impedance gt 5 0MQ Input current lt 0 1 uA Baseline recovery Monitor mode lt 3 s Electrode offset potential 500 mV d c ECG signal input range 6 0mV to 6 0mV CMRR Diagnostic mode gt 89dB Monitor mode gt 105dB Bandwidth 3d B Diagnostic mode 0 05Hz to 100Hz Monitor mode 0 5Hz to 40Hz Noise lt 30uVpp RTI Standardizing signal ImV 5 PocketSigns PS8x Monitor User s Manual revl Electrode off indicator Esa Work mode Monitor and Diagnostic mode HR range 10 bpm 300 bpm HR Resolution 1 bpm HR Accuracy 1 or 1 bpm whichever is the greater HR Detecting gt 0 20mVpp sensitivity Tall T Wave rejection lt 1 0mV capability Protection defibrillator proof Baseline recovery lt 5s after Defibrillation Recovery time of ECG waveform will recover to the baseline in electrodes after 10 seconds defibrillation Response time of HR HR changes from 80 bpm to 120 bpm less meter to change in than 6s to 10s HR HR changes from 80 bpm to 40 bpm less than 6s to 10s AppendixB EMC Guidance and manufacturer s declaration electromagnetic emission The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that 1t is used in such an environment PocketSigns PS8x Monitor User s Man
6. E When the monitor is not in use for a long time the battery should be removed from it Dispose of battery in accordance with local ordinances and regulations 8 2 Installing Batteries Battery compartment is at the back of the device please follow the following steps to install or change batteries 8 2 PocketSigns PS8x Monitor User s Manual rev1 8 2 1 Opening the Battery Door 1 Turn the monitor off first 2 Use the screw driver to lose the screw that secures the battery door to the monitor Fig 8 1 Loose the screw 3 Press the battery door push it downwards and remove the battery door Fig 8 2 Push the battery door PocketSigns PS8x Monitor User s Manual revl 8 2 2 Installing the Alkaline Battery 1 Insert the AA alkaline batteries in the battery compartment aligning the on each battery with the shown inside the battery compartment 2 Close the battery door and push it upwards 3 Tighten the screw that secures the battery door to the pulse monitor a Caution m Check the batteries periodically for corrosion Replace batteries if corrosion is present otherwise damage to the monitor may occur E Do not run the pulse monitor using alkaline batteries of different types or capacities at the same time 8 2 3 Installing the Lithium Ion Battery 1 Insert the lithium ion battery in the battery compartment shown as follows 8 4 PocketSigns PS8x Monitor User s Manual rev1
7. Low If a SpO measurement is lower than the low alarm limit the SpO2 Too Low alarm will be triggered 5 6 3 Setting Desat SpO desat means when SpO measuring value is lower than the desat a high physiological alarm will be trigged Its setting is as follows 1 Select Menu System Maintenance then pops up a password entering window 2 Input the password and select OK to enter the maintenance window Select Desat Lim Then set its value through the Up and Down button 5 6 PocketSigns PS8x Monitor User s Manual revl 5 7 PR Alarm Setup 5 7 1 Switching On Off PR Alarm 1 Select Menu gt Alarm Setup 2 Set the PR Alarm to Off to shut off PR alarm When PR alarm is off there is a BR sign in the PR parameter display area 5 7 2 Seting Alarm Level 1 Select Menu Alarm Setup 2 Set the PR Alarm to Med or High 5 7 3 Adjusting the 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 5 7 PocketSigns PS8x Monitor User s Manual revl Chapter 6 Measuring ECG 6 1 Introduction Before mechanical systole the heart firstly produces electrical excitement which results in biological current and conducts the current to t
8. Manual rev1 Chapter 7 Reviewing 7 1 Introduction Select Menu Trend to enter trend reviewing window In the window you can review SpO and PR data previously stored 7 2 Reviewing Screen Time 11 37 20 11 36 50 11 36 20 11 35 20 Menu Fig 7 1 SpO PR reviewing window Above is the SpO PR review window In the window you can review SpO PR value measured in different times When SpO2 or PR is over the setting alarm limit their values are red If the trend date is over one page you can turn pages by the up down button 7 3 Reviewing Setup After entering the review window press the left button to enter Trend Setup window shown as the following 7 1 PocketSigns PS8x Monitor User s Manual rev1 30 Sec 5 Delete Selected Delete All Export Trend Select Fig 7 2 Trend Setup In the window you can set Interval Select ID Delete Selected Delete All and Export Trend Interval To adjust recording time interval within the range from 2 seconds to 30 minutes Select ID To select patient ID No The user may change ID No to browse trend data of related patients Delete Selected To delete trend data of the selected ID No Delete All To delete trend data of all patients Export Trend To send trend data of the selected ID No before the operation related computer software must be opened and the infrared interfaces of the instrument and the computer must be aligned
9. presented are different 4 3 1 Alarm tone The different level alarms are indicated by the system in these different audio ways 4 3 PocketSigns PS8x Monitor User s Manual rev1 Alarm level Audible prompt High DO DO DO DO DO DO DO DO DO DO Medium DO DO DO Low DO 4 3 2 Alarm Lamp When an alarm occurs the alarm levels are visually indicated differently in the following ways Alarm level Visual prompt High Alarm lamp flashes in red with 2 Hz Medium Alarm lamp flashes in yellow with 0 5 Hz Low Alarm lamp lights on in yellow without flashing B Caution When multiple alarms of different levels occur at the same time the monitor will select the alarm of the highest level and give its visual and audible alarm indications E When multiple alarms occur at the same time the alarm message will be displayed in the alarm area in turn 4 4 PocketSigns PS8x Monitor User s Manual rev1 4 3 3 Alarm Message 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 Low level alarms The system uses different background colors for the alarm message to match the alarm level High level alarms red Medium level alarms yellow Low level alarms yellow 4 3 4 Flashing N
10. service time and frequency This lithium battery can be charged and discharged for 300 times generally E The operating time of a battery depends on the configuration and operation of the pulse monitor 8 8 PocketSigns PS8x Monitor User s Manual rev1 8 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 or dispose of them in fire or cause them to short circuit They may ignite explode or leak causing personal injury 8 9 PocketSigns PS8x Monitor User s Manual revl 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 Always dilute according the manufacturer s instructions or use lowest possible concentration 2 Do not immerse part of the equipment in the liquid 3 Do not pour liquid onto the equipment or 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 Warning Be sure to shut down the system and disconnect all power cables from the outlets before cleaning the equipment a Caution If you spill liquid onto the equipment or accessories contact us or your service personnel 9 1 Po
11. shut off the alarm volume Then there wil be a symbol DX shown in the alarm status area The alarm lamp and alarm messages are still active after the alarm volume is off The audible alarm is reactivated automatically when The factory configuration is loaded O Set the alarm volume to a nonzero value When a factory configuration is selected the alarm volume of the monitor may be lower than the minimum alarm volume In this case the alarm volume is automatically adjusted according to the minimum alarm volume 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 careful about switching off the alarm sound or not 4 7 PocketSigns PS8x Monitor User s Manual rev1 YA Warning Don t rely exclusively on the audible alarm system for patient monitoring Adjusting 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 G Note When an alarm occurs you should always check the patient s condition first Check the alarm message appeared on the screen It is needed to identify the alarm and action appropriately according to the cause of the alarm Check the patient s condition Identify alarming parameter and alarm category Identify the cause of the alarm Silence the alarm if necessary When cause of alarm has been solved check t
12. the high alarm limit or fallen Medium oo Hi RTS E E below the low alarm limit oo Low No Pulse The pulse signal was too weak to High 10 15 PocketSigns PS8x Monitor User s Manual revl be analyzed D 2 Technical alarm Messages Cause Level Sensor Off The SpO sensor detached the patient or the monitor Medium Lead Off The ECG leads were disconnected Battery Low The battery power is low Medium SpO Low Perf The signal detected is weak Low Product name PocketSigns PS8x Product type HandHeld Monitor Manufacturer Digicare Biomedical Technology Inc Address 107 Commerce Rd Boynton Beach Florida 33426 USA Tel 561 689 0408 Fax 561 689 0021 Post code 33426 10 16
13. 0min After the first low battery alarm A 5 Hardware Specifications A 5 1 Display Type OLED Size diagonal 2 4 inch Resolution 320 X 240 pixels PocketSigns PS8x Monitor User s Manual rev1 A 5 2 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 doesn t 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 doesn t light A 5 3 Audio indi cations Speaker Gives audible alarm button tone 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 Tested 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 PocketSigns PS8x Monitor User s Manual revl A 5 5 Sensors Pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 905 nm The total optical output power of the sensor LEDs is less than 15 mW This information may be useful to clinicians such as Wavelength tho
14. 3 4 PocketSigns PS8x Monitor User s Manual rev1 1 Select System Maintenance a password entering window will pop up input the password and select OK lto enter the maintenance window shown as follows 50 Hz Normal Continuous Lim Al Vol Desat Lim Select Fig 3 3 Maintenance window 2 Select Work Mode you can set the monitor s work mode to Continuous or Spot Check 3 6 1 Continuous Monitoring Mode The continuous monitoring mode is intended for long term monitoring This mode is normally selected when the patient is in hospital or under transport At the time the patient ID defaulted by the system is 0 When the memory reaches the above limit the data stored primarily will be cleared 3 6 2 Spot checking Mode Spot checking mode is intended for short term on site measurement This mode is normally selected to check outpatient when doctors make rounds of the wards The patient ID will automatically 3 5 PocketSigns PS8x Monitor User s Manual revl increase from 1 to 99 Details are as follows Apply the SpO sensor to the patient After valid SpO2 signals are detected 1 The patient ID flashes and automatically increases by 1 after 8 seconds to admit a new patient 2 Press the Left button when the current patient ID is flashing the patient ID will stop flashing and remain unchanged The patient will not be admitted and new measurements will be stored under the current patient
15. 6 ECOS UD a 6 6 6 6 Hum filter Setup ectie ranean ARES SEE 6 7 6T UR Alarm Set aa 6 7 Chapter 7 Reviewing oooooccccncnnnnanincnnonnnnnnnnanononncnnnnncnnanonicccncnnnnnnos 7 1 TA Mntrod c Miri A tania 7 1 TREVI WII diia 7 1 1 3 REVIEWING SUD ad 7 1 Chapter 8 Battery oooooococcnocnnnnnaninoononnnnncnnanananococononananannnninccncnancnnas 8 1 8 1 Introduction ooooooocononononononononononononnnnnnnnnnnnnnonononononineninineness 8 1 8 2 Installing Batteries oooooocoooconococcnononcnnnnnononcnnnnnnnnnnnanininnnos 8 2 8 3 Charging the Lithium Ion Battery oooooooccccccnnnconnnnninncinns 8 6 8 4 Optimizing Battery Performance ooooooooonocnnncnnnnnonnnnnnincnnno 8 7 8 5 Checking the Lithium Battery occccocooocococonccnnnnnonnnnnnnncnnnn 8 8 8 6 Disposing of the BatterieS ooooociccccconcnnoonoccncnnnnononcnnnnoncnnnos 8 9 PocketSigns PS8x Monitor User s Manual rev1 Chapter 9 Maintenance and Cleaning oooooococononnnnnnanininocnnnnnnnnos 9 1 9 1 Introducido 9 1 9 2 Cleaning the Monitor ooooooococnccnononnnnnconcnnnnnnnnnnnonancnnnnnnnnnns 9 2 9 3 Cleanin SpO 7 SENSO eere AN OE s 9 3 9 4 Cleaning ECG Cablesescz csssvesevccecepecnsaee steeds e pAs 9 3 IDAS Ad a Wik Serta Bate tes 9 4 Chapter 10 Accessaries scccccccscssssscssccscccsceeeescsscescessseseeaees 10 1 LOTS POs eictectee O dae 10 1 ONECARE 10 2 AppendixA Product Specifications ooocococcnononooconnnnnnnnaniconoono 10 1 A l Safety Specificati
16. 8x Monitor User s Manual rev1 2 2 Explanation of Symbols Symbol Symbol Note Type CF applied part defibrillation protected Attention Consult this manual Direct Current DC Alarm volume off Alarm volume pause parameter alarm off Beep volume off Power supply connector Left right button Up button Down button Date of manufacture Manufacturer 2 3 PocketSigns PS8x Monitor User s Manual rev1 SN Serial number 0 0 Power button Symbol for the marking of electrical and electronics devices according to Directive 2002 96 EC a 2 4 PocketSigns PS8x Monitor User s Manual revl Chapter 3 Basic Operations 3 1 Unpacking and Checking Open the package In the package are an SpO probes DB9 plugs a 3 lead ECG cable 3 AA batteries a lithium battery optional an AC DC adapter optional an infrared receiving adapter optional a battery charger optional and user s manual this manual Take out the monitor and its accessories 3 2 Getting Started 1 Before you start to make measurements carry out the following checks on the monitor including all connected modules Check for any mechanical damage Check for any incorrect connection of all the external cables and accessories 2 Put batteries into the battery compartment Make sure that the battery has sufficient power for monitoring When you
17. Black clavicle and near the left shoulder On the left lower F Green LL Red abdomen 6 5 PocketSigns PS8x Monitor User s Manual rev1 6 4 ECG Display O ECG Parameter 1 2 20 3 50 Fig 6 2 ECG Parameter 1 HR label 2 HR high alarm limit 3 HR low alarm limit 4 HR value 5 Heartbeat icon Oo ECG Waveform Fig 6 3 ECG waveform 1 Lead label 2 ECG scale 3 ECG waveform 6 5 ECG Setup Select Menu ECG Setup Press the up and down button to set Lead ECG Gain and Mode Lead Select an ECG lead as required You can select from I DI Y and CI 6 6 PocketSigns PS8x Monitor User s Manual revl ECG Gain Select an ECG gain as required You can select from X 0 25 X0 5 and X1 0 Mode Select a mode as required You can select from MON and DIAG 6 6 Hum filter Setup Select Menu System Maintenance Hun Set its value to the local main power frequency 6 7 HR Alarm Setup 6 7 1 Alarm Switch Setup Select Menu Alarm Setup Set Alarm of HR to Off to shut off HR alarm There is a sign shown in the left corner of HR display area or the HR alarm is on 6 7 2 Alarm Level Setup Select Menu Alarm Setup Set Alarm of HR to Low Med and High 6 7 3 Alarm Limit Setup Select Menu Alarm Setup Set the high low alarm limit of HR to a value as required 6 7 PocketSigns PS8x Monitor User s
18. EC 61000 4 4 Surge IEC N A N A N A 61000 4 5 Voltage dips short interruptions N A N A N A and voltage variations on power supply input lines IEC 61000 4 11 Power Power frequency magnetic frequency 3 A m 3 A m fields should be at levels 50 60 Hz characteristic of a typical magnetic field location in a typical IEC 61000 4 8 commercial or hospital environment Note U is the AC mains voltage prior to applic ation of the test level Guidance and Declaration electromagnetic Immunity used in such an environment The device is suitable for use in the electromagnetic environment specified below The customer or the user of device should assure that it is Immunity test IEC 60601 test level Compliance level Conducted RF IEC 61000 4 6 N A N A Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m Electromagnetic environment guidance frequency of the transmitter Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the 10 10 PocketSigns PS8x Monitor User s Manual rev1 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
19. ID 3 When the storage of patient measuring data reaches its limit the newly measuring data will cover for the primary one 3 7 Entering Exiting the Demo Mode To enter the demo mode 1 Select Menu System Maintenance enter the required password 2 Set Screen to Demo and the message Demo Mode is shown in the technical alarm area To exit the demo mode 1 Select Menu System Maintenance enter the required password Set Screen to Normal 3 6 PocketSigns PS8x Monitor User s Manual revl a Caution The Demo mode is for demonstration purposes only To avoid the simulated data being mistaken for the monitored patients data you should not enter the Demo mode while a patient is being monitored Otherwise improper patient monitoring and delayed treatment could result 3 8 Checking the Version Select Menu System the last line of the menu Version is the version used in the monitor 3 9 Restoring the Factory Configuration If you have changed the system s configuration and want to restore the factory configuration follow this procedure 1 Select Menu System 2 Select Load Default Conf poping up a confirming window select OK to restore the factory configuration 3 10 Shutting off the Monitor Please follow these steps to shut off the monitor 1 Confirm that the patient monitoring is finished 2 Disconnect the SpO sensors form the monitor
20. PocketSigns PS8x Monitor User s Manual rev1 Product Information e Product Model PS8x Product Name PocketSigns PS8x O Manufacturer Name Digicare Biomedical Technology Inc e Contact Information Address 107 Commerce Rd Boynton Beach Florida 33426 USA Tel 561 689 0408 Fax 561 689 0021 Post code 33426 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 O Revision number 1 O Release time 2011 11 PocketSigns PS8x Monitor User s Manual rev1 Statement Manufacturer holds the copyright of this manual and we are also entitled to deal with this manual as confidential files This manual is only used for operation maintenance and service of product someone else can not publish the manual This manual contains exclusive information protected by copyright laws and we reserve its copyright Without written approval of manufacturer no parts of this manual shall be photocopied or translated into other languages The contents contained in this manual are subject to amendments without notification Manufacturer s Responsibility Only under the following circumstances will manufacturer be responsible for the safety reliability and performance of the instrument All the installation expansion readjustment renovation or repair
21. apter weight lt 200g AC DC adapter size 41 5mm W x90mm H x32mm D PocketSigns PS8x Monitor User s Manual rev1 A 3 Environmental Specifications Temperature Operating 0 C to 40 C Storage 20 C to 50C Atmospheric Operating 860hPa to 1060hPa pressure 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 Specification 1 5V AA alkaline battery Capacity 2000mAh Quantity 3 Run time gt 16 hours With ECG SpO monitored continuously Audio indicators off and backlight brightness set to minimum and using new full power batteries at ambient temperature 25 C Shutdown delay 10 min After the first low battery alarm PocketSigns PS8x Monitor User s Manual revl Optional Type Lithlum ion rechargeable battery Size 50mm X 46 5 mm X 13 5mm Weight 50g Quantity 1 Rated voltage 3 7 VDC Capacity 1850 mAh Run time gt 16 hours With ECG SpO monitored continuously Audio indicators off and backlight brightness set to minimum and using new full power batteries at ambient temperature 25 C Charge time 3 hours to 90 4 hours to 100 Shutdown delay 1
22. ative to only use the ECG electrodes and cables specified by manufacturer Interference from instruments near the patient and ESU interference can cause problems with the ECG wave The monitor cannot be directly applied to heart and cannot be used for the measurement of endocardio ECG PocketSigns PS8x Monitor User s Manual revl 6 3 Monitoring Procedure 6 3 1 Skin Preparation Good electrode to skin contact is important for a good ECG signal as the skin is a poor conductor of electricity It is necessary to deal with the skin properly before placing the electrodes The steps are shown as follows 1 Select sites with intact skin without impairment of any kind 2 Clip or shave hair from sites as necessary 3 Gently abrade the skin to remove dead skin cells to improve the conductivity of the electrode site 4 Wash sites thoroughly with soap and water leaving no soap residue We do not recommend using ether or pure alcohol because this dries the skin and increases the resistance 5 Dry skin thoroughly 6 3 2 Placing Electrode 1 Preparation before placement 1 Skin preparation refers to Chapter 7 3 1 2 Check if the buttons on the electrodes are clean and free of damage 3 Place the electrodes on the patient s body Before attaching smear some conducting cream on the electrodes if the electrodes are not electrolyte self supplied 6 3 PocketSigns PS8x Monitor User s Manual rev1 4 Connect the cable lea
23. cketSigns PS8x Monitor User s Manual revl 9 2 Cleaning the Monitor dis 2 3 Common detergents and non corrosive disinfectants used in hospitals can be applied to clean monitor however you must be aware that many kinds of detergents must be diluted prior to use and please use it according to the instruction of detergent manufacturer Avoid the use of alcohols amino or acetonyl detergent The enclosure and monitor s screen shall be free of dust and they can be wiped with lint free soft cloth or sponge soaked in detergent While cleaning be careful and do not spill liquid onto the instrument and keep any liquid away from it When wiping the side panel of monitor you must be especially careful to keep water away from the cable and outlet on the panel 4 Do not use abrasive materials including wire brushes or metal Is brighteners during cleaning because these materials will damage the panel and monitor screen Do not submerge the monitor in liquid 6 If the cable or plug accidentally gets wet please rinse it with distilled water or deionized water and dry it in room temperature 40C to 80 for at least one hour 9 2 PocketSigns PS8x Monitor User s Manual revl 9 3 Cleaning SpO Sensor 1 The sensor s and light tube s case can be cleaned with swab or non velvet soft cloth dipped in with medical alcohol 2 The sensor cable can be cleaned or sterilized with Hydrogen Peroxide 3 or lsopropylalcohol 70
24. conditioned regularly to maintain its useful life Condition a battery once when it is used or stored for two months or when its run time becomes noticeably shorter To optimize a battery follow this procedure 1 Disconnect the monitor from the patient and stop all monitoring and measuring procedures 2 Place the battery in need of optimizing into the battery compartment to the monitor 3 Place the monitor in the charger stand and connect the AC mains Allow the battery to be charged uninterruptedly for over 4 hours 4 Remove the AC mains and allow the monitor to run from the battery until it shuts off 5 Replace the monitor in the charger stand and connect the AC mains Allow the battery to be charged uninterruptedly for over 4 hours 6 The optimizing of the battery is over 8 7 PocketSigns PS8x Monitor User s Manual revl 8 5 Checking the Lithium Battery The performance of a battery may deteriorate over time To check the performance of a battery follow this procedure 1 Disconnect the monitor from the patient and stop all monitoring and measuring procedures 2 Place the monitor in the charger stand and connect the AC mains Allow the battery to be charged uninterruptedly for over 4 hours 3 Disconnect AC mains and allow the monitor to run on the battery until it shuts off 4 The operating time of a battery reflects its performance directly a Caution The service life of battery depends on the
25. decubitus Mattress 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 Separation distance according to frequency of Rated transmitter m maximum 150 kHz to 80 80 MHz to 800 MHz to output power MHz 800 MHz 2 5 GHz of transmitter 3 5 3 5 a W d VP d WP d WP Y E E 0 01 1 2 0 12 0 23 0 1 3 8 0 38 0 73 1 12 1 2 2 3 10 38 3 8 7 3 100 120 12 23 10 12 PocketSigns PS8x Monitor User s Manual rev1 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 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 AppendixC Factory Defaults This sect
26. ds to the electrodes through the buttons of the electrodes Note For patients who tremble a lot or patients with especially weak ECG signals it might be difficult to extract the ECG signals and it is even more difficult to conduct HR count For severely burnt patients it may be impossible to stick the electrodes on and it may be necessary to use the special pin shape electrodes In case of bad signals care should be taken to place the electrodes on the soft portions of the muscle Check the irritation caused by each electrode to the skin and in case of any inflammations or allergies the electrodes should be replaced and the user should relocate the electrodes every 24h or at a shorter interval Electrode Placement Take the AHA standard as an example when conducting 3 lead ECG monitoring use 3 lead ECG cable The three limb leads of RA LA and LL as shown in below figure will be placed on the relevant locations This connection can establish the lead of I II III 6 4 PocketSigns PS8x Monitor User s Manual rev1 A ha Fig 6 1 Electrode placement 3 The following table shows the ECG electrode label to identify each electrode and its associated color of AHA and IEC standards Electrode Electrode Electrode Electrode labels colors labels colors Placement IEC IEC AHA AHA Directly below the R Red RA White clavicle and near the right shoulder Directly below the L Yellow LA
27. e patient Gi Warning Do not use the SpO sensor on a limb where the NIBP cuff is applied This may result in inaccurate SpO reading due to blocked blood flow during cuff inflation E Do not conduct SpO measurement on the finger smeared with nail polish otherwise unreliable measurement results might be produced E When using finger sensor make sure the nail faces to the light window 5 4 SpO Display O Parameter Display SpO2 3 Fig 5 1 SpO parameter 1 SpO label 2 High alarm limit of SpO 3 Low alarm limit of SpO 4 SpO value 5 SpO unit 5 4 PocketSigns PS8x Monitor User s Manual rev1 Oo Waveform Display Fig 5 2 SpO waveform 1 Pleth waveform 5 5 PR Display 1 2 120 3 50 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 6 SpO Alarm Setup 5 6 1 Switching On Off SpO Alarm 1 Select Menu gt Alarm Setup 2 Set the SpO Alarm to Off to shut off SpO alarm When the SpO alarm is off there is a 2 sign in the SpO parameter display area 5 5 PocketSigns PS8x Monitor User s Manual revl 5 6 1 Seting Alarm Level 1 Select Menu Alarm Setup 2 Set the SpO Alarm to Med or High 5 6 2 Adjusting the Alarm Limit 1 Select Menu Alarm Setup 2 Adjust High If a SpO measurement is higher than the high alarm limit the SpO2 Too High alarm will be triggered 3 Adjust
28. evice can be used in institutions or units with health care capability For instance outpatient departments emergency rooms and departments of internal medicine in hospitals and ordinary departments in clinics nursing hospitals and medical institutions for communities as well as home care 1 2 Components This device consists of a main unit a SpO probe DB9 plugs a 3 lead ECG cable 3 AA batteries a lithium battery optional an AC DC adapter optional an infrared receiving adapter optional and a battery charger optional PocketSigns PS8x Monitor User s Manual rev1 1 3 Main Unit 1 3 1 Front View 3 a ae Fig 1 1 Front view of the monitor f 1 Alarm indicating lamp When an alarm occurs this lamp will light up as defined below e High level alarm the lamp quickly flashes red O Medium level alarm the lamp slowly flashes yellow e Low level alarm the lamp lights yellow without flashing 2 Display screen PocketSigns PS8x Monitor User s Manual rev1 3 Left button Press this button to O Enter the main menu under the monitoring screen e Select the highlighted menu item under the menu screen 4 Right button Press this button to O Change the screen display between Big numeral mode SpO waveform mode and ECG waveform mode under the monitoring screen O Exit current menu under the menu screen 5 Alarm pause button It s invalid to press this button w
29. ges telling the system status Prompt messages are displayed in the technical alarm area 4 2 Alarm Levels 1 By severity the pulse monitor s physiological alarms can be classified into three categories high level alarms medium level alarms and low level alarms E High level alarms Indicate that the patient is in a life threatening situation and an emergency treatment is demanded E Medium level alarms Indicate that the patient s vital signs appear abnormal and an immediate treatment is required E Low level alarms Indicate that the patient s vital signs appear abnormal and an immediate treatment may be required 2 By severity the pulse monitor s technical alarms can be classified into two categories medium level alarms and low level alarms 4 2 PocketSigns PS8x Monitor User s Manual revl a Caution The level of technical alarm can t be changed by the user 4 3 Alarm Indicators When an alarm occurs the pulse monitor will indicate it through the following indications Alarm tone According to the alarm level the monitor s speaker gives alarm sounds in different tones Alarm lamp According to the alarm level the monitor s alarm lamp flashes in different color and speed Alarm message Alarm messages are displayed on the screen Flashing numeric The numeric of the alarm s parameter flashes a Caution For different alarm levels the alarm lamp alarm tone and alarm messages
30. hat the alarm system is working properly You will find the alarm messages for the individual parameter in Appendix D Alarm message 4 8 PocketSigns PS8x Monitor User s Manual rev1 Chapter 5 Measuring SpO 5 1 Introduction The measurement of oxygen saturation of arterial blood also known as pulse oxygen saturation usually shortened as SpO adopts the principles of light spectra and volume tracing The LED emits lights with two specific wavelengths which are selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin The optical receptor measures the changes in the light intensity after the light passes the capillary network and estimates the ratio of oxygenated hemoglobin and the total hemoglobin oxygenated hemoglobin sp0 _x100 oxyhemoglobin deoxyhemoglobin 5 2 Safety Information Ye Warning Use only SpO sensors specified in this manual Follow the SpO sensor s instructions for use and adhere to all warnings and cautions 5 1 PocketSigns PS8x Monitor User s Manual revl Warning When a trend toward patient deoxygenation is indicated blood samples should be analyzed by a laboratory co oximeter to completely understand the patient s conditions Do not use the monitor and the Sp0z sensor during magnetic resonance imaging MRI Induced current could cause burns Prolonged continuous monitoring may increase the risk of unexpected changes in skin characteristics such as irrita
31. he body surface through tissue and humour Different potential changes take place at various parts of the body thus body surface potential differences are formed Changes in potential differences are recorded to form the dynamic curve 1 e ECG also called body surface ECG or regular ECG Through many electrodes connected with ECG cables the monitor examines the changes of body surface potential caused by the patient s heart observes the ECG activities records the ECG waveform and calculates the HR The monitor can achieve 3 lead monitoring 6 1 PocketSigns PS8x Monitor User s Manual rev1 6 2 Safety Information YY Warning It is imperative to only use the ECG electrodes and cables provided by manufacturer or specified in this manual Users shall use the electrode which has little polarization voltage and little contact resistance Check the ECG cable and its package for any signs of damage before use Do not use the cable if any damage is detected When you are connecting the electrodes or the patient cable make sure that the connectors never come into contact with other conductive parts or with ground In particular make sure that all of the ECG electrodes are attached to the patient to prevent them from contacting conductive parts or ground Please check the skin where the electrodes are placed replace the electrodes or relocate the electrodes in case of skin allergy occurs When conducting defibrillation it is imper
32. hen the alarm volume is off O It can pause the alarm for 120s when the alarm volume is on It can change the alarm message to import message when Lead off or Sensor off alarm happens 6 Power button After the batteries are installed O Press this button to turn on the monitor O Press and hold it for 2 seconds to turn the monitor off 7 Up button Press this button to Raise the beat volume under the monitoring screen PocketSigns PS8x Monitor User s Manual rev1 O Move the cursor upwards or increase the value of selected menu item under the menu screen 8 Down button Press this button to Lower the beat volume under the monitoring screen Move the cursor downwards or decrease the value of selected menu item 9 Battery charging indicating lamp e Lights orange when the battery is being charged e Is shuts off when the battery is fully charged or not being charged PocketSigns PS8x Monitor User s Manual rev1 1 3 2 Rear View Fig 1 2 Rear view of the monitor 1 Speaker 2 Battery door PocketSigns PS8x Monitor User s Manual rev1 1 3 3 Side View Top side Down side Left side S Fig 1 3 Side view of the monitor 1 SpO probe connector ECG cable connector Cord hold poa Power supply connector It is used to connect the charger stand 5 Infrared port It is a port through which a personal computer is communicated to export data in real time PocketSigns PS8x Moni
33. his area System time Current time is shown in this area Shift After startup Shift shows the functions of the right button At the time press the right button to shift between different display modes Battery symbol The symbol indicates the current quantity of electricity of batteries PocketSigns PS8x Monitor User s Manual rev1 1 4 2 SpO Waveform Display Mode Continuous Fig 1 5 SpO waveform display mode 1 SpO2 waveform area The waveform shown in this area is the current SpO volume curve 2 SpO parameter area The values shown in this area are the current SpO gt value and its upper and lower alarm limits 3 PR parameter area The values shown in this area are the current PR value and its upper and lower alarm limits PocketSigns PS8x Monitor User s Manual rev1 1 4 3 ECG Waveform Display Mode Continuous SpO02 MM 13 28 Fig 1 6 ECG Waveform Display Mode 1 ECG waveform display area Waveform shown in this area is the current ECG waveform 2 SpO parameter area The values shown in this area are the current SpO gt value and its upper and lower alarm limits 3 HR parameter area The values shown in this area are the current HR value and its upper and lower alarm limits 1 5 Contraindications None PocketSigns PS8x Monitor User s Manual rev1 Chapter 2 Safety 2 1 Safety Information Warning Explosion hazard Do not use the monitor in the presence of flammable anesthe
34. in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol a 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 10 11 PocketSigns PS8x Monitor User s Manual rev1 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
35. ion lists the most important factory default settings These settings can be adjusted and you can load the factory defaults if you need C 1 Alarm Setup Alarm Setup Factory Default Alarm Vol 2 SpO Alarm Level Med PR Alarm Level Med HR Alarm Level Med 10 13 PocketSigns PS8x Monitor User s Manual rev1 C 2 System Setup System Setup Factory Default Beep Vol 2 Key Vol 2 Brightness 3 Scan Speed 25mm s C 3 SpO Setup SpO gt Setup Factory Default SpO2 High Limit 100 SpO2 Low Limit 90 PR Setup Factory Default PR High Limit 120 PR Low Limit 50 C 4 ECG Setup ECG Setup Factory Default HR High Limit 120 HR Low Limit 50 Lead I 10 14 PocketSigns PS8x Monitor User s Manual rev1 ECG Gain x 1 0 Mode MON C 5 Trend Setup Trend Setup Factory Default Interval 30s AppendixD Alarm Message This section lists some important alarm messages In the tables 663699 below means the alarm level is user adjustable D 1 Physiological alarm Messages Cause Level SpO Too High A measurement has risen above SpO Too Low the high alarm limit or fallen Medium below the low alarm limit SpO Desat SpO measurement has fallen High below the SpO Desat PR Too High BRS A measurement has risen above 00 Low UR Tooth
36. ntial 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 1 4 PocketSigns PS8x Monitor User s Manual rev1 Contents Chapter 1 General Introduction comooccccocccnononenonccnnncnnnncccnncnos Did Intended USE a a LAO ON dt 1 3 Main Unit diaria 1 4 Display Vie WS oooooooccccnocononnnooncnnnnnnnnnononononcnnnnnnnnnnnnnincnnnss 1 5 ContraindicatiONS ccooccnnccnnconnconioconaconoconocnnccnnccnncconccnninns Chapter 2 Safety cccscscssssscccsssssccccccssceccecssccecccsscessecssceeseess 2 1 Safety Informati om eeose e airea 2 2 Explanation of Symbols ooooocococococococcnncnnnnnnnnonincnnnnnnnnnns Chapter 3 Basic Operations ooocccooocnnoncncnoccnonocccncccnoncnnnacccnnonos 3 1 Unpacking and Checking oooooccccnnconnnnnonocincnnnnononnnnonincnnnns 3 2 Getting Started ooooocccnnocoonoonococnnonononnnononononcnnnnnnonnnnnnincnnnos 3 3 Starting the MONItOT ococooocnnnncnoccnnncnoncnnnnnnncnnnnnnnninnnnnnnoos 3 4 General Setup oriee A AOTEA EA 3 5 Date and Time Setup ceria E E EES 3 6 Selecting the Work Mode oooooccccncconcnncococoncnnnnnnonnnnnnioncnnnos 3 7 Entering Exiting the Demo Mode 0ooooooooccncncnnnccnnnonicncinnns 3 8 Checking the VerSi0O oooooooococcconononononononcncnnnnnnonnnnnnancnnnos PocketSigns PS8x Monito
37. ons oocccccoooccnnnnnoconnnnnncnnnnnnnnccnnnnnnncnnns 10 1 A 2 Physical Specifications occcccoccnnoococnccnononononnnonancnnnnnnnnnns 10 1 A 3 Environmental Specifications ooooccncccoocnnnnnnnnccnnnnnacinnns 10 2 A 4 Charging Specifications occccocooooocococcnnnoncnnnnnnnoncnnnnnnnnnns 10 2 A 5 Hardware Specifications paesone an RR 10 3 A 6 Data Stora Set ceca notan lalala sli dlls de 10 5 A 7 Infrared Communication ooocccccccnnnnnococnnnnonnnnnnnonincnnnnnnnnnns 10 5 A 8 Measurement SpecificatiONS coooooccnnncnoconnnnnnnconnnnnnnonnns 10 6 AppendixB EMCo oooocccccccnnnnonononnonnnnnnnnanonoconononanannoncoccnncnncnnannnnnnss 10 8 AppendixC Factory Defaults ccccccsscsssssccscscceeseeeeeeesees 10 13 PocketSigns PS8x Monitor User s Manual rev1 CASALS MUDA AAA ERN 10 13 EN EOS 10 14 C3 SpOs AUN A Sa ee ae a eas 10 14 CA ECG Setup ceciciecsssssyecsgsnivarsiectvaecdeatnesdvendteedseatneseveceneness 10 14 C 5 Trend Setup iio idas 10 15 AppendixD Alarm Message ooccccocooccnnonocccnnnnonccnnnonccnnnnocaccninnonocn 10 15 D 1 Physiological alaimo n a 10 15 D2 Technical alartt vs stcssccsuvonsesieteahecesesadacseseadecsabaeady mavens 10 16 PocketSigns PS8x Monitor User s Manual rev1 Chapter 1 General Introduction 1 1 Intended Use The PocketSigns PS8x monitor is intended for continuously monitoring or spot checking of SpO2 PR ECG and HR signals of a single adult pediatric or neonatal patient This d
38. r Down button You can select from 0 to 4 0 is the minimum key volume while 4 is the maximum one 3 4 3 Adjust the Screen Brightness Press the Left button to select the item then set its value through the Up or Down button You can select from 1 to 5 1 is the minimum screen brightness while 5 is the maximum one Selecting the minimum brightness can save power a Caution If the monitor is used outdoors or 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 set its value through the Up or Down button You can select from 12 5mm s to 25mm s 3 3 PocketSigns PS8x Monitor User s Manual rev1 3 5 Date and Time Setup After starting up you need to set the date and time of this monitor Operations are as follows 1 Select Menu System to enter the System menu shown as follows Date 09 12 10 Time 11 06 Load Default Conf Maintenance Version 1 0 Select Return Fig 3 2 System setup window 2 Select the year month and day on the right of Date and set them to the current date 3 Select the hour and minute on the right of Time and set them to the current time 3 6 Selecting the Work Mode The monitor is designed to operate in the continuous monitoring and spot checking mode Its work mode is shown in the technical alarm area You can set the monitor s work mode following these steps
39. r User s Manual rev1 3 9 Restoring the Factory Configuration ccceeeeeeeee eee 3 10 Shutting o Chapter 4 Alarm ff tHE MOI ie 4 1 Alarm Categories ccocooooocococononononcnnoninonnnnnonononnnnnnincnnnnnnnnnns AD Alarm Evelio ada 4 3 Alarm Indicators occocccoccnnccnnccnnccnnccnaconocnnocnnnonnccnnccnnccnnons 4 4 Alarm Status Symbol oooooooocccnncconcnncnoocnnnnnononononnnnnncnnnnnnnnnns 4 5 Alarm Tone Configuration cccococconcnoocnnnnnnnncnnnnnnnoncnnnnnnnnnns 4 6 Pausing the Alarm ToneS oocccccconcnncooocnnnnnnnnnononnnnnncnnnnnnnnnns 4 7 Shutting off the Alarm Volume ooooooccnnnnnnncnnonnnnnncinnnnnnnnns 4 8 When an Alarm OCCUIS ococccnccnnccnnccnnconiccnocnnocnnccnncconccnnccns Chapter 5 Measuring SpO gt 2 ccoooccccnooncccnnnoncccnnnoncccnnnonccccnnnnccccnnocccns SA 5 2 Safety InformatiOn ci cad 5 3 Monitoring Proced te ec and cost a O do ido De 5 4 SpO Display oooooooococcccnonononononoconcnnnonnnnonannoncnnnnnnonnnnnninnnnnos 5 5 PR Display 5 6 SpOs Ad end cae en ane et 527 PR Alarm Setup inline ae PocketSigns PS8x Monitor User s Manual rev1 Chapter 6 Measuring ECG coooonoooococononnnnaneninonconnnnnnnnanicanccnnnanannns 6 1 6 1 Introduction ysis cc ssccee cep siseeecicteeeedeseseeevovane aa a 6 1 6 2 Saf ty Information aau ie e lie eee eee 6 2 6 3 Monitoring Procedure o ooooocnccnnnoncncnnnncncnnnnnnnnnnnnoninonnnnnnnnnns 6 3 GAECO Dispara Aa 6 6
40. s are conducted by the personnel certified by manufacturer The storage condition operation condition and electrical status of the instrument follow the product specification O The instrument is used in accordance with the user s manual 1 2 PocketSigns PS8x Monitor User s Manual rev1 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 and ensures patient s and operator s safety This manual is based on the maximum configuration and therefore some contents may not apply to your product 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 obtained conveniently when needed All illustrations in this manual serve as examples only They may not necessarily reflect the setup or data displayed on your product Conventions Bold Italic text is used in this manual to quote the referenced chapter or section Oo is used to enclose screen texts O is used to indicate operational procedures 1 3 PocketSigns PS8x Monitor User s Manual rev1 Signs in this manual w Warning Indicates a potential hazard or unsafe practice that if not avoided will result in death or serious injury Caution Indicates a pote
41. se performing photodynamic therapy A 6 Data Storage The changing trends of SpO and PR data will be shown in the monitor Displaying way Trend tabular Trend interval 2 seconds to 30 minutes Trend parameter PR SpO Spot check ID from 1 to 99 300 group can be Trend data stored for each ID Continuous ID is 0 60000 group can be stored A 7 Infrared Communication Infrared adapter In compliance with IrDA 1 2 Steady communication gt 0 3 meters distance PocketSigns PS8x Monitor User s Manual rev1 A 8 Measurement Specifications A 8 1 Digicare Digital SpO Spo Technique Digital SpO technique Range 0 100 Resolution 1 70 to 100 2 Accuracy 0 to 69 unspecified Refreshing rate lt 30 seconds Pitch Tone Yes PR Range 25 bpm to 250 bpm Resolution 1 bpm Accuracy 2 or 1 bpm whichever is greater Refreshing rate lt 30 seconds A 8 2 Nellcor SpO SpO Range 0 to 100 Resolution 1 Accuracy 70 to 100 3 0 to 69 unspecified PocketSigns PS8x Monitor User s Manual revl Refreshing rate 7 seconds Pitch Tone Yes PR Range 20 bpm to 250 bpm Resolution 1 bpm Accuracy 3 bpm Refreshing rate Ts A 8 3 ECG Lead type Standard 3 lead RA LA LL or R L F Lead I I Il Gain 2 5mm mV x0 25 5mm mV x0 5
42. tics mixtures with air oxygen or hydrogen When the monitor is in use there should not be any great power appliances as high voltage cables X ray machine ultrasound equipment and high frequency electronic equipment in use nearby Keep the monitor away from dust vibration corrosive substances explosive materials high temperature and moisture The monitor is not designed for the sterilized room The monitor should be handled with care so as to avoid shocks and falls When the monitor is in use it must be ensured the batteries have sufficient capacity otherwise there might be such phenomena as starting up abnormalities or inaccurate measurement data etc PocketSigns PS8x Monitor User s Manual rev1 Warning Do not conduct SpO measurement on the finger smeared with nail polish otherwise this will lead to unreliable measurement results Measurements and pulse signals can be affected by certain environmental conditions sensor application errors 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 and or create invalid readings of the monitor It is advised to check it at least once a month a Caution In order to have more accurate measurement results the monitor should be used in a quiet and comfortable environment PocketSigns PS
43. tion reddening blistering or burns Inspect the sensor site every two hours and move the sensor if the skin quality changes For neonates or patients with poor peripheral blood circulation or sensitive skin inspect the sensor site more frequently Check the SpO sensor and its package for any sign of damage before use Do not use the sensor if any damage is detected When disposing the disposable SpO probe or other SpO probes please observe all local state and federal regulations that relate to the disposal of this products or similar products PocketSigns PS8x Monitor User s Manual rev1 a Caution In case it is necessary to add a clip to fix the fingertip sensor the cable instead of the sensor itself should be clipped Please note that the sensor s cable should not be pulled with force Note m The pleth wave is not equal to the intensity of PR signal E The monitor does not provide automatic self examination alarm signal and the operator has to use SpO simulator for self examination 5 3 Monitoring Procedure 1 Selecting SpO Sensor You can select the SpO2 sensor depending on the patient category weight and application site 2 Connecting SpO Sensor Plug the SpOz sensor cable into the SpO connector on the measurement module 5 3 PocketSigns PS8x Monitor User s Manual rev1 3 Applying SpO Sensor Clean the application site removing any substance such as nail polish and apply the sensor to th
44. tor User s Manual rev1 1 4 Display Views This device has a function of direction sensing Under monitoring screen when the angle between the screen and horizontal plane exceeds 60 corresponding display screen will be shown on the device automatically no matter whether you hold it transversely or longitudinally 1 4 1 Big Numeric Display Mode 6 Continuous X 12 7 SpO2 100 en 50 90 8 4 PR bpm HR bpm 3 9 2 10 1 11 Fig 1 4 Big numeric display mode 1 Menu After startup Menu shows the functions of the left button At the time press the left button to enter Menu 2 Patient ID No When Continuous is selected for work mode the value is 0 at all times when Spot Check is selected the value is between 1 and 99 10 11 12 PocketSigns PS8x Monitor User s Manual rev1 PR parameter area Current PR value and its high and low alarm limits are shown in this area Physiological alarm area Current physiological alarm information is shown in this area SpO parameter area Current SpO value and its high and low alarm limits are shown in this area Technical alarm and prompt information area Current technical alarm and prompt information are shown in this area Alarm status area Alarm status symbols and alarm pause time are shown in this area Pleth bar Pulse intensity is denoted by the quantity of blocks HR parameter area HR parameter and its high and low alarm limits are shown in t
45. ual revl Emissions test Compliance Electromagnetic environment guidance The device uses RF energy only for its Radio frequency internal function Therefore its RF RF emissions Group 1 emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment Radio frequency RF emissions Class B pe The HANDHELD PLUSE MONITOR is Harmonic suitable for use in all establishments EMISSIONS N A including domestic establishments and IEC 61000 3 2 those directly connected to the public low voltage power supply network that Voltage supplies buildings used for domestic purposes fluctuations flic N A ker emissions IEC 61000 3 3 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 assure that it is used in such an environment Immunity test TEC 60601 test level Compliance level Electromagnetic nvironment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air Floors should be wood 6 kV contact concrete or ceramic tile If 8 kV air floors are covered with synthetic material the relative humidity should be at least 30 Electrical PocketSigns PS8x Monitor User s Manual revl fast N A N A N A transient burst EFT I
46. umeric When a physiological alarm occurs the numeric of parameter flashes 4 4 Alarm Status Symbol XX indicates the alarm sound is turned off IX indicates the alarm sound is paused 2 indicates individual measurement alarms are turned off 4 5 PocketSigns PS8x Monitor User s Manual rev1 4 5 Alarm Tone Configuration 4 5 1 Setting the minimum Alarm Volume 1 Select Menu System Maintenance enter the required password 2 Select Min Al Vol and then select a value between 0 and 4 4 5 2 Changing the Alarm Volume 1 Select Menu General Setup 2 Select Alarm Vol and then select a value between X and 4 X is the minimum volume which depends on the setting of the minimum alarm volume and 10 is the maximum volume 4 6 Pausing the Alarm Tones Press the alarm pause button IX to keep the alarm paused for 120 seconds The alarm paused symbol and paused time will show in the alarm status O The audible alarm is paused but the alarm lamp remains lit and the alarm message remains displayed O The remaining alarm pause time is displayed in the alarm status area e The symbol IX is displayed in the alarm status area 4 6 PocketSigns PS8x Monitor User s Manual rev1 Audible alarm starts again automatically after the alarm pause period expires You can also press the IX key to restart the audible alarm 4 7 Shutting off the Alarm Volume Set the Min Al Vol and Alarm Vol to 0 to
47. use a lithium battery for the first time you must charge it following the instructions given in the Battery chapter 3 1 PocketSigns PS8x Monitor User s Manual rev1 Warning m Warning If the monitor is mechanically damaged or if it is not working properly do not use it for any monitoring procedure on a patient Contact your service personnel E To avoid explosion hazard do not use the monitor in the presence of flammable anesthetics vapors or liquids 3 3 Starting the monitor Press the button to turn on the monitor For you to use the monitor more conveniently after starting the monitor you can make the following setting as shown in section 3 4 first 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 the following parameters values Alarm Vol Beep Vol Key Vol Brightness Scan Speed Select Fig 3 1 General setup window PocketSigns PS8x Monitor User s Manual revl 3 4 1 Beep Volume Setup Press the Left button to select the item then set its value through the Up or Down button You can select from 0 to 4 0 is the minimum beep volume while 4 is the maximum one There will be a nce sign at the bottom of the monitoring screen to indicate that the beep volume is off when you select 0 3 4 2 Key Volume Setup Press the Left button to select the item then set its value through the Up o
48. ze gt 30kg MAX P Pediatric foot hand patient size 10 50kg Disposable MAX I Neonatal foot hand patient size 3 20kg MAX N Adult finger or neonatal foot hand patient size gt 40 kg or lt 3 kg DS 100A Adult Reusable OXI A N Adult neonatal OXI P I Pediatric neonatal Digicare SpO sensor Type Patient Category PN Adult PO732 Reusable Pediatric PO723 Neonatal PO723 PocketSigns PS8x Monitor User s Manual revl 10 2 ECG ECG Electrode Type Patient category PN Adult 15 100 0008 Disposable Pediatric Neonatal 15 100 0009 4 pin ECG Cable Type Description Standard PN Snap 3 lead IEC 15 033 0001 Snap 3 lead AHA 15 033 0002 AppendixA Product Specifications A 1 Safety Specifications SFDA classification II CE classification IIb Type of protection against electric shock II with internal power device Degree of protection against electric shock CF Degree of protection against hazards of Ordinary equipment without protection against hazards of explosion explosion Degree of protection a cacao APA against ingress of liquid Equipment type Handheld A 2 Physical Specifications Mainframe weight lt 200g Mainframe size 58 5mm W x123mm H x28mm D Charger weight lt 100g Charger size 96mm W x66mm H x78mm D AC DC ad
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