CUPH2 Patient Monitor
Contents
1. 50 TEE EEN 51 7 Safety E e E d a CN 52 8 Data Management And RevievV 55 S S z H loooidiolq nnnn D1551155707005050707757777747777U7775 55 56 General Thank you for choosing the i Vievver CU PH2 Please read this Operator s Manual carefully and thoroughly before using the i Viewer CU PH2 This Manual contains instructions on how to operate and maintain the i Viewer CU PH2 The features of the i Vievver CU PH2 are all discussed in this Manual It is very important for you to fully understand all the instructions and guidelines discussed in this Manual in order to fully utilize the features of this device and to ensure safe operation CU Medical Systems Inc designs and manufactures all its products in accordance with international standards NS EN 1509001 2000 15013485 1996 MDD 93 42 EEC This ensures that CU Medical Systems Inc provides products of high quality and reliability In this regard e Only persons authorized by CU Medical Systems Inc must do all servicing of the device e You must ensure that the correct batteries are properly installed before using this device e You must operate this device in accordance with the instructions specified in this manual To ensure safety and reliability use only parts and accessories recommended by CU Medical Systems Inc VVarranty e products of CU Medical Systems Inc are designed and manufa2. mum and minimum absorption measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effect s of nonpulsatile absorbers such as tissue bone and venous blood excerpt from Oximax N 595 Pulse Oximeter Operator s Manual Nellcor Puritan Bennett Inc 43 Pulse Oximetry Sensors The i Viewer CU PH2 comes with a DSLOOA reusable Nellcor sensor that is meant to be used with a finger of the patient Other sensors from Nellcor may also be used with the i Vievver CU PH2 The following table shows the all the Nellcor Oximetry sensors that may be used with the i Viewer CU PH2 Choose the sensors to suit the weight of the patient Sensor Type Patient Patient Ideal Site Size MAX disposable Pediatric gt 10 kg forehead FAST Adult d Neonatal Neonatal ball Of the foot Adult gt 40 kg Adult index finger Adult gt 40kg index finger Neonate Pediatric 15 40kg index DURA Y Reusable Pediatric gt 1 kg finger Adult Infant 3 15kg great toe Neonate 1 3kg ball of the foot DYSE Reusable 1 adult gt 30 kg Ear lobe and pinna EAR CLIP DYSPD Reusable Pediatric 3 to 40 kg Index finger PED CLIP DS100A gt 40 kg Index finger Reusable sensors may be reused on different patients after cleaning and disinfecting Disposable sensors may be used only once NOTICE Only Nellcor SPO2 sensors Oximax are compatible with the Nellcor SPO2 modu
3. and the EXIT screen Pressing the MENU button while any of the recording summaries is displayed deletes the particular ECG record from the memory Pressing the MENU button while the DELETE ALL RECORD S screen is displayed deletes all the ECG recording in the memory of the i Viewer CU PH2 The screen is Shown in the following figure DELETE RECORD DELETE ALL RECORD S MEMORY USE 70 Pressing the MENU button while the EXIT screen is displayed takes the MENU to one sublevel higher 36 HR VARIATION HR VARIATION AVERAGE BPM 74 CURRENT BPM 73 PRESS ARROW KEY TO RETURN HR VARIATION shows the variation of heart rate over time The average BPM and the current BPM values are shown on the screen The graph s horizontal axis represents the average BPM Each marking on the vertical scale is equal to 10 BPM DEVICE INFORMATION RECORD REVIEW REVIEW ECG RECORD SER AL NUMBER Software Version DEVICE INFOMATION RETURN TO UPPER MENU DEVICE INFORMATION indicates the Serial Number of the device and the version of its software 37 5 3 4 SAVE AND EX T Submenu Item SAVE AND EXIT LOAD DEFAULT ECG CALIBRATION SAVE AND EXIT LOAD DEFAULT ECG CALIBRATION RETURN TO UPPER MENU Settings When the MENU button is pressed while this is highlighted all the changes done when the MENU operation is entered are saved and thus these become effective When the MENU button is pressed while th
4. battery is empty the prompt BATTERY IS EMPTY is displayed at the center of the LCD screen GE indicates that the i Viewer CU PH2 is powered using the AC DC adapter Time Displays the time elapsed since the device was turned ON Format is hours minutes seconds ee The elapsed time from 00 00 00 to 99 59 59 is displayed If the device is ON beyond 99 59 59 the display wraps around to 00 00 00 Plethysmo graphic wave display Plethysmographic wave display if both ECG and plethysmographic wave States are displayed Alarm limits if only the ECG or the plethysmographic wave is displayed SPO2 Value Displays the SPO2 value of the patient Displays the plethysmographic wave of the patient States 70 to 100 SPO2 value Recording es Indicates the recording status of the I Viewer CU PH2 recording is ongoing States No recording memory is full Memory Space Indicates the availability of memory space indicator Not displayed Memory space Is available States Displayed and flashing 9 out of 10 memory partitions are used up and there is memory for at most 2 hours of recording time 5 3 USER INTERFACE The menu is activated by pushing the MENU button The highlight can be scrolled sideways or up and down by pushing the RIGHT or LEFT button The submenu field values are scrolled by pressing the MENU button The heart rate and SPO2 limit values are incremented decremented using the RIGHT or LEF
5. the IrDA port Do not sterilize the i Viewer CU PH2 There are no user serviceable parts inside the i Viewer CU PH2 For those conditions not specified in this troubleshooting guide please consult the manufacturer or its authorized representatives 53 GENERAL SAFETY CONSI DERATI ONS SAFETY LEVEL POSSI BLE DANGERS and HAZARDS The manufacturer will not be liable for any damage or injury that may arise from an attempt to repair the device beyond what is described in this troubleshooting guide Attempts to repair the i Viewer CU PH2 beyond what NOTICE is described in the troubleshooting guide will make the warranty null and void Do not operate the device in electrically noisy environments near big motors generators or power transformers as these will interfere with the Signals being acquired Some electrode conducting gel may cause skin irritation on some patients users If this occurs switch to electrodes with different conducting gel Turn the device OFF before removing the batteries during battery replacement Do not short the electrodes when the device is ON If the i Viewer CU PH2 is powered by the AC DC adapter do not use the it alongside with high frequency electrocautery equipment The i Viewer CU PH2 may be used alongside with high frequency electrocautery equipment if it is powered by batteries The device is designed to be used only in the acquisition and processing display of surface ECG s The
6. used to change the Lead of the ECG signal being acquired Used to activate the menu MENU button When the menu is activated it is used to select the highlighted menu item RIGHT arrow Used to scroll the menu highlight to the right or downward button This button is also used to turn the QRS beeper ON or OFF 17 UART Port IrDA Port i Viewer CU PH2 right side view IrDA port used to transmit data from the i Viewer CU PH2 to a personal computer using an IrDA transmission UART port used to transmit data from the i Vievver CU PH2 to a personal computer using serial wired connection AC DC Power Port Sensor Port ECG Sensor Port i Viewer CU PH2 back side view SpO2 Sensor Port used to connect the SpO2 sensor to the i VI EVVER CU PH2 ECG Sensor Port used to connect the ECG electrode assembly to the i VI EVVER CU PH2 AC DC Povver Port used to connect the AC DC adapter to the i VIEWER CU PH2 18 Battery Cover i Viewer CU PH2 Bottom View covers the battery compartment The battery compartment Battery Cover contains the four AA batteries that are used to power the device 19 3 1 2 ACCESSORIES onap Electrode Connector ECG Sensor Port Connector 5 electrode Cable and Connector Assembly snap Electrode Connector ECG Sensor Port Connector 3 electrode Cable and Connector Assembly ECG Sensor Port used to connect the cable and connector assembly to Connector
7. 40 SPO2 LIMIT 90 RETURN TO UPPER MENU The screen enables the user to set the limits of the ALARM system of the i Viewer CU PH2 Pressing the RIGHT or LEFT button cycles the highlight through lower limit upper limit and alarm status of ECG and SPO2 alarms Pressing the MENU button while one of the limits or the alarm status is highlighted enables the user to set the limits or the status ALARM SETTING ALARM UNDER 40 BPM LIMIT 40 sam o RETURN TO UPPER MENU The limits are set by pressing the RIGHT or LEFT button while the alarm status is set by pressing the MENU button 33 Submenu Item Settings H The ECG signal is displayed with a 5 mm mvV gain Setting is changed by pressing the MENU button 10 mm mV The EGG signal is displayed with a 10 mm mvV gain ECG GAIN 20 mm mV The ECG signal is displayed with a 20 mm mvV gain ECG is displayed with autoscaled gain When the peak to peak value of the acquired signal is within 0 3 mV to 1 mV the ECG is AUTO displayed using LOmm mV When the acquired signal is beyond the range 0 3 mV to 1 mV the peak to peak value is displayed as 10 mm on the LCD screen The ECG is displayed with a time base of 25 mm s Setting is 25 mm s changed by pressing the MENU button SWEEP SPEED The ECG is displayed with a time base of 50 mm s The ECG waveform is displayed on the main display while the ECG SPO2 plethysmographic wave is displayed on the plethysmographic display
8. CU PH2 i VIFVVER Operator s Manual CardioMefter Serltes Medical Systems Inc CU Medical Systems I nc Operator s Manual I VIEWER CU PH2 ver 1 00 Medical Systems nc OPERATOR S MANUAL Version 1 00 Notice This Operator s Manual applies to i VIEWER CU PH2 the portable ECG and SPO2 monitoring equipment from CU Medical Systems Inc The information contained in this manual is subject to change without prior notice Copyright Copyright 2006 CU Medical Systems Inc Medical Instrument Industry Park 1720 26 Taejang Dong Wonju Si Kangwon Do Korea This document may not be reproduced without prior written consent of CU Medical Systems Inc Medical Systems Inc Table of Contents Table EEGEN 4 General aaa 6 Vie EE 7 17 14 EE 8 Sole le all ao 9 1 How to Use This Manual 10 died Content ol TMS MIMU Alk aaa YY YAY aaa 10 1 2 Safety Messages 11 2 Device Operation Guidelines 12 2 1 Storage and Operating Environment Guidelines 12 2 2 Notes Oni Electrical Safety sey UD oa i anadan 14 2 5 Cleaning and Malhtenafice EE 15 OR Rod ge e UE d e E 16 2 1 Product Ee gll e Le adada aaa a a 16 1 1 COohtrols and P
9. DISPLAY ECG FIRST The ECG waveform is displayed on the main display while the alarm limits are displayed on the plethysmographic display The plethysmographic waveform is displayed on the main display SPO2 FIRST while the alarm limits are displayed on the plethysmographic display 34 5 3 3 RECORD REV EVV RECORD REVIEW REVIEW ECG RECORD CLEAR ECG RECORD HR VARIATION DEVICE INFOMATION RETURN TO UPPER MENU Submenu Item Settings REVIEW ECG Pressing the MENU button while REVIEW ECG RECORD is highlighted displays the RECORD following screen that contains record summary REVIEW RECORD NOV 11 2005 15 37 54 RECORDING MEMORY USE 70 Pressing the RIGHT or LEFT button cycles the screen through all the recordings and the EXIT screen Pressing the MENU button while any of the recording summaries is displayed displays the ECG recording for review This is shown in the following figure REVIEW RECORD LEAD II BPM 60 2 50 SPO2 98 PRESS MENU KEY TO RETURN Pressing the MENU button while the EXIT screen is displayed takes the MENU to one sublevel higher 35 Submenu Item Settings CLEAR ECG Pressing the MENU button while REVIEW ECG RECORD is highlighted displays the RECORD following screen that contains record summary DELETE RECORD NOV 11 2005 15 37 54 PROTECT MEMORY USE 70 Pressing the RIGHT or LEFT button cycles the screen through all the recordings the DELETE ALL RECORDS
10. EVICE SETTING SUBMENU ITEMS DEVICE SETTING BACKLIGHT SYSTEM TIME SEND TO PC IRDA ECG LEAD 5 LEAD RETURN TO UPPER MENU Submenu Item Settings The backlight is always ON Setting is changed by pressing the MENU button BACKLIGHT The backlight is always OFF The backlight is ON for 5 seconds when any key is activated LEFT ARROW MENU RIGHT ARROW The backlight turns OFF after 5 seconds SYSTEM TIME Pressing the MENU button while SYSTEM TIME is highlighted displays the following MONTH 6 2 am om mr Oom a n Pressing the RIGHT or LEFT button cycles the highlight through MONTH DAY YEAR AM PM HOUR MINUTE RETURN TO UPPER MENU MOHTH Pressing the MENU button while any of the date variables is highlighted enables the user to change the date or time variable Values are changed by pressing the LEFT or RIGHT button After the variable is set the user must press the MENU button to go one level higher in the menu subsystem 30 Submenu Item Settings SEND TO PC Pressing the MENU button while SEND TO PC is highlighted displays the following PC COMMUNICATION NOV 11 2005 15 37 54 RECORDING MEMORY USE 70 Pressing the RIGHT or LEFT button cycles the screen through all the recordings the LINK SELECT screen and the EXIT screen Pressing the MENU button while any of the recording summaries is displayed sends the recording to the PC PC COMMUNICATION LINK SELECT UAR
11. F text prompt on the LCD when the leads are off The leads are off when the pads are not properly connected or the cable and connector assembly is damaged 41 5 4 2 ECG Acquisition Using the 5 Electrode ECG Cable Assembly The 5 electrode ECG Cable Assembly can be used by placing the electrodes in the following positions o RA R LA L 2 3 RL N LL F Placement of the RA LA LL and RL electrodes Lecatiom forth infercoctal space an 5 AE forth intercostal space xi left sternal Aen 17 2 midway between VICI and VACA fifth inz rcoztal space at left m delamizulur ine H m eee E i same level as ANCA on aneno axillary bme san bevel as VACA at left ma axillary Lone Placement of the V electrode The following table shows the leads that can be displayed by the device when the 5 electrode ECG cable assembly is used 42 5 4 3 SPO2 Monitoring The i Viewer CU PH2 is fitted with a Nellcor SPO2 Module The SPO2 Module measures functional oxygen saturation in the blood The measurement determines the oxygenated hemoglobin as a percentage of the hemoglobin that can transport oxygen Light Emitting Diodes KKK Photodetector Pulse oximetry vvorks by having light emitting diodes pass red and infra red light into arteriolar vascular beds such as a finger or a toe and having the light detected by a photo detector afterv
12. OTS EEN 17 2 1 S SORE ra a ee eee Tee 20 GEHEIERT ENEE ER Leen BEE 23 4 Operating Controls Indicators Ports And Accessories 23 ale Giel eieiei ge Daban 23 O L nated 24 Ro e EE 24 4 4 Equipment Symbhbols 25 S OPER AU ON aaa YUYUR Yasi 26 Sr Balo NC WEE 26 SEENEN 26 52 EE 27 20 INEI CE EE 29 Device etin HEEN 29 5 3 2 MOMONING E eg Tu e DEE ER 5 3 3 Record ROWI OW vias tte deg 35 210010 Ve Ore a a 38 5 4 Using The i Vievver CU PH2 39 5 4 1 ECG Acquisition Using the 3 Electrode ECG Cable Assembiy 39 Step eg e aaa d 39 Device Preparation 39 User Patient Preparation 39 Step 2 EGG Signal ACQUISITION wisi nrece aaa Rana 41 5 4 2 ECG Acquisition Using the 5 Electrode ECG Cable Assembly 42 5 4 5 5P02 Menitorihe eect dd entities 43 Pul OXIME y EE 44 Application and Connection of the Sensor 45 POZ MORnUOHTNRSAu Da aaa bbbda 45 SPO2 Monitoring Notes and VVarnings 46 6 Maintenance And Troubleshooting 48 G Viale 15121 21 EE 48 6 2 Cleaning ines Viewen 50 6 3 Troubleshooting Gulde
13. T MEMORY USE 70 Pressing the MENU button while the LINK SELECT screen cycles the setting between IrDA and UART PC COMMUNICATION MEMORY USE 70 Pressing the MENU button while the EXIT screen is displayed takes the MENU to one sublevel higher The PH2 is capable of displaying Leads I II 111 aVR 5 LEAD aVL aVF and V Setting is changed by pressing the ECG LEAD MENU button 3 LEAD The PH2 is capable of displaying Leads I II and III 31 NOTICE The backlight draws a considerable amount of power When it is on the battery will be depleted faster than when the backlight is disabled It is recommended that the backlight be turned ON only when absolutely necessary e g device operation in dark places Data Transmission to a Personal Computer Data is transmitted to a personal computer using the IrDA Com Port Serial Adapter or the UART cable The CU Expert ECG Data Management Software must also be running on the PC during data transmission see CU Expert User s Manual To transfer data to a personal computer do the following steps 1 Connect the IrDA Com Port Serial Adapter or the UART cable to the COM 1 or COM 2 port of the PC 2 Ifthe IrDA port is used align the IrDA transceiver of the IrDA Com Port Serial Adapter to the IrDA port of the i Viewer CU PH2 If the UART port is used connect the UART cable to the ECG UART port of the i Vievver CU PH2 3 Open the CU Expert ECG Data Management Softwa
14. T buttons For example to change the BACKLIGHT settings highlight the BACKLIGHT option and then cycle through the choices ON OFF 5 SEC by pressing the MENU button repeatedly When the desired setting is selected effect the change by moving the highlight away from the BACKLIGHT option using the RIGHT or LEFT key There are four main MENU items These are a Device Setting enables the user to change device configuration b Monitoring Setting enables the user to change ECG and SPO2 acquisition parameters c Record Review enables the user to review the recorded ECG signals The average bom trend can also be tracked under the Review submenu d Save and Exit used to exit from the MENU and go back to the ECG display screen When the MENU button is pushed while the device is ON the following is displayed DEVICE SETTING The arrovv buttons can be used to scroll the highlight across the main menu items DEVICE SETTING MONITORING SETTING RECORD REVIEW and SAVE AND EXIT When the RIGHT arrow button is pushed the highlight scrolls to the right When the LEFT arrow button is pushed the highlight scrolls to the left 5 3 1 DEVICE SETTING SUBMENU When the MENU button is pushed while DEVICE SETTING is highlighted the menu goes one level down and the highlight can be scrolled up and down from BACKLIGHT to RETURN TO UPPER MENU Any sub item is entered by pushing the MENU button while the sub item is highlighted 29 D
15. bly is connected properly Check for any apparent damage in the cable and connector assembly The lead connectors should be properly connected to the trunk cable The connections are color coded RA is colored RED LA is colored YELLOW and LL is colored GREEN 5 Attach the electrode connectors to the corresponding electrodes 6 Attach the other end of the trunk cable to the ECG input port of the i Viewer CU PH2 7 Turn the device ON Electrode positions 39 NOTICE Make sure that the disposable electrodes are not yet past their expiration date Do not use electrodes that are past their expiration dates If you are using electrodes that are packaged in a pouch close and reseal the pouch after getting the electrodes that you need Resealing the packaging pouch will help prolong the life of the electrodes Do not reuse disposable electrodes These are for one time use only NOTICE Some electrode conducting gel may cause skin irritation on some patients users If this occurs switch to electrodes with different conducting gel The i Vievver CU PH2 may be left on the patient during defibrillation The device is defibrillation protected 40 Step 2 ECG SIGNAL ACQUISITION As soon as the i Viewer CU PH2 is properly connected to the patient and turned ON it will begin ECG signal acquisition and ECG display It will also automatically begin recording the data in its internal memory During ECG data acquisition th
16. ctured according to international standards NS EN 1509001 2000 15013485 1996 MDD 93 42 EEC Every device that goes out of the assembly line passes through a battery of reliability tests In case of problems our maintenance and exchange policies are in accordance with the relevant consumer protection laws and regulations of the particular country where this device is sold s The warranty period of this device is within two years after the date of purchase e When the device malfunctions during the warranty period it will be repaired free of charge at our service centers e When you submit the device for maintenance please specify the details as listed below The device model serial number date of purchase name of sales representative customer information and a brief description of the problems Name of Product CardioMeter i Viewer CU PH2 Serial No Date of Sales Purchase Representative Customer Contact No Brief Description of Problems Service Request Only CU Medical Systems Inc or its authorized representatives should service the device If the device is serviced by unauthorized personnel during the warranty period the warranty will become null and void CU Medical Systems Inc or its authorized representatives are obliged to service the device free of charge during the warranty period Damage to the device incurred beyond normal use is not covered by the warranty When the device is not functioning p
17. device is not to be used in direct cardiac application i e applied directly to the heart during open chest operations The device will issue a LEADS OFF text prompt on the LCD when the leads are off The leads are off when the pads are not properly connected or the cable and connector assembly is damaged The IrDA transceiver is tested and certified by its NOTICE manufacturer to conform with the provisions of IEC60825 1 54 8 DATA MANAGEMENT AND REVIEW VVhen the i Vievver CU PH2 is turned ON the data is automatically saved in its nonvolatile internal memory The data is then available for review and transfer to external devices Data is stored in the memory of the device in 60 minute memory partitions There are 10 memory partitions for a total recording time of 600 minutes When the device is operated continuously for more than 60 minutes it automatically saves the data in the next memory partition VVhen all of the memory partitions are full turning the device ON makes it operate vvithout saving ECG data 55 9 SPECIFICATIONS ECG SpO2 Device Classification Nellcor Sensor DS100A Alarm Display Data Recording capacity Power Communication Environmental VVeight Input cable Lead Il 11 aVL aVR aVF V With 5 Cable Electrodes Input voltage Bandwidth ECG vertical scales Pulse Rate Perfusion Type CF Defibrillation protected Wavelength Near 660 nm and 890 nm Power Not e
18. e patient or user should keep still to avoid having motion artifacts in the ECG signal Motion artifact is caused by electrical interference from muscular activity As long as the i Vievver CU PH2 is acquiring ECG signal it will do analysis and will indicate the heart rate in bpm It will also prompt the user through the alarm beeper if the ECG it has acquired is abnormal Abnormal ECG is ECG that has a rate outside the range defined by the user NOTICE The CU PH2 will indicate only the heart rate in bpm and whether the ECG signal is normal or not It will not analyze the ECG signal for arrhythmias or other heart abnormalities NOTICE The CU PH2 is capable of acquiring any of the leads Leads I II III aVL aVF aVL and V without having the position of the electrodes changed However only the chosen lead is acquired analyzed and recorded at any given time Do not short the electrodes when the device is ON If the i Vievver CU PH2 is powered by the AC DC adapter do not use the it alongside with high frequency electrocautery equipment The i Viewer CU PH2 may be used alongside with high frequency electrocautery equipment if it is powered by batteries The device is designed to be used only in the acquisition and processing display of surface ECGs The device is not to be used in direct cardiac application i e applied directly to the heart during open chest operations NOTICE The device will issue a LEADS OF
19. ep Turns the QRS synchronized beep ON or OFF d indicates that the QRS synchronized beep is ON States indicates that the QRS synchronized beep is OFF Indicates the gain setting of the ECG display in mm mvV 5 the ECG is displayed with a 5 mm mvV gain 10 the ECG is displayed with a 10 mm mvV gain 20 the ECG is displayed with a 20 mm mvV gain States A the ECG is displayed with autoscaled gain When the peak to peak value of the acquired signal is within 0 3 mV to 1 mV the ECG is displayed using 10mm mvV When the acquired signal is beyond the range 0 3 mV to 1 mV the peak to peak value is displayed as 10 mm on the LCD screen 27 Screen display continued 2 Main Displays the acquired signal from the user This may either be the ECG display or the plethysmographic wave Displays ECG signal in the range 0 05mV to 5 5 mV SES Displays the plethysmographic vvave of the patient Sensor connection Indicates when the leads or the SPO2 probe is OFF status State The battery life is determined using Duracell batteries Indicator can run the device continuously for approximately 5 hours S i indicates that the battery has medium charge In this state the battery can run the device continuously for approximately 3 hours can operate for approximately one hour States T indicates that the battery is almost empty In this state the battery can run the device continuously for approximately 15 minutes more When the
20. er CU PH2 used to transmit data from the i Viewer CU PH2 to a personal computer using an IrDA transmission used to transmit data from the i Viewer CU PH2 to a personal computer using serial wired connection used to connect the AC DC adapter to the i Viewer CU PH2 24 4 4 Equipment Symbols Power ON OFF Switch Attention consult accompanying documents Date of manufacture Signal transfer port Infrared data communications port Battery state displayed on LCD screen Symbol of data recording displayed on LCD screen QRS beeper state indicator displayed on LCD screen 25 5 OPERATI ON 5 1 UNPACKING Upon receiving the device 1 Carefully inspect the packing container for any apparent damage 2 Inspect the unit for apparent damage that it might have sustained during shipping 3 Check the shipping list to ensure that the unit comes with the complete accessories 5 1 1 Battery Installation The battery compartment cover of the i Vievver CU PH2 is located at its bottom side Slide the cover as indicated see the bottom view figure in section 3 1 The i Viewer CU PH2 needs four 4 1 5V AA size batteries The polarities are shown inside the battery compartment NOTICE Avoid storing the batteries at extreme temperatures Batteries perform best when stored and used between 15 C and 55 C Keep batteries in lovv humidity locations vvith lovv temperature variations NOTICE Keep batterie
21. fied limits Operating Conditions Temperature 0 C to 50 C Humidity 5 to 95 non condensing Storage Conditions Temperature 20 C to 70 C Humidit 5 to 95 non condensing Do not store the device in areas that are directly exposed to sunlight Do not store the device in areas with highly fluctuating temperatures Do not store the device near heating equipment Do not store the device in areas where there is high vibration in excess of Category 10 of MIL STD 810E Do not operate or store the device in areas with high concentration of dust Only personnel authorized by the manufacturer shall open the device for servicing The following are the general guidelines in storage and operating environment conditions BS BS RRR RA Do not expose the device to direct sunlight during storage Do not store the device in locations vvith temperature and humidity conditions that are beyond the specified safe range Temperature 20 C to 70 C Relative Humidity 5 to 95 non condensing Do not store the device close to heating equipment and appliances Do not store the device near sources of vibration Do not store and operate the device in locations that are exposed to chemicals explosive gas and solvents Keep the device away from dusty environments There are no user serviceable parts inside the i Vievver CU PH2 Only authorized service personnel should open the device for repairs The Standard Operating Condit
22. he ECG signal is normal or the device keeps an accurate record of the ECG The i Vievver CU PH2 is capable of acquiring any of changed Hovvever only the chosen lead is acquired The user should understand this User s Manual well before attempting to use this device are past their expiration dates electrodes that you need Resealing the packaging During ECG data acquisition the patient or user interference from muscular activit not It will not analyze the ECG signal for which can be used by a qualified physician for the leads Leads II 111 aVL aVF aVL and V analyzed and recorded at any given time GENERAL SAFETY CONSI DERATI ONS Make sure that the disposable electrodes are not yet If you are using electrodes that are packaged in a pouch will help prolong the life of the electrodes should keep still to avoid having motion artifacts in The i Viewer CU PH2 will indicate only the heart rate arrhythmias or other heart abnormalities However analysis without having the position of the electrodes Used consumables disposable electrodes batteries should be disposed of in accordance with local regulations Do not immerse any part of the i Viewer CU PH2 in Do not let any fluid enter the case of the device Do not spill liquids on the case of the device Do not use strong acetone based cleaners in cleaning the device Do not use abrasive materials in cleaning the unit especially the LCD display and the infrared filter on
23. ions are as Follows 45 BS Temperature 0 C to 50 C Relative Humidity 5 to 95 non condensing The standard storage and shipping conditions are as follows BS BS Temperature 20 C to 70 C Relative Humidity 5 to 95 non condensing 13 2 2 Notes On Electrical Safety During operation the device should be placed avvay from sources of electromagnetic interference such as motors generators X Ray equipment radio transmitters cellular mobile telephones and others as these might interfere with the signals being acquired NOTICE The i Viewer CU PH2 is classified as follows It is a Class I Type CF equipment in terms of electrical shock prevention EN 60601 1 It is not proper to operate this device around combustible anesthetic or solvents The noise level is B Class according to EN 60601 1 Safety of Electric Medical Equipment and the noise redemption is B level according to the EN 60601 1 2 Electromagnetic Compatibility Requirements 14 2 3 Cleaning and Maintenance When the case is contaminated with dirt clean the i Viewer CU PH2 using a soft damp cloth moistened with any of the following solvents Soap and water 70 solution isopropyl alcohol Chlorine bleach and water mixture 30 ml bleach liter of water Ammonla based cleaners Hydrogen peroxide Do not immerse any part of the i Vievver CU PH2 in fluids Do not let any fluid enter the case of the device Do not spil
24. is is highlighted the factory default settings are loaded and become effective These settings are shown below reem sino sur spero me eum somom 0 VVhen the MENU button is pressed vvhile this is highlighted the ECG subsystem of the i Vievver CU PH2 is calibrated 38 5 4 USI NG THE i Vievver CU PH2 5 4 1 ECG Acquisition Using the 3 Electrode ECG Cable Assembiy Step 1 Preparation Device Preparation Every time you use the i Vievver CU PH2 1 2 Inspect the physical condition of the device Ensure that the case the control buttons and the ECG port are in good condition Inspect the ECG cable and connector assembly Ensure that the cable insulation and the connectors on both ends electrode side and i Viewer CU PH2 side are not damaged Make sure that you have the proper electrodes Electrodes should be in good condition They must not be past their expiration date Ensure that the conducting gel has not dried out Do not reuse disposable electrodes User Patient Preparation 4 1 Ensure that the areas where the electrodes will be attached are free of moisture grease or dirt See the figure below for the position of the electrodes 2 Shave excessive hair 3 Remove the protective plastic backing of the disposable electrodes Make sure that the conducting gel has not dried out Place the electrodes in the positions indicated in the figure below Ensure that the cable and connector assem
25. l liqulds on the case of the device Do not use strong acetone based cleaners in cleaning the device Do not use abrasive materials in cleaning the unit especially the LCD display and the infrared filter on the IrDA port Do not sterilize the i Viewer CU PH2 Although there are no user serviceable parts inside the i Vievver CU PH2 you can do some maintenance check that will help ensure that the device stays in mint condition Check the case of the device for any apparent damage Check the ports ECG connector port to see that it is tightly in place Check the accessories especially the ECG electrodes to see that they are in good condition and that they have not yet reached their expiration dates RRR A more comprehensive maintenance routine is discussed in the chapter on Maintenance of this User s Manual 15 3 INTRODUCTION 3 1 PRODUCT DESCRI PTION The i Viewer CU PH2 is a lightweight portable battery operated 5 lead Electrocardiogram ECG and SPO2 monitoring device It has a high resolution 320x240 pixels liquid crystal display LCD One of the leads and the plethysmographic wave is displayed simultaneously The i Vievver CU PH2 runs on four AAA size 1 5V batteries It may also run using a supplied AC DC adapter ECG signal acquisition is achieved through a five electrode ECG acquisition assembly with disposable electrodes while SPO2 signal acquisition is done using the recommended Nellcor SPO2 Sen
26. le of the Paramedic CU ER3 Do not use any other sensors aside from the ones recommended 44 Before using carefully read the OxiMax sensor directions for use including all vvarnings cautions and instructions Application and Connection of the Sensor Apply the sensor to the site specified in the table above Connect the sensor cable to the SPO2 Sensor Port as shovvn in the follovving figure 5 2 Sensor Port As soon as the SPO2 Cable is connected the i Vievver CU PH2 acquires the SPO2 signal of the patient SPO2 Monitoring The plethysmographic wave of the patient may be displayed on the screen choosing ECG SPO2 or SPO2 FIRST in the MONITORING SETTING Submenu Set the alarm limits as described in the ALARM submenu of MONITORING SETTING 45 SPO2 Monitoring Notes and VVarnings The SPO2 module in the i Viewer CU PH2 measures functional oxygen saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen The range of the peak vvavelengths and maximum optical povver are stated in the Specifications found in the Appendices of this Operator s Manual This is useful to clinicians performing therapies that are using light emissions e g photodynamic therapy Do not rely solely on SPO2 readings The SPO2 module of the i Viewer CU PH2 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Failure to c
27. n this troubleshooting guide NOTICE Attempts to repair the i Viewer CU PH2 beyond what is described in this troubleshooting guide will make the warranty null and void 50 ACTI ON S TO BE TAKEN CAUSE S POSSIBLE SYMPTOMS CONDITIONS CAUSE S Low Battery Indicator ON Noisy ECG or SPO2 signal Noisy ECG or SPO2 signal Noisy or no ECG or SPO2 signal Noisy or no ECG or SPO2 Signal Faulty connection when using the IrDA port 6 4 Device Life Low Battery The device is operated in electrically noisy environment near generators big transformers big motors Motion artifact The user patient is moving doing exertion of major muscles One or all of the electrodes are not connected or electrode Skin contact is poor SPO2 sensor is not properly attached to the patient Cable and connector assembly is not properly connected to the i Viewer 2 IrDA port filter is contaminated with dirt Replace all batteries with fresh batteries do not use a combination of a fresh battery anda drained battery Do not operate the device in the mentioned environments The patient user should keep still when using the device Check the electrodes See to it that the electrodes have not dried out during storage Check that the SPO2 sensor is properly attached to the patient Check the connection between the ECG cable and connector assembly and the i Vievver CU PH2 Clean the IrDA p
28. nters and sub acute centers Intra hospital transport includes transport of a patient witching the hospital or hospital type facility Home Care use is defined as managed used by a lay person parent or other similar non critical caregiver in the home environment 4 OPERATING CONTROLS INDICATORS PORTS AND ACCESSORIES 4 1 OPERATING CONTROLS Turns the power of the i Vievver CU PH2 ON or OFF ON OFF Switch Scrolls the Menu highlight UP or to the LEFT EC Scrolls the ECG record to the left displaying the earlier parts of a recorded ECG during RECORD REVIEW LEFT BUTTON Changes the ECG Lead acquired by the device when pressed during ECG acquisition Scrolls the Menu highlight DOWN or to the RIGHT gt scrolls the ECG record to the right displaying the later parts of a recorded ECG during RI GHT BUTTON RECORD REVIEW Turns the QRS beep ON or OFF ven Used to activate the menu select an item during menu operation MENU BUTTON 23 4 2 INDICATOR LAMPS On POVVER ON LED L ALARM LED 4 3 PORTS ECG Sensor Port SPO2 Sensor Port IrDA PORT UART PORT AC DC Power port When ON indicates that the i Viewer CU PH2 is ON This LED is colored green When ON indicates an abnormal ECG or SPO2 This is used together with the beeper This LED is colored RED used to connect the ECG electrode assembly to the i Viewer CU PH2 used to connect the SpO2 sensor to the i View
29. ort filter as suggested in the Cleaning section of this manual The i Vievver CU PH2 s device life is dependent on the useful lives of its components When minor components go out of service they can be replaced in designated service centers The flash memory device vvhere the program is stored has a maximum life of 20 years When this period elapses the memory device will have to be replaced and the system program will have to be downloaded again 51 7 SAFETY CONSI DERATI ONS The user must be aware of the following safety considerations when operating the i Vievver CU PH2 These safety considerations had been stated in other parts of this Manual These are repeated here for emphasis and easy reference The safety concerns are labeled according to the seriousness of the resulting injuries when an accident involving these safety concerns occurs a WARNING conditions hazards or unsafe practices that can result in personal injury b CAUTION conditions hazards or unsafe practices that can result in minor personal injury damage to the i Vievver CU PH2 or loss of data stored in the device c NOTICE Notes items that are important during installation operation or maintenance of the device 52 POSSI BLE DANGERS and HAZARDS past their expiration date Do not use electrodes that pouch close and reseal the pouch after getting the the ECG signal Motion artifact is caused by electrical in bpm and vvhether t
30. over the SPO2 sensor site with opaque material in high ambient light conditions may result in inaccurate measurements As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation Disconnect the i Viewer CU PH2 and the SPO2 sensor from the patient during magnetic resonance imaging MRI scanning Induced current could potentially cause burns Do not use SPO2 sensor or cable that appear damaged The SPO2 sensor may remain attached to the patient during defibrillation or while an electrosurgical unit is in use but the SPO2 readings may be inaccurate during defibrillation and shortly thereafter Physiological conditions medical procedures or external agents that may interfere with the monitor s ability to detect and display measurements include dysfunctional hemoglobin arterial dyes low perfusion dark pigment and externally applied coloring agents such as nail polish dye or pigmented cream Each time the i Viewer CU PH2 is used to monitor SPO2 check alarm limits to ensure that they are appropriate for the patient being monitored 46 Do not attach any cable that is intended for computer use to the SPO2 sensor port of the i Vievver CU PH2 Tissue damage can be caused by incorrect application or duration of use of an SPO2 OxiMax sensor Inspect the OxiMax sensor site periodically as directed in the OxiMax sensor directions for use Do not immerse or vvet
31. re in the PC Set the options in accordance with the instructions given in its User s Manual Make the connection by performing the following step Open the serial port and click the OK button in the dialog that prompts for the reception to begin 4 Inthe i Viewer CU PH2 set the appropriate PC link UART or IrDA 5 Choose the recording to be transmitted and begin transmission by pressing the MENU button 6 When transmission begins the following screen is displayed in the LCD display of the i Viewer CU PH2 pl TEXT PROMPT 7 The text prompts indicate the status of the data transmission The follovving are the text prompts that the i Viewer CU PH2 displays a PREPARING FOR TRANSMISSION the i Vievver CU PH2 is preparing for transmission b TRANSFERRING DATA data is being transferred through the IrDA port c TRANSMISSION COMPLETE the data transmission is finished d TRANSMISSION ERROR OCCURRED the data transfer failed 8 As the data transfer proceeds the data transfer progress will be shown through the progress bar When the transmission is finished the TRANSMISSION COMPLETE text prompt is displayed 9 After the data transmission is finished turn OFF the i Vievver CU PH2 32 5 3 2 MONITORING SETTING MONITORING SETTING y DISPLAY ECG SPO2 RETURN TO UPPER MENU Submenu Item Settings ALARM Pressing the MENU button while ALARM is highlighted displays the following screen ALARM SETTING BPM LIMIT
32. roperly it has to be submitted for maintenance immediately When any problems are found in the device or when a danger to bodily harm exists the device has to be repaired immediately by authorized personnel When the need for maintenance arises Please contact CU Medical Systems Inc or its authorized representatives immediately Prepare a summary of the problems x Contact Us You can contact us at the following address and telephone number for services and supplies Product and Order Inquiries International Marketing Team CU Medical Systems Inc Medical Instrument Industry Park 1720 26 Taejang Dong Wonju Si Kangwon Do Korea Tel 82 33 747 7657 Fax 82 33 747 7659 email address sales cu911 com Service Request and Technical Support Customer Service Team CU Medical Systems Inc Medical Instrument Industry Park 1720 26 Taejang Dong Wonju Si Kangwon Do Korea Tel 82 33 747 7657 Fax 82 33 747 7659 email address service cu911 com Our website http www cu911 com Authorized European Representative of CU Medical Systems Inc A M I Italia s r l Via Cupa Reginella N 17A 80010 Quarto Napoli Italy Tel No 0039 0 81 806 34 75 0039 0 81 806 34 75 Fax No 0039 0 81 876 47 69 Email info amitaliasrl it Website www amitaliasrl it 1 How to Use This Manual 1 1 Contents of This Manual s This Operator s Manual contains all the information a user needs to operate the i Vie
33. s are beyond their expiration date replace them immediately Dispose of the expired electrodes in accordance with local regulations If there is any apparent damage to the case of the device consult the manufacturer If there is dirt contamination clean the case as suggested in the section on Cleaning of this Manual When not in use turn the device OFF to prolong the life of its batteries 49 6 2 CLEANI NG THE i Vievver CU PH2 If the case is contaminated with dirt clean the 1 VI EVVER CU PH2 using a soft damp cloth moistened with any of the following solvents Soap and water Chlorine bleach and water mixture 30 ml bleach liter of water Ammonia based cleaners Hydrogen peroxide Do not immerse any part of the i Vievver CU PH2 in fluids Do not let any fluid enter the case of the device Do not spill liquids on the case of the device Do not use strong acetone based cleaners in cleaning the device Do not use abrasive materials in cleaning the unit especially on the LCD display and the infrared filter on the IrDA port Do not sterilize the CU PH2 6 3 TROUBLESHOOTING GUIDE There are no user serviceable parts inside the i Vievver CU PH2 For those conditions not specified in this troubleshooting guide please consult the manufacturer or its authorized representatives The manufacturer will not be liable for any damage or injury that may arise from an attempt to repair the device beyond what is described i
34. s away from direct sunlight Do not attempt to recharge non rechargeable batteries 26 5 2 SCREEN DI SPLAY Upon turning the device ON it vvill display the screen shovvn belovv Screen Display of the i Viewer CU PH2 I ndicates the lead number of the ECG signal being displayed I indicates that LEAD 1 bipolar limb lead is being displayed Il indicates that LEAD II bipolar limb lead is being displayed III indicates that LEAD III bipolar limb lead is being displayed States aVR indicates that LEAD aVR is being displayed aVL indicates that LEAD aVL is being displayed aVF indicates that LEAD aVF is being displayed V indicates that LEAD V is being displayed Indicates the source of the BPM value calculation and the detection of QRS waves in the acquired ECG signal BPM source and QRS detection Displayed the source of the BPM calculation is the ECG signal Not displayed the source of the BPM calculation is the SPO2 signal States Y heart icon is not flashing indicates that no QRS wave is detected Y heart icon is flashing indicates that QRS wave is detected Heart icon alternates between small and large sizes to simulate heart beat display Displays the heart rate in bpm of the acquired ECG signal or the pulse rate of the displa acquired SPO2 signal BPM rate is displayed when it falls within the limits of 30 and 300 bpm States is displayed when the heart rate is beyond the limits of 30 and 300 bom QRS be
35. sors User interaction is through three function buttons LEFT RIGHT and MENU Through these buttons the settings of the device can be changed ECG signals can be recorded in the internal nonvolatile memory of the device The stored signals can later be reviewed These recorded signals can also be transferred to a personal computer that is running the CU Expert ECG Data Management Software The CU Expert is available as an option The i Viewer CU PH2 analyzes the signal it acquires from the user and determines the heart rate of the user The device prompts the user through the beeper and the LED alarm indicator if it detects an abnormal heart rate Abnormal heart rate is any heart rate beyond the normal limits defined by the user 16 3 1 1 Controls and Ports Alarm LED Power Switch LCD Display Power Indicator gt o 1 Left Arrow Button Right Arrow Button Menu Button i Viewer CU PH2 top view Green LED lit when the device is ON Used to turn the device ON or OFF Red LED flashes when the device detects an ECG signal Alarm LED with beat rate that is beyond the normal range defined by the user Displays the following ECG signal acquired from the patient LCD display ECG signal recorded in the memory of the device Plethysmographic wave of the patient Menu Device settings Used to scroll the menu highlight to the left or upward LEFT arrow button This button is also
36. the OxiMax sensor If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure the pulse oximeter is functioning properly To get an accurate reading see to it that there is no excessive motion from the patient and that the sensor is applied properly Do not place the sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line 47 6 MAINTENANCE AND TROUBLESHOOTING 6 1 MAINTENANCE There are no user serviceable parts inside the i Viewer CU PH2 However the user can do simple maintenance tasks that will help prolong the life of the device The following are the activities together with their frequencies that the user can do Used consumables disposable electrodes batteries must be disposed of in accordance with local regulations Turn the device OFF before removing the batteries during battery replacement 48 Maintenance Activities Activity Actions to be Taken Check the battery level Indicator on the LCD display Check the expiration date of the disposable electrodes Check the case of the i Viewer CU PH2 and the accessories for any sign of apparent damage Check for dirt contamination If a message that the battery is low is displayed replace the batteries The i Viewer CU PH2 runs on 4 AA size batteries The device should be turned OFF before the batteries are removed If the electrode
37. the i Viewer CU PH2 Snap Electrode used to connect the cable and connector assembly to Connector the disposable ECG electrodes 20 onap Connector Disposable ECG Electrodes Snap Connector used to connect the electrode to the cable assembly SPO Sensor SPO2 Sensor Port Connector SPO2 Sensor Assembly SPO2 Sensor used to acquire the SPO2 signal from the patient SPO2 Sensor Port used to connect the sensor assembly to the SPO2 sensor Connector port on the i Vievver CU PH2 21 3 1 3 Optional Accessories 45 45 Leather Case Cradle CU Expert Patient Management Software IrDA Cable UART Cable 22 3 2 INTENDED USE The i Viewer CU PH2 is intended for ECG and SPO2 signal monitoring It is intended for the continuous non invasive monitoring of ECG functional oxygen saturation of arterial hemoglobin SPO2 and pulse rate It is intended for use with neonatal pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospitals hospital type facilities intra hospital transport and home environments For prescription use only NOTICE Hospital use typically covers such areas as general care floors operation rooms Special procedure areas intensive and critical care areas within the hospital plus hospital type facilities Hospital type facilities include physician office based facilities sleep labs skilled nursing facilities surgice
38. vards Bone tissue pigmentation and venous vessels normally absorb a constant amount of light over time The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations The ratio of light absorbed is translated into a measurement of functional oxygen saturation 5 2 Pulse oximetry is based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LED in the oximetry OXI MAX sensor serve as light sources a photo diode serves as the photo detector Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of a rterial blood enters the vascular bed and blood volume and light absorption incre ase During diastole blood volume and light absorption reach their lowest point The pulse oximeter bases its SoO2 measurements on the difference between maxi
39. vver CU PH2 properly The i Viewer CU PH2 is designed to acquire display and extract the heart rate of the ECG of a patient user The i Viewer 2 is also equipped with the capability to monitor the SPO2 of a patient s case you have any problems regarding the operation of the device please don t hesitate to contact us s Specifications and information in this manual are subject to change without prior notice 10 1 2 Safety Messages Safety messages are used throughout this manual to emphasize important things that must be follovved during the operation of the i Vievver CU PH2 You must follovv the instructions in all the VVarnings Cautions and Notice messages found throughout this Operator s Manual In the event that the product is damaged due to misuse or negligence by a user the manufacturer or its authorized representatives shall not be responsible for the said damage or loss to the product Conditions hazards or unsafe practices that can result in serious personal injury Conditions hazards or unsafe practices that can result in minor personal injury damage to the CU PH2 or loss of data stored in the device These messages are used to denote items that are important during installation operation or maintenance of the device 11 2 Device Operation Guidelines 2 1 Storage and Operating Environment Guidelines Do not operate or store the device in conditions that are beyond the following speci
40. xceeding 15 mW Alarms when the input ECG Heart Rate Alarm rate is outside the limits defined by the user Alarms when the SPO2 value is 9 2 Alarm outside the limits defined by the user LCD 4 Mono LCD Sweep speed 25mm s 50mm s Viewing time Back light Electroluminescent backlight 600 minutes Disposable Alkaline AA BAT 4ea Battery Pack Capacity 1 Up to 10 hours Adaptor DC 12V 3 6A UART rDA Operating 5 C to 40 C Temperature Storge 40 C to 70 C Temperature Operating 5 to 95 non condensing Humidity Operating 1060 to 500 mbar pressure Altitude 108 x 133 x 38 Wx Lx H 275g Battery ECG Cable CU Medical Systems Inc Address Medical Industry Park 1720 26 Taejang dong Wonju si Kangwon do Korea TEL 82 33 747 7657 FAX 82 33 747 7659 I HOMEPAGE http www cu911 com E mail admin cu911 com Medical Systems Inc 57
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