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Warnings and Cautions

9

Cautions

A caution indicates a condition that may lead to equipment damage, malfunction, or inaccurate operation.

Federal law (US) restricts this device to sale by, or on the order of a licensed physician. This
instrument should be used only under the supervision of a physician.

1. Perform the functional self-test if the SmartMonitor 2 has been x-rayed by an airport security check.
2. Do not place liquids on or near the SmartMonitor 2. Liquids may damage the electronic components

inside the monitor. Should liquid spill onto monitor, shut monitor off and call Respironics to have it
serviced.

3. Do not send information via modem during electrical storms. Information could be lost or equipment

could be damaged.

4. Handle the lead wires carefully to prevent them from breaking inside the insulation. Always grasp the

lead wire at the

strain relief area

to remove them from the

electrodes

or patient cable.

5. Insure that the auxiliary devices used do not exceed SELV (Safety Extra Low Voltage) levels as

described in EN60601-1. It is the dealer’s responsibility to ensure that auxiliary devices comply with
either UL2601-1 or UL544.

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Содержание SmartMonitor2

Страница 1: ...Professional Operator s Manual ...

Страница 2: ...H IMPLIED WARRANTY IMPOSED BY LAW SHALL BE LIMITED TO A PERIOD OF NINETY 90 DAYS FROM THE DATE OF THE INITIAL PURCHASE FROM RESPIRONICS User Owner Responsibility This Respironics equipment and the authorized accessories are designed to work as described in the operator s manual The user s of this equipment should not use parts that have failed exhibit excessive wear are contaminated or otherwise i...

Страница 3: ...C Part 15 14 Getting to Know the Monitor 15 SmartMonitor 2 Features 15 Top Panel Features 15 POWER Button 15 RESET Button 15 Front Panel Features 16 Patient Input Connector 16 Respiration Lights 16 Heart Lights 16 Speaker 16 System Lights 16 Side Panel Features 17 Self Test Connector 17 Memory Card Optional 17 Back Panel Features 18 Remote Alarm Optional 18 Modem Optional 18 DC Power 18 I O Connec...

Страница 4: ...ess and hold the POWER button Hold both buttons down for 5 seconds 45 Release POWER button continue to hold the RESET button until the monitor turns off 45 Monitoring the Baby s Breathing 46 Respiration Light 46 Apnea Light 46 Monitoring the Baby s Heart Activity 47 Heart Rate Light 47 High Heart Rate Light 47 Low Heart Rate Light 47 Portable Operation of the SmartMonitor 2 49 Charging the SmartMo...

Страница 5: ...ontents Performing a Functional Self Test 60 Self Test Troubleshooting 61 Troubleshooting 63 Ordering Information 65 Glossary 67 Appendix A 69 Flow Chart of SmartMonitor 2 Parameters 69 Specifications 71 Index 73 ...

Страница 6: ...Table of Contents ...

Страница 7: ... of these activities exceeds the limits prescribed by the physician Patient alarm limits are set by the health care professional before the SmartMonitor 2 monitor is delivered to the patient During monitoring when the baby s breathing effort and heart activity are not within these set boundaries an indicator light comes on and an alarm sounds This manual explains how to set up the SmartMonitor 2 h...

Страница 8: ...rate signals were recorded using infant electrocardiogram electrodes The Alice system was used to gather physiological signals and record signals for airflow breathing effort and movement All Alice System data were reviewed by a qualified credentialed clinician using an Alice polysomnograph system Waveforms were manually reviewed and scored on an electronic medium The beat breath detection and ala...

Страница 9: ...al patient Demographic Summary Ethnicity Clinical Site Number of Patients Male Female Cauca sian African American Asian Hispanic Other Mean Birth Weight grams Mean Gesta tional Age Weeks Site 1 10 6 4 10 0 0 0 0 1779 70 31 10 Site 2 5 4 1 3 2 0 0 0 2340 40 32 80 Site 3 10 2 8 2 2 2 3 1 3746 90 39 20 Site 4 7 3 4 4 2 0 1 0 1387 00 30 00 Site 5 13 4 9 8 1 0 4 0 1504 46 29 77 Site 6 7 5 2 6 1 0 0 0 2...

Страница 10: ...with Alarm Apnea without Alarm Site 1 25 21 20 28 21 17 Site 2 2 2 3 2 2 3 Site 3 3 12 6 3 13 6 Site 4 10 21 10 11 11 9 Site 5 21 19 25 18 19 28 Site 6 7 22 10 11 19 6 Totals 68 97 74 73 85 69 Analysis of Results SmartMonitor Apnea with Alarm SmartMonitor 2 Apnea with Alarm Difference SmartMonitor 2 SmartMonitor Difference 68 73 5 6 8 The sensitivity for SmartMonitor is 100 68 142 47 89 with 95 co...

Страница 11: ...SmartMonitor 2 SmartMonitor Difference 97 85 12 12 3 The false apnea rate for SmartMonitor is 97 95 95 1 01 The false apnea rate for SmartMonitor 2 is 85 95 95 0 89 SmartMonitor Apnea with No Alarm Missed Event SmartMonitor 2 Apnea with No Alarm Missed Event Difference SmartMonitor 2 SmartMonitor Difference 74 69 5 6 8 ...

Страница 12: ...Introduction 6 ...

Страница 13: ... This could result in strangulation 11 Do not connect to an electrical outlet controlled by a wall switch to prevent inadvertently turning the power off to the monitor 12 Do not block the speaker or place items in front of the speaker located on the front of the unit This could prevent the monitor alarm from being heard 13 Never use the monitor on the baby while the baby is being bathed This could...

Страница 14: ...nce 19 If monitoring two or more infants in the same area keep the monitors patient patient cables and lead wires at least three 3 feet apart Having the patient cables and lead wires close together may cause missed apneas due to interference 20 Do not connect the infant to the SmartMonitor 2 if the monitor is placed in the Communications Mode The apnea and heart alarms do not work when the SmartMo...

Страница 15: ...age the electronic components inside the monitor Should liquid spill onto monitor shut monitor off and call Respironics to have it serviced 3 Do not send information via modem during electrical storms Information could be lost or equipment could be damaged 4 Handle the lead wires carefully to prevent them from breaking inside the insulation Always grasp the lead wire at the strain relief area to r...

Страница 16: ...Warnings and Cautions 10 ...

Страница 17: ...uced by the heart If the SmartMonitor 2 detects the heart rate limit outside the range ordered by the physician a light will come on and an alarm will sound How the Alarms Operate Whenever the patient s breathing effort and heart activity are not within the limits set by the physician an indicator light will come on and an alarm will sound The SmartMonitor 2 has two types of alarms patient and sys...

Страница 18: ...y Charging Temperature 10ºC to 35ºC IEC Classification The SmartMonitor 2 is classified as Class II Internally Powered Type BF Applied Part Ordinary Protection against the ingress of liquids Not suitable for use in the presence of a flammable anesthetic mixture with air or with nitrous oxide Continuous Operation Symbols Table Symbol Definition Attention Important information that should be read At...

Страница 19: ... of devices that may be connected to the line as determined by the total number of RENs contact the telephone company to determine the maximum RENs for the calling area If the SmartMonitor 2 causes harm to the telephone network the telephone company will notify you in advance that temporary discontinuance of the service may be required But if advance notice is not practical your telephone company ...

Страница 20: ...nnections of the power utility telephone lines and internal metallic water pipe system if present are connected together This precaution may be particularly important in rural areas Caution Users should not attempt to make such connections themselves but should contact the appropriate electric inspection authority or electrician as appropriate The Ringer Equivalent Number REN assigned to the Smart...

Страница 21: ...ray POWER button turns the SmartMonitor 2 on When you turn the monitor on all lights and the alarm come on briefly and the monitor performs a system test After a pause monitoring will begin To turn the monitor off do the following Press and hold the blue RESET button Press and release the gray POWER button Wait 2 seconds and then release the RESET button RESET Button The blue RESET button resets t...

Страница 22: ...et by the physician The red low light comes on when SmartMonitor 2 detects a heart rate lower than the limit set by the physician Speaker The SmartMonitor 2 speaker allows you to hear any alarm that sounds during monitoring System Lights The lights across the bottom of the front panel indicate if the SmartMonitor 2 is working properly Light Indicates Power The power to the SmartMonitor 2 is on Cha...

Страница 23: ...nt cable and SmartMonitor 2 are working properly See the section Performing a Functional Self Test for more information Memory Card Optional The Memory Card transfers monitor data out of the monitor to give to the physician See the section on Transferring Monitor Memory for more information Memory Card Push button to remove Memory Card Memory Card LA Connection RA Connection ...

Страница 24: ... Memory for more information See the sections on FCC Part 68 and IC CS 03 for information on connecting the modem to the telephone line DC Power Use the DC Power connector with the power cord battery charger Whenever the SmartMonitor 2 is not in portable use on battery power only it should be connected to the battery charger I O Connector This connector connects the SmartMonitor 2 with other devic...

Страница 25: ...onitor 2 is in Menu mode The SmartMonitor 2 will beep once every 10 seconds to signal that it is powered on and in Menu mode To Set or Modify Parameters Manually Enter Menu Mode Press the POWER button to turn the monitor ON After a short delay the display will read INITIALIZING PLEASE WAIT Then MENU MODE ENTER PROPER KEY SEQUENCE Press the keys in the following sequence within 10 seconds Down arro...

Страница 26: ...ATIENT NAME To enter the Patient Name Press Enter to begin entering patient name Press t or u to browse through the alphabet and select the letter you need When the letter you want appears press Enter Press Enter twice to place a space in between the first and last name When you have finished the name press t or u until the appears Then press Enter The is just before the letter a Press t to procee...

Страница 27: ...t based on frequency of detected respiratory effort Values OFF 4 5 6 7 8 9 10 12 14 16 18 20 25 30 breaths per minute Standard value OFF All Menus Alarm Menu Bradycardia Alarm BRADYCARDIA ALARM BPM Establishes the LOW heart rate alarm set point based on the average detected ECG signal Values 40 50 60 70 80 90 100 beats per minute Standard value 80 bpm All Menus Alarm Menu Bradycardia Alarm Delay B...

Страница 28: ...s violated and an entry is made into the Patient Events Log EVENT LOG Patient alarms are acknowledged by an entry in the Patient Events Log but no waveforms are recorded CONTINUOUS Active waveforms are recorded continuously regardless of alarm conditions All equipment related events are entered in the Equipment Events Log All Menus Record Menu Apnea for Record APNEA RECORD LIMIT in seconds Allows ...

Страница 29: ...the number of seconds that waveforms are recorded prior to the occurrence of a physiologic event and after the event has terminated PRE defines the number of seconds that waveforms will be recorded prior to the event POST defines the number of seconds that waveforms will be recorded after the event has terminated Values 30 15 30 60 45 45 60 30 30 30 75 15 60 15 45 15 seconds Standard value 30 15 s...

Страница 30: ...lect whether or not waveforms will be recorded on Auxiliary 3 Standard value OFF For additional information refer to the Auxiliary Signal Interface section of this manual All Menus Record Menu Auxiliary 4 Record RECORD AUXILIARY 4 This parameter allows the user to select whether or not waveforms will be recorded on Auxiliary 4 Standard value OFF For additional information refer to the Auxiliary Si...

Страница 31: ... the date the display will stop flashing Press t to proceed to the next menu or u to move to the previous menu All Menus System Menu Time TIME To enter the Time Press Enter to begin Press t or u until the number required is displayed Press Enter to select Once you have entered the time the display will stop flashing Press t to proceed to the next menu or u to move to the previous menu All Menus Sy...

Страница 32: ...ssible messages Insert Card Retry Transferring Data Data Transferred This menu is used to down load the recorded data to the PCMCIA card To move data to the PCMCIA card Press the ENTER button The word NO will begin to blink To select YES press either arrow button Should a PCMCIA card not be inserted the monitor will ask for the card Place card in slot located just below the display Press the ENTER...

Страница 33: ...ss the ENTER button 3 times Scroll to MENU OPTIONS and press ENTER Scroll to SYSTEM MENU and press ENTER The following table lists the additional options available from the System menu Menu Option LCD Display Description of Option or Instructions Date Format DATE FORMAT Permits the selection of two formats for displaying the DATE MONTH DAY YEAR or DAY MONTH YEAR Standard value Month Day Year Memor...

Страница 34: ...BLK SW REVISION Display only menu Displays the revision of the Boot Block Code Serial Number SERIAL NUMBER Display only menu Displays the Serial Number View Menu Mode Should there be a need the SmartMonitor 2 also allows you to use a View Only option of the Menu Selections The caregiver can download monitor data to a PCMCIA card using the View Menu but cannot make any changes to the settings in th...

Страница 35: ... cable to the number 1 slot on the AIB The other end of the cable should be connected to the auxiliary device Insert into the I O connector on the back of the SmartMonitor 2 Connect device interface cable into the 1 slot on the AIB and the other end into the external device Before turning on the SmartMonitor 2 insure that the external devices are connected For every signal you want to record you w...

Страница 36: ...Using Auxiliary Equipment 30 ...

Страница 37: ... cables extended out rather than coiled up Set the simulator to output respiration and heart beats at rates and amplitudes that are appropriate and in the normal range with respect to the patients age Determine that the monitor detects respiration and heartbeats at the rates to which the simulator is set Place the simulator in the apnea mode for two 2 minutes Determine that the monitor continues t...

Страница 38: ...Dealer Preparation for Home Setup 32 ...

Страница 39: ...eave your emergency phone number s and procedures with the caregiver s Step 1 Set the SmartMonitor 2 on a Clean Flat Surface Be sure the speaker is not blocked To avoid interference be sure that no other electrical appliances are within three feet of the monitor patient and patient leads Make sure the monitor is close enough to connect to the baby comfortably Step 2 Connect the Patient Cable to th...

Страница 40: ...et snaps into place When you need to remove a lead wire grasp and pull at the strain relief area located near the connecting tip Do not grasp the wire Use of the third green RL electrode and lead wire is normally not required but may help reduce excessive false low heart rate alarms Step 4 Connect the Lead Wires to the Electrodes Insert the black LA lead wire into one electrode Insert the white RA...

Страница 41: ...ocated along the mid line of the side just below or lined up with the nipples Be sure the lead wires and patient cable are leading down and away from the baby s face and neck see illustration Baby s right side Baby s left side The white lead wire location is illustrated with a white electrode Step 6 Wrap the Electrode Belt around the Baby Wrap the belt around the baby s chest and fasten it with th...

Страница 42: ...Home Setup 36 Baby s right side Baby s left side ...

Страница 43: ...wo finger widths below or lined up with nipples Place the electrode with the black lead wire on the baby s left side along the mid line of the side two finger widths below or lined up with nipples An electrode belt is not needed when using disposable electrodes Use of the third green RL electrode and lead wire is normally not required but may help reduce EMI interference Place the green electrode ...

Страница 44: ...he monitor will now come on When the SmartMonitor 2 is not operating portably keep the power cord battery charger connected and plugged into an AC outlet at all times Insure that the AC outlet has been installed to conform to the National Electrical Code NEC The batteries cannot be overcharged The green charger light stays on as long as the charger is connected The Power Cord Connector must be plu...

Страница 45: ...device will allow you to hear the alarm from a different room from where the monitor is located If an Alarm Sounds If an alarm sounds while the baby is being monitored check the baby first Then follow the instructions below to respond to lights and alarms Always check the baby s skin color Is it normal Always check to see if the baby is breathing If the baby is not breathing follow the Respond Lik...

Страница 46: ...eck the connections between the electrodes lead wires patient cable and the monitor If something has come loose reconnect it and press the RESET button The alarm should stop If alarm continues to sound see section Performing a Functional Self Test Red Loose Lead Continuous Baby is breathing and is responsive Color is good If the monitor passed the Functional Self Test turn off the monitor Then che...

Страница 47: ...minutes if the monitor has not been plugged in The yellow light will continue to flash This is a warning that the battery is too low for the SmartMonitor 2 to operate properly The SmartMonitor 2 must be recharged Turn the monitor off Then recharge the battery See Charging the Battery in this manual If you do not recharge the battery the system will automatically shut down Memory Full Flashing yell...

Страница 48: ...stop However the yellow light remains on until you press the RESET button Power Continuous green light continuous alarm with no other lights lit Check the display for error messages If no error messages are displayed the SmartMonitor 2 was turned off improperly causing a sibling alarm To resolve Press and hold the blue RESET button Press and release the gray POWER button Wait 2 seconds then releas...

Страница 49: ...finger widths below or lined up with the nipples The skin should be clean and dry If the skin is unusually dry you may add a few drops of moisture water to the baby s skin prior to electrode belt placement When using the black reusable electrodes ensure that the electrode surface is clean The optional green RL electrode and lead wire may help reduce EMI interference Place the green electrode along...

Страница 50: ...Reducing False Alarms 44 ...

Страница 51: ...rtMonitor 2 section in this manual and be sure you have followed all instructions Turning the Monitor off Sibling Alarm The SmartMonitor 2 has a built in safety feature called a sibling alarm If the monitor is not turned off in a specific sequence the green power light will remain on and the alarm will sound continuously This safety feature makes sure the power is not accidentally turned off To tu...

Страница 52: ...SmartMonitor 2 detects breathing again the beeping alarm stops The red light will stay on until you press the RESET button Low Breath Rate You the health care professional may have set the SmartMonitor 2 to signal Low Breath Rate If so the following will occur Breath rate falls below the setting but pauses are short and do not cause an apnea alarm The apnea light will blink twice each second and t...

Страница 53: ...ked high heart rate will come on and the alarm beeps twice each second The beeping alarm stops when the condition no longer exists The red light stays on until you press the blue RESET button Low Heart Rate Light When the SmartMonitor 2 determines that the baby s heart rate is lower than the limit set by the physician the following will happen The red light marked low heart rate will come on The a...

Страница 54: ...Monitoring the Baby 48 ...

Страница 55: ...ing on the level of use number of alarms and other factors When the low battery light comes on you should recharge the battery immediately A fully drained battery should be recharged for 6 hours When you need to recharge the SmartMonitor 2 battery follow the steps below Connect the power cord battery charger to the back panel of the SmartMonitor 2 Plug the power cord battery charger into a power o...

Страница 56: ...tery pack or batteries The batteries contain electrolytes which can cause injury to eyes skin and clothing Do not dispose of the old battery in fire or incinerator The battery pack contains ingredients that could be explosive and cause serious personal injury Cautions A caution indicates a condition that may lead to equipment damage malfunction or inaccurate operation The battery pack has a lockin...

Страница 57: ...Safely dispose of all old battery packs in accordance with your area s environmental laws 4 Insert the connector of the new battery pack into the plug located in the upper left corner It can only be inserted one way See figure 2 Place the battery pack in the battery compartment Secure the battery pack in the proper position by aligning the Velcro on the battery pack to the Velcro in the battery co...

Страница 58: ...Transferring SmartMonitor 2 Information 52 ...

Страница 59: ...ta and needs the space occupied by the old data To recover the old data using a PCMCIA card Transfer the data to the card using the SmartMonitor 2 Now import the card into Synergy E When prompted with Only obtain data not previously retrieved answer NO to obtain all data Synergy E will then display all the data that was in the SmartMonitor 2 To recover the old data by downloading using Synergy E C...

Страница 60: ... is programmed to call at 7am but fails to make a connection after 8 attempts it will stop trying The next day at 7am it will try again This will continue until a connection is made Modem Auto Answer in Communications Mode The SmartMonitor 2 must be connected to AC power during modem download 1 Connect a phone cord from the wall jack to the modem connector on the back of the SmartMonitor 2 2 To al...

Страница 61: ...n emergency and access to the telephone is required while the modem is in use remove phone cord from modem slot and use a working phone 2 To allow the SmartMonitor 2 to work with the modem when the monitor is in monitor mode the baby is being monitored When the Home Care Dealer calls for a download and the phone rings the caregiver should press and hold down the blue RESET button Hold down the RES...

Страница 62: ...lay will read 4 INITIALIZING PLEASE WAIT 5 Then 6 MENU MODE ENTER PROPER KEY SEQUENCE 7 Press the keys in the following sequence within 10 seconds 8 Press the ENTER button 9 The display will read SMARTMONITOR 2 MENU SELECTION 10 Press the u arrow until you see Move Data To Card 11 Press the ENTER button The word NO will begin to blink To select YES press either arrow button 12 Press the ENTER butt...

Страница 63: ...ort on the monitor and the COM Port on the computer The monitor can be placed in Communications Mode Press and release the POWER button to turn the SmartMontior 2 on Press and hold the blue RESET button Wait until the monitor alarms constantly Release the RESET button Briefly press and release the RESET button again The SmartMonitor 2 display will read Monitor is in Communication Mode The SmartMon...

Страница 64: ...Transferring SmartMonitor 2 Information 58 ...

Страница 65: ...ust be rinsed well to remove any traces of soap film Soap film can prevent heart and breathing signals from being picked up clearly by the monitor Insure that the electrodes are completely dry before using Soft Carrying Case Although the care label in the carrying case suggests machine washing in warm water the appearance of the carrying case will change noticeably after washing Respironics recomm...

Страница 66: ...according to the instructions given by the health care professional You should also perform the test After a lead wire is changed After the patient cable is changed To perform the functional self test follow the steps listed below Insert the patient cable into the socket located on the front of the monitor Connect the lead wires to the patient cable Insert the white lead wire into the opening labe...

Страница 67: ...han half a minute the batteries are completely discharged Turn the monitor off using the correct Power Off procedure described in the Turning the Monitor Off Sibling Alarm section in this manual Make sure the power cord battery charger is plugged into a live power outlet and is properly connected to the monitor See Charging the Battery for more information Allow the battery to charge approximately...

Страница 68: ...Caring for the SmartMonitor 2 62 ...

Страница 69: ...ts Pressing RESET will not silence alarm Internal error condition detected by SmartMonitor 2 Reduce likelihood of electrostatic discharge around SmartMonitor 2 Contact your dealer If an Error number is displayed on the LCD the LCD is located on the bottom of the monitor record this information Contact your dealer If there is an internal software error a special power off procedure is required Pres...

Страница 70: ...nections between electrodes lead wires and patient cable are not properly made Defective lead wires Defective patient cable Defective electrodes Internal part failure Verify that a baby s skin underneath electrodes is clean b electrodes are clean and c lead wires are fully inserted into the electrodes and patient cable Replace lead wires and perform Functional Self Test Replace patient cable and p...

Страница 71: ...30VAC 50HZ 5000 SmartMonitor 2 Simulator ECG Respiration 9510 Small Disposable Sticky Electrodes 3 electrodes per set Pkg of 5 sets 9515 Large Disposable Sticky Electrodes 3 electrodes per set Pkg of 5 sets 9520 1 Safety Lead Wires Pin to Socket 24 in 080 in socket 9521 1 Safety Lead Wires Pin to Socket 40 in 080in Socket 5 pair per package 9916 12 Start up Accessory Kit 6 pair electrode belts 6 p...

Страница 72: ...Ordering Information 66 ...

Страница 73: ...s are working properly Heart rate The number of heart beats per minute Impedance The opposition offered by an electrical circuit to the flow of an alternating current measured by the ratio of the effective applied voltage to the effective current This is the method used by SmartMonitor 2 to detect respiration LA Connection The opening on the patient cable marked LA is the connector for the black l...

Страница 74: ...Appendices 68 ...

Страница 75: ... Time Record Impedance Memory Status Clear Memory Dial if Memory Full Record Resp Rate Record Heart Rate Record ECG Record Auxiliary 1 Record Auxiliary 2 Record Auxiliary 3 Record Auxiliary 4 Date Time Rate Display Computer Phone When to Call Move Data to Card Dial if Memory Full Ext Physio Trigger Ext Equip Trigger Record Resp Rate Ext Physio Trigger Ext Equip Trigger System Setup Menus Patient N...

Страница 76: ...Appendices 70 ...

Страница 77: ...hours of continuous HR trend and impedance Oximetry or other signals can be recorded with reduced capacity Signal Channels Internal QRS heart rate trend and impedance Oximeter Saturation and pulse or pulse rate External Input Airflow pH strain gauge or other low frequency physiological signals 1 25 V maximum Event Parameters Internal Apnea Record Apnea Alarm Low Breath Rate Bradycardia for Record ...

Страница 78: ...Specifications 72 ...

Страница 79: ...ient alarms 11 S setting up the SmartMonitor 2 steps 33 sibling alarm 45 SmartMonitor 2 contents 15 SmartMonitor 2 features back panel 18 front panel 16 side panel 17 top panel 15 SmartMonitor 2 turning it off 45 SmartMonitor 2 turning it on 45 system alarms 11 system alarms responding to 41 T transferring information 53 using a memory card 56 troubleshooting 63 W warnings and cautions 7 ...

Страница 80: ...H577 4000 10 KK 5 3 06 ...

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