iPac® Pachymeter
Contents
1. 19 Power Up MOS 220000 14 Measurement 14 SIGSD Mode nennen ende 14 PAC Setup MER enter RR 15 Menu nennen bene er 17 PETE OO NN I7 PDOU en 18 Date TIE ee ee 19 Bel AR REF ANN 20 Instrument Opera Oll GU a een 21 Measurement 21 OU ne ose IR T REA 23 Operational 23 Patient Prepafalion nun een 23 Measurement 24 BIUGIOOUT Printing T m 26 Bluetooth Printer TENER 27 Cleaning and DisInfection oe nre nnns 28 Cleaning Instructions see 28 Measurement Tip Cleaning Instructions 28 Maintenance and 5 0 29 General Maintenance 29 NN FN WN FR EN TO 29 ceps M D 29 TROUDISSNOOIING ac T 30 s seecctta eaa rrert NK tan NF 31 pileo MC I FN HRN EIR PN FR ee 31 Software Revision 31 Guidance amp Manufacturer s Declaration 22 Regulatory Complian2. 3 Give the patient the appropriate time for the anesthetic to start working 16040 101 Rev D 23 Instrument Operation continued Measurement Process 4 Note The corneal surface needs only to be contact 24 Instruct the patient to look straight ahead at a fixation target e g ear nose distant object to minimize eye movement with eyes fully open to prepare for a measurement Hold the iPac Pachymeter as you would a pencil and to enable viewing of the sensor and the patient s cornea where contact will be made For normal corneas central corneal contact is highly recommended ed for a short time Indentation or additional pressure is not required and may lead to injury to the eye Support the iPac with your hand and if necessary stabilize the movement of the iPac by resting your hand against the patient Press and release the Control button one time 2 The iPac will initiate the measurement process and beep once After the beep three asterisks are displayed Minimizing the time the Pachymeter is touching the eye lightly touch the center of the cornea until the iPac completes a series of beeps followed by a single beep After the series of beeps and the final beep remove the iPac from the eye The iPac will display the average reading 16040 101 Rev D Instrument Operation continued Measurement Process continued 10 Move the Control button to the right or left as needed to acquir
3. Bluetooth device is connected Note When the Bluetooth is connected a message is displayed Bluetooth Connected If the connection was unsuccessful then a message is displayed indicating Bluetooth Connection Failed 4 the connection was unsuccessful ensure that the printer has power to it and then repeat the Bluetooth connection process Note When a connection is made to a Bluetooth printer the connection information is stored in the iPac Whenever Bluetooth is turned on and no other connection has been made the iPac will attempt to reconnect to the same printer 16040 101 Rev D Instrument Setup continued iPac Menu Options continued Bluetooth continued Detectable The Detectable mode sets the iPac in a mode that allows qu communication with a Bluetooth compatible computer When this Decane mode is selected the green color is set ON and the iPac is available to connect to a computer however the connection must be established by the computer to enable the transfer of data The iPac s Bluetooth passkey is shown at the bottom of the display when the Detectable mode is active The computer may request this passkey code when attempting to connect to the iPac Note The iPac can only have one active Bluetooth connection at a time SEARCH is performed while DETECTABLE mode is active the DETECT ABLE mode will be turned OFF and any Bluetooth connection with the com puter will be lost If
4. function and then move to the next value using the right or left function Once all changes are made press the control button in and the display will return to the main Date Time menu 16040 101 Rev D 19 Instrument Setup continued iPac Menu Options continued Display The Display screen allows changes to the following options Eye Displays the selected eye as OD OS or OD Right Eye OS Left Eye IOP Corr IOP Correction value is displayed if the Option is set ON The option is indicated by a green or gray icon next to the option Gray is OFF Green is ON An IOP 4 adjustment table is shown in Appendix A IOP Carr e Std Dev Displays the standard deviation for the CCT measurement If this option is set OFF then no standard deviation is displayed Gray is OFF Green is ON Lock The display will change orientation as the instrument is rotated if this option is OFF If the option is ON the orientation of the display remains the same even if the instrument is rotated Gray is OFF Green is ON Contrast Sets the contrast level of the display Use the UP and DOWN Control button function to change the contrast of the screen Language English guag Sets the language of the instrument Languages available are English German French Spanish Portuguese Italian 20 16040 101 Rev D Instrument Operation Measurement Screen In the measureme
5. If a problem persists after using this guide contact Reichert for further assistance SYMPTOM PROBABLE CAUSE CORRECTION Attach the charger to the iPac and fully Battery is defective Replace Battery Battery symbol Low iPac battery Attach the charger to the iPac and low capacity charge it until the icon indicates full Review Measurement Section of this Improper technique manual Multiple inaccurate Debris on tip Clean sensor tip readings Mechanical or electronic Arrange for service through Reichert damage Technical Service Group on puton Ngt Press Control button properly pressed No beeps when Battery is drained na cnarger to the ang charge it until the icon indicates full measuring Mechanical or electronic Arrange for service through Reichert Technical Service Group Battery will not Defective battery Replace iPac battery pack Software anomaly Remove and install the battery pack to reset hardware Error Code Displayed Contact the Reichert Technical Service Malfunction of the iPac Group for technical support and provide error message 30 16040 101 Rev D Specifications PHYSICAL DIMENSIONS ENVIRONMENTAL REQUIREMENTS Size Operational Environment Length 7 05 in 179 mm Ambient Temperature range Width 1 46 in 37 0 mm 50 F to 95 F 10 C to 35 C Height 2 20 in 56 0 mm Relative Humidity range 20 to 80 Atmospheric Pressure range 70 to 106 kPa
6. 20 7 to 31 6 in Hg Weight 3 53 0z 100 g Measurement Tip Diameter 08 in 2 0 mm Transport and Storage Environment 45 C 90 _ 106 kPa Ambient Temperature range 4 e 41 F to 113 F 5 C to 45 C 5c af 10 50 kPa Relative Humidity range RANGE OF MEASUREMENTS 10 to 90 RH non condensing 200 to 1000 um 5 um Atmospheric Pressure range 50 to 106 kPa 14 8 to 31 6 in Hg ELECTRICAL Measurement tip Ultrasound Frequency 10 5 MHz Straight Probe Battery Pack Voltage 3 7V LI ION Battery Pack A C Adaptor Input Voltage 100 240 Vac 50 60 Hz 0 16 A max A C Adaptor Output 5Vdc 1 2A max Disposal This product does not generate any environmentally hazardous residues At the end of its product life follow your local laws and ordinances regarding the proper disposal of this equipment Software Revision The software revision can be obtained by contacting Reichert Inc The serial number identifies the manufacture date and will provide access to the software version 16040 101 Rev D 31 Guidance amp Manufacturer s Declaration Table 201 Guidance and Manufacturer s Declaration Electromagnetic Emissions All Equipment and Systems Guidance and Manufacturer s Declaration Electromagnetic Emissions The iPac is intended for use in the electromagnetic environment specified below The customer or user of the iPac should ensure that it is used in such an environment Guidance The iPac uses RF energy
7. DETECTABLE is activated while the iPac has a Bluetooth connection to a printer the printer connection will be lost After the computer connection is established the iPac can send data to the computer using the PRINT command Please contact your EMR EHR software provider so that they can help configure your system to allow Bluetooth connectivity About The About screen displays the following information Serial displays the serial number of the unit Revision Provides the revision of the operating software of the iPac 18 16040 101 Rev D Instrument Setup continued iPac Menu Options continued Date Time The Date and Time format can be changed in Setup Date Format Sets the month day and year format lefedh 12 or 24 Sets the option to display the hours in 12h 12 hour or 24 hour format Set Allows the user to set the current date and time To make changes to the Date Time 1 Highlight the option you want to change with the control button move up the menu screen 2 Press the control button and the display will change to show the available options 3 Highlight the new option moving up down the menu 4 To select the new option press the control button in and the option is selected and the display will returTTto the main Date Time screen 5 To make changes to the date and time value use the control button up
8. Press and hold the Control button for the indicated time Press the Control button once and then release it Bluetooth ON Bluetooth Connected Printer Connected Printer Not Connected Clear Battery Requires Charging Battery Low Power Battery Fully Charged Battery Charging 16040 101 Rev D Instrument Setup continued Charging the iPac Pachymeter WARNING CARE MUST BE TAKEN TO ARRANGE THE CABLES FOR THE ACCESSORIES SUCH THAT THEY DO NOT PRESENT A TRIPPING HAZARD TO THE EXAMINER OR A DANGER TO THE PATIENT WARNING POSITION THIS INSTRUMENT SO THAT IT IS NOT DIFFICULT TO OPERATE THE DISCONNECTION DEVICE PLUG CAUTION USE ONLY THE SUPPLIED CHARGER PROVIDED WITH THE UNIT IT IS RECOMMENDED THAT THE IPAC BE ATTACHED TO ITS CHARGER OR CHARGING BASE WHEN NOT IN USE TO ENSURE PROPER OPERATION CAUTION DO NOT ATTEMPT TO CHARGE THE IPAC OR POWER THE CHARGING CRADLE USING THE USB PORT OF A COMPUTER OR DAMAGE TO THE IPAC OR COMPUTER MAY OCCUR The iPac can be charged directly with the A C adaptor or on the Charging Cradle In either case it is important to be sure that the Mini USB Plug is correctly oriented to the Mini USB Port either on the iPac or the Charging Cradle Without a Charging Cradle Note The Mini USB Port and the Mini USB Plug have a flat side a curved side The flat side of the Plug has a small rectangular cutout visible from the flat side When connecting the Plug to the Port be sure that the flat side o
9. are missing please contact the Reichert Customer Service Department Contact information can be found on the back cover of this User s Guide 16040 101 Rev D Instrument Setup continued Parts Identification 1 Pachymeter 2 Measurement Tip 3 Control button 4 OLED Display iPac Pachymeter Accessories MW i User Guide P N 16040 101 iPac Pachymeter Carrying Case P N 16040 380 Lanyard P N 13851 096 Measurement Tip Cover P N 16040 027 iPac Rechargeable Lithium lon Battery P N 16042 A C Adapter w Mini USB P N 16040 430 Including Country Specific Pin Connector North America P N 16040 410 001 Australia P N 16040 410 002 United Kingdom Hong Kong Singapore P N 16040 410 003 European Union South America P N 16040 410 004 Korea P N 16040 410 005 Argentina P N 16040 410 006 China P N 16040 410 007 India P N 16040 410 008 Charging Cradle Optional Accessories iPac Pachymeter Charging Cradle P N 16041 iPac Bluetooth Printer P N 16043 When ordering a replacement A C Adapter the corresponding Country Specific Pin must be orders as well 16040 101 Rev D 11 Instrument Setup continued Icon Description lt Move Control button forward to go UP Move the Control button back to go DOWN Move the Control button back to go DOWN Move the Control button left to go LEFT Move the Control button right to go RIGHT
10. button initiates the iPac the display will show Press button to measure after about one minute of inactivity the iPac will go into sleep mode the display will turn off To wake up the iPac press the control button and With Charging the display will light up Cradle Measurement Mode In this mode the iPac has about 15 seconds to start the measurement process if no measurements are taken then the display will show Measurement Timeout and then revert back to the Press button to measure display Sleep Mode The iPac will automatically go into a power saving sleep mode after a period of inactivity the display will turn off Press the control button to exit the sleep mode and resume operation There is no ON OFF switch on this instrument 14 16040 101 Rev D Instrument Setup continued iPac Setup Menu The iPac setup menu enables the user to select the options that are preferred when using the pachymeter Press and hold he Control button for three seconds to display the Setup menu At the top of the Display is a menu title e g SETUP If there is a small arrow on the left or right moving the Control button LEFT or RIGHT will navigate through the menu screens in accordance with the arrows Selecting the LEFT arrow displays the previous menu screen Selecting the RIGHT arrow displays the highlighted selection Selecting options in the menu screens is performed by moving the Control button UP DOWN LEFT or RIG
11. closer to any MHz part of the iPac including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF 80 MHz to 2 5 1 3 V m IEC 61000 4 3 GHz 3V m Recommended Separation Distance d 3 5 V1 Sqrt P d 3 5 E1 Sqrt P 80 to 800 MHz d 7 E1 Sqrt P 800 MHz to 2 5 GHz Where P is the max output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels in each frequency range Interference may occur in the vicinity of equipment marked with the following 2 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 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 The measured field strength in the location in which the ME Equipment or ME Sys
12. the recommended separation distance d in meters 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 32 16040 101 Rev D Guidance amp Manufacturer s Declaration continued Table 202 Guidance and Manufacturer s Declaration Electromagnetic Immunity Equipment and Systems Guidance and Manufacturer s Declaration Electromagnetic Immunity The iPac is suitable for use in electromagnetic environment specified below The customer or user of the iPac should ensure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Test Test Level Level Environment Guidance ESD IEC 61000 4 2 EFT 2kV Mains 2kV Mains IEC 61000 4 4 1kV I Os 1kV I Os Surge 61000 4 5 Voltage Dips Dropout IEC 61000 4 11 Power Frequency 50 60Hz Magnetic Field IEC 61000 4 8 16040 101 Rev D 6kV Contact 8kV Air 1kV Differential 2kV Common gt 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds 6kV Contact 8kV Air 1kV Different
13. to ISPTA 3 Wo is the total time average power For the operating condition giving rise to ISPPA 3 Wo is the ultrasonic power associated with the transmit pattern giving rise to the ISPPA 3 value fc center frequency MHz For MI and ISPPA 3 fc is the center frequency associated with the transmit pattern giving rise to the global maximum value of the respective parameter zsp axial distance at which the reported parameter is measured centimeters X 6 y 6 are respectively the in plane azimuthal and out of plane elevational 6 dB dimen sions in the x y plane where zsp is found centimeters 36 16040 101 Rev D Acoustic Output continued Definitions Continued PD pulse duration microseconds PRF pulse repetition frequency Hz EBD entrance beam dimensions for the azimuthal and elevational planes centimeters Tissue Exposure To Ultrasound Energy The ultrasound energy emitted by the iPac is of low intensity and will have no adverse effects on the patient and or user However the user is still cautioned to perform examinations using the principle of ALARA As Low As Reasonably Achievable All examinations should be done so that the patient receives as little ultrasound radiation as possible Do not hold the mea surement tip against the eye or other tissue with the system activated except when making a measurement Do not make unnecessary measurements Ultrasonic Intensities The iPac has only one mode and ul
14. HT until the desired option is selected highlighted Press D the Control button to activate the desired option The iPac SETUP screens are the following e Bluetooth Bluetooth e Date Time Dat Du Display About e Exit In the Setup menus there are options that will have specific colored indicator icons The colors are Green Icon Indicates this option is turned On Gray Icon Indicates this option is turned Off Q Yellow Icon Indicates this option is in the process of turning On 16040 101 Rev D 15 Instrument Setup continued iPac Setup Menu continued Bluetooth The Bluetooth screen has three options e Bluetooth Press the control button to turn the Bluetooth option ON or OFF llu ei gt Search Highlight the search option and press the control search button to find any Bluetooth printer in the immediate area such as the iPac Bluetooth printer The display will show the devices that have been discovered See printing section in this guide for connection instructions for the iPac Bluetooth printer Detectable This option allows the user to connect with a computer for electronic medical record data transfer Date Time The Date Time menu is used to change the date and time format and also to set the current date and time this will be printed with the measurement data Display The display menu options are The eye can be set to either OD OS or Right Left R L
15. ISE THE PATIENT OF WHAT TO EXPECT DURING A SCAN TO REDUCE REPETITIVE SCANS THE AMERICAN INSTITUTE OF ULTRASOUND IN MEDI CINE AIUM HAS A PUBLICATION MEDICAL ULTRASOUND SAFETY 1994 WHICH HAS MORE INFORMATION ON THIS TOPIC CAUTION AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT CAUTION DO NOT IMMERSE THE IPAC PACHYMETER IN FLUIDS OR DAMAGE TO THE ELEC TRONICS MAY OCCUR CAUTION DO NOT ATTEMPT TO MODIFY THE IPAC PACHYMETER OR PATIENT INJURY AND OR INACCURATE READINGS MAY OCCUR CAUTION THIS DEVICE HAS NOT BEEN TESTED IN CONJUNCTION WITH HF SURGICAL E G ELECTROCAUTERY EQUIPMENT AND SHOULD NOT BE USED WITH SUCH EQUIPMENT 16040 101 Rev D 5 Warnings and Cautions continued CAUTION THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTAINS ELECTROSTATIC DISCHARGE SENSITIVE DEVICES ESDS THAT MAY BE SENSITIVE TO STATIC CHARGES PRODUCED BY THE HUMAN BODY DO NOT REMOVE THE COVERS WITHOUT TAKING PROPER ESDS PRECAUTIONS CAUTION THIS INSTRUMENT IS NOT INTENDED TO BE CONNECTED TO EQUIPMENT OUTSIDE THE CONTROL OF REICHERT INC OR MUST BE TESTED TO AN APPLICABLE IEC OR ISO STANDARDS CAUTION DO NOT USE SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART OF THIS INSTRUMENT AS DAMAGE TO THE UNIT MAY OCCUR SEE MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTION CAUTION DO NOT AUTOCLAVE OR DISINFECT USING HIGH TEMPERATURES EXCEEDING THE RECOMMENDED TEMPERATURES INDICATED IN THE SPECIFICATIONS SECTION OF THI
16. OP Correction can be set ON or OFF e Standard Deviation can be set ON or OFF Locks the screen viewing orientation Sets the contrast on the display Sets the operating language Note Move the control button down to access the language op tion About SENER AUN Displays the serial number and the software revision of the iPac Exit Exits the Setup menu and returns to the Measure screen 16 16040 101 Rev D Instrument Setup continued iPac Menu Options Bluetooth Enable the following options by pressing the Control button The status indicators on th Pac tooth indicate the following Green The Bluetooth function is ON Gray The Bluetooth function is OFF Yellow The iPac is enabling the Bluetooth function Note If you are not using the Bluetooth feature turn this option OFF This will extend the battery life of the iPac Search To perform a search for Bluetooth printing devices perform the following 1 Press the Control button and the iPac searches the local area for Bluetooth devices 2 When the iPac is searching for a Bluetooth device the Bluetooth icon will blink After the icon stops blinking the iPac has completed its search and displays the available devices 3 Highlight the Bluetooth device using the UP or DOWN icon and press the Control button The Bluetooth icon will start blinking After it stops blinking the iPac will display if the
17. OR OR PATIENT MAY OCCUR WARNING ENSURE THAT THE VOLTAGE APPLIED TO THE UNIT IS THE SAME AS THE VOLTAGE THAT IS INDICATED ON THE DATA PLATE OR DAMAGE TO THE UNIT MAY OCCUR WARNING THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURES SUCH AS OXYGEN OR NITROUS OXIDE WARNING THE BATTERY SHOULD ONLY BE REPLACED WITH THE BATTERY SPECIFIED IN THIS MANUAL USE OF ANOTHER BATTERY MAY CAUSE FIRE OR AN EXPLOSION WARNING AFTER EACH PATIENT PERFORM THE CLEANING INSTRUCTIONS AS INDICATED IN THE CLEANING SECTION OF THIS MANUAL WARNING THE BATTERY SHOULD ONLY BE REPLACED WITH THE BATTERY SPECIFIED IN THIS MANUAL USE OF ANOTHER BATTERY MAY CAUSE FIRE OR AN EXPLOSION WARNING DO NOT USE THE IPAC PACHYMETER IF THE MEASUREMENT TIP IS CRACKED CHIPPED OR SHOWS ANY IRREGULARITY OF THE SURFACE TO PREVENT PATIENT INJURY AND OR INACCURATE READINGS WARNING IF THIS INSTRUMENT IS MODIFIED APPROPRIATE INSPECTION AND TESTING MUST BE CONDUCTED TO ENSURE CONTINUED SAFE USE OF THIS INSTRUMENT WARNING DO NOT EXPOSE THE BATTERIES TO TEMPERATURES ABOVE 140 F DISASSEMBLE THE BATTERIES OR DAMAGE TO THIS UNIT AND OR SERIOUS PERSONAL INJURY MAY RESULT 4 16040 101 Rev D Warnings and Cautions continued WARNING DO NOT PLACE A SHORTING DEVICE BETWEEN THE BATTERY TERMINALS OR ALLOW THE BATTERY TO BECOME WET MISUSE OR IMPROPER DISPOSAL OF THIS BATTERY MAY CAUSE IT TO BECOME VERY HOT IGNITE OR EXPLODE DAMAGE TO
18. S MANUAL OR DAMAGE TO THE UNIT MAY OCCUR CAUTION DO NOT ATTEMPT INTERNAL STERILIZATION OF IPAC OR DAMAGE TO THE ELEC TRONICS MAY OCCUR CAUTION USE OF AMMONIA BASED CLEANERS ON THE DISPLAY OLED MAY CAUSE DAMAGE TO THE DISPLAY SEE MAINTENANCE SECTION FOR DETAILED CLEANING INSTRUCTION CAUTION MEDICAL ELECTRICAL EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFOR MATION PROVIDED IN THIS GUIDE PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT CAUTION ELECTROMAGNETIC INTERFERENCE FROM OTHER DEVICES MAY AFFECT THIS INSTRUMENT IF INTERFERENCE IS PRESENT TURN OFF OTHER ELECTRONIC DEVICES OR REMOVE THEM FROM THE IMMEDIATE AREA WHILE OPERATING THIS INSTRUMENT CAUTION ALWAYS ENSURE THE IPAC IS CHARGED SUFFICIENTLY OR ERRATIC READINGS MAY OCCUR USE ONLY THE SUPPLIED CHARGER PROVIDED WITH THE UNIT IT IS RECOM MENDED THAT THE IPAC BE ATTACHED TO ITS CHARGER OR CHARGING BASE WHEN NOT IN USE TO ENSURE PROPER OPERATION CAUTION DO NOT ATTEMPT TO CHARGE THE IPAC OR POWER THE CHARGING CRADLE US ING THE USB PORT OF A COMPUTER OR DAMAGE TO THE IPAC OR COMPUTER MAY OCCUR 6 16040 101 Rev D Symbol Information o REF SN Indicates that important operating and maintenance instructions are included in this User s Guide Protective Earth Indicates that a protective earth ground is connected where the symbol is lo
19. THIS UNIT AND OR SERIOUS PERSONAL INJURY MAY RESULT WARNING ALWAYS KEEP BATTERIES OUT OF THE REACH OF INFANTS AND YOUNG CHILDREN TO PREVENT THEM FROM BEING SWALLOWED IF SWALLOWED CONSULT A PHYSICIAN IMMEDIATELY WARNING NEVER ALLOW LIQUID LEAKING FROM THE BATTERY TO GET IN YOUR EYES OR MOUTH AS THIS LIQUID COULD CAUSE SERIOUS PERSONAL INJURY IF IT COMES IN CONTACT WITH YOUR EYES OR MOUTH FLUSH THEM IMMEDIATELY WITH PLENTY OF WATER AND CONSULT A PHYSICIAN WARNING IN ORDER TO PREVENT PATIENT TO PATIENT TRANSFER OF INFECTION AFTER EACH USE DISINFECT THE MEASUREMENT TIP FOLLOWING ACCEPTED LOCAL CLINICAL PRO CEDURES REGARDING THE USE OF DISINFECTANTS ANY CLINICALLY APPROVED CHEMICAL DISINFECTANT CAN BE USED WARNING MEASUREMENTS SHOULD NOT BE ATTEMPTED WHEN OCULAR INTEGRITY IS QUESTIONABLE THE HANDHELD TRANSDUCER MUST TOUCH THE EYE DURING OPERATION CONSEQUENTLY THE USER NEEDS TO EXHIBIT CARE IN MANIPULATING THE TRANSDUCER FORCE SHOULD NOT BE EXERTED AGAINST THE EYE THE TRANSDUCER ONLY NEEDS TO LIGHTLY TOUCH THE CORNEA WARNING TO ENSURE PATIENT ISOLATION FROM HIGH ELECTRICAL POTENTIAL DO NOT USE THE IPAC ON A PATIENT WHEN THE INSTRUMENT IS CHARGING IPAC CHARGING MUST ONLY TAKE PLACE AT A DISTANCE OF AT LEAST 1 5 M FROM THE PATIENT WARNING IT IS PRUDENT TO MINIMIZE THE PATIENT S EXPOSURE TO ULTRASOUND ENERGY TO A LEVEL AS LOW AS REASONABLY ACHIEVABLE ALARA BY REDUCING THE NUMBER OF SCANS NEEDED TO BE PERFORMED ADV
20. UMBER OF SCANS NEEDED TO BE PERFORMED ADVISE THE PATIENT OF WHAT TO EXPECT DURING A SCAN TO REDUCE REPETITIVE SCANS THE AMERICAN INSTITUTE OF ULTRASOUND IN MEDICINE AIUM HAS A PUBLICATION MEDICAL ULTRASOUND SAFETY 1994 WHICH HAS MORE INFORMATION ON THIS TOPIC Operational Check Measure the patient according to the following procedure and precautions WARNING DO NOT USE THE IPAC PACHYMETER IF THE MEASUREMENT TIP IS CRACKED CHIPPED OR SHOWS ANY IRREGULARITY OF THE SURFACE TO PREVENT PATIENT INJURY AND OR INACCURATE READINGS 1 Before using visually inspect the Pachymeter s sensor for cracks chips or other irregularities Do not use the pachymeter if the tip is cracked chipped or shows any kind of irregularity of its surface 2 Press and release the control button D to activate the iPac Note The instrument will automatically enter the power OFF sequence after inactiv ity of approximately one minute 3 Check the battery icon to ensure that the battery is fully charged If the iPac needs charging plug in the charger until the icon indicates that it is fully charged or place it in the iPac Charging Cradle CAUTION ALWAYS ENSURE THE IPAC IS CHARGED SUFFICIENTLY OR ERRATIC READINGS MAY OCCUR Patient Preparation 1 Advise the patient of the measuring process and what to expect before taking measurements 2 Have the patient sit comfortably and install a drop of topical anesthetic into the eye to be examined
21. ble for the office in clinics at the hospital bedside and in remote locations Bluetooth Technology wireless connectivity enabling communication to associ ated remote devices OLED Color Display Intuitive graphical display for ease of use Device Regulatory Classification Insulation Protection Class Il Ingress Protection IPXO Applied Part Type BF Operation Mode Continuous 16040 101 Rev D Instrument Setup Unpacking Instructions Great care has been taken to deliver your iPac Pachymeter to you The packaging was specifically designed to transport this instrument Please retain the packaging for future use in case transportation is required Removing the iPac Pachymeter 1 2 SE Lift the insert that contains the case and charger out of the box Refer to Figure 1 Unfold the insert and slide the case and charger out of the insert Open the carrying case remove the User s Guide and read the instructions carefully Remove the iPac from the case and charge the instrument according to the Charging the iPac Pachymeter section Store the box and insert in a safe place so that if it is needed for future shipping it will be available The items listed below should be included in the iPac Pachymeter packaging Carrying Case iPac Pachymeter Lanyard Tip Cover User s Guide Battery in the iPac A C Adapter w Mini USB Shipping Box amp Insert Note If any of these items
22. cated Catalog Number Serial Number Date of Manufacture Waste of Electrical and Electronic Eguipment Compliance to Medical Device Directive 93 42 EEC Consult Instructions for Use Indicates that important operating and maintenance instructions are included in this User s Guide Authorized Representative in European Community Fragile Contents in Shipping Container handle with care Keep Dry Package shall be kept away from rain Type BF Product Classification Authorized to mark given by Intertek Semko for conformance with electrical standards C Tick mark for ACMA in Australia Trade Marks Act 1995 and RSM in New Zealand under section 47 of the New Zealand Trademarks Acts 16040 101 Rev D Introduction Congratulations on your purchase of the Reichert iPac Pachymeter This User s Guide is designed as a training and reference manual for operation maintenance and troubleshooting We recommend that you read it carefully prior to use and follow the instructions in the guide to ensure optimum performance of your new instrument If used properly the iPac Pachymeter will provide you with fast accurate and reliable measurements for many years Properly trained eyecare professionals such as ophthalmologists optometrists opticians and eye care technicians should operate this instrument Please retain this manual for future reference and to share with other users Additional copies can be obtained from the Reich
23. ce 95 Uc OU DU ERE ME 36 WY Kc DM 38 POC P Qo RE RE T 39 16040 101 Rev D Warnings and Cautions WARNING AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY DEATH WARNING UNITED STATES FEDERAL LAW AND EUROPEAN REGULATIONS REQUIRE THAT THIS DEVICE BE PURCHASED ONLY BY A PHYSICIAN OR A PERSON ACTING ON BEHALF OF A PHYSICIAN ONLY USERS TRAINED IN THE USE OF OPHTHALMIC INSTRUMENTS THAT CONTACT THE EYE SHOULD USE THIS DEVICE REICHERT TECHNOLOGIES CANNOT BE HELD RESPONSIBLE FOR ANY DAMAGE OR INJURY THAT RESULTS FROM A FAILURE TO FOLLOW DIRECTIONS IN THE USER S MANUAL PLEASE ENSURE THAT YOU ARE ENTIRELY FAMILIAR WITH THE CORRECT PROCEDURES FOR OPERATING THE INSTRUMENT BEFORE USE WARNING THIS INSTRUMENT SHOULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS USER S GUIDE THE SAFETY OF THE OPERATOR AND THE PERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN AMANNER NOT SPECIFIED BY REICHERT TECHNOLOGIES WARNING DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUT AUTHORIZATION FROM THE MANUFACTURER ANY REPAIR OR SERVICE TO THIS INSTRUMENT MUST BE PERFORMED BY EXPERIENCED PERSONNEL OR DEALERS WHO ARE TRAINED BY REICHERT OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY OCCUR WARNING MODIFICATIONS TO THIS INSTRUMENT ARE NOT ALLOWED ANY MODIFICATION TO THIS UNIT MUST BE AUTHORIZED BY REICHERT OR SERIOUS INJURY TO THE OPERAT
24. charge Battery Replacement 1 On the back of the iPac is the battery door Open it by pushing the latch towards the door and lifting the door Disconnect the battery harness from the iPac 3 Replace the battery and connect the battery harness to the iPac Note Be sure that the battery is oriented correctly so Battery Harness that the door can close properly If the bat tery is oriented incorrectly the harness may become damaged and the door may not close If the battery harness becomes damaged the battery will need to be replaced The bat tery should connect at the harness the wires should lay flat along the side of the battery compartment and then attach to the battery at the bottom If the wires are bunched up at the top near the point of connection to the iPac then the battery is oriented incorrectly Do 4 Attach the door and ensure that it latches closed 5 Charge the battery for approximately 10 hours before using Note Refer to Disposal section of this manual for your local laws and ordinances regarding the proper disposal of the battery Incorrect Battery Orientation Storage If the instrument is to be stored for an extended period or prepared for transportation remove the iPac battery to avoid possible damage to the instrument due to battery leakage 16040 101 Rev D 29 Troubleshooting The table below provides a guide for troubleshooting some basic iPac Pachymeter operational problems
25. e There are 3 Bluetooth modes which are visible from the measurement screen of the iPac 06 Bluetooth OFF The Bluetooth icon is not shown x mr 639 OS Bluetooth ON The basic Bluetooth icon is shown Bluetooth The Bluetooth icon is blue with a highlight around ED 05 the icon and indicates that it is connected to Connected device and ready to send data to the device iPac Bluetooth Printer To connect to the iPac Bluetooth printer follow the instructions below 1 Ensure the iPac Bluetooth option is turned on see iPac Menu Options Bluetooth 2 Press the ON OFF button on the iPac printer so that the printer is ON A green LED will indicate the printer is working 3 In the iPac Bluetooth setup mode select the search option and press the control button the Bluetooth icon will blink on and Off while the iPac searches for the printer 4 Once the search is complete the iPac display will usually show the iPac printer as MARTEL MCP7880 Highlight this option and press the control button in the iPac will then connect to the printer The display will show Bluetooth connected Note If the display shows Bluetooth connection failed ensure that the printer is turned on and then repeat the process described above continued 26 16040 101 Rev D Instrument Operation continued iPac Bluetooth Printer continued 5 Exit the iPac setup mode 6 The iPac is now connected to iPac printer to s
26. e breach of warranty strict liability or any other damages resulting from or relating to design manufacture sale use or handling of the product PATENT WARRANTY If notified promptly in writing of any action brought against the purchaser based on a claim that the instrument infringes a U S Patent Reichert will defend such action at its expense and will pay costs and damages awarded in any such action provided that Reichert shall have sole control of the defense of any such action with informa tion and assistance at Reichert s expense for such defense and of all negotiation for the settlement and compromise thereof PRODUCT CHANGES Reichert reserves the right to make changes in design or to make additions to or improvements in its products without obligation to add such to products previously manufactured 38 16040 101 Rev D The IOP correction value is based on data of Ehlers al 1975 modified from Stodmeis ter 1998 Mean of corneal thickness in healthy subjects 545um Doughty and Zaman 2000 See adjustment chart indicated below for more information 16040 101 Rev D Com eal Thickness i 495 505 515 525 235 545 555 555 575 5B 585 BOS 615 G25 535 B45 Correction Value UTE EIU 4 3 2 1 1 1 1 39 y Reichert TECHNOLOGIES Reichert Technologies 3362 Walden Ave Depew NY 14043 USA Toll Free 888 849 8955 Phone 716 686 4500 Email reichert informati
27. e measurements on other eye and repeat the above process 11 To review the measurement data you can toggle between the right and left eye by moving the control button right or left 12 To send the measurement data to a Bluetooth printer or computer EMR system move the Control button down The data will be sent to the connected device if the data IS hot transferred refer to the Bluetooth setup section of this user s guide Note If a Bluetooth device was found and the connection estab lished in Setup then move the Control button down to send the data to the Bluetooth device 13 To clear the measurement data move the control button up and hold it until the display shows measurement cleared 14 Perform the cleaning instructions in the Cleaning and Disinfection section of this manual Note f you are unable to take 25 measurements the average will be displayed for the number of measurements that were taken Either press the control button down once or wait for about 15 seconds and the display will change to show the print and clear icon 16040 101 Rev D 25 Instrument Operation continued Bluetooth Printing Bluetooth is a wireless communication protocol for exchanging data over short distances The iPac uses Bluetooth for printing and communicating with a computer EMR system To setup these options please refer to the iPac Menu Options Bluetooth section of this User s guid
28. end measurement data to the printer after measuring a patient move the Control button down the data will be sent to the iPac printer and printed A sample printout is shown below Narre 12 15 08 09 2011 OD 05 612 814 5 IOP 5 5D 19 50 17 Reichert Note If the printer fails to print check that the printer is turned on green LED illuminated and ensure that the Bluetooth icon on the iPac display shows it is connected Note When a connection is made to a Bluetooth printer the connection information is stored in the iPac Whenever Bluetooth is turned on and no other connec tions have been made the iPac will attempt to reconnect to the same printer 16040 101 Rev D 21 Cleaning and Disinfection iPac Cleaning Instructions Perform the following procedure when cleaning the outside of the iPac Pachymeter CAUTION DO NOT IMMERSE THE INSTRUMENT IN LIQUIDS OR AUTOCLAVE OR DAM AGE TO THE ELECTRONICS OF THE PACHYMETER WILL OCCUR 1 After using the iPac Pachymeter we recommend wiping the outside of the instrument with a soft cotton cloth lightly moistened with 7096 isopropyl alcohol 2 After cleaning wipe the outside of the instrument with a soft cotton cloth lightly moistened with sterile distilled water 3 Dry the unit with a lint free cloth or tissue Note Always store the pachymeter in its case when not being used for an extended period of time Measurement Tip Cleaning Instruction
29. ert Customer Service Department Contact information is provided at the end of this guide Intended Use The iPac Pachymeter is intended to measure thickness of the cornea in the human eye using ultrasound energy Indications for Use The indications for use is to measure the thickness of the cornea Contraindications None Device Description The iPac Pachymeter is an ergonomic hand held Pachymeter that measures central corneal thickness The body of the instrument is designed to fit comfortably in the user s hand facilitating fast and accurate measurements The tip of the Pachymeter contains a sensor which measures central corneal thickness The electronics housed in the ergonomic iPac Pachymeter body process and analyze the waveforms produced by each measurement of the corneal thickness of the eye These are used to produce an averaged pachymetry measurement The measurement is displayed on the Organic Light Emitting Diode OLED display A rechargeable battery is used in the iPac Pachymeter and consists of a lithium ion battery continued 8 16040 101 Rev D Introduction continued Features The iPac Pachymeter has the following features Easy to Use corneal thickness can be measured accurately by medical eye care professionals Portable The iPac Pachymeter weighs just 3 53 oz 100 g and is rechargeable Versatile The iPac Pachymeter may be used easily with the patient in any position making the instrument suita
30. f the Plug is lined up with the flat side of the Port CAUTION IF THE MINI USB PLUG IS NOT ALIGNED PROPERLY WITH THE MINI USB PORT THE PORT MAY BREAK OFF AND THE PLUG MAY BECOME DAMAGED Note It is important to initially charge the iPac Pachymeter for the recommended period of time to ensure correct operation Correct 1 Plug the A C Adaptor with Mini USB into an appropriately volted outlet 2 Connect the Mini USB charging cord to the iPac Pachymeter Incorrect 3 Initially charge the unit for 10 hours d E Without Charging continued Cradle 16040 101 Rev D 15 Instrument Setup continued Charging the iPac Pachymeter continued With a Charging Cradle Note The Mini USB Port and the Mini USB Plug have a flat side a curved side The flat side of the Plug has a small rectangular cutout visible from the flat side When connecting the Plug to the Port be sure that the flat side of the Plug is lined up with the flat side of the Port CAUTION IF THE MINI USB PLUG IS NOT ALIGNED PROPERLY WITH THE MINI USB PORT THE PORT MAY BREAK OFF AND THE PLUG MAY BECOME DAMAGED Note It is important to initially charge the iPac Pachymeter for the recommended period of time to ensure correct operation 1 Plug the A C Adaptor with Mini USB into an appropriately volted outlet 2 Connect the Mini USB charging cord to the Charging Cradle 3 Initially charge the unit for 10 hours Power Up Mode Pressing the Control
31. iPac Pachymeter User s Guide ai Reichert ULTRA PRECISION TECHNOLOGIES TECHNOLOGIES 2014 AMETEK Inc Reichert and Reichert Technologies are registered trademarks of Reichert Inc The Bluetooth word mark figure mark and combination mark are registered trademarks owned by Bluetooth SIG AMETEK is a registered trademark of AMETEK Inc The information contained in this document was accurate at time of publication Reichert Inc reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold ISO 9001 13485 Certified Reichert products are designed and manufactured under quality processes meeting ISO 9001 13485 requirements No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical recording or otherwise without the prior written permission of Reichert Inc Caution Federal law restricts this device to sale by or on the order of a licensed physician Rx Only Table of Contents Warnings and Cautions rischen 4 Symbol Lu ue Lu EET TO T n M E m MEE 8 ISI EIE DIE SEID anne een 10 Unpacking nennen 10 Parts Identification ae 11 C HP 11 Optional Accessories 11 icon DESC MOG TNT m 12 Charging the iPac
32. ial 2kV Common gt 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds Floors should be wood concrete or ceramic tile If floors are synthetic the R H should be at least 30 Mains power quality should be that of a typical residential commercial or hospital environment Mains power quality should be that of a typical residential commercial or hospital environment Mains power quality should be that of a typical residential commercial or hospital environment If the user of the iPac requires continued operation during power mains interruptions it is recommended that the iPac be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be that of a typical residential commercial or hospital environment 33 Guidance 8 Manufacturer s Declaration continued Table 204 Guidance and Manufacturer s Declaration Electromagnetic Immunity Equipment and Systems that are NOT Life supporting Guidance and Manufacturer s Declaration Electromagnetic Immunity The iPac is intended for use in the electromagnetic environment specified below The customer or user of the iPac should ensure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Test Test Level IAS Environment Guidance Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 equipment should be no
33. ic Output MI Ispta 3 IsPPA 3 mW cm W cm Global Maximum Value 0 155 0 014 3 72 0 98 12 2 2 0 MPa 0 70 0 07 W mW 0 040 0 010 0 040 0 010 Associated fe MHz 20 2 1 4 20 2 1 4 20 2 1 4 Acoustic Parameters Zsp cm 0 3 0 3 Beam Dimensions X6 0 11 0 11 cm y 0 11 0 11 PD ms 0 07 0 07 PRF Hz EBD cm Operator Controls There are no operator controls that alter the acoustic output power Uncertainties in the above values are reported as 1 standard deviation The derated intensi ties were derived from those measured in water based on the measured center frequency of the acoustic signal fc MHz and the distance from the transducer to the point at which the intensity was measured d cm using the formula Derated Intensity lt Measured Intensity e 0 069 fc d In compliance with IEC61157 the peak rarefaction acoustic pressure pr is less than 1 MPa the output beam intensity lob is less than 20 mW cm2 and the spatial peak temporal average derived intensity Ispta is less than 100 mW cm2 Definitions ISPTA 3 derated spatial peak temporal average intensity milliwatts per square centimeter ISPPA 3 derated spatial peak pulse average intensity watts per square centimeter MI Mechanical Index pr 3 derated peak rarefactional pressure megapascals associated with the transmit pattern giving rise to the value reported under MI Wo ultrasonic power milliwatts For the operating condition giving rise
34. iver Connect the equipment to outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV techni cian for help Any changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment Caution Exposure to Radio Frequency Radiation This device must not be co located or operating in con junction with any other antenna or transmitter Canada Industry Canada IC This device complies with RSS 210 of Industry Canada Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of this device L utilisation de ce dispositif est autoris e seulement aux conditions suivantes 1 il ne doit pas produire d interference et 2 l utilisateur du dispositif doit tre pr t accepter toute interference radio lectrique recu m me si celle ci est susceptible de compromettre le fonctionnement du dispositif Caution Exposure to Radio Frequency Radiation The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit RF field in excess of Health Canada limits for the general population consult Safety Code 6 obtainable from Health Canada s website www hc sc gc ca rpb 35 Acoustic Output Acoust
35. nt mode the display will have the following information displayed OD OS This represents the patient s eye The highlighted option is the eye selected to be measured The iPac always defaults to the right eye at the beginning of the measurement process Move the control button right or left to select the eye you wish to measure Bluetooth The Bluetooth symbol will be displayed if this option has been turned on in the setup menu If the icon is OD OS Gray then there is no connection to a printer or other device Bluetooth The Bluetooth icon will be blue in color when a connection is Battery made Battery The battery symbol indicates how much battery life is available The battery symbol changes from green full to yellow to red empty When the battery symbol is red it is time to re charge the battery Clear Move the control button UP and hold it until the display shows Measurement cleared All data will be cleared Reading and a new measurement can be started Readings This number represents the CCT measurement IOP Offset for the selected eye To review the measurement of the opposite eye move the control button right or left Print Measurements can be sent to the iPac Bluetooth printer or an EMR computer system Move the control button down to send the measurement data To clear the data after printing move the button up and all the measurement data will be cleared IOP Offset The number the lower right is the IOP Off
36. ntains transmitter module IC 1520A LMX9838 20 1 1 3 End Product Manual Information In the user manual final system integrator must ensure that there is no instruction provided in the user manual to install or remove the transmitter module LMX9838SB must be installed and used in strict accor dance with the manufacturer s instructions as described in the user documentation that comes with the product The following information is required to be incorporated in the user manual of final system 16040 101 Rev D USA Federal Communications Commission FCC This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of FCC Rules These limits are designed to pro vide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with the instructions it may cause harmful interference to radio communica tions However there is no guarantee that interference will not occur in a particular installation If this equip ment does cause harmful interference to radio or televi sion reception which can be determined by tuning the equipment off and on the user is encouraged to try and correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the distance between the equipment and the rece
37. om the date of invoice to the original purchaser An authorized dealer shall not be considered an original purchaser Under this warranty Reichert s sole obligation is to repair or replace the defective part or product at Reichert s discretion This warranty applies to new products and does not apply to a product that has been tampered with altered in any way misused damaged by accident or negli gence or which has had the serial number removed altered or effaced Nor shall this warranty be extended to a product installed or operated in a manner not in accordance with the applicable Reichert instruction manual nor to a product which has been sold serviced installed or repaired other than by a Reichert factory Tech nical Service Center or authorized Reichert Dealer Lamps bulbs charts cards and other expendable items are not covered by this warranty All claims under this warranty must be in writing and directed to the Reichert factory Technical Service Center or authorized instrument dealer making the original sale and must be accompanied by a copy of the purchaser s invoice This warranty is in lieu of all other warranties implied or expressed All implied war ranties of merchantability or fitness for a particular use are hereby disclaimed No representative or other person is authorized to make any other obligations for Reich ert Reichert shall not be liable for any special incidental or consequent damages for any negligenc
38. on ametek com www reichert com AMETEK GmbH Business Unit Reichert Carl von Linde Strasse 42 85716 Unterschleissheim Munich GERMANY Tel 49 89 315 8911 0 Fax 49 89 315 891 99 Email info reichert de ametek com 0120 ISO 9001 13485 Registered September 5 2014 16040 101 Rev D AMETEK ULTRA PRECISION TECHNOLOGIES
39. only for its internal function RF Emissions Group 1 Therefore its RF emissions are very low and are not CISPR 11 Class B likely to cause any interference in nearby electronic equipment Harmonics Class A The iPac is suitable for use in all establishments IEC 61000 3 2 other than domestic establishments and those directly Flicker connected to the public low voltage power supply IEC 61000 3 3 Complies network that supplies building used for domestic power Table 206 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the iPac for ME Equipment and ME Systems that are NOT Life supporting Guidance and Manufacturer s Declaration Electromagnetic Immunity Recommended Separation Distances for between Portable and Mobile RF Communications Equipment and the iPac The iPac is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the iPac can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the iPac as recommended below according to the maximum output power of the communications equipment Max Output Power Separation m Separation m Separation m of Transmitter 150kHz to 80 MHz 80 to 800 MHz 800MHz to 2 5GHz d 3 5 V1 Sqrt P d 3 5 E1 Sqrt P d 7 E1 Sqrt P For transmitters rated at a maximum output power not listed above
40. s Perform the following procedure when cleaning and disinfecting the iPac measurement tip WARNING DO NOT ATTEMPT TO USE THE IPAC IF THERE IS ANY INDICATION THE MEASUREMENT TIP HAS BEEN DAMAGED AND OR THEIR PHYSICAL INTEGRITY HAS BEEN COMPROMISED IF THE MEASUREMENT TIP HAS MADE CONTACT WITH ANYTHING BETWEEN APPLANATIONS CLEAN THE TIP ACCORDING TO THE MEA SUREMENT TIP CLEANING INSTRUCTIONS OR SERIOUS INJURY MAY OCCUR 1 After each patient we recommend wiping the measurement tip with a cotton swab soaked in 7096 isopropyl alcohol CAUTION DO NOT IMMERSE THE INSTRUMENT IN LIQUIDS EXCEPT FOR ONLY THE MEASUREMENT TIP OF THE PACHYMETER OR DAMAGE TO THE ELECTRONICS OF THE PACHYMETER WILL OCCUR 2 Immerse only the measurement tip for 10 minutes in 7096 isopropyl alcohol or an equivalent locally approved disinfectant 3 After cleaning rinse the end of the measurement tip thoroughly with sterile distilled water 4 Dry the measurement tip with a lint free cloth or tissue Note Always store the pachymeter in its case when not being used for an extended period of time 28 16040 101 Rev D Maintenance and Storage General Maintenance This instrument performs an internal check of the unit just before the unit indicates that itis ready to measure If the unit displays that it is ready to measure then the system check was successfully completed and the unit is ready for use Battery Replace the iPac Battery when it stops holding a
41. set number that is associated with the pachymetry reading Standard Refer to Appendix A for the IOP adjustment chart Deviation Std Dev The number in the lower left of the screen is the standard deviation of the CCT measurement The standard deviation is how much variation or dispersion there is from the average measured value Note If the CCT measurement is displayed in orange then the standard deviation is greater than 10 o gt 10 This is an indication that another set of measurements should be taken 16040 101 Rev D 21 Instrument Operation continued Measurement Screen continued Asterisks When the instrument is ready to take measurements three asterisks are displayed on the screen After five or more measurements are acquired the asterisks will change and display the average value The number of measurements are displayed below the asterisks e g 6 25 If itis difficult to get measurements from a patient fewer than 25 measurements can be taken the average will be based on the fewer measurements Clearing Data To clear data on the display move the Control button up for about 2 seconds until the display indicates that the measurements have been cleared 22 Asterisks 16040 101 Rev D Instrument Operation continued Operation CAUTION IT IS PRUDENT TO MINIMIZE THE PATIENT S EXPOSURE TO ULTRASOUND ENERGY TO ALEVEL AS LOW AS REASONABLY ACHIEVABLE ALARA BY REDUCING THE N
42. tem should be observed to verify normal operation If abnormal performance is observed additional measures many be necessary such as re orienting or relocating the ME Equipment or ME System Over the frequency range 150 kHz to 80 MHz field strengths should be less then V1 V m 34 16040 101 Rev D Regulatory Compliance Bluetooth The LMX9838 has been tested and approved to be com pliant to the following regulatory standards CE Compliance e EN 300 328 v1 7 1 EN 301 489 17 v1 2 1 IC Compliance RSS GEN Issue 1 RSS 210 Issue 7 Annex 8 and RSS GEN issue 2 FCC Compliance FCC Part 15 Subpart C 20 1 FCC INSTRUCTIONS 20 1 1 Safety Information For Rf Exposure 20 1 1 1 FCC Radiation Exposure Statement This module may only be installed by the OEM or an OEM integrator The antenna used for this transmitter must not be co located or operating in conjunction with any other antenna or transmitter OEM integrators and End users and installers must be provided with antenna installation instructions and transmitter operating condi tions for satisfying RF exposure compliance Only the antenna filed under FCC ID EDOLMX9838 can be used with this device 20 1 1 2 End Product Labeling FCC ID label on the final system must be labeled with Contains TX FCC ID ED9LMX9838 or Contains trans mitter module FCC ID EDOLMX9838 IC label on the final system must be labeled with Con tains TX IC 1520A LMX9838 or Co
43. trasonic intensity settings are not under the control of the user Thus the values below are the values to be expected for a typical transducer In Water In the Eye SPTA mw cm2 5 14 5 13 SPPA W cm2 10 23 10 22 Ml unitless 0 171 0 170 Since the iPac is a contact instrument the energy will always be attenuated by the tissue when used as recommended However since the focal length point of maximum intensity is very short 1 mm and thus penetration into the eye is limited the water values are effectively the same as the tissue values for all practical purposes If more accuracy is desired the intensity in the eye at the transducer focus corresponding to maximum intensity may be calculated according to the formula recommended by the FDA It Iw x e 0 069 x f x 2 where It is the estimated in situ intensity Iw is the measured intensity in water at the focus of the transducer f is the ultrasonic frequency and z is the distance from the face of the measure ment tip to the transducer focus which is the point of measurement 1mm The nominal fre quency of these transducers is 20 MHz The actual frequency of a particular transducer may vary from this value The tissue calculations above were done with the measured frequency of the transducer used for the tests 16040 101 Rev D 37 Warranty This product is warranted by Reichert Inc against defective material and work manship under normal use for a period of three years fr
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