background image

16040-101 Rev. J 

7

Symbol Information

Caution

Protective Earth - Indicates that a protective earth ground is connected 

where the symbol is located.

REF

Catalog Number

SN

Serial Number

Manufacturer

2017

Date of Manufacture

Waste of Electrical and Electronic Equipment

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 ETL 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. 

Содержание iPac

Страница 1: ...iPac Pachymeter User s Guide...

Страница 2: ...es 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...

Страница 3: ...0 Instrument Operation 21 Measurement Screen 21 Operation 23 Operational Check 23 Patient Preparation 23 Measurement Process 24 Bluetooth Printing 26 iPac Bluetooth Printer 27 Cleaning and Disinfectio...

Страница 4: ...R 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 OPERATOR OR PATIENT MAY OCCUR WARN...

Страница 5: ...NSDUCER 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 TIP ONLY NEEDS TO LIGH...

Страница 6: ...AGE 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 EL...

Страница 7: ...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 Con...

Страница 8: ...s 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...

Страница 9: ...The iPac Pachymeter may be used easily with the patient in any position making the instrument suitable for the office in clinics at the hospital bedside and in remote locations Bluetooth Technology w...

Страница 10: ...er s Guide and read the instructions carefully 4 Remove the iPac from the case and charge the instrument according to the Charging the iPac Pachymeter section 5 Store the box and insert in a safe plac...

Страница 11: ...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...

Страница 12: ...tton left to go LEFT Move the Control button right to go RIGHT Press and hold the Control button for the indicated time Press the Control button once and then release it Bluetooth ON but not connected...

Страница 13: ...ither on the iPac or the Charging Cradle With a Charging Cradle Note Initially charge the unit for 10 hours Note The Mini USB Port and the Mini USB Plug have a flat side and a curved side The flat sid...

Страница 14: ...to be removed before charging directly 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 Power Up Mode Pressing the...

Страница 15: ...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 RIGHT until the d...

Страница 16: ...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 print...

Страница 17: ...ops 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...

Страница 18: ...connect to the iPac Note The iPac can only have one active Bluetooth connection at a time If a SEARCH is performed while DETECTABLE mode is active the DETECT ABLE mode will be turned OFF and any Blue...

Страница 19: ...down 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 and down the menu 4 To select the new option press the co...

Страница 20: ...d 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 t...

Страница 21: ...e charge the battery Clear Move the control button UP and hold it until the display shows Measurement cleared All data will be cleared and a new measurement can be started Readings This number represe...

Страница 22: ...red the asterisks will change and display the average value The number of measurements are displayed below the asterisks e g 6 25 If it is difficult to get measurements from a patient fewer than 25 me...

Страница 23: ...gularities 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 to activate the iPac Note The instrument will...

Страница 24: ...additional pressure is not required and may lead to injury to the eye Note Do not tap the iPac on the cornea Hold it steadily against the cornea 6 Support the iPac with your hand and if necessary stab...

Страница 25: ...is not 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 th...

Страница 26: ...ta 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 t...

Страница 27: ...sent to the iPac printer and printed A sample printout is shown below Note If the printer fails to print check that the printer is turned on green LED illuminated and ensure that the Bluetooth icon on...

Страница 28: ...ARNING 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...

Страница 29: ...R ONLY THE MEASUREMENT TIP OF THE PACHYMETER OR DAMAGE TO THE ELECTRONICS OF THE PACHYMETER WILL OCCUR 3 Immerse only the measurement tip for 10 minutes in freshly daily constituted solution or minimu...

Страница 30: ...ry 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 harn...

Страница 31: ...his manual Debris on tip Clean sensor tip Mechanical or electronic damage Arrange for service through Reichert Technical Service Group No beeps when measuring Control button not properly pressed Press...

Страница 32: ...ng Atmospheric Pressure range 50 to 106 kPa 14 8 to 31 6 in Hg 5 C 45 C 10 90 106 kPa 50 kPa RANGE OF MEASUREMENTS 200 to 1000 m 5 m ELECTRICAL Measurement tip Ultrasound Frequency 10 5 MHz Straight P...

Страница 33: ...in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 Class B The iPac uses RF energy only for its internal function Therefore its RF emis...

Страница 34: ...cording to the maximum output power of the communications equipment Max Output Power of Transmitter W Separation m 150kHz to 80 MHz d 3 5 V1 Sqrt P Separation m 80 to 800 MHz d 3 5 E1 Sqrt P Separatio...

Страница 35: ...power quality should be that of a typical residential commercial or hospital environment Surge IEC 61000 4 5 1kV Differential 2kV Common 1kV Differential 2kV Common Mains power quality should be that...

Страница 36: ...tion 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 occ...

Страница 37: ...ial 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...

Страница 38: ...Iob 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 squa...

Страница 39: ...er In the Eye I SPTA mw cm2 5 14 5 13 I SPPA W cm2 10 23 10 22 MI unitless 0 171 0 170 Since the iPac is a contact instrument the energy will always be attenuated by the tissue when used as recommende...

Страница 40: ...hnical 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...

Страница 41: ...The IOP correction value is based on data of Ehlers et al 1975 modified from Stodmeis ter 1998 Mean of corneal thickness in healthy subjects 545 m Doughty and Zaman 2000 See adjustment chart indicate...

Страница 42: ...42 16040 101 Rev J Notes...

Страница 43: ...16040 101 Rev J 43 Notes...

Страница 44: ...eichert information ametek com www reichert com Authorized European Representative AMETEK GmbH Business Unit Reichert Carl von Linde Strasse 42 85716 Unterschleissheim Munich GERMANY Tel 49 89 315 891...

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