Ametek iPac User Manual Download Page 37

16040-101 Rev. J 

37

The LMX9838 has been tested and approved to be com-

pliant to the following regulatory standards:

CE Compliance:

• 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: ED9LMX9838 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: ED9LMX9838”.

IC label on the final system must be labeled with “Con

-

tains TX IC: 1520A-LMX9838” or “Contains 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.

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 

receiver.

• 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 autorisée seulement aux 

conditions suivantes :

(1) il ne doit pas produire d’interference et

(2) l’ utilisateur du dispositif doit étre pr?t ? accepter 

toute interference radioélectrique reçu,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.

Regulatory Compliance - Bluetooth

Summary of Contents for iPac

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

Page 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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