Ametek iPac User Manual
iPac® Pachymeter
User’s Guide
©2017 AMETEK, Inc.
iPac, 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.
16040-101 Rev. J 3
Table of Contents
Warnings and Cautions ........................................................... 4
Symbol Information.................................................................. 7
Introduction .............................................................................. 8
Instrument Setup .....................................................................10
Unpacking Instructions ........................................................10
Parts Identication ...............................................................11
Accessories .........................................................................11
Optional Accessories ...........................................................11
Icon Description ...................................................................12
Charging the iPac Pachymeter ............................................ 13
Power Up Mode ...................................................................14
Measurement Mode ............................................................14
Sleep Mode .........................................................................14
iPac Setup Menu .................................................................15
iPac Menu Options .............................................................17
Bluetooth ..........................................................................17
About ................................................................................18
Date/Time .........................................................................19
Display ..............................................................................20
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 Disinfection .......................................................28
iPac Cleaning Instructions ...................................................28
Measurement Tip Cleaning Instructions ..............................28
Measurement Tip High Level Disinfection Instructions ...... 29
Maintenance and Storage .......................................................30
General Maintenance ..........................................................30
Battery .................................................................................30
Storage ................................................................................30
Troubleshooting .......................................................................31
Specications ..........................................................................32
Disposal ...............................................................................32
Software Revision ...............................................................32
Guidance & Manufacturer’s Declaration .................................. 33
Regulatory Compliance - Bluetooth ......................................... 37
Acoustic Output .......................................................................38
Warranty ..................................................................................40
Appendix A...............................................................................41
4 16040-101 Rev. J
Warnings and Cautions
WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR 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 A MANNER 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 OPERATOR 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 140ºF, DISASSEMBLE
THE BATTERIES, OR DAMAGE TO THIS UNIT AND/OR SERIOUS PERSONAL INJURY MAY RESULT.
16040-101 Rev. J 5
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 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 TIP 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. ADVISE 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.
6 16040-101 Rev. J
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 THIS
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 INFORMATION 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 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.
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.
8 16040-101 Rev. J
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 Reichert 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-
16040-101 Rev. J 9
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 suitable for the ofce, 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 II
• Ingress Protection IPX1
• Applied Part Type BF
• Operation Mode Continuous
10 16040-101 Rev. J
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. Lift the insert that contains the Carrying Case and
iPac Charging Cradle out of the box.
2. Unfold the insert and slide the Carrying Case and
iPac Charging Cradle out of the insert.
3. Open the carrying case, remove the User’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 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
• iPac Pachymeter Charging Cradle
Note: If any of these items are missing, please contact the Reichert Customer
Service Department. Contact information can be found on the back cover of
this User’s Guide.
Carrying
Case
Shipping Box
iPac Charging Cradle
Shipping Box & Insert
Insert
16040-101 Rev. J 11
Instrument Setup (continued)
Parts Identification
1. Pachymeter
2. Measurement Tip
3. Control button
4. OLED Display
5. iPac Pachymeter Charging Cradle
Accessories & Spare Parts
User Guide (P/N 16040-101)
Carrying Case (P/N 16040-380)
Lanyard (P/N 13851-096)
Measurement Tip Cover (P/N 16040-027)
iPac Rechargeable Lithium Ion Battery (P/N 16042)
iPac Pachymeter Charging Cradle (P/N 16041)
A/C Adapter w/ Mini USB (P/N 16040-430) Including Country Specic 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)
Optional Accessories
iPac Bluetooth Printer (P/N 16043)
Spare Printer Paper (5 pack) (P/N 12441)
* When ordering a replacement A/C Adapter, the corresponding Country Specic
Pin must be orders as well.
1
4
3
2
iPac Pachymeter
iPac Pachymeter
Charging Cradle
5
12 16040-101 Rev. J
Instrument Setup (continued)
Icon Description
Move the Control button forward to go UP
Move the Control button back to go DOWN
Move the Control button 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
Bluetooth ON, Bluetooth Connected
Printer Connected
Printer Not Connected
Clear
Battery Requires Charging
Battery Low Power
Battery Fully Charged
Battery Charging
16040-101 Rev. J 13
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 Charging Cradle or the A/C adaptor. 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.
With a Charging Cradle
Note: Initially charge the unit for 10 hours.
Note: The Mini USB Port and the Mini USB Plug have a at
side and a curved side. The at side of the Plug has a
small rectangular cutout visible from the at side. When
connecting the Plug to the Port, be sure that the at side
of the Plug is lined up with the at 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.
Note: The iPac comes with a mini USB port cap installed in the mini USB port hole.
This should remain in the iPac to help ensure the iPac properly sits on the cradle.
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. Place the iPac on the Charging Cradle.
-continued-
Correct
Incorrect
Plug
Port
Plug
Port
With Charging
Cradle
14 16040-101 Rev. J
Instrument Setup (continued)
Charging the iPac Pachymeter (continued)
Without a Charging Cradle
Note: Initially charge the unit for 10 hours.
Note: The Mini USB Port and the Mini USB Plug have
a at side and a curved side. The at side of the
Plug has a small rectangular cutout visible from the
at side. When connecting the Plug to the Port, be
sure that the at side of the Plug is lined up with the
at 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.
Note: The iPac comes with a mini USB port cap installed in the mini USB port hole.
This needs 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 Control 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 the display will
light up.
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.
Correct
Incorrect
Plug
Port
Plug
Port
Without Charging
Cradle
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