ARATHYROID DETECTION SYSTEM
P
MODEL PTEYE
NSTRUCTI ON FOR USE
I
Proprietary I nformati on
This manual contains information deemed proprietary to AiBiomed. The information contained herein,
including all of the designs and related materials, is the sole property of AiBiomed and/or its licensors.
AiBiom ed and / o r it s licen s o rs res erv e al l patent, copyright, and other proprietary rights to this document,
including all design, manufacturing methodology, and reproduction.
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AiBiomed reserves the right to revise this publication and to make changes from time to time in the
contents hereof without obligation to notify any person of such revision or changes, unless otherwise
required by law.
© Copyright 2015 AiBiomed. All Rights Reserved. Printed in USA.
AiBiomed
114 E Haley St. Suite K
Santa Barbara, CA 93101
www.aibiomed.com
D121254_EN Rev L May 29, 2020
Record the Model and Serial Number of your AiBiomed Model PTeye device in the table bel ow, and
include t h e d at e recei v ed . Retain this in fo rm at ion for future referen ce.
Model Number Ser ial Number Date Received
Page 3 of 48
Table of Contents
1 Introduction .......................................................................................................................... 4
1.1 Intended Use ................................................................................................................ 4
1.2 Contraindications ......................................................................................................... 4
1.3 Device Warnin gs an d Precautions ................................................................................ 5
1.3.1 Warnings .............................................................................................. 5
1.3.2 Precautions ....................................................................................................... 7
1.3.3 User Responsibility ........................................................................................... 8
1.3.4 Electrical In t erference [See “Det ai l ed EM C Informati on” s ect ion] .................... 8
1.4 Symbol Definitions ...................................................................................................... 8
1.5 Unpacking the System ............................................................................................... 10
1.5.1 List of Delivered Components ......................................................................... 10
1.5.2 Verifying Probe Assembly Function ............................................................... 10
1.6 Returning the System ................................................................................................. 10
2 System Installation .............................................................................................................. 12
2.1 Connecting Peripherals to the Back ............................................................................ 12
2.2 Connecting Peripherals to the Front of the Console .................................................... 13
3 Pre-Operative S t ep s ............................................................................................................. 15
4 Operating the PTeye ............................................................................................................ 16
4.1 Collecting Baseli n e Thyro i d Data .............................................................................. 16
4.2 Detecting Parathyroid Tissue ..................................................................................... 18
5 Maintenance........................................................................................................................ 20
5.1 Life Expect ancy ......................................................................................................... 20
5.2 Periodi c M ai n t en an ce ................................................................................................ 20
5.3 Cleaning .................................................................................................................... 20
5.3.1 Cleaning the Console, Power Cord, Cable(s) and Footswitch........................... 21
6 Compatible Peripherals ....................................................................................................... 21
7 Troubleshooting .................................................................................................................. 21
8 End of Life Environmental Directives ................................................................................. 23
9 Technical In fo rm at ion ......................................................................................................... 23
9.1 Theory of Operation .................................................................................................. 23
9.1.1 Energy ............................................................................................................ 24
9.1.2 Disease ........................................................................................................... 24
9.2 Technical S p eci f i cat i o n s ............................................................................................ 24
9.2.1 General ........................................................................................................... 24
9.2.2 Laser .............................................................................................................. 25
9.2.3 Dimensions ..................................................................................................... 25
9.2.4 Environmental ................................................................................................ 25
9.2.5 IP Ingress Class .............................................................................................. 25
9.2.6 Safety Tes t i n g ................................................................................................. 26
9.2.7 Power Cord Requirements .............................................................................. 26
10 Software Vers i o n Acces s ..................................................................................................... 26
11 Detailed EMC Information .................................................................................................. 26
12 Summary of Clinical Information ........................................................................................ 31
D121254_EN Rev L PTeye Instructions for Use
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1 Introduction
The Parathyroid Detection (PTeye) System aids surgeons in confirming suspected parathyroid tissue that
has been located visually by the surgeon during thyroid and parathyroid surgeries using a probe assembly.
The probe assembly includes one quartz (fused si lica) fiber optic element that emits non-ionizing
radiation at 785nm in the near IR range (NIR) and one other fiber opt i c d et ect o r element that coll ect and
transmit the fluorescence emitted by the tissue to a photo detector. Tissue detecti o n is bas ed o n th e ratio
of the fluorescent response of the parathyroid to the thyroid tissue; the fluorescence of thyroid tissue is
much lower than the parathyroid.
During surgery, five data points are collected by touching the probe assembly (Applie d Pa r t) on the
thyroid tissue (or neck muscle/trachea in a patient with no thyroid). The system calcu l at es a b as el i n e
median for t h e thyroid tissue based on those points. The baseline value establishes a reference point for
each patient t o h el p the surgeon confirm parathyroid tissue, which produces a higher level of
fluorescence.
The system consists of the following components:
1. A console that includes:
• A LED display that indicates if the laser is on.
• A display for visual feedback.
• A speaker for auditory feedback.
2. A probe assembly that interfaces into the console unit using two unique connectors. One connector
plugs into the laser output and the other plugs into the phot o detector input (fluorescent signal)
3. A foot pedal attached by a cable to the rear of the unit, used to turn on the laser and initiate d at a
collection
4. An external power supply and power cord that plugs into the power supply
1.1 Intended Use
The AiBi omed P ar at h yr oid Detection Sys tem (Model PTeye) is an adjunctive tool intended to aid in the
identification of parathyroid tissue by confirming parathyroid tissue already visually located by the
surgeon.
1.2 Contraindications
There are no known contraindications for use for the AiBiomed Parathyroid Detection System (Model
PTeye).
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1.3 Device Warnings and Precautions
WARNING: The safety and/or health of the patient, user, or a third party is at risk.
PRECAUTION: This contains information concerning the intended use of th e device
This equipment is designed for use by medical professionals familiar with its required techniques and
these instructions for use. Read and follow all warning and cautionary notices and i nstructions included in
this IFU.
The words WARNING, PRECAUTION, and NOTE carry special meanings and they should be
read carefully.
Comply with this warning to avoid injury to the patient, user, or third party.
or accessory. Damage to the equipment is possible if these instructions are not
followed.
NOTE: A note is added to provide additional, focused, information.
1.3.1 Warnings
1. Due to limitations in parathyroid detection of autofluorescence by the PTeye System in certain
disease states, the device is not recommended for use in patients with secondary
hyperparathyroidism and in patients with parathyroid cysts.
2. The PTeye Syst em is intended to be an aid in the identification of parathyroid tissue and not as a
parathyroid locator. The use of this device has not been evaluated as a parathyroid tissue locator.
3. The device is only completely isolated from the mains if the External Power Supply’s power pl ug is
disconnected from the AC Mains.
4. Use of controls or adjustments or performance of procedures other than those specified herein may
result in hazardous radiation exposure.
5. Do not attempt to open or service the console, as this may void your warranty. The console
does not contain any user-serviceable parts inside. Removing the cover may produce an
electric shock hazard by exposing you to dangerous high voltage or other risks. Should the
system malfunction, return it for service immediately.
6. Always connect the probe assembly and the foot pedal before turning on the power switch.
Turn the power off before disconnecting the probe assembly or foot pedal. Never
disconnect the probe assembly or foot pedal while the system is in use. If the unit is on and the
probe assembly is not connected, the laser wil l emit potentially harmful light from the front of the
console, which could harm eyes and skin.
7. Do not use the AiBiomed Model PTeye system if LED power indicator does not light up when the
power switch is in the ON position and the foot pedal is pressed. (See Figu r e 3 in Section 2.2 for
LED power indicator and power switch location).
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8. When the unit is on, never point t he tip of the probe assembly at someone else’s face or look at it
directly. Looking at the laser could potentially be harmful to the eyes. If you are unsure if the laser
is on, look at the laser-on LED on the front of the console, not at the probe assembly itself.
9. Never point t h e laser at eyes, skin or point away from the surgical site. The laser radiation can
damage eyes and other sensitive skin. In an unusual case, the system may detect parath y ro i d ti ssu e
when pointed at a light source with a specifi c wav el en g t h an d f req uen cy .
10. Do not use the AiBiomed Model PTeye sys tem in the presence of flam m ab l e materials.
This includes anesthetics, gases, disinfecting agents, cleaning products, or any similar
materials susceptible to igniting due to electri cal s p ark i n g .
11. Equipment grounding is vital for safe operation. Plug the power cord into a properly grounded main
supply outlet with voltag e and frequ en cy ch aracteristics compatible with thos e li s t ed on the
unit/power supply or in the Technical Specifications section 9.2. Do not use plug adapters or
extension cords as these devices nullify the safety ground and could cause injury.
12. Thi s dev ice shall only be used wi th original and manu fact u rer ’s accessories an d r eplacement part s .
Use of other par t s or mat erials may degrade s af et y .
13. This equipment should not share an electrical outlet or grounding with life support or life sustaining
equipment.
14. For the protection of service personnel, and for safety during transportation, all devices and
accessories that are return ed fo r rep ai r m u s t be prepared for s h i pmen t as des cribed in “Returning
the Device” section of this manual. The manufacturer has the right to refuse to carry out repairs if
the product is contaminated.
15. NOT for use in an Oxygen Rich Environment.
16. NO modifications of this equipment is allowed.
17. Connecting any equipment that has not been supplied as part of this System to Multiple Socket
Outlets may result in increased leakage currents. Use an IEC Approved Isolation Transformer to
isolate any such interconnections from the ME System.
18. Keep the device in its upright position at all times. Feet downwards. This will allow for simple
installation and disconnection of the probe assembly (Applied Part).
19. Do not reuse the probe assembly. The PTeye-1 Probe is provided clean and sterile in its original
sterile p ack age. The probe i s no lo n g er cl ean o r sterile past its us e in each p at ient. Do not resterilize as no method can guarantee clean l iness or st er ili t y past th e fi rs t use. Discard probe
assembly after each surgery.
20. The PTeye device will acquire a baseline data point by the probe making contact with the thyroid
tissue whenever the foot pedal is pressed for more than one second. If unintended data points are
acquired becau s e t h e pr ob e h as m ad e cont act from tissues other than the thyroid (unless the thyroid
has been previously removed or ablated for which muscle or trachea tissue may be used instead of
the thyroid tissue) be sure to reset the unit by pressing the power switch on the console off and on
again to cl ear an y co l l ected data and start a new m eas u rement .
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21. The PTeye sound level can be decreased to Zero by pressing the Volume Down button repeatedly.
At that stage, the system does not emit any sound and the user can only receive feedback via the
display. The system resets to sound ON whenever the power to the system is cycled.
1.3.2 Precautions
1. Due to a small sample size, limited clinical data i s avai lable regarding t h e s afety and effecti ven es s
of the PTey e Sy s t em for r are d i s eas e s t at es such as tertiary hyperparathyroidism, concomitant
thyroid-parathyroid diseases, malignant parathyroid diseases, or other circumstances when
prophylactic thyroidectomies are performed in individuals at high-risk for certain diseas es s u ch as
MEN2A .
2. Do not use the device with incompatible equipment or peripherals that are not authorized by
AiBiomed. Doing so may void existing certifications and/or warranties.
3. Before plugging in the device, visuall y in s p ect th e PTey e s y s t em prior to each use, including
console, probe assembly, external power supply, power cord, and foot pedal to ensure there are no
visible cuts, cracks, or other damage. If any damage is found, do not use the syst em; contact your
AiBiom ed cus t o m er s erv i ce rep res en t at ive for assistance.
4. Do not expose the console to moisture, operate it in wet areas, or place liquids on or above the
console.
5. Place the console on a rigid surface to ensure good audio reception (the speaker is on the bott om of
the unit).
6. Do not excessively bend or kink the probe assembly. Handle the flexible portion of the probe
assembly w i th care.
7. Do not excessively bend or kink the ins trument power cord or the cord for the foot pedal.
8. Store the device and all peripherals in a protective container to prevent the possibility of damage
when not in use. Do not store the device in a location where it will be exposed to temperatures
exceeding 140°F (+ 60°C).
9. After each use, thoroughly clean the consol e.
10. Handle all equipment carefully. If the fiber optic probe assembly is dropped, it can be damaged,
which renders the system unusable.
11. This device should only be used i n compliance with its intended use.
12. To carry out safe operation it is absolutely necessary to carry out proper care and maintenance of
the device an d acces so ries. See “Maintenance” section of this manual.
NOTE: Receipt of technical documentation from the manufacturer does not authorize individuals
to perform repairs, adj ustments, or alterations to the device or accesso ries.
Only authorized serv ice personnel may perform repairs, adjustments or alterations on the devi ce
and accessories. An y violat io n will void the manufacturer’s w arranty. Authorized service
D121254_EN Rev L PTeye Instructions for Use
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technicians are t rain ed and cert ified only by the manufacturer. The Manufactu rer wi ll make
available on request circuit diagrams, componen t part lists, descriptions, calib rat io n inst ructions
and other information requ ired for service to any AiBiomed Authorized Service Center.
1.3.3 User Responsibility
External equipment that will be connected to signal input and signal output ports or other connectors,
shall comply with relevant IEC standards (IEC 60950 for IT equipment and IEC 60601 series for medical
electrical equipment). In addition, all such combinations (systems) shall comply with the standard IEC
60601-1-1 (safety requi rements for m edical electri cal sys t em s ).
If you plug in any peripherals not listed i n this IFU, you are responsible for any potential damage.
Any person who connects external equipment to signal input and signal output ports or other connectors
has formed a system and is therefore responsible for the system to comply with the requirements of IEC
60601-1-1. If in doubt, contact a qualified technician or your local representative.
1.3.4 Electrical Interference [See “Detailed EMC Information” section]
This equipment has been tested and found to comply with the limits for medical devices for EN60601-1
and EN60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical m ed i cal ins tallation. Th i s equ i pmen t g en erates, uses, an d can radi ate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that interferen ce w i l l n o t
occur in a part i cu l ar i n stal l ation. If this equipment does cause h arm fu l interference t o o t h er d ev i ces ,
which can be determined by t urning the equipment off and on, you are encouraged to try to correct the
interference by one or more of the following measures:
• Reorient o r rel o cat e t h e r ecei v i n g d ev i ce.
• Increase the s ep aration betw een the equipment .
• Connect the equipment into an outlet on a circuit different from that to which the other devices are
connected.
• Consult the manufacturer or field s erv ice technici an f or help.
1.4 Symbol Definitions
The following table lists symbols used on the PTeye console and in this manual and their meaning.
Symbol Definition
Attention, consult instructions for use
Safety Sign; Foll ow Operating Instructions
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Symbol Definition
Precaution or Warning Notice
Type BF equipment
Direct current
Foot pedal
Equipotential (equipment potential)
WEEE (Waste Elect r onics and Electrical Equipment) Symbol. Regarding European Union end-of-life of
product
No user service recommended. Refer servicing to qualified service personnel.
Not for use in the Presence of flammable anesthetics
Indicates the medical device manufacturer
Caution: Federal Law restricts this device to sale by or on the order of a physician.
Audio volume control
Warning label- Hazard symbol
Fragile
This Side Up
Keep Dry
Temperature Limits for Storage and Transport
Pressure Limits for Storage and Transport
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1.5 Unp acking the System
Upon receipt, carefully unpack the console and peripherals and ensure all items are free from damag e. If
any damage i s not ed, contact your service repr es entative. Save all packaging materials; they may be
needed to verify any claims of damage by the shipper.
1.5.1 List of Delivered Components
This is a complete list of PTeye system components. All items in this list are required for system
operation. Verify the shipment against your purchase order.
• PTeye console
• PTeye fiber optic probe assembly (Sold and Shipped Separately)
• Foot pedal with connecting cord
• Power cord and external power supply
• Instructions for use
1.5.2 Verifying Probe Assembly Function
The probe ass em b l y co ntai n s d eli cat e fi b er o p t i c cab l es. T o veri fy t h at t hes e h av e n ot b een damaged
during the shipment process, follow these steps.
1. Inspect the probe sterile package for any signs of damage. If any damage is found, discontinue
using the probe and return the probe to AiBiomed.
2. Inspect the probe for any signs of damage, particularly paying attention to the probe tip. If any
damage is found, discontinue usi ng the probe and return the probe to AiBiomed.
Without compromising sterility, follow instructions in section-4 to take all 5 baseline data points with the
probe pointed towards the ground so as to get a low measurement on purpose. Apply the tip of the probe
to any sterile drape available or the probe tray Tyvek lid. The Detection Ratio at the upper right-hand
corner of the display must increase to a greater number when the probe is applied to a fluorescent source,
indicating proper probe function. If the Detection Ratio is below 0.2, the probe may be damaged, and you
should discontinue using the probe, return the probe to AiBiomed and use an alternative probe.
Note: AiBiomed recommends that you purchase additional probe assemblies so that a backup i s avai l ab l e
in case one is dropped or becomes unsterile during an operation.
1.6 Returning the System
If it becom es n eces s ary t o retu rn t h e d ev i ce, al way s u s e the o ri gin al packaging . Th e manu fact u rer d o es
not take responsibility for damage that has occurred during transportation if the damage was caused by
inadequate transport packaging. Please make sure that all required information has been supplied. Call
AiBiomed for a RMA Number for the device return for service.
• Owner’s Name
• Owner’s Address
D121254_EN Rev L PTeye Instructions for Use
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• Owner’s Daytime Telephone Number
• Device type and model.
• Serial Number
• Detailed exp l an at i o n o f the d am ag e.
Note: The PTeye Console shall be cleaned per section Cleaning prior to returning for service.
AiBiomed shall not implement repairs on equipment which is not returned cleaned.
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2 System Installation
2.1 Connecting Peripherals to the Back
The Figure 1 illus t rat es a vi ew o f PTey e co n s o l e fro m the back .
Figure 1: PTeye Console Back
Note: The purpose of potential equalization is to equalize potentials between different metal parts
that can be touched simultaneously or to reduce differences of potential which can occur during
operation b et ween t h e b o d i es of medi cal electrical d ev i ces an d co n du ct ive parts of oth er o bject s .
To begin the installation, follow these steps:
3. Unpack the devi ce an d place it in the locati on w her e i t will b e used . B ecau s e t h e s p eak er i s on the
bottom of the console, the device should be located on a rigid surface.
Note: Make s u re the device location meets the requirements listed for the operating environment in
Section 9.2.4.
4. Connect the external power supply to the back of the console.
5. Plug the power cord into a properly grounded main supply outlet with voltage and frequency
characteristics compatible with those listed on the unit/power supply. Warning: Do not turn on the
device yet.
Warning: Equipment grounding is vital for safe operation. Do not use plug adapters or extension
cords. Th es e d ev i ces d efeat the safety ground and could cause injury.
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6. Connect the foot pedal to the back of the console by aligning the red dot on the connector with the
red dot on the mating connector in the back of the System as shown in Figure 2 below.
Note: To disconnect the Foot Pedal, pull on the textured nut outwards to unlatch.
Figure 2: Foot Pedal with Connector Orientation
2.2 Connecting Peripherals to the Front of the Console
Figure 3 illustrat es t h e fr on t of th e P T ey e con s ole.
Figure 3: P Te y e C onsole Front
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Figure 4: Fiber Optic Probe Assembly
1. Inspect the functionality of the fiber opt ic probe assembly by following the instructions in section
1.5.2 above.
2. Securely connect the fiber optic probe assembly to the console.
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Connect to left
Connect to middle
Figure 5: Probe Assembly Connecto rs
of console
side of console
• Connect the laser cable, which has the smaller end (at the top of Figure 5), to the connector
in the middle of the console.
• Connect the detector cable, which has the larger end (at the bottom of Figure 5), to the
connector on the left side of the console.
3. Plug the power cord into a grounded power source. When power is supplied to the unit, the power
switch should be lit.
3 Pre-Operative Steps
Before attem p t ing to use the PTeye, make sure you have read t h e en t i re I FU and p ay s p eci al att ention to
the warnin g s ection. Then comp l ete these steps :
1. Visually in s p ect th e fiber optic prob e as s em bly to en s ure th ere ar e no v i s ible cuts, cracks, or other
damage. In s p ect al l cabl es as w el l.
2. Make sure that the foot pedal and the probe assembly have been properly connected to the console
before turning the unit on.
3. Turn the power switch to the ON position. The unit should emit a startup beep. Verify that the unit
is working by observing the display. The console screen should look like the one in Figure 6 on
page 16.
4. After turning the unit on, make sure that the foot pedal works properly by pressing the foot pedal
and verifying that the laser LED is lit when the foot pedal is pressed.
5. Turn the unit off and on again in order to clear all data points taken in the previous testing step.
6. Make sure the volume control buttons work correctly and are set at an appropriate volume level.
D121254_EN Rev L PTeye Instructions for Use
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