Temp Fs Manual

FIELD SERVICE MANUAL
FIELD SERVICE MANUAL Eeva System

FIELD SERVICE MANUAL Page 2

TABLE OF CONTENTS

1.0 Introduction. 3
2.0 Indication for Use.. 3
3.0 Contraindications 3
4.0 Warnings and Precautions... 3
5.0 Eeva System Description & Components. 5
6.0 Eeva System Installation . 8
7.0 Operating Instructions 8
8.0 Troubleshooting & Service 8
9.0 Returned Product Decontamination 13



1.0 INTRODUCTION
To ensure proper installation and service of this device; authorized and trained Auxogyn service
personnel must carefully read all information contained in these instructions and observe all
warnings and precautions.
This manual uses references to the latest information on Instructions for use (IFU) Work
Instructions (WI), Standard Operating Procedures (SOP) and Forms (FM).

2.0 INDICATIONS FOR USE OF EEVA
The Eeva System is indicated to provide adjunctive information on events occurring during the first
two days of development that may predict further development to the blastocyst stage on Day 5 of
development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3
when, following morphological assessment on Day 3, there are multiple embryos deemed suitable
for transfer or freezing.

3.0 CONTRAINDICATIONS
There are no contraindications for the Eeva System.

4.0 WARNINGS AND PRECAUTIONS
Before using the Eeva System, read and make sure you understand each of the following safety
warnings and precautions. Please refer to alternate Instruction for Use for and maintenance
information for components not provided in this manual.

WARNING: The Eeva System is not to be used as a substitute for traditional morphology
evaluation. When using the Eeva System, always conduct traditional morphology evaluation first
to identify the embryos that are suitable for transfer or freezing. The use of the Eeva Test Results
begins only after embryos that are morphologically good/fair have been identified. The Eeva Test
Result is then used to assist in predicting which embryos will potentially arrest among the
selected embryos.
4.1 Warnings
WARNING
Use of the equipment other than as directed in the IFU may impair proper protection of the
user and operation of the equipment, and may impair the embryo prediction capability of the
system.
Prior to use, visually inspect the product for external damage. If damage is found, do not use
the product. Contact an Auxogyn, Inc. service representative immediately.
Do not plug additional equipment into the system Uninterruptable Power Supply (UPS).
In case of a hazard, unplug the Eeva System from the UPS.
Only an authorized Auxogyn, Inc. service representative can install, repair, remove, or
service the equipment. Failure to properly install and service the Eeva System according to
the instructions and specifications provided may result in harm to the embryo and/or the
operator, and may also result in the Eeva System not being able to capture images and/or
not being able to provide prediction results.
Do not modify this equipment or software.
To avoid risk of electrical shock, the equipment must only be connected to supply mains with
protective earth (ground).
Do not stack other equipment around the Eeva System or block access to plugs.

4.2 Precautions
GENERAL PRECAUTIONS
The adjunctive value of the Eeva Test to predict which embryo is likely to achieve
implantation and live birth has not been evaluated.


Determination of good/fair embryo retention (cryopreservation) should be made according to
traditional morphology only (not based on the Eeva Test Result).
For safe and effective use of the Eeva System, read the complete Instructions for Use prior to
using the Eeva System.
Users of the Eeva System should be trained in, and familiar with, standard in vitro fertilization
(IVF) and incubator operating procedures. Only users trained on the use of the system should
use the system. Eeva System training is provided by an authorized Auxogyn Trainer during
the installation process or may be given by a trained member of the site personnel.
The Eeva
Test Result does not provide any information beyond the likelihood of an embryo
to progress to the blastocyst stage. It does not provide any information regarding embryo
genetic quality.
Only Eeva
Dishes may be used with the Eeva System. The system will not permit the
initiation of imaging with other types of dishes.
The dish containing embryos should be placed onto the Eeva
Scope stage and the patient

session initiated 20 hours from time of insemination. Delays may prevent proper imaging
and/or prevent the analysis of all embryo development events, which may result in a No
Result (NR).
A dish may only contain embryos from a single patient. Each dish is associated with a
patient session. Do not mix embryos from different patients into a single dish. Depending on
the number of embryos that a patient has, it may be required to use multiple dishes and run
multiple patient sessions in order to analyze all embryos.
An embryo can be displaced from its original microwell. These embryos are referred to as
displaced embryos. When an embryo is displaced from its original microwell while the Eeva
Test is in progress, the Eeva System will not complete the analysis for the displaced embryo,
it will return an NR. If displaced embryos are observed, follow traditional morphology and
ignore results generated by the Eeva Test for those microwells.
To prevent embryo displacement, wait a few seconds after placing embryos into the dish prior
to transferring the dish to the scope. This ensures that the embryos have an opportunity to
settle to the bottom of the dish.
Embryo displacement can be caused by inappropriate handling of the dish. It can also be
caused by jolts or vibrations to the dish due to bumps to the incubator or counter. Always be
gentle when closing the incubator door after placing the dish onto the scope stage.
A displaced embryo may move to another microwell already containing another embryo.
There is no harm for the embryos to share the same microwell, however the Eeva System will
likely return an NR for all the embryos occupying the same well.
Stopping image capture during the first 42 hours of a patient session will cancel the Eeva
Test. Therefore, no result will be generated.
Removing the dish from the scope during the first 42 hours of a patient session will prevent
the Test from being completed. Therefore, no result will be generated.
Any obstruction of the scopes view of the embryo or interruption of the recording of the
images prior to the completion of the analysis for all embryos in the dish may prevent the
generation of a blastocyst prediction for that patient.
Laboratory Standard Operating Procedures should be followed to verify and ensure embryo
identification. Do not rely exclusively on the patient information displayed on the scope
screen or the scope.
If any of the Eeva Systems internal diagnostic tests fail, the Eeva Test will display an error
message and halt. In the event of an error, discontinue use and contact an Auxogyn, Inc.
service representative immediately.



4.3 Biohazard

BIOHAZARD
When cleaning and disinfecting, always refer to Section 9.0 Maintenance, Cleaning and
Disinfection for effective cleaning and disinfection procedures to avoid damage to the system
or residual contamination.
Do not spray cleaning agent directly onto the Eeva
Scope Screen, Eeva
Station, Eeva

Computer or Eeva
Control Box. When wiping clean, always make sure that moisture does
not enter into these components.
If the Eeva
Scope stage window is streaked or dirty, wipe with a soft, lint-free cloth dry, or
with distilled water, if necessary, to clean the window.
All components outside the incubator can be wiped with a soft, lint-free cloth dampened with
distilled water, if desired.
If condensation forms on the outside of the scope window and causes a blurry image, wipe it
with a soft, dry cloth or distilled water if necessary.
If the contents of the dish spill onto the surface of the scope stage, the stage surface may
become contaminated and must be cleaned and disinfected immediately.

4.4 Electrical Safety Precautions
Use of the equipment other than as directed in the IFU may result in user injury or damage to
the equipment, as well as impairing the capability of the system to perform analysis.
Portable and mobile radio frequency communications equipment can affect the operation of
the Eeva System. Special Electromechanical Compatibility (EMC) precautions should be
observed when installing and using the Eeva System. Do not attempt to modify the Eeva
System installation or any of the components, including disconnection from the UPS supplied
with the System.
The Eeva System may be affected by the EMC environment in which it is used but there is no
effect that would result in any hazard to the user.
Eeva System components should not be stacked with other equipment except as installed by
Auxogyn, Inc.
Do not use any spray or liquid solution on Eeva System components in a manner that is not
defined in the IFU.
Do not subject the scope to temperatures over 40
o
C, such as those encountered in high
temperature incubator decontamination cycles. Refer to Section 8.0 Maintenance, Cleaning
and Disinfection for more information.
Only a qualified Auxogyn, Inc. service representative can service the Eeva System or perform
preventive maintenance.
Keep the optics and stage of the scope clean. See Section 8.0 Maintenance, Cleaning, and
Disinfection for more information.

5.0 EEVA SYSTEM DESCRIPTION, COMPONENTS OF USE
5.1 Eeva System Description
The Eeva System includes an assisted reproductive scope with time-lapse image capture
and automated embryo prediction capability.
The Eeva System should only be used with the sterile, disposable Eeva Dish.

5.2 Eeva System Components & Accessories
The Eeva System consists of the following components:


Component
Name
Quantity
per
System
Image Description
Computer 1

Operates the four scopes, the station and the scope screen(s).
Runs the analysis and computes the Eeva Test Result.

Stores images and patient data for a maximum of 200 patient
sessions.
Control Box 1

Receives commands from the computer and operates the
scopes accordingly.

Provides power to the scopes and continuously monitors the
Eeva Scope power consumption. If the power consumption
exceeds normal operating limits, then a hardware error is
triggered and the Eeva Control Box turns off the power to the
scope. The Eeva Control Box reports errors to the Eeva
Computer and the user is alerted on the Eeva Station and the
Eeva Scope Screen.
Scopes 4

An assisted reproductive scope with a stage designed to hold
the dish. It houses the optics and provides illumination needed
to create dark field image capture.
Scope
Screen(s)
1 or 2*

The scope screen is a touchscreen display that is used to
select and operate the scope for the patient session. Via the
scope screen, the user can enter patient data and initiate,
pause or stop the image capture and/or analysis for that patient
session. The scope screen can also be used to view the most
recent image captured for each active scope.

The scope screen is mounted on the incubator door.
Station 1

A large touchscreen monitor that allows the user to manage the
patient session data stored on the Eeva System. Via the
station, the user can view the status of each scope, review and
download captured images and videos, and generate reports.
Uninterrup-
tible Power
Supply
(UPS)
1

An uninterruptible power supply to provide backup power to
the Eeva System.
Stopper 1

Provides a thru-hole for the Eeva Scope cables to pass
from the Eeva Scope inside the incubator to the Eeva
Control Box outside the incubator, while maintaining the
incubator environment.
Connection
Cords
4

Connects the Eeva Scope to the Eeva Control Box,
supplying power to the Eeva Scope and communication
channels.

Accessory
Name
Quantity
per System
Image Description
Printer 1

A black and white printer for printing reports.
Installation of the printer is optional.

*See Figure 2 and 3 for configuration options for the Eeva System



Figure 2: Configuration Option 1: Four (4) Scopes in one incubator with one (1) Scope Screen

Figure 3: Configuration Option 2: Two incubators with two (2) Scopes and one (1) Scope Screen
each



6.0 EEVA SYSTEM INSTALLATION

Review SOP 1472 for complete installation and service process.

6.1 Pre-Installation Site Inspection
Upon receipt of an order, a Pre-Installation inspection of the site shall be scheduled to
complete the Equipment Preparation Form (FM 1656) for each Eeva system to be installed.
This form is to be completed by Clinical Operations or Field Service Engineer for
investigational products and by Field Service, Medical Affairs or Sales for Commercial
products and forwarded to Manufacturing to aid the system configuration.
6.2 Installation Instructions
Follow complete installation procedure on document WI 2070.
Review instructions to access Engineering Mode.
Forms to be completed upon completing installation:
FM 1787 Site Installation of Eeva System
FM 1656 Eeva Equipment Preparation Form

7.0 Operating Instructions

Review Eeva Instructions for use (IFU) for operating instructions.

8.0 Troubleshooting and Service

Review SOP 1472 for details of service process

Forms used for field service
Product Feedback report (FM 2440)
Field Service Report (FM 1473)
Microscope Replacement Datasheet (FM 2046)
Control Box Replacement Datasheet (FM 2829)

Basic service instructions

Retrieval of system and individual session logs manually.

Reboot system instructions

Use of Auxogyn Service Interface Tool (WI 2624)

8.1 Scope errors

8.1.1 Potential Issue: Scope shut off for no apparent reason

Potential Cause: The safety system may be tripped to protect the embryos from harm.
The Eeva System has circuitry that monitors how long and how frequently the scope
systems (camera, focusing motor, illumination LED, etc.) are on for each individual
scope. If any of these items pass a safety threshold the microscope will be shut off and
an error will be displayed. The only consequence will be the lack of results since the
scope will no longer be taking images.



Potential Solutions: Consecutive dish loading/focusing on the SAME scope can
occasionally trigger the safety circuitry.
If you are verifying the system doing several dish loads in succession DO NOT do it on
the same scope. Instead move to a different scope or wait 10 minutes before loading
again on the same scope.
One safety circuitry trigger (CamIntSum: XXXXX.X (XXX %)) can be observed on the
session log for the scope in question. A value of 100% or greater will generate an error
and shut off the microscope.
Inspect control box channel LED for microscope in Error. If LED is red, perform a control
box channel reset by pressing the blue reset button to the left of the LED to reset the
control box channel, LED should turn green. Press RESET on scope screen and verify
operation per WI 2070.

Channel Reset Channel LED

2014-02-01-105217-923 [Scope1] ALARM
2014-02-01-105217-923 [Scope1] EngineEvent: ERROR
2014-02-01-105217-923 [Scope1] MsgStatesUpdate: msgEvent = 3
2014-02-01-105217-923 [Scope1] MsgStatesUpdate: old mMsgState = 11
2014-02-01-105217-923 [Scope1] MsgStatesUpdate: NEW mMsgState = 7
2014-02-01-105218-079 [Scope1] AgCameraIds::TermSvc
2014-02-01-105219-186 [Scope1] CameraPowerSet( OFF )
2014-02-01-105219-202 [Scope1] CameraPowerState: OFF
2014-02-01-105219-202 [Scope1] CamIntSum: 10599.7 (115%)
2014-02-01-105219-202 [Scope1] Camera Standby: 1537922008 Freerun: 1048401
2014-02-01-105219-202 [Scope1] AgMotorStepperBoard::TermSvc
2014-02-01-105219-202 [Scope1] MotorPowerSet( OFF )
2014-02-01-105219-217 [Scope1] AgWatchdog::AlarmSet: [0200]
2014-02-01-105219-217 [Scope1] Alarm: SW_CAMERA
2014-02-01-105219-217 [Scope1] Camera Standby: 1537922008 Freerun: 1048401
2014-02-01-105219-217 [Scope1] StateGrab: LAMP_OFF_WAIT
2014-02-01-105219-217 [Scope1] EngineState: ERROR_WAIT
2014-02-01-105219-217 [Scope1] FsmState: Error
2014-02-01-105219-217 [Scope1] ScreenState: ERROR

8.1.2 Potential Issue: Scope in error while idle or in session, and scope reset and control box
channel reset do not correct error.

Potential Cause:
Camera Integrator -
Safety circuitry trigger



a) Microscope standby current is out of range.

Potential Resolution:
Refer to WI 2587 Field Service - Camera Current Measurement.
If criteria for scope replacement are met, replace microscope per WI 2045.

Potential Cause:
b) Microscope camera is defective.

Potential Resolution:
Review session log for microscope in error. On the session log, locate the line:
CameraIdSerial from Configuration:[Camera Serial #]. This line will show the
camera serial number assigned on the scope configuration file.
After this line, the session log will show how the software matches this serial number
to the cameras connected to the system on the line labeled (Cameras Serial
Number from Device:[Camera Serial #]). All connected cameras are checked by
the software until a serial number match is found. If the camera is damaged, the
software will not be able to recognize the camera as connected to the system and an
error is generated.
In addition to reviewing the session log, proceed to measure camera standby current
per WI 2587. If camera is damaged, during camera standby current measurement,
uEye Cockpit software will prompt one the following errors: Cant open camera
error -1 or No uEye Camera Present. Replace microscope per WI 2045.

Example of session log for a defective camera shown below:

2014-05-06-125514-603 [Scope2] AgCameraType: IDS
2014-05-06-125514-603 [Scope2] IDS version: 3.82.10
2014-05-06-125514-603 [Scope2] CameraIdsSerial from Configuration: [4102631365]
2014-05-06-125514-603 [Scope2] Camera's Serial Number from the device: [4102665572]
2014-05-06-125514-603 [Scope2] WARNING: Camera's serial number [4102665572] does not match configured [4102631365].
2014-05-06-125514-603 [Scope2] Camera's Serial Number from the device: [4102700501]
2014-05-06-125514-603 [Scope2] WARNING: Camera's serial number [4102700501] does not match configured [4102631365].
2014-05-06-125514-603 [Scope2] CameraIdsExposure: 10.00
2014-05-06-125514-603 [Scope2] CameraIdsTimeout: 1
2014-05-06-125514-603 [Scope2] CameraIdsFps1x: 1.90
2014-05-06-125514-603 [Scope2] CameraIdsPixelClock: 13
2014-05-06-125514-603 [Scope2] StandbySetSvc ( 1 ): 0 msec (6 tries): FAILURE ERROR
2014-05-06-125514-603 [Scope2] AgWatchdog::CameraInit failed: 5

Example of uEye cockpit error for defective camera shown below:



Potential Cause:
c) Microscope configuration is incorrect.

Potential Solutions:
If a microscope has been replaced, the microscope configuration file must be
reviewed to confirm the following entries correspond to the replacement microscope:
Serial: [microscope serial number]
CameraIdsSerial: [microscope camera serial number]
IllumLevelStart: [Initial illumination value]
MotorDishPos: [Initial focus position]

Confirm that the illumination file that corresponds to the replacement microscope has
been copied into the C:\Program Files\Auxogyn\Eeva v2.0 directory. Ensure that the
serial number in the illumination file name contains the serial number of the NEW
replacement microscope. If corrections to microscope configuration were required,
reset control box channel for microscope in error. Select RESET from scope
screen. Once microscope initializes, verify operation per WI 2070.

8.1.3 Potential Issue: Microscope unable to focus.

Potential Cause:
a) Eeva dish incorrectly positioned on microscope dish stage.

Potential Solution:
Review IFU instructions for loading an Eeva dish.

Potential Cause:
b) Something is obstructing the view of the scope. Condensation may have formed
on the outside of the scope window or under the dish. Condensation may also
form under the stage window if the dish temperature is slightly different than the
stage temperature.

Potential Solution: Ensure bottom of the dish and scope are completely dry and clear
of particles before placing dish onto scope stage. Any moisture under the dish may
create condensation and interfere with the focus process. Wipe with a soft, lint free dry
cloth. If condensation was formed under the stage window, press the CANCEL button
and wait for ten minutes before initiating a new session so the condensation can
dissipate.

Potential Cause:
c) Dark and blurry image of the microwells due to degrading optics on microscope.

Potential Solution:
Review and adjust scope illumination start value. (Scope Illumination Adjustment)



Example of a low illumination on scope

Example of microscope out of focus



9.0 RETURNED PRODUCT DECONTAMINATION

Procedure for the cleaning and disinfection of returned product which has been used in a clinical
setting or that may be contaminated.(SOP 1260)

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FIELD SERVICE MANUAL

FIELD SERVICE MANUAL Eeva System

Scope stage and the patient

Scope Screen, Eeva

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