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User Manual MUT_RD_009H_GB                                                                                          Page 

22 

of 43 

 

4.2.2

 

The single-use EYEOP-PACK consumable 

 

The  EYEOP-PACK  is  a  sterile  single-use  consumable,  necessary  for  operating  the  medical  device  via 
connection  to  the  EyeOP1  Control  Unit.  It  is  prescribed  by  an  ophthalmologist  for  a  given  patient,  and 
contains the therapy probe, as well as the coupling cone linked to a liquid trap (see figure 1). The EYEOP-
PACK comes in three diameters, i.e. 11, 12 and 13 mm. All elements are described hereafter. 

The EYEOP-PACK elements are ethylene-oxide sterilized and are packaged in a PETg blister closed with a 
tyvek covering, and inserted in an individual carton box with a sheet of traceability labels. The EYEOP-PACK 
must be stored in a dry place at normal pressure, protected from light. 

 

Figure 1: Contents of the EYEOP-PACK 

 

 

The EYEOP-PACK is a sterile single-use consumable. Contamination of the patient could 
occur in case of re-use. An inappropriate re-sterilization by the user, not authorized by 
EYE TECH CARE, could damage the elements of the EYEOP-PACK consumable, such as the 

probe’s

 transducers, and could lead to under-treatment and/or undesired treatment on 

surrounding tissues. 

 

The  EYEOP-PACK  elements  are  ethylene-oxide  sterilized.  Make  sure  that  the  plastic 
packaging and tyvek covering are not damaged before use, in order to ensure that the 
sterility has been preserved. Make sure that the sterility indicator placed on the carton 
box is green, meaning that the sterilization process has been successfully processed on 
the consumable. 

Do  not  re-sterilize  the  EYEOP-PACK  elements,  before  or  after  use.  In  case  of  sterility 
problem due to damaged packaging, do not use the product.

 

 

The expiry date is printed on the various labels of the EYEOP-PACK device. Do not use the 
EYEOP-PACK after this date. Use the EYEOP-PACK elements only with the EyeOP1 device. 

 

The EYEOP-PACK also contains a short illustrated 

‘Instructions for use’ leaflet which doe

s 

not exempt the user from reading the present User Manual. 

4.2.2.1

 

The therapy probe 

 

Summary of Contents for EyeOP1

Page 1: ...ted EYEOP PACK USER MANUAL Version H of 2020 11 17 English Date of CE marking affixing 05 2011 Printed by Manufacturer EYE TECH CARE 2871 Avenue de l Europe 69140 RILLIEUX LA PAPE FRANCE Tel 33 0 4 78 88 09 00 Fax 33 0 4 78 97 45 11 support eyetechcare com ...

Page 2: ..._________________________________ 9 3 2 1 Warnings on the medical device_____________________________________________________ 9 3 2 2 Main warnings on treatment ______________________________________________________ 10 3 3 Protection against electric shocks ___________________________________________ 11 3 4 Labelling _______________________________________________________________ 11 3 4 1 Signage ...

Page 3: ..._______________________________________ 39 6 4 5 Language selection ______________________________________________________________ 40 6 4 6 Checking replacing and repositioning the printer paper ________________________________ 40 7 SECTION 7 ERRORS AND WARRANTY ________________________________________ 41 7 1 Warranty_______________________________________________________________ 41 7 2 Management...

Page 4: ...n order to make reading and understanding of the manual easier the following symbols will be used Information This symbol is used when specific or additional information is added by the writer Caution This symbol is used to indicate an important recommendation regarding the use of the product Prohibited This symbol informs the user of a ban or potential hazard for the patient health or of a proble...

Page 5: ...l hematoma Aphakic patient Presence of a valve tube or any other element on the eye surface preventing proper positioning on the patient s eye ex chemosis caused by the anesthesia scaring filtration bleb after filtering surgery etc Patient s history of retinal detachment macular edema choroidal hematoma and or uveitis Practitioner is asked to not treat under these conditions Precautions A second t...

Page 6: ...cataract clouding of the lens Progression of existing cataract Phacodonesis tremulousness or vibration of the lens with eye movement often due to lens subluxation Subluxation of the lens Visual acuity Refraction Change in refraction induced astigmatism etc Transient 3 months or permanent 3 months decrease in visual acuity Transient monocular diplopia Retina Choroid Vitreous humor Retinal complicat...

Page 7: ...ent session A treatment session corresponds to the treatment of one eye the therapy probe being set up with appropriate parameter configuration The treatment must be prescribed by a qualified physician 2 7 Anesthesia Anesthesia general local or topical must be performed on the patient before the treatment session The patient must lie on his back supine position and remain still throughout the trea...

Page 8: ...presented herein have been developed and tested for a specific use within the frame of glaucoma treatment by coagulation of the patient s ciliary body upon prescription of a qualified physician and upon selection of parameters specific to each therapy probe No other use shall be made of this device Installation of the medical device must be carried out by a physician approved by EYE TECH CARE Only...

Page 9: ...s associated accessories EYEOP PACK consumables and mains supply cables described in the present manual The EyeOP1 control unit is only compatible with the associated EYEOP PACK consumables Consequently only EYEOP PACK sterile consumables can be used with the EyeOP1 control unit Likewise EYEOP PACK sterile consumables should not be used with a device other than the EyeOP1 control unit Use of the m...

Page 10: ...ommended to read and understand the message to write it down in order to make the technical diagnostic easier to discontinue treatment if the procedure is not described in the present manual and to rapidly inform EYE TECH CARE or the local distributor If unusual events persist or if unidentified problems occur do not try to dismantle the medical device Take note of the problem and contact the tech...

Page 11: ...apy probe is essential so the patient must remain still in order not to displace them If these recommendations are not complied with this may cause improper treatment to be delivered or even patient injury The operator must be present at all times during the treatment and carefully supervise the medical device and the patient 3 3 Protection against electric shocks In order to protect the persons a...

Page 12: ... use c Applied part of the type BF medical device d Temperature of storage e CE marking f Storage in a dry place g The control unit to be discarded is WEEE waste electrical and electronic equipment Return it to an appropriate collection point for processing recovery and recycling of this type of waste or to a distributor 3 4 2 EYEOP PACK labels The EYEOP PACK contains several labels affixed in var...

Page 13: ...ot reuse single use d Manufacturer symbol accompanied by manufacturer s address on the label e Sterilization by ethylene oxide f Warning Imperatively refer to instructions for use g Do not use if packaging is damaged h Storage conditions store in a dry place away from light i Symbol which identifies the sterile barrier system covered blister 3 4 2 2 Adhesive label of the individual carton box A la...

Page 14: ... consumables requires specific precautions to be taken with respect to the EMC and must be installed and operated according to the EMC information provided in the tables below Cellular phones and other mobile communication devices must not be used close to the medical device since they could affect its operation Any other device used close to the medical device must comply with the IEC 60601 1 2 s...

Page 15: ...acturer s claim electromagnetic immunity The medical device is intended for use in the electromagnetic environment described below The customer or medical device user must ensure that it is used in such an environment Immunity testing Test level IEC 60601 Compliance level Electromagnetic environment directives Electrostatic discharge ESD IEC 61000 4 2 6 kV in contact 8 kV in the air Complies Compl...

Page 16: ...ectromagnetic immunity The medical device is intended for use in the electromagnetic environment described below The customer or medical device user must ensure that it is used in such an environment Immunity testing Test level as per IEC 60601 Compliance level Electromagnetic environment directives Conducted RF emissions IEC 61000 4 6 Radiated RF emissions IEC 61000 4 3 3 Veff from 150 kHz to 80 ...

Page 17: ... or repositioning the medical device b As pertains to the frequency range from 150 kHz to 80 MHz the field intensities must be less than 3 V m Recommended separation distances between RF communication mobile devices and medical device The medical device is intended for use in an electromagnetic environment in which RF radiated emissions are controlled The customer or medical device user can contri...

Page 18: ...y stops it in case of pedal release User equipment Turns off power supply to the RF electronic board of the generator Continuously Watchdog communication Displays a message when communication between MMI and RF generator is lost Device equipment software Displays a user message Start screen Suction release Displays a message when suction is lost vacuum decay Device equipment software Displays a us...

Page 19: ...therwise depressed during treatment which will automatically stop the treatment procedure If needed stop aspiration by pressing on the suction button on top of the firing pedal Remove the therapy probe and the coupling cone from the patient s eye To start treatment again if needed and appropriate follow the procedure described in part 2 Management of interruptions in the treatment sequence of Sect...

Page 20: ...act with the eye which ensures proper positioning of the therapy probe on the eye 4 2 Description of the device elements The system is composed of the following elements 5 The EyeOP1 Control Unit 6 The sterile single use EYEOP PACK consumable containing a therapy probe and a coupling cone 4 2 1 The EyeOP1 Control Unit It comprises the following elements Touch screen ON OFF button Mains supply feed...

Page 21: ...uit 2 is on the right side 8 Connection for the pedal 5 cables is on its right 9 The mains supply connection 6 is on the left Potential equalization terminal 4 marked with This is provided only to have a reachable earth potential during electrical test leakage current It is not necessary to plug it during treatment This conductor is not intended for protecting grounding Front view of the Control U...

Page 22: ... use An inappropriate re sterilization by the user not authorized by EYE TECH CARE could damage the elements of the EYEOP PACK consumable such as the probe s transducers and could lead to under treatment and or undesired treatment on surrounding tissues The EYEOP PACK elements are ethylene oxide sterilized Make sure that the plastic packaging and tyvek covering are not damaged before use in order ...

Page 23: ... the therapy probe In order to do that the therapy probe can be rotated by the user after the treatment of the six first sectors to treat the additional sectors in the second position obtained Therapy probe in the coupling cone Left in its first position for the treatment of the first six sectors Right in its second position for the treatment of the following sectors for 8 sectors protocol 4 2 2 3...

Page 24: ...il address support eyetechcare com Ensure that only the latest version of the nomogram that has been sent to you by EYE TECH CARE is used 4 3 Description of the system installation and treatment configuration The EyeOP1 Control Unit must be used in a hospital environment in an operating theatre and connected to an adequate electrical plug 230 V on a mains supply withholding at least 10A To fully s...

Page 25: ... to recharge the battery thus preventing complete discharge that would require servicing by EYE TECH CARE before the device could be reused As long as the battery is not completely flat however knowing that it is not used to back up the control module data internally and knowing it recharges whenever the module is powered on there is no risk of the control module powering off and a treatment can b...

Page 26: ...screen figure 2 Pressing the right hand side arrow enables to go to the next screen Pressing the left hand side arrow enables to return to the previous screen Same User New User Start Home User information Settings Patient identification Selection of the Eye of the treatment protocol and of the IOP Report Shut down Probe connection Vacuum test Cone and probe positioning Treatment Patient informati...

Page 27: ...d 2 Enter the characters using the virtual keyboard 3 Validate the entry by pressing on After each entry validate by clicking on in order to move to the next step If no data has been entered the field color is blue If the entry is not valid the field color is red When entered data are correct the field color becomes green and the move to the next step is authorized and automatic In case of error o...

Page 28: ...each treatment make sure that the printer is fed with enough paper in order to print the treatment report see 4 3 Checking replacing and repositioning the printer paper of Section 7 5 3 1 Step 1 Information for the physician ophthalmologist user After turning on the machine the user must identify himself in the Main Menu 1 Select USER If the previous treatment procedure was performed by the same u...

Page 29: ...ding key 6 Go to next step by pressing on the arrow at the bottom right corner of the screen 5 3 3 Step 3 Selection of the eye and of the number of sectors to treat 1 Select the patient s eye to be treated by pressing on the desired eye The selected eye then lights up in green L for patient s left eye R for patient s right eye Only one eye can be selected at a time To change the selection click on...

Page 30: ...the product a Remove the covered blister from the carton box Before unpacking the EYEOP PACK consumable make sure the packaging is not damaged and sterility has not been altered The covered blister is the sterile barrier system if its visual examination blister lid sealing reveals the loss of the sterility of the content damaged or unintentionally opened do not use the product b Remove the lid of ...

Page 31: ...is unsuccessful if No probe is connected as shown opposite The probe is defective The probe has previously been used The probe is incompatible In this case connect a new appropriate probe check its connection and select Probe Try again 3 Connecting the coupling cone tubing to the Control Unit a Connect the coupling cone tubing to the Control Unit as shown on the screen and opposite illustration by...

Page 32: ...uum test has been carried out If the test does not comply 1 Check proper connection and integrity of the tubing and make sure it is clamped If a leak is detected replace the device 2 Repeat the test by pressing on Test Restart while making sure the tubing is correctly clamped It is impossible to move to the next step as long as the vacuum test is unsuccessful 5 Positioning the coupling cone on the...

Page 33: ...re to keep the coupling cone correctly centered throughout the treatment procedure Should centering of the coupling cone be unsatisfactory stop suction by pressing again on the suction button then start over again from step Moving to the next step is possible only if the coupling cone is properly secured on the eye via sufficient and stable vacuum level in which case the bar on the left side goes ...

Page 34: ...t step a Visually ensure that the tabs of the probe are securely locked into place on the rim of the coupling cone Always be sure to not move the coupling cone and the therapy probe in its position on the eye throughout the treatment procedure maintain it centred c Fill the therapy probe and the coupling cone with standard sterile saline at room temperature to a level between Min and Max as shown ...

Page 35: ...hots Maintain the coupling cone and the therapy probe in its position on the eye throughout the treatment procedure in order to keep it correctly centered Pressure must be maintained on the pedal throughout the treatment including off time between two sectors as shown on the screen by a countdown Releasing this pedal results in immediate stoppage of the treatment Management of interruptions in the...

Page 36: ...cone in the clockwise direction up to the stop without forcing by using the wings of the probe Once done release the wings in order to maintain the probe in its second position Then push the OK button Do not move the coupling cone and keep it centered on the eye during the rotation of the therapy probe 5 Start the second treatment session by releasing if not already done then by pressing and maint...

Page 37: ...matic print is systematically delivered Accuracy of values displayed is as follows Negative pressure 5 Firing time 0 1 sec Frequency 10 Hz Power 10 3 Remove the coupling cone and therapy probe from the patient s eye while carefully sponging up the liquid contained in the center of the device and discard everything appropriately contaminated waste 4 Disconnect the therapy probe by grabbing it by th...

Page 38: ...on the bottom left corner of the screen 2 Press on the left and right arrows on each side of the bargraphs to adjust the screen brightness and volume With some Control Units the sound volume is not adjustable 3 Press on OK to validate the changes and return to the Settings Menu or press on Cancel to return to the Settings Menu without modifying these parameters It is possible to adjust the volume ...

Page 39: ...nting is enabled and that a paper printout will automatically be produced upon completion of each treatment 3 Press OK to validate your changes and return to the Settings Menu or press Cancel to return to the Settings menu without changing these settings 6 4 3 System information This screen summarizes information on the Control Unit software serial number etc Select INFORMATION in the Setting Menu...

Page 40: ...NCEL to return to the Settings Menu without modifying these parameters 6 4 6 Checking replacing and repositioning the printer paper To check change or reposition the printer paper lift the black lever at the rear of the Control Unit as shown here in order to open the printer cover Replace the paper and or reposition if necessary The two buttons under the printer have the following functions 5 scro...

Page 41: ...nel 4 When parts or accessories have been replaced with parts or accessories non qualified or non authorized by EYE TECH CARE 7 2 Management of interruptions in the treatment sequence The firing sequence automatically stops at treatment completion However in some cases the sequence can be prematurely discontinued either on purpose in case of emergency or inadvertently firing pedal release or due t...

Page 42: ...own If the interruption occurs while firing in a sector it will be partially treated and may not be completed If the interruption occurs during a pause or before firing in the first sector the treatment will resume in the sector that would have been treated after that pause If the treatment interruption is due to a suction problem intentional break or otherwise etc and the user opts to continue tr...

Page 43: ...treatment needs to be transmitted to EYE TECH CARE the user must ensure that the patient s data are anonymized in order to not reveal his identity first name last name birthday it is recommended to use the same codification as the one proposed by EyeOP1 for example for Jean Dupont JE DUP 8 SECTION 8 MAINTENANCE AND CLEANING Use a cloth moist with soapy or bleach water 2 teaspoons per litre of wate...

Page 44: ... C Relative humidity 20 to 80 Pressure At atmospheric pressure close to normal pressure 1 atm When the medical device is stored after use disconnect the firing pedal and the power cable from the control unit 9 3 Lifetime The lifetime of the EyeOP1 control unit is 7 years The validity period of the EYEOP PACK consumable is 36 months 10 INFORMATION ON USER MANUAL UPDATES Compared to the previous ver...

Page 45: ...and during the unpacking procedure of the EYEOP PACK consumable Addition of a note orientating the user in case of need of printer paper Addition of a note asking the user and or the patient to contact EYE TECH CARE and the competent authority in case of occurrence of a serious incident involving the medical device Addition of the transport conditions ...

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