FAQ ISIRIS α
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What is Isiris α, the single-use flexible cystoscope ?
Isiris α is a single use flexible cystoscope with an integrated grasper for double loop ureteral stent removal for adults. Isiris α is connected to the reusable mobile monitor Isiris Monitor. The flexible cystoscope is designed to be inserted into the patient through the urethra up to the bladder. In men and women flexible scopes are better tolerated and are less painful compared to rigid cystoscopy. The stent removal can be undertaken anywhere so releasing limited time and specific equipment for other procedures in dedicated operating or endoscopy areas.
What can Isiris α bring to DJ stent removal ?
Isiris α simplifies the organization of a DJ stent removal by making it more flexible. Indeed, Isiris α provides clinicians with the choice and opportunity to remove JJ stents in almost any place at any time. Following their surgical procedure, patients can have their ureteral stent removed in an out-patient setting. In addition, the Isiris α can be inserted in the urinary tract without the need for a general or spinal anesthesia, generating less pain and discomfort. Flexible cystoscopies for stent removals are considered more comfortable and since JJ stent retrievals with Isiris α can be performed in a consultation room, equipped rooms can be allocated to more complex and time-sensitive procedures. Consequently, more patients can benefit from DJ stent retrieval in a comfortable setting. Isiris α allows a simple act in a simple environment and permits to manage challenges. Thus, Isiris α allows to reduce the overbooking of the operating rooms/endoscopy rooms and help hospitals to reduce the diagnostic and cancer follow-up delays.
How can Isiris α be used for a ureteral stent removal procedure ?
Isiris α is used to remove a double J ureteral stent, which is a stent placed in the ureter, the section of the urinary tract that goes from the kidney to the bladder. Due to its integrated grasper used to retrieve a double loop stent, Isiris α can be used to perform a one-step procedure. Flexible cystoscopy can be conducted in an out-patient setting, directly during a consultation. Once the stent is removed, the patient can leave the doctor’s office. Isiris α is easy to use! It only required a one-step removal procedure.
What is the difference for between a flexible and a rigid cystoscopy? Can it be used in men and women ?
Isiris α can be used in both men and women. It is made by a long flexible tube called a cystoscope and a grasper that will retrieve the double loop stent. Contrary to rigid cystoscopy, flexible cystoscopy generates less pain. Indeed, rigid cystoscopy require a general anesthetic or a spinal anesthetic. Flexible cystoscopy, however, doesn’t require either and can be performed simply by applying a local anesthetic at the entry of the urinary tract. Isiris α can be used in the same conditions than reusable rigid and flexible scopes, i.e. can be in contact with the following solutions : Local anesthetic gel (e.g. Xylocain gel, Lidocain gel or Instillagel)
• Local anesthetic solution (e.g. Betadine® or any other iodine based solutions)
• Water based lubricant gel (e.g. Kygel or Kygel-like gel solution)
• Sterile water
Have the Isiris Monitor and the Scope received their own CE Certificate ?
Yes, and they are in a different Class.
What should I do if the irrigation water comes out while the patient lies on the bed ?
It is recommended to always use protective sterile sheets adapted to urological operations (such as Foley catheter placement).
What should I do if cannot find the IFU in the box ?
Each box contains a paper version of the user’s guide (simplified IFU) as well as a CD-ROM with the complete IFU in 23 languages.
May Isiris System be disrupted by other electrical medical instruments ?
Like any other electrical medical equipment, the Isiris System requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC) the Isiris System must be installed and operated according to the EMC information provided in IFU (Appendix 1: Electromagnetic Compatibility).
May Isiris System cause interferences or disrupt nearby equipment and operations?
The Isiris System has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices. See IFU: Appendix 1: Electromagnetic Compatibility
How does the flexible camera work ?
The flexible cystoscope has a camera at the end of the insertion cord, next to the grasper that provides a high-quality image with 85° field of view and supports physicians in correctly performing the procedure. During the procedure, the flexible cystoscope is then inserted through the urinary tract, guided by the camera.
Any illuminated object emits light rays (consisting of photons) from the filmed scene (image). These photons pass through a camera lens and will hit a sensitive CMOS sensor (the famous CMOS). The CMOS sensor is a semiconductor that will convert each photon into an electric signal. The electrical signal is then processed through a digitalization mechanism (which is for us in the monitor) to recreate the image on a screen or store it on a memory card.
What is the grasper´s shape?
The grasper has a rat tooth design which makes it very efficient to grasp stents.
What is the cord’s diameter ?
The cord’s diameter is 5 mm.
What is the “working channel’s” diameter ?
There is no working channel as such, but an irrigation connector for irrigation/aspiration connection via a Luer lock
Is the Isiris System MRI safe or MRI compatible ?
Can I insert endoscopic equipment in the irrigation channel ?
Isiris α cannot accept any insertion of endoscopic instruments as the irrigation channel is only designed for introduction of liquids and aspiration.
Why can’t the grasper button be locked to close the grasper ?
This is a safety design decision made to prevent the scope from remaining stuck in the catheter loop.
Can I apply a water based lubricant gel directly on the cord or in the patient’s urethra ?
Isiris α has been tested with different water based lubricant gels. Each user may decide to apply lubricant gel directly onto the insertion cord or into the patient’s urethra.
Why is Isiris α equipped with this shape of grasper ?
Isiris α has a “2:1 rat tooth” grasper designed for stent retrieval.
Why is the gasper oriented vertically ?
We evaluated during the development phase that this orientation offers the best efficacy.
What electrical power is required for ISIRIS α ?
Isiris α is internally powered to protect again electrical shocks.
Power requirements: 18 V 1,67A DC input.
Battery type: 11,1 V 3760 mAh
Is Isiris α electrically safe ?
Isiris α is built for cystoscopy usage and has successfully passed all electrical checks performed by an independent laboratory (UL). Note that UL electrical check is mandatory for EC and US certification.
Do we need to perform white balance?
There is no white balance system needed. White balance (WB) is the process of removing unrealistic color casts, so that objects which appear white in person are rendered white in your picture.
Can I use Isiris α for something else than stent removal ?
Isiris α is only intended for stent removals.
Can I use Isiris α without irrigation ?
The device is designed with a luer lock system. Each user may decide or not to irrigate or aspirate.
Can ISIRIS α be reused ?
No, ISIRIS α is single use and reprocessing may create a potential harm to the patient.
Can the Isiris Monitor be cleaned with Incidin Foam ?
Yes. The following procedure needs to be followed:
First of all, wipe the surface of the Isiris Monitor for approximately 15 minutes using a piece of sterile gauze. The gauze needs to be moistened with the alcohol mixture indicated below (approximately once every 2 minutes). We advise you to follow safety procedures for the handling of isopropyl. The gauze should be moist and not dripping since liquid can affect the electronics inside the Isiris Monitor. Pay close attention to the buttons, rubber covers, screen, external casing and stand, slots and gaps on the Isiris Monitor. Use a sterile cotton swab for these areas.
Will the manufacturer perform regular safety inspections on the Isiris Monitor ?
No, we do not perform specific safety checks. All checks and recommendation are found in the IFU. It has come to our attention that some biomed take the initiative of performing certain electric checks before releasing the monitor into the hospital. In addition, yearly checks can also be conducted on the monitor, but it is country/hospital dependent.
Will there be software updates and, if so, how will they be conducted ?
If mandatory software updates are required, they will be performed through an USB stick.
How much does the Isiris Monitor weight ?
The Isiris Monitor weights 1.5Kg
Should I expect battery damage if I charge the monitor very often or if it is always plugged into a wall socket?
Your monitor will continue to work normally, but over time your battery autonomy will reduce (the same happens with mobile phones or tablets on LI-ion battery)
What is the electric power required to charge the battery ?
Power requirements are: 100 – 240V AC; 50-60Hz; 0.6A for Monitor power supply.
The Isiris Monitor comes with interchangeable types of plugs.
Isiris Monitor Power out: 18V DC; 1.67A
Protection against electrical shock Class I= grounded
Can I lose recorded images/videos when the battery is fully discharged ?
No. Images (Jpeg format) and videos (Avi format) are stored on an external SD card. SD stands for Secure Digital.
How can I transfer the images ?
The Isiris Monitor is equipped with an USB port to transfer images or update the software.
What is the SD card’s storage capacity ?
The SD card’s storage capacity is of 8 GB (equivalent of approximately 3 000 pictures or 1 to 1.5 hours of video).
Why does the battery drain when the monitor is switched off ?
The battery still powers some back up activity even when the monitor is off. The battery will drain to a safety level within 2 weeks of no activities. It means that the monitor will need to be plugged in after this lapse of time to restart.
What is the battery average duration ?
In normal use, the battery lasts about 3 to 4 hours.
Will the battery crash if it is not recharged according to instructions every 3 months at least ?
No, but this will affect the battery’s autonomy over the time.
How long does it take to fully charge the battery ?
Recharging the full battery takes approximately 5 hours. The On/Off button turns green when fully charged.
Can images be sent to the external monitor ?
No output video connection.
How should we clean and disinfect the monitor ?
Instructions for cleaning and disinfection have been validated according to AAMI TIR 12 & 30 (US Association for the Advancement of Medical Instrumentation). Endoscope manufacturers are required to provide customers with disinfection procedures that have been tested and validated. It is however possible that hospital implement their own cleaning procedure. Note that any deviation from the instructions should be properly evaluated by the reprocessor for effectiveness and potential adverse consequences to ensure that the device continues to fulfil its intended purpose. For details, refer to chapter 9 of the IFU.
How should the Isiris Monitor be discarded ?
The Isiris Monitor should be discarded according to the WEEE directive (see EDS).
How should the Isiris α be discarded ?
After use, the Isiris α is considered as infected. Due to contamination, this product should not be disposed as electronic waste but should be handled as contaminated waste (see EDS).
I have low quality image because of blood or urine on the lens. What can I do ?
Gently rub the distal tip against the mucosa. If the lens cannot be cleaned this way remove Isiris α and wipe the lens with sterile gauze.
I have low image quality. What should I do ?
1) Move the Isiris Monitor to a position where no direct light influences the screen. It is recommended to perform the endoscopy in a dark area,
2) Adjust the contrast and brightness using the designated menu on Isiris monitor,
3) Wipe the screen with a clean cloth.
I have no live image on the left side of the screen, but the user interface is present on the display. What can I do ?
The Isiris Monitor is operated through the yellow file management tab or the green settings tab. Return to live image by pressing the blue live image tab or the red button with a black X in the top right corner.
If it does not work, restart the system by pressing the ON/OFF button on the Isiris Monitor for at least 2 seconds. When the Isiris Monitor is OFF restart it by pressing the ON/OFF button once more. If it still does not work, Isiris α could be damaged. In this case, you should replace Isiris α with a new one.
The image shown to the left of the monitor is frozen or black. What can I do ?
The image shown to the left of the monitor is frozen or black. What can I do ?This indicates that a communication error has occurred between the Isiris α and the Isiris Monitor. Check that your Isiris α is connected to the red port on the Isiris Monitor. Restart the system by pressing the ON/OFF button on the Isiris Monitor for at least 2 seconds. When the Isiris Monitor is OFF restart it by pressing the ON/OFF button once more. If it still does not work, Isiris α could be damaged. In this case, you should replace Isiris α with a new one.