Isiris α Instructions for Use Rev 1 June 2015

List of subsidiaries on the box / Liste des filiales sur la boîte / Liste der Niederlassungen auf der Verpackung / Elenco delle filiali sulla confezione / Lista de filiales en la caja / Lista de subsidiárias na embalagem / Lijst van de filialen op de verpakking / Κατάλογος θυγατρικών παρέχεται στο κουτί / Список дочерних предприятий на упаковке / Lista oddziałów lokalnych na pudełku / Seznam poboček na krabičce / Kutudaki bağlı kuruluş listesi / Tytäryhtiöiden luettelo pakkauksen päällä / Lista över dotterbolag på förpackningen / Oversigt over datterselskaber på kassen / Liste med underselskaper på esken / 盒子上的子公司名单/ Списък на фирмените отдели

Jordan – Al Eiman Drug store, PO Box 402 - 7th Circle, Airport Street Beside City Terminal, 11810 Amman Phone : +962 6 581 0108 / Fax: +962 6 581 8850 - samerissa@eiman-eds.com Korea – Suntek Medical Systems, 3rd Fl. Zero BD- 84 Gil, 14 Teheran-Ro , Kangnam-Ku-Seoul 135-845 Phone : +82 2 5143214 / Fax +82 2 547 2446 - Park Chong Young -cypark99@chol.com Kuwait – Ashraf & Co., P.O. Box 3555, 13036 Safat Phone : +965 531 2960 / Fax: +965 533 6372 - consumamedical@ashraf.com

върху кутията / A leányvállalatok listája a dobozon van feltüntetve / Dukterinių

Lebanon – Saramed SARL, 1022 Ryad El Solh, 1107 2070- Beyrut

įmonių sąrašas ant dėžutės / Lista filialelor menţionate pe cutie / Lista podružnica se nalazi na

Phone : +961 1577 111 / Fax: +961 1575 600 - m.hasswany@saramed.com

pakovanju / ‫قائمة الشركات الفرعية على العبوة‬ Distributed by: / Distribué par : / Vertrieben durch: / Distribuito da: / Distribuido por: / Distribuído por: / Gedistribueerd door: / Διανέμεται από: / Поставщик: / Dystrybucja: / Distributor: / Dağıtıcı: / Jälleenmyyjä: / Distribueras av: / Distribueres af: / Distribuert av: / 分销商： / Дистрибутор: / Disztribútor: / Platintojas: / Distribuit de: / Distribuira: / :‫تم التوزيع بواسطة‬

Libya – Kema Medical, Ras-hassan Eman, Elgharezi Street -Tripoli Phone : +218 1335 1197 / Fax: +218 1335 1199 - Info@kema-ly.com Lithuania – Skirgesa Ltd, Ekskavatorininku str. 1b, LT-52461 Kaunas Phone : +370 37 45 77 46, 45 21 68 / +370 37 45 81 61 - saulius@skirgesa.lt Malaysia – Pro Element Technologies , 18-34-A3 Persiaran Gurney, Gurney Tower-10250 Penang Phone : +604 226 32 86 / Fax +604 227 3286 - info@pro-element.com.my Malta – Pharma-Cos Ltd., Pharma-Cos House Triq. C. Portanier, 1732 Santa Venera HMR 11

Algeria – EURL BM Sante ,188 Rue des Frères Hamidate – Ouled Chebel –Alger Phone : +213 21 28 27 57 / Fax : +213 21 28 50 13 Mohamed Bordji - bmsante_dg@yahoo.fr Argentina – Forum Technologies S.R.L, Av. Dr. Ricardo Baldin 4282. (1430) C.A.B.A - Argentina Phone : +54 11 4547 3037 – www.forumgrp.com.ar

Phone : +356 2144 1977 / Fax: +356 2144 1388 - mmifs@pharma-cos.com Mexico – Geoworks Durango 225-204, Col. Roma – Mexico, D.F 06700 Phone : +52 55 5514 0381 - Alberto Favilla - geoworks@geoworks.com.mx

Bahrain – Yousuf Mahmood Husain, PO Box 23 Tijjar Road-Manama Phone :+973 172 761 76 / Fax :+973 172 758 19 - thomas@ymh.com.bh

Morocco – Sahmed, 2, rue des Acacias & Boulevard Y El Mansour El Maarif, 20100 Casablanca

Brazil – Bioprime: Rua José Versolato, 111- Domo Business – Torre B 24°Andar, Sala 2412 CEP 09750-730 Sao Bernardo do Campo-SP. Phone : +55 11 2534-9947 - inez@bioprimesp.com.fr

Norway – Endomed A.S., Prof. Birkenlands vei 34B – 1081 Oslo

Bulgaria – Medical Technics, Engineering Ltd., Mladost 1, Bl 28B Dimitar Mollov Str. BG-1750 Sofia Phone +359 2 971 2061 / Fax :+359 2 971 2410 - petkova@mte-bg.com Chile – Promex , Nueva de Lyon 145, Piso 11, Providencia- Santiago Phone: +56 2 484 80 00, Fax: +56 2 225 7966 – karina.navarrete@promexsa.cl Hongkong – Keymax Technology, Unit 2103, 21/F., Kodak House II, 39 Healthy Street East, North Point- Hong Kong Phone :+852 31508913 / Fax :+852 31508412 - keymaxtechnology@yahoo.com.hk Colombia – Ordenes y Suministros , Carrera 13 A No78-88, barrio El Retiro. Bogota Fax : 57 16347244 - ivonnesalcedob@hotmail.com Cuba – Medicuba, Maximo Gomez n° 1, Habana Vieja, Ciudad Habana, Phone : +53 7 862 40 61/62/63 / Fax: +53 7 866 85 16 medicuba@medicuba.sld.cu

Phone : +212 2298 1177 / Fax: +212 2298 1178 - logistics@claesmedical.com

Phone : +47 23 17 24 00 / Fax: +47 23 17 24 01 - endomed@endomed.no Oman – Muscat Pharmacy and Stores LLC, Po Box 438, 113 Muscat, Phone : +968 24814501 / Fax: +968 24815201 - mphq@mpmct.com mansoor@nationalpharmacyllc.com Pakistan – F.W. Distributors, FW Building, Opposite Poonch House, Adamjee Road, Saddar - Rawalpindi Phone : +92 515516729 / Fax: +92 515120061 - fw@fwdpak.com.pk Peru – Famedical - AV. Aviacion 3143, Ofic.101, San Borja-Lima Phone : +511 225 88 02 - importaciones@famedical.com.pe Pologne – Skamex, Spolka z ogr. odp. Sp. k., Czestochowska 38/52, 93-121 Łodź Phone : +48 42 677 14 11 / Fax: +48 42 672 40 10 - katarzyna.kowalczyk@skamex.com.pl

Cyprus – Cyprus Pharmaceutical, P.O. Box 1005, 11 King Paul Street, 1500 Nicosia Phone : +357 2863 100 / Fax: +357 2675 136 - cpomeditec@papellinas.com

Qatar – Ali Bin Ali, P.O. Box 75 Al Jelaiat str 37 Bin Omran-behind Hamad Hosp-Centre Doha

Czech Republic – Promedica Praha Grp , Novodvorska 136 – 142 00 Praha 4 Phone : +420 /221 595 111 / Fax +420 224 257 838 rozsafny@promedica-praha.cz

Romania – Steril Romania, 3-5, Metalurgiei Blvd., Sector 4 041831, Bucharest

Dominican Republic – Santos & Ortiz Group, Calle Dr Angel Severo Cabral 69, Ensanche Julieta- Santo Domingo Phone : +1 809 979 92 44 – rufinosantosh@gmail.com Egypt – Egyptian Group, 11 Ebad El Rahman St, behind Tourism Institute, Sheraton Heliopolis 11799 Cairo Phone : +20 2268 7712 / Fax: +20 2268 7714 - shymaa.abdelrahman@eggroup-eg.com Egypt – Egypt care for Supplies & Commercial Agencies 4H Dar El-Defaa El Gawy st., El Nozha st. takseem Asmaa Fahmy, Ard El Golf, Heliopolis flat10 Cairo Phone : +2 02 24 191471 / Fax : +2 02 24 153079 - maimostafa@egypt-care.com Estonia – AB Medical Group Estonia, Reti tee 12, Peetri kula, 75312, Rae vald, Harjumaa Phone : +372 655 2310/610 6461 / Fax: +372 659 3250 - grete@abmedical.ee Finland – Fenno Medical OY, PO Box 153- FI- 01531 Vantaa Phone : +358 9 276 360 / Fax: +358 9 2763 6199 - kari.bergman@fennomedical.fi Greece – Anastasios Mavrogenis SA, Passov 15, GR11141 Athens Phone : +30 2101010132 / Fax: +30 210 2020775 - m.mavrogeni@coloplast.gr Hungary – C.P.P Budapest Kft, Amerikai UT 33, H-1145 Budapest HU Phone : +3614223700 / / Fax: +36 1 422 37 08 - gergely.jancso@cppbudapest.hu

Phone : +9744867871 / Fax: +9744882585 - shadi.sleiman@alibinali.com

Phone : +4021 460 07 79 / Fax: +4021 460 04 52 - import@steril.ro Saudi Arabia – JAT – 80 Amr Ibn Al-Aas street, Al Wisham Area Office 308 , Riyadh Phone : +966 114040470 - maman@janatalarab.com Senegal – Kima Health Partner , 89 Rue 03 Mamelles Elevage Ouakam – Dakar Phone : +221 33 821 42 37 - kimakhp@gmail.com Serbia – Magna Pharmacia, Resavska 60, 11000 Belgrade, Phone : +381 11 32 84 744 - dejana.boskovic@magnapharmacia.rs Slovakia – SEQ-MED S.R.O , Biskupicka 21 , 986 01 Filakova Phone : +421.2 555 766 05– seqr@stonline.sk Slovenia – Apollonia d.o.o., Zaloska 155, 1000 Ljubljana Phone : +386 1/548 35 10 / Fax: +386 1 540 03 97 - apollonia@amis.net South Africa – Nu Angle, Postnet Suite 93, Private Bag X33, Rivonia Phone : +27 114674145 - dawn@nuangle.co.za Syria – Zarzour Co, P.O. Box 72, Al Tal, Aldaheia N.H Way- Damascus

Iran – Arman Tandorost Co., Nr. 23, 5th floor Etminan Bldg 480, Tehran Phone : +98 2166 413870 / Fax: +98 2166 412885 - atc@mavara.com

Phone : +963 11 59 48 000 / Fax: +963 11 59 47 000 - az@zarzourmn.com

Israel – Sela Medical, 6 Ravnitzky St. Petach, 42799 Tikva Phone : +972 3 9043433 / Fax: +972 3 9045474 - yuval@selamedical.co.il

Phone : +216 71899 750 / Fax: +216 7189 7050 - medico.chirurgi@gnet.tn

Tunisia – Medico Chirurgical, 31 BD Hedi Saidi , 1005 Tunis

Turkey – Intra Medikal Gerecler Pazarlama Ltd., Koresehitleri cad. No.48/50 34394 Istanbul Phone : +90 212 274 4752 / Fax: +90 212 288 2082 - porges@intramedical.com.tr

United Arab-Emirates – Pharmatrade, P.O. Box 11397, Dubai Phone : +971 4268 3339 / Fax: +971 4262 5735 - amgad@pharmatradeuae.com Uruguay – H. Strattner –Neomed SRL ,Francisco Llambi 1556, Montevideo, Uruguay, Phone : +598 2 622 8326/ Fax: +598 2 622 5567 - rocioabella@neomed.com.uy USA – Coloplast Corp. Minneapolis, MN 55411. Phone : +1 612-588-4685 - www.coloplast.com For customer service, please call 1-800-533-0464 in USA;Outside USA, contact your local Coloplast representative Vietnam – Toan Anh CO. LTD, Appt. 300, Room 218, District 1, Hôchiminh City Phone : +848 39574066 - ivf_vietnam@yahoo.com

Isiris α

Isiris Monitor

0543

The Coloplast logo is a registered trademark of Coloplast A/S. © [2015-06.] All rights reserved. Coloplast A/S, 3050 Humlebaek, Denmark.

GB

INSTRUCTIONS FOR USE SH2204

ISIRIS™ α STENT REMOVAL SYSTEM

Contents

Page

1. Important information – read before use ... 6 2. System Parts ... 8 3. Technical Product Specifications ... 12 4. Inspection and preparation of Isiris α and Isiris Monitor ... 14 5. Operating Isiris α ... 16 6. Use of Isiris Monitor and connecting accessories ... 19 7. How to Operate Isiris Monitor... 20 8. After Use... 27 9. Cleaning and Disinfection of Isiris Monitor... 28 10. Trouble Shooting... 29 Appendix 1: Electromagnetic Compatibility... 30 Appendix 2. Standards Applied... 32 Appendix 3. Warranty and Replacement Program... 33

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1. Important information – read before use NOTE Read these safety instructions carefully before using the Isiris System. The Instructions for use may be updated without further notice. Copies of the current version are available upon request.

WARNING - Isiris α is a sterile, single-use device and must be handled in a manner consistent with accepted medical practice for such devices in order to avoid contamination of Isiris α prior to insertion. - Images produced by or with the Isiris System must not be used as an independent diagnostic tool of any pathology. Health care professionals must interpret and substantiate any finding by other means and in the light of the patient's clinical characteristics.

1.1 Instructions Please be aware that these instructions do not explain or discuss clinical procedures. They describe only the basic operations and precautions related to the operation of the Isiris System. Before initial use of the Isiris System, it is essential for operators to have received sufficient training in clinical ­cystoscopic techniques and to be familiar with the intended use, warnings, cautions, notes, indications and contraindications mentioned in these ­instructions.

1.2 Intended use Isiris α is a sterile, single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via an urethral insertion. Isiris α has been designed to be used with the reusable Isiris Monitor to visualize the observations obtained by Isiris α.

1.3 Indications for use The Isiris System is for use in hospital or in a medical office environment. Isiris α is a sterile, single-use device designed for patients, accepting a scope diameter of 5.5 mm, implanted with a double loop ureteral stent, ranging from size CH4.8 to CH9.

WARNING Do not use the Isiris System for any other purpose than its intended use

WARNING Do not use active endoscopic accessories such as laser probes and electrosurgical equipment in conjunction with the Isiris System, as this may result in patient injury or damage to the Isiris System.

1.4 Warnings, Cautions and Notes Throughout these instructions, appropriate warnings, cautions and notes are given describing potential safety hazards associated with the use of the Isiris System. The information given in these instructions serves only to instruct in the correct handling of the system. Throughout these instructions, the following definitions are used :

WARNING Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the Isiris System.

CAUTION Alerts the user to the possibility of a problem with the Isiris System associated with its use or misuse. Such problems include the Isiris System malfunction, the Isiris System failure, damage to the Isiris System or damage to other property.

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NOTE Advises the user about important information on the use of this equipment.

GENERAL WARNINGS - Do not use the Isiris System if it is damaged in any way. - Perform a functional check before using the Isiris System (see section 4). Do not use the Isiris System if any part of the functional check fails. - Do not attempt to clean and reuse Isiris α as it is a single-use device. Reuse of the product can cause contamination, leading to infections. - Isiris α is a single use device. Isiris α is considered infected after use and must be disposed of in accordance with local guidelines for collection of infected medical devices with electronic components. Do not soak, rinse, or sterilize this device as these procedures may leave harmful residues or cause malfunction of the device. The design and material used are not compatible with conventional cleaning and sterilization procedures. - The Isiris System is neither MRI safe nor MRI compatible. - Do not use the Isiris System during defibrillation. - When handling the patient do not simultaneously touch the Isiris Monitor power socket or docking connector. - Only to be used by skilled physicians trained in clinical endoscopic techniques and procedures. - Excessive force should never be used when operating Isiris α. - Patients should be adequately monitored at all times during use. - Always watch the live endoscopic image on Isiris Monitor when advancing or withdrawing the scope, deflecting the distal tip or aspirating. Failure to do so may harm the patient. - The Isiris System may cause interference or disrupt equipment operations nearby. It may be necessary to adopt procedures for mitigation, such as reorientation or relocation of the equipment or shielding of the room in which it is used. - Do not activate the grasper during suctioning.

GENERAL CAUTION - Be careful not to damage the insertion cord or distal tip when using sharp devices such as needles in combination with Isiris α. - Be careful when handling the distal tip of the insertion cord and do not allow it to strike other objects, as this may result in damage to the equipment. The lens surface of the distal tip is fragile and visual distortion may occur. - Do not exert excessive force on the deflective tip as this may result in damage to the equipment. Examples of inappropriate handling of the deflective tip include: - Manual twisting and bending such as performing retrograde vision inside bladder. - Operating it in any case where resistance is felt. - Keep the Isiris α hand piece and Isiris Monitor dry during preparation, use and storage. - The batteries in Isiris Monitor are not changeable and must only be removed upon disposal. - Portable electronic equipment may affect the normal function of the Isiris System.

GENERAL NOTES Have a suitable backup system readily available for immediate use so the procedure can be continued if a malfunction should occur. Coloplast is not responsible for any damage to the system or patient resulting from incorrect use.

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2. System Parts CAUTION The Isiris System consists of the parts described in section 2. They may only be replaced by Coloplast authorised parts. Failure to comply with this may reduce safety and efficiency.

2.1 System Parts Before you install and use the Isiris System please ensure that the following items are available: Isiris α – Single use device: Isiris α

Instructions for Use Stent removal system

Instructions For Use GB

STENT REMOVAL SYSTEM

FR

SYSTÈME DE RETRAIT DE SONDE

DE

SYSTEM ZUR STENTENFERNUNG

IT

SISTEMA PER LA RIMOZIONE DI STENT

ES

SISTEMA DE RETIRADA DE LA ENDOPRÓTESIS

PT

SISTEMA DE REMOÇÃO DE SONDA

NL

SYSTEEM VOOR HET VERWIJDEREN VAN EEN STENT

SYSTEM USUWANIA STENTU

CZ

SYSTÉM ODSTRANĚNÍ STENTU

STENT ÇIKARMA SISTEMI

FI

STENTIN POISTOJÄRJESTELMÄ

SE

SYSTEM FÖR AVLÄGSNANDE AV STENT SYSTEM TIL FJERNELSE AF STENT SYSTEM FOR FJERNING AV STENT

BG

RU PL

TR

DK NO CN

GR

HU

SZTENTELTÁVOLÍTÓ RENDSZER

LT

STENTO IŠTRAUKIMO SISTEMA

RO

SISTEM DE ÎNDEPĂRTARE A STENTULUI

RS

SISTEM ZA UKLANJANJE STENTA

REF.:SH2204 Date of issuance: Jan. 2015 Revision Number : 1

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Manufactured for Coloplast A/S Holtedam 1 3050 Humlebæk Denmark

The Coloplast logo is a registered trademark of Coloplast A/S. © [2015-01.] All rights reserved Coloplast A/S, 3050 Humlebæk, Denmark.

Isiris Monitor – Reusable device: Isiris Monitor

Bracket (e.g. for attaching Isiris Monitor to an I.V. pole)

Power supplies Isiris Monitor power supply manufacturer: FSP Group Inc.

x5

Isiris Monitor power supply part number: FSP030-REAM

2.2 Description of the Isiris System The Isiris System consists of Isiris α and Isiris Monitor. Isiris α is a sterile single use device. Isiris Monitor is reusable.

Isiris α Hand piece Suitable for left or right hand

Deflection lever (European movement) Moves the distal tip up or down

Grasper activation button Activates grasper when pressed

Image cable Transmits the image signal to Isiris Monitor

Irrigation connector Allows for irrigation and aspiration connection via a Luer lock

Connector on image cable Connects to red socket on Isiris Monitor Grasper Protrudes when activated by the grasper activation button

Insertion cord Flexible endoscope insertion cord

Deflective tip Manoeuvrable part

Distal end Contains the camera, light source (two LEDs), as well as the irrigation and grasper channel exit

Protective sheath Protects the insertion cord during transport and storage. Remove before use.

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Isiris Monitor Isiris Monitor displays the video image from Isiris α. During start up, Isiris Monitor powers up and configures Isiris α.

Monitor Casing Input/output connections Composite and USB interface Red socket For image cable. Protected by a cover Stand To place Isiris Monitor on a solid surface

Touch Screen Displays the image from the camera and a touch screen interface

Power supply Powers the system and charges the battery. Power cord with selection of country-specific plugs

x5

Bracket Secures Isiris Monitor to e.g. an IV pole

ON/OFF button Push button for power ON before procedure and power OFF after procedure

Power Power socket for charging Isiris Monitor. Protected by a cover

Pouch hook Slide the hook through the 3 holes on the bracket. It can now be used to hold the Isiris α pouch (hole in the top) for easy storage before and during use

Hexagonal key To tighten the bolt on the bracket

2.3 Explanation of symbols used Symbols for Isiris α

Indication Working length of Isiris α insertion cord

Max OD

Maximum insertion portion width (Maximum outer diameter)

18 mm 4.5 mm

Maximum length of protruded open grasper and minimum grasper opening distance

Field of view

Not manufactured with Natural Rubber Latex

Connection for Isiris α

Electrical Safety Type BF Applied Part

Use By

Sterilized using ethylene oxide

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Do not re-use Symbols for Isiris Monitor

Indication Lights up when Isiris α is connected

Max. battery status of Isiris Monitor

Min. battery status of Isiris Monitor

Fully charged battery still ­connected to charger

The icon remains white until one block is left, after which it turns red. When remaining battery capacity is 10% the red battery icon starts flashing

Battery is charging

Battery current capacity

Battery damaged

Charging is shown with blocks flashing Current capacity is shown with non-flashing blocks Standby button for Isiris Monitor. The button will light up green when turned ON and not charging (power adaptor not connected to mains) and orange when charging (power adaptor connected to mains). Connection to external monitor

Direct current Alternating current IP30

Protection against solid objects Waste Bin symbol, indicating that waste must be collected according to local regulation and collection schemes for disposal of batteries. Only applicable for the battery inside Isiris Monitor Waste Bin symbol, indicating that waste must be collected according to local regulation and collection schemes for disposal of electronic and electrical waste (WEEE). Only applicable for Isiris Monitor

Li-ion

Battery type Lithium ion. Only applicable for the battery inside Isiris Monitor Tested to comply with FCC Standards - Medical Equipment

VESA MIS, D, 75, C

VESA Mounting Interface Standard MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005/(R):2012 CAN/CSA-C22.2 No. 60601-1:08 (R2013) IEC 60601-2-18:2009 UL60601-1, 1st ed.: 2006 CAN/CSA-C22.2 No. 601.1-M90, 2005 IEC 60601-2-18:1996 Control no 4UD1. Only applicable for Isiris Monitor Only for indoor use

Serial Number

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Keep dry

DC supply, positive tip polarity

USB connection Symbols covering both Isiris α and Isiris Monitor

Indication Manufacturer CE mark. The product complies with the EU Council directive concerning Medical Devices 93/42/EEC

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Reference Number Batch Code Warning Consult Instructions for use Date of manufacture

Russian mandatory [Gosstandard's mark of conformity]

Keep away from sunlight CAUTION, Federal (USA) Law restricts this device to sale by or on the order of a physician Temperature limit France and Germany : Symbol of contribution for sorting and recycling the packaging materials. Do not use if package is damaged

%

Humidity limitation: relative humidity between 30 and 85% in operating environment

Atmospheric pressure limitation: between 80 and 109 kPa in operating environment

Recycling UL Recognized Component Mark for Canada and the United States. Only applicable for Isiris α

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3. Technical Product Specifications 3.1 Isiris α Specifications Optical System Field of View

85°

Depth of Field

8-19 mm

Illumination method

LED

Insertion portion Deflecting section3

90° down, 80° up

Insertion cord diameter

5.0 mm (15 Fr / 0.20 inch)

Distal end diameter

5.4 mm (16 Fr / 0.21 inch)

Maximum diameter of insertion portion

5.5 mm (16.5 Fr / 0.22 inch)

Working length

390 mm (15.4 inches)

3. Please be aware that the deflection angle can be affected if the insertion cord is not kept straight

Grasper Maximum length of protruded grasper

18 mm (0.71 inch)

Minimum grasper opening distance

4.5 mm (0.16 inch)

Irrigation connector Connection type

Standard Luer connector

Operating environment Temperature

10 ~ 40° C (50 ~ 104° F)

Relative humidity

30 ~ 85%

Atmospheric pressure

80 ~ 109 kPa

Altitude

≤ 2000 m

Storage and transportation Temperature

10 ~ 40° C (50 ~ 104° F)

Relative humidity

30 ~ 85%

Atmospheric pressure

80 ~ 109 kPa

Sterilisation Method of sterilisation

EO

3.2 Isiris Monitor Specifications Display Max. resolution

800 * 480 pixels

Orientation

Landscape

Display type

8.5 inch colour TFT LCD

Brightness control

Yes, (“+” / ”-“)

Contrast control

Yes, (“+” / ”-“)

Start up time

About 1 second

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Memory Storage capacity

8 GB

Electrical power Power requirement

18 V 1,67A DC input

Battery type

11,1 V 3760 mAh

Protection against electrical shock

Internally Powered

Operating environment Temperature

10 ~ 40° C (50 ~ 104° F)

Relative humidity

30 ~ 85%

IP Protection Classification System

Isiris Monitor is classified IP30.

Atmospheric pressure

80-109 kPa

Altitude

≤ 2000 m

Dimensions Width

241 mm (9.49 inch)

Height

175 mm (6.89 inch)

Thickness

33.5 mm (1.32 inch)

Weight

1500 g (3.31 lbs)

Connections USB connection

Type A

Storage and transportation Temperature

10 ~ 40° C (50 ~ 104° F)

Relative humidity

30 ~ 85%

Atmospheric pressure

80-109 kPa

Mounting interface Mounting interface standard

VESA MIS-D, 75 C, VESA FDMI compliant display, Part D, with centre located mounting interface

Fixture Mounting interface

75 mm (2.95 inch)

Fits poles with thicknesses

10 mm ~ 45 mm (0.4 ~ 1.8 inch)

Isiris Monitor power supply Weight

360 g (0.79 lbs)

Electrical power Power requirement

100 - 240V AC; 50-60Hz; 0.6A

Power out

18V DC; 1.67A

Protection against electrical shock

Class I

Operating environment Temperature

10 ~ 40° C (50 ~ 104° F)

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Storage Temperature

10 ~ 40° C (50 ~ 104° F)

Relative humidity

10 ~ 90%

Plugs Between the power supply and Isiris Monitor

Ø5.5 mm (0.20 inch) DC jack connector

5 interchangeable types

1) Model NEMA 5 AC grounded power plug 2) UK configuration: BS1363, AC grounded power plug 3) European configuration: CEE 7, AC grounded power plug 4) Danish configuration: 2-5a, AC grounded power plug 5) Swiss configuration: Type J, AC grounded power plug

WARNING • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • The equipment is disconnected from mains by removing the mains plug from the wall outlet.

4. Inspection and preparation of Isiris α and Isiris Monitor NOTE Have a suitable backup system readily available for immediate use so the procedure can be continued if a malfunction should occur.

WARNING • Do not use the Isiris System if it is damaged in any way or if any part of the functional check described below fails.

CAUTION The Isiris System consists of the parts described in section 2. They may only be replaced by Coloplast authorised parts. Failure to comply with this may reduce safety and efficiency.

4.1 Visual inspection of Isiris α 1. Check that the pouch seal is intact.

WARNING • Do not use Isiris α if the product sterilisation barrier or its packaging is damaged. • Do not use a knife or other sharp instrument to open the pouch or cardboard box. 2. Make sure to remove the protective Sheath from the insertion cord. 3. Check that there are no impurities on the product. 4. Check that there is no evidence of shipping damage or other damage such as rough surfaces, sharp edges or protrusions which may harm the patient.

WARNING • Check that the grasper is not protruding from the endoscope irrigation channel.

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4.2 Visual inspection and preparation of Isiris Monitor CAUTION • Pay attention to the battery symbol indicator on Isiris Monitor. Recharge Isiris Monitor when the battery level is low (see section 6.1). • It is recommended that Isiris Monitor is recharged before every procedure and that a charger be readily available during use. • Place or hang Isiris Monitor on a stable support while in use. Dropping, bumping or applying any kind of shock to Isiris Monitor could damage it. • Position the power cord where it is unlikely to be stepped on. Do not place any objects on the power cord. • If the Isiris System is used adjacent to or stacked with other equipment, observe and verify normal operation of the Isiris System prior to using it. Consult the tables in Appendix 1 for guidance in placing the Isiris System. 1. 2. 3. 4. 5. 6. 7.

Check for any damage to the Isiris Monitor cable and power supply (free from wear and tear). Closely examine Isiris Monitor for any damage. Switch Isiris Monitor on by pressing the on/off button. Check the battery indicator on Isiris Monitor. If the time remaining is not sufficient for the procedure – charge Isiris Monitor. Be sure that the power supply is present and working at any time. It is recommended to locate the nearest wall socket before start of the procedure. For instructions on how to use Isiris Monitor with the mounting bracket, please refer to chapter 6.3.

4.3 Inspection of the Image

1. Connect Isiris α to Isiris Monitor by plugging the white connector with red arrow into the corresponding red port on Isiris Monitor. The connector must not be twisted when inserted into the plug - this could potentially damage the scope connector or the monitor plug.

2. Verify that a live video image appears on the screen. 3. Point the distal end of Isiris α towards an object, e.g. the palm of your hand. 4. Adjust the image brightness and contrast preferences on Isiris Monitor if necessary – please refer to chapter 7 for details. It is not possible to adjust the white balance since this is predefined in the system. 5. If the object cannot be seen clearly, wipe the lens at the distal end using a sterile cloth.

4.4 Preparation of Isiris α WARNING • If any of the recommended checks do not show proper functioning, discard the device and use a new one. Note: the full deflection is minimun 90° down and 80° up. 1. Carefully slide the deflection lever up and down in each direction until it stops. Confirm that the deflective tip functions smoothly and correctly. 2. Slide the deflection lever slowly to its neutral position. Confirm that the deflective tip returns smoothly to a neutral position. 3. Activate the grasper by pressing the button and observe that the opening, closing and grasper retraction movements are completely executed. Perform this check in a straight position and in a full up and down deflection. 4. Connect to the irrigation line, turn on irrigation and make sure that irrigation flushes through the scope. 5. Aspiration might be required during the procedure. Make sure to prepare a 50cc syringe for this. When required, adapt the syringe to Isiris α and apply an aspiration force according to the wanted effect. Disconnect, empty the syringe and reconnect it should there be a larger quantity of liquid to aspirate.

4.5 Additional preparations In addition to the Isiris System, prepare the following: - medical grade water based lubricant - irrigation line with Luer connector and irrigation bag - 50 cc syringe

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5. Operating Isiris α WARNING • Excessive force should never be used when operating Isiris α. • Passive deflection and retrovision manoeuvers may be hazardous as it may affect the device, especially the grasper functionality. • If any malfunction should occur during the endoscopic procedure, stop the procedure immediately, put the distal tip in its neutral and straight position and slowly withdraw Isiris α without touching the deflection lever. • Always observe the live endoscopic image while operating the grasper and manoeuvering and withdrawing Isiris α. • If needed partly or completely empty the bladder to the wanted volume by using a syringe adapted to the irrigation connector. • The distal end of the endoscope may get warm due to heating from the light emission part. Avoid long periods of contact between the tip of the device and the mucosal membrane as long, sustained contact with the mucosal membrane may cause mucosal injury. • Do not enter any part of Isiris α into the ureter.

5.1 Holding Isiris α The hand piece of Isiris α can be held in either hand. Use the thumb to move the deflection lever and the index finger to operate grasper activation button. The hand that is not holding Isiris α can be used to advance the insertion cord into the patient’s urinary tract.

5.2 Manipulating the tip of Isiris α The deflection lever is used to flex and extend the tip of Isiris α up and down. Moving the deflection lever downward will make the tip deflect up. Moving it upward will make the tip deflect down (European movement).

CAUTION The insertion cord should be held as straight as possible at all times in order to secure an optimal tip deflection angle and grasper functionality.

CAUTION Do not exert excessive force on the deflective tip as this may result in damage to the equipment. Examples of inappropriate handling of the deflective tip include: - Manual twisting and bending such as performing retrograde vision inside bladder. - Operating in any case where resistance is felt.

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5.3 Irrigation with saline solution Connect the irrigation line Luer connector to Isiris α irrigation connector and make sure irrigation flushes through the irrigation channel. Check that the Luer connector is correctly locked. Failure to do so may result in the saline solution spilling, which may harm the device and reduce the irrigation flow.

WARNING • Do not inject any other substances than saline solution (e.g. contrast agent injected by the surgeon during fluoroscopy) through the irrigation connector. This could damage the functionality of the grasper. • Be sure to connect the irrigation line properly onto the irrigation connector before introducing the fluid. Failure to do so may result in the fluid spilling from the irrigation connector which may harm the device. • The maximum allowed irrigation pressure limit is 200cmH2O or 0,2bar • Always use a new sterile irrigation set for each new patient

5.4 Aspiration Aspiration might be required during the procedure. Make sure to prepare a 50cc syringe for this. When required, adapt the syringe to Isiris α and apply an aspiration force according to the wanted effect; disconnect, empty the syringe and reconnect it should there be a larger quantity of liquid to aspirate.

WARNING • Apply a vacuum of 0.9 bar or less when aspirating.

CAUTION Secure the syringe properly on the irrigation connector before aspiration is applied.

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5.5 Grasper The grasper is integrated in Isiris α and cannot be removed or detached. It is activated by firmly pressing the grasper activation button as follows: 1. Grasper opening: press the grasper button approximately half-way down. 2. Grasper closing over the double loop stent: continue pressing the grasper button to the maximum possible. 3. Release of the double loop ureteral stent from the grasper: at any time the double loop ureteral stent can be released by releasing the button. In rare cases, a second pressing and release of the button may be necessary. Catching the double loop ureteral stent is performed the following way and always under visual control: once the double loop ureteral stent is in the field of view of Isiris α, open the grasper as indicated above, advance Isiris α with the opened grasper until getting in contact with the double loop ureteral stent, close the grasper as indicated above and maintain the button fully pressed. Release any deflection of the deflective tip. The removal of the double loop ureteral stent can start by gently pulling Isiris α.

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WARNING • The grasper teeth are sharp and should not be touched. Opening of the grasper when the deflective tip is in contact with or too close to the tissues may cause tissue damage. • Do not activate the grasper when the distal end is inside the urethra. • Do not activate the grasper during suctioning.

CAUTION The grasper maximum protruding length is 18 mm.

WARNING • Isiris α cannot accept any insertion of endoscopic intruments as the irrigation channel is only designed for introduction of liquids. Do not try to insert any device as it may damage the grasper and the irrigation channel.

3 5.6 Insertion of Isiris α Lubricate the insertion cord with a medical grade water based lubricant to ensure the lowest possible friction when Isiris α is inserted into the patient's urethra. It is usual practice to lubricate the patient's urethra using the same water based lubricant. If the camera image of Isiris α becomes unclear the tip can be cleaned by removing Isiris α and cleaning the tip with a piece of sterile gauze. Continue the procedure until a satisfactory image is obtained.

WARNING • Check that the grasper is not protruding from the endoscope irrigation channel.

5.7 Withdrawal of Isiris α WARNING • While withdrawing Isiris α, the distal tip must be in a neutral and non-deflected position. Do not operate the deflection lever, as this may result in injury to the patient and/or damage to Isiris α. • During removal of the double loop ureteral stent, it is the physician's responsibility to evaluate the pull strength and adapt the removal force and speed. Never exceed the physician's usual pulling force as it may damage the patient's urinary tract and to a second degree the Isiris System.

When withdrawing Isiris α, make sure that the deflection lever is in the neutral position. Slowly withdraw Isiris α while watching the live image on Isiris Monitor.

NOTE Ensure that the pull force is applied onto the insertion cord and not only onto the hand piece to avoid damaging the device.

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6. Use of Isiris Monitor and connecting accessories CAUTION • The Isiris System consists of the parts described in section 2. They may only be replaced by Coloplast authorised parts. Failure to comply with this may reduce safety and efficiency. • Isiris Monitor is not intended to be repaired. If defective Isiris Monitor shall be discarded. • No modification of this equipment is allowed. • If Isiris Monitor battery icon on the screen changes from fully charged to low battery (red battery) within 30 minutes, Isiris Monitor must be replaced. Isiris Monitor can be placed on a solid flat surface by using the stand on the back of Isiris Monitor. If needed, Isiris Monitor can be placed by using the supplied bracket.

6.1 Charging Isiris Monitor Connect Isiris Monitor power supply to the wall socket and insert the power plug into the power inlet of Isiris Monitor.

The Isiris Monitor power button will light orange during charging. The battery icon will change as shown here:

Max. battery status of Isiris Monitor

Min. battery status of Isiris Monitor

The icon remains white until one block is left, after which it turns red. When remaining battery capacity is 10% the red battery icon starts flashing

Battery is charging

Battery current capacity

Charging is shown with blocks flashing Current capacity is shown with non-flashing blocks

If the battery is fully charged and still connected to a charger the battery icon changes to:

6.2 Maintenance of battery To prolong battery life it is recommended to fully charge Isiris Monitor at least every third month and store it in a cool place. If the battery is fully discharged the charging takes approximately 5 hours. The battery should be charged at temperatures between 10 - 40°C.

6.3 Mounting of Isiris Monitor to the bracket It is recommended to use the bracket supplied. The bracket is mounted on a pole by tightening the wing nut and Isiris Monitor can then be placed on the bracket. To adjust the position of Isiris Monitor horizontally, loosen the wing nut and the bracket can be repositioned. To adjust the position of Isiris Monitor vertically, it can be moved up and down and will stay in the position chosen. Occasionally it may be necessary to tighten the screw on the side of the bracket. This is done with the hexagonal key supplied with Isiris Monitor. The maximum allowed weight on the bracket must not exceed the weight of one Isiris Monitor and one Isiris α.

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7. How to Operate Isiris Monitor 7.1. How to operate Isiris Monitor Isiris Monitor only has one physical button located on the top for power ON and OFF. All other functions are operated using the User Interface controlled from the front touch screen panel.

How to turn ON Isiris Monitor (Assumption: Isiris Monitor is powered down)

on top of Isiris Monitor for at least one second. Press power button - The power button will light up orange for 2 seconds - The power button will stay lit and orange if Isiris Monitor is charging or change to green and stay lit green if not charging. - Isiris Monitor is now in STARTUP IMAGE MODE. - A live image will appear within 1-2 seconds if a device is connected or a blue screen will appear. - After about one minute, Isiris Monitor will be ready in Simple Mode.

NOTE: During startup the screen may flicker for about a second. How to turn OFF Isiris Monitor (Assumption: Isiris Monitor is powered ON)

Press the power button on top of Isiris Monitor for at least two seconds. The light of power button goes off if not charging or stays lit orange if charging. - A blue hourglass indicating that Isiris Monitor is powering down will appear on the screen and Isiris Monitor will power down.

7.2. MODES in Isiris Monitor Isiris Monitor has 3 modes of operation: STARTUP IMAGE MODE - Live image available while Isiris Monitor is loading. When the User Interface is loaded Isiris Monitor automatically initiates SIMPLE MODE. SIMPLE MODE - Live image available and the User Interface displays basic user functions. Advanced functions can be initiated from SIMPLE MODE by pressing ADVANCED MODE button Isiris Monitor loads the User Interface for ADVANCED MODE.

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ADVANCED MODE - Live image available and the User Interface displays advanced user functions. - Isiris Monitor starts up in the Blue tab for Live Image

- Viewing and recording live image

Startup Image Mode STARTUP IMAGE MODE starts one second after the ON/OFF button is pressed and continues until the User Interface is loaded. - Live image from a plugged in device is available.

NOTE: The moving icon to the right of the live image indicates that Isiris Monitor is ­loading the User Interface.

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Simple Mode SIMPLE MODE starts automatically once Isiris Monitor User Interface is loaded. - Live image from a plugged in device is available. Further functions available are battery status, brightness/contrast control and possibility of displaying device usage time for the connected device.

NOTE: Press

to enter ADVANCED MODE

Advanced Mode In SIMPLE MODE press

to enter ADVANCED MODE

ADVANCED MODE has 3 tabs with different functions Blue tab for Live Image

- Viewing and recording live image

Yellow tab for File Management Green tab for Settings

- Managing saved files

- System settings and User Accounts

- To change between the tabs press the tab.

NOTE: Press the RETURN TO SIMPLE MODE

to enter SIMPLE MODE.

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