FMS Remote Hand Control for FMS VUE and NEXTRA Fluid Management and Tissue Debridement Systems

ENGLISH FMS® Remote Hand Control

DESCRIPTION The FMS Remote Hand Control is a non-sterile reusable device that activates pump and shaver features of the FMS VUE™ and NEXTRA™ Fluid Management and Tissue Debridement Systems.

INTENDED USE The FMS Remote Hand Control is intended for use with the FMS VUE and NEXTRA Fluid Management and Tissue Debridement Systems in a surgical setting by personnel trained in arthroscopy.

INDICATION FOR USE The FMS Remote Hand Control is an accessory to the FMS VUE and NEXTRA Fluid Management and Tissue Debridement Systems. The FMS VUE and NEXTRA systems are intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

CONTRAINDICATIONS Do not use the Remote Hand Control with systems other than the FMS VUE or NEXTRA Fluid Management and Tissue Debridement Systems.

WARNINGS • Prior to use, check the system components for damage. Check the cable integrity carefully. If there are signs of damage, do not use.

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• Failure to follow all applicable instructions may result in serious surgical consequences to the patient. • Do not use flammable agents when cleaning and disinfecting. • Do not wrap Remote Hand Control cable around metal objects. Wrapping cables around metal objects may induce currents that could lead to electric shock, fire and/or injury to patient or surgical personnel. • This device has been tested and found in compliance with limits of medical devices according IEC 60601-1-2 standard. These limits are designed to provide reasonable protection in a typical medical installation, against harmful interference when devices are located in close proximity. If the pump is causing harmful interference with other devices, turn the main power off, then on again to determine if it is causing the interference, relocate the system or separate it from other devices. If you cannot resolve the problem contact DePuy Customer Service at 1-800-382-4682. In the European Union, contact your local affiliate. • Disconnect the device from the pump when cleaning or inspecting.

PRECAUTIONS • Read the instructions, cautions, and warnings provided with all FMS VUE System accessories before use. Your sales representative can advise which accessories are used with the FMS VUE System. • Electrical safety testing should be performed by a biomedical engineer or other qualified person.

INSTRUCTIONS FOR USE Refer to the following documents for instructions for use with each system. FMS VUE Operator’s Manual (Ref. 110665) FMS NEXTRA Instruction Manual (Ref. 109652)

CLEANING AND DISINFECTION This Remote Hand Control can be soaked and autoclaved. DO NOT WET THE CONNECTOR.

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Automated Cleaning Clean before and after each use: 1. Place the protective cap securely onto the Remote Hand Control cable connector. 2. Carry out a first soaking bath in a pH-neutral detergent such as CIDEXPLUS® for a minimum of 15 minutes (or an equivalent solution) and refer to cleaning agent solution manufacturer’s instructions for immersion time and bath temperature. 3. Carry out five (5) to-and-fro motions with a swab-type brush on all surfaces, paying particular attention to the buttons, the screws on the back side and the seam around the sides. 4. Check for remaining debris and remove as needed. 5. Carry out a second soaking bath in a pH-neutral detergent such as CIDEXPLUS for a minimum of 15 minutes while using an ultrasound bath frequency of 50–60Hz (or an equivalent decontaminant solution) and refer to cleaning agent solution manufacturer’s instructions for immersion time and bath temperature. 6. Rinse with deionized water for 30 seconds. 7. Confirm that the protective cap is securely on the Remote Hand Control cable connector. 8. Clean in a validated washer disinfector using the “INSTRUMENTS” cycle and a pH neutral cleaning agent intended for use in automated cleaning. Effective cleaning can be achieved using the following parameters: • Pre-wash at ambient temperature for 4 min. • Enzyme washes with enzymatic cleaning agent for 4 min. • Wash at 60°C with pH neutral cleaning agent for 3 min. • Rinse with hot water for 20 seconds. • Dry at 95°C for 5 min. 9. After automated cleaning, proceed to inspection instructions below.

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Manual Cleaning Clean before and after each use: 1. Place the protective cap securely onto the Remote Hand Control cable connector. 2. Carry out a first soaking bath in a pH-neutral detergent such as CIDEXPLUS for 15 minutes (or an equivalent decontaminant solution) and refer to decontaminant instructions for immersion time and bath temperature 3. Carry out 5 (five) to-and-fro motions with a swab-type brush on all surfaces, paying particular attention to the buttons, the screws on the back side and the seam around the sides. 4. Check for remaining debris and remove as needed. 5. Carry out a second soaking bath in a pH-neutral detergent such as CIDEXPLUS for a minimum of 15 minutes while using an ultrasound bath frequency of 50–60Hz (or an equivalent decontaminant solution) and refer to cleaning agent solution manufacturer’s instructions for immersion time and bath temperature. 6. Rinse with deionized water for 30 seconds at ambient temperature. 7. Dry with medical air at less than 100°C or 212°F for 30 seconds.

Inspection after cleaning 1. Inspect before sterilization or storage to ensure the complete removal of soil from surfaces and holes. 2. If areas are difficult to inspect visually, check for blood by immersing or flushing in a 3% hydrogen peroxide solution. If bubbling is observed, blood is present. Rinse thoroughly after using hydrogen peroxide solution. 3. If soil is still present, re-clean.

STERILIZATION • The Remote Hand Control is factory sealed and can be completely sterilized using a steam autoclave. • Use a validated, properly maintained and calibrated steam sterilizer. • Effective steam sterilization can be achieved using a pre-vacuum cycle of 132°C for 4 minutes.

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WARNING: These guidelines do not guarantee that the device is sterile after the procedure. The institution is responsible for sterility assurance validation.

MAINTENANCE • Inspect all equipment and cables periodically for wear. If damage is noted, replace or return to Repair Service Center. • Any repairs must be performed by a qualified Biomedical Engineer. • Clean and disinfect after every use.

STORAGE Room temperature: –10°C (14°F) to +50°C (122°F) Relative humidity: 30% to 70% condensation included. Atmospheric pressure: between 500 hPa & 1060 hPa.

SPECIFICATIONS Weight 0.7 kg Cable length 2.99m

OPERATING CONDITIONS The FMS Remote Hand Control operates under normal operating room conditions. Temperature: +10°C (50°F) to +40°C (104°F)

ESPANOL Control remoto manual FMS® DESCRIPCIÓN El control remoto manual FMS es un dispositivo reutilizable no estéril que activa características de la bomba y el motor de los sistemas de gestión de líquidos y desbridamiento de tejidos FMS VUE™ y NEXTRA™. 6

Type B Class 1 Conforms to standard EN 60601-1 Tipo B Clase 1 Cumple con la norma EN 60601-1 Tipo B Classe 1 Conforme agli standard EN 60601-1 Typ B, Klasse 1 Entspricht den Normen EN 60601-1, Type B Classe 1 Conforme aux normes EN 60601-1 Type B, klasse 1 Voldoet aan de norm EN 60601-1 Tipo B Classe 1 Em conformidade com a norma EN 60601-1 Type B Klasse 1 Overholder EN 60601-1 Type B Klasse 1 I samsvar med standard EN 60601-1 Tyyppi B, Luokka 1 Täyttää standardin EN 60601-1 vaatimukset Τύπος B, Κλάση 1 Συμμορφώνεται με το πρότυπο EN 60601-1

Typ B Klass 1 Följer SS-EN 60601-1 Typ B třída 1 Odpovídá EN 60601-1 Typ B, trieda 1 Spĺňa požiadavky normy EN 60601-1 Typ B, klasa 1 Zgodny z normą EN 60601-1 Тип B, класс 1 Соответствует стандарту EN 60601-1 „B” típus, 1. osztály Megfelel az EN 60601-1 szabványnak. Tip B Sınıf 1 EN 60601-1’e uygun B型第1类 符合 EN 60601-1 B型1類 符合 EN 60601-1 타입 B 클래스 1 EN 60601-1을 준수합니다.

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