CARE SERVICE USER GUIDE. Sonicision System

Transcription

1 CARE SERVICE USER GUIDE Sonicision System

2 TABLE OF CONTENTS Sonicision device product return instructions for post-use cleaning and sterilization...3 How to contact the carrier...5 Frequently asked questions...6

3 Product return instructions for post-use cleaning and sterilization 1 CAUTION! IF DAMAGED Lithium Ion Battery DO NOT LOAD OR TRANSPORT PACKAGE IF DAMAGED For more information, call Within the US Outside the US Packaging materials Please note that the plastic trays, lids, and matching plastic shipping boxes supplied with the Sonicision products are designed to be reused for return shipment. Please do not discard these packaging materials. 2. Preparing the components for return After surgical use, prepare the Sonicision device components for return by manually wiping or rinsing them with water to remove all residues. Dry the components immediately. Do not place components in a heated drying chamber Packaging a. Pack each Sonicision device component individually into one transparent plastic bag provided. Place the single bagged Sonicision device components into their protective trays and secure the matching lid. b. Fill the protective tray with the same number of components as received. Note: If a component has stopped working, contact Medtronic and do not return the component in the tray. Instead, document the missing component on the attached Product Return Transfer Note to indicate the need for replacement. c. Insert each assembled tray into the supplied plastic shipping box. 3

4 Product return instructions for post-use cleaning and sterilization 4. Completing the Transfer Note Carefully complete the Transfer Note attached to these instructions. Place a copy of this document in each plastic shipping box being returned. Keep a copy for your records Preparing the box for shipment Close the plastic shipping box and seal by securing two plastic ties through any two holes on the front of the box. Place the provided UPS return shipping label and the provided warning labels applied medical devices and CAUTION! Lithium Ion Battery onto the label placard on the shipping box. 5 4

5 How to contact the carrier 6. Shipping The transport box is now ready for pickup. Please call UPS or use the online system at UPS.com for pickup. ups.com/content/at/en/contact/index.html 6 Phone number:... Contact person:... Pick-up location:... Pick-up time: between...on... Parcel dimension: 63 x 27 x 7 cm Parcel weight: 3 kg Other comments: Dedicated address relating to the Sonicision Care Service: Sonicision.Care.Service@medtronic.com Questions Delivery issues Suggestions ideas 5

6 Frequently asked questions: General Q What process is followed for the cleaning and sterilization of Sonicision device through this service? A The validated and verified Sonicision device cleaning and sterilization process, as stated in the Sonicision device User s Guide, is precisely followed to ensure clean and sterile components are received by hospitals. Q What is the process used for cleaning? A In accordance with the Sonicision device User s Guide, components are inspected and then soaked in Ruhof Endozime, a ph neutral enzymatic detergent, for 5-10 minutes. Then, components are scrubbed with a nylon bristle brush, rinsed, and air dried. Q What is the process used for disinfection? A After being cleaned, each component is air dried, inspected, then wiped with a lint-free cloth and an isopropanol based disinfectant. Q How has the cleaning and sterilization process been validated and verified? A The validated and verified Sonicision device cleaning and sterilization process adheres to all relevant standards as they apply to this product and service: ISO 14937:2000, ISO 17664:2004, AAMI TIR12:2004, AAMI TIR30:2003, and AAMI ST81:2004. All cleaning and sterilization for this service is performed at an ISO certified facility located in Europe. Additionally, auditing and process verification of this facility performed by Medtronic confirms that all steps required by the validated and verified cleaning and sterilization process are followed. Lastly, both Medtronic and the sterilization facility are audited by Accredited European Union Notified Bodies. For additional information concerning this topic, please contact Medtronic to request the following memoranda: Cleaning Verification: Document R Sterilization Verification: Document R

7 Frequently Asked Questions: Cleaning and Sterilization The validated and verified Sonicision device cleaning and sterilization process adheres to all relevant standards as they apply to this product and service: After surgical use, prepare the Sonicision device components for return by manually wiping or rinsing them with water only to remove all residues. Dry the components with a lint-free cloth. Do not place components in a heated drying chamber. If required by hospital procedure, components may also be wiped with an isopropyl alcohol (up to 100%) surface disinfectant. Note that the return packaging provided (single bag, box seal) as well as package labeling (used medical equipment label) complies with shipping regulations for transporting contaminated medical equipment. Therefore, it is not required by regulation to disinfect components prior to shipping back to Medtronic. Q Does this service comply with ISO or EN 285? A These standards relate to steam sterilization and automated washing, respectively. The Sonicision care service uses a low temperature hydrogen peroxide method of sterilization, hence these regulations do not apply. See above sections regarding the standards with which this service does comply. Q What happens if the hospital does not wipe down the Sonicision device components properly prior to return for cleaning and sterilization? A The sterilization facility s protocol ensures that only components that can be completely cleaned proceed with the sterilization process. If product is returned from the hospital with dried fluid residue that cannot be removed through the thorough cleaning process, that component will be discarded and the customer will be billed for a new component. Therefore, it is important that customers wipe down components with water and dry them immediately following surgical use. Q How long after the use of the components can sterilization of reusable components be performed? A After surgical use, customers should prepare the Sonicision device components for return by manually wiping or rinsing components with water to remove all residues and dry the components immediately. Medtronic has conducted cleanability studies by soiling the Sonicison device reusable components with bacterial spore suspensions and allowing the soiled devices to dry at room temperature for > 12 hours to represent the worst case scenario before cleaning the device per the recommended cleaning procedures as outlined in the Sonicision device User s Guide. 7

8 Frequently Asked Questions: General Q What paperwork is required for shipping used product back to Medtronic? Where can this paperwork be found? A Included with each shipment to the customer are Return Instructions that specify steps to be taken to return products to Medtronic through this service. In addition, a pre filled UPS return shipping label is included and should be adhered to the outer box in the designated location PLACE LABELS HERE. Q Who will recycle the battery when it reaches its end of life? A Medtronic will handle the recycling or disposal of components once they can no longer be used. In the event that a component is nonfunctional at the hospital, follow the steps to file a complaint with Medtronic, as listed in these FAQs. Q How long does it take for a customer to receive sterilized product from the time their first order is placed with Medtronic? A In total, it may take up to 1-2 weeks for the customer to receive their first sterile sets. Upon initial order, Medtronic ships new product to the sterilization facility in Germany, at which point it is assigned to the specified customer, the product is bar coded, and the cleaning/ sterilization process begins. Once sterilized, product is shipped to the customer using UPS Express Service (approx. 1 business day). Q How do I determine how many batteries and generators a customer should initially order? A Your Medtronic sales representative will recommend the number of required batteries and generators (SCS App) based on the number of procedures in the hospital and your surgical specialties. Q What is the process to add additional components at a later date? A Customers must simply work with Medtronic or distributor to place an order for new components, always in multiples of 12 total components. Customers have the flexibility to order unique quantities of batteries (SCCB) and generators (SCCG) that total a multiple of 12. 8

9 Frequently Asked Questions: General Q What steps should a customer follow in the event that a component does not work? Does this procedure differ for Sonicision device disposables (dissectors) ordered separately? A Please do not send any nonfunctional components back to the sterilizer. Simply notify your Medtronic sales representative who will assist further, which is the same process that should be followed for any disposable issues. For battery and generator issues, please indicate on the Product Return Transfer Note, included with each shipment, the type and quantity of component(s) not being returned. This will ensure that missing components are replaced in the next shipment to the hospital. Q What documentation can be provided to customers to demonstrate compliance with the relevant European regulations that apply to this service? A Medtronic can provide a copy of the ISO Certificate, which demonstrates Quality System compliance for Sonicision device and service, including all relevant aspects of cleaning and sterilization processes. In addition, Medtronic can provide a copy of its Declaration of Conformity which declares conformity to the Medical Devices Directive for this product and service offering. Lastly, Medtronic can provide additional details regarding cleaning and sterilization verification testing in the following documents: Cleaning Verification: Document R Sterilization Verification: Document R Q Who should customers contact if they have questions about this service? A The local Medtronic sales representative should be the first point of contact for the customer, as always. Q What is the guaranteed shelf life of the battery and Sonicision device battery and generator? A Sonicision device sterilized batteries and generators offered through this service will have a 30-day shelf life. This date is primarily driven by battery pack charge; over time, stored batteries will lose some of their charge. Performance claims of the Sonicision device are guaranteed for 30 days following charging /sterilization. After this time, battery life may be reduced. 9

10 Frequently Asked Questions: General Q What steps should I take if components have passed their expiration date? A It is important that hospitals follow the FIFO (First in First Out) principle with this service. Medtronic sales representatives will do their best to ensure hospitals order batteries and generators through this service in quantities that optimize throughput and use. In the event a battery or generator passes its expiration date, please return the component for reprocessing. Q During certain times of the year with lower procedural volumes, how should I manage to avoid an excess of sterile inventory that will risk becoming expired before use? A It is the customer s responsibility to pace the timing of returning components to Medtronic for cleaning and sterilization to coincide with expected procedural volume. During periods of low use, the customer may want to delay returning components for reprocessing. Likewise, during period of high use, the customer should return components for reprocessing as quickly as possible to ensure the fastest turnaround. Q A How is product traceability ensured? Will I receive the same unique components with each shipment? Upon initial order, Sonicision batteries and generators will be laser engraved at the sterilization facility with a unique bar code to ensure product remains with the same customer. In addition, customers may use the unique alphanumeric serial number printed on both the battery pack and generator to track their product, if required by hospital protocol. 10

11 Frequently Asked Questions: Packaging and Shipping Q What steps must be taken to arrange for UPS pick up of components to be returned? A As specified on the Return Instructions provided with each shipment, customers should call the provided UPS telephone number or use their online system to arrange a pick up. The location of pick up at the hospital should be determined by each customer. Q With what standards does Medtronic comply for the transportation of Sonicision device components through this service? A Medtronic meets several standards that apply to this service, including: IEC 62133:2002, IEC 62281:2004, UN DOT (ADR), IATA lithium battery guidance document, and ISTA 2 A. These standards cover the shipment of Sonicision battery packs, used medical equipment, and the associated package integrity required to meet these standards. Q What testing has been performed to ensure components remain sterile following shipping and receipt by hospitals? A Medtronic has verified that the sterile barrier is maintained by double DuPont Tyvek * pouching following worst-case shipping test simulations, including extremes of temperature, humidity, vibration, drop, and pressure conditions according to ISTA 2 A. This testing was also performed in accordance with ISO as well as ASTM F2096. Q How is product traceability ensured? Will I receive the same unique components with each shipment? A Upon initial order, Sonicision batteries and generators will be laser engraved at the sterilization facility with a unique bar code to ensure product remains with the same customer. In addition, customers may use the unique alphanumeric serial number printed on both the battery pack and generator to track their product, if required by hospital protocol. 11

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