3M Steri-Vac GS Series Operator'smanual
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3M Steri-Vac GS Series Operator'smanual

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  • Page 1 ™ ™ Steri-Vac Sterilizer/Aerator GS Series Operator’s Manual...

  • Page 3: Table Of Contents

    12.2. Display Screen Indications ..........41 U.S. Ordering Information .............63 7.  Specifications..............9 12.3. Overview of GS Series Ethylene Oxide (EO) Orders for Supplies (e.g. 3M™ Steri-Gas™ EO Gas Sterilization Cycle ............42 7.1. 3M™ Steri-Vac™ Sterilizer/Aerator GS Series Cartridges, 3M™ Attest™ Biological Indicators, 12.3.1. Cycle Stages and Descriptions ......42 Structural Specifications..........9...

  • Page 4: Explanation Of Symbols

    ™  Steri-Vac Sterilizer / Aerator GS Series – Operator’s Manual ™ Explanation of Symbols: product and package labels and pictograms Refer to the package and product labels to see which symbols apply to specific products. Attention - Refer to the Operator Manual for additional information. Warning - Indicates a hazardous situation, which, if not avoided, could result in death or serious injury. Waste Electrical and Electronic Equipment (WEEE) and EU Battery Directive.

  • Page 5: Operator Manual

    The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series hardware and software are subject to change. The system images, screen images, hardware components, and hardware specifications included in the manual may not match the system as installed. In the event that hardware or software changes are made, 3M will verify their compatibility with the functionality described in this document.

  • Page 6: Description

    1.  Description The 3M™ Steri-Vac™ Sterilizer/Aerators GS Series is for use in health care, industrial sterilization, research labs, veterinary surgical and other appropriate settings. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, Models GS5 and GS8 and have been validated per US FDA Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities reference 510(k) number K142034.

  • Page 7: Safety

    • Over-the-door vent hood (i.e. exhaust hood) supplements the room’s directional air flow, and draws air away from Operators removing a load from the chamber. • The GS Series sterilizers are designed with a specialized disposal cycle for full damaged, expired, or excess 3M™ Steri-Gas™ EO Gas Cartridges. The Cartridge Dispose Cycle is a custom, abbreviated cycle that safely empties and aerates the Steri-Gas EO Gas Cartridges at a rate of one per cycle.

  • Page 8: Dangers And First Aid

    Do not use damaged 3M™ Steri-Gas™ EO Gas Cartridges. If an individual 3M™ Steri-Gas™ EO Gas Cartridge is ever dropped, the cartridge should be used immediately or disposed of as described in the cartridge disposal section of this manual. Sterilize only medical devices manufactured with materials compatible with ethylene oxide (EO) sterilization processes. Do not sterilize leather, liquids, or materials reactive to EO.

  • Page 9: First Aid

    WARNING: To reduce the risks associated with fire and explosion: 3M™ Steri-Gas™ EO Gas Cartridges contain 100% ethylene oxide (EO) which is an extremely flammable gas and a liquid under pressure. Do not use near flame, electrical sparks, hot surfaces, or allow sources of ignition near the cartridges. Do not puncture cartridge outside the sterilization chamber. Do not incinerate cartridges. Exposure to temperatures above 150ºF (65.5ºC) may cause cartridge to burst.

  • Page 10: Cautions

    Do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside the environmental conditions as stated in this manual. Immediately call 3M Health Care service personnel or authorized 3M service personnel if there is a failure of the display or backlight and the GS Series sterilizer continues to operate.

  • Page 11: Specifications

    7.2. Sound Levels The average decibel level of an active GS5 or GS8 sterilizer is <60 dBA. For more information on sound levels, in the US contact 3M Health Care Helpline at 1-800-228-3957. Outside the US contact your local 3M office or to locate your local office go to www.3M.com 7.3.

  • Page 12: Air Supply Specifications

    “C” and “US” based on compliance to the standards UL 61010-1 and CAN/CSA 22.2 No. 61010-1. The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series complies with the RoHS Directive, Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

  • Page 13: Installation And Set Up

    9. Installation and Set Up To ensure proper operation of this equipment and Operator safety, the 3M™ Steri-Vac™ Site Planning and Installation Guide must be followed and the equipment must be installed by authorized 3M service personnel. To arrange installation, contact your local 3M subsidiary (www.3m.com).

  • Page 14: Room And Installation Requirements

    9.2. Room and Installation Requirements DANGER: To reduce the risks associated with exposure to ethylene oxide, ensure a minimum of ten (10) air exchanges per hour (ACHs) for the room in which the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is installed. Location Do not place the sterilizer or ethylene oxide (EO) cartridges in an area of possible ignition sources. ONLY USE INDOORS.

  • Page 15: Set Up And Connections

    9.3. Set up and Connections Figures 3 - 7 illustrate the components and connections for the 3M™ Steri-Vac™ Sterilizer/Aerator Series, Models GS5 and GS8. Table 2 contains additional details regarding specific components and connections for the GS Series Models GS5 and GS8. Chamber Door Touch Screen & Display Water Reservoir, Printer & USB Ports...
  • Page 16 Top Connection - 3M™ Steri-Vac™ Sterilizer/Aerator GS Series 8. User Screen 9. USB Ports 10. EO Gas Cartridge Barcode Scanner 11. Printer w/ Paper 12. Distilled Water Reservoir Figure 6. Front Panel - 3M™ Steri-Vac™ Sterilizer/Aerator GS Series, Model GS8 8. User Screen 11. Printer with Paper 9. USB Ports 12. Distilled 10. EO Gas Cartridge Figure 7.
  • Page 17 The Abator connection is intended to only be made by 3M Health Care service personnel or authorized 3M service personnel during installation. Air inlet is for the connection of the compressed air supply per Chapter 9 and is intended for use only by trained 3M Health Care Air Inlet service personnel or 3M authorized service personnel.

  • Page 18: Using The Touch Screen

    Screen for the option to open the Unload door. The Operator controls the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series via a touch screen. A fingertip, stylus, ball tip pen or a computer mouse can be safely used to navigate the touch screens.

  • Page 19: Reports

    10.3.  Reports The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series has a variety of reporting options as shown in Figure 10. 04/20/2015 22.2 98.0 Sterilizer ˚ 05:19:53 Select cycle temperature: Reports Cycle reports 55 °C Cycles EO usage report Setup Site setup report Status Printer form feed Figure 10.

  • Page 20: Ethylene Oxide Usage Reports

    ™  Steri-Vac Sterilizer / Aerator GS Series – Operator’s Manual ™ There are three (3) Cycle Report formats. The desired format can be selected in the Cycle Report options screen (Figure 11). Each of the Cycle Report formats is described in Chapter 12 in Table 5. 04/20/2015 22.2 98.0 Sterilizer ˚...

  • Page 21: Site Setup Report

    10.3.3. Site Setup Report View a Site Setup Report for the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series by viewing, printing, or exporting electronically to a USB drive via Menu>Reports>Site Setup Report. The Site Setup Report contains the site settings established in the Site Setup menu. Figure 15 is the display screen view of the Site Setup Report.

  • Page 22: Printer Form Feed

    ™  Steri-Vac Sterilizer / Aerator GS Series – Operator’s Manual ™ 10.3.4. Printer Form Feed The Printer Form Feed button advances the printer paper by approximately 5cm (2 in.). Figure 16 details the location of the Printer Form Feed button. 04/20/2015 22.2 98.0 Sterilizer ˚ 05:19:53 Select cycle temperature: Reports Cycle reports 55 °C...

  • Page 23: Supervisor Cycles

    1. Aeration performs aeration only at the selected temperature. Duration is user-programmed in either 30 minute intervals or continuous. 2. Cartridge dispose cycle is a custom abbreviated cycle used to safely empty and aerate 3M™ Steri-Gas™ EO Gas Cartridges at the rate of one per cycle. This cycle cannot sterilize devices.

  • Page 24: Setup Menu

    10.5. Setup Menu The Setup Menu provides several options for customizing the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series function and preferences. Site setup is specific for the GS Series sterilizer. The User setup is specific for Operators and Supervisors. Figure 20 illustrates the button to access the Site Setup options.
  • Page 25 Disabled Supervisor bypass scan 3M™ Steri-Gas™ EO Gas Cartridge during the cycle programming stage. When enabled, system will produce an audible tone upon cycle failure. The audible Audible tone on notification will sound at a pulsed rate of two (2) seconds on, one (1) second off, for total of...
  • Page 26 ™ The minimum default aeration time on the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series can be changed for the 38 °C and 55 °C cycles. Press the minimum aeration time and an iWheel will appear to adjust the minimum aeration default time. Figure 23 illustrates changing the minimum aeration default time.
  • Page 27 The Site Setup>Date-Time tab (Figure 25) provides options for setting the date and time for the GS Series sterilizer. 04/20/2015 22.2 98.0 Sterilizer ˚ 12:40:12 Setup Preferences Cycle Setup Date-Time Network Site Date Date format Select cycle temperature: 04/20/2015 MM/dd/yyyy Time Time format 12:40:12 24 hours...

  • Page 28: User Setup

    10.5.2. User Setup Access the User Setup menu (Figure 28) to establish personal identification numbers (PINs) for Supervisors and Service. 3M Health Care service personnel or authorized 3M service personnel must create the first Supervisor user and PIN. Supervisors can then set up additional Supervisors. Only Service can set up additional Service users. Figures 28 - 31 illustrate the use of the User Setup Menu.
  • Page 29 04/20/2015 22.2 98.0 Sterilizer ˚ 05:20:11 Enter supervisor PIN: Select cycle temperature: Reports Site setup 55 °C Cycles User setup Setup Status Figure 29. Service User Setup Menu – Enter Supervisor PIN Cancel Cancel View Only Figure 30. User Setup Menu – Adding a Supervisor 04/20/2015 22.2...

  • Page 30: Status

    The Info tab of the Status option provides version numbers for 3M™ Steri-Vac™ Sterilizer/Aerator GS Series components and software. 10.6.3.  Log The Log tab of the Status option provides ongoing output of the software commands while the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is running a cycle. The Log is not saved and is overwritten as new data information appears.

  • Page 31: Medical Device Packaging And Loading

    11. Medical Device Packaging and Loading 11.1. Preparing Medical Devices for Sterilization Clean devices for sterilizing according to the device manufacturer’s instructions for use before processing in the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series. Thorough cleaning is essential to achieve sterilization efficacy. The definition of a lumen as noted in the cleared Intended Use statement, is an opening or pathway into a medical device. Lumens have several configurations. A lumen may have only 1 opening into the device that serves as both the entrance and exit for sterilant penetration and contact.

  • Page 32: Packaging Medical Devices

    ™ 11.2. Packaging Medical Devices Non-compatible packaging and/or incorrect loading of the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series may compromise the sterility of the processed devices. Before packaging, ensure that the medical devices are clean and dry per manufacturer’s instructions for use. 11.2.1. Packaging Endoscopes for EO Sterilization Each facility should verify appropriate packaging materials and procedures with the endoscope manufacturer(s) to ensure the endoscopes are suitably packaged for sterilization (i.e., endoscope...

  • Page 33: Package Medical Devices

    Biological indicators, such as the 3M™ Attest™ Biological Indicators for ethylene oxide, in a routine biological indicator process challenge device (PCD, also known as a Test Pack or BI PCD) should be used in every load. A BI PCD such as 3M™ Attest™ Biological Indicator Test Pack for EO or 3M™ Attest™ Rapid Readout Biological Indicator Test Pack for EO should be placed in the center of the load (Chapter 13: Process Monitoring, Load Release, and Sterilizer Qualification).

  • Page 34: Operating Instructions

    12.1. Starting a Cycle The Operator controls the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series via a touch screen. A fingertip, stylus, ball tip pen or a computer mouse can be safely used to navigate the touch screens. To use a computer mouse, simply plug the mouse into one of the two USB ports (reference Figures 6 and 7) and the mouse arrow will appear on the touch screen. There are seven (7) programming steps to start a cycle.
  • Page 35 2. Select Aeration Time Use the aeration time iWheel to select the appropriate aeration time. Aeration times can be set in intervals of 30 minutes. Press Next to continue. 04/20/2015 22.2 98.0 Sterilizer ˚ 05:21:01 Cycle: 55 ˚C Select aeration time: hh:mm Continuous Back Next Back...
  • Page 36 Put on personal protective equipment (PPE) consisting of safety goggles, long sleeves, and butyl rubber gloves when handling full Ethylene Oxide (EO) Gas Cartridges. The barcode is a small square, located on the top of the cartridge, in the area of the black stripe. To scan, place the barcode under the red light of the cartridge scanning bay on the front of the 3M™ Steri-Vac™...
  • Page 37 EO Gas Cartridge Barcode Menu Menu Open door Only valid 3M Steri-Gas EO Gas Cartridges will be accepted by the sterilizer. See Figure 39 for an example display message of an invalid gas cartridge. Invalid cartridges include: • A used cartridge • An expired cartridge • An invalid barcode •...
  • Page 38 Figure 40. Steri-Gas EO Gas Cartridge Barcode Override Message Menu Open door Menu If enabled the sterilizer will require a Supervisor PIN to bypass or override scanning of the 3M™ Steri-Gas™ EO Gas Cartridge. Reference the Site Setup Preferences menu (Figure 21).
  • Page 39 5. Insert 3M™ Steri-Gas™ EO Gas Cartridge, Load Chamber, and Close Door Insert the 3M™ Steri-Gas™ EO Gas Cartridge into the cartridge bay located inside the GS Series sterilizer chamber (Figures 42). Push the green lever down over the Steri-Gas EO Gas Cartridge to secure in place (Figure 43).
  • Page 40 ™  Steri-Vac Sterilizer / Aerator GS Series – Operator’s Manual ™ Figure 42. Steri-Gas EO Gas Cartridge in Cartridge Bay Figure 43. Green Lever Securing Steri-Gas EO Gas Cartridge Insert the load into the GS Series sterilizer chamber. Close the sterilizer door by gently pressing the door to the chamber seal. The sterilizer will engage a physical latch to secure and lock the door. The display screen will automatically advance to the Operator ID screen.
  • Page 41 6. Enter Operator ID (Optional) The Operator ID is optional. The Operator ID can be a combination up to 20 characters. The system will accept ‘A –Z’ , ‘a-z’ , 0-9 space, period, and dash (“-“). Caps lock can be activated by double tapping the shift (up arrow) button. Touch the white data entry field to activate the keyboard then enter the Load ID (Figures 44 and 45). Press Next to continue. 04/20/2015 22.2 98.0...
  • Page 42 DANGER: To reduce the risks associated with exposure to ethylene oxide, call 3M Health Care service personnel or authorized 3M service personnel immediately if there is a failure of the display or backlight and the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series continues to operate.

  • Page 43: Display Screen Indications

    Error Message. Indicates a fault has occurred. See Chapter 15: Cautions, Error Messages and Troubleshooting for specific errors and corrections. Indication that a used 3M™ Steri-Gas™ EO Gas Cartridge is in the chamber. Indication that an unused 3M™ Steri-Gas™ EO Gas Cartridge is in the chamber.

  • Page 44: Overview Of Gs Series Ethylene Oxide (Eo) Sterilization Cycle

    12.3.1. Cycle Stages and Descriptions 3M™ Steri-Vac™ Sterilizer/Aerator GS Series ethylene oxide (EO) sterilization cycles consist of ten stages. After the sterilization cycle is complete, an aeration cycle is required to remove any residual EO from the medical devices per the manufacturers’ instructions for use (IFUs).

  • Page 45: Cycle Reports

    12.3.2. Cycle Reports There are five (5) standard sections of a cycle report: Header, Graph, Table, Set-points, and Footer. The contents for each of the five report sections are illustrated in Figures 49 – 53. There are three options for assembling a cycle report: Graph, Table and Detailed. Table 5 explains the sections included in each cycle report option. Header Graph Table...
  • Page 46 ™  Steri-Vac Sterilizer / Aerator GS Series – Operator’s Manual ™ minutes Figure 50. Example Cycle Report – Graph Option Figure 51. Example Cycle Report – Table Option...

  • Page 47: Cartridge Dispose Cycle For 3M™ Steri-Gas™ Eo Gas Cartridges

    12.4. Cartridge Dispose Cycle for 3M™ Steri-Gas™ EO Gas Cartridges The 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is designed with a specialized dispose cycle for full, damaged, expired, or excess 3M™ Steri-Gas™ EO Gas Cartridges. Cartridge Dispose is a custom abbreviated cycle to safely empty and aerate Steri-Gas EO Gas Cartridges, one per cycle. This cycle cannot sterilize devices. The cycle time for a Cartridge Dispose cycle is estimated...

  • Page 48: Ethernet Connection

    The 3M™ Steri-Vac™ Sterilizer/Aerators GS Series software application will introduce a minimal amount of active network traffic when connected to a local area network (LAN). Adding the GS Series sterilizer to a LAN allows the ability for 3M Health Care service personnel or authorized 3M service personnel to map to read-only, shared network folders on the sterilizer from a client workstation within the LAN to access diagnostic information.

  • Page 49: Software Update

    Software can be updated by Supervisor level users by selecting the Update software button on the Site tab (Menu>Setup>Site Setup>Site) reference Figure 27. Notifications of pending software updates will also be sent to registered users via the email address used to register the GS Series sterilizer on www.3M.com/SteriVacService. The user‘s facility 3M Health Care service personnel or authorized 3M service personnel can assist with completing software updates after communication with the user’s facility management.

  • Page 50: Printer Overview

    Inspect the display screen and cycle reports for errors and listen for audible notifications (if enabled). Always take action for errors as indicated in this manual. Do not attempt to access any internal mechanisms of the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series. Operators should not service the sterilizer as there are no user serviceable parts.

  • Page 51: Unloading The 3M™ Steri-Vac™ Sterilizer/Aerator Gs Series - Cycle Complete

    3. Open the GS Series sterilizer door. 4. Remove the load from the chamber. Remove the empty 3M™ Steri-Gas™ EO Gas Cartridge. 5. Press the Stop button to generate a printout of the cycle report (Figure 58). The display will return to the main screen.

  • Page 52: Accessing The Chamber During The Aeration Stage

    During the Aeration stage, the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series door can only be opened with a Supervisor or Service PIN (Figures 59 and 60 ). Aeration timing will be interrupted if the door is opened.

  • Page 53: Empty 3M™ Steri-Gas™ Eo Gas Cartridges

    12.10. Empty 3M™ Steri-Gas™ EO Gas Cartridges The 3M™ Steri-Gas™ EO Gas Cartridge should be aerated for a minimum of two hours before disposal. Cycles with two or more hours of aeration time will provide sufficient aeration as required for a Steri-Gas EO Gas Cartridge. An empty cartridge will aerate while located inside the 3M™ Steri-Vac™ Sterilizer/Aerators GS Series chamber cartridge bay. After aeration is complete, remove the cartridge from the holder and dispose of the cartridge in a non-incinerated waste receptacle or recycle the cartridge per your facility’s requirement.

  • Page 54: Process Monitoring And Load Release

    (%RH) in conditioning. Documentation for physical parameters is provided on the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series cycle reports (printout and electronic file). Under normal operating conditions, the paper cycle report produced at the end of the cycle will be similar to the one shown in Figures 48 – 52.
  • Page 55 Steri-Vac Sterilizer GS5-1D Serial number: AA121212 Software version: 1.0.1 Facility: City Hospital Sterilizer ID: Machine 2 Start time: 04/20/2015 05:27:42 Cycle count: Cycle name: 55° C Figure 61. Operator ID: Verifying Cycle Report – Header Load ID: 120413-1 EO cartridge lot: 2017-02AB WARNING: To reduce the risks associated with fire and explosion: Inspect the display screen and cycle reports for errors and listen for audible notifications (if enabled).

  • Page 56: Biological Indicators And Process Challenge Devices

    A routine BI PCD (or Test Pack) per ANSI/AAMI ST41, or an equivalent commercially available BI PCD such as the 3M™ Attest™ Biological Indicator Test Pack for EO or 3M™ Attest™ Rapid Readout Biological Indicator Test Pack for EO , is used for routine biological monitoring of ethylene oxide (EO) sterilization cycles.

  • Page 57: Internal Chemical Indicators

    This internal CI may be a multivariable indicator or an integrating indicator. The CI, such as the 3M™ Comply™ EO Chemical Indicator Strips, should be placed in that area of the package, tray, or containment device (rigid sterilization container system, instrument case, cassette, or organizing tray) considered least accessible to EO penetration;...

  • Page 58: Preventive Maintenance

    It is the user’s facility management’s responsibility to complete appropriate decontamination in case of spillage of hazardous material on or inside of the equipment. Reference the appropriate Safety Data Sheet (SDS) for decontamination procedures. If there are questions regarding the appropriate cleaning procedures and/or cleaning agents, contact your local 3M Health Care service...

  • Page 59: Cautions, Error Messages, And Troubleshooting

    15.1. Caution Messages If the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series detects a fault condition that does not adversely affect the performance of the sterilization cycle, a caution message will appear on both the display screen and cycle report to notify the Operator (Figure 64 ).

  • Page 60: Error Messages

    15.2. Error Messages If the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series detects a fault condition that adversely affects the performance of the cycle, an error message will appear on the display screen and cycle report to notify the Operator. Additionally, an optional audible notification will accompany the error message if the audible notification option is enabled.

  • Page 61: Error Levels And Corrective Actions

    EO Injection Document per facility procedures. is required. Errors that will require 3M Service. EO may or may not Call Service. − Failure in controller pressure sensor after EO Injection be present in the chamber. Errors that occur during an Service must access load and clear error.
  • Page 62 Error Description 3M service personnel. Press this button to acknowledge and clear the error. Some errors must be cleared by 3M Health Care service personnel or Error Clear Button authorized 3M service personnel with a Service PIN. See Table 7 – Descriptions for Error Levels and Corrective Actions for more details.

  • Page 63: Repair And Replacement

    16. Repair and Replacement 3M Health Care has established a worldwide service organization to provide trained technicians to maintain and repair 3M™ Steri-Vac™ equipment. For servicing information or warranty claims in the U.S., contact the local 3M Service Representative or the 3M Health Care Service Center at the following address: 3M Health Care Service Center...

  • Page 64: Ordering Accessories And Supplies

    ™ 18. Ordering Accessories and Supplies One set of upper and lower loading baskets are provided with each new 3M™ Steri-Vac™ Sterilizer/Aerator GS Series. Additional baskets are available for purchase. Table 9 provides order information for products used with the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series.

  • Page 65: Contact Information

    3M Health Care Customer Service Telephone Orders Mail Orders 1-800-592-3979 3M Health Care Customer Service 3M Center, Building 275-5E-08 P.O. Box 33275 Fax Orders St. Paul, MN 55133-3275 1-800-772-2547 * Outside of the United States, contact the local 3M Subsidiary. In Canada, contact your local 3M sales representative or 3M Canada office.
  • Page 68 3M, Steri-Vac, Attest, Comply, and Steri-Gas are trademarks of 3M. Used under license in Canada. © 2017, 3M. All rights reserved. Infection Prevention Division SanDisk and Cruzer are trademarks of 3M Health Care 3M Deutschland GmbH Made in the U.S.A. for SanDisk Corporation, registered in the...

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