Xerafy Autoclavable XS and XXS User Guide

Transcription

1 Xerafy Autoclavable XS and XXS User Guide General Information This user guide provides instructions for attaching Xerafy autoclavable XS and XXS series tags onto surgical instruments. This document is written for use by hospital surgical departments, surgical tracking solution companies, instrument service companies, medical instrument manufacturers and any other organizations that are attaching passive UHF RFID tags on medical instruments, including those that want to use RFID for UDI marking. Due to the wide variety of surgical instruments, we cannot provide specific attachment instructions for each type. Several common types are used to illustrate attachment techniques. However these examples are not exhaustive, and this user guide is relevant even for instruments not described here. Commonly used surgical instruments Figure 1 Scalpel Figure 2 Tweezers Figure 3 Hemostatic forceps Figure 4 Surgical scissors 1

2 Recommended Tag Placement on Surgical Instruments The tag placement location on surgical instruments is extremely important for the following reasons: The addition of a tag should in no way interfere or obstruct the surgeon s use or balance of the instrument during surgery; Tag attachment should not weaken the instrument or have any impact on its integrity; Tag location should enhance the RFID read performance; In our experience, the most non-intrusive attachment location is usually at the end of the instrument. Figures 5 through 7 illustrate examples of favorable attachment methods for a few common instruments. Figure 5 Scalpel with autoclavable Dot Carrier Figure 6 Hemostatic forceps attached with autoclavable Dash directly Figure 7 Surgical scissors with autoclavable Dot embedded 2

3 Attachment Methods There are three primary methods to attach autoclavable XS and XXS series tags onto surgical instruments: 1. Carrier attachment 2. Glue attachment 3. Embedding 1. Carrier Attachment The carrier is a separate component that is designed to provide a simple, quick and inexpensive method of attaching tags onto surgical instrument securely. The autoclavable Dot tag is encased within a high strength polymer carrier formed through injection moulding. The carrier is welded onto the surgical instrument through a stainless steel connector. Using a fixed reader, the carrier has a read range of up to 1.5m. Figures 8 shows actual examples of Xerafy carrier that were laser welded to surgical instruments. Figure 8 Autoclavable Dot carriers welded to the scalpels Laser Welding Laser welding is a welding technique used to join multiple pieces of metal through the use of a laser. The laser beam provides a concentrated heat source, allowing for narrow, deep welds and high welding rates. This is a very secure and reliable form of attachment of tags onto surgical instruments. Recommended minimum welding depth for the carrier is 1mm. Attachment Orientation The RFID tags in the carriers are linear polarized; therefore the best direction for attaching is parallel to the surgical instruments as illustrated in Figures 9 through 11. 3

4 The polarization line The polarization line Figure 9 Figure 10 The polarization line Figure 11 Using Carriers in the Actual Environment In actual use, instruments are often randomly facing upward or downward when placed in surgical trays. In such instances, tag read range of approximately 30 to 50 cm can be obtained. However, if there are instances where the top of the carrier is completely covered by another metallic instrument or object, the tags may not be read successfully. 4

5 Carrier Drawing (mm) Figure 12 Dot Carrier 1mm = in Notes of Caution: Carrier tags may not be read or written if they are completely covered by another metallic surface or object, or if they are kept inside a solid metallic container. If a carrier tag is submerged in a liquid substance the RF performance will be reduced. Glue Attachment The easiest way to attach an autoclavable XS and XXS Series tag on a surgical instrument is affixing the tag directly to the instrument s surface using special glue. The recommended tag location is one that will not affect the surgeon s use or surgical instrument function. Either autoclavable Dot or Dash tags can be chosen for direct attachment to surgical instruments. The optimal choice depends on each instrument s dimension and shape. 5

6 Attachment Orientation The RFID tags are linear polarized therefore the best direction for attaching is parallel to the surgical instruments. Gluing Process Before affixing a tag on a surgical instrument the attachment location has to be cleaned so the surface does not have oil or dust. An unclean surface will affect the glue adhesion strength, which could cause the tag to fall off. We recommend using Xerafy custom glue to affix the tag onto the surgical instrument. The medical glue is able to withstand repeated sterilizations, including radiation, ethylene oxide, sterilization chemicals and especially autoclaving. It is also FDA approved and complies with the ISO for biocompatiability. To ensure reliability throughout the service life of the surgical instrument, we strongly recommend completely covering the entire tag in epoxy, as shown in Figure 13. Tags remain readable even when completely covered. Figure 13 Autoclavable Dash directly attached to scissors Embedding To embed an XS and XXS tags in a metallic asset, first prepare a cavity in the asset where the tag will be placed. The cavity size should be slightly bigger than the tag and at least half the tag thickness. Once the cavity or recess has been prepared, place the tag in the center of the cavity or recess using a high performance adhesive and then completely cover the tag with epoxy resin, ensuring all spaces are filled. Once again, it is important to ensure a flat metallic surface is used to eliminate any gap between the tag and the asset. Embedding can reduce the read range of the tag due to some detuning. Figure 14 and 15 show the concept of embedding the tag into a surgical instrument. 6

7 Autoclavable Dash (XS or XXS) Autoclavable Dot (XS or XXS) Figure 14 Autoclavable Dot embedded in a scissors Figure 15 Autoclavable Dash embedded in a scissors When selecting the location to embed the tag, it is important not to affect the instrument s function or structural strength. For example, the handle area and the functional area should be avoided. 7

8 Writing Information to Tags (Encoding) Tag already come with a set of unique numbers and can be successfully read with any EPC Global Gen2 standard hardware. However customers have the option to rewrite this set of numbers with a different set of numbers that makes sense to them. Writing information to tags can be achieved either with a fixed-position reader (recommended for ease of use) or a handheld. For best performance tags should be written individually. Specific instructions on writing to a tag can be obtained from your reader hardware supplier. XS and XXS Specifications Performance Characteristics Description Operating frequency UHF MHz (US) MHz (EU) RF air protocol EPC Global Gen2, Class 1 Functionality Read / Write (user programmed). Full duplex protocol Memory 96-bits EPC, 128bits user memory Memory-expected read / write cycles 50 years at up to 100,000 read / write cycles at 25 ºC Data Retention Life of Product Read rate Up to 400 per second, but is application-dependent Polarization Linear Mounting system Laser welding Compliance RoHS, CE Technical Specification Comparison Product Autoclavable Dash XXS Autoclavable Dot XXS Autoclavable Dash XS Autoclavable Dot XS Operating frequency MHz (US) MHz (EU) MHz (US) MHz (EU) MHz (US) MHz (EU) MHz (US) MHz (EU) Memory configuration 96 EPC bits, extendable to 480 bits (512 bit user memory) 96 EPC bits, extendable to 480 bits (512 bit user memory) 96 EPC bits, extendable to 480 bits (512 bit user memory) 96 EPC bits, extendable to 480 bits (512 bit user memory) Read range (2W ERP) Up to 3 ft (0.9 m) Up to 1.6 ft (0.5 m) Up to 6.6 ft (2 m) Up to 5 ft (1.5 m) Operating temperature -40 F to +185 F (-40 C to +85 C) -40 F to +185 F (-40 C to +85 C) -40 F to +185 F (-40 C to +85 C) -40 F to +185 F (-40 C to +85 C) Application temperature -40 F to +302 F (-40 C to +150 C) -40 F to +302 F (-40 C to +150 C) -40 F to +302 F (-40 C to +150 C) -40 F to +302 F (-40 C to +150 C) Compliance RoHS, CE, FDA(Class I) RoHS, CE, FDA(Class I) RoHS, CE, ATEX, FDA(Class I) RoHS, CE, ATEX, FDA(Class I) Suggested applications Surgical instrument tracking, Source tagging Surgical instrument tracking, Source tagging Surgical instrument tracking, medical device management Surgical instrument tracking, medical device management 8

9 Radiation Patterns Autoclavable Dot XXS Autoclavable Dot XS Autoclavable Dash XXS Autoclavable Dash XS Cleaning and Disinfection Process (ANSI/AAMI ST79) Chemical sterilization for decontamination Liquid chemical sterilants include glutaraldehyde, hydrogen peroxide, hydrogen peroxide-peracetic acid combinations, sodium hypochlorite, and peracetic acid. Thermal (hot water) disinfection Washer-sanitizers, washer-decontaminators, utensil washers, and cart washers reduce microbial contamination by means of cleaning agents, hot water, rinsing, and drying. Pasteurization equipment provides cleaning and high-level disinfection at water temperatures of 65 C to 77 C (150 F to 170 F) for a contact time of at least 30 minutes. Washer-disinfectors provide a cycle of cleaning, rinsing, disinfection, and drying at temperatures that are usually higher than those of washer-sanitizers 9

10 Thermal sterilization for decontamination Saturated steam can be used to decontaminate devices capable of withstanding high temperatures (121 C to 135 C [250 F to 275 F]) and pressures (16 to 35 psig). Washer-sterilizers provide cleaning and rinsing followed by exposure to saturated steam at temperatures of 121 C to 135 C (250 F to 275 F). Ultrasonic cleaner 3KHz for 30 min Disinfection by light C wave ultraviolet and wavelength range is from 200nrn to 275nrn Detergent enzyme cleaner Autoclave sterilization 134 C and 0.6 Mpa for more than 1000 cycles Order Information X4102-US040-H3 X4202-US040-H3 X4101-US040-H3 X4101-EU040-H3 X4302-US040-H3 X4302-EU040-H3 X4301-US040-H3 X4301-EU040-H3 Autoclavable Dot XS US Autoclavable Dot XS EU Autoclavable Dash XS US Autoclavable Dash XS EU Autoclavable Dot XXS US Autoclavable Dot XXS EU Autoclavable Dash XXS US Autoclavable Dash XXS EU About Xerafy Xerafy helps improve patient safety and process efficiency with RFID tags for surgical instruments and trays that survive repeated autoclaves to provide traceability through SPD, storage and the OR. Xerafy s read-on-metal RFID UHF tags comply with stringent FDA, ISO and EPCglobal requirements. XS and XXS Series tags provide a long read range and are small enough to be embedded or attached to surgical instruments and medical devices. Applications include: Automatically record when items enter and exit the autoclave to build sterilization records. Create an accurate inventory of each instrument contained within a tray. Automatically record all stock movements of trays and instruments to support asset management, audit and inventory control operations. Automatically count and detect items in the OR to prevent URFOs By providing accurate, hands-free monitoring, Xerafy and its partners are helping hospitals raise patient safety, improve asset management, reduce search time and streamline reporting. Visit for more information. 10