WORK INSTRUCTION FM-DVSOP Rev. 000

Transcription

1 WI Type: Assembly Instruction Effective Date: Page 1 of 9 DOCUMENT VERIFICATION Prior to using this document, the user is responsible for verifying that the revision and effective date are current. REVISION HISTORY Owning Site: Rev. Effective Date Additional Sites Using Document: Change Order No. 100 Release Changes Made to Document

2 WI Type: Assembly Instruction Effective Date: Page 2 of SCOPE This specification will detail the requirements for the component, Sensor Oximetry Wrap Probe. This specification covers these component part numbers. Part # Description 3025 Sensor Oximetry Wrap Probe, Infant 3026 Sensor Oximetry Wrap Probe, Neonatal 2.0 REFERENCE DOCUMENTS The documents listed should be used along with this specification to purchase and/or manufacture the respective component(s). Document revisions are per the controlled bill of material. IPC-A-610E, Class 1 Acceptability of Electronic Assemblies 3025Q Test Procedure Reusable Wrap Probe FM-3025Q-01 Probe Testing Data Form In addition to graphics in the specification, use with drawing respective to part. 3.0 PHYSICAL REQUIREMENTS See following pages.

3 WI Type: Assembly Instruction Effective Date: Page 3 of & 3026 Parts List Item # Part # Description Qty 1 None Silicone Housing (LSR-40) B1 Ceramic Substrate w/leds Red 661/IRED 905nm B1 Ceramic Substrate w/detector (OSI 001PC) B2 Cable Overmolded Wrap, Probe 1 5 OSI PN: PN: 20542B5 Label, White, THT ,.50 x 1.00 inch 1 6 OSI PN: PN: 31197B2 Label, Flag B2 Label, WEEE Directive : 20530B1 Tape, Neonatal Wrap, Probe : 20530B2 Tape, Infant Wrap, Probe : _ Insert, IFU, Infant Wrap 3025, rev per BOM : : _ Insert, IFU, Neonatal Wrap 3026, rev per BOM 1 10 OSI PN: PN: 54073B2 Bag, Poly, Reclosable, 6x8 inch B2 Bag, Heat Seal 4x6 inch 1 12 None Label, White B2 Label, White, 1.25 x 2.75 inch 1 14 Nusil MED-4044 Potting Material, LSR MED-4044, Clear AR 15 Supplier selected Fabric AR Strip and tin wires.04 inch. Cut jacket and shield of inner cable flush or.05 max from outer jacket. De-flash Cable Overmold (Item 4) after overmolding. Probes need to be tested prior to shipping. Use these test procedures: 3025: 3025Q Test Procedure Reusable Wrap Probe, Infant 3026: 3026Q Test Procedure Reusable Wrap Probe, Neonatal

4 WI Type: Assembly Instruction Effective Date: Page 4 of 9 Black and White Wires Orange Wire Red Wire.65 4 Cut Jacket/Shield ±.25 Detail A 9-Pin Male Outer Shield Inner Shield Red Wht Blk Orn Wrap Probe Det IRED RED Schematic

5 WI Type: Assembly Instruction Effective Date: Page 5 of 9 Verify orientation of ceramic during assembly. Connect wires as shown in Detail B/C. Backfill both windows with Potting Material (Item 14), flush or.02 maximum above surface. 1 Black White Ceramics (4 places) See Note 14 2 White Black 14 Orange 3 Red Red Orange Detail B Detail C Item 1 to have a layer of cloth reinforcement material (Item 15) sandwiched in it and wrapped around cable entry point. Trim fabric per dimensions shown. Wrap tab of fabric completely around cable See Note Tolerance = ±.10 Detail D

6 WI Type: Assembly Instruction Effective Date: Page 6 of 9 Print label (Item 5) as shown Lot number information: J will be unique identifier for K will be unique identifier for YYYY= year WW = week of manufacture. The box is reserved for manufacturer s information Manufacture date is: YYYY=year MM=month of manufacture SN=Serialize each assembly with a unique number. Apply label to flag label (Item 6). Apply WEEE directive (Item7) to opposite side of flag label. Apply flag label where shown on graphic. 7 Opposite side of flag label 1.25 ±.25 REF LOT 6 SN 5 REF LOT SN 3025 JYYWW- YYYY-MM XXXXX Unique 5 digit number Label for 3025 Manufacturers information Manufacture Date REF 3026 LOT KYYWW- YYYY-MM SN XXXXX Label for 3026

7 WI Type: Assembly Instruction Effective Date: Page 7 of 9 Print barcode on label (Item 13), style 128b,2. Use the same lot code as the assembly label one. Include the country or origin on this label. Insert 10 tapes (Item 8) into the heat sealed bag (Item 11) and seal. Create label as shown (Item 12) and apply to bag. Use the same lot code as others. TAPE ATTACHMENT INFANT LOT XXXXXX LATEX Insert cable, tape bag and IFU (Item 9) as shown into reclosable bag (Item 10). Ensure the CE mark is visible through the bag (BARCODE) REF 302_ LOT _YYWW- MADE IN XXXXX REF 302_ Reusable XXXX Wrap Sensor Ref # 3025 or 3026 and Description (depending upon assembly) 9 12 TAPE ATTACHMENT INFANT LOT XXXXXX LATEX 11

8 WI Type: Assembly Instruction Effective Date: Page 8 of ADDITIONAL SUPPLIER REQUIREMENTS 4.1 Cleanliness The inspection of the component will be with bright ambient lighting provided by the use of standard lighting equipment. Visual inspection is done with the unaided eye for 3 to 5 seconds at a distance of 10 to 18 inches. Ensure that component contains none of the following on it: - Filmy foreign material/residue - Liquids, grease, oil 4.2 Damage The inspection of the component will be with bright ambient lighting provided by the use of standard lighting equipment. Visual inspection is done with the unaided eye for 3 to 5 seconds at a distance of 10 to 18 inches. Minor cosmetic damage to exterior surface including cuts, tears, holes, or creases shall not be present when using the visual inspection criteria for inspection. 4.3 Latex Free The device manufacturing, packaging and labeling shall not contain natural rubber latex. 4.4 RoHS/REACH Compliant Not applicable. 4.5 Workmanship This assembly will conform to the applicable sections of IPC-A-610E. 4.6 Shelf Life Not applicable. 4.7 Sterilization Requirements Not applicable. 5.0 QUALITY ASSURANCE REQUIREMENTS 5.1 Acceptance Criteria It is the responsibility of the supplier to meet the requirements of this specification. SMASD may, at its discretion, perform any inspections or tests to assure the supplier s compliance with this specification.

9 WI Type: Assembly Instruction Effective Date: Page 9 of Disposition of Non-Conforming Components/Materials Any component/materials classified as non-conforming to specifications are subject to return to supplier for credit or replacement or other disposition as determined by the SMASD Material Review Board and mutually agreeable with the supplier. 5.3 Notification/Approval of Change Prior to producing or shipping product, the supplier shall notify, and receive written approval for, any change which may affect performance, quality, reliability or interchangeability. This includes, but is not limited to, raw material, process, or tooling changes. 5.4 Traceability Supplier shall be able to reconstruct manufacturing history and material composition from a specific supplier control number (lot/batch number). 5.5 Certification Requirements The supplier shall provide a certification with each lot shipped, which specifies that the articles shipped meet the requirements of this specification and accompanying documentation. As a minimum the certification shall contain the following information: Purchase Order Number and Date Suppliers Lot Number Quantity of articles shipped Signature of the person certifying the component was manufactured, inspected, tested, and found to be in compliance with applicable specifications Certification of testing must be provided. Supplier may contact a Purchasing Agent to obtain information for preparing an appropriate certification. 6.0 PACKAGING CONFIGURATION Packaging shall be adequate to provide protection from damage and contamination from expected handling, transit, and storage. 7.0 SHIPMENT IDENTIFICATION Each shipping carton shall have adequate identification to positively identify the components to the respective purchase order.