Healthcare - Swissmedic
Transcription
Healthcare - Swissmedic
Healthcare Siemens Healthcare Diagnostics AG, Rautistrasse 33, CH-8047 Zürich Name Abteilung Robert Schlatter RAQS-EHS Telefon Telefax Mobil E-mail Internet Ihre Nachricht vom Unser Zeichen Datum +41( 0) 585 581 066 +41 (0) 585 581 151 robert.schlatter@siemens.com www.siemens.com/diagnostics RJS 31. Mai 2010 Wichtige Korrekturmassnahme im Feld: _ Dimension Vista® Intelligentes Analysesystem Dimension Vista® mit Alpha Technology™ USV - Überhitzung des externen Batterie Packs Sehr geehrte Kundin, sehr geehrter Kunde, Sie betreiben Dimension Vista® Analysesysteme die über eine mitgelieferte Alpha Pinnacle 10kVA USV mit externem Batterie Pack (EBP) an die Netzspannung angeschlossen sind. Der Hersteller, Alpha Technologies™ hat uns über mögliche technische Probleme an den im Batterie Pack installierten Batterien, wie im beiliegenden Brief beschrieben, informiert. Siemens Healthcare Diagnostics arbeitet eng mit der Firma Alpha zusammen um mögliche Fehler zeitnah zu beheben. Sollten Sie feststellen, dass an Ihrem Batterie Pack Flüssigkeit austritt, berühren Sie diese bitte nicht. Bitte informieren Sie umgehend Ihren zuständigen Sicherheitsbeauftragten und befolgen Sie die für Ihr Labor für solche Fälle erstellten Sicherheitsprozeduren. Unsere Serviceingenieure sind daran alle Dimension Vista® zu besuchen, um die Alpha 10K Batterie Packs (EBP) auf eventuelle Fehler zu überprüfen und diese, falls erforderlich, auszutauschen. War ein USV Batterie Pack fehlerhaft, wurde die UPS temporär überbrückt und bis zur Lieferung von Ersatzbatterien ausser Betrieb genommen. Aus regulatorischen Gründen möchten wir Sie bitten, den Erhalt und die Kenntnisnahme dieser Information durch die Rücksendung des beigefügten Formulars zu bestätigen. Bitte senden Sie das ausgefüllte Formular innerhalb von 7 Tagen an folgende Faxnummer: 0 585 581 151. Sollten Sie Fragen zu dieser Information haben oder wenn Ihnen auffällt, dass Ihr Batterie Pack heiss wird oder eine Flüssigkeit ausläuft bevor unser Serviceingenieur Sie besucht, rufen Sie bitte unsere Hotline unter 0 585 581 155 an. Siemens Healthcare Diagnostics AG Leitung: Dr. Willi Tillmann Rautistrasse 33 CH-8047 Zürich Hauptrufnummer +41 (0) 585 581 150 www.siemens.ch www.siemens.com/diagnostics Seite 1 von 3 Wichtige Korrekturmassnahme im Feld: ® Dimension Vista Intelligentes Analysesystem ® Dimension Vista mit Alpha Technology™ USV - Überhitzung des externen Batterie Packs Vielen Dank für das uns und dem Dimension Vista® entgegengebrachte Vertrauen. Wir sind bestrebt, Sie mit qualitativ hochwertigen Produkten zu versorgen, die Ihre Erwartungen erfüllen und entschuldigen uns für eventuelle Unannehmlichkeiten. Freundliche Grüsse Siemens Healthcare Diagnostics AG Dr. Willi Tillmann Dr. Ingo Waschuleswki General Manager Switzerland Senior Manager Marketing Anhang 1: Brief der Firma Alpha Technologies™ Anhang 2: Sicherheitsdatenblatt für CBS Battery Co., LTD, Sealed Lead Acid Battery Anhang 3: Sicherheitsdatenblatt für Taiwan Yuasa Battery Co., LTD, Lead Acid Battery Anhang 4: Fax-Rückantwort Seite 2 von 3 Bitte unbedingt ausfüllen, da die Siemens Healthcare Diagnostics AG - den Empfang der Korrekturmassnahme nachweisen muss! FAX-ANTWORT 0585 581 151 An Siemens Healthcare Diagnostics AG Herr Robert Schlatter Rautistrasse 33 CH-8047 Zürich Bestätigung Korrekturmassnahme Dimension Vista® mit Alpha Technology™ USV Überhitzung des externen Batterie Packs _ Kunde «Kunde» «Zusatz» «Abteilung» «Strasse» «PLZ» «Ort» Kontaktperson: «Vorname» «Name» Telefon: _________________________________________________________________________ FAX: _________________________________________________________________________ Eingangsdatum der Korrekturmassnahme: Bitte füllen Sie dieses Formblatt aus und faxen Sie dieses an die oben angegebene Fax-Nummer. Mit dieser Rückantwort bestätigen den Erhalt dieser Feldkorrekturmaßnahme und dass Sie den Inhalt verstanden und die empfohlenen Maßnahmen durchgeführt haben. _______________________________________________________________________________________ Datum Unterschrift des verantwortlichen Laborleiters Stempel Seite 3 von 3 L84 CSB BATTERY CO., LTD. MATERIAL SAFETY DATA SHEET – L84 SECTION I: CHEMICAL PRODUCT AND COMPANY INDENTIFICATION PRODUCT IDENTITY: “Battery, Electric Storage, Wet, Nonspillable, Not Regulated”. NONSPILLABLE Absorbed Electrolyte Battery – Electrical Storage Valve Regulated Lead-Acid (VRLA) Battery – Absorbed Glass Mat (AGM) Date issued: Sept. 28, 1986 Date revised: March 2006 Manufacturer Name : CSB BATTERY CO., LTD. Telephone numbers: Address : 5F.-1, No.36, Nanjing W. Rd., Tel : +886-2-2555-5600 Datong District, Taipei City Fax : +886-2-2555-3300 103, Taiwan (R.O.C.)., Web site: www.csb-battery.com.tw CSB BATTERY SHENZHEN Tel : +86-755-8831-6488/6396/16356 CSB BATTERY (U.S.A) Tel : +1-817-244-7777/1-(800)3-CSB-USA(272872) SECTION II: COMPOSITION / INFORMATION ON INGREDIENTS HAZARDOUS OSHA COMPONENT CAS# OSHA PEL ACGIH TLV % BY WEIGHT * Sulfuric Acid / Battery Electrolyte 1.300 sg 40 wt % *Lead/Grid 7664-93-9 1mg/m3 1mg/m3 STEL 22 7439-92-1 50 ug/m3 150 ug/m3 50 *Lead Oxide/Dioxide 1309-60-0 50 ug/m3 150ug/m3 21 *Lead Sulfate/ 7446-14-2 50ug/m3 150ug/m3 Anglesite Section 313 (40 CFR 372) Listed Toxic Chemicals are Preceded by an* <1 SECTION III: HAZARDOUS IDENTIFICATION Appearance and Odor : Acid is a clear to cloudy liquid. Lead is metallic gray in color. Formed lead dioxide is a dark brown in color with a slight acidic odor. Routes of entry: Sulfuric Acid: Inhalation, skin, ingestion. Lead: Inhalation and Ingestion. Ingestion of lead occurs by hand to mouth contamination. After handling lead or its compounds, hands must be washed prior to eating or drinking. Metallic lead cannot be absorbed through the skin. HMIS label rating for sulfuric acid: 302X X = acid Health Hazards (Acute & Chronic) Acute : Sulfuric acid exposure may cause irritation of the skin, corneal damage of the eyes, irritation of the mucous membranes and upper respiratory system, including the lungs. Acute lead exposure may cause GI upset, loss of appetite, diarrhea, constipation, fatigue, joint pain, and difficulty sleeping. Chronic : Exposure to lead may cause anemia, kidney damage and damage to the central nervous and reproductive systems. Lead exposure may also affect developing fetuses in pregnant women. Chronic exposure to sulfuric acid may cause scarring of skin and mucous membranes, bronchitis, contact dermatitis, and erosion of tooth enamel. Hazardous Material Information System Page 1 of 4 L84 SECTION III (Continued) Rating Codes: 0= Insignificant, 1= Slight, 2= Moderate, 3= High, 4= Extreme NFPA label rating for sulfuric acid: 201X X = acid National Fire Protection Agency HMIS and NFPA Hazard labels are used to identify the battery(s) dilute 1.300sg sulfuric acid. The first number represents the Health hazard, second number represents Fire hazard, and the third number represents the Reactivity hazard. The fourth space identifies the hazardous material, which is acid and/or typical recommended personal protective equipment, i.e., safety glasses, rubber or neoprene gloves etc. California Proposition 65 Warning – Battery posts, terminals, and related accessories contain lead and lead compounds, chemicals known to the State of California to cause cancer and reproductive harm. Batteries also contain other chemicals known to the State of California to cause cancer. Wash hands after handling. SECTION IV: FIRST AID PROCEDURES – Sulfuric Acid - Skin/Eyes Flush the affected area with water for 15 minutes Remove contaminated clothing If irritation continues, seek medical attention - Ingestion/Inhalation Do not induce vomiting Drink 8 oz. of water or milk If difficulty in breathing occurs, remove to fresh air, give CPR if necessary Seek medical attention immediately SECTION V: FIREFIGHTING MEASURES FIRE AND EXPLOSIVE PROPERTIES: Hydrogen Flash point: -259°C Hydrogen Autoignition point: 580°C Hydrogen Flammable Limits in Air (% by Volume): LEL: 4.1 UEL: 74.2 Lower Explosion Limit (LEL), Upper Explosion Limit (UEL) Unusual Fire and Explosion Hazards: Hydrogen and Oxygen gases are produced in cells during normal battery operation. Ventilate Area. Extinguishing Media: Dry Chemical, Foam or CO2 Special Firefighter Procedures: Use Positive Pressure, self-contained breathing apparatus. SECTION VI: ACCIDENTAL RELEASE MEASURES STEPS TO BE TAKEN IF BATTERY IS BROKEN: Neutralize exposed battery parts with soda ash or sodium bicarbonate until fizzing stops, pH should be at neutral 6-8. Provide adequate ventilation. Heat, carbon dioxide and hydrogen gas may be given off during neutralization. Collect residue in a suitable container. Place the broken battery in a heavy-duty plastic bag or other non-metallic container. Properly recycle all battery residue and parts. SECTION VII: HANDLING AND STORAGE Store in a cool; dry area away from combustibles. Do not store in sealed, unventilated areas. Avoid overheating and overcharging. Do not use organic solvents or other than manufactures recommended cleaners on the batteries. Page 2 of 4 L84 SECTION VIII: EXPOSURE CONTROLS/PERSONAL PROTECTION Engineering Controls: General room ventilation is sufficient during normal use and handling. Do not install these batteries in a sealed, unventilated area. PERSONAL PROTECTIVE EQUIPMENT (DURING INSTALLATION OR IN THE EVENT OF BATTERY BREAKAGE) Eye Protection = Chemical goggles, safety glasses with sideshields and or a full-face shield. Protective gloves = Rubber or neoprene Respiratory Protection = NIOSH approved acid mist/organic vapor respirator, if OSHA PEL is exceeded. Other Protective Equipment = Acid resistant apron or clothes. WORK PRACTICES: Use standard lead-acid battery practices. Do not wear metallic jewelry when working with batteries. Use non-conductive tools only. Discharge static electricity prior to working on a battery. Maintain eyewash, fire extinguisher and emergency communication device in the work area. SECTION IX: PHYSICAL AND CHEMICAL PROPERTIES ACID : Boiling Point: 110°C to 112°C Vapor Pressure: 13.8 mm Hg @ 25°C Vapor Density: (Air=1) 3.4 Melting point: N/A Solubility in water: N/A Specific Gravity 1.300 +/- 0.030 Appearance/Odor: clear to cloudy with slightly acidic odor SECTION X: STABILITY AND REACTIVITY STABILITY: This battery and contents are stable. Conditions to avoid: Overheating, overcharging which results in acid mist/Hydrogen generation. Incompatibility (materials to avoid): Strong alkaline materials, conductive metals, organic solvents, sparks or open flame. Hazardous Byproducts: Hydrogen gas may be generated in an overcharged condition, in fire or at very high temperatures. In fire, may emit CO, CO2 and Sulfur Oxides. Hazardous polymerization will not occur Page 3 of 4 L84 SECTION XI: TOXICOLOGICAL INFORMATION – SULFURIC ACID The CSB VRLA batteries are a sealed, recombinant design that require no water replacement throughout their service life, thus no contact is made with the battery’s internal components or chemical hazards. Under normal use and handling, these batteries do not emit regulated or hazardous substances. Dose Test Animal Administration Route O ra l Rat LD 50 2140 mg/kg Unreported 135 mg/kg Man LDLo Inhalation 510 mg/m3 Rat LC50 Carcinogenicity : The International Agency on Cancer (IARCC) has classified “strong inorganic acid mists containing sulfuric acid” as a category 1 carcinogen (inhalation), a substance that is carcinogenic to humans. This classification does not apply to the liquid forms of sulfuric acid contained within the battery. Misuse of the product, such as overcharging, may result in the generation of sulfuric acid mist at high levels. SECTION XII: DISPOSAL CONSIDERATIONS Waste Disposal Method : Send to lead smelter for reclamation following applicable Federal, State and Local regulations. Product can be recycled along with automotive (SLI) lead-acid batteries. SECTION XIII: TRANSPORTATION AND INTERNATIONAL REGULATIONS All CSB batteries, when transported by air, surface or by vessel are identified as “Battery, Electric Storage, Wet, Nonspillable, Not Regulated”. The battery(s) must be identified as above on the Bill of Lading and properly packaged with their terminals protected from short circuit. NA or UN numbers do not apply. CSB battery(s) warning label identifies each battery as NONSPILLABLE. CSB battery(s) preprinted cartons identifies each battery as NONSPILLABLE. CSB battery(s) shipped without CSB cartons (bulk packed) need to be Identified as NONSPILLABLE or NONSPILLABLE BATTERY on the outer packaging. Air: CSB batteries meet the conditions in IATA/ICAO Special Provision A67. Surface: CSB batteries meet the conditions for DOT Haz Mat Regulations CFR-Tittle 49 parts 171-189. Vessel: CSB Batteries meet the conditions of IMDG exception 238. SECTION XIV: REGULATORY INFORMATION See 29 CFR 1910.268(b)(2) SECTION XV: OTHER INFORMATION The information herein is given is good faith, but no warranty, expressed or implied, is made. Page 4 of 4 MATERIAL SAFETY DATA SHEET 1/4 TAIWAN YUASA BATTERY CO.,LTD QA Dept. Emergency contact TEL 886-2-2901-8261 FAX 886-2-29039626 No.11, Lane 227 Fuying Road, Hsinchuang City, Taipei Hsien, Taiwan Prepared on 2006.09.07 Product NameΚΰChemicals name or Merchandise NameαΚ TYPE - NP、NPH、NPX、NPW、RE、REW、REC、UXH、NPL、SWL、TRE、PW Lead-Acid Battery Identification of substance Identification of single - or mixed substance productΚMixed-substance product Components Compositions Approximate% CAS Number 65-75% 7439-92-1ΰPbα 0.3% or below 7440-39-3ΰBaα abt. 40% dilute sulfuric acidΰH2SO4+H2Oα 15-25% 7664-93-9 ABS resinΰsynthetic resinα 5-15% 9003-56-9 Antimony trioxideΰSb2O3α 2% or below 1309-64-4 Tetrabromobisphenol A 4% or below 79-94-7 1-3% Ё 1% or below Ё Lead and lead compoundsΰPb & PbO2α Plate Electrolyte Battery container / Cover ++ Barium compoundΰBa α Separator Glass Fiber Other metal parts Brass PP Other resin parts 9003-07-0 1-5% Epoxy resin and Rubber Ё Classification of Hazardousness and Poisonousness Classification name Classification standard not applicable to batteries. Charging a battery generates hydrogen and oxygen gases. Hazardousness Poisonousness Exposure of fire to them may catch a fireΔresulting in an explosion. Exposure of electrolyte to skin or an eye may result in a burn or a loss of eyesight. Highly concentrated electrolyte may adversely affect living things such as animals Effect on Environment and plants. Emergency Measures When electrolyte is inhaledΚ Move to a place full of fresh air and have immediate medical treatment. When electrolyte is Immediately rinse the mouth with a large quantity of fresh waterΔand drink another swallowedΚ large quantity of fresh water. ThenΔhave immediate medical treatment. When electrolyte is attached Immediately wash it down with a large quantity of waterΔand thoroughly wash the to skinΚ skin with soap. If there is a fear of burnΔhave immediate medical treatment. When electrolyte contacts Immediately flush the eye sufficiently with waterΔand have immediate medical the eyesΚ treatment. MATERIAL SAFETY DATA SHEET 2/4 TAIWAN YUASA BATTERY CO.,LTD Action at the Time of Fire Extinguish a fire using a fire extinguisher of dry powder agentΔfoam agent or Fire fighting method non-combustible gas. Action at The Time of Electrolyte Leak or Outflow Neutralize the leaked electrolyte with soda bicarbonate or slaked limeΔthen wash it down.ΰAt that timeΔbe sure to wear protective gogglesΔglovesΔand boots.α Handling and Storing Precautions z Do not disassemble or modify the batteryΔnor short it between the terminals. z Do not put a fire close to the batteryΔor throw it into a fire. z Handle batteries as heavy objects. HandlingΚ z With vents provided in a cubicleΔfor exampleΔcharge the battery in a well ventilated room. Choose a place that is not exposed to high temperaturesΔhigh humidityΔwind and StoringΚ rainΔdirect sunlightΔfireΔpoisonous gassesΔdropletsΔdust generation or ingressΔ or submersion. Exposure inhibiting Device Not applicable to batteries. Physical / Chemical Properties Not applicable to batteries. Materials Dilute sulfuric acid ΰreferenceα ΰfor 1.3 of specific gravityα Lead ABS resin Transparent liquid Silver white solid Black or Gray solid 1.30 11.3 1.20 z Boiling point 110к 1,740к Ё z Melting point -40к 327к z Other appearance z Specific gravity z Freezing point z Vapor pressure Soften point about 130-150к Ё -56.4к 3.17 kPaΰfor 30% 0.1 kPaΰat 25кα concentration at 30кα Hazardousness information As perϚClassification of Hazardousness and Poisonousnessϛabove. Poisonousness information As perϚClassification of Hazardousness and Poisonousnessϛabove. Ё MATERIAL SAFETY DATA SHEET 3/4 TAIWAN YUASA BATTERY CO.,LTD Environmental information As perϚClassification of Hazardousness and Poisonousnessϛabove. Disposing precautions Used batteries shall be recycled for reuse in accordance with relative national law and regulations. Transporting precautions Try to avoid mingling batteries with other substances. Handle with care so that no electrolyte leak occurs by overturning or dropping a battery. Applicable LawΰSulfuric Acidα Toxic and Hazardous Substances Control Act Hazardous substances Specific chemical substances – substances of third Labor Safety and Sanitation Law category Shipping and Storage Regulation of Dangerous Goods Corrosive substance Fire Service Law Fire Nuisance Shipping Methods Hazardous ClassΚ 8 Packing GroupΚ III Label / Placard RequiredΚCorrosive Marine Transportation The battery accordance with UN2800 (Special regulation of nonspillable battery) Air Transportation In accordance with IATA’s dangerous goods regulation A67ΰnonspillable batteryα Transportation between USA and Canada According to US Department of Transportation’s regulation, (173埛159αΕbattery itself or package of battery should indicates “NONSPILLABLE”or “NONSPILLABLEʳ BATTERY” Suitable specification JAPANΚAccord with JIS C8702-ΰ1α Εΰ2α Εΰ3α Ζ OverseasΚAccord with IEC 61056-1Ε61056-2Ε61056-3 MATERIAL SAFETY DATA SHEET 4/4 TAIWAN YUASA BATTERY CO.,LTD Other information The following battery compositions is listed in TSCAΰToxic Substance Control ActΰU.S.A.α α. Components CAS No. TSCA lists the state sulfuric acid(H2SO4+H2O) 7664-93-9 Listed Lead(Pb) 7439-92-1 Listed lead compounds(PbO2) 1317-36-8 Listed Inorganic lead Lead sulfate(PbSO4) 7446-14-2 Listed Compound Calcium (Ca) 7440-70-2 Listed Tin(Sn) 7440-31-5 Listed Barium(Ba) 7440-39-3 Listed Antimony trioxide (Sb2O3) 1309-64-4 Listed 79-94-7 Listed Electrolyte Battery containerϟ Cover Tetrabromobisphenol A(C15H12Br4O2) California Prop 65 Battery posts, terminals and related accessories contain lead and lead compounds, and other chemicals known to the state of California to cause cancer and birth defects or other reproductive harm. Wash hands after handling. RoHS Instruction Lead and lead compound contained in the lead-acid battery is off the subject of the RoHS instruction. 垸All statements described here are based on the materials, information, and date collected at this point. the above statements may not reflect the most updated information. Thereby, All the substances may include un-described hazardous substances. All statements described here do no guarantees that all the possible hazardous substance is included. In addition, please read the warning and notes on caution label before using rechargeable battery. 垸If you have any questions regard to rechargeable battery or the MSDS content, please contact us for further information.