Healthcare - Swissmedic

Transcription

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
[email protected]
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
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
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.
2/4
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
Ё
3/4
Environmental information
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
4/4
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.

Healthcare - Swissmedic

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