Publicité
Year I
Year II
Production
Maximum 2 years in use
first use
Measuring prism - what time of usage?
• Due to the number of variables involved (type and concen-
tration of disinfecting material used, number of patients, hand-
ling, etc.) it is almost impossible to put a figure on the number
of times and / or period of time that a measuring prism can
safely be used.
• Haag-Streit recommend that no measuring prism may be used
longer than two years under 'normal' conditions, i.e. as per the
instructions contained within this instruction manual.
• A measuring prism may be retained indefinitely as a spare part
under room temperatures and protected from sun exposure,
deterioration does not start until it is used for the first time.
• This recommended time is overruled if the prism is in any way
damaged within this period of time; damaged prisms should
be replaced immediately.
Statutory requirements
• The Applanation Tonometer is designated as Class I product
with measuring functions under the EEC Directive 93/42 for
medical equipment products.
• The CE designation is beeing then granted on the basis of
this Directive as per Conformity Module B.
• The Applanation Tonometer complies with the Tonometer
regulation ISO 8612.
• A copy of the declaration of conformity of the present instru-
ment can be requested at any time from Haag-Streit.
• Statutory accident regulations are also to be observed.
• National calibrating regulations for measuring equipment are
also to be observed.
• Classification
CE-Regulation 93/42 EEC
Class Im (measuring functions)
FDA
Class II
Pictograms
a Read very carefully (in the instruction manual)!
b Legend plate
Year III
Year IIII
replace
1500.7006000.04091
a
Applanation Tonometer
b
Type: AT 900 BQ
HS-Part Number: 7200034
Serial Number: 12345
© Haag-Streit AG, CH-3098 Koeniz, Switzerland
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Publicité
Chapitres
