Haag-Streit OCTOPUS 600 Instructions For Use Manual - page 13
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
Patient response button Octopus 600 1806150
1x
Dust cover
1802304
1x
Eye patch set
1802349
2x / set
*IFU = Instructions for use
B. Legalregulations
•
HAAG-STREIT maintains a quality management system in accordance with EN
ISO 13485. The device was developed and designed in accordance with all the
standards listed in section 'EMC'.
•
The Octopus 600 is a Class IIa device in accordance with Appendix IX of Direc-
tive 93/42/EEC. By affixing the CE mark we confirm that our device complies
with the applicable standards and directives.
•
You can request a copy of the declaration of conformity for the appliance from
HAAG-STREIT at any time.
•
This appliance fulfils the European Directive 2011/65/EC.
C. Classification
Standard EN 60601-1
Perimeter Octopus 600 acc. to protection class I
Applied part:
Type B
Operating mode:
Continuous operation
CE Directive 93/42/EEC Class IIa
Standard EN 62471
Exempt group
Standard EN ISO 15004-2 Group 1
D. Disposal
Electrical and electronic devices must be disposed of separately from
household waste! This appliance was made available for sale after the
13th August 2005. For correct disposal, please contact your
HAAG-STREIT representative. This will guarantee that no hazardous
substances enter the environment and that valuable raw materials are
recycled.
E. Standards
EN 60601-1
ISO 9022
EN 60601-1-2
EN ISO 10993
EN ISO 15004-1, -2
EN 1041
EN ISO 12866
EN 15223-1
EN 62471
F.
RoHS China
Environment friendly use period (EFUP). The following formula applies for products
that can be repaired:
EF =
21900
X
8,5
60
X
365
30000
X
125%
8,5
X
365
12
125% = Factor for products which can be repaired. Daily use = service use, from
field tests Average data: 21,900 patients/year, 10 minutes/patient.
Technical service life x 125%
(Daily use)x 365
Daily use
8.5 hours per day
12.1 years
Technical service life ~ 30,000 hours.
Consequently, the environment friendly use period is approx. 12 years.
F.1
RoHS declaration
Name of sub-assembly
Camera mount.
(Distance ring 1820224)
Camera mount.
(Front threaded ring 1820153)
Stepping motor mount. (Short coupling flange 1802009)
Ribbon cable clip
(1008504)
Lead (Pb)
■
■
■
○
Mercury(Hg)
○
○
○
○
Cadmium (Cd)
○
○
○
○
Chromium VI compounds (Cr6+)
○
○
○
○
Polybrominated biphenyl (PBB)
○
○
○
○
Polybrominated diphenyl ether (PBDE)
○
○
○
■
■Contains ○Does not contain
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