14
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
A. Appendix
A.1 Accessories / spare parts
Component
Type
HS art. no.
Note
Instrument table
IT 02
7220004
See separate IU*:
Patient response button
Octopus 900
1802032
1x
Dust cover
1803061
1x
Eye patch set
1802349
2x / set
*IU = Instructions for use
B. Legal regulations
•
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 E, 'Standards'.
•
The Octopus 900 is a Class IIa device in accordance with Appendix IX of Directive
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.
C. Classification
Standard EN 60601-1
Perimeter Octopus 900 acc. to protection class I
Application part:
Type B
Operating mode:
Continuous operation
CE Directive 93/42/EEC
Class IIa
Standard EN 62471
Exempt group
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
EN ISO 15004-1 EN 62471
ISO 9022
EN 60601-1-2
EN ISO 12866
EN ISO 10993-1
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.
01-IFU_Octopus900-7220343_04070_eng.indd 14
18.11.2016 14:03:44
