SCHWIND Amaris 500E - Approved System Combinations and Optional Accessories; Features

USER MANUAL (Instruction for Use) SW 6.1
Device / System Description
Version 6.1.6 dated 2020-01-31 EN Page 71 of 201
4.15 Approved System Combinations and Optional Accessories / Features
IMPORTANT NOTE
When combining the AMARIS 500E / AMARIS 750S / AMARIS 1050RS excimer
laser with a patient bed or with other medical products, take care to ensure
that the combination complies with the requirements of the European Medical
Device Directive (93/42/EEC), of the standard IEC 60601-1 and any other local
regulations that may apply. The combination of the SCHWIND AMARIS with
other SCHWIND products meets these requirements.
CAUTION
Do not install any devices other than those defined in the prescribed system
combination as shown in the table below.
Only these are approved by SCHWIND eye-tech-solutions!
SCHWIND does not assume responsibility for any other combinations and the
implications of misuse!
The table below lists devices for
 Approved system combination
1
specified by SCHWIND eye-tech-solutions according to
Declaration of Conformity Article 12 of European Council Medical Device Directive MDD
93/42/EEC and
 Approved optional components / features
2
which are intended for the use with the AMARIS
laser system and may be equipped optionally
for the respective AMARIS model (500E, 750S, 1050RS)
Device Class System
combination
1
Optional
features
2
SCHWIND Custom Ablation Manager IIb X ---
Patient bed swivelling for the respective AMARIS
model (500E, 750S, 1050RS)
I X ---
SCHWIND CXL-365 vario IIa X X
WLAN-Set for printer connection and data
exchange with workstations (incl. WLAN Access
point Dlink and WLAN print server)
--- X X
Inkjet printer (USB connection) --- X X
Video system AMARIS incl. observer camera --- X X
TFT Monitor 19”
--- X X