EC DECLARATION OF CONFORMITY
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1 NATIONAL APPROVAL 1 (5) Issued, date Name Title/Role :35 Dahlke Mikael QA-RA Reviewed, date Name Title/Role :46 Johansson Micael QA-RA Approved, date Name Title/Role :52 Berken Lars Vice President MCC-Q EC DECLARATION OF CONFORMITY according to Annex II to Council Directive 93/42/EEC of June 14, 1993
2 NATIONAL APPROVAL 2 (5) Manufacturer Address Röntgenvägen 2 SE Solna, Sweden Medical device Critical Care Ventilator Product identification Classification SERVO-U Ventilator System, see next page System version Class IIb (according to Annex IX to Council Directive 93/42/EEC) We declare the compliance of the above medical device with the requirements of the Council Directive 93/42/EEC of June 14, 1993 and LVFS 2003:11, the Swedish implementation of the same directive. Any modification of the medical device not authorized by us will invalidate this declaration. The conformity of the full quality assurance system is certified with Certificate No. G , dated , by the following Notified Body: TÜV SÜD Product Service GmbH Zertifizierstelle Ridlerstraβe 65, München, Germany The identification number of the notified body for implementation of the procedure set out in Annex II to the above Directive is For conditions of guarantee and liability please refer to our General Conditions of Sale.
3 NATIONAL APPROVAL 3 (5) Attachment 1 Product(s) Covered: SERVO-U SW Automode, SERVO-U SW CO 2 analyzer, SERVO-U SW NIV, SERVO-U SW Neonatal option, SERVO-U SW Nasal CPAP, SERVO-U SW Alarm output, SERVO-U SW NIV NAVA, SERVO-U SW Y sensor, SERVO-U Expiratory cassette, SERVO-U O 2 cell O 2 sensor Battery module, SERVO ventilator USB memory stick Data cable SERVO ventilator to PC, 2.4 m Test tube, grey Support Arm Waterbag/IV pole SERVO-U/SERVO-n Thermoshell, Expiratory cassette chamber. SERVO-U/SERVO-n, 5 pcs/pkg
4 NATIONAL APPROVAL 4 (5) Mobile Cart SERVO-U/SERVO-n without drawers Handle, new SERVO-U Mounting kit for Compressor Mini on Mobile Cart SERVO-U / SERVO-n Humidifier Holder SERVO-U/SERVO-n Teleflex Neptune adapter for Humidifier Holder Cable holder SERVO-U/SERVO-n Gas cylinder restrainer kit, SERVO-U/SERVO-n Drawer for Mobile Cart, SERVO-U/SERVO-n Shelf Base, SERVO-U/SERVO-n Pendant/bed holder, SERVO-U/SERVO-n User interface holder, SERVO-U/SERVO-n CO 2 analyzer module Capnostat 5, SERVO ventilators Capnostat 5 mainstream CO 2 sensor CO 2 Airway adapter Neonatal reusable CO 2 Airway adapter Adult reusable CO 2 Airway adapter Neonatal disposable CO 2 Airway adapter Adult disposable CO 2 /Y sensor adapter, 10 pcs disposable Y sensor module, SERVO-U/SERVO-n Y sensor Pressure line 1.8m, 10 pcs disposable Y-piece 10 mm angled, sampling port, 5 pcs, 10 mm reusable
5 NATIONAL APPROVAL 5 (5) Y Sensor neonatal 5 pcs, disposable Y Sensor neonatal, 1 pc, reusable Y piece holder and hook, SERVO-U/SERVO-n Edi module, SERVO ventilator 50 Hz Edi module, SERVO ventilator 60 Hz
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