NATIONAL APPROVAL 1 (5) Issued, date Name Title/Role 2015-06-26 14:35 Dahlke Mikael QA-RA Reviewed, date Name Title/Role 2015-06-26 14:46 Johansson Micael QA-RA Approved, date Name Title/Role 2015-06-26 16:52 Berken Lars Vice President MCC-Q EC DECLARATION OF CONFORMITY according to Annex II to Council Directive 93/42/EEC of June 14, 1993
NATIONAL APPROVAL 2 (5) Manufacturer Address Röntgenvägen 2 SE-171 54 Solna, Sweden Medical device Critical Care Ventilator Product identification Classification SERVO-U Ventilator System, see next page System version 1.01.02 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. G1 13 09 72017 004, dated 2013-12-05, by the following Notified Body: TÜV SÜD Product Service GmbH Zertifizierstelle Ridlerstraβe 65, 80339 München, Germany The identification number of the notified body for implementation of the procedure set out in Annex II to the above Directive is 0123. For conditions of guarantee and liability please refer to our General Conditions of Sale.
NATIONAL APPROVAL 3 (5) Attachment 1 Product(s) Covered: 66 94 800 SERVO-U 66 93 655 SW Automode, SERVO-U 66 93 680 SW CO 2 analyzer, SERVO-U 68 80 513 SW NIV, SERVO-U 68 80 514 SW Neonatal option, SERVO-U 68 80 515 SW Nasal CPAP, SERVO-U 68 80 516 SW Alarm output, SERVO-U 68 80 517 SW NIV NAVA, SERVO-U 68 80 518 SW Y sensor, SERVO-U 66 93 752 Expiratory cassette, SERVO-U 66 50 118 O 2 cell 66 70 680 O 2 sensor 64 87 180 Battery module, SERVO ventilator 68 80 101 USB memory stick 65 23 570 Data cable SERVO ventilator to PC, 2.4 m 64 87 941 Test tube, grey 66 93 715 Support Arm 178 66 93 722 Waterbag/IV pole SERVO-U/SERVO-n 68 80 848 Thermoshell, Expiratory cassette chamber. SERVO-U/SERVO-n, 5 pcs/pkg
NATIONAL APPROVAL 4 (5) 66 93 695 Mobile Cart SERVO-U/SERVO-n without drawers 68 80 248 Handle, new SERVO-U 66 92 675 Mounting kit for Compressor Mini on Mobile Cart SERVO-U / SERVO-n 66 93 735 Humidifier Holder SERVO-U/SERVO-n 68 80 102 Teleflex Neptune adapter for Humidifier Holder 66 93 747 Cable holder SERVO-U/SERVO-n 66 93 720 Gas cylinder restrainer kit, SERVO-U/SERVO-n 66 93 707 Drawer for Mobile Cart, SERVO-U/SERVO-n 66 93 712 Shelf Base, SERVO-U/SERVO-n 66 93 710 Pendant/bed holder, SERVO-U/SERVO-n 68 80 099 User interface holder, SERVO-U/SERVO-n 68 81 766 CO 2 analyzer module Capnostat 5, SERVO ventilators 68 82 078 Capnostat 5 mainstream CO 2 sensor 47 21 788 CO 2 Airway adapter Neonatal reusable 47 21 796 CO 2 Airway adapter Adult reusable 66 84 610 CO 2 Airway adapter Neonatal disposable 66 84 612 CO 2 Airway adapter Adult disposable 68 80 104 CO 2 /Y sensor adapter, 10 pcs disposable 66 93 662 Y sensor module, SERVO-U/SERVO-n 66 93 672 Y sensor Pressure line 1.8m, 10 pcs disposable. 68 80 253 Y-piece 10 mm angled, sampling port, 5 pcs, 10 mm reusable
NATIONAL APPROVAL 5 (5) 66 93 667 Y Sensor neonatal 5 pcs, disposable 66 93 670 Y Sensor neonatal, 1 pc, reusable 68 80 548 Y piece holder and hook, SERVO-U/SERVO-n 66 72 330 Edi module, SERVO ventilator 50 Hz 66 72 332 Edi module, SERVO ventilator 60 Hz