Owner's Manual
Table Of Contents
- 1 Introduction
- 2 Quick Start
- 2.1 Setting Up the Equipment
- 2.2 Gathering Supplies and Equipment
- 2.3 Preparing the Urocap NXT
- 2.4 Preparing the NXT Go Pump Hub
- 2.5 Preparing the Roam NXT
- 2.6 Preparing the UPP Puller NXT (Optional)
- 2.7 Setting Up Consumables and Preparing the Patient
- 3 How to Perform a Study
- 4 Synergy Software
- 5 Maintenance and Service
- 5.1 Cleaning and Disinfection
- 5.2 Preventive Maintenance
- 5.3 Verifying Calibration
- 5.4 Configuration
- 5.5 Computer Virus Protection
- 5.6 Disposing of Product After Use
- 5.7 Environmental Consideration of Waste Disposal
- 5.8 Backups
- 5.9 Troubleshooting Guide
- 6 Hardware
- 7 Appendix
Appendix
NXT Go Owner’s Manual, LBL-00145, MAN2030 114
Classification and Applicable Directives
Classifications
Class I Type BF Applied Part
Mode of Operation: Continuous
Equipment not suitable for use in the presence of a Flammable
Anesthetic Mixture with Air or Oxygen or Nitrous Oxide.
Applicable Directives
and Standards
IEC 60601-1:2012
CAN/CSA C22.2 No. 60601-1:14
AAMI/ANSI ES60601-1:2005/(R)2012 + A1:2012
EN 60601-1:2006/A1:2013
IEC 60601-1-6:2006 + A1:2013
IEC 60601-2-49:2011
CAN/CSA C22.2 No. 60601-2-49:11 (R2016)
IEC 60601-1-2:2014
CAN/CSA-C22.2 NO. 60601-1-2:16
EN 60601-1-2:2015
IEC 62304:2006 + A1:2015
EN 62304:2006/AC:2008
IEC 62366-1:2015
EN 62366:2008
IEC 62133:2012
Related Standards
TIR57:2016
ANSI/UL 2900-1:2017
ISO 15223-1:2016
IEC TR 62354:2014
ISO/IEC 17025:2017
Table 16: Classifications and Directives
Status DRAFT Effective