Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Summary of Contents for Nuvo Navigator Lift 180 Single
- Page 1 Operating Instructions [en] Navigator Lift ™ 180 Single, Navigator Lift ™ 180 Dual, Navigator Lift ™ 180 Friction – Single, Navigator ™ ™ Plus ™ Plus Lift 180 Friction – Dual, Navigator Lift 180 Air – Single, Navigator Lift 180 Air –...
- Page 2 Versions Figure 1: Pendant system Navigator Lift ™ 180 Single 340° 20° 40° 340° ™ Figure 2: Pendant system Navigator Lift 180 Dual 340° 340° 20° 40° 340° ™ ™ The two Figures illustrate examples of the pendant systems Navigator Lift 180 Single and Navigator Lift 180 Dual.
- Page 3 Brakes Figure 3: Brakes on the pendant system Navigator Lift ™ 180 Single / Dual For more detailed information on the various brake designs refer to Chapter 2.4 1568913, Edition 2019-06, Version 0...
- Page 4 The spring arm is adjustable in height Drop tube – The Drop tube has a variable length for compensating different ceiling heights. Approved Nuvo adaptions CEMOR (only for the pendant systems Navigator Lift ™ 180, Navigator Lift ™ ™ Friction and Navigator Lift XL 180) –...
- Page 5 Thank you very much Thank you very much for purchasing this Nuvo product. Please read these Operating In- structions very carefully, abide by the safety notices and observe all operating and clean- ing requirements. For which appliances do these Operating Instructions apply? Pendant systems Navigator Lift ™...
- Page 6 Any other use than that regulated by law must be approved in writing by Nuvo Surgi- cal, hereinafter referred to as Nuvo. • Nuvo does not take any liability for or in relation to the misuse of this information in the prohibited manner by any person or company. Modifications and translations Modifications to the appliance •...
- Page 7 1568913, Edition 2019-06, Version 0...
-
Page 8: Table Of Contents
1.6.1 Incorrect use 1.6.2 Contraindications Ambient conditions 1.7.1 Ambient conditions for storage and transport 1.7.2 Ambient conditions for operation Approved Nuvo products Combination with products of other manufacturers 1.10 Patient environment 2 Safety Instructions Structure of the safety instructions 2.1.1 Warnings of risk of injury 2.1.2 Warnings of damage to property... - Page 9 14 Electromagnetic Compatibility (EMC) Information 14.1 Guidelines and manufacturer’s declarations 14.1.1 Electromagnetic emissions 14.1.2 Electromagnetic immunity 14.1.3 Test specifications 15 Approved Nuvo Products 16 Optional Accessories 17 Possible Combination with Third-Party Products 18 Inspection plan 1568913, Edition 2019-06, Version 0...
-
Page 10: Important Information For Safe Use
Important Information for Safe Use Information for identification of the device • These Operating Instructions are intended solely for appliances with the manufac- turer's rating plate bearing the following information: Device identification – Type designation: Pendants systems Navigator Lift ™ 180 Single, Navigator Lift ™... -
Page 11: Notes For The Operator
• For safety reasons, any operator actions or interventions exceeding this scope may only be carried out by Nuvo or companies authorised by Nuvo. As a prerequisite for the authorisation of a company, its service technicians must have successfully partic- ipated in technical training organised by Nuvo. -
Page 12: Notes For The User
Operating Instructions, contact your supplier for your own safety. 1.5.3 Marking CE mark: Nuvo declares that the products comply with the relevant regulations set forth in the applicable European Directives. CE mark with the ID number of the indicated conformity assessment body: Nuvo declares that the assessment of conformity in accordance with 93/42 EEC (Medical Device Direc- tive) has been performed by the indicated body. -
Page 13: Intended Purpose
Important Information for Safe Use Intended purpose • The pendant system is individually equipped; depending on the version and equip- ment, it serves for: – carrying and positioning medical end devices in OR or intensive care rooms and medical environments; •... -
Page 14: Approved Nuvo Products
– The combination of any other Nuvo product with the pendant system must be approved by Nuvo. If applicable, the conformity assessment must be repeated. Combination with products of other manufacturers Read the Operating Instructions •... -
Page 15: Safety Instructions
Safety Instructions Structure of the safety instructions 2.1.1 Warnings of risk of injury Important notes in this document are marked with graphic symbols and signal words. Signal words such as DANGER, WARNING or CAUTION describe the degree of risk of injury. -
Page 16: Description Of Graphic Symbols Possibly Used On The Appliance And The Package
Environmentally friendly disposal: warns of damage to the environment caused by improp- er disposal of the pendant system (must not be disposed of as normal household waste). CE mark: Nuvo declares that the products comply with the relevant regulations set forth in the applicable European Directives. -
Page 17: Information On The Rating Plate
Safety Instructions Information on the rating plate Figure 5: Information on the rating plate (See Figure 5) • The rating plates are attached to the top side of the extension arm or TYPE: Navigator Lift,180, Sing e XL extension arm and under the front cover of the spring arm. Extension Arm 1000 mm 6000000 AC 100-240V/50-60Hz 220VA... -
Page 18: Overview Of The Most Important Safety Instructions
Safety Instructions Overview of the most important safety instructions The safety instructions in the following chapters must be adhered to. 2.5.1 Operation WARNING Sudden release of the spring arm Warns of the spring arm suddenly jumping up whilst dismantling the end devices from the CEMOR or the Navigator M6 or whilst dismantling the adaption device, such as the Navigator M6 or the CEMOR, from the spring arm:... -
Page 19: Mounting / Dismantling
Safety Instructions 2.5.2 Mounting / dismantling WARNING Electric shock hazard To prevent the risk of electric shock, the pendant system may only be con- nected to a power supply network equipped with a protective conductor: • The pendant system must be connected in such a way that it can be disconnected from the mains at all poles and at the same time. -
Page 20: Maintenance Work
• only genuine spare parts or accessories and those defined and approved by Nuvo are used. The use of other parts may involve unknown risks and must be avoided in all cases. • inspections and maintenance are carried out at the specified time intervals. -
Page 21: Proper Use Of Oxygen
Safety Instructions Proper use of oxygen DANGER Oxygen explosion Oxygen becomes explosive when in contact with oils, greases and lubri- cants. Compressed oxygen presents an explosion hazard: • Make sure that the oxygen and gas outlet points are free from oily, greasy and lubricating materials! •... -
Page 22: Further Applicable Operating Instructions
180, Navigator Lift 180 Fric- Plus tion, Navigator Lift ™ XL 180 and Navigator Lift ™ 180 Air Part 02: Approved Nuvo adaptions CEMOR ™ ™ (only on the pendant systems Navigator Lift 180, Navigator Lift ™ Friction and Navigator Lift... -
Page 23: Device And Functional Description
Device and Functional Description Device description Canopy Since the points for connecting the electrical cables of the pendant system are located un- der the canopy , the canopy may only be removed by specialist personnel author- ised by the operator. Extension arm (dual-arm type only) The extension arm or the XL extension arm... - Page 24 Device and Functional Description Brake on the Drop tube The CEMOR or the Navigator M6 are braked by means of a mechanical brake (fric- tion brake) on the Drop tube and remain stable in any adjusted position. The braking force can be adjusted as described in Chapter 8.2.2 on page 28 or Chapter 8.4 on page 29.
-
Page 25: What Are The Max. Load Bearing And The Max. Loading Capacity (Payload)
CEMOR must not be changed. • The pendant system may only be dismantled and mounted by the Nuvo technical service team or by trained and authorised service personnel. • Related documents for dismantling, mounting and adjustment work are available from Nuvo on request. -
Page 26: Initial And Repeated Commissioning And Handover
Initial and Repeated Commissioning and Handover Initial commissioning 1. The pendant system must be installed. Instructions for installation are included in the scope of delivery of the product. 2. For commissioning following installation, proper initial commissioning must be carried out for the entire pendant system. Functional test Prior to using the pendant system and the CEMOR or the Navigator M6 on a patient for the first time, a functional test must take place at the installation site. -
Page 27: Replacing An End Device
Replacing an End Device Figure 9: Replacing an end device (See Figure 9) WARNING Sudden release of the spring arm 0° Warns of the spring arm suddenly jumping up whilst dis- mantling the end devices from the CEMOR or the Naviga- tor M6 or whilst dismantling an adaption device, such as the Navigator M6 or the CEMOR, from the spring arm: •... -
Page 28: Adjusting The Mechanical Brake For The Extension Arm And Spring Arm
Adjustments Adjusting the mechanical brake for the exten- Figure 10: Adjusting the brake on the bearing unit sion arm and spring arm ™ Plus (only Navigator Lift 180 Air 8.2.1 Adjusting the brake on the bearing unit (only Navigator Lift 180 Air Plus ) ™... -
Page 29: Adjusting The Brake On The Drop Tube Friction (Slide Bearing)
Adjustments Adjusting the brake on the Drop tube Friction Figure 12: Adjusting the brake on the Drop tube Friction (slide (slide bearing) bearing) (See Figure 12) For all pendant system versions the mechanical brake (friction brake) on the Drop tube keeps the adaption (CEMOR or Navigator M6) in the ad- justed position. -
Page 30: Adjusting The Load Bearing Capacity On The Spring Arm
Adjustments Adjusting the load bearing capacity on the Figure 14: Opening the lower, rear cover panel spring arm (See Figure 14) 0° The simplified representation illustrates the extension arm and spring arm without the cables mounted. The adjustment is identical for all ver- sions. -
Page 31: Adjusting The Load Bearing Capacity
Adjustments 8.5.2 Adjusting the load bearing capacity Figure 15: Adjusting the load bearing capacity and closing the lower, rear cover panel (See Figure 15) Tool to be used Use an Allen key (size 10) or a ring spanner (size 24). Unscrew the Allen cylinder screw M8 x 16mm③... -
Page 32: Adjusting The Vertical Lift On The Spring Arm
Adjustments Adjusting the vertical lift on the spring arm Figure 16: Adjusting the vertical lift on the spring arm (See Figure 16) When replacing an end device (e.g. flat screen, medical device, etc.) the spring arm must be adjusted to the horizontal (0 degree position). 8.6.1 Opening the front, upper cover panel (See Figure 16) Follow the general safety instructions prescribed in Chapter 8.1 on... -
Page 33: Correcting The Vertical Alignment Of The Cemor Or The Navigator M6
Adjustments Correcting the vertical alignment of the CEMOR Figure 17: Correcting the vertical alignment of the CEMOR or or the Navigator M6 the Navigator M6 (See Figure 17) After mounting an end device (e.g. flat screen, medical device, etc.) there is a risk that the CEMOR or the shelf of the Navigator M6 are no longer in a precisely vertical position due to the weight of the end device. -
Page 34: Adjusting The Swivel Stop On The Extension Arm, Spring Arm And Drop Tube
8.8.2 Tool to be used 22,5° A magnetic pin or a similar tool is required in order to offset the ball stop. The telescopic magnet pick-up tool set is available from Nuvo as an option. 15° 1568913, Edition 2019-06, Version 0... -
Page 35: Stop Recommendation: Dual-Arm Pendant System With Bearing Unit Friction (Roller Bearing)
(See Figure 19) For all dual-arm pendant systems with a Bearing Unit Friction as interme- diate bearing , Nuvo recommends that you mount 2 ball stops ③ (po- sition illustrated in the Figure). The detailed representation illustrates the intermediate bearing (with- out external bearing ring) and the position of the stop screw①to the ball... -
Page 36: Mounting The Swivel Stop
Adjustments 8.8.4 Mounting the swivel stop Figure 20: Mounting the swivel stop (See Figure 20) Follow the general safety instructions prescribed in Chapter 8.1 on page 27. The assignment and size of the setscrew①and the ball stop③for the different versions of the pendant system and the Drop tube are described in Chapter 8.8.1, “Versions”, on page 34. -
Page 37: Changing Or Dismantling The Swivel Stop
Adjustments 8.8.5 Changing or dismantling the swivel stop Figure 21: Changing or dismantling the swivel stop (See Figure 21) Follow the general safety instructions prescribed in Chapter 8.1 on page 27. The assignment and size of the setscrew①and the ball stop③for the different versions of the pendant system and the Drop tube are described in Chapter 8.8.1, “Versions”, on page 34. -
Page 38: Cleaning And Disinfection
Cleaning and Disinfection General safety instructions WARNING Electric shock hazard The appliances can carry an electric current and must be treated with the utmost care during cleaning and disinfection: • If a mains plug exists, pull out the mains plug. •... -
Page 39: Maintenance
Maintenance 10.1 General safety instructions WARNING Electric shock hazard Power supply cables are laid in the pendant system and in the CEMOR or the Navigator M6. Contact with energised components presents a danger to life from electric shock. Disconnect the pendant system from the mains before any maintenance work: •... -
Page 40: Technical Description
Technical Description Figure 22: Spring arm Navigator Lift ™ 180 / Navigator Lift ™ 180 Friction – Single-arm variant with CEMOR ™ The Figure illustrates the spring arm Navigator Lift 180 with CEMOR as an example. Please note that your individual pendant system con- figuration can differ from the illustration. - Page 41 Technical Description ™ ™ Figure 23: Spring arm Navigator Lift 180 / Navigator Lift 180 Friction – Single-arm variant with Navigator M6 ™ The Figure illustrates the spring arm Navigator Lift 180 with Navigator M6 as an example. Please note that your individual pendant system configuration can differ from the illustration.
- Page 42 Technical Description ™ ™ Figure 24: Extension arm with spring arm Navigator Lift 180 / Navigator Lift 180 Friction – Dual-arm variant with CEMOR ™ The Figure illustrates the extension arm with spring arm Navigator Lift 180 with CEMOR as an example. Please note that your individual pendant system configuration can differ from the illustration.
- Page 43 Technical Description ™ ™ Figure 25: Extension arm with spring arm Navigator Lift 180 / Navigator Lift 180 Friction – Dual-arm variant with Navigator M6 ™ The Figure illustrates the extension arm with spring arm Navigator Lift 180 with Navigator M6 as an example. Please note that your indi- vidual pendant system configuration can differ from the illustration.
- Page 44 Technical Description ™ Figure 26: Extension arm XL with spring arm Navigator Lift XL 180 – Dual-arm variant with CEMOR ™ The Figure illustrates the extension arm XL with spring arm Navigator Lift XL 180 with CEMOR as an example. Please note that your in- dividual pendant system configuration can differ from the illustration.
- Page 45 Technical Description ™ Figure 27: Extension arm XL with spring arm Navigator Lift XL 180 – Dual-arm variant with Navigator M6 ™ The Figure illustrates the extension arm XL with spring arm Navigator Lift XL 180 with Navigator M6 as an example. Please note that your individual pendant system configuration can differ from the illustration.
-
Page 46: Technical Data
Technical Data Modes of operation • The pendant systems Navigator Lift ™ 180 Single, Navigator Lift ™ 180 Air Plus – Sin- ™ ™ ™ gle, Navigator Lift 180 Dual, Navigator Lift 180 Friction – Single, Navigator Lift ™ Plus ™... - Page 47 Technical Data Maximum loading capacity on the pendant system Navigator Lift ™ 180/Navigator Lift ™ Spring arm 1015mm ....................180kg Friction – Single arm ™ ™ Navigator Lift 180/Navigator Lift Extension arm 600mm with spring arm 1015mm .............180kg Friction Extension arm 800mm with spring arm 1015mm .............170kg –...
- Page 48 – The combination of any other Nuvo product with the pendant system must be approved by Nuvo Surgical. If applicable, the conformity assessment must be repeated.
-
Page 49: Electromagnetic Compatibility (Emc) Information
Electromagnetic Compatibility (EMC) Information 14.1 Guidelines and manufacturer’s declarations 14.1.1 Electromagnetic emissions The Navigator Lift ™ 180 is intended for use in the ELECTROMAGNETIC ENVIRONMENT specified below. The customer or the user of the Navigator Lift ™ 180 must ensure that it is used in such an environment. -
Page 50: Electromagnetic Immunity
Electromagnetic Compatibility (EMC) Information 14.1.2 Electromagnetic immunity The Navigator Lift ™ 180 is intended for use in the ELECTROMAGNETIC environment specified below. The customer or the user of the Navigator Lift ™ 180 should ensure that it is used in such an environment. Interference immunity test Test level in accordance with IEC 60601 Test result... - Page 51 Electromagnetic Compatibility (EMC) Information Cont. The Navigator Lift ™ 180 is intended for use in the ELECTROMAGNETIC environment specified below. The customer or the user of the Navigator Lift ™ 180 should ensure that it is used in such an environment. Interference immunity test Test level in accordance with IEC 60601 Compliance level...
-
Page 52: Test Specifications
Electromagnetic Compatibility (EMC) Information 14.1.3 Test specifications Test specifications for the INTERFERENCE IMMUNITY of ENCLOSURES against high- frequency wireless communication facilities Test frequency Frequency band Radio service Modulation Maximum Distance IMMUNITY TEST power LEVEL 380 to 390 TETRA 400 Pulse modulation 18Hz 430 to 470 GMRS 460,... - Page 53 Electromagnetic Compatibility (EMC) Information WARNING Do not operate this device immediately next to or together with other devices stacked on top of each other because this could result in improper operation. If operation in the described manner is unavoidable, this device and all other devices should be monitored in order to ensure proper opera- tion."...
-
Page 54: Approved Nuvo Products
Possible Combination with Third-Party Products Approved third-party products with CE mark For more detailed information on the requirements for the interface towards the pendant system please contact Nuvo customer service in order to prevent damage to persons or property: •... -
Page 55: Inspection Plan
Medical Product Book. Test reports, including this report, must be filed out in the corresponding Medical Product Book. Nuvo Surgical • 1565 West 12th Street • Erie, PA 16501 • USA • Phone +1 (800) 663-1152 (US / CA) • Phone +1 (814) 899-4220 (intl.) 1568913, Edition 2019-06, Version 0...