Nouvag HighTorQ Operation Manual

Nouvag HighTorQ Operation Manual

Power tools for large bone surgery, orthopaedic cordless drill/saw system
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Operation Manual
HighTorQ Power Tools
for large bone surgery
Orthopaedic Cordless Drill / Saw System
Nouvag AG
St.Gallerstrasse 25
CH-9403 Goldach
REF: 31523 EN
HighTorQ Power Tools
V20220824

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Summary of Contents for Nouvag HighTorQ

  • Page 1 Operation Manual HighTorQ Power Tools for large bone surgery Orthopaedic Cordless Drill / Saw System Nouvag AG St.Gallerstrasse 25 CH-9403 Goldach REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 2: Table Of Contents

    Sternum saw/ reciprocating saw with keyless chuck (3704nou) ............18 2.1.5 Oscillating reaming machine (3756nou) ....................19 2.1.6 Power Pack (3705) ..........................20 2.1.7 Charging unit (e.g. 3706) ........................20 Start up ..............................21 REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 3 Application of reciprocating saw (3704nou) .................... 42 2.9.1 Start up of reciprocating saw ........................42 2.9.2 Replacement of saw blades ........................43 2.9.3 Works with saw blades ........................... 44 2.9.4 Recommendations for handling of saw blades ..................44 REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 4 Attachments/chucks and tools ........................ 65 Charging unit ............................66 Technical data ............................67 Operating cycle ............................67 Device specification ..........................68 Environmental conditions ........................71 Applicable standards ..........................71 Electromagnetic compliance ........................72 REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 5 Order information ........................76 Handpieces ............................. 76 Power Pack (battery, motor, electric) ...................... 76 Attachments ............................76 Cleaning and care of the system ......................77 Used symbols ............................78 Address / Report ........................... 80 REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 6: General Information

    The attending physician or an appropriate medical staff member shall be responsible for cleaning kit selection with accessories for defined applications, as well as for adequate training and correct management. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 7: Application

    Protective covers and films shall fully be removed before sterilisation. • In order to assure proper performance of the system, the Nouvag AG recommends its cleaning and • care after every use to be performed according to the instructions provided in the chapter “Care and Maintenance”...
  • Page 8: Combination Products And Tools

    Moving parts shall be maintained for their smooth operation with a special lubrication oil; • recommended by Nouvag AG is a spray oil agent (3727) or a paraffin oil, suitable for sterilisation. • The Power Pack shall by no means be processed (by manual or automatic cleaning) or...
  • Page 9: Combinability Of Individual System Components

    For cleaning and care of the system, special means are recommended, such as cleaning brushes and oil spray (3727). Nouvag AG recommends the use of a tray, specifically designed for the system (e.g. 3740) to sterilize and store the system. Otherwise, Nouvag AG shall assume no guarantee for flawless performance of the system.
  • Page 10 Jacobs drill chuck, big 3719 Rohm drill chuck 3720 Quick-action 3721 chuck with lock Quick-action 3722 chuck without lock Albrecht quick 3723 action chuck Keyless top 3757 for sternum XL Keyless top 3758 for sternum REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 11 Rinsing set 3735 Power Tools system chuck: 3736 Miele / Stielco / Webeco Power Tools system adapter 3737 Belomed Power Tools system adapter 3738 Maquet / MediKomp / Getinger Cleaning brushes - set 3739 REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 12 REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 13: Recommended Cutting Tool

    The environmental conditions for storage and transport are addressed in this User’s Manual. Before disposal or return transport to Nouvag AG, the devices/handpieces, as well as the chucks, shall undergo the complete procedure of clinical processing for protection against infections. In addition, the products shall appropriately be marked as either „hygienically safe“...
  • Page 14: Disposal

    The guarantee for the devices and accessories shall be cancelled in case of their unintended use and/or inappropriate operation, storage or transport. The Manufacturer shall assume no responsibility for damages, which may arise from improper operation of the system. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 15: Operation Of The Device

    (safety position), left-hand rotation 4. Locking latches 5. Switch lever to switch oscillating mode ON or OFF. 6. Rotating ring for the DRILL mode or REAM mode 7. Sight glass for LED indications and lighting REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 16: Drilling Machine (3700Nou)

    3. Slider for switching in the right direction, locking (safety position), left-hand rotation 4. Locking latches 5. Switch lever to switch oscillating mode ON or OFF 6. Sight glass for LED indications and lighting REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 17: Oscillating Saws (3702Nou; 3755Nou)

    4. Slider to unlock the lid with the locking latches 5. Switch lever to switch the “Normal” and “Fast” (Quick) mode 6. Unlocking sleeve for setting the saw head in 45° steps 7. Sight glass for LED indications and lighting REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 18: Sternum Saw/ Reciprocating Saw With Keyless Chuck (3704Nou)

    2. Trigger for RPM regulation/ oscillation frequency 3. Slider for switching ON, locking (safety position), On 4. Locking latches 5. Switch lever to switch the “Normal” and “Schnell” (Quick) mode 6. Sight glass for LED indications and lighting REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 19: Oscillating Reaming Machine (3756Nou)

    3. Slider for switching in the right direction, locking (safety position), left-hand rotation 4. Locking latches 5. Switch lever to switch oscillating mode ON or OFF 6. Sight glass for LED indications and lighting REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 20: Power Pack (3705)

    4 POAG connection (POAG-connection cable enclosed) on the back of the machine (not shown) 5 Mains connection (Mains connection cable enclosed) on the back of the machine (not shown) Remark: Further chargers available (dual and quadruple, see the list below). REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 21: Start Up

    Fold and secure the mounting bracket. During insertion, take care that the power pack is correctly seated and that the “unsterile” person does not touch the outer side of the sterile handpiece. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 22 The “unsterile” person takes the sterile funnel away from the handpiece The person in sterile clothes closes the lid. Hold the handpiece, as shown on the picture and close the latches REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 23: Power Pack Removal

    Attention: The power pack shall under no circumstances be immersed, washed or sterilised in a fluid. Caution: Destruction of the power pack with possible consequential damages! REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 24: Battery Capacity

    2.3.3 Energy saving function By means of an integrated switch, the device control shall always switch voltage-free. No electric energy consuming standby function shall be necessary in the system. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 25: Power Pack, Charging, Transport And Storage

    - Do not wash, rinse, sterilise, drop or apply any pressure or force. These factors could destroy the power pack with resulting possible damage. Caution: Device defect! - The power pack shall be charged exclusively in a charger of Nouvag AG (e.g. 3706). Caution: Device defect! - Do not use defective power pack.
  • Page 26: The Meaning Of Light Indications

    Further work shall be possible after the device is cooled down. Attention: In case of long-lasting surgical procedures, another device shall be at hand and ready for use or the necessary cooling time shall be taken into account in the course of surgery. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 27: Charging Units

    Plugging the cable switches on the green light indicator on top of the charger. 2.6.2 Charger cleaning Perform cleaning only after the supply cable is unplugged from the mains socket. Wipe the charge occasionally with a dry cloths (using no solution agent). REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 28: Power Pack Charging

    Do not use the power packs which have not been directly picked up from a charger and which do not show green indicator light (full charge). The charge status may otherwise be too low for use. Warning: Extension of surgical operation time! REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 29: Charge Control Indicators On The Charger And On The Power Pack

    - After supply failure or a change onto emergency power supply, the charger shall automatically switch on. Only (3705) power packs shall be charged in the charger. Charging other batteries may pose a fire or explosion hazard. Warning: Hazard to users! REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 30: Application Of Drilling / Reaming Machines (Ref 3701Nou And 3700Nou)

    - Drilling mode (till 1000 RPM max) - Reaming mode (till 250 RPM max) Attention: Do not change the operation mode on a running device. Caution: Device defect! 2.7.4 Assembly/disassembly of the attachments/chucks for drilling/reaming REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 31 - After an attachment or a cutting tool is mounted, check its proper seat by pulling. Warning: Danger for the user! - Use exclusively original attachments and tools from the Nouvag AG or from manufacturers recommended by this Company. Caution: Device defect! - Damages, resulting from the use of attachments or cutting tools of other manufacturers, shall not be covered by the warranty.
  • Page 32: Attachment Mounting

    Before application of the tool in a patient, ensure that the correct mode is set, therefore, release the device shortly in the air. 2.7.6 Mount cutting tools into the attachments / chucks and remove again See the detailed description of all attachments (Chapter 2.7.) REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 33: Attachment Removal

    Mount / dismount the cutting tool till closure, hold the rear ring of the drill chuck and rotate the front ring in counter clockwise direction. Fasten with the key. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 34 Rotation speed: 1000 RPM max (DRILL mode / 250 RPM max (REAM mode) Cannulation: 4.3 mm Hudson chuck (3715) Rotation speed: 1000 RPM max (DRILL mode / 250 RPM max (REAM mode) Cannulation: 4.3 mm REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 35 - Insertion of screws with the driving unit calls for special care. Screw the screws not completely by means of the driving unit. The last screw rotations or fastening should always be done by hand. Warning: Danger for the patient! REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 36 Attention: Nouvag AG shall take no responsibility for the performance and results with the use of tools from another manufacturer. Quick-action coupling for Kirschner wires (3708 and 3709) For insertion/removal of Kirschner wires of any length and in diameter from 1.0 till 4.0 mm.
  • Page 37 With long Kirschner wires, which exceed the device dimensions and, at the back, protrude from its lid, an extension sleeve (3710) shall always be used. Warning: Danger for the user! Fix an extension sleeve in the lid of the device run. REF: 31523 HighTorQ Power Tools V41/19 Seite 37...
  • Page 38 - For protection of the gear transmission, the radiolucent gear is equipped with a slipping clutch which shall disengage in overloading. It is recognisable by some clattering noise. - The following procedures may lead to overloads: REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 39 - Drill/ Boring angle correction: Pull out the drill till the cutting grooves are visible and start the drilling procedure again. - DrilBoring of a spike: Pull out the drill till the cutting grooves are visible, start drilling again or, if necessary, replace the drill. REF: 51523 EN HighTorQ Power Tools V20220824...
  • Page 40: Application Of Oscillating Saws (3702Nou; 3755Nou)

    - In order to avoid injuries during saw head positioning, keep always the saw head, together with the assembled saw blade away from the body. Warning: Danger for the user! 2.8.3 Replacement of saw blades REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 41 Warning: Danger for the patient and for the user! Caution: Device defect! Nouvag AG recommends saw blades of the Gomina AG Company or the Risa GmbH Company; the use of saw blades of other manufacturers shall not be covered by the guarantee. These saw blades are optimally customised to the requirements.
  • Page 42: Application Of Oscillating Saws

    2.8.5 Recommendations for handling of saw blades requires that a new saw blade is used for every surgical In order to obtain optimal results, Nouvag AG procedure. In this way, it is assured that saw blades shall always be sharp and clean. Worn saw blades pose...
  • Page 43: Replacement Of Saw Blades

    Warning: Danger for the patient and for the user! Caution: Device defect! Nouvag AG recommends saw blades of the Gomina AG Company or the Risa GmbH Company; the use of saw blades of other manufacturers shall not be covered by the guarantee. These saw blades are optimally customised to the requirements.
  • Page 44: Works With Saw Blades

    2.9.4 Recommendations for handling of saw blades requires that a new saw blade is used for every surgical In order to obtain optimal results, Nouvag AG procedure. In this way, it is assured that saw blades shall always be sharp and clean. Worn saw blades pose...
  • Page 45: Application Of Sternum Saws (3704Nou)

    Warning: Danger for the patient and for the user! Caution: Device defect! Nouvag AG recommends saw blades of the Gomina AG Company or the Risa GmbH Company; the use of saw blades of other manufacturers shall not be covered by the guarantee. These saw blades are optimally customised to the requirements.
  • Page 46: Recommendations For Handling Of Saw Blades

    2.10.4 Recommendations for handling of saw blades requires that a new saw blade is used for every surgical In order to obtain optimal results, Nouvag AG procedure. In this way, it is assured that saw blades shall always be sharp and clean. Worn saw blades pose...
  • Page 47 Insert the attachment/chuck until you feel it reach the stop. Release the unlocking sleeve. In addition, check the correct seat by light pulling of the clamp. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 48: Application Of Oscillating Reaming Machine (3756Nou)

    Warning: Danger for the user! - After a cutting tool is mounted, check its proper seat by pulling. Warning: Danger for the user! - Use exclusively original tools from Nouvag AG or from manufacturers recommended by this Company. Caution: Device defect! - Damages, resulting from the use of cutting tools of other manufacturers, shall not be covered by the warranty.
  • Page 49: Cutting Tool Mounting

    In addition, check the correct seat by light pulling of the tool. Before application of the tool in a patient, ensure that the correct mode is set, therefore, release the device shortly in the air. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 50: Cutting Tool Dismounting

    Retract the release sleeve till the stop and hold Grip the attachment/chuck with the other hand and remove. Release again the release sleeve. Put aside the dismounted tool. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 51: Care And Maintenance (After Validated Cleaning And Sterilisation Procedures)

    - The used cleaning agents come in contact with the following materials: Stainless steel, aluminium, plastic and rubber seals. - Nouvag AG requires that new sterile cutting tools are used at every surgical procedure. 3.1.1 Extraordinary transmissible pathogens In case of patients with the Creutzfeldt-Jakob disease (CJD), who - because of associated infection hazards - are regarded to be risk patients - the procedures should always be undertaken with the use of disposable instruments.
  • Page 52: Preparation To Cleaning

    The power packs shall not be washed, rinsed, disinfected or sterilised. Caution: Device defect! Clinical processing of handpieces and attachments can be done by: a) manual cleaning or b) automatic cleaning cycle with manual pre-cleaning (see the following chapters) REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 53: Manual Cleaning

    7.) Final rinsing with demineralised/purified water Finally rinse the components for a minimum of 2 minutes with desalted (demineralised/purified) water. 8.) Drying Handpieces and components shall be dried with a soft lint-free cloth or in cleaned compressed air. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 54: Attachments

    7.) Final rinsing with demineralised/purified water Finally rinse the components for a minimum of 2 minutes with desalted (demineralised/purified) water. 8.) Drying Handpieces and components shall be dried with a soft lint-free cloth or in cleaned compressed air. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 55: Mechanical Cleaning After Manual Pre-Cleaning

    Warning: Danger for the patient! Caution: Device defect! - No cleaning / disinfection procedure, alternative to the procedures, which are described below (including manual pre-cleaning) has been validated by Nouvag AG. Warning: Danger for the patient and for the user! Caution: Device defect! 3.4.1 Manual pre-cleaning of the machine/handpiece...
  • Page 56: Manual Pre-Cleaning Of The Attachments / Chucks

    (attachments) are placed vertically, i.e. in their upright position. Place the rinsing adapter (3732, 3733, 3734) above the handpieces. Connect the rinsing adapter, located above the washing machine basket, to the medium supply system (internal rinsing of handpieces). REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 57 - Rinsing adapter for drilling machine (3733) Oscillating saws (3702nou; 3755nou) with: - Universal rinsing adapter (3732) Reciprocating saw / Sternum saw (3704nou) with: - Universal rinsing adapter (3732) - Rinsing adapter for reciprocating - sternum saws (3734) REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 58: Oiling / Maintenance

    Protect pointed or sharp instruments from damage by mutual contact. Caution: Device defect! Then, take care that sharp or pointed objects do not damage the sterile barrier material. Warning: Danger for the patient! REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 59: Sterilisation

    - Sterilisation in hot air, ethylene oxide, radiation, plasma and formaldehyde shall not be applied. Caution: Device defect! Repairs and Technical Service In case of any defect or malfunction of the device, qualifying it to repair, send it to Nouvag AG or to any authorised service station. Caution: Device defect! A dropped device shall be sent for inspection and repair.
  • Page 60 The Manufacturer shall assume no responsibility for damages, which may arise from improper operation of the system or from its maintenance provided by unauthorised service stations Warning: Danger for the patient and for the user! Caution: Device defect! REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 61: Troubleshooting

    The machine or the power Insert a fully charged power pack is defective pack into the machine. Send the machine to the Nouvag AG Service Station REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 62 Distribute some oil and move the mechanical parts. When Defect of the locking it does not help, send the mechanism machine to a Nouvag AG Service Station The unlocking sleeve for the Control the unlocking sleeve, attachments is jammed / possibly clean and oil.
  • Page 63: Power Pack

    The trigger is blocked by Clean and oil the trigger deposits The trigger is difficult to move Send the machine to a Defects of the mechanic part Nouvag AG Service Station Power pack Problem Possible cause Remedy/ corrective action Turn the power pack by 180°...
  • Page 64 The power pack could Send the power pack to the incidentally be washed, Carelessness or negligence Nouvag AG Service Station, immersed in fluid or sterilised of the personnel adhere to item 3.9 Repairs and is thus defective. and technical service.
  • Page 65: Attachments/Chucks And Tools

    The Kirschner wire was Send the Kirschner wire in the chuck and is not obliquely inserted and has chuck to the Nouvag AG moving any farther tilted / twisted in the chuck Service Station Both bone and the tool heat...
  • Page 66: Charging Unit

    Power pack is flashing yellow means of the delivered power plugged in cable with the supply mains. Remark: If the above steps fail to remedy the problem, please contact your local Nouvag AG Service Station. REF: 31523 EN HighTorQ Power Tools...
  • Page 67: Technical Data

    - In order to avoid heat necrosis, always flush the cutting tools with cooling fluid. Manual flushing Warning: Danger for the patient! - Careful care and maintenance of the system reduces heat up development in the handpiece and in attachments. Caution: Device defect! REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 68: Device Specification

    Mass of handpiece with power pack 1760 g Continuously adjustable rotation speed 0 - 9000 rpm (Step I) 0 - 11000 rpm (Step II) Protection class B, EN 60601-1 Power supply Internal battery REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 69 Mass of handpiece with power pack 1550 g Continuously adjustable rotation speed 0 - 9000 rpm (Step I) 0 - 11000 rpm (Step II) Protection class B, EN 60601-1 Power supply Internal battery REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 70 2.0 A 3751; charger (double) Dimensions 240 x 190 x 130 mm Mass 4939 g Type Li-ion battery charger 100-240 V AC Input 50-60 Hz 0.9 A 16.8 V DC Output 2.0 A REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 71: Environmental Conditions

    Air pressure Attention: The devices shall not be stored or operated in an explosive atmosphere. Applicable standards The devices shall comply with the following standards and directives: Medical directives: 93/42/EEC and 2007/47/EC; IEC 60601-1 REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 72: Electromagnetic Compliance

    Portable and mobile RF communications equipment (radio equipment) (including their accessories, like, for example, aerial cables or external aerials) shall be used no closer to the HighTorQ Power Tools than 30 cm (or 12 in.). Any non-observance of this recommendation may lead to reduced performance of the devices.
  • Page 73 50/60 correspond to their standard Hz shall conform to values at typical business or IEC 61000-4-8 hospital environment. standard Remark: U is the a.c. mains voltage prior to application of the test level REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 74 Above the frequency range from 150 kHz to 80 MHz, the field strength shall be lower than 3 V/m. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 75 The higher frequency range applies at 80 MHz and 800 MHz Remark 2 These guidelines may not be applicable in all cases. The propagation of electromagnetic waves is influenced by their absorption and reflection by buildings, objects and persons. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 76: Order Information

    Wire/ pin driver (K-wire) Jacobs drill chuck, large 3709 3719 1-4 mm for 3700nou Extension for Kirschner Roehm drill chuck 3710 3720 wire chuck Adaptor for drill Quick-action chuck with 3711 3721 guide, radiolucent lock REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 77: Cleaning And Care Of The System

    Getinger Cleaning brushes - set 3739 Cleaning and sterilisation tray with a lid for one machine and 3740 accessories Cleaning and sterilisation tray with a lid for two machines and 3753 accessories REF: 31523 HighTorQ Power Tools V41/19 Seite 77...
  • Page 78: Used Symbols

    Battery disposal shall comply with national laws or with the European battery directive: 2006/66/EC. Attention: Fire, explosion and burn hazard. The battery cells (batteries) shall not be segmented or taken apart, shorted or crushed, or heated over +60°C or burned. REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 79 User’s Manual FAULT (The power pack is inserted into the charging unit) READY The charging unit is operational READY The charging unit is charging the power pack (yellow / orange / red light) REF: 31523 EN HighTorQ Power Tools V20220824...
  • Page 80: Address / Report

    Address / Report Nouvag AG St.Gallerstrasse 25 CH-9403 Goldach Phone: +41 071 846 66 00 info@nouvag.com www.nouvag.com REF: 31523 EN HighTorQ Power Tools V20220824...

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