DORO ® Instruction Manual DORO® Headrest System Teflon Document no.
DORO® Instruction Manual DORO® Quick Guide - DORO Headrest System Teflon DORO Headrest System Teflon Receptacles for Skull Pins Rocker Arm Torque Screw Index Knob Quick-Rail Skull Pin Extension Assembly upper Starburst Connection Release Knob lower Starburst Connection Skull Clamp Base upper Locking Screw Swivel Base Transitional Member lower Locking Screw Table Rod Adjustable End Bracket fixed End Bracket Base Handle Assembly Hex Screw Connecting Tube Hex Wrench Tension Knob with Lock S
DORO® Instruction Manual Contents 1. Conformities........................................................................ 4 1.1 Guidelines and norms.......................................................... 4 1.2 CE conformity....................................................................... 4 1.3 FDA Registration.................................................................. 4 2. General Safety Information................................................. 4 2.
DORO® Instruction Manual DORO® This instruction manual contains important information on the safe, correct and efficient use of the device. Carefully read this manual and observe all the notes and information. This instruction manual should be used in conjunction with the instruction manuals for your other equipment. Make sure to read those manuals very carefully as well. Always keep all the instruction manuals at hand. 1. Conformities 1.
DORO® Instruction Manual DORO® Important: This symbol indicates important information on the proper use of the device. Failure to observe this information and to follow the appropriate instructions may cause damage to the equipment. Note: This symbol provides tips concerning the use of the device. Such information will help you use the device to its full potential. Exclusion of liability: This symbol points out exclusions of liability of the manufacturer.
DORO® Instruction Manual 2.2 DORO® Proper handling and permitted user The device may only be used and applied by qualified professional persons belonging to the operating team. 2.3 Creutzfeldt Jakob Disease Warning: If the patient is suspected of having the Creutzfeldt Jakob Disease, adequate measures must be taken to prevent possible transmission to other patients, users, and third parties. The device also should not be reused with any other patient.
DORO® Instruction Manual 3.3 DORO® Use as per instructions The device is designed and built according to the latest technical developments and to approved safety standards. DORO Headrest and Retractor Systems may be used o only as a support mechanism for head and neck surgery, o only if the device is in a proper state as far as the safety aspects are concerned.
DORO® Instruction Manual 4. Product description 4.1 General description/Intended use The DORO Headrest System Teflon is similar in design and function to the DORO Headrest System Aluminum but it features a Teflon coating which allows it to be reprocessed in a washer/disinfector and it can be steam sterilized. It is a mechanical support system, which is used in head and neck surgery. This system allows the patient’s head to be positioned and secured for the operation.
DORO® Instruction Manual DORO Disp. Skull Pins Titanium Tip, Pediatric DORO Disp. Skull Pins stainless steel, Adult DORO Disp.
DORO® Instruction Manual 4.4 Technical specifications Type of device: Serial number: Weight: Material: Dimensions: DORO Headrest System Teflon on each part Base Unit 3110 g Swivel Adaptor 480 g Skull Clamp 1600 g aluminum cast, stainless steel, high performance polymer materials, Polytetrafluoroethylene (Teflon®) see outline drawings Outline drawing DORO Swivel Adaptor in mm Outline drawing DORO Skull Clamp in mm Outline drawing DORO Base Unit in mm max.
DORO® Instruction Manual DORO® 5. Mounting 5.1 Mounting of the DORO Base Unit The DORO Base Unit is mounted to the receptacles of the OR Table. Since the distance between the receptacles of OR Tables vary, the distance of the end brackets need to be adjusted. Inspect all parts prior to use for any noticeable damage i.e. cracking, surface defects etc. Note: The adjustable end bracket allows you to easily mount the DORO Base Unit to standard OR Tables. 5.1.
DORO® Instruction Manual DORO® 7. open Open the Locking Lever to position the Base Handle Assembly at the center of the connecting tube. Make sure that the Transitional Member is connected to the Base Handle Assembly, otherwise connect the Transitional Member before closing. Close the Locking Lever to lock the position. close To adjust the Locking Lever tension see chapter 8.2.1 Important: Never close the Locking Lever without the Transitional Member. This will damage the Base Handle Assembly.
DORO® Instruction Manual 5.2 DORO® Mounting the DORO Swivel Adaptor Mount the Swivel Adaptor to the Transitional Member of the Base Unit: 1. Position the teeth of the starburst connection of the Transitional Member and the teeth of the lower starburst connection of the Swivel Adaptor in a manner that they engage. 5.3 2. Fully tighten the lower locking screw of the Swivel Adaptor by turning it clockwise. Note: the teeth of the starburst connections must be fully engaged and seated properly.
DORO® Instruction Manual DORO® 6. Use and Handling 6.1 Detailed description of application Note: The user decides the best approach to secure the patient to the Skull Clamp. We recommend to secure the patient‘s head first to the Skull Clamp with Skull Pins and then to connect the Skull Clamp carefully by means of the Swivel Adaptor to the Base Unit and the OR Table. The following 3 steps - A B C - are required: A Mount the Base Unit and the Swivel Adaptor to the OR Table 1.
DORO® Instruction Manual 3. DORO® When you have obtained the desired width make sure that the theeth of the Extension Assembly and the Skull Clamp Base are fully enganged. Danger: Avoid inadvertent opening of the the Quick-Release Knob of the Skull Clamp during procedure. 4.
DORO® Instruction Manual DORO® Danger: The pinning of the patient should only be performed by a licensed physician or a licensed surgeon. Danger: Take extra precautions when pinning young infants, the elderly, or on restored surgical areas, including previously drilled burr holes, or any diseased bone because of the varying consistencies and thickness from that of healthy bone.
DORO® Instruction Manual DORO® 9. Adjust the clamping force by means of the torque screw. The adjusted clamping force is readable at the scale in stages up to 360 N/80 lbs (maximum setting). The visible scale stages are 90/180/270/360 N or 20/40/60/80 lbs. 10. If necessary, readjust the clamping force. Turn the torque screw clockwise to increase the clamping force. Note: Before applying pressure make sure that the four pressure lines are not showing.
DORO® Instruction Manual C DORO® Connecting the Skull Clamp to the Swivel Adaptor ↑ ↑ 1. After securing the patient's head to the Skull Clamp (Step B) position the patient’s head exactly as required for surgery and stabilize the head. Carefully hold the patient's head and Skull Clamp while proceeding. 3. Carefully hold Skull Clamp and Swivel Adaptor to prevent the system from losing its stability. ↑ ↑ ↑ ↑ ↑ 2. Connect the Skull Clamp to the Base Unit by means of the Swivel Adaptor.
DORO® Instruction Manual 6.2 DORO® Function and safety inspection The user is responsible for function and safety inspections before and after each clinical use. Exclusion of liability: The manufacturer shall not be liable for damages resulting from improper function and safety inspections or failure of the user to perform such inspections. Danger: Check all fastening screws and the stability of the Headrest - and Retractor System before and after each clinical use. 6.2.
DORO® Instruction Manual 7. Care 7.1 Manual Precleaning DORO® Clean, inspect and test the device carefully. A good cleaning and maintenance procedure will extend the useful life of the device. Cleaning and rinsing must take place immediately after each use for best effect. Failure to clean promptly may result in adherent particles or dried secretions that may resist cleaning and complicate or resist future cleaning.
DORO® Instruction Manual 7.2 DORO® Automated Cleaning Place the precleaned and dismantled products in an OP rack and start the automated cleaning and disinfection procedure: 1. 2. 3. 4. 5. 6. 7. 8. 2 min pre-washing with cold water Drain 5 min cleaning with mildly alkaline cleaner (like 0,5% neodisher MediClean, Dr. Weigert) at 55°C/131°F Drain 3 min neutralizing with cold water.
DORO® Instruction Manual 7.3 DORO® Sterilization The DORO Products listed below are delivered in non-sterile conditions. Important: The components listed below can be sterilized.
DORO® Instruction Manual DORO® IGS Articulated Support Arm 3114-70 DORO Blades 3116-10 to 3116-65 (3116-101 to 3116-601) DORO Quick-Clamp 1202.014 DORO Quick-Clamp Coupling Universal 1202.015 DORO Quick-Clamp Coupling J-Arm 1203.015 DORO Halo Support Rod Holder 1202.016 DORO Quick-Clamp IGS Articulated Support Arm 1201.041 DORO Quick-Clamp Coupling Twin QR 1201.043 DORO Easy Connect Navigation Adaptor, Stryker® 1204.001 DORO Easy Connect Navigation Adaptor, BRAINLAB 1204.
DORO® Instruction Manual 7.4 DORO® Lubrication Lubrication on all UNCOATED moving parts and threads of the ALUMINUM parts (exceptions see below) should be done after every wash; failure to lubricate the Aluminum Headrest System and Retractor System as recommended will result in a greatly reduced life of the equipment. Please pay attention to all screws and threads. You can lubricate with any medical grade lubricant for metals and Teflon. Do NOT lubricate RADIOLUCENT parts and TEFLON coated parts.
DORO® Instruction Manual DORO® 8. Maintenance and Repair 8.1 Maintenance intervals The purchaser shall be obliged to send the device to the manufacturer or to the authorized distributor once a year for maintenance. The manufacturer will perform all required repair work. Exclusion of liability: The manufacturer shall not be liable for damages resulting from the failure of the purchaser or user to submit the device for maintenance.
DORO® Instruction Manual 8.2 DORO® Maintenance to be performed by the purchaser The Base Unit is adjustable in all directions. Frequent realignment of the Base Unit may cause the adjustable parts to loosen. Therefore, we strongly recommend performing the following maintenance work on a regular basis: 8.2.1 Adjusting the Locking Lever The Locking Lever of the Base handle assembly arrests both the Base Handle Assembly to the connecting tube and the Transitional Member to the Base handle assembly.
DORO® Instruction Manual 8.2.2 DORO® Checking the stability of the Transitional Member Place the Base Unit on a straight surface e.g a clean table. Align the Base Handle Assembly with the Transitional Member at an angle of 45° to this surface. Close the Locking Lever and apply pressure to the Transitional Member in order to check it‘s stability. There must be no movement detectable. If there is movement, re-adjust as described about in 8.2.1.
DORO® Instruction Manual DORO® Danger: Push until the click can be clearly detected. US-Version: Turn the manual lock counter-clockwise completely until you have reached the end position. Ensure that the Transitional Member is safely locked in the Base handle assembly. Otherwise, the system stability is not ensured. Do not use Transitional Members provided by other manufacturers. IMPORTANT: Never depress or close the Locking Lever without the Transitional Member in place.
DORO® Instruction Manual 9. DORO® Environmentally Compatible Disposal The purchaser or user is responsible for rendering the device unusable if it is no longer to be applied (prevention of misuse). Disposal: Segregate the components of the device according to material (aluminum, high performance polymer materials, etc.) for recycling. You can return old devices to the manufacturer or authorized distributor. 10. Manufacturer information Manufacturer pro med instruments GmbH Bötzinger Str.
