DORO DORO® Headrest System including QR3 Skull Clamp - 1001.001 Skull Clamp Aluminum - 3003-00 ® Skull Clamp 3003-00 QR3 Skull Clamp 1001.001 ® Instruction Manual DORO® Headrest System Document no.
DORO® Instruction Manual DORO Quick Guide - DORO Headrest System Rocker Arm Receptacles for Skull Pins DORO QR3 Skull Clamp Item-No. 1001.001 Torque Screw Index Knob Skull Pin Starburst for DORO Easy Connect Navigation Adaptors Quick-Rail 3rd Gen. Skull Clamp Base Extension Assembly Release Knob Starburst Receptacles for Skull Pins DORO Headrest System shown with Item-No.
DORO® Instruction Manual DORO Contents 1. Conformities.................................................................................... 4 1.1 Guidelines and norms...................................................................... 4 1.2 CE conformity.................................................................................. 4 1.3 FDA Registration.............................................................................. 4 2. General Safety Information.....................................
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 DORO 4. Product description 4.1 General description/Intended use The DORO Headrest System 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. It can be used for cranial fixation of the patient in prone, supine, lateral and sitting positions. 4.2 Component description DORO Base Unit The Base Unit is designed for patient positioning in prone or supine positions.
DORO® Instruction Manual DORO DORO Disp. Skull Pins Stainless Steel, Adult DORO Disp.
DORO® Instruction Manual DORO Always make sure to have the complete set of accessories and tools available. Exclusion of liability: The manufacturer shall not be liable for third-party components which are used in conjunction with the DORO Headrest System and DORO Accessories. 4.4 Technical specifications Type of device: DORO Headrest System Serial number: on each part Weight: Base Unit 3110 g Swivel Adaptor 480 g Skull Clamp (3003-00) 1750 g Skull Clamp (1001.
DORO® Instruction Manual DORO Outline drawing DORO Base Unit in mm max. The two table rods of the DORO Base Unit are equipped with an internal isolation to prevent electrical stray currents when the Base Unit is connected to the OR Table. Type of device: Serial number: Weight: Material: Dimensions: Outline drawing Item-No. 1202.014 in mm DORO Quick-Clamp on part 180g stainless steel see outline drawings Outline drawing Item-No. 1201.
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 open DORO 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 and the Connecting Tube in place.
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 5.5 DORO Mounting of the DORO Easy Connect Navigation Adaptors The Navigation Adaptors (1204.001/ 1204.002) can be attached directly to the built-in starburst connections on each Quick-Rail of the QR3 Skull Clamp (1001.001). Please refer to the instruction manual of the DORO Easy Connect Navigation Adaptors. 5.6 Mounting Additional Accessories 5.6.1 Quick-Clamp w/ Interface for Mizuho-Type Retractors Use the Quick-Clamp w/ Interface for Mizuho-Type Retractors, Item-No.
DORO® Instruction Manual DORO There are two possibilities to secure additional accessories to the Quick-Clamp: 2. Use the appropriate accessories to mount the DORO Quick-Clamp Retractor Systems like the DORO Quick-Clamp Halo and Quick-Clamp McCue Halo Retractor System, the DORO Quick-Clamp J-Arm Retractor System or the DORO Quick-Clamp Brain Retractor System or the DORO Quick-Clamp IGS Support Arm. Refer to the appropriate instruction manuals for further mounting and use instructions. Quick-Clamp 1202.
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 (Item-No. 3003-00) 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 (3003-00; 1001.001) 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.
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 Cleaning 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 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 and the Connecting Tube 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.
