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.:
3000-90_EN
Version:15
Date of creation:
1998-09-19
Last revision:
2013-06-11
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
Starburst for
DORO Easy Connect
Navigation Adaptors
Skull Pin
Quick-Rail 3rd Gen.
Skull Clamp Base
Extension Assembly
Release Knob
Starburst
Receptacles for Skull Pins
DORO Headrest System
shown with
Item-No. 3003-00
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 Screw
-2-
Locking Lever
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............................................................. 4
2.1 Symbols used for safety information................................................ 4
2.2 Proper handling and permitted user................................................. 6
2.3 Creutzfeldt Jakob Disease............................................................... 6
3.
Basic Information............................................................................ 6
3.1 Warranty and liability........................................................................ 6
3.2 Obligations of the purchaser............................................................ 6
3.3Use as per instructions.................................................................... 7
3.4 Improper use.................................................................................... 7
4.
Product description......................................................................... 8
4.1 General description/Intended use.................................................... 8
4.2 Component description.................................................................... 8
4.3Components..................................................................................... 8
4.4 Technical specifications................................................................. 10
5.
Mounting....................................................................................... 12
5.1 Mounting of the DORO Base Unit.................................................. 12
5.1.1 Adjusting DORO Base Unit to standard OR Table.................... 12
5.1.2 Mounting DORO Base Unit to standard OR Table.................... 13
5.2 Mounting the DORO Swivel Adaptor.............................................. 14
5.3 Mounting of the DORO Skull Clamp.............................................. 14
5.4 Mounting of the DORO Skull Pins.................................................. 14
5.5 Mounting DORO Easy Connect Navigation Adaptors.................... 15
5.6 Mounting Additional Accessories................................................... 15
5.6.1 Quick-Clamp w/ Interface for Mizuho-Type Retractors............. 15
5.6.2 Quick-Clamp and Accessories.................................................. 15
6.
Use and Handling......................................................................... 17
6.1 Detailed description of application................................................. 17
6.2 Function and safety inspection...................................................... 22
6.2.1 Prior to clinical use of a DORO device...................................... 22
6.2.2 After clinical use of a DORO device.......................................... 22
7.
Care ............................................................................................. 23
7.1 Manual Cleaning............................................................................ 23
7.2 Automated Cleaning ..................................................................... 24
7.3Lubrication..................................................................................... 25
8.
Maintenance and Repair .............................................................. 26
8.1 Maintenance intervals.................................................................... 26
8.2 Maintenance to be performed by the purchaser............................ 27
8.2.1 Adjusting the Locking Lever...................................................... 27
8.2.2 Checking the stability of the Transitional Member.................... 28
8.2.3 Replacing the Transitional Member.......................................... 28
9.
Environmentally Compatible Disposal ......................................... 30
10.
Manufacturer information.............................................................. 30
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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
1.1
Guidelines and norms
Description
Guidelines and norms
DORO Headrest and DIN EN ISO 13485 Medical Devices - QM System
Retractor Systems
DIN EN ISO 14971 Risk Management
93/42/EEC Medical Device Directive
1.2
CE conformity
DORO Headrest and Retractor Systems conform to the basic requirements
of the applicable guideline and the corresponding norms of the Council of
the European Union.
1.3
FDA Registration
The DORO Headrest and Retractor Systems are registered with the 510(k) Numbers K001808,
K032331, K063494.
Note:
Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order
Only of a physician.
2.
General Safety Information
2.1
Symbols used for safety information
This instruction manual contains the basic information required for the safe use of the device.
The symbols explained below might be used in this instruction manual and/or on the product
labels to point out safety-relevant information:
Danger: This symbol indicates a danger to the health of the patient. Failure to observe
this information and to follow the appropriate instructions may result in serious
injury to the patient and may even endanger the patient’s life.
Warning: This symbol indicates a danger of injury to the user of the device.
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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.
Such disclaimers result if the purchaser or user does not employ the device
properly or fails to follow the instructions.
Attention:
Read operating instructions!
Manufacturer:
Manufacturer's name and address.
Production date:
Printed on package!
Safe usage until:
Printed on package! Do not use after this date.
Sterile:
Sterilized with gamma radiation or ethylene oxide according to the label on
the outside box.
Use only once:
Do not reuse! Destroy after usage!
MR Safe
an item that poses no known hazards in all MR environments.
MR Unsafe
an item that is known to pose hazards in all MR environments.
Lot number:
Printed on package or product.
Item number:
Printed on package or product.
Serial number:
Printed on package or product.
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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. Please consult individual national infection control/
prevention protocols for specific guidance regarding processing medical devices with suspected exposure to Creutzfeldt Jakob Disease.
3.
Basic Information
3.1
Warranty and liability
All warranty claims presuppose proper operation and treatment of the device. The manufacturer guarantees that all parts are free from defects in both materials and workmanship at
the time of delivery.
Exclusion of liability: The manufacturer shall not be liable for damages resulting from incorrect
use of the device, failure to follow the instructions furnished in this manual
or improper or insufficient maintenance.
3.2
Obligations of the purchaser
The purchaser must ensure that all users of the device are trained in the proper use of the
device and fully understand all safety-relevant information.
o
The purchaser shall be obliged to permit only trained staff, i.e. the OR team,
to use the device.
o
The purchaser shall also be responsible for storing this instruction manual in such a way that it is always available when the device is being used.
Exclusion of liability: The manufacturer shall not be liable for damages resulting from the failure
of the purchaser to train the users of the device.
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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.
Use as per instructions also implies
o
that you follow all information furnished in this manual
o
that you clean and maintain the device as described.
3.4
Improper use
Improper use or use not conforming to the instructions contained in this manual may result
in serious injuries or even death to the patient or the user and damage the device and other
equipment.
Exclusion of liability: The manufacturer shall not be liable for damages resulting from improper use.
Exclusion of liability: DORO Headrest and Retractor Systems can be mounted to all standard OR
Tables. The manufacturer shall not be liable for damages resulting from the
use of the device in conjunction with non-standardized OR Tables.
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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. For lateral positioning we recommend using the DORO Adjustable Base Unit Parkbench (Item-No. 3001-006).
Note: For patients undergoing surgery in sitting positions, use the DORO Crossbar
Adaptor (Item-No. 3007-00) which is mounted to the side rails of the OR Table
(see instruction manual DORO Crossbar Adaptor for mounting instructions).
DORO Swivel Adaptor
The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the
Skull Clamp. The Swivel Adaptor is pivotable by 360 degrees. This allows a fully flexible
adjustment of the DORO Headrest System to the patient’s position.
DORO Skull Clamp Item-No. 3003-00 and 1001.001
The Skull Clamp provides the receptacles for the Skull Pins which penetrate the patient’s
skull for rigid cranial fixation.
4.3
Components
The DORO Headrest System consists of the following components:
Description:
Item-No.
DORO Base Unit Aluminum
3001-00
DORO Swivel Adaptor Aluminum
3002-00
And one of the DORO Skull Clamps:
DORO Skull Clamp Aluminum 3003-00
DORO QR3 Skull Clamp
1001.001
We recommend using the following components with the Headrest System (refer to instruction
manual Skull Pins):
Description
DORO Reusable Skull Pins for Adults
DORO Reusable Skull Pins Pediatric
DORO Disposable Skull Pins Adult
DORO Disposable Skull Pins Pediatric
DORO Disposable Skull Pins Titanium, Adult
DORO Disposable Skull Pins Titanium, Pediatric -8-
Item-No.
3005-00
3004-00
3006-00
3006-10
3006-20
3006-30
DORO® Instruction Manual
DORO
DORO Disp. Skull Pins Stainless Steel, Adult
DORO Disp. Skull Pins Stainless Steel, Pediatric
3006-50
3006-60
Additional Base Units:
DORO Adjustable Base Unit US
DORO Adjustable Base Unit Muranaka
DORO Adjustable Base Unit Mizuho
DORO Base Unit Eschmann
DORO Base Unit Parkbench
DORO Base Unit Australia
DORO Base Unit Eschmann T-Series
3001-00-US
3001-001
3001-002
3001-003
3001-006
3001-008
3001-010
Additional Swivel Adaptors:
DORO Ball Pivot Adaptor
DORO Swivel Adaptor Navigation
3002-50
3002-60
Navigation Adaptors (refer to instruction manual Navigation Adaptors)
used with Skull Clamp 3003-00:
Navigation Adaptor Quick-Rail, Stryker®, Aluminum 3114-64
Navigation Adaptor Quick-Rail, Medtronic, Aluminum 3114-65
Navigation Adaptor Quick-Rail, BRAINLAB, Aluminum 3114-66
used with Skull Clamp 1001.001:
DORO Easy Connect Navigation Adaptor, Stryker®1204.001
DORO Easy Connect Navigation Adaptor, Brainlab1204.002
DORO Easy Connect Navigation Adaptor, Medtronic
1204.003
Accessories:
DORO Quick-Clamp
DORO Quick-Clamp w/ Interface for Mizuho-Type Retractors
1202.014
1201.045
Additional Accessories (refer to the appropriate instruction manuals):
DORO Armrest Parkbench
3001-007
DORO Crossbar Adaptor
3007-00
Universal Side Rail Fitting
3007-50
Table Adaptor
3010-00
Side Rail Adaptor 3011-00
Side Rail Adaptor Amsco®3011-10
DORO Amsco® Headrest Adaptor
3011-11
Cervical Spine Support 3012-00
Headrest Wall Storage Unit
3013-00
For more accessories and product pictures please refer to our DORO Cranial Stabilization
and Retractor Systems brochure or visit us at www.headrest.de.
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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 Unit3110 g
Swivel Adaptor
480 g
Skull Clamp (3003-00)
1750 g
Skull Clamp (1001.001) 1700 g
Material:
aluminum cast, stainless steel, high performance polymer materials
Dimensions:
see outline drawings
Outline drawing Item-No. 1001.001 in mm
Outline drawing Item-No. 3003-00 in mm
300-430
85-215
24,0
247
111,72
113
254
158
75
24,5
Outline drawing DORO Swivel Adaptor in mm
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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.
Outline drawing Item-No. 1202.014 in mm
Type of device:DORO Quick-Clamp
Serial number: on part
Weight:180g
Material:
stainless steel
Dimensions:
see outline drawings
Outline drawing Item-No. 1201.045 in mm
Type of device: DORO Quick-Clamp
w/ Interface for Mizuho-
Type Retractors
Serial number: on part
Weight:300g
Material:
stainless steel
Dimensions:
see outline drawings
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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.
5.1.1 Adjusting the DORO Base Unit to a standard OR Table
1. Remove the Hex Wrench from its storage holder on the lefthand side of the Connecting Tube.
↑

2. Locate the Hex Screw at the adjustable End Bracket to
adjust the width.

3. Using the Hex Wrench, loosen (do not remove) the Hex
Screw at the left End Bracket by turning the Hex Screw
counter-clockwise until the adjustable end bracket is loose.


4. Carefully slide the Adjustable End Bracket over the
connecting tube to adjust the width of the table rods
to the width of the receptacles of the OR Table.
5. Insert the two table rods into the receptacles of the OR
Table to verify that the width match and the Base Unit is
seated properly.

6. Make sure that the Hex Screw is seated properly in the slot
of the connecting tube. Using the Hex Wrench, lock the
width by turning the Hex Screw clockwise. Return the Hex
Wrench to its storage holder.
Once this adjustment is made for your OR Table, this step can be skipped in future use.
-12-
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. This will damage the Base Handle Assembly.
5.1.2 Mounting the DORO Base Unit to a standard OR Table
1. Position the Base Unit at the head of the OR Table with the Base Handle
Assembly centered on the connecting tube.
2. If you need to adjust the Base Unit to the width of the receptacles of the OR Table see
chapter 5.1.1.
3. Insert the two table rods into the receptacles of the OR Table.
4. Turn the receptacle fastening screws at the OR Table until they are fully tightened.
5. Position the Base Handle Assembly at the desired position as described in chapter 5.1.1.7.
6. Ensure that all adjustable joints are tightly fastened and secured.
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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.
Mounting of the DORO Skull Clamp
Mount the Skull Clamp (Item-No. 3003-00 or 1001.001) to the Swivel Adaptor
1. Position the teeth of the upper starburst connection of the
Swivel Adaptor and the teeth of the starburst connection of
the Skull Clamp in a manner that they engage.

2. Position the Skull Clamp as desired.
3. Fully tighten the upper locking screw of the Swivel Adaptor
by turning it clockwise. Note: the teeth of the starburst
connections must be fully engaged and seated properly.
Danger: Check all fastening screws and all starburst locking mechanisms on the device and check the stability of the complete DORO system before and after
each clinical use. Make sure that the device is exactly mounted as described
in this manual.
Important: QR3 only : The main starburst of the QR3 Skull Clamp (base) is designed for connecting the QR3 Skull Clamp to DORO Swivel Adaptors and other accessories.
When connecting non-DORO accessories with similar starburst connections, test
that the connection is tight and secure and the teeth of both starbursts are fully engaged with no gap. A poor connection could be caused by a screw on the accessory
which is too long. These accessories must not be used with the QR3 Skull Clamp.
5.4
Mounting of the DORO Skull Pins
This system requires three DORO Skull Pins of the same versions to be used. Please refer
to the instruction manual of the appropriate DORO Skull Pins.
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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. 1201.045, to connect
Mizuho-Type Retractors to the DORO Skull Clamp 3003-00 or 1001.001.
1.

2.
1. Mount the Quick-Clamp w/ Interface for Mizuho-Type
Retractors (1201.045) on the Quick-Rail of the Skull Clamp
(3003-00 or 1001.001) over the sterile drape that is covering
the Skull Clamp. Fully tighten the Locking Screw of the
Quick-Clamp w/ Interface for Mizuho-Type Retractors by turning it clockwise. (Picture shows Quick-Clamp w/ Interface
for Mizuho-Type Retractors mounted on QR3 Skull Clamp
without sterile drape).
2. To mount the Mizuho-Type Retractor Arm, insert the connection piece of the Retractor Arm into the reception of
the Quick-Clamp until the stop is reached and position the
retractor arm as desired.
X
3.

3. Securely tighten the locking screw of the Quick-Clamp w/
Interface for Mizuho-Type Retractors by turning it clockwise.
The teeth of the starbust connections must be fully engaged
and seated properly.
5.6.2 Quick-Clamp and Accessories
Connecting the DORO Quick-Clamp to the Skull Clamp 3003-00 or 1001.001

1202.014
1. Mount the Quick-Clamp (1202.014) on the Quick-Rail of the
Skull Clamp (3003-00 or 1001.001) over the sterile drape
that is covering the Skull Clamp. Fully tighten the Locking
Screw of the Quick-Clamp by turning it clockwise. (Picture
shows Quick-Clamp mounted on QR3 Skull Clamp without
sterile drape).
-15-
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 1202.014
shown with Quick-Clamp
Coupling Universal 1202.015
and Halo Support rod Holder
1202.016
Quick-Clamp 1202.014
shown with Quick-Clamp
Coupling J-Arm 1203.015
Quick-Clamp 1202.014
shown with Quick-Clamp
Coupling Twin QR 1201.043
Quick-Clamp 1202.014
shown with IGS Articulated
Support Arm 1201.041
3. Use the built-in Quick-Rail of the Quick-Clamp 1202.014 to connect current accessories (with interface for the Quick-Rail of the Skull Clamp (3003-00)) like the Quick-Rail
Adaptor Halo 3114-55 and Quick-Rail Adaptor J- Arm 3114-56 as well as the Flexible
Arms.

Danger:
Ensure that all adjustable joints are tightly fastened and secured.
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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. Mount the Base Unit to the OR Table (see Chapter Mounting).
2. Mount the Swivel Adaptor to the Transitional Member of
the Base Unit (see Chapter Mounting).
3. For ease in mounting, we recommend that the Transitional Member of the Base Unit and the Swivel Adaptor are
loosely connected (not fully tightened) and the Swivel
Adaptor is hanging loose and pointing to the floor.
B
Secure the patient's head to the Skull Clamp
(Item-No. 3003-00 or 1001.001)
Insert the Skull Pins into the receptacles of the Skull Clamp
(refer to instruction manual Skull Pins).
↑
↑
Adjusting the required Skull Clamp width:
1. Pull down the Release Knob at the Skull Clamp
base and pull the Extension Assembly away from the Skull
Clamp base to widen the Skull Clamp.
2. Place the patient’s head in the desired position within the
Skull Clamp. Push the Extension Assembly into the Skull
Clamp Base to reduce the Skull Clamp width.
-17-
↑
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. Adjust the Skull Clamp to the width of the patient’s head in the manner that the
two Skull Pins in the rocker arm are equidistant from the centerline of the head
and the single Skull Pin at the Extension Assembly is in line with this centerline.
CORRECT INCORRECT
5. Adjust the Rocker Arm to the desired position.
6. Turn the Index Knob from „OPEN“ until it engages in the
„Lock“ position and make sure that the mark is in the correct position. If this cannot be done without problems, return
to the „OPEN“ position, turn the rocker arm slightly and try
again to engage the Index Knob in the „LOCK“ position.
Important
Only turn the rocker arm while the Index Knob is in the “OPEN” position.
Otherwise the locking mechanism will be damaged.
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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. It is the responsibility of the
user to select the proper type of fixation and the correct clamping
pressure in view of the skull thickness and bone structure of the
patient’s head. For rigid fixation, ensure the proper position of
the patient’s head. The two skull pins in the Dual-Pin Rocker Arm
should be equidistant from the centerline of the head and the single
skull pin in line with this centerline. The angle of the pins should be
as close to 90 degrees possible to the patient skull. Use the proper
clamping force.
Danger:
The user decides which type of fixation and what clamping force are
required, based on the thickness of the skull and the bone structure.
Therefore: refer to the instruction manual Skull Pins. For pediactric
cases we recommend the DORO Multi-Purpose Skull Clamp with
4-point fixation or non-invasive gel pads
Danger:
Failure to properly position the Skull Pins may cause serious injury
to the patient. Therefore: Avoid sensitive areas like the frontal
sinus, temporal fossa, blood vessels or nerves.
7. Turn the torque screw in order to drive the Skull
Pins at an angle of 90 degrees into the patient’s
head (refer to instruction manual Skull Pins, section
mounting).
Danger:
Angles other than 90 degrees may cause the system to become
unstable and may result in serious injury to the patient.
8. Ensure proper position of the Skull Pins.
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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. When applying pressure the first line (20lbs/90N) becomes visible, then the second line and the third line become visible.
Danger:
The DORO Skull Clamp may cause damage to the patient’s skull.
The head may fall out of the Skull Clamp or the Skull Pins may
break through into the brain if using an incorrect clamping force. It is
absolutely necessary to follow the instruction of the surgeon, when
defining the clamping force to be applied.
Danger:
The DORO Headrest System is temporarily destabilized when you
loosen handles and fastening screws. Therefore: Ensure that all
handles and fastening screws at the device are properly locked prior
to each clinical application of the system.
Danger:
The maximum load for the Headrest System is 12.5 kgs/27.5 lbs.
Please make sure to safely position the patient’s neck and shoulders
to avoid excess weight.
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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. Connect the Skull Clamp to the Base Unit by means of
the Swivel Adaptor: Position the teeth of the upper starburst connection of the Swivel Adaptor and the teeth of
the starburst connection of the Skull Clamp in a manner
that they engage.
4. Fully tighten the upper locking screw of the Swivel Adaptor
by turning it clockwise. Note: The teeth of all starburst
connections must be fully engaged and seated properly.
5. Ensure that the patient's head is in the required position.
Tighten and check all adjustable joints starting with Skull
Clamp then Swivel Adapter, Transitional Member, Base
Unit and receptacles of the OR Table.
Danger:
Always make sure to stabilize the patient‘s head before adjusting the
fastening screws of the Headrest System. Ensure that all adjustable
joints are tightly fastened and secured. Ensure that the patient‘s head
is secured while tightening joints.
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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.
6.2.1 Prior to clinical use of a DORO device
Perform the following function and safety tests before using the device in clinical applications:
Make sure that:
- the device is perfectly adjusted to the patient position required for surgery.
- all joints of the device are locked and all fastening screws are tightened.
- all components are tightly attached to each other and the starburst connection teeth of all
components are fully engaged and interlocked.
- the Index Knob is engaged in correct position and Locking Screws of the device are properly tightened.
- the Base Handle Assembly of the Base Unit is tightly locked and that the Transitional
Member is properly attached to the Base Handle Assembly.
- the Skull Clamp Base and Skull Clamp Extension Assembly are properly engaged. There
must be no movement detectable in the mechanism.
- the stability of the complete system is ensured.
6.2.2 After clinical use of a DORO device
Perform the following function and safety tests after having used the device in clinical applications:
Make sure
-
that the device is complete and is not damaged. If the device appears to be damaged or
does not seem to function properly, immediately send the device to the manufacturer or
to your authorized distributor for repair.
- to check if the Base Unit Locking Lever needs to be readjusted and that the Transitional
Member of the Base Unit is properly mounted.
You may only use the device if it is fully functional as described above.
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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. Do not use a fixating detergent or hot
water (>40°C/104°F) as this can cause the fixation of residual which may influence the result of the
reprocessing process. Devices must be completely cleaned and rinsed of all foreign matter.
Storage and transport of the device to the reprocessing location must be ensured in a sealed container to avoid any damage to the device and any contamination of the environment.
All reusable components of the device described in Section Product Description, can be cleaned
by mildly alkaline cleaner safe for all types of surgical grade stainless steel, aluminum, Teflon (Polytetrafluoroethylene) and high performance polymer materials or with a manufacturer‘s approved
detergent designed for use with stainless steel, aluminum, Teflon and high performance polymer
materials (like 0,5% neodisher MediClean, Dr. Weigert).
Disassemble all components as described in Sections Mounting and Maintenance. Remove gross
soil by using paper wipes. Prepare the cleaning solution (like 0,5% neodisher MediClean, Dr. Weigert) per the cleaning solution manufacturer’s instructions. Soak soiled instruments for 5 minutes.
Use a soft nylon bristle brush to scrub all exposed surfaces thoroughly under running tap water
until all traces of blood and debris are visually removed. Take extra care around threads, lumens,
crevices, seams and any hard to reach areas. If the device has sliding mechanisms or hinged joints,
actuate the area to free any trapped blood and debris. Brush delicate features of the instruments
with care to avoid bending or breaking of such features. Using a syringe filled with cold tap water,
flush internal areas that cannot be accessed with a brush for at least 20 seconds with a static water
pressure of at least 4.2 bar.
Rinse each component thoroughly under warm running tap water until all visible traces of detergent
are removed. Rinse all lumens, internal areas, sliding mechanisms, and hinged joints, actuating
sliding mechanisms and hinged joints while rinsing.
We recommend manual cleaning of the device. An automated cleaning procedure may be used
secondary, but is not required or recommended for routine reprocessing. Repeated automated
reprocessing has negative effects on these device.
Manual Cleaning as described above must be followed by a disinfection procedure.
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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 min pre-washing with cold water
2. Drain
3. 5 min cleaning with mildly alkaline cleaner (like 0,5% neodisher MediClean, Dr. Weigert)
at 55°C/131°F
4. Drain
5. 3 min neutralizing with cold water.
6. Drain
7. 2 min intermediate rinsing with cold water
8. Drain
Thermal Disinfection has to be processed according national requirements and to the A0- value
according to ISO 15883.
Dry immediately after final rinse. Use the drying cycle of the washer/desinfector and - if required
- a clean lint-free cloth for drying. Dry internal areas with filtered compressed air, if available.
Inspect each component for remaining debris; if any are present, repeat the cleaning procedure
using fresh detergent. Assemble all components as described in Section Mounting and Maintenance. Inspect all devices prior to cleaning or storage to ensure instruments are suitable for use.
Store the device in a clean, dry, moisture free area at a temperature of 5°C/41°F to 40°C/104°F.
Important:
Please refer to chapters Mounting and Maintenance for dismantling information.
When dismantling the device for cleaning purposes and storage, make sure to
restore to the original state of the system.
Important:
Do not immerse radiolucent parts longer than 12 minutes in the cleaning solution
as it may cause swelling of the material.
Exclusion of liability:
The manufacturer shall not be liable for damages resulting from improper
cleaning and handling of the product and its parts.
Danger:
Never steam sterilize the device. If you autoclave the device, the heat will
damage the internal components and may damage the exterior finish.
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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.
Important:
The cylinder of the Base Unit Transitional Member, the Ball and the Socket
area of the Ball Pivot Adaptor and the flexible segments of the retractor arms
should NEVER be lubricated.
DORO Base Unit:
The cylinder of the Base Unit Transitional
Member should NEVER be lubricated.
However, discrete lubrication of the ball
bearings on the cylinder of the Transitional
Member should be done, as long as the
lubricant does not contact the rest of the
cylinder. Do not lubricate the Connecting
Tube.
DORO Ball Pivot Adaptor:
The Ball and the Socket area of the Ball Pivot Adaptor should NEVER be lubricated.
DORO Retractor Arm:
Do not lubcricate link area. Lubricate all
moving parts except the flexible segments
of the Retractor Arm.
Warning:
Radiolucent parts and Teflon coated parts should NEVER be lubricated.
Water-based lubricant on radiolucent parts may cause swelling and ANY
type of lubricant on radiolucent parts, especially on POM material will prevent
proper tightening of connections.
Warning:
Failure to properly lubricate as instructed may cause uncoated Aluminum
moving parts to dry out and be damaged.
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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.
Please refer to the appendix to this instruction manual for the address of the manufacturer
or the authorized distributor.
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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.
Frequent releasing and depressing of the lever may cause changes in the fastening tension
which need to be compensated.
Check the tension of the Locking Lever at regular intervals. Proceed as described below in
order to readjust the Locking Lever tension:
1. Open the Locking Lever.
2. Remove the Hex Wrench from its storage holder.

↑
↑
↑ ↑
3. Hold the Tension Knob at the Base Handle Assembly and turn
the lock screw inside the Tension Knob counter-clockwise using
the Hex Wrench.
4. Check the Locking Lever tension by depressing and releasing
the Locking Lever. Make sure that the Locking Lever with the
two bolts is properly engaged in the inside of the Base Handle
Assembly.
5. If necessary, turn the Tension Knob until you obtain the required
tension. The lever movement should be smooth, but firm.
6. Holding the Tension Knob, close the lock screw inside the
Tension Knob by turning it clockwise using the Hex Wrench.
Note: The Locking Lever must be open, while readjusting the
Tension Knob.
Ensure that the Locking Lever lip is properly placed under the
two Stainless Steel pegs
WARNING:
The Locking Lever should not be removed and should never be forced into
place. Should the Locking Lever be disengaged from the internal Tension
Stainless Steel Rod, carefully re-insert, ensuring that the Locking Lever lip
is properly placed under the two Stainless Steel pegs (see picture) and that
it is squarely positioned before lowering the Locking Lever. If the Locking
Lever is on an angle it may damage the internal mechanism.
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DORO® Instruction Manual
DORO
8.2.2 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.
↑
apply pressure
Transitional Member
Base Handle Assembly
Locking Lever
45°
8.2.3 Replacing the Transitional Member
1. Open the Locking Lever by lifting up to release.
2. Removing: Align the Transitional Member with the slot of
the base handle assembly at an angle of 90°. Remove the
Transitional Member from the Base Handle Assembly by
pulling it slowly to the left-hand side (or to the right-hand
side). US-Version: The Transitional Member is equipped with a manual
lock lever. Turn the manual lock lever clockwise to unlock the Transitional
Member, then remove it as described above.

t
slo
↑
knob
°
90
3. Replacing: Align the cleaned (or new) Transitional Member
with the slot of the base handle assembly at an angle of 90°
(knob should glide through slot). Insert the cleaned (or new)
Transitional Member into the receptacle of the Base Handle
Assembly until a click indicates that you have fully engaged
the Transitional Member. US-Version: After replacing the Transitional Member, turn the manual lock counter-clockwise to lock the Transitional Member in place. The Transitional Member should be locked before
using or transporting the base unit.
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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. This will cause damage to the Base
Handle Assembly.
Exclusion of liability:
The manufacturer shall not be liable for damages resulting from inexpert
replacement of the Transitional Member.
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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. 38
79111 Freiburg, Germany Phone +49 761 384 222 10
Fax
+49 761 384 222 80
E-mail
pmi@headrest.de
Internet
http://www.headrest.de
______________________________
USA
pro med instruments, Inc.
4529 SE 16th Place, Suite # 101
Cape Coral, FL 33904
Toll Free 877 225 4086
Fax
239 369 2370
Authorized distributor
Imprint
© pro med instruments GmbH (PMI). DORO and Quick-Rail are registered trademarks of pro
med instruments GmbH (PMI). All rights reserved. Third party registered trademarks, product
images, designs and trade names are the property of their associated registrants and no
claim of association is made. Any and all names of third party companies, including third party
company logos, product images, and product names are used for descriptive purposes only. ©
Reprint of document or parts thereof only with permission of pro med instruments GmbH (PMI).
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