Synthes Air Pen Drive System Ref J8803A Users Manual June 2010

Table of Contents

Introduction

Operating Instructions

Product Information

Indications

2

Specifications

3

Drive Unit

13

Hand Switch

14

Foot Switch

20

Irrigation

21

Drilling Speed Attachments

24

Screw Insertion Attachments

28

K-Wire Attachment

29

Sawing Attachments

30

Burring Speed Attachments

35

Hudson Coupling Attachment

40

Craniotomy Attachments

41

Drill/Burr Attachment, for 2.35 mm Shafts

43

Adaptor for Intra-Coupling

45

Sterilization

46

Troubleshooting

47

Set Lists

49

Cutting Tools

53

Synthes

Indications

The Air Pen Drive is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive, and spine surgery.

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Synthes Air Pen Drive User’s Manual

General traumatology

Spine surgery

Maxillofacial surgery

Hand surgery

Foot surgery

Neurosurgery and ENT

Specifications - System

Environmental conditions Operation

Transportation and storage

Temperature

10 °– 40°C 50 °– 104°F

-20 °– 50°C -4 °– 122°F

Relative humidity

30 – 75%

10 – 75%

Atmospheric pressure

500 – 1060 hPA 0.5 – 1.06 bar

500 – 1060 hPA 0.5 – 1.06 bar

Duty cycles Intermittent operation with 6.5 bar

Xmin on

Ymin off

Cycles

Drilling Attachment

5

3

unlimited

Burr Attachment

unlimited –

unlimited

Hudson Coupling Attachment

5

3

unlimited

Reciprocating Saw Attachment

3

2

unlimited

Oscillating Saw Attachment

1

2

unlimited

Sagittal Saw Attachment

1

2

unlimited

Intermittent operation with 12 bar*

Xmin on

Ymin off

Cycles

Burr Attachment

10

10

2

Hudson Coupling Attachment

3

5

unlimited

Caution – The Air Pen Drive must never be operated with oxygen, due to danger of explosion. The Air Pen Drive should also not be stored or operated in an explosive atmosphere. – Dirt inside adaptors, air hoses, angled coupling, and pen can cause loss of power. – Heavy side loads and long operating periods may cause an attachment to overheat, making it uncomfortable to hold. – Never place an overheated Drive Unit on the patient, or on patient draping during surgery. – Mitigate overheating of an attachment by discontinuing use until it cools completely, or by using the attachment intermittently. – Never immerse an attachment or the Drive Unit, or wrap with a moist sterile towel, as this will attract excessive moisture to the internal components.

* For 10 minutes maximum.

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Specifications - Air Pen Drive (05.001.080)

– Weight: 169 g (5.96 oz) – Length: 144 mm (5.7 in) – Recommended pressure: 6 – 8 bar – Recommended air flow rate: 200 liters/minute at 6.5 bar For maximum 10 minutes (continuous operation) it is possible to run the Air Pen Drive up to 12 bar with the following attachments: 05.001.045 – 05.001.050, 05.001.055, 05.001.063, 05.001.059, 05.001.123, 05.001.177 – Continuously variable speed: 0 – 60,000 rpm at 6.5 bar 0–80,000 rpm at 12 bar (only with 05.001.045–05.001.050, 05.001.055).

3

2 4

1 5

7

6

Note: Use a regulator to verify that the pressure of the air supply is within the recommended pressure range for the system. Mode Switch To avoid an unintentional change of the operating mode, the mode switch locks automatically. To move the mode switch, the lock has to be pushed backward. Release the lock to secure the mode switch in the desired position. By turning the mode switch to the HAND position , the Drive Unit can be used with the Hand Switch. In the FOOT position , only the Foot Switch can be used. If the FOOT position is set and no Foot Switch is attached, the Drive Unit will run with full speed. Either a Hand Switch or a Foot Switch can be used for speed control. The LOCK position is used for safety when changing attachments and tools. This prevents accidental start-up of the unit. For instructions on mounting the attachments, see “Operating Instructions” (pages 18 and 19). Adjusting the Drive Unit

7

Mode switch Release ring for attachment Coupling for hoses LOCK position HAND position FOOT position Locking mechanism for mode switch

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1 2 3 4 5 6

Lock position

Hand switch position

Foot switch position

Specifications - Angled Coupling (05.001.085) and Hand Switch (05.001.082)

Angled Coupling The Angled Coupling (05.001.085) connects the Air Hose to the Drive Unit and is used to guide the Air Hose away from the Drive Unit at a 45° angle. It allows 360° rotation.

Hand Switch – May be removed without disconnecting the Air Hose from the Drive Unit – Allows variable speed control of the Drive Unit – Includes a safety switch and pull-out finger rest 1 2 3 4 5

2

5

Positioning arrow Pull-out finger rest Positioning arrow Guide groove Locking switch

1

3

4

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Specifications - Foot Switch (05.001.081)

Foot Switch – Dimensions: 267 mm x 160 mm x 47 mm (bar included: 151 mm) 10.5 in x 6.3 in x 1.9 in (bar included: 5.9 in) – Allows variable speed control of the Drive Unit – Includes an irrigation ON / OFF switch

1

2

3

5

Pedal Irrigation ON/OFF button Plug for Double Air Hose Plug for Irrigation Flow Control Unit Plug for Air Hose

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Synthes Air Pen Drive User’s Manual

1 2 3 4

4 5

Specifications - Attachments for Air Pen Drive

Drilling Attachments The drilling speed attachments are geared for a maximum speed of 1,800 rpm. 05.001.030 05.001.031 05.001.032 05.001.110

Drill Attachment, mini quick coupling Drill Attachment, J-latch coupling Drill Attachment, AO coupling Drill Attachment, hex coupling

Function: – Accept drill bits and burrs with mini quick, J-latch, hex and AO couplings

45° Drill Attachments 05.001.042 45° Drill Attachment, mini quick coupling 05.001.043 45° Drill Attachment, J-latch coupling 05.001.044 45° Drill Attachment, AO coupling Function: – Accept drill bits and burrs with mini quick, J-latch and AO couplings

90° Drill Attachments 05.001.035 90° Drill Attachment, short, mini quick coupling 05.001.036 90° Drill Attachment, long, mini quick coupling Functions: – Improve visibility during operations with narrow access – Accept drill bits and burrs with mini quick coupling

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Specifications - Attachments for Air Pen Drive

45° Drill Attachment, cannulated 05.001.120 Drill Attachment, with Jacobs Chuck Speed: – 0 to 1,800 rpm Function: – 1.6 mm cannulation permits the use of this attachment for drilling and reaming over K-wires (e.g., for cannulated screws and for cup and cone technique)

45° Oscillating Drill Attachment 05.001.033 45° Oscillating Drill Attachment, mini quick coupling Frequency: – 3,200 oscillations / minute Function: – Accepts drill bits and burrs with mini quick coupling – Prevents tissue and nerves from wrapping around the drill bit or burr

Screw Insertion Attachments 05.001.028 Screw Insertion Attachment, AO coupling 05.001.029 Screw Insertion Attachment, hex coupling 05.001.034 Screw Insertion Attachment, mini quick coupling Speed: – 0 to 400 rpm Function: – Accept mini quick, hex, or AO coupling screwdriver shafts

K-Wire Attachment 05.001.037 K-Wire Attachment Speed: – 0 to 2,700 rpm Function: – To insert/remove Kirschner wires 0.6 mm to 1.6 mm (0.02 to 0.06 in) in diameter, in any length

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Synthes Air Pen Drive User’s Manual

Sawing Attachments

05.001.038

Oscillating Saw Attachment

Frequency: – 16,000 oscillations/minute Function: – Accepts Synthes crescentic and mandibular saw blades for Pen Drive

05.001.039

Sagittal Saw Attachment

Frequency: – 22,000 oscillations/minute Function: – Accepts Synthes sagittal saw blades for Pen Drive

05.001.040

Reciprocating Saw Attachment

Frequency: – 18,000 oscillations/minute Function: – Accepts Synthes reciprocating saw blades and Synthes rasps for Pen Drive

05.001.121

Guide for K-wires

Function: – Attaches to oscillating saw attachment – Accepts wires up to 1.6 mm diameter

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Specifications - Attachments for Air Pen Drive

Burring Speed Attachments The burring speed attachments transfer the speed of the Drive Unit, with a maximum speed of 60,000 rpm (at 6.5 bar) and 80,000 rpm (at 12 bar). Function: – Accept Synthes short, medium and long burrs for Pen Drive 05.001.045

Burr Attachment, short

05.001.048

Burr Attachment, short, angled

05.001.046

Burr Attachment, medium

05.001.049

Burr Attachment, medium, angled

05.001.047

Burr Attachment, long

05.001.050

Burr Attachment, long, angled

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Synthes Air Pen Drive User’s Manual

05.001.063

Burr Attachment, extra long (XL), angled

05.001.055

Burr Attachment, extra extra long (XXL), angled

05.001.123

Drill / Burr Attachment, for 2.35 mm Shafts

05.001.059

Craniotome Attachment

05.001.051 05.001.052 05.001.053

Dura Guards Short Medium Long

Additional attachments 05.001.177

Hudson Coupling Attachment Maximum speed: 620 rpm

05.001.103

Adaptor for Intra-Coupling Maximum speed: 60,000 rpm

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Specifications - Attachments for Air Pen Drive

Speed/Torque values for Air Pen Drive Attachments Operating Pressure 6.5 bar 8.0 bar 12.0 bar

Maximum Speed (rpm) Drill Burr Attachments Attachments 1800 60000 1975 65800 n/a 78000

Hudson Attachment 620 680 810

K-Wire. Attachment 2700 2960 n/a

Screw Insertion Attachments 400 440 n/a

Operating Pressure 6.5 bar 8.0 bar 12.0 bar

Maximum Torque (Nm) Drill Burr Attachments, Attachments 0.970 0.035 1.200 0.042 n/a 0.050

Hudson Attachment 3.120 3.630 4.250

K-Wire. Attachment 0.650 0.800 n/a

Screw Insertion Attachments 4.180 5.100 n/a

Drill Attachments

05.001.030 05.001.031 05.001.032 05.001.033 05.001.035 05.001.036 05.001.042 05.001.043 05.001.044 05.001.110 05.001.120

Burr Attachments

05.001.045 05.001.046 05.001.047 05.001.048 05.001.049 05.001.050 05.001.055 05.001.059 05.001.063 05.001.123

Hudson Coupling Attachment

05.001.177

K-Wire Attachment

05.001.037

Screw Attachments

05.001.028 05.001.029 05.001.034

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Synthes Air Pen Drive User’s Manual

Operating Instructions - Drive Unit (05.001.080)

Connecting the Air Hose to the Drive Unit Double Air Hoses 05.001.083* 3 meter hose 05.001.084

5 meter hose

Connecting the Air Hose to the Drive Unit Connect the Air Hose by fitting the pins on the hose coupling into the grooves on the coupling for hoses on the Drive Unit and turning the hose coupling clockwise. To remove the Air Hose, turn the air supply off, then run the Drive Unit to release the pressure in the hose. Turn the hose coupling counterclockwise and pull it off the Drive Unit. Angled Coupling (05.001.085) The Angled Coupling connects the Air Pen Drive and the Air Hose and is used to guide the Air Hose away from the Drive Unit at a 45° angle. It allows 360° rotation. Connecting the Angled Coupling Connect the Angled Coupling to the Drive Unit by fitting the pins into the grooves on the coupling for hoses on the Drive Unit and turning the Angled Coupling clockwise. Connect the Air Hose to the Angled Coupling by fitting the pins on the Air Hose coupling into the grooves of the Angled Coupling and turning it clockwise. To disassemble, turn the air supply off, then run the Drive Unit to release the pressure in the hose. Turn the parts counterclockwise and pull the Air Hose off the Angled Coupling, and then the Angled Coupling off the Drive Unit.

* Also available

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Operating Instructions - Drive Unit (05.001.080)

Attaching the Hand Switch to the Drive Unit Instrument 05.001.082

Hand Switch

Position the Hand Switch on the Drive Unit by aligning the positioning arrows on the Hand Switch and the positioning arrows on the Drive Unit above the guide grooves (Figure 1). Press down on the Hand Switch until it clicks into place on the Drive Unit (Figure 2).

Figure 1

Figure 2

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Synthes Air Pen Drive User’s Manual

Correct position for the Hand Switch: The Synthes logo is in the upright position with the Hand Switch facing up (Figure 3). Incorrect position for the Hand Switch (Figure 4).

Figure 3

Figure 4

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Operating Instructions - Drive Unit (05.001.080)

Removing the Hand Switch from the Drive Unit To remove the Hand Switch, grasp the lever and pull it away from the Drive Unit.

Operating the Hand Switch For safety, slide the switch to the LOCK position during Drive Unit and/or attachment exchange.

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Synthes Air Pen Drive User’s Manual

To operate the Drive Unit, slide the switch to the ON position. The speed can be continuously adjusted by depressing the Hand Switch.

Adjusting the Hand Switch The pull-out finger rest can be adjusted by sliding it in and out of the Hand Switch.

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Operating Instructions - Drive Unit (05.001.080)

Inserting attachments on the Drive Unit Important: To prevent injuries, the mode switch on the Drive Unit, or the ON / LOCK switch on the Hand Switch, should be in the LOCK position when inserting or removing attachments or instruments. The attachments can be inserted in 8 different positions, in 45° increments. Turn the release ring clockwise until it locks in the open position. The release ring will protrude slightly from the main body of the Drive Unit. Insert the attachment into the coupling, aligning the positioning pins of the attachment with the grooves on the release ring. Press the attachment lightly against the Drive Unit; the release ring will lock automatically. Pull lightly on the attachment to confirm that it is secure. Note: If the release ring closes before the attachment is fully inserted, align the positioning pins of the attachment with the grooves on the release ring and turn the attachment clockwise while applying slight pressure against the Drive Unit until the attachment engages. Pull lightly on the attachment to confirm that it is secure.

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Synthes Air Pen Drive User’s Manual

Removing attachments from the Drive Unit While holding the Drive Unit with the attachment facing up, turn the release ring clockwise until it locks in the open position (Figure 1). Remove the attachment. The release ring should stay in the open position, ready for the next attachment (Figure 2).

Figure 1

Figure 2

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