Medtronic 29150 Instructions for Use

AccuMist

Blower/Mister

29150

®

Instructions for Use

Caution: Federal law (USA) restricts this

device to sale by or on the order of a physician.

Explanation of symbols on package labeling

Refer to the outer package label to see which symbols apply to this
product

Conformité Européenne (European Conformity). This
symbol means that the device fully complies with European
Council Directive 93/42/EEC.

Nonpyrogenic

Sterilized Using Ethylene Oxide

Do Not Reuse

Use By

Lot Number

Quantity

Open Here

Attention, See Instructions for Use

For US Audiences Only

Manufacturer

1

12

10

11

9

8

8

7

7

6

5

4

3

2

1

1. Tip

2. Malleable Shaft

3. Handpiece

4. CO2/Medical Air/Fluid “On” Switch

5. CO2/Medical Air/Fluid “Off” Switch

6. Roller Clamp

7. Fluid Line

8. CO2 /Medical Air Line

9. In-line Filter

10. CO2/Medical Air Connector

11. Line Pressure Vent

12. Spike

2

Figure 1

1

3

7

6

5

2

4

Figure 2

1. Sterile Fluid (not included)

2. Pressure Cuff (mm Hg) (not included)

3. Fluid Line

4. CO2/Medical Air Line

5. Flow Meter (L/min) (not included)

6. CO2/Medical Air Source (not included)

7. Pressure Regulator

3

Instructions for Use

AccuMist® Blower/Mister

Model

29150

Description

The AccuMist® Blower/Mister consists of a handpiece, a malleable shaft,
and a tubing set (CO2/medical air line tubing co-joined to fluid line tubing).
The proximal end of the tubing has a spike for fluid attachment and a
vented connection for CO2/medical air source attachment. The roller
clamp provides a means to adjust fluid flow. The tubing set is
approximately 304.8 cm (10 ft) in length. The handpiece has controls for
on/off of CO2/medical air/fluid.
Sterile, nonpyrogenic, disposable.

Indications

This device is intended for use during procedures when a wound or
surgical site must be cleared by non-contact means for improved visibility.

Contraindications

This device is not intended for use except as indicated above. Do not use
where the effects of a CO2/medical air stream or irrigation mist are
contraindicated.

Warnings

DO NOT USE OXYGEN WITH THIS DEVICE.
Use caution when moving the tip of the device near the wound or surgical
site. DO NOT ALLOW TIP TO CONTACT TISSUE.

Precautions

To release compressed CO2/medical air in a controlled fashion, point tip
of device away from the wound or surgical site before turning device on.
This device is designed and intended for single-use only. DO NOT
RESTERILIZE OR REUSE.

Adverse Effects

None known.

Instructions for Use

1. Inspect the package and product for damage and expiration date.
Open the package and transfer product onto the sterile field utilizing
aseptic technique.

2. Push the CO2/medical air connector onto the CO2/medical air source
regulator's tapered adapter.

Note: When connected to the CO2/medical air source, an audible
sound may be heard at the line pressure vent.

3. Use the following recommended settings:

If Using:

Pressure Regulator Only 83 – 172 kPa (12 – 25 psi)
Flow Meter Only 4 – 6 L/min
Both Pressure Regulator

and Flow Meter

4. Use the Off switch on the handpiece to turn off the CO2/medical
air/fluid.

5. Aseptically connect the spike to a new bag of sterile fluid (not
included) and place in a pressure cuff (not included). Inflate the
pressure cuff to approximately 150 mm Hg.

Set At:

276 – 345 kPa (40 – 50 psi) and
4 – 6 L/min

4 Instructions for Use English

6. To release compressed CO2/medical air in a controlled fashion, point
tip of device away from the wound or surgical site before turning
device on.
Compressed CO2/medical air results whenever the device is cycled
off, then on. This compressed CO2/medical air is released by turning
the handle control to the “ON” position.

7. Use roller clamp to adjust fluid flow.

8. Bend the malleable shaft to optimize wound or surgical site access
and visualization.

9. Use caution when moving the tip of the device near the wound or
surgical site. DO NOT ALLOW TIP TO CONTACT TISSUE.

Instructions for Use English 5

The following disclaimer of warranty applies to United
States customers only:

Disclaimer of Warranty

ALTHOUGH THE ACCUMIST® BLOWER/MISTER, HEREAFTER
REFERRED TO AS “PRODUCT” HAS BEEN MANUFACTURED
UNDER CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC
HAS NO CONTROL OVER THE CONDITIONS UNDER WHICH THIS
PRODUCT IS USED. MEDTRONIC, THEREFORE DISCLAIMS ALL
WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO
THE PRODUCT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE LIABLE TO
ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES OR ANY
DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES CAUSED
BY ANY USE, DEFECT, FAILURE OR MALFUNCTION OF THE
PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED
UPON WARRANTY, CONTRACT, TORT OR OTHERWISE. NO
PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY
REPRESENTATION OR WARRANTY WITH RESPECT TO THE
PRODUCT.

The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held
to be illegal, unenforceable or in conflict with applicable law, by a court
of competent jurisdiction, the validity of the remaining portions of this
Disclaimer of Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

The following disclaimer of warranty applies to customers
outside the United States:

Disclaimer of Warranty

ALTHOUGH THE ACCUMIST® BLOWER/MISTER, HEREAFTER
REFERRED TO AS “PRODUCT” HAS BEEN CAREFULLY
DESIGNED, MANUFACTURED AND TESTED PRIOR TO SALE, THE
PRODUCT MAY FAIL TO PERFORM ITS INTENDED FUNCTION
SATISFACTORILY FOR A VARIETY OF REASONS. THE WARNINGS
CONTAINED IN THE PRODUCT LABELING PROVIDE MORE
DETAILED INFORMATION AND ARE CONSIDERED AN INTEGRAL
PART OF THIS DISCLAIMER OF WARRANTY. MEDTRONIC,
THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESS
AND IMPLIED, WITH RESPECT TO THE PRODUCT. MEDTRONIC
SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR
CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, OR
FAILURE OF THE PRODUCT, WHETHER THE CLAIM IS BASED ON
WARRANTY, CONTRACT, TORT OR OTHERWISE.

The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held
by any court of competent jurisdiction to be illegal, unenforceable or in
conflict with applicable law, the validity of the remaining portion of the
Disclaimer of Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

6 Instructions for Use English

Europe

*M931110A001*

Europe/Africa/Middle East
Headquarters

Medtronic International Trading
Sàrl
Route du Molliau 31
Case Postale 84
CH - 1131 Tolochenaz
Switzerland
Internet: www.medtronic.co.uk
Tel. [phone]
Fax [phone]

Medtronic E.C. Authorized
Representative/Distributed
by

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. [phone]
Fax [phone]

Asia-Pacific

Japan

Medtronic Japan
Comodio Shiodome 5F
2-14-1 Higashi-Shimbashi,
Minato-ku
Tokyo 105-0021
Japan
Tel. [phone]
Fax [phone]

Australia

Medtronic Australasia Pty. Ltd.
Business Address:
97 Waterloo Road
North Ryde NSW 2113
Mailing Address:
PO Box 945
North Ryde NSW 1670
Australia
Tel. [phone]
Fax [phone]

Asia

Medtronic International Ltd.
Suite 1602 16/F,
Manulife Plaza
The Lee Gardens,
33 Hysan Avenue
Causeway Bay
Hong Kong
Tel. [phone]
Fax [phone]

Americas

Latin America

Medtronic Latin America
3750 NW 87th Avenue
Suite 700
Miami, FL 33178
USA
Tel. [phone]
Fax [phone]

Canada

Medtronic of Canada Ltd.
6733 Kitimat Road
Mississauga, Ontario L5N 1W3
Canada
Tel. [phone]
Fax [phone]
Toll-free in Canada:
1-800-268-5346

United States

Manufacturer:
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.medtronic.com
Tel. [phone]
Fax [phone]
Toll-free in the USA:
1-800-328-2518
(24-hour consultation service)

© Medtronic, Inc. 2004,
2007, 2008
All Rights Reserved
M931110A001 Rev. A