Abbott IonicRF User manual

IonicRF™ Generator Pole Mount
Model RF-POLE
Instructions for Use

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
™ Indicates a trademark of the Abbo group of companies.
‡ Indicates a third-party trademark, which is property of its respecve owner.
Pat. hp://www.abbo.com/patents
© 2021 Abbo. All Rights Reserved.

Contents
Product Descripon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indicaons for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Clinical Benet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Precauons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Adverse Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Compability Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Pole Mount Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Preparing to Use the Pole Mount. . . . . . . . . . . . . . . . . . . . . . . 4
Step 1: Aach the Pole Mount to the Roll Stand. . . . . . . . . . . . . . . 4
Step 2: Remove the Countertop Stand. . . . . . . . . . . . . . . . . . . . . . . 6
Step 3: Aach the Generator to the Pole Mount. . . . . . . . . . . . . . . 7
Cleaning Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Incident Reporng. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Symbols and Denions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Addional Symbols for Product Labels. . . . . . . . . . . . . . . . . . . . . . 11
Technical Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Warranty Informaon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
i

Product Descripon
The IonicRF™ generator pole mount is a bracket that provides a
method of mounng the IonicRF™ generator on a compable
equipment pole (roll stand).
Intended Use
The IonicRF™ generator pole mount (hereaer referred to as the "pole
mount") is an accessory that is intended to be used to secure the
IonicRF™ generator to a compable roll stand.
Indicaons for Use
For informaon such as indicaons for use, refer to the clinician's
manual for the IonicRF™ generator.
Contraindicaons
For informaon related to contraindicaons, refer to the clinician's
manual for the IonicRF™ generator.
Clinical Benet
As an accessory, the IonicRF™ generator pole mount contributes to the
intended clinical benet of the compable IonicRF™ generator.
Warnings
The following warnings apply to these components:
▪Before attaching the generator, ensure the pole mount is▪
securely fastened to the roll stand. Failing to secure the pole
mount may cause the product to fall, resulting in injury or
product damage.
▪Before starting a procedure, ensure the generator is ▪
fastened securely to the pole mount. Failing to secure the
1

generator may cause the product to fall, resulting in injury or
product damage.
▪When installed, ensure the top of the generator is no higher▪
than 139.7 cm (55 in) from the floor.
▪Do not mount or suspend any item on the roll stand other▪
than the pole mount and generator.
▪Do not place any items exceeding 4.4 pounds (2 kilograms)▪
on the roll stand tray.
▪Unlock the roll stand wheels before moving the pole-▪
mounted generator.
▪Pulling on the roll stand when the wheels are locked may ▪
cause the roll stand to tip or fall, which may cause injury or
interrupt the procedure.
Precauons
The following precauons apply to these components:
▪Only use the IonicRF™ pole mount with the IonicRF™▪
generator model RFG‑IONIC and the roll stand
model RD‑0856.
▪Before moving the roll stand with the generator attached or▪
using the pole-mounted generator, ensure that any cables
attached to the generator will not become entangled with
other objects or present a tripping hazard.
▪Two people are required to assemble the generator and pole ▪
mount to prevent the product from falling, resulting in injury
or product damage.
▪The roll stand assembly requires two people. ▪
▪Observe caution when moving the pole-mounted generator ▪
to avoid toppling of the device which may cause injury or
product damage.
2

Adverse Events
Supercial ssue injury may occur if the pole mount is not installed
and used according to this manual.
Compability Guidelines
Only the following products may be used with the IonicRF™ generator
pole mount (model RF‑POLE):
Product Model
IonicRF™ generator RFG‑IONIC
Roll stand RD‑0856
Pole Mount Components
The following gure provides informaon about the pole mount
components.
Figure 1. Pole mount shown with compable roll stand
Pole Mount
1. Pole mount clamp base
2. Capve thumb screws (4)
3. Pole mount clamp cap
4. Cap-head screws (2)
5. Hex drive screwdriver
(5 mm)
Roll Stand (packaged separately)
6. Tray
7. Pole
8. Wheels (3 non‑locking,
3 locking)
3

Preparing to Use the Pole Mount
The IonicRF™ generator is portable and can be placed on a level
surface using the countertop stand or mounted to a compable roll
stand using the IonicRF™ generator pole mount.
To use the pole mount with the IonicRF generator, follow the steps in
this secon.
NOTE: This assembly requires two people.
Step 1: Aach the Pole Mount to the Roll
Stand
NOTE: The roll stand must be assembled before use. For informaon
about assembling the roll stand, refer to the assembly instrucons
for that product.
Figure 2. Locking the wheels on the roll stand
1. Locked
2. Unlocked
1. Lock the wheels on the roll stand by pressing down on the 1.
three black brakes.
4

Figure 3. Placing the pole mount on the pole
2. Slide the pole mount onto the pole unl the top of the pole2.
mount clamp is below the boom edge of the black pole cap.
NOTE: The top of the pole mount clamp should be at least
1.2 cm below the top of the pole. When installed, ensure the
top of the generator is no higher than 139.7 cm (55 in) from the
oor.
Figure 4. Tightening the cap-head screws
1. Top of pole mount clamp
placed at least 1.2 cm
(0.5 in) below the boom
edge of the black pole cap
3. Using the screwdriver included in the kit, ghten the cap-head
3.
screws, alternang between the two, unl the pole mount
clamp base is rmly aached to the clamp cap.
5

WARNING: Ensure the pole mount is securely fastened to the
pole before aaching the generator. Failing to secure the pole
mount may cause the product to fall, resulng in injury or
product damage.
Step 2: Remove the Countertop Stand
NOTE: The IonicRF™ generator is supplied with an aached
countertop stand. Before aaching the generator to the pole mount,
the countertop stand must be removed. Always place the generator
on a level surface when adding or removing the countertop stand.
Figure 5. Removing the countertop stand from the generator
1. Using your ngers, fully loosen each of the four capve thumb
1.
screws on the countertop stand unl they are disengaged from
the generator.
2. Remove the stand from the generator. 2.
6

Step 3: Aach the Generator to the Pole
Mount
NOTE: Aaching the generator requires two people—one to hold the
generator in posion and one to aach the generator.
1. Person 1: Lock the wheels on the roll stand. 1.
2. Person 1: Ensure that the pole mount is fastened securely to 2.
the pole.
Figure 6. Aligning the screw holes with the capve thumb screws
1. Generator
2. Pole mount
3. Pole
4. Screw holes
5. Capve thumb screws
3. Person 1: Hold the generator in place. 3.
Person 2: Align the four screw holes on the back of the
generator with the capve thumb screws on the pole mount.
7

Figure 7. Fastening the generator
4. Person 2: Thread each of the four capve thumb screws unl all4.
are engaged.
5. Person 2: Hand ghten each of the four capve thumb screws5.
unl the generator is fastened securely.
Cleaning Guidelines
To clean the pole mount, use any of the following:
▪A cotton cloth soaked with 99% isopropyl alcohol ▪
▪Sani-Cloth‡ AF3 germicidal disposable wipes ▪
For informaon about cleaning the generator or roll stand, refer to the
instrucons for use for the appropriate product.
Incident Reporng
In the course of use of this device, if you have reason to believe that a
serious incident occurred, please report it to the manufacturer. For
customers in the European Union, report the serious incident to your
naonal authority as well as to the manufacturer.
8

For user facilies in the United States, report a medical device-related
serious injury to the manufacturer, or to the FDA if the medical device
manufacturer is unknown.
Symbols and Denions
The symbols below and harmonized symbols may be found on the
product or product label. For harmonized symbols, refer to the
Universal Symbols Glossary at medical.abbo/manuals.
Symbol Denion
Cauon
Refer to instrucon manual/booklet
Consult instrucons for use
Follow instrucons for use on this website
Installaon requires two people
Safe working load
Date of manufacture
Do not use if package is damaged
9

Symbol Denion
Catalog number
Manufacturer
Packaging unit
Batch code
Unique Device Idencaon
Medical Device
Prescripon use only
Authorized representave in the European
Community
Importer
European conformity, axed in accordance with
the relevant provisions of European Council
Regulaon 2017/745. Hereby, Abbo Medical
declares that this device is in compliance with
the relevant provisions of this regulaon.
10

Addional Symbols for Product Labels
The following table shows addional symbols that may appear on the
product labels for parts related to this kit.
Symbol Denion
Generator Pole Mount
Technical Support
For technical quesons and support for your product, use the
following informaon:
▪[phone] (toll-free within North America) ▪
▪[phone] ▪
For addional assistance, call your local Abbo Medical
representave.
Warranty Informaon
See product packaging and relevant commercial agreements for
specic warranty informaon.
11

Abbott Medical
5050 Nathan Lane North
Plymouth, MN 55442 USA
[phone]
[phone]
Abbott Medical
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
[phone]
2021-08
ARTEN600218257 A
*600218257*