Stryker SPY-PHI Articulating Arm Bedienungsanleitung

INSTRUCTION FOR USE

SPY-PHI Articulating Arm

HH1001 Main Arm / HH1002 Table Clamp / HH1003 Imaging Head Holder

EN | FR | DE | IT | PT | PT-BR | ES | NL | CZ |

DA | FI | NO | SV | PL | EL | TR | RU | JA | KO |

ZH-CN | ZH-TW

| RO

Table of Contents

SPY-PHI Articulating Arm Instruction for Use [EN] 3

SPY-PHI Articulating Arm Mode d’emploi [FR]

SPY-PHI-Gelenkarm Bedienungsanleitung [DE] 26

Braccio articolato SPY-PHI Istruzioni per l’uso [IT] 39

Braço articulado SPY-PHI Instruções de

utilização [PT] 51

Braço articulado SPY-PHI Instruções de uso [PT-BR] 63

Brazo articulado SPY-PHI Instrucciones de uso [ES] 74

SPY-PHI scharnierende arm Gebruiksaanwijzing [NL]

Kloubové rameno SPY-PHI Návod k použití [CZ] 97

SPY-PHI bevægelig arm Brugsanvisning [DA] 108

SPY-PHI-nivelvarsi Käyttöohjeet [FI]

119

SPY-PHI-leddarm Bruksanvisning [NO] 130

SPY-PHI vridbar arm Bruksanvisning [SV] 141

Ramię przegubowe SPY-PHI Instrukcja obsługi [PL] 152

Αρθρωτός βραχίονας

SPY-PHI

Οδηγίες χρήσης

[EL] 164

SPY-PHI Mafsallı Kol Kullanım talimatları [TR] 177

Шарнирно-сочлененная консоль SPY-PHI Инструкция по

применению [RU] 188

SPY-PHI Articulating Arm

使用説明書

[JA] 200

SPY-PHI 굴절 암사용 설명서 [KO] 211

SPY-PHI 关节臂使用说明 [ZH-CN] 222

SPY-PHI 多節臂使用說明

[ZH-TW] 232

Instrucțiuni de utilizare brațarticulat SPY-PHI [RO]

242

INSTRUCTION FOR USE

SPY-PHI Articulating Arm

HH1001 Main Arm / HH1002 Table Clamp /

HH1003 Imaging Head Holder

Axcess Surgical Innovations

141 California Ave, Suite 102

Half Moon Bay, CA 94019 USA

Distributed by:

Novadaq Technologies ULC

8329 Eastlake Drive, Unit 101

Burnaby, BC V5A 4W2

Canada

Customer and Technical Service

Customer Support

Phone: (800) 624 - 4422 Toll Free (USA only)

Fax: (800) 729 - 2917 Toll Free (USA only)

Email: EndoCustomerSupport@stryker.com

Technical Support

Phone: (877) 478-7953 Toll Free

Fax: (408) 754 2037

Email: endots@stryker.com

Axcess Surgical Innovations, B.V.

Kantstraat 19. NL-5076 NP Haaren

P.O. Box NL-5060 GA Oisterwijk

SPY-PHI Articulating Arm

Table of Contents

Definitions

Introduction

Intended Use

Contraindications

Warnings

Possible Adverse Effects

Storage

Product Description and Use

8.1.

Main Arm (HH1001)

8.2.

Table Clamp (HH1002)

8.3.

Imaging Head Holder (HH1003)

Inspection

10.

Cleaning and Sterilization

10.1.

Manual Cleaning Instructions

10.2.

Automated Cleaning Instructions

10.3.

Sterilization Instructions

11.

Complaint Handling/ Reporting

1. Definitions

Explanation of Symbols

Reference number

Batch Code

Product Quantity

Compliant with European

Medical Device Regulation

Date of Manufacture

Manufacturer

Authorized Representative in

the European Community

Product Supplied Non-Sterile

Indicates product is a Medical Device

2. Introduction

The SPY-PHI Articulating Arm consists of three components:

Main Arm (HH1001), Table Clamp (HH1002) and Imaging Head

Holder (HH1003).

3. Intended Use

The SPY-PHI Articulating arm is intended as an accessory to

the SPY Portable Handheld Imaging System, HH9000, for use

during surgical procedures or other applications where the user

wishes to position the imaging head in a fixed location while

imaging, instead of holding it by hand.

Main Arm (HH1001): This component is used to position and

hold the Imaging Head Holder (HH1003).

Table Clamp (HH1002): This component is used to mount the

Main Arm (HH1001) to the table and hold position.

Imaging Head Holder (HH1003): This component is used to

hold the HH9000 Imaging Head.

4. Contraindications

This product is not intended for use except as indicated above.

5. Warnings

1. CAUTION: US Federal law restricts this device to sale by

or on the order of a physician.

2. The product must only be used by trained medical

personnel capable of judging and controlling danger to

patients.

3. The products will be delivered non sterile. Prior to the

initial use, and each following use, the products must be

cleaned, disinfected, and sterilized as well as checked for

visible irregularities and malfunctions according to the

instructions given in this Instructions for Use.

4. Components of the SPY-PHI Articulating Arm (including

table clamp, main arm and imaging head holder) are only

to be used with each other to make up the SPY-PHI

Articulating Arm. Components of the SPY-PHIArticulating

Arm may not be used with other manufacturer’s products.

5. End of life is normally determined by wear and damage

due to use.

6. Use of this component for any purpose, or in any manner

other than those described here may cause component

damage or failure which could result in serious patient

injury or death. If needed, all SPY- PHI Articulating Arm

metal components or fragments thereof can be located by

means of an X-Ray.

7. To maintain intended clamping capacity of the table rail

clamp, do not tighten the table rail clamping knob when

the main arm column is not fully installed.

8. The Rail Clamps are not insulated. If grounding of patient

is NOT ACCEPTABLE, DO NOT use the system.

9. DO NOT FORCE BLACK KNOB OF THE MAIN ARM

PAST STOP WHEN OPENING/LOOSENING.

6. Possible Adverse Effects

Delayed surgical procedure.

7. Storage

Components should be stored in a clean and dry area. Inspect

each component prior to use for functionality and damage.

When necessary, dispose of products in accordance with

national regulations and approved hospital practices for

surgical component disposal.

8. Product Description and Use

8.1

Main Arm (HH1001)

Provides three-point positioning of the

imaging head into the surgical field. The

articulating segments of the Main Arm are

connected to a rigid column.

To position and lock in place:

Hold the distal end with one hand

and loosen the central knob by

turning it counterclockwise.

Position the imaging head as needed

and turn the knob clockwise to lock in

place. Check to see that the Main

Arm is secure enough to hold its

position.

8.2

Table Clamp (HH1002)

Provides an attachment point to the operating table side rail.

Accepts and holds the column of the main arm in position

and allows for full range of rotation.

To attach to the rail:

Open the rail clamping knob until

the L-brackets fit over the rail,

then tighten to secure.

Insert the column of the Main Arm

into the column opening, adjust

the column to the desired angle,

and tighten the column clamping

knob when the main arm is in the

desired position.

8.3

Imaging Head Holder (HH1003)

Connects to the distal end of the main

arm to provide an attachment point for

the SPY-PHI imaging head.

To connect the imaging head holder to

the distal end of the main arm:

Insert the imaging head

hex shaft into the chuck

until it is fully seated.

Twist the collar clockwise to

lock the quick connect

accessory into place. Check

to see that the shaft is

secured, and the collar is in

the locked position.

To disassemble: Reverse the above steps.

To position the imaging head and lock in place:

Rest the neck of the draped

imaging head against the

thin rigid band of the holder

(as shown).

With one hand, pinch the sliding

u-piece until the imaging head

is firmly held in place.

With your other hand, turn the

knob to tighten and lock.

To loosen: Reverse the above steps.

9. Inspect Before Use

All products should be inspected throughout their lifetime to

ensure proper function and performance. If product does not

pass the inspection, do not use.

Main Arm (HH1001)

1. Visually inspect component for damage or cracks.

2. Check to make sure that the arm is rigid at all three joints by

turning central tightening knob clockwise.

3. Insert arm column into table clamp, turn column clamping knob

clockwise and ensure that it holds securely.

4. Check quick connect distal end to make sure the collar locks

and unlocks accessory securely.

Table Clamp (HH1002)

1. Visually inspect component for damage or cracks.

2. L-Bracket on Table Clamp should clamp securely to tablerail.

3. Insert Main Arm into column opening, turn central tightening

knob clockwise and make sure the post is held securely inside

the column opening.

Imaging Head Holder (HH1003)

1. Visually inspect instruments for damage orcracks.

2. Quick connect shaft should freely engage and disengage in

and out of the quick connect distal end

10. Cleaning and Sterilization

NOTE:

1. The color of the SPY-PHI Articulating Arm components may

vary due to the anodizing process or alloy used. Shading or

loss of color may also occur after sterilization. This is not a

defect in the products or material and will not affect the

performance of your high-quality product.

2. Automated cleaning is not suitable for instruments with ball

joints. Such instruments should only undergo a manual

cleaning prior to sterilization.

CAUTION: Only cleaning and sterilization procedures as

indicated in this IFU should be used for cleaning and sterilization.

Supplies and Equipment Needed:

•

Ultrasonic Cleaner

•

FDA Cleared CSR Wrap

•

pH Neutral Cleaner such as Prolystica manufactured

by Steris Corp. or equivalent

•

3-1000 MILTEX Component Cleaning Brush, Nylon

Bristles or equivalent (available from IntegraMiltex)

•

Chemical Indicator Tape

10.1

Manual Cleaning Instructions

NOTE: Turn tightening knob of the main arm clockwise to tighten

ball joint prior to placing arm in ultrasonic cleaner (sonicator).

1. Rinse each component individually with a steady stream of

warm tap water (16.9°C to 18.9°C) until gross

contaminants are removed. This process should take

approximately 1-2 minutes.

2. Place each component into an ultrasonic cleaner (sonicator)

containing an enzymatic, pH neutral detergentsolution

and warm tap water (25°C to 35°C) prepared according to

the detergent manufacturer’s instructions and sonicate for

10 minutes.

3. In a wash container, large enough to immerse each

component, prepare a wash solution using an enzymatic,

pH neutral detergent solution and warm tap water (25°C to

35°C) prepared according to the detergent manufacturer’s

instructions.

4. Transfer each component to a manual wash container

and fully immerse in the cleaning solution prepared in

Step 3.

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