Stryker SPY-PHI Articulating Arm User manual

©2020 IFU-0100 / rev3
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

©2020 IFU-0100 / rev3
Table of Contents
SPY-PHI Articulating Arm Instruction for Use [EN] 3
SPY-PHI Articulating Arm Mode d’emploi [FR] 14
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] 86
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

©2020 IFU-0100 / rev3 3
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: [e-mail]
Technical Support
Phone: [phone] Toll Free
Fax: [phone]
Email: [e-mail]
Axcess Surgical Innovations, B.V.
Kantstraat 19. NL-5076 NP Haaren
P.O. Box NL-5060 GA Oisterwijk

©2020 IFU-0100 / rev3 4
SPY-PHI Articulating Arm
Table of Contents
1. Definitions
2. Introduction
3. Intended Use
4. Contraindications
5. Warnings
6. Possible Adverse Effects
7. Storage
8. Product Description and Use
8.1. Main Arm (HH1001)
8.2. Table Clamp (HH1002)
8.3. Imaging Head Holder (HH1003)
9. Inspection
10. Cleaning and Sterilization
10.1. Manual Cleaning Instructions
10.2. Automated Cleaning Instructions
10.3. Sterilization Instructions
11. Complaint Handling/ Reporting

©2020 IFU-0100 / rev3 5
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

©2020 IFU-0100 / rev3 6
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.

©2020 IFU-0100 / rev3 7
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:
1. Hold the distal end with one hand
and loosen the central knob by
turning it counterclockwise.
2. 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.

©2020 IFU-0100 / rev3 8
To attach to the rail:
1. Open the rail clamping knob until
the L-brackets fit over the rail,
then tighten to secure.
2. 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:
1. Insert the imaging head
hex shaft into the chuck
until it is fully seated.
2. 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:
3. Rest the neck of the draped
imaging head against the
thin rigid band of the holder
(as shown).

©2020 IFU-0100 / rev3 9
4. With one hand, pinch the sliding
u-piece until the imaging head
is firmly held in place.
5. 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

©2020 IFU-0100 / rev3 10
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.

©2020 IFU-0100 / rev3 11
5. While still submerged, any visible contamination and debris
should be removed by scrubbing each component with a
soft nylon bristle brush until visibly clean, paying particular
attention to hard-to-clean areas such as crevices and
joints. This process should take approximately 1-2minutes.
6. Rinse with flowing, cold deionized water (17°C to 21°C) for
30-60 seconds until no visible soil remains.
7. Dry each component using clean, absorbent, low lint wipes
to remove excess rinse water.
10.2 Automated Cleaning Instructions
CAUTION: Use only washer/disinfector machines that have
been validated in accordance with ISO 15883. AUTOMATED
CLEANING IS NOT SUITABLE FOR MAIN ARM. AUTOMATED
CLEANING IS ONLY SUITABLE FOR TABLE CLAMPS AND
IMAGING HEAD HOLDER.
Perform pre-cleaning to remove gross contaminants as follows:
1. Prepare a wash solution using an enzyme pH neutral
detergent, in a wash container with tap water (27°C to 33°C)
using the minimum concentration recommended by the
detergent manufacturer.
2. Submerge and soak in wash solution for a minimum of 1
minute.
3. While still submerged, remove visible soil by scrubbing with a
soft nylon bristle brush for a minimum of 4 minutes until no
visible soil is observed.
4. Rinse with flowing, cold deionized water (18.5°C to 20.2°C)
for a minimum of 30 seconds for each component.
5. Load components into washer/disinfector in accordance with
the manufacturer’s instructions.
6. Arrange components with curved surfaces and cannulations
facing downward to prevent pooling of water.
7. Operate the washer/disinfector cycle according to the
manufacturer’s instructions.

©2020 IFU-0100 / rev3 12
Recommended minimal washer /disinfector parameters:
Temperature
Time
Heated Wash
60°C (140°F)
2 Min.
Heated Tap Water Rinse
60°C (140°F)
20 Sec.
Heated Deionized Water Rinse
82°C (180°F)
1 Min.
Forced Air Drying
116°C (240°F)
9 Min.
10.3 Sterilization Instructions
NOTE:
1. For components with moving parts, lubricate joints with a
steam-permeable, water soluble component lubricant prior
to sterilization.
2. Components should be sterilized in the opened or unlocked
position. Central knob of the articulating arms must be
opened for sterilization.
3. Components should be sterilized by standard cycles using
steam with the procedures listed below.
Preparation for Sterilization:
Note: Use only FDA Cleared CSR Sterilization Wrap for
component packaging.
• Each component should be wrapped in two layers of FDA
Cleared CSR Wrap using the simultaneous double-
wrapping equal fold technique.
• Chemical Indicator Tape should be used to secure
packaging and for labeling the contents. Note: Chemical
Indicator Tape will change color or display diagonal stripes
when exposed to temperatures of 121°C (250°F).
Note: Only use wrappers validated for use in double simultaneous
wrapping.
Two single-layer wrappers or one bonded double wrapper can
be used. Simultaneous double wrapping refers to when two
layers of wrap material are wrapped together simultaneously
using the fold technique described below:
1. Place the edge of the wrapper parallel with the edge of
the table. Place the device in the center of the wrapper
parallel with the edge of the wrapper.
2. Fold the edge of the wrapper over the top of the contents,
covering the entire item. Fold the edge back over itself
(toward the technician) to form a cuff. This will facilitate
aseptic opening of the pack when used.

©2020 IFU-0100 / rev3 13
3. Bring the upper edge of the wrap down completely over
the contents and fold it back on itself to form another
cuff,
overlapping the original.
4. Fold the left edge of the wrapper snuggly over the pack
and back on itself to form a cuff.
5. Fold the right side of the wrapper over the pack, overlapping
the previous fold and folded back to form a cuff, or tuck
under and secure with indicator tape.
Gravity
Sterilize at 121°C (250°F) for 30 minutes with a 30-minute dry
time.
Prevacuum United States Standards
Sterilize at 132°C (270°F) for 4 minutes with a 30-minute dry time.
Prevacuum EU Standards
Sterilize at 134°C (273°F) for 3 minutes with a 30-minute dry time.
Autoclave temperatures should not surpass 280°F (137°C), as
the handle, insulation or other non-metallic parts may be
affected. (Note: The steam autoclave manufacturer may be
contacted to confirm appropriate temperatures and sterilization
times.)
11. Complaint Handling/ Reporting
Any adverse event involving the SPY-PHI Articulating Arm
should be reported to Stryker and the country specific
regulatory authorities immediately. To report an event to
Stryker, call:
(800) 624 - 4422 Toll Free (USA only) or Email:
[e-mail]

©2020 IFU-0100 / rev3 14
French
MODE D’EMPLOI
SPY-PHI Articulating Arm
HH1001 Bras articulé / HH1002 Pince de table /
HH1003 Repose-tête d’exploration
Axcess Surgical Innovations
141 California Ave, Suite 102
Half Moon Bay, CA 94019 USA
Distribué par:
Novadaq Technologies ULC
8329 Eastlake Drive, Unit 101
Burnaby, BC V5A 4W2
Canada
Assistance client/ Assistance technique
Assistance client
Téléphone: (800) 624 - 4422 Toll Free (USA only)
Fax: (800) 729 - 2917 Toll Free (USA only)
Email: [e-mail]
Assistance technique
Téléphone: [phone] Toll Free
Fax: [phone]
Email: [e-mail]
Axcess Surgical Innovations, B.V.
Kantstraat 19. NL-5076 NP Haaren
P.O. Box NL-5060 GA Oisterwijk

©2020 IFU-0100 / rev3 15
SPY-PHI Articulating Arm
Table des matières
1. Définitions
2. Introduction
3. Usage prévu
4. Contre-indications
5. Avertissements
6. Effets indésirables possibles
7. Stockage
8. Description et utilisation du produit
8.1. Bras principal (HH1001)
8.2. Pince de table (HH1002)
8.3. Repose-tête d’exploration (HH1003)
9. Inspection
10. Nettoyage et stérilisation
10.1. Instructions de nettoyage manuel
10.2. Instructions de nettoyage automatique
10.3. Instructions de stérilisation
11. Gestion des réclamations/ Rapports

©2020 IFU-0100 / rev3 16
1. Définitions
Explication des symboles
N° de référence
Code de lot
Quantité de produit
Conforme à la réglementation
européenne relative aux les
dispositifs médicaux
Date de fabrication
Fabrication
Mandataire pour la Communauté
européenne
Produit fourni non stérile
Indique que le produit est un dispositif
médical

©2020 IFU-0100 / rev3 17
2. Introduction
Le bras articulé SPY-PHI est constitué de trois composants :
Le bras principal (HH1001), la pince de table (HH1002) et le
repose-tête d’exploration (HH1003).
3. Usage prévu
Le bras articulé SPY-PHI a été conçu comme un accessoire
pour le système d’imagerie portatif SPY, HH9000, pour une
utilisation dans le cadre d’interventions chirurgicales ou
d’autres applications où l’utilisateur souhaite placer la tête
d'exploration à un endroit fixe pendant la prise d’images, au
lieu de la tenir à la main.
Bras principal (HH1001) : Ce composant sert à placer et à
maintenir le repose-tête d’exploration (HH1003).
Pince de table (HH1002) : Ce composant sert à monter le
bras principal (HH1001) sur la table et à le maintenir en
position.
Repose-tête d'exploration (HH1003) : Ce composant sert
à tenir la tête d'exploration HH9000.
4. Contre-indications
Ce produit n’est pas destiné à être utilisé autrement qu’indiqué
ci-dessus.
5. Avertissements
1. MISE EN GARDE: La loi fédérale américaine restreint
ce dispositif à la vente par ou sur l’ordre d’un médecin.
2. Le produit doit être utilisé uniquement par un
personnel médical qualifié, capable de juger et de
contrôler tout danger pour les patients.
3. Les produits sont livrés non stériles. Avant la première
utilisation et chaque utilisation suivante, les produits
doivent être nettoyés, désinfectés et stérilisés, et
inspectés pour détecter les irrégularités visibles et les
dysfonctionnements éventuels conformément aux
instructions données dans ce mode d'emploi.
4. Les composants du bras articulé SPY-PHI (y compris la
pince de table, le bras principal et le repose-tête
d’exploration) doivent être utilisés ensemble afin de
constituer le bras articulé SPY-PHI. Les composants du
bras articulé SPY-PHI ne doivent pas être utilisés avec
des produits d’un autre fabricant.
5. La fin de vie est normalement déterminée par l’usure
et les détériorations causées par l’utilisation.

©2020 IFU-0100 / rev3 18
6.Pour maintenir la capacité de serrage prévue de la
pince du rail de table, ne serrez pas le bouton de
serrage du rail de table lorsque la colonne du bras
articulé n’est pas complètement installée.
7. Pour maintenir la capacité de serrage prévue de la
pince de rail de table, ne serrez pas le bouton de
serrage du rail de table lorsque la colonne du bras
principal n'est pas complètement installée.
8. Les pinces de rail ne sont pas isolées. Si la mise à la
terre du patient N'EST PAS ACCEPTABLE, NE PAS
utiliser le système.
9. NE PAS FORCER LE BOUTON NOIR DU BRAS
PRINCIPAL AU-DELÀ DE LA BUTÉE LORS DE
L'OUVERTURE/DU RELÂCHEMENT.
6. Effets indésirables possibles
Intervention chirurgicale retardée.
7. Stockage
Les composants doivent être stockés dans un lieu propre et sec.
Inspectez chaque composant et leur bon fonctionnement avant toute
utilisation, afin de vérifier qu’ils ne présentent aucun dommage. Si
nécessaire, éliminez les produits conformément à la réglementation
nationale et aux pratiques hospitalières approuvées pour l’élimination
des composants chirurgicaux.
8. Description et utilisation du produit
8.1 Bras principal (HH1001)
Permet un positionnement à trois points
de la tête d’exploration dans le champ
chirurgical. Les segments articulés du
bras principal sont reliés à une colonne
rigide.
Pour positionner le bras principal et verrouiller sa position:
1. Tenez l’extrémité distale d’une
main et desserrez le bouton
central en le tournant dans le
sens anti-horaire.
2. Placez la tête d’exploration comme
vous le souhaitez, puis tournez le
bouton dans le sens horaire pour
verrouiller la position. Vérifiez que le
bras principal est suffisamment fixé
pour maintenir cette position.

©2020 IFU-0100 / rev3 19
8.2 Pince de table (HH1002)
Fournit un point de fixation sur le rail latéral de la table
d’opération. Accueille et maintient la colonne du bras
principal en position et offre un rayon de rotation complet.
Pour fixer le rail:
1. Ouvrez le bouton de serrage du
rail jusqu’à ce que les crochets en
L correspondent à la largeur du
rail, puis serrez-les pour fixer le
rail.
2. Insérez la colonne du bras
principal dans l’ouverture de la
colonne, ajustez la colonne jusqu’à
obtenir l’angle désiré et, une fois le
bras principal dans la position
désirée, serrez le bouton de
serrage.
8.3 Repose-tête d’exploration (HH1003)
Se connecte à l’extrémité distale du
bras principal pour fournir un point de
fixation pour la tête d’exploration SPY-
PHI.
Pour connecter le repose-tête
d’exploration à l’extrémité distale du
bras principal:
1. Insérez l’arbre hexagonal
de la tête d’exploration dans
le mandrin jusqu’à ce qu’il
soit complètement en place.
2. Tournez le collier dans le
sens horaire pour verrouiller
en place l'accessoire de
connexion rapide. Vérifiez
que l'arbre est bien fixé et
que le collier est en position
verrouillée.
Pour le démonter : Exécutez les étapes dans le sens inverse.

©2020 IFU-0100 / rev3 20
Pour positionner la tête d’exploration et verrouiller sa position:
3. Faites reposer le cou de la
tête d’exploration
enveloppée dans du papier
contre la fine bande rigide
du repose-tête d’exploration
(comme illustré).
4. D’une main, pincez le collier
coulissant jusqu’à ce que la tête
d'exploration soit maintenue
fermement en place.
5. De l’autre, tournez le bouton
pour serrer et verrouiller la
position.
Pour desserrer : Exécutez les étapes
dans le sens inverse.
9. Inspection
Tous les produits doivent être inspectés tout au long de leur
durée de vie afin de garantir leur bon fonctionnement et leurs
performances. Si le produit ne passe pas l'inspection, ne
l’utilisez pas.
Bras principal (HH1001)
1. Procédez à une inspection visuelle du composant pour
détecter les dommages ou fissures éventuels.
2. Vérifiez que le bras est rigide aux trois articulations en
tournant le bouton de serrage central dans le sens horaire.
3. Insérez la colonne du bras dans la pince de table, tournez le
bouton de serrage de la colonne dans le sens horaire et
assurez-vous qu’elle est bien fixée.
4. Vérifiez l'extrémité distale à connexion rapide pour vous
assurez que le collier verrouille et déverrouille l'accessoire
de manière sécurisée.