HyperBranch Adherus AutoSpray ET Dural Sealant User manual

NUS-009
Instructions for Use
Instrucciones de uso
Gebrauchsanweisung
Istruzioni per l’uso
Mode d’emploi
Instruções de uso
Bruksanvisning
Bruksanvisning
Käyttöohjeet
Brugsanvisning
Οδηγίες χρήσης
תוארוה שומיש
Kullanma Talimatı
Инструкция по применению
800-12 Capitola Drive
Durham, NC 27713 USA
www.hyperbranch.com
0050
MedPass International Limited
Windsor House
Bretforton
EVESHAM
Worcestershire
WR11 7JJ
United Kingdom

Explanation of Symbols
The following table shows symbols used in this manual, on system components and on packaging labels. The
table gives the corresponding meaning of each symbol. Pay attention to these symbols as they may relate to
important safety precautions and warnings.
Symbol
Meaning
Consult Instructions For Use for additional information
Single use only; Do not reuse
Do not re-sterilize
Sterilized using irradiation
Use by date; Expiration date –year and last day of month
Do not use if package is damaged
Keep away from sunlight
Not for general waste
Authorized representative in the European Community
0050
CE mark and identification number of Notified Body
Lot number
Catalog Number
Quantity
Manufacturer
Type BF equipment (Non-cardiac Floating—Applied Part)
Direct Current
Temperature Limitations (store below)
Biohazard
“On”/”Off” (push-push)

Table of Contents
Device Description ............................................................................................................... 4
Indication ............................................................................................................................. 4
Contraindications ................................................................................................................. 5
Warnings .............................................................................................................................. 5
Precautions .......................................................................................................................... 5
Adverse Events .................................................................................................................... 5
Clinical Information .............................................................................................................. 6
Adherus AutoSpray ET Dural Sealant Sterilization Method and Device Disposal .............. 9
Environmental Operating Conditions .................................................................................. 9
How Supplied ....................................................................................................................... 9
Adherus AutoSpray ET Dural Sealant Operations ............................................................... 9
Reconstituting the Crosslinking Components ..........................................................................9
Turning the Adherus AutoSpray ET Dural Sealant Device On...............................................10
Device and Treatment Site Preparation.................................................................................10
Treatment Delivery................................................................................................................10
Stopping a Spray Application ................................................................................................11
Finishing a Delivery...............................................................................................................11
Adherus AutoSpray ET Dural Sealant Disposal.................................................................. 12
Adherus AutoSpray ET Dural Sealant Electrical Specifications ......................................... 12
Guidance & Manufacturer’s Declaration –Electromagnetic Emissions.................................. 12
Guidance and Manufacturer’s Declaration –Electromagnetic Immunity for all
Equipment and Systems .......................................................................................................13
Guidance and Manufacturer’s Declaration –Electromagnetic Immunity................................14
Recommended Separation Distances Between Portable and Mobile RF
Communications and Adherus AutoSpray ET Dural Sealant................................................. 15
EN

4
Device Description
Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, battery operated
device with internal system components that provide air flow to aid in the delivery of a synthetic, absorbable, two-
component hydrogel sealant system and allow delivery to be interrupted without clogging.
The device is supplied as a pre-assembled applicator and two separate glass vials. The two glass vials contain
either an activated polyethylene glycol (PEG) ester powder or a polyethyleneimine (PEI) dissolved in sterile water.
The crosslinking components are reconstituted prior to use by their respective reconstitution buffers which are
housed within the applicator. The resulting solutions mix within the extended applicator tip and quickly crosslink to
form the hydrogel sealant soon after exiting the applicator tip. The delivered solution immediately crosslinks to
form a hydrogel sealant which is absorbed over approximately 90 days, sufficient time to allow for healing.
The Adherus AutoSpray ET Dural Sealant device is comprised of the following primary components:
Extended Tip Nozzle
The integrated extended tip nozzle is malleable and may be bent or shaped to preference. The extended tip
nozzle thoroughly mixes the two sealant solutions and delivers the mixed solution to the target site through a tight
spray pattern. The spray nozzle is integral to the system and is not removable.
Vial Adapter Hubs
The vial adapter hubs accept the vials containing the crosslinking components. During the reconstitution phase,
the vials are attached to the vial adapter hubs. After reconstitution is completed, the hubs are removed from the
Adherus AutoSpray ET Dural Sealant device by rotating them counterclockwise. Removing the hubs opens the
pathways for the solutions to flow through the nozzle.
On/Off Push Button Switch
The On/Off switch turns the battery powered air pump on and off. The device is shipped with the switch in the off
position which isolates the air pump from the battery power source. Before removing the vial adapter hubs, push
the On/Off switch to On and the air pump will be engaged.
Battery Door
A door on the underside of the housing allows the operating room (OR) staff to remove the batteries for
appropriate disposal at the end of the device use. The battery door is glued shut. Use a flat instrument to pry the
battery door open and remove the batteries for disposal.
Syringe Pusher Assembly
The syringe pusher assembly mechanically locks the two syringe plungers such that advancement of both syringe
plungers occurs simultaneously.
Indication
Adherus AutoSpray ET Dural Sealant is intended for use as an adjunct to standard methods of dural repair, such
as sutures, to provide watertight closure during cranial and spinal procedures.
Syringe Pusher
Assembly
Vial Adapter Hubs
Extended Tip Nozzle
On/Off Push Button

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Contraindications
Adherus AutoSpray ET Dural Sealant should not be used in confined anatomical spaces where nerve
compression is of concern. The hydrogel may swell by up to 13% of its size in any dimension.
Warnings
Adherus AutoSpray ET Dural Sealant has not been studied in:
Subjects who require a procedure involving a translabyrinthine, transsphenoidal, or transoral approach, or any
procedure that penetrates the air sinus or mastoid air cells;
Subjects whose dural edge gaps are larger than 2 mm;
Subjects with severely altered renal or hepatic function;
Subjects with an active infection present at the surgical site;
Subjects who have treated or untreated hydrocephalus (e.g., those with devices designed to evacuate
cerebrospinal fluid (CSF) or altered CSF dynamics);
Subjects who have an underlying medical co-morbidity or are on a medication known to interfere with wound
healing (e.g., those with previous intracranial neurosurgical procedure in the same anatomical location,
radiation and chemotherapy treatment, known malignancy, diabetes, steroid toxicity and chronic corticosteroid
use, compromised immune system, or on an anticoagulant agent, aspirin or non-steroid anti-inflammatory
agent);
Subjects with a known allergy to FD&C Blue #1 Dye or FD&C Yellow #5 Dye; or
Subjects who are pregnant or lactating.
Adherus AutoSpray ET Dural Sealant is intended for use as an adjunct to standard methods of dural repair. The
effectiveness of Adherus AutoSpray ET Dural Sealant on other tissue types has not been studied.
Precautions
The Adherus AutoSpray ET Dural Sealant is packaged sterile. Do not use if the trays have been damaged or
opened. Do not re-sterilize.
The Adherus AutoSpray ET Dural Sealant package is intended for single patient use only. Discard all unused and
/ or opened product. Reuse of the device may result in cross contamination which may lead to injury, illness or
death of the patient.
Keep away from sunlight. Do not use if the PEG ester powder is not free flowing.
Use Adherus AutoSpray ET Dural Sealant within 2 hours of reconstituting the crosslinking components. When
tested 8 hours after reconstitution, the resulting sealant swelled a small but statistically significant amount more
when compared to samples reconstituted for 1, 2, or 4 hours.
The extended applicator tip has been designed to conform to the surgical need by the introduction of bends along
the tip length. Apply careful pressure when bending the tip. Do not bend to angles of greater than 90°. Ensure
hydrogel flow once the applicator has been contoured for the surgical need.
The applicator system has a battery life of approximately 2 hours of continuous use.
Prior to application of the Adherus hydrogel, ensure that fluid (cerebrospinal fluid, blood etc.) outflow has been
suspended.
Do not use the Adherus AutoSpray ET Dural Sealant in the presence of flammable anesthetics or flammable
anesthetics with oxidants.
Keep the Adherus AutoSpray ET Dural Sealant device away from strong magnetic fields to avoid possible
interference of RF communication. Magnetic resonance equipment may generate interference with pump
operations.
Do not remove system covers other than the battery door.
Adverse Events
A similar device, Adherus AutoSpray Dural Sealant, containing the same sealant formulation, Adherus Dural
Sealant, was evaluated in 124 investigational patients in a prospective, controlled, multicenter pivotal clinical
study. The incidence and nature of adverse events observed in this patient population was consistent with the
type and complexity of the neurosurgical procedures performed and the co-morbid state of the treated patients.
There were 4 patient deaths among Adherus AutoSpray Dural Sealant subjects and five deaths among control
subjects. The deaths were attributed to the subjects’prior condition. The adverse events occurring at a rate of 1%
or higher among the adverse events reported for the subjects treated with Adherus AutoSpray Dural Sealant are
summarized in the table below. There were no unanticipated adverse device effects.

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Table 1. Summary of Adherus AutoSpray Dural Sealant Adverse Events
Adverse Event
Patients (n (%))
N=124
Anaemia
3 (2.4)
Leukocytosis
2 (1.6)
Deafness Unilateral
2 (1.6)
Tinnitus
4 (3.2)
Diplopia
5 (4.0)
Eyelid Ptosis
2 (1.6)
Periorbital Oedema
6 (4.8)
Vision Blurred
7 (5.6)
Dysphagia
4 (3.2)
Nausea
2 (1.6)
Adverse Reaction
6 (4.8)
Chest Pain
3 (2.4)
Disease Progression
3 (2.4)
Fatigue
2 (1.6)
Pneumonia
2 (1.6)
Urinary Tract Infection
2 (1.6)
Wound Infection
2 (1.6)
Incision Site Hypoaesthesia
3 (2.4)
Incision Site Pain
4 (3.2)
Periorbital Haemorrhage
3 (2.4)
Post Procedural Oedema
2 (1.6)
Pseudomeningocele
9 (7.3)
Seroma
3 (2.4)
Subdural Haematoma
3 (2.4)
Wound Dehiscence
2 (1.6)
Muscular Weakness
2 (1.6)
Aphasia
4 (3.2)
Balance Disorder
2 (1.6)
Convulsion
5 (4.0)
Cranial Nerve Palsies Multiple
2 (1.6)
Dizziness
7 (5.6)
Embolic Stroke
2 (1.6)
Headache
14 (11.3)
Hemiparesis
2 (1.6)
Hypoaesthesia
4 (3.2)
Hypoglossal Nerve Paralysis
2 (1.6)
Memory Impairment
2 (1.6)
Nystagmus
3 (2.4)
Paraesthesia
5 (4.0)
Sensory Loss
3 (2.4)
Tremor
2 (1.6)
VIIth Nerve Paralysis
3 (2.4)
Vocal Cord Paralysis
2 (1.6)
Atelectasis
2 (1.6)
Respiratory Failure
2 (1.6)
Alopecia
2 (1.6)
Rash
2 (1.6)
Swelling Face
4 (3.2)
Clinical Information
A prospective, randomized, controlled, multicenter pivotal trial has been conducted to evaluate the use of Adherus
Dural Sealant, delivered using the Adherus AutoSpray applicator, as an adjunct to standard methods of dural
repair, such as sutures, to provide watertight closure during cranial surgery. The primary endpoint of this study
was a composite evaluation of the safety and effectiveness of Adherus AutoSpray Dural Sealant (n=124 subjects)
when compared to an active control (n=126 subjects). The endpoint results were based on the number of subjects
who were free from intra-operative CSF leakage from dural repair after up to two applications of sealant during
the Valsalva maneuver, CSF leak/pseudomeningocele during the 120-day follow-up period and unplanned

7
retreatment of the original surgical site within 120 days post-surgery. The overall success rate for the complete
case analysis was 91.2% in the Adherus group compared to 90.6% in the control group. Adherus was found to be
non-inferior to the control with the non-inferiority margin of 10% (p = 0.005). In the early post-surgical period when
the sealants are expected to function, the overall success rate at the 14-day follow-up on subjects who completed
the visit was 99.1% in the Adherus group compared to 95.0% in the control group. In addition, the overall success
rate at the 45-day follow-up on subjects who completed the visit was 96.6% in the Adherus group compared to
91.9% in the control group. The freedom from primary endpoint failure analysis also showed that the primary
endpoint failures in the control group tended to occur early in the follow-up period while a majority of Adherus
endpoint failures were identified through protocol-required radiographic imaging at the 120-day follow-up visit.
Safety was assessed based on evaluation of wound healing, surgical site infections, meningitis, worsening
Modified Rankin Score, surgical site swelling and adverse events through the 120 day follow-up period. One
hundred (80.6%) subjects in the Adherus group and 98 (77.8%) subjects in the control group experienced at least
one adverse event within the 120 day follow-up period. There were no unanticipated adverse device effects.
Among the subjects treated with Adherus AutoSpray Dural Sealant, there were no device related deep wound
infections and no cases of meningitis. The type and rate of adverse events observed in this study are consistent
with the complexity of the surgical procedure and the co-morbid condition of the treated subjects.
Key Inclusion/Exclusion criteria for the study included the following:
Pre-Operative Inclusion Criteria:
Subject was ≥ 18 and ≤ 75 years of age.
Subject was scheduled for an elective cranial procedure involving a dural incision using any of the
following surgical locations / approaches (or combination): frontal, temporal, occipital and parietal (i.e.
supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial).
Subject required a procedure involving a Class I/clean wound (uninfected surgical wound in which no
inflammation was encountered).
Pre-Operative Exclusion Criteria:
Subject required a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any
procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air
cells was not an exclusion if cells were appropriately sealed (e.g. bone wax).
Subject had a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-
peritoneal shunts.
Subject had an external ventricular or lumbar CSF drain that must be left in place after surgery.
Subject had clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
Subject had undergone a previous intracranial neurosurgical procedure in the same anatomical location.
(Note: stereotactic biopsy was not exclusionary).
Subject experienced previous CSF leak (secondary to trauma, neoplasm, surgery or other etiology).
Subject had radiation treatment to the surgical site, or standard fractionated radiation therapy was
planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index
procedure was not an exclusion criterion).
Subject had experienced a traumatic injury to the head within 30 days prior to the planned index
procedure resulting in basilar skull fracture or fractures involving the paranasal sinuses.
Subject had a known malignancy or another condition with anticipated survival shorter than six months.
Subject had undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to
the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or
chemotherapy treatment was planned within two weeks after the index procedure was performed.
Standard use of peri-operative steroids (i.e., corticosteroids) was permitted. Chronic steroid use (defined
as daily use of corticosteroids for >/= 8 weeks) for the purposes of reducing the side effects of
chemotherapy and/or radiation therapy for cancer was not exclusionary unless the patient was deemed
by the investigator to be suffering from steroid toxicity. Use of corticosteroids on a chronic basis (as
defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy was
exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure.
Subject received warfarin, heparin, other anticoagulant agents, aspirin or non-steroid anti-inflammatory
agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
Subject had a documented clinically significant coagulopathy with a PTT > 37 seconds, or INR > 1.3 INR
units.
Subject had a compromised immune system or autoimmune disease, or was on chronic
immunosuppressant agents at baseline.
Subject had a systemic infection or evidence of any infection near planned operative site.
Subject had a serum creatinine level > 2.0 mg/dL.
Subject had a serum total bilirubin > 2.5 mg/dL at baseline.

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Subject had uncontrolled diabetes as evidenced by the Institution’s standard of care (HbA1c >7%, blood
glucose, etc) at baseline.
Intra-Operative Inclusion Criteria:
Subject’s linear extent of durotomy was ≥ 2 cm.
Subject’s dural margins from the edges of bony defect were ≥ 3 mm throughout.
Subject’s CSF leak was present intra-operatively following completion of primary dural closure (with or
without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva
maneuver, at up to 20 cm H2O for up to five (5) seconds.
Intra-Operative Exclusion Criteria:
Subject had an Incidental finding that met any pre-operative exclusion criterion listed above.
Subject required the intra-operative placement of a CSF diversion device (e.g. ventricular catheter,
subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that was left in
place after the procedure. Note: Subgaleal drains used for acute post-operative management of the
incision site were permitted.
Subject had a gap > 2 mm present between dural edges, or between the edge of dura and duraplasty
material, based on visual estimate by surgeon before application of the surgical sealant.
Table 2. Summary of Demographic Information for Study Patients
Characteristics
Adherus AutoSpray
Dural Sealant
Population
Control Population
Number of Subjects
124
126
Men/Women
41/83
40/86
Median Age (years)
54.2
51.1
Subject ASA score (N (%))
I
2 (1.6)
8 (6.3)
II
47 (37.9)
50 (39.7)
III
69 (55.6)
62 (49.2)
IV
6 (4.8)
6 (4.8)
V
0 (0.0)
0 (0.0)
Primary indication for surgery (N (%))
Tumor
56 (45.2)
53 (42.1)
Epilepsy
1 (0.8)
1 (0.8)
Nerve decompression
17 (13.7)
21 (16.7)
AVM
3 (2.4)
5 (4.0)
Aneurysm
28 (22.6)
26 (21.3)
Chiari malformation
17 (13.7)
18 (14.3)
Cyst
2 (1.6)
1 (0.8)
Other
0 (0.0)
1 (0.8)
Approach (N (%))
Infratentorial
53 (42.7)
52 (41.3)
Supratentorial
71 (57.3)
74 (58.7)
Primary technique for dural closure (N (%))
Suture
48 (38.7)
48 (38.1)
Suture + autologous dural material
29 (23.4)
34 (27.0)
Suture + non-autologous dural material
45 (36.3)
39 (31.0)
AEs reported at a rate of great than 1% in the intent to treat (ITT) subject population are summarized in Table 1,
above.

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Adherus AutoSpray ET Dural Sealant Sterilization Method and Device Disposal
The following table details the method of sterilization and disposal of the Adherus AutoSpray ET Dural Sealant
device.
Description
Part Number
Sterilization
Method
Frequency of
Use
Method of Disposal
Adherus
AutoSpray
ET Dural
Sealant
NUS-009
Radiation
Single Use Only
Dispose of the Adherus
AutoSpray ET Dural Sealant
device in a hospital approved
biohazard container.
Do not place in the trash!
Environmental Operating Conditions
Storage Temperature
Store below 30oC
Operating Temperature
5oC to 35oC
Noise Level
≤60 db
How Supplied
The components of the Adherus AutoSpray ET Dural Sealant package are:
Adherus AutoSpray ET Dural Sealant kit tray (1)
Pre-Assembled applicator (1)
Activated PEG powder in green capped vial (1)
PEI solution in silver capped vial (1)
Adherus AutoSpray ET Dural Sealant Operations
The following sections give instructions for preparing and powering Adherus AutoSpray ET Dural Sealant.
Reconstituting the Crosslinking Components
1) Using aseptic technique, introduce the contents of the outer tray labeled Adherus AutoSpray ET Dural
Sealant into the sterile field.
2) Remove the lid from the Adherus AutoSpray ET Dural Sealant kit tray.
3) Remove the pre-assembled Adherus AutoSpray ET Dural Sealant applicator.
4) With the device oriented such that the extended tip nozzle is pointing up, remove and discard the red caps
covering the spikes on the blue vial adapter hubs on the applicator (Fig. A-1).
Note: It may be necessary to use hemostats or a similar tool to remove the caps. A twisting motion while
removing the cap is also recommended.
5) Remove the vial containing PEI solution (silver capped vial) from the tray and seat the capped end into the
blue vial adapter hub of the applicator corresponding to the white syringe plunger by grasping the applicator
and fully depressing the vial so that the spike penetrates the septa and the silver aluminum seal bottoms out
in the vial adapter hub (Fig. A-2).
6) Remove the vial containing the PEG ester powder (green capped vial) from the tray and seat the capped
end into the blue vial adapter hub of the applicator corresponding to the green syringe plunger by grasping
the applicator and fully depressing the vial so that the spike penetrates the septa and the green aluminum
seal bottoms out in the vial adapter hub (Fig. A-2).
7) With the vials oriented upward, depress the syringe pusher assembly to transfer the liquids into the vials.
Continue to depress the syringe pusher assembly (Fig. A-3).
Note: Use two hands to depress the syringe pusher assembly if necessary.
8) With the syringe pusher assembly still depressed, gently shake the device intermittently until the powder is
completely dissolved (Fig. A-3).
Note: The PEG ester powder will continue to dissolve in between periods of gentle shaking; overly
aggressive shaking can cause excessive entrapped air bubbles.
9) Release the syringe pusher assembly to allow it to rebound backwards and depress a second time to ensure
both solutions are homogeneous.

10
10) Allow the syringe pusher assembly to rebound backwards again and pull the syringe pusher assembly
backwards until all of the reconstituted ingredients are transferred from the vials (overhead view in Fig. A-4).
Note: If the On/Off Push Button is accidentally engaged during the reconstitution phase, the device may be
turned off with no detrimental effects. Use must be completed within two hours of reconstitution for optimal
results.
Turning the Adherus AutoSpray ET Dural Sealant Device On
11) Push the On/Off button on the bottom of the device to “activate” the system prior to hydrogel spray
application (Fig. B-1).
Note: The Adherus AutoSpray ET Dural Sealant applicator should be activated prior to removal of the vial
adapter hubs, just prior to spray application, to avoid inadvertently clogging the nozzle.
Device and Treatment Site Preparation
12) If not already on, push the On/Off button to turn on the Adherus AutoSpray ET Dural Sealant applicator (Fig.
B-1).
Note: The internal air pump is activated by pushing the On/Off button, providing an audible sound that the
system has been activated. If the audible sound from the pump is not present, discontinue use of the current
Adherus AutoSpray ET Dural Sealant unit and follow instructions in the Troubleshooting section.
13) Prior to treatment delivery, orient the device so that the vials are pointed upwards and remove and discard
both vial adapter hubs by rotating the blue hubs counterclockwise until the hubs are ejected from the device
(overhead view in Fig. B-2).
14) For optimal tissue adherence at the treatment site, ensure that 2 to 3 millimeter margins around the defect
are clear of blood, hemostatic agents or other loose tissues and that cerebrospinal fluid outflow is minimized.
15) If necessary, bend or shape the extended tip nozzle to improve access to and/or visualization of the
treatment site.
Treatment Delivery
16) To apply the prepared product, if not already on, push the On/Off button in to turn on the device.
17) Orient the device such that the body of the applicator is pointed up and hold a piece of gauze approximately
5 to 10 centimeters above the nozzle (Fig. B-3).
18) Apply firm even pressure to the center of the syringe pusher assembly until product begins to spray out of
the nozzle (Fig. B-3).
19) Once a green sealant begins to form on the piece of gauze, stop depressing the syringe pusher assembly.
Adherus AutoSpray ET Dural Sealant is now ready for the treatment delivery.

11
20) While aiming at the treatment site and holding the device nozzle approximately 2 to 4 centimeters away,
apply firm even pressure to the center of the syringe pusher assembly to dispense the mixed solution (Fig.
B-4).
21) Continue applying the Adherus sealant system until a thin coating (approximately 1 –2 mm) is formed.
Note: Gauging Thickness:
Sutured dural closure: Ensure that all suture knots are completely covered with hydrogel
sealant. Typically, size 4-0, size 3-0 and size 2-0 sutures are used for dural closure. The
smallest of these is size 4-0 which has a diameter of 0.15 mm to 0.2 mm. A knot of size 4-0
suture will have at least four widths of suture or approximately 0.6 to 0.8 mm of thickness.
Complete knot coverage ensures that the minimum thickness of application is achieved.
Onlay duraplasty closure: Ensure that enough hydrogel sealant is applied to cover the
duraplasty onlay and at least 3-4 mm of surrounding native dura with 1-2 mm of hydrogel
using the height of the onlay material as a depth reference. Note that when moistened with
saline, two common onlay duraplasty materials, DuraGen®Dural Graft Matrix and
Durepair®Dura Regeneration Matrix are approximately 3 mm and 1 mm thick respectively.
Stopping a Spray Application
22) The application may be interrupted at any time during a treatment by halting the pressure applied to the
pusher assembly. However, to prevent clogging, do not turn off the pump until the final sealant application
has been completed.
Note: If excess hydrogel forms on the spray nozzle during an application, it may be removed by gently
wiping with a piece of gauze.
Finishing a Delivery
23) If necessary, excess sealant beyond the edges of the dural margin may be removed with a Penfield probe,
scissors or mechanical disruption.

12
Adherus AutoSpray ET Dural Sealant Disposal
When the final spray application is complete, turn off the device, open the battery door to break the internal seal
and remove the batteries for appropriate disposal. The following table relays important information regarding
disposal of the Adherus AutoSpray ET Dural Sealant components.
Device
Disposal Instructions
Adherus AutoSpray ET
Dural Sealant
Adherus AutoSpray ET Dural Sealant consists of a plastic
enclosure and electrical components. This device must be taken
to separate collection at the product end of life. Do not dispose
of this product as unsorted municipal waste.
Troubleshooting Adherus AutoSpray ET Dural Sealant
The following potential failure modes for Adherus AutoSpray ET Dural Sealant have been identified. Each of the
failure modes includes a safeguard (as listed below) to control for the results of such malfunctions.
Potential Failure Modes
Safeguard
1. Air-pump not activated
1. On/Off switch not depressed
2. Spray nozzle blocked
2. Do not remove vial adapter hubs prior to turning
on air pump, wipe off nozzle after use.
To avoid complications, follow exactly the Adherus AutoSpray ET Dural Sealant Troubleshooting Flow Chart in
the above table. During a procedure, the user’s efforts to troubleshoot Adherus AutoSpray ET Dural Sealant
should be strictly limited to the steps described above. If troubleshooting is not successful, discontinue use of the
current Adherus AutoSpray ET Dural Sealant unit immediately and open a new Adherus AutoSpray ET Dural
Sealant unit.
Adherus AutoSpray ET Dural Sealant Electrical Specifications
The Adherus AutoSpray ET Dural Sealant meets the following standards:
IEC 60601-1 3rd edition Electrical safety standard requirements
IEC 60601-1-2 3rd edition Immunity requirements
Guidance & Manufacturer’s Declaration –Electromagnetic Emissions
Adherus AutoSpray ET Dural Sealant is intended for use in the electromagnetic environment specified below. The
customer or user of Adherus AutoSpray ET Dural Sealant should assure that it is only used in such an
environment.
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions CISPR 11
Group 1
Adherus AutoSpray ET Dural Sealant uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are
not likely to cause interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Adherus AutoSpray ET Dural Sealant is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2
Not applicable
Voltage fluctuations /Flicker
emissions IEC 61000-3-3
Not applicable

13
Guidance and Manufacturer’s Declaration –Electromagnetic Immunity for all Equipment and Systems
Adherus AutoSpray ET Dural Sealant is a battery operated system and is intended for use in the electromagnetic
environment specified below. The customer or user of Adherus AutoSpray ET Dural Sealant should assure that it
is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment-
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
Not Applicable Battery
Operated System with
no Digital Circuitry
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
Not Applicable Battery
Operated System
Main power quality should be that of a
typical commercial or hospital
environment
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
Not Applicable Battery
Operated System
Main power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)for
0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95 % dip in UT)
for 5 sec
Not Applicable Battery
Operated System
Main power quality should be that of a
typical commercial or hospital
environment. If the user of the
equipment requires continued operation
during power main interruptions, it is
recommended that the equipment be
powered from an uninterruptible power
supply or battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
Not Applicable Battery
Operated System with
no Magnetically
Sensitive Components
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
*NOTE: UTis the a.c. main voltage prior to application of the test level.

14
Guidance and Manufacturer’s Declaration –Electromagnetic Immunity
Adherus AutoSpray ET Dural Sealant is intended for use in the electromagnetic environment specified below. The
customer or user of Adherus AutoSpray ET Dural Sealant should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment-Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80MHz to 2.5GHz
Not Applicable
Battery
Operated
System with no
Digital Circuitry
Not Applicable
Battery
Operated
System with no
Digital Circuitry
Portable and mobile RF communications equipment
should be used no closer to any part of Adherus
AutoSpray ET Dural Sealant, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended Separation Distance
d = 1.2√P
d= 1.2√P 80MHz to 800MHz
d= 2.3√P 800MHz to 2.5GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a, should
be less than the compliance level in each frequency
range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which Adherus AutoSpray ET Dural
Sealant is used exceeds the applicable RF compliance level above, the Adherus AutoSpray ET Dural Sealant
device should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the Adherus AutoSpray ET Dural Sealant device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less the 3V/m

15
Recommended Separation Distances Between Portable and Mobile RF
Communications and Adherus AutoSpray ET Dural Sealant
Adherus AutoSpray ET Dural Sealant is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of the Adherus AutoSpray ET Dural Sealant device can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Adherus AutoSpray ET Dural Sealant device as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.2√P
80 MHz to
800 MHz
d = 1.2√P
800 MHz to
2.5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.

16
Explicación de los símbolos
La tabla siguiente muestra los símbolos utilizados en este manual, en los componentes del sistema y en las
etiquetas del envase. La tabla indica el significado correspondiente de cada símbolo. Preste atención a estos
símbolos, ya que pueden relacionarse con precauciones y advertencias importantes de seguridad.
Símbolo
Significado
Consultar las instrucciones de uso para obtener más información
Para un solo uso; no reutilizar
No reesterilizar
Producto esterilizado con radiación
Fecha de caducidad: año y último día del mes
No utilizar si el envase está dañado
Mantener alejado de la luz solar
No desechar con los residuos normales
Representante autorizado en la Comunidad Europea
0050
Marca CE y número de identificación del organismo notificado
Número de lote
Número de catálogo
Cantidad
Fabricante
Equipo de tipo BF (pieza aplicada, flotante no cardíaca)
Corriente continua
Límites de temperatura (almacenar por debajo)
Peligro biológico
Encendido y apagado (botón pulsador)

17
Índice
Descripción del dispositivo ............................................................................................... 18
Indicaciones ....................................................................................................................... 19
Contraindicaciones ............................................................................................................ 19
Advertencias: ..................................................................................................................... 19
Precauciones ..................................................................................................................... 19
Efectos adversos ............................................................................................................... 20
Información clínica ............................................................................................................. 21
Método de esterilización del sellador de duramadre Adherus AutoSpray
ET y eliminación del dispositivo ........................................................................................ 24
Condiciones ambientales de funcionamiento ................................................................... 24
Presentación ...................................................................................................................... 24
Operaciones del sellador de duramadre Adherus AutoSpray ET ..................................... 24
Reconstitución de los componentes reticulantes...................................................................24
Encendido del dispositivo del sellador de duramadre Adherus AutoSpray ET....................... 25
Preparación del dispositivo y del lugar del tratamiento..........................................................25
Administración del tratamiento ..............................................................................................26
Detención de la aplicación de pulverización.......................................................................... 26
Finalización de una administración .......................................................................................26
Eliminación del sellador de duramadre Adherus AutoSpray ET ........................................ 27
Especificaciones eléctricas del sellador de duramadre Adherus AutoSpray ET .............. 28
Guía y declaración del fabricante: Emisiones electromagnéticas ..........................................28
Guía y declaración del fabricante: Inmunidad electromagnética de todos los equipos
y sistemas............................................................................................................................. 29
Guía y declaración del fabricante: Inmunidad electromagnética............................................ 30
Distancias de separación recomendadas entre los equipos portátiles o móviles
de comunicación por radiofrecuencia y el sellador de duramadre Adherus AutoSpray ET ....31
ES

18
Descripción del dispositivo
El sellador de duramadre de punta extendida Adherus AutoSpray (Extended Tip, ET) es un dispositivo
electromecánico, alimentado por pilas, estéril y de un solo uso con componentes de sistema internos que
proporcionan un flujo de aire para facilitar la administración de un sistema sellador de hidrogel sintético,
absorbible y de dos componentes, y permitir la interrupción de la administración sin que se produzcan
obstrucciones.
El dispositivo se suministra como un aplicador preensamblado y dos frascos de vidrio aparte. Los dos frascos de
vidrio contienen uno polvo de éster de polietilenglicol (PEG) activado y el otro una polietileneimina (PEI) disuelta
en agua estéril. Los componentes reticulantes son reconstituidos antes de su uso por sus tampones de
reconstitución respectivos, contenidos en el interior del aplicador. Las soluciones resultantes se mezclan dentro
de la punta extendida del aplicador y se reticulan rápidamente para formar el sellador de hidrogel poco después
de salir por la punta del aplicador. La solución aplicada se reticula inmediatamente para formar un sellador de
hidrogel que es absorbido en un periodo de unos 90 días, tiempo suficiente para permitir la cicatrización.
El sellador de duramadre Adherus AutoSpray ET está compuesto por los siguiente componentes principales:
Boquilla de punta extendida
La boquilla de punta extendida integrada es maleable y puede doblarse o moldearse como se desee. La boquilla
de punta extendida mezcla bien las dos soluciones selladoras y administra la solución mezclada en el lugar
deseado a través de un estrecho patrón de pulverización. La boquilla pulverizadora está integrada en el sistema
y no es de quita y pon.
Conectores adaptadores para frascos
Los conectores adaptadores para frascos permiten acoplar los frascos que contienen los componentes
reticulantes. Durante la fase de reconstitución, los frascos se acoplan a los conectores adaptadores para frascos.
Una vez finalizada la reconstitución, los conectores se retiran del sellador de duramadre Adherus AutoSpray ET
girándolos en sentido contrario al de las agujas del reloj. Al retirar los conectores se abren las vías que permiten
que las soluciones fluyan a través de la boquilla.
Interruptor de botón pulsador de encendido y apagado
El interruptor de encendido y apagado enciende y apaga la bomba de aire alimentada por pilas. El dispositivo se
suministra con el interruptor en la posición de apagado que aísla la bomba de aire de la fuente de alimentación
por pilas. Antes de retirar los conectores adaptadores para frascos, pulse el interruptor de encendido y apagado
para ponerlo en la posición de encendido y accionar la bomba de aire.
Cubierta de las pilas
Una cubierta situada en la parte inferior de la carcasa permite al personal de quirófano extraer las pilas para la
eliminación adecuada al acabar de utilizar el dispositivo. La cubierta de las pilas está cerrada con pegamento.
Utilice un instrumento plano para abrir la cubierta de las pilas y retirar estas para la eliminación.
Conjunto impulsor de las jeringas
El conjunto impulsor de las jeringas fija mecánicamente los dos émbolos de las jeringas de forma que el avance
de los dos émbolos tiene lugar simultáneamente.
Conjunto impulsor de
las jeringas
Conectores adaptadores
para frascos
Boquilla de punta extendida
Botón pulsador de encendido
y apagado

19
Indicaciones
El sellador de duramadre Adherus AutoSpray ET está indicado para utilizarse como complemento de los
métodos habituales de reparación de la duramadre —como, por ejemplo, la sutura—para conseguir un cierre
hermético durante los procedimientos craneales y de columna vertebral.
Contraindicaciones
El sellador de duramadre Adherus AutoSpray ET no deberá utilizarse en espacios anatómicos confinados en los
que exista la posibilidad de que se produzca compresión de nervios. El hidrogel puede hincharse hasta un 13 %
de su tamaño en cualquier dimensión.
Advertencias
El sellador de duramadre Adherus AutoSpray ET no se ha estudiado en:
Pacientes que requieran un procedimiento que incluya un acceso translaberíntico, transesfenoidal o
transoral, o cualquier procedimiento que penetre en el seno aéreo o en las celdillas aéreas mastoideas;
Pacientes cuyos huecos entre los bordes de la duramadre tengan más de 2 mm;
Pacientes con alteraciones graves de la función renal o la hepática;
Pacientes con una infección activa presente en la zona quirúrgica;
Pacientes con hidrocefalia tratada o no tratada (esto es, aquellos que tengan dispositivos diseñados para
evacuar líquido cefalorraquídeo (LCR) o alteraciones de la dinámica del LCR);
Pacientes que tengan una enfermedad concomitante subyacente o que estén tomando una medicación que
se sepa que interfiera en la cicatrización de heridas (p. ej., aquellos en los que se haya realizado un
procedimiento neuroquirúrgico intracraneal previo en el mismo lugar anatómico, que se hayan sometido a
radioterapia o quimioterapia, que se sepa que tienen cáncer, diabetes, toxicidad por esteroides y uso crónico
de corticoesteroides, que tengan afectado el sistema inmunitario o que estén tomando un anticoagulante,
ácido acetilsalicílico o un antiinflamatorio no esteroideo);
Pacientes alérgicos al colorante azul FD&C n.° 1 o al colorante amarillo FD&C n.° 5; o
Pacientes embarazadas o lactantes.
El sellador de duramadre Adherus AutoSpray ET está indicado para utilizarse como complemento de los
métodos habituales de reparación de la duramadre. No se ha estudiado la eficacia del sellador de duramadre
Adherus AutoSpray ET en otros tipos de tejido.
Precauciones
El sellador de duramadre Adherus AutoSpray ET está envasado estéril. No utilice el producto si las bandejas
presentan daños o han sido abiertas. No reesterilice el producto.
El sellador de duramadre Adherus AutoSpray ET está indicado para uso en un solo paciente. Deseche todo el
producto no utilizado o abierto. La reutilización del dispositivo puede producir contaminación cruzada que, a su
vez, puede provocar lesiones, enfermedades o la muerte del paciente.
Mantenga el producto alejado de la luz solar. No utilice el producto si el polvo de éster de PEG no fluye
libremente.
Utilice el sellador de duramadre Adherus AutoSpray ET en las 2 horas posteriores a la reconstitución de los
componentes reticulantes. Cuando se probó 8 horas después de la reconstitución, el sellador resultante se
hinchó más —en un grado pequeño, pero estadísticamente significativo—que los que llevaban reconstituidos 1,
2 o 4 horas.
La punta extendida del aplicador está diseñada para adaptarse a la necesidad quirúrgica mediante la
introducción de curvas a lo largo de la longitud de la punta. Aplique presión con cuidado al doblar la punta. No
doble a ángulos de más de 90°. Asegúrese de que haya flujo de hidrogel una vez que se haya moldeado el
aplicador para la necesidad quirúrgica.
La vida de las pilas del sistema aplicador es de aproximadamente 2 horas de uso continuo.
Antes de la aplicación del hidrogel Adherus, asegúrese de que se haya suspendido el flujo saliente de líquido
(líquido cefalorraquídeo, sangre, etc.).
No utilice el sellador de duramadre Adherus AutoSpray ET en presencia de anestésicos inflamables o
anestésicos inflamables con oxidantes.
Mantenga el dispositivo del sellador de duramadre Adherus AutoSpray ET alejado de campos magnéticos
intensos para evitar posibles interferencias en las comunicaciones por RF. Los equipos de resonancia magnética
pueden interferir en las operaciones de la bomba.
No retire ninguna de las cubiertas del sistema, aparte de la cubierta de las pilas.

20
Efectos adversos
Un dispositivo similar, el sellador de duramadre Adherus AutoSpray, que contiene la misma fórmula de sellador,
el sellador de duramadre Adherus, se evaluó en 124 pacientes tratados en el marco de un estudio clínico
fundamental prospectivo, controlado y multicéntrico. La incidencia y la naturaleza de los efectos adversos
observados en esta población de pacientes fueron congruentes con el tipo y la complejidad de los
procedimientos neuroquirúrgicos realizados, así como con las enfermedades concomitantes de los pacientes
tratados. Hubo cuatro muertes de pacientes en el grupo del sellador de duramadre Adherus AutoSpray y cinco en
el grupo de control. Las muertes se atribuyeron al cuadro clínico anterior de los sujetos. Los efectos adversos
que se dieron con una proporción de un 1 % o más entre los efectos adversos documentados en los pacientes
tratados con el sellador de duramadre Adherus AutoSpray se resumen en la tabla siguiente. No se observaron
efectos adversos debidos al dispositivo no esperados.
Tabla 1. Resumen de los efectos adversos del sellador de duramadre Adherus AutoSpray
Efecto adverso
Pacientes (n (%))
N=124
Anemia
3 (2,4)
Leucocitosis
2 (1,6)
Sordera unilateral
2 (1,6)
Acúfenos
4 (3,2)
Diplopía
5 (4,0)
Ptosis palpebral
2 (1,6)
Edema periorbitario
6 (4,8)
Visión borrosa
7 (5,6)
Disfagia
4 (3,2)
Náuseas
2 (1,6)
Reacción adversa
6 (4,8)
Dolor torácico
3 (2,4)
Empeoramiento de la enfermedad
3 (2,4)
Fatiga
2 (1,6)
Neumonía
2 (1,6)
Infección de las vías urinarias
2 (1,6)
Infección de la herida
2 (1,6)
Hipoestesia del lugar de la incisión
3 (2,4)
Dolor en el lugar de la incisión
4 (3,2)
Hemorragia periorbitaria
3 (2,4)
Edema posterior al procedimiento
2 (1,6)
Pseudomeningocele
9 (7,3)
Seroma
3 (2,4)
Hematoma subdural
3 (2,4)
Dehiscencia de la herida
2 (1,6)
Debilidad muscular
2 (1,6)
Afasia
4 (3,2)
Trastorno del equilibrio
2 (1,6)
Convulsión
5 (4,0)
Parálisis múltiples de nervios
craneales
2 (1,6)
Mareo
7 (5,6)
Ictus embólico
2 (1,6)
Dolor de cabeza
14 (11,3)
Hemiparesia
2 (1,6)
Hipoestesia
4 (3,2)
Parálisis del nervio hipogloso
2 (1,6)
Deterioro de la memoria
2 (1,6)
Nistagmo
3 (2,4)
Parestesia
5 (4,0)
Pérdida de sensibilidad
3 (2,4)
Temblor
2 (1,6)
Parálisis del nervio VII
3 (2,4)
Parálisis de las cuerdas vocales
2 (1,6)
Atelectasia
2 (1,6)
Insuficiencia respiratoria
2 (1,6)
Alopecia
2 (1,6)
Erupción cutánea
2 (1,6)
Inflamación facial
4 (3,2)