Ambu VivaSight™ 2 SLT Instrucțiuni de utilizare

Tip
Instrucțiuni de utilizare
INSTRUCTIONS
FOR USE
For use by trained clinicians/physicians only.
For use with Ambu® displaying units.
Ambu® VivaSight 2 SLT
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Jun 21 2019
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Ambu is a registered trademark and VivaSight is a trademark of Ambu A/S.
Contents Page
English (Instructions for use) ............................................................................................................................... 4 - 15
Български (Указания за ползване) ............................................................................................................... 16 - 29
Česky (Návod k použití) .......................................................................................................................................30 - 42
Dansk (Brugsanvisning) ......................................................................................................................................43 - 54
Deutsch (Bedienungsanleitung) ...................................................................................................................... 55 - 68
Eλληvıĸά (δηγίες Xρήσεως) ................................................................................................................................69 - 83
Español (Manual de instrucciones) .................................................................................................................84 - 96
Eesti (Kasutusjuhised) ....................................................................................................................................... 97 - 108
Suomi (Käyttöohje) .......................................................................................................................................... 109 - 120
Français (Mode d´emploi) .............................................................................................................................121 - 133
Hrvatski (Upute za uporabu) ........................................................................................................................134 - 146
Magyar (Használati útmutató) .....................................................................................................................147 - 159
Italiano (Manuale d’uso) ................................................................................................................................160 - 172
日本語 (使用法) ............................................................................................................................................... 173 - 184
Lietuviškai (Naudojimo instrukcijos) .........................................................................................................185 - 196
Latviski (Lietošanas instrukcija) ................................................................................................................... 197 - 208
Nederlands (Gebruiksaanwijzing) ..............................................................................................................209 - 221
Norsk (Brukerveiledning) ...............................................................................................................................222 - 233
Polski (Instrukcja obsługi) .............................................................................................................................. 234 - 246
Português (Manual de instruções) .............................................................................................................247 - 259
Română (Instrucţiuni de utilizare) .............................................................................................................. 260 - 272
Pусский (Инструкция по применению) ...............................................................................................273 - 287
Slovenčina (Návod na použitie) ..................................................................................................................288 - 300
Slovenšcina (Navodila za uporabo)............................................................................................................301 - 312
Svenska (Instruktionshandbok)...................................................................................................................313 - 324
Türkçe (Kullanım talimatları) ........................................................................................................................325 - 337
中文 (使用说明 ) ............................................................................................................................................ 338 - 347
Ambu® VivaSight™ 2 SLT Ambu® VivaSight™ 2 Adapter Cable
3
1. Important Information – Read Before Use
Read these safety instructions carefully before using the Ambu® VivaSight™ 2 SLT.
The instruction for use may be updated without further notice. Copies of the current version
are available upon request. Please be aware that these instructions do not explain or discuss
clinical procedures. They describe only the basic operation and precautions related to the
use of VivaSight 2 SLT. Before initial use of VivaSight 2 SLT, it is essential for operators to have
received sufficient training in oral intubation procedures and to be familiar with the intended
use, warnings and cautions described in these instructions.
There is no warranty on VivaSight 2 SLT.
In this document the term VivaSight 2 SLT refers to the Ambu® VivaSight™ 2 SLT and the term
adapter cable refers to the Ambu® VivaSight™ 2 Adapter Cable. The VivaSight 2 SLT system refers to
information relevant for the VivaSight 2 SLT, adapter cable and Ambu displaying unit.
1.1. Intended Use
VivaSight 2 SLT is a sterile, single-use endotracheal tube intended for oral intubation
procedures. It is intended to be used as a temporary artificial airway in adults requiring
mechanical ventilation.
The VivaSight 2 SLT system is intended for general inspection of the airways and for
visualization during intubation procedures.
Intended patient population
VivaSight 2 SLT is intended for adult patients.
Intended use environment
The VivaSight 2 SLT system is for use in operating rooms, intensive care units and
emergency rooms.
Intended user profile
Medical doctors or nurses under medical responsibility trained within mechanical lung
ventilation and anaesthesia. The VivaSight 2 SLT system must be handled in accordance with
the local medical procedures for performing lung ventilation.
1.2. Indications for Use
Intubation with VivaSight 2 SLT is indicated for patients with difficult airway anatomy,
pathological lung conditions or other medical conditions that require endotracheal intubation
and mechanical ventilation and may in conjunction with an endobronchial blocker include
isolation of one lung from the other, e.g. for thoracic surgery.
1.3. Contraindications
Patients suffering from conditions or undergoing specific surgeries making them at risk of
or requiring them to undergo an MRI scan.
1.4. Clinical benefits
Provision of a secure airway, controlled ventilation and airway protection.
Visualization during oral intubation procedures facilitating surveillance of tube positioning.
Facilitating lung separation when used in conjunction with an endobronchial blocker.
Facilitating visualization and real-time monitoring of the medical procedure in lung
separation in conjunction with an endobronchial blocker without the use of a bronchoscope.
1.5. Warnings and Cautions
Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment. Ambu is not responsible for any damage to the system or patient injury
resulting from incorrect use.
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WARNINGS
1. Do not intubate, reposition, or extubate VivaSight 2 SLT without deflating the cuff
completely. Movement of the VivaSight 2 SLT with an inflated cuff may result in
trauma to the soft tissue.
2. The surface temperature of the VivaSight 2 SLT may reach above 43 °C when the tube
is placed outside the patient. Therefore, switch off the displaying unit or disconnect
the Viva Sight 2 SLT from the displaying unit after the pre-use test. Switch the
displaying unit back on or reconnect the tube immediately before use to prevent the
risk of having an impact on the tissue.
3. Do not use an intubation stylet other than the one provided. Using a stylet that
protrudes beyond the tube tip can cause damage to vocal cords during intubation.
4. Ensure cables and tubes from the VivaSight 2 SLT do not fall onto patient's eyes during
intubation and use, as this can lead to eye damage.
5. VivaSight 2 SLT camera images must not be used for diagnostic purposes. Doing so
may result in incorrect or missing diagnosis, or damage to mucosal membrane or
tissue due to excessive movement of tube.
6. The cuff pressure should not exceed 30 cmH2O as over-inflation of the cuff can
damage the tracheal mucosa.
7. Do not use VivaSight 2 SLT with flammable anaesthetic gases or agents in the
immediate area of VivaSight 2 SLT as this can lead to patient injury, damage Viva-Sight
2 SLT or disturb image on displaying unit.
8. Do not use VivaSight 2 SLT with laser equipment and electrosurgical equipment in the
immediate area of VivaSight 2 SLT as this can lead to patient injury, damage VivaSight
2 SLT or disturb image on displaying unit.
9. Patient leakage currents may be additive and too high when using an energised
endoscope in VivaSight 2 SLT. Only energised endoscopes classified as "type CF" or
"type BF" applied part shall be used with VivaSight 2 SLT to minimise total patient
leakage current.
10. Do not attempt to clean and reuse any part of the VivaSight 2 SLT product as they are
single use devices. Reuse of the product can cause contamination leading to infections.
11. Do not reuse the adapter cable on another patient as it is a single patient use device.
Reuse of the adapter cable can cause contamination leading to infections.
12. Do not use the product if the Preparation and Inspection (section 4.1.) of the product
fails as it can cause patient injury.
13. Do not use VivaSight 2 SLT with other connectors than standard 15 mm connectors
for connection to ventilation equipment and circuits, as this can lead to insufficient
ventilation.
14.
VivaSight 2 SLT is classified as MR unsafe. It is recommended to reintubate the
patient with an alternative MR conditional product if MRI scan is clinical indicated.
15. In cases with obstruction of upper airway due to pathology or foreign body, risk of
failure with intubation is increased. Consider alternative method or device.
CAUTIONS
1. Do not use the product if the cuff is damaged as it may result in insufficient ventilation,
hypoxia and reintubation. Care must be taken to avoid damaging the cuff during
intubation as teeth or any intubation aid with sharp surfaces can damage the cuff.
2. Before use, always check for compatibility between the SLT and the external device
(e.g. endobronchial blocker (EBB), bronchoscope, suction catheter) to avoid devices
not being able to pass through lumen.
3. Do not intubate the patient with the VivaSight 2 SLT through a laryngeal mask, as
it will not be possible to remove the mask as the video connector is too large to fit
through the mask.
4. Caution should be taken when using suction catheter and EBB in VivaSight 2 SLT at the
same time, as more devices in the lumen may cause devices to block for each other.
5. Do not use the flush tube for suctioning as this can occlude the flush tube.
6. When intubating patients with soiled airways beware that visualization may be
impaired during intubation due to secretion on the camera lens. Recover visualization
by flushing camera when possible.
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1.6. Potential Adverse Events
Potential adverse events in relation to the use of endotracheal tubes (not exhaustive):
hoarseness, sore throat, oral laceration, vocal cord injury, mucosal injury, tracheobronchial
injury, laryngospasm, bronchospasm, pneumothorax, dysphonia, esophageal intubation,
aspiration of gastric content, ventilator-associated pneumonia, hypoxemia, hypotension,
arrhythmia, cardiac arrest.
1.7. General Notes
If, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.
2. System Description
VivaSight 2 SLT can be connected to Ambu displaying units. For information about the Ambu
displaying units, please refer to the Ambu displaying unit's instruction for use.
2.1. Product Parts
Ambu® VivaSight™ 2 SLT REF Numbers:
412700000 Ambu® VivaSight™ 2 SLT 7.0
412750000 Ambu® VivaSight™ 2 SLT 7.5
412800000 Ambu® VivaSight™ 2 SLT 8.0
All tubes are delivered with a stylet.
Tube Sizes Size (inside
diameter)
[mm]
Outside
Diameter
[mm]
Cuff
Diameter
[mm]
Effective Inside
Diameter
[mm]*
Ambu® VivaSight™ 2 SLT 7.0
Ambu® VivaSight™ 2 SLT 7.5
Ambu® VivaSight™ 2 SLT 8.0
7.0
7.5
8.0
10.0 ± 0.2
10.5 ± 0.2
11.0 ± 0.2
25 ± 3.7
25 ± 3.7
26 ± 3.9
Min. 4.6
Min. 4.8
Min. 5.2
* See explanation of "effective inside diameter" in section 2.2.
Ambu® VivaSight™ 2 Adapter Cable REF Numbers:
412030000 Ambu® VivaSight 2 Adapter Cable
Cable length: 2000 mm ± 50 mm
2.2. Product Compatibility
Ambu® Displaying Units REF Numbers:
VivaSight 2 SLT and adapter cable must be
powered by and used in conjunction with:
405002000 Ambu® aView™
405011000 Ambu® aView™ 2 Advance
For Ambu displaying unit model no.,
please check the backside label on the
displaying unit. Please refer to the Ambu
displaying unit instruction for use.
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Devices to be Used Within the Lumen of VivaSight 2 SLT
Ambu® VivaSight™ Endobronchial
Blocker Tube
REF Numbers:
412900000
Other Devices
Other endobronchial blockers
Bronchoscopes
Airway exchange catheters
Airway intubation catheters
Suctions catheters
Size guide for selection of appropriate size of devices to be used within the VivaSight 2 SLT lumen:
Tube Size Effective Inside Diameter [mm]*
Ambu® VivaSight™ 2 SLT 7.0
Ambu® VivaSight™ 2 SLT 7.5
Ambu® VivaSight™ 2 SLT 8.0
Min. 4.6
Min. 4.8
Min. 5.2
* The effective inside diameter is intended as a guide for selecting the appropriate diameter of a bronchoscope
or other device to be passed through the lumen. The effective inside diameter differs from the ID by taking into
account the restriction on the lumen at the camera position.
Ventilation Equipment
Lung ventilation systems with 15 mm female conical connectors in compliance with ISO 5356-1.
Accessories
Standard 6 % conical Luer syringes
Cuff pressure gauges with Luer connector
2.3. VivaSight 2 SLT Parts
123 4 6 7 8 9
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No. Part Function
1Flush exits Channels air and saline for cleaning of camera lens
2Video camera and
LED light source
Provides visual feedback aiding the user to verify
endotracheal tube and endobronchial blocker placement
3Murphy Eye Ensures flow through the tube if main opening is blocked
4Tracheal cuff High volume low pressure (HVLP) cuff providing sealing
against tracheal wall
5Endotracheal tube Channels air for ventilation of the lungs
6Video connector Connects to the tube connector on the adapter cable for
connection of VivaSight 2 SLT and adapter cable
7Stylet Gives shape to the tube for navigation during intubation
8Tracheal tube
connector
Connects VivaSight 2 SLT to the ventilation system
9Pilot balloon with
check valve
Provides luer compatible port for cuff inflation/deflation
and indicates state of cuff inflation/deflation
10 Flush port Provides luer compatible port for injection of air and saline
for cleaning of camera lens
2.4. Adapter Cable Parts
131211
No. Part Function
11 Tube connector Connects to VivaSight 2 SLT
12 Cable Connects VivaSight 2 SLT to the Ambu displaying units for
live video image
13 Displaying unit
connector
Connects to the Ambu displaying unit
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3. Explanation of Symbols Used
Symbols Indication Symbols Indication
ID
Inside diameter of the
endotracheal tube (also
referred to as tube size) EFF ID Effective inside diameter
OD Outside diameter of the
endotracheal tube Cuff D Diameter of the inflated cuff
MD Medical device Global Trade Item Number
Country of
manufacturer
Do not use if package
is damaged
Single Patient Use Sterile barrier. Sterilised
using ethylene oxide
Defibrillation-proof type
BF applied part Non-sterile product
MR Unsafe
UL Recognized Component
Mark for Canada and the
United States
A supplementing list of symbol explanations can be found on:
www.ambu.com/symbol-explanation.
4. Use of the VivaSight 2 SLT
The numbers in gray circles below refer to illustrations on page 2.
4.1. Preparation and Inspection
1. Choose the VivaSight 2 SLT size according to patient anatomy.
2. Check that the seal of the sterile pouch is intact 1a . Do not use the product if the sterile
pouch is damaged or has been unintentionally opened before use.
3. Check that all product parts are present and that there are no impurities or damage to the
product, such as rough surfaces, sharp edges or protrusions which may harm the patient. 1b
4. If using devices inside the tube, check their compatibility by verifying that the devices can
pass through the tube without resistance.
Use the effective inside diameter presented in the table in section 2.2 as a guide for
choosing device size. There is no guarantee that devices selected solely using VivaSight 2
SLT effective inside diameter will be compatible in combination with VivaSight 2 SLT.
5. Check the cuff for integrity by inflating and deflating it completely. 2
6. VivaSight 2 SLT may be lubricated if needed; avoid the area around the camera lens at the
end of the tube.
7. Turn ON the Ambu displaying unit by pressing the power button. Refer to the Ambu
displaying unit instruction for use. 3
8. Connect the adapter cable to the tube and the displaying unit. Be careful to align the
arrows. 4 5
9. Verify that a correctly oriented live video image appears on the screen by pointing the
distal end of VivaSight 2 SLT towards an object, e.g. the palm of your hand 6. Adjust the
image preferences if necessary (refer to the Ambu displaying unit instruction for use).
If the object cannot be seen clearly, wipe the lens at the distal end using a sterile cloth
or a swab containing alcohol.
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4.2. Operating VivaSight 2 SLT
Intubation
1. Prior to intubation, secure the wire and tubes around or in your hand to prevent the
connectors from falling into the patient's face or eyes during intubation.
2. Introduce VivaSight 2 SLT orally and advance it through the vocal cords with the tip of the
tube facing upwards. 7
3. Remove the stylet. 8
4. While observing the live image on the displaying unit, advance the tube further until final
positioning above the carina.
5. Inflate the cuff up to a maximum pressure of 30 cmH₂O. Verify the position of the tube on
the displaying unit 9. If the patient is moved after intubation, make sure to re-verify the
position of the tube on the displaying unit.
6. Connect the ventilation system to the tracheal tube connector. Use capnography for
monitoring end-tidal CO₂, auscultation, and observation of chest wall movement to verify
correct tube position.
7. Secure the VivaSight 2 SLT and the breathing circuit according to local guidelines.
Cleaning the Camera Lens
If the VivaSight 2 SLT camera lens becomes soiled or obscured by secretions, it can be cleaned
by injecting air and saline, where permitted by institutional policy, into the flush port.
1. Open the flush port lid.
2. With a 5 ml syringe, inject 3 ml air into the flush port and then check image clarity.
3. With a 5 ml syringe, inject 3 ml saline into the flush port and then check image clarity.
4. If the live image on the Ambu displaying unit is still unclear repeat step 2 and 3.
5. Close the flush port lid.
Use of Accessories and Other Devices
When using devices inside VivaSight 2 SLT, always perform a compatibility check between
VivaSight 2 SLT and the device according to section 4.1 step 4. Inspect the accessory or other
device before using it. If there is any irregularity in its operation or external appearance,
replace it.
Extubation
1. Disconnect the lung ventilation system.
2. Deflate the cuff completely. 10a
3. Slowly withdraw the tube. 10b
Long Term Intermittent Monitoring/Duration Of Use
VivaSight 2 SLT can be used for ventilation and intermittent monitoring after surgery.
Disconnect the adapter cable from the tube, but keep the adapter cable with the patient in
case intermittent monitoring is needed. If necessary, VivaSight 2 SLT and adapter cable can be
wiped with water or a swab containing alcohol.
VivaSight 2 SLT can be used for up to 14 days with an intermittent use of the video camera for
up to 8 hours in total. When exceeding 8 hours of video camera usage, use the depth marks on
VivaSight 2 SLT to monitor tube position.
4.3. After use
Visual Check
Examine the integrity of the product and check if there are any missing or broken parts.
In case any corrective actions are needed, act according to local hospital procedures.
Disconnect
1. Disconnect the adapter cable from the Ambu displaying unit. 11a
2. Turn off the Ambu displaying unit by pressing the power button. 11b
3. VivaSight 2 SLT and the stylet are single-use devices and the adapter cable is for
single-patient use. Do not soak, rinse, sterilise or reuse the devices as this may leave
harmful residues or cause malfunction of the devices. The design and materials used
are not compatible with conventional cleaning and sterilisation procedures. 12
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Disposal
VivaSigth 2 SLT is a single use device and must be disposed of after use. VivaSight 2 adapter
cable is a single-patient use device and must be dis-posed of with its designated tube after
use. VivaSight 2 SLT and VivaSight 2 adapter cable, is considered contaminated after use and
must be disposed of in accord-ance with local guidelines for collection of infected medical
devices with elec-tronic components.
5. Technical Product Specifications
5.1. Standards Applied
VivaSight 2 SLT function conforms with:
EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
EN 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the basic
safety and essential performance of endoscopic equipment.
5.2. Specifications of VivaSight 2 SLT and Adapter Cable
VivaSight 2 SLT and Adapter Cable Specification
Power VivaSight 2 SLT and adapter cable can only be
powered by compatible Ambu displaying units.
See section 2.2 Product Compatibility.
Sterility VivaSight 2 SLT is sterilized using ethylene oxide;
the adapter cable is supplied non-sterile.
Environmental Conditions Operation Storage
Ambient temperature 10 – 35 °C (50 – 95 °F) 10 – 25 °C (50 – 77 °F)
Ambient relative humidity 30 – 75 % -
Ambient atmospheric pressure 70 – 106 kPa -
Storage recommendation -Store in a dry, cool and
dark place
5.3. Cuff Performance
Endotracheal tube cuff performance (per ISO 5361 method)
The performance information shown below was collected using a bench test that is
intended to provide a comparison of the sealing characteristics of tracheal tube cuffs only
in a laboratory setting. The bench test is not configured or intended to predict
performance in the clinical setting.
for size 7.0 mm tracheal tube
Minimum tracheal diameter: 19 mm Maximum tracheal diameter: 24 mm
Cuff pressure Leakage rate (ml/h) Cuff pressure Leakage rate (ml/h)
hPa (cmH₂O) 50th
percentile
90th
percentile
hPa (cmH₂O) 50th
percentile
90th
percentile
27 633.6 ml/h 1225.2 ml/h 27 25.2 ml/h
3754.8 ml/h
for size 7.5 mm endotracheal tube
Minimum tracheal diameter: 19 mm Maximum tracheal diameter: 24 mm
Cuff pressure Leakage rate (ml/h) Cuff pressure Leakage rate (ml/h)
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Endotracheal tube cuff performance (per ISO 5361 method)
The performance information shown below was collected using a bench test that is
intended to provide a comparison of the sealing characteristics of tracheal tube cuffs only
in a laboratory setting. The bench test is not configured or intended to predict
performance in the clinical setting.
hPa (cmH₂O) 50th
percentile
90th
percentile
hPa (cmH₂O) 50th
percentile
90th
percentile
27 498.0 ml/h 1696.8 ml/h 27 294.0 ml/h
8659.2 ml/h
for size 8.0 mm endotracheal tube
Minimum tracheal diameter: 20 mm Maximum tracheal diameter: 25 mm
Cuff pressure Leakage rate (mL/h) Cuff pressure Leakage rate (mL/h)
hPa (cmH₂O) 50th
percentile
90th
percentile
hPa (cmH₂O) 50th
percentile
90th
percentile
27 0.0 ml/h 594.0 ml/h 27 823.2 ml/h
1423.2 ml/h
Appendix 1. Electromagnetic Compatibility
Like other electrical medical equipment the system requires special precautions to
ensure electromagnetic compatibility with other electrical medical devices. To ensure
electromagnetic compatibility (EMC) the system must be installed and operated according to
the EMC information provided in this manual.
The system has been designed and tested to comply with IEC 60601-1-2 requirements for EMC
with other devices.
Guidance and manufacturer’s declaration – electromagnetic emission
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guidance
RF emission CISPR 11 Group 1 The system uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emission CISPR 11 Class A The emissions Characteristics of this
equipment makes it suitable for use in
industrial areas and hospitals (CISPR
11 class A). If it is used in a residential
environment (for which CISPR 11 class B
is normally required) this equipment
might not offer adequate protection to
the radio-frequency communication
service. The user might need to take
mitigation measures, such as relocating
or re-orientation the equipment.
Harmonic emission
IEC/EN 61000-3-2
Not applicable
Voltage
fluctuations/flicker
emissions IEC/EN
61000-3-3
Complies
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Guidance and manufacturer’s declaration – electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Immunity test IEC 60601-1-2
test level
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
+/- 8 kV contact
+/- 2, 4, 8,
15 kV air
+/- 8 kV contact
+/- 2, 4, 8,
15 kV air
If floors are covered with
synthetic material the relative
humidity shall be least 30 %.
Electrical fast
transient/
burst
IEC 61000-4-4
+/- 2 kV
for power
supply lines
+/- 1 kV
for input /
output lines
+/- 2 kV power
supply lines
N/A
Mains power quality shall be
that of a typical commercial
or hospital environment.
Surge
IEC 61000-4-5
for power supply
+/- 1 kV line
to line
+/- 2 kV line
to earth
for input/output
+/- 1 kV line
to line
+/- 2 kV line
to earth
for power
supply lines
+/- 1 kV line
to line
+/- 2 kV line
to earth
for input /output
N/A
Mains power quality shall 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
Voltage dips:
0 % UT, 0.5 &
1 cycle
70 % UT, 25
cycles
Voltage
interruptions:
0 % UT, 250
cycles
Voltage dips:
0 % UT, 0.5 &
1 cycle
70 % UT, 25 cycles
Voltage
interruptions:
0 % UT, 250 cycles
Mains power quality shall be
that of a typical commercial
or hospital environment.
If the use of the system
requires continued operation
during power mains
interruptions the system can
be powered by the built in
rechargeable battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE : UT is the a.c. mains voltage prior to application of the test level.
13
Guidance and manufacturer’s declaration – electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Immunity test IEC 60601-1-2
test level
Compliance
Level
Electromagnetic
Environment Guidance
Conducted
Radio
Frequency
IEC 61000-4-6
For power lines:
3 V RMS
0,15 MHz –
80 MHz
6 V RMS
in ISM bands
80 % AM at
1 kHz
For power lines:
3 V RMS
0,15 MHz –
80 MHz
6 V RMS
in ISM bands
80 % AM at
1 kHz
Portable and mobile RF
communications equipment
should be used no closer
to any part of the system,
including its cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
d = 1.17
d = 1.17 80 MHz to 800 MHz
d = 2.33 800 MHz to 2.7 GHz
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 metres (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.
Radiated Radio
Frequency
IEC 61000-4-3
3 V/m 80 MHz
to 2.7 GHz
80 % AM at
1 kHz
Proximity to
RF wireless
communications
equipment
385 MHz –
5785 MHz, up to
28 V/m
3 V/m
80-2700 MHz
80 % AM at
1 kHz
Proximity to
RF wireless
communications
equipment
385 MHz –
5785 MHz, up to
28 V/m
NOTE 1: At 80 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.
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a) Field strengths from fixed transmitters, such as base stations for radio (celluar/ cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey shall be
considered. If the measured field strength in the location in which the system is used
exceeds the applicable RF compliance level above, the system shall be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the system.
b) Over the frequency range 150 kHz to 80 MHz, field strengths shall be less than 3 V/m.
Recommended Separation Distances Between Portable and Mobile
RF Communication Equipment and system
The system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters and the system as recommended below,
according to the maximum output power of the communication equipment.
Rated maximum
output power (W)
of transmitter
Separation distance (m) according to frequency of transmitter
150 kHz to 80 MHz
d = 1.17
80 MHz to 800 MHz
d = 1.17
800 MHz to 2.7 GHz
d = 2.33
0.01 0.12 m 0.12 m 0.23 m
0.1 0.37 m 0.37 m 0.74 m
11.17 m 1.17 m 2.33 m
10 3.70 m 3.70 m 7.37 m
100 11.7 m 11.7 m 23.3 m
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.
15
1. Важна информация – Прочетете преди употреба
Прочетете внимателно тези инструкции за безопасност, преди да използвате
Ambu® VivaSight™ 2 SLT.    подлежат на актуализиране без
допълнително уведомление. Копия на текущата версия са налични при поискване.
Имайте предвид, че тези инструкции не дават обяснения и не разглеждат клиничните
процедури. Те описват само основната работа и предпазните мерки, свързани с
използването на VivaSight 2 SLT. Преди първоначалната употреба на VivaSight 2 SLT е
важно операторите да са получили достатъчно обучение относно процедурите за орална
интубация и да са се запознали с предназначението, предупрежденията и предпазните
мерки, описани в тези инструкции.
Няма гаранция за VivaSight 2 SLT.
В този документ терминът VivaSight 2 SLT се отнася за Ambu® VivaSight™ 2 SLT, а терминът
   се отнася за Ambu® VivaSight™ 2 Adapter Cable. Системата VivaSight
2 SLT се отнася до релевантната информация за VivaSight 2 SLT, кабела на адаптера и
дисплейния модул Ambu.
1.1. Предназначение
VivaSight 2 SLT е стерилна ендотрахеална тръба за еднократна употреба, предназначена
за процедури за орална интубация. Тя е предназначена за употреба като временен
изкуствен дихателен път за възрастни, нуждаещи се от механична вентилация.
Системата VivaSight 2 SLT е предназначена за обща инспекция на дихателните пътища и за
визуализация по време на интубационни процедури.
Целева пациентска популация
VivaSight 2 SLT е предназначена за възрастни пациенти.
Целева среда на употреба
Системата VivaSight 2 SLT е предназначена за употреба в операционни зали, отделения за
интензивна грижа и спешни отделения.
Профил на целевата група потребители
Лекари или медицински сестри с медицински задължения, обучени за механична
белодробна вентилация и анестезия. Със системата VivaSight 2 SLT трябва да се борави
в съответствие с местните медицински процедури за извършване на белодробна
вентилация.
1.2. Показания за употреба
Интубацията с VivaSight 2 SLT е показана за пациенти с трудна анатомия на дихателните
пътища, патологични белодробни състояния или други медицински състояния, които
изискват ендотрахеална интубация и механична вентилация, и могат в комбинация с
ендобронхиален блокер да включват изолиране на единия бял дроб от другия, напр. за
торакална хирургия.
1.3. Противопоказания
Пациенти, страдащи от заболявания или подлагани на специфични хирургични
интервенции, които ги излагат на риск
или изискват за тях да бъдат подложени на ЯМР сканиране.
1.4. Клинични ползи
Предоставяне на сигурни дихателния пътища, контролирана вентилация и защита на
дихателните пътища.
Визуализация по време на процедури на орална интубация, улесняваща наблюдението
на позиционирането на маркуча.
Улесняване на разделянето на белия дроб, когато се използва заедно с
ендобронхиален блокер.
Улесняване на визуализацията и мониторинга в реално време на медицинската
процедура при разделяне на белия дроб заедно с ендобронхиален блокер без
използването на бронхоскоп.
16
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1.5. Предупреждения и предпазни мерки
Неспазването на тези предупреждения и предпазни мерки може да доведе до
нараняване на пациента или повреда на оборудването. Ambu не носи отговорност за
каквато и да било повреда на системата или нараняване на пациента в резултат на
неправилно ползване.
ПРЕДУПРЕЖДЕНИЯ
1. Не интубирайте, не променяйте позицията и не екстубирайте VivaSight 2 SLT без
цялостно изпускане на въздуха от маншета. Преместването на VivaSight 2 SLT с
надут маншет може да доведе до травма на меките тъкани.
2. Възможно е температурата на повърхността на VivaSight 2 SLT да се повиши
над 43°C, когато тръбата е поставена извън пациента. Ето защо изключвайте
дисплейния модул или разкачвайте VivaSight 2 SLT от дисплейния модул след
изпитването преди употреба. Включете обратно дисплейния модул или свържете
отново тръбата непосредствено преди употреба, за да предотвратите риска от
сблъсък с тъканта.
3. Не използвайте различен от предоставения интубационен стилет. Използването
на стилет, който се показва извън върха на тръбата, може да причини увреждане
на гласните струни при интубация.
4. Уверете се, че кабелите и тръбите от VivaSight 2 SLT не падат върху очите на
пациента по време на интубация и употреба, тъй като това може да доведе до
увреждане на очите.
5. Изображенията от камерата на VivaSight 2 SLT не трябва да се използват за
диагностични цели. В противен случай може да се стигне до неправилна или
липсваща диагноза или до увреждане на лигавичната мембрана или тъкан
поради прекомерно движение на тръбата.
6. Налягането на маншета не трябва да превишава 30 cmH2O, тъй като
пренадуването на маншета може да увреди трахеалната лигавица.
7. Не използвайте VivaSight 2 SLT със запалими анестетични газове или агенти
в непосредствена близост до VivaSight 2 SLT, тъй като това може да доведе
до нараняване на пациента, до повреда на VivaSight 2 SLT или да наруши
изображението върху дисплейния модул.
8. Не използвайте VivaSight 2 SLT с лазерно оборудване или електрохирургично
оборудване в непосредствена близост до VivaSight 2 SLT, тъй като това може да
доведе до нараняване на пациента, до повреда на VivaSight 2 SLT или да наруши
изображението върху дисплейния модул.
9. Токът от утечки към пациента може да е кумулативен и твърде силен, когато се
използват ендоскопи под напрежение във VivaSight 2 SLT. С VivaSight 2 SLT трябва да се
използват само ендоскопи под напрежение, класифицирани като приложни части от
„тип CF“ или „тип BF“, за да се намали до минимум общият ток от утечка към пациента.
10. Не се опитвайте да почиствате или да използвате повторно която и да е част от
продукта VivaSight 2 SLT, защото това са изделия за еднократна употреба. Повторната
употреба на продукта може да причини контаминация, водеща до инфекции.
11. Не използвайте повторно кабела на адаптера върху друг пациент, защото той е
изделие за употреба само от един пациент. Повторната употреба на кабела на
адаптера може да причини контаминация, водеща до инфекции.
12. Не използвайте продукта, ако подготовката и проверката (раздел 4.1.) на продукта
са неуспешни, тъй като това може да доведе до нараняване на пациента.
13. Не използвайте VivaSight 2 SLT с други конектори освен със стандартни 15 mm
конектори за свързване към вентилационно оборудване и вериги, тъй като това
може да доведе до недостатъчна вентилация.
14.
VivaSight 2 SLT се класифицира като небезопасно за работа в
магнитнорезонансна среда. Препоръчва се пациентът да се интубира отново с
алтернативен продукт, безопасен за МР при определени условия, ако е клинично
показано сканиране с ЯМР.
15. В случай на обструкция на горните дихателни пътища, дължаща се на патология
или чуждо тяло, рискът от неуспех при интубация се увеличава. Обмислете
използването на алтернативен метод или изделие.
17
УКАЗАНИЯ ЗА ВНИМАНИЕ
1. Не използвайте продукта, ако маншетът е повреден, тъй като това може да доведе
до недостатъчна вентилация, хипоксия и реинтубация. Трябва да се внимава за
избягване на повреда на маншета по време на интубация, тъй като зъбите или
помощни средства за интубация с остри повърхности могат да го повредят.
2. Преди употреба винаги проверявайте съвместимостта между SLT и външното
устройство (напр. ендобронхиалния блокер (EBB), бронхоскопа, смукателния катетър),
за да избегнете употребата на устройства, които не могат да преминат през лумена.
3. Не интубирайте пациента с VivaSight 2 SLT през ларингеална маска, тъй като няма
да е възможно да свалите маската, защото видеоконекторът е твърде голям за
преминаване през маската.
4. Трябва да се обръща внимание, когато с VivaSight 2 SLT се използват сукционен
катетър и EBB едновременно, тъй като повече изделия в лумена може да доведе
до взаимно блокиране на изделията.
5. Не използвайте тръбата за промиване за засмукване, тъй като това може да
запуши тръбата.
6. Внимавайте, когато интубирате пациенти със замърсени дихателни пътища,
защото визуализацията може да се влоши по време на интубацията поради
натрупване на секрети върху обектива на камерата. При възможност
възстановявайте визуализацията чрез промиване на камерата.
1.6. Потенциални нежелани събития
Потенциални нежелани събития във връзка с използването на ендотрахеални тръби
(неизчерпателен списък): дрезгав глас, възпалено гърло, орална лацерация, нараняване
на гласните струни, нараняване на лигавиците, трахеобронхиално нараняване,
ларингоспазъм, бронхоспазъм, пневмоторакс, дисфония, езофагеална интубация,
аспирация на стомашно съдържание, свързана с апарат за вентилация пневмония,
хипоксемия, хипотензия, аритмия, сърдечен арест.
1.7. Общи бележки
Ако по време на употреба на това изделие или като резултат от неговата употреба
възникнат сериозни инциденти, съобщете за тях на производителя и на националния
компетентен орган.
2. Описание на системата
VivaSight 2 SLT може да бъде свързана с дисплейни модули Ambu. За информация относно
дисплейните модули Ambu вижте техните инструкции за употреба.
2.1. Части на продукта
Ambu® VivaSight™ 2 SLT Реф. номера:
412700000 Ambu® VivaSight™ 2 SLT 7.0
412750000 Ambu® VivaSight™ 2 SLT 7.5
412800000 Ambu® VivaSight™ 2 SLT 8.0
Всички тръби се доставят със стилет.
Размери на тръбите
Размер
(вътрешен
диаметър)
[mm]
Външен
диаметър
[mm]
Диаметър
на маншета
[mm]
Ефективен
вътрешен
диаметър
[mm]*
Ambu® VivaSight™ 2 SLT 7.0
Ambu® VivaSight™ 2 SLT 7.5
Ambu® VivaSight™ 2 SLT 8.0
7,0
7,5
8,0
10,0 ± 0,2
10,5 ± 0,2
11,0 ± 0,2
25 ± 3,7
25 ± 3,7
26 ± 3,9
Мин. 4,6
Мин. 4,8
Мин. 5,2
* Вижте обяснението на „ефективен вътрешен диаметър“ в раздел 2.2.
18
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Ambu® VivaSight™ 2 Adapter Cable Реф. номера:
412030000 Ambu® VivaSight™ 2 Adapter Cable
Дължина на кабела: 2000 mm ± 50 mm
2.2. Съвместимост на продукта
Дисплейни модули Ambu® Реф. номера:
VivaSight 2 SLT и кабелът на адаптера
трябва да се захранват от и да се използват
заедно със:
405002000 Ambu® aView™
405011000 Ambu® aView™ 2 Advance
За номера на модела на дисплейния модул
Ambu проверете етикета от задната страна
на дисплейния модул. Вижте 
  на дисплейния модул Ambu.
Устройства, които да се използват с лумените на VivaSight 2 SLT
Тръба на ендобронхиален блокер
Ambu® VivaSight™
Реф. номера:
412900000
Други устройства
Други ендобронхиални блокери
Бронхоскопи
Катетри за замяна на дихателните
пътища
Катетри за интубация на
дихателните пътища
Смукателни катетри
Ръководство за размерите за избор на подходящ размер устройства, които да се
използват в лумените VivaSight 2 SLT:
Размер на тръбата Ефективен вътрешен диаметър [mm]*
Ambu® VivaSight™ 2 SLT 7.0
Ambu® VivaSight™ 2 SLT 7.5
Ambu® VivaSight™ 2 SLT 8.0
Мин. 4,6
Мин. 4,8
Мин. 5,2
* Ефективният вътрешен диаметър е предназначен за насока за избиране на подходящия диаметър на
бронхоскопа или на друго устройство, което да се прекара през лумена. Ефективният вътрешен диаметър
се различава от ID, тъй като взема под внимание ограничението върху лумена при позицията на камерата.
Оборудване за вентилация
Белодробни вентилационни системи с 15 mm женски конични конектори в съответствие
с ISO 5356-1.
19
Аксесоари
Стандартни 6 % конични спринцовки тип Luer
Маншети с манометър с конектор тип Luer
2.3. Части на VivaSight 2 SLT
123 4 6 7 8 9
5
10
№ Част Функция
1Изходи за
промиване
Прекарва въздуха и физиологичния разтвор за
почистване на обектива на камерата
2Видеокамера
и светодиоден
източник на
светлина
Осигурява визуална обратна връзка, която подпомага
потребителя при проверка на поставянето на
ендотрахеалната тръба и ендобронхиалния блокер
3Око на Мърфи Гарантира дебита през тръбата, ако основният отвор
е блокиран
4Трахеален
маншет
Високообемен маншет с ниско налягане (HVLP),
който осигурява уплътнение към трахеалната стена
5Ендотрахеална
тръба
Прекарва въздуха за вентилация на белите дробове
6Видеоконектор Свързва се към конектора за тръбата върху кабела
на адаптера за свързване на VivaSight 2 SLT и кабела
на адаптера
7Стилет Дава форма на тръбата за навигация по време
на интубация
8
Конектор за
трахеалната тръба
Свързва VivaSight 2 SLT към вентилационната система
9Пилотен балон с
възвратен клапан
Осигурява съвместим с тип Luer порт за надуване/
спадане на маншета и указва състоянието на надуване/
спадане на маншета
10 Порт за
промиване
Осигурява съвместим с тип Luer порт за инжектиране
на въздух и физиологичен разтвор за почистване на
обектива на камерата
20
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Ambu VivaSight™ 2 SLT Instrucțiuni de utilizare

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Instrucțiuni de utilizare