Brainlab 53151 Bedienungsanleitung

EN
Disposable Clip-on Remote Control
53151, 53153
①② ③
Intended Purpose
The device enables active patient registration for image guided surgery and remote control of
selected features within the software when used in combination with passive Pointers and
compatible IGS and stereotactic software applications.
Intended Use and Indications for Use
The device enables active patient registration for image guided surgery and remote control of
selected features within the software when used in combination with passive Pointers and
compatible IGS and stereotactic software applications. It is indicated for spinal and orthopedic
procedures.
Intended Patient Population
There are no cultural, demographic or ethnic limitations for patients.
Intended Part of the Body or Tissue Applied to or Interacted With
The device is not intended to have patient contact according to its intended use.
Intended User Profile
The device is used by surgeons, their assistants and nurses for performing image guided surgery
procedures in combination with Brainlab navigation systems.
Intended Use Environment
The Disposable Clip-on Remote Control is intended to be used sterile in rooms which are
appropriate for surgical interventions (e.g., operating rooms) in hospitals and healthcare
institutions. For electronic equipment, the ambient limits as described in the table below are
required for proper function.
Storage Conditions
Temperature 0 °C to 30 °C (32 °F to 86 °F)
Relative humidity 15% to 80% non-condensing
Altitude 700 hPa to 1060 hPa
Contraindications and Side Effects
There are no known contraindications for the use of this device.
Report Incidents Related to This Product
You are required to report any serious incident that may have occurred related to this product to
Brainlab, and if within Europe, to your corresponding national competent authority for medical
devices.
CE Label
The CE label indicates that the Brainlab product complies with the General
Safety and Performance Requirements of European Regulation 2017/745, the
Medical Device Regulation ("MDR").
Disposable Clip-on Remote Control is a Class Is product according to the
rules established by the MDR.
General Information
The Disposable Clip-on Remote Control (53151, 53153) can be used in combination with the
following compatible pointers to enable active patient registration and software control:
• Navigation Pointer Spine (52780A)
• Hip Pointer (52781A)
• Knee Pointer (52782)
The Disposable Clip-on Remote Control is a single-use device and cannot be resterilized.
Verify the sterile packaging prior to opening that it is not damaged. Visually inspect for
breaches in the sterile barrier system integrity prior to use. If the sterile packaging is
damaged, do not use the Disposable Clip-on Remote Control.
If battery leakage is visible inside the sterile packaging, do not open it and dispose of the
Disposable Clip-on Remote Control immediately.
Brainlab AG Customer Support:
Olof-Palme-Str. 9 support@brainlab.com
81829 Munich North/ South America: +1 800 597 5911
Germany Europe & Rest of the world: +49 89 99 15 68 1044
④ ⑤
Operating Conditions
10 °C to 40 °C (50 °F to 104 °F)
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⑥ ⑧
⑦
Do not look directly into infrared LED of the Disposable Clip-on Remote Control in close
distance when control button is activated.
During registration point acquisition always ensure that the pointer tip remains in contact
with patient or bone when activating the infrared LED of the Disposable Clip-on Remote
Control.
Do not completely immerse the Disposable Clip-on Remote Control into any liquids.
Components
No. Component Function
①
Infrared LED Detected by camera, but not visible to naked eye
② Status LED Indicates battery status and functionality
③ Center opening Attachment interface to pointer
④
Control button Activates infrared LED
NOTE: Do not press on the housing of the Disposable Clip-on Remote Control where LEDs are
located.
How to Perform a Functionality Test
Prior to use, verify the functionality of the device.
1. Remove the Disposable Clip-on Remote Control from its sterile package.
2. Press the control button ④ and ensure that:
- The status LED ② is on.
- The infrared LED ① is displayed as a colored flash on the camera display of the
navigation screen.
How to Attach the Disposable Clip-on Remote Control
1. Place the center opening ③ over the indicated attachment pin ⑤ on the pointer handle.
Plan the position of the Disposable Clip-on Remote Control on the Pointer handle for a
right-handed ⑥ or left-handed ⑦ user, as well as OR setup prior to surgery. The
camera must have an unobstructed view of the reflective marker spheres and infrared
LED.
2. Snap the Disposable Clip-on Remote Control fully onto the pointer handle.
3. Attach Disposable Reflective Marker Spheres to the pointer.
NOTE: Make sure to properly attach the Disposable Clip-on Remote Control to the pin on
the pointer, and to completely screw on the marker sphere until there is no gap between the
sphere and the base of the pin.
How to Detach the Disposable Clip-on Remote Control
1. After use, remove the Disposable Clip-on Remote Control from the pointer.
2. Prior to disposal, clean all surfaces with a surface disinfectant.
3. If required, open the housing at the notch ⑧ with a small sharp tool and remove the
electronics ⑨ and battery ⑩ for separate disposal.
No modification of the device is allowed. Do not reuse or replace the battery after use.
Doing so destroys the device and could cause injury to the patient or user or cause severe
damage to reprocessing equipment.
The Disposable Clip-on Remote Control contains a primary lithium cell. Check local
regulations for special disposal restrictions of lithium batteries. Consider disinfecting
device after use and dispose of it separately.
https://userguides.brainlab.com/
⑨
⑩
53153ML Rev. 9.0
*53153ML*
Date of issue: 2022-08-03 (ISO 8601)