stryker TD80000 Patient Tracker Electromagnetic Instruction Manual

stryker TD80000 Patient Tracker Electromagnetic

How to Use this Document

About this Document
This manual is the most comprehensive source of information for the safe, effective, and compliant use and/or maintenance of the product. Read and understand this manual as well as the respective system user manual before using the product or any component compatible with the product. When combined with other medical devices, the user manual of these devices is to be considered as well. This manual is a permanent part of the product. Keep this manual for future reference.

The following conventions are used in this document:
The signal word WARNING highlights a safety-related issue. Comply with this information to prevent patient or medical staff injury. The signal word CAUTION highlights a product reliability issue. Comply with this information to prevent product damage. Supplements or clarifies information.

EN ISO 15223-1 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Product-specific symbols

IEC 60417 Graphical symbols for use on equipment

Safety Information

WARNING

• The product is delivered in a non-sterile condition. Before first use, as well as before each following use, the product must be processed according to a validated procedure.
• Before using a medical product, assure yourself of its functional safety and proper condition via a visual inspection. Do not use the product if any defects, such as breaks, cracks, deformations or wear, are detected. Particularly important parts such as tips, notches and all moveable components should be checked with extra care.
• Unauthorized modifications of the product are forbidden for safety reasons.
• Due to its composition, the product is not to be used together with other magnetically sensitive medical products, devices or instruments (e.g. MRI).
• The product is a high-precision instrument. Avoid subjecting it to serious strains, such as heavy impacts. The product cannot be used if there are visible defects. After a heavy impact, the product must be checked for defects.
• The healthcare provider performing any procedure is responsible for determining the appropriateness of using the product and for the specific technique for each patient. Stryker, as a manufacturer, does not recommend a specific surgical procedure.

The user and/or patient should report any serious product-related incident to both the manufacturer and the national competent authority where the user and/or patient is established.

Product Information

WARNING

• The product may only be used for its intended purpose and in accordance with this document and all current versions of relevant system and software application documentation.
• This document is part of the product and must be accessible to personnel at all times. It must be provided to subsequent owners or users.

Intended Use
The Patient Tracker Electromagnetic is an accessory to the Electromagnetic Navigation Unit and intended for locating the patient.

Indications for Use
The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT- or MR- based model of the anatomy.

Example procedures include, but are not limited to the following ENT procedures:

• Transsphenoidal access procedures
• Intranasal procedures
• Sinus procedures, such as maxillary antrostomies, ethmoidectomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies
• ENT-related anterior skull base procedures

Contraindications
None known.

User Group
Healthcare professionals (surgeon/resident, nurse/professional caregiver) educated in computer-assisted surgery and thoroughly familiar with the instructions for use and with the operation of this product. To request an additional in-service instruction, contact Stryker.

Product Overview

Instructions for Application
The patient tracker provides a reference for the patient during surgery. For this purpose, the tracker is securely fixed onto the patient with appropriate accessories as near as possible to the operation area.

WARNING: Ensure that the patient tracker does not move with respect to the patient. If the patient tracker moves, the system displays inaccurate positional information of the instruments. For instructions on how to use the product for a surgical procedure, refer to the instructions for use supplied with the respective software application.

For Use With

WARNING: Use only Stryker-approved products, unless otherwise specified.
For information related to compatible software applications, refer to the user manual supplied with the respective software application. For information related to product-specific compatibility, refer to the table below.

Disassembly

1. Carefully remove the patient tracker from the patient skin.
2. Remove the Patient Tracker Tab from the patient tracker, and dispose of the Patient Tracker Tab.

Reprocessing
Necessary steps in the reprocessing of medical products include preparation, cleaning, disinfection, testing, maintenance, inspection, and storage. Details on how to carry out these steps for the listed products will be provided below. Also consult the CDC Guidance Document Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Also refer to the following for the purpose of additional education but not in lieu of validated reprocessing instructions: professional organizations’ clinical practice guidelines or clinical guidelines of the CDC. The following cleaning and disinfection process has been validated by Stryker. If other reprocessing methods are used, make sure the reprocessing cycle is validated.

• Reprocess devices as soon as practical, typically within two hours after use.
• Reprocess devices before you return devices for service.

WARNING

• The product requires at minimum an intermediate level of disinfection for safe use.
• The product is not intended for sterilization.
• Instruments used to treat patients whose diagnosis is unclear, shall be regarded as potentially contaminated with the CJD, such instruments shall be quarantined until a non-prion diagnosis is identified.
• If the product is used on a patient who suffers from a disease whose pathogens cannot be eliminated with conventional, standardized procedures, the product must be disposed of or reprocessed following the requirements of the responsible public authority (e.g. WHO, RKI, CDC).
• When preparing and applying chemical solutions, the manufacturer’s instructions regarding mixing ratios and dwell times must be followed closely. Using false mixing ratios or extended dwell times can lead to product contamination.
• Do not overload the washer-disinfector. Avoid unwashed areas. Ensure that the product is placed securely in the machine.

CAUTION
In regard to the composition of materials, ensure that the reprocessing is monomaterial. Instruments made out of titanium may change their surface color. Base metals may develop surface rust.

Personal Safety
Use the following personal protective equipment:

• (single-use) shirt
• (single-use) gloves
• safety glasses
• anti-splash mask

Refer to the user instructions of the cleaning agent and disinfectant for additional protective equipment.

Preparation for Reprocessing
To prevent residues from drying out, the following steps are recommended as soon as practical after use:

1. Wipe off the instruments.
   WARNING – Do not use any fixing agents or hot water, as this could interfere with the success of the reprocessing procedure.
   CAUTION – Do not use any NaCl solution for pre-cleaning, as chloride ions can lead to corrosion on metals.

2. Rinse the instruments thoroughly with water (water temperature max. 45 °C).

3. Hard-to-access areas such as joints or cavities can be pre-cleaned with a cleaning pistol (static water pressure of at least 2 bar) or a syringe.

4. During transport to the reprocessing site, store the instruments in a closed container, in order to prevent residues from drying out. Cover devices with a damp cloth or enclose devices in a heat-sealed bag.

5. Check the instruments for damage and wear both before and after each application. Pay special attention to breaks, cracks, deformations, distortions, and corrosions. Check particularly important parts such as tips, notches, and all moveable components with extra care.

6. Dispose of any damaged instruments.

Cleaning and Disinfection

The cleaning can be performed manually or automated, but automated decontamination is preferred.

Manual Cleaning and Disinfection

Required equipment:

• Low-lint cloth, swab, cotton swabs
• Soft cleaning brushes without metal, for surgical instruments (e.g. Medisafe MED100.25, bristle length 7 mm)
• Cleaning pistol (at least 2 bar static water pressure, e.g. Stoeckert SELECTA, REF 1769534)
• Alkaline cleaner (neodisher MediClean forte, Dr. Weigert, Hamburg, Germany)
• Freshly prepared purified water, highly purified water or sterile water with less than 10cfu/ml and 0.25_EU/ml. In the U.S., refer to AAMI TIR 34 for guidance on water quality
• High-level disinfectant based on aldehyde (Cidex OPA, Johnson & Johnson Advanced Sterilization Products, Irvine, CA, USA)
• Medical grade compressed air and/or 70% ethyl or isopropyl alcohol

WARNING: If the product is intended for use in known immunocompromised patients or potentially immunocompromised patients, based on institutional procedures (e.g., high risk population served), the instruments shall be rinsed with purified water, using sterile technique when rinsing and handling. For all other devices, a sterile water rinse is recommended when practical. Otherwise, potable tap water rinse is acceptable.

CAUTION

• Do not use any sharp objects such as metal brushes or other metal objects for manual cleaning.
• Inadequate rinsing or prolonged immersion in a cleaning or disinfection bath may lead to corrosion. Consult the instruction leaflet of the respective cleaning and disinfection products regarding dwell times.
• Do not use ultrasonic baths for cleaning the electromagnetic instruments.

Manual Cleaning
For manual cleaning, Stryker validated the alkaline cleaner neodisher MediClean forte (Dr. Weigert, Hamburg, Germany) with 0.5 – 3.0% in purified water.

Prepare the equipment and the devices:

1. Dilute the cleaning agent at 22–40 °C. Stir the cleaning solution to homogenize it.

2. Place the dismantled instruments in a cleaning solution (22-40 °C) for 5-10 minutes Refer to the exposure times indicated by the detergent manufacturer.
   WARNING

   • Completely wet all instruments with the cleaning solution, keeping them free from air bubbles. Ensure that all cavities are accessible. If necessary, enable bubbles to escape by moving and tilting the instruments.
   • Thorough cleansing is necessary to ensure successful disinfection.
   • It is essential to pay attention to the instructions for use from the detergent and disinfectant manufacturers.

3. Remove remaining soil with the help of the cleaning tools described above:

   • Brush off any coarse soiling from the product surface.
   • Wipe off the cable with a soft cloth soaked in purified water.

4. Flush the instruments with a cleaning pistol (purified water, 22-35 °C) for at least 20 seconds.

5. Rinse all parts at least twice for 10 seconds each under running water (purified water, 22-35 °C), in order to remove all residues.

6. Dry the instrument carefully using a low-lint cloth or swab. Hard-to-access areas can be dried using medical grade compressed air.

7. Verify that no visible staining or cleaning solution, especially in hard-to-reach areas remains on the instrument. Remove visible staining or cleaning solution by repeating the cleaning process from the beginning.
   WARNING – Make sure that all product parts are dried. Take special care to ensure that areas inside the product are dried.

Manual Disinfection
For manual disinfection, Stryker recommends high-level chemical disinfectant Cidex OPA (Advanced Sterilization Products, REF 20391, active concentration of 0.55% orthophthalaldehyde). Refer to the Cidex OPA labeling and instructions for use for additional instructions.
Non-sterilizable, but disinfectable instruments have a red plug.

1. Immerse the instrument completely, in Cidex OPA solution for a minimum of 12 minutes at 22 °C (72 °F) or higher to destroy all pathogenic microorganisms. Make sure that you eliminate air pockets (e.g. in the plug).

2. Remove the instrument from the Cidex OPA solution, and thoroughly rinse the instrument:

3. Immerse the instrument completely in a large volume (e.g. 2 gallons) of sterile-filtered water, and keep the device totally immersed for a minimum of 1 minute.

4. Remove the device and discard the rinse water. Do not reuse the water for rinsing or any other purpose.

5. Repeat steps 2a-b twice (for a total of 3 rinses).

6. Visually inspect the device. In case of any residues of disinfectant solution, repeat step 2 a–b.
   WARNING

   • Three (3) separate, large volume water immersion rinses are required. Disinfectant residues may cause serious side effects.
   • When using potable water for rinsing, the user should be aware of the increased risk of recontaminating the device or medical equipment with microorganisms which may be present in potable water supplies. Water treatment systems, such as softeners or deionizers, may add microorganisms to the treated water to the extent that microbial content of the water at the point of use could exceed that of the pretreated drinking water.
   • Do not use any disinfectants that contain phenols, chlorine components, or peracetic acid without corrosion protection.

7. Dry the product carefully using a low-lint cloth or swab. Hard-to-access areas can be dried using medical grade compressed air. For better drying, a final rinse using a 70% isopropyl alcohol solution can be used to speed the drying process.

WARNING
A device that is not completely dried provides an ideal situation for rapid colonization of bacteria. As these waterborne bacteria are highly resistant to drying, rapid drying will avoid possible colonization but may not result in a device free from these bacteria. A final rinse using a 70% isopropyl alcohol solution can be used to speed the drying process and reduce the numbers of any organism present as a result of rinsing with purified water.

Automated Cleaning and Thermal Disinfection
A combined cleaning and disinfection process should take place in a fully automatic washer-disinfector. Stryker recommends the alkaline cleaning agent neodisher MediClean forte (Dr. Weigert, Hamburg, Germany) and thermal disinfection methods.

Required equipment:

• Automatic washer-disinfector compliant with DIN EN ISO 15883-1 with a validated procedure (e.g. Miele G7836 CD.
• Small part sieves for safe fixation of the device.
• Alkaline cleaner (neodisher MediClean forte, Dr. Weigert, Hamburg, Germany)
• Cleaning pistol (at least 2 bar static water pressure, e.g. Stoeckert SELECTA, REF 1769534)
• Purified water

WARNING

• Only use washer-disinfectors that are suitable for the cleaning and disinfection of surgical instruments.
• Refer to the maximum load of your washer-disinfector.
• It is essential to pay attention to the instructions for use from the detergent manufacturers.
• To ensure the effectiveness of the cleaning process, follow the described pre‑cleaning steps prior to cleaning.

1. Manually pre-clean the instruments:
   • For the removal of coarse dirt, place the instruments in cold purified water for 5-10 minutes and wipe off visible staining with a soft cloth soaked in cleaning solution.
   • Flush the instruments with a cleaning pistol (purified water, 22-35 °C) for at least 20 seconds.
   • Visually inspect the instruments. If the instruments are not visually clean, repeat step 1.
2. Place the instruments in the washer-disinfector.
   • Safely fix all instruments using a small part sieve tray from the manufacturer of your washer-disinfector.
   • Place devices such that they do not collide during cleaning.
   • Ensure that no device is obstructed by a large device (e.g. plates cup).
   • For devices with recessed features (holes, cannulae, crevices), connect the hoses of the washer-disinfector to the recessed features.
   • Place articulated devices in the fully open position and cannulated devices in the horizontal position.
   • Arrange the instruments in such a way that no areas are left unwashed and inner and outer surfaces are reached by the rinsing medium.
   • Do not overload the washer-disinfector.
3. Set the parameters on the washer-disinfector. Note the instructions from the manufacturer of your washer-disinfector for surgical instruments. The following cleaning cycle was validated in a Miele G7836 CD (two level rack, injection rate 5 ml/l). The used automated cleaning program had the following parameters:
   • At least 2 minutes pre-cleaning with purified water (16 °C).
   • At least 10 minutes cleaning at 50 °C with 0.5% solution of neodisher MediClean forte (Dr. Weigert, Hamburg, Germany) in purified water.
   • At least 2 minutes rinsing with purified water (22-35 °C).
   • Thermal disinfection with purified water at 90 °C for 1 or 5 minutes or in conformance with the national requirements according the A0 value (without an additional agent).
   • Drying at 110 °C for at least 15 minutes if the machine cycle includes a drying step.
4. Unload the washer-disinfector.
5. If the machine cycle does not include a drying step, dry the devices in an oven at 110 °C for at least 15 minutes.
6. Inspect cannulated, flexible and articulated devices for complete dryness. If required, use medical grade compressed air to further dry.

WARNING: Make sure that all product parts are carefully dried. Take special care to ensure that area inside the product are dried.
CAUTION : Do not use any rinsing agents with drying aids for the last wash cycle. These could remain on the surface causing interactions that damage the instrument

Visual Inspection and Functionality Testing

1. Visually inspect the products. Pay special attention to rough surfaces and hard‑to‑access areas. It may be necessary to use a magnifying glass.
   Ensure that the products are:

   • visually clean
   • dried
   • free from all contamination, such as organic material
   • free from cleaning agent residues

2. If the product parts are not visually clean, repeat the cleaning and disinfecting cycle until this is achieved. Otherwise effective disinfection cannot be guaranteed.

3. Check the products for proper function and against damage and wear before and after each application. Check particularly important parts such as tips, notches, and all moveable components with extra care.
   Pay special attention to:

   • breaks
   • cracks
   • deformations
   • corrosiom

4. Dispose of any damaged instruments.

Maintenance
Maintenance and repair may only be conducted by the manufacturer or authorized partners. The product components may only be sent back to the manufacturer in a cleaned and disinfected condition. Sharp or pointed components need to be sent back in a protected state.

Disposal
Risk of injury or infection can be avoided by safe disposal of the product components. Sharp and pointed components need to be collected and locked in a tight and break-proof container. They must be stored in such a way that they are protected from unauthorized use. Contaminated products are to be supplied to a hazardous waste site and handled in a way that contamination of third parties is excluded.

• In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) product should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling.
• The plugs used in the electronic products contain the following substance: Lead, CAS No. 7439-92-1 (1907/2006 REACH). Handling Instructions: No specific precautions are required for handling items manufactured from alloys containing lead in the supplied condition.
• The silicone glue used in the products contains the following substances:
  Decamethylcyclopentasiloxane, CAS No. 541-02-6 and Dodecamethylcyclohexasiloxane, CAS No. 540-97-6 (1907/2006 REACH).

Technical Specifications

References

• Patents | Stryker

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