Oral Examination Device and Intraoral Camera: TelScope Telehealth System Registered with FDA, TGA, and CE Marked

Holland Healthcare’s newest telehealth device and intraoral, TelScope Telehealth System, is now registered as a Class 1 Medical Device with the FDA, registered with the TGA, and is CE Marked.

The United States Food and Drug Administration (FDA) classifies Class 1 Medical Devices as devices with low or moderate risk to patient safety.  TelScope Telehealth System is registered with the FDA as a system, meaning that both the TelScope device and the TelScope App are registered with the FDA.

The Australian Therapeutic Goods Administration (TGA) is Australia’s governing body for therapeutic goods, including medical devices, in Australia. TelScope Telehealth System is registered with the TGA as a system. Once again, this means that both the TelScope device and the TelScope App are registered with the TGA.

Finally, TelScope is now CE Marked. The Certification Mark indicates that “conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards.” As with the FDA and TGA, TelScope Telehealth System is CE Marked as a system, meaning both the TelScope device and the TelScope App are CE Marked as per the EEA.

It is important to remember that the TelScope Throat Scope single-use depressors are registered for single-use only by the FDA. Throat Scope depressors attach to the TelScope Telehealth System as an illuminating tongue depressor to complete an oral telehealth exam. The Throat Scope single-use depressors are designed to reduce risk of cross-contamination. They come individually-wrapped, and they should not be cleaned and reused. The single-use depressors are recyclable, so we encourage you to recycle them after use. ♻️

To preorder TelScope Telehealth System, click here.

Download the TelScope App:

Get it on Google Play

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Holland Healthcare to Partner with The TeleDentists for Instant Teledentistry

Coming Soon: TelScope Care 24/7

Connect your intraoral issue to a dentist instantly.

Holland Healthcare is partnering with The TeleDentists, using the TelScope Oral Telehealth System. Together, the TelScope intraoral camera and examination device and The TeleDentists can capture a superior-quality images inside the mouth and connect that image to a dentist instantly.

Available only in the United States.

More to come soon…

About the TeleDentists

The TeleDentists is transforming the way people treat urgent oral and dental problems. Their first-to-market virtual care solution for teledentistry creates an improved way to access care, providing essential dental services 24/7/365 wherever a dentist is needed.

Learn more about The TeleDentists

Teledentistry image captured with TelScope.

TelScope Telehealth System

Examine. Capture. Connect.

TelScope Telehealth System allows you to complete an intraoral examination, transform any smart device into an intraoral camera to capture a superior quality telehealth image or video, and connect that telehealth image or video to a professional.

TelScope Images with Different Smart Devices

TelScope Telehealth System

Phone Image Comparison

How to Capture Amazing Oral Telehealth & Teledentistry Images with TelScope Telehealth System

How to Get Amazing Oral Telehealth & Teledentistry Images with TelScope Telehealth System

Examine the patient with the TelScope handle and single-use depressor before attaching to the smart device

Be sure to depress the tongue to illuminate inside the mouth.

For teledentistry and to get a good view of the molars and the teeth, retract the cheek and slide the TelScope sideways between the gum and the cheek.

If you see something of interest, proceed to attach TelScope to your smart device. Open the TelScope app to capture an intraoral telehealth or teledentistry image.

  • The single-use depressor should be attached to the TelScope handle before attaching the TelScope handle to your smart device

Now capture an amazing telehealth or teledentistry image.

The TelScope app is automatically set with optimal lighting, focus, and zoom settings for superior quality intraoral imagery.

The TelScope app camera is automatically zoomed to focus on the inside of the mouth. We do not recommend zooming in or out except for capturing specific images.

Place the TelScope blade inside your patient’s mouth and depress the tongue to illuminate inside the mouth. 

A good indication of a well-lit mouth is when the uvula is illuminated. 

For teledentistry images, turn your phone sideways, retract the cheek, and slide the depressor sideways between the cheek and the gum. This technique will allow you to capture images of the molars and the teeth.

We recommend practicing with TelScope on yourself in the mirror to get a hang of how to capture amazing images.

TelScope App Best Practices

• Make sure you are using a HIPAA compliant smart device

• Images should be uploaded to your patient file or sent to a peer for review, and then deleted from the app directly after your patient’s appointment

• Capture multiple images during the patient exam, then choose the best images from the app to upload to the patient file. Delete images from app after upload

• For measurement indications, your TelScope metal clip must be accurately placed and depressor visible in photo

Watch a TelScope Telehealth System Demonstration with Inventor Jennifer Holland:

Still need help? 

Reach out to Mike at mvogel@hollandhealthcareinc.com to schedule a free TelScope live tutorial!

Introducing TelScope Oral Telehealth System

Introducing TelScope Oral Telehealth System

Introducing the telehealth version of Throat Scope: TelScope Oral Telehealth System.

Connect intraoral concerns to a doctor or specialist quickly without leaving home, or have clients connect directly to you.

TelScope is a product and app combination. The TelScope handle is like the upgraded Throat Scope – it’s antimicrobial, rechargeable, and connects to any smart device.

When you connect TelScope to your smart device, open the TelScope app (available on iOS and Android) to snap an intraoral picture. Then you can measure, circle and comment on any areas of concern. Finally, send the image instantly to a doctor, dentist or specialist securely within the app.

 

TelScope Oral Telehealth System TelScope Oral Telehealth System

You can learn more about TelScope on our parent company website here.

TelScope is ready for preorder – for an amazing discount – via Indiegogo. Preorder here.

 

Head and Neck Cancer Screening

Head and neck cancer screening event

Surgeons and oncologists who work in Head and Neck Cancer Multidisciplinary Teams (MDTs) are qualified to do head and neck cancer screening. The process involves asking about possible symptoms, examining the mouth and the top of the throat with a good light source, and palpating the neck for lumps. Screening clinics which run outside traditional hospital environments are a great way to raise awareness of the signs and symptoms of these cancers, especially among people who may never have heard of the disease. Head and neck cancer screening also has one big advantage over many over screening clinics – we can examine the vast majority of patients without asking them to remove any items of clothing. In this blog I am sharing how we ran our screening clinic and what we learned in the hope that I can inspire other clinicians to do the same.

Clear objectives

The goal for our head and neck cancer screening clinic was to raise awareness. My practice team had been brainstorming ideas for activities for World Head and Neck Cancer Day (WHNCD) to help bring attention to these diseases.  Not only do most people know very little about head and neck cancer but also the majority of those who have heard about it are under the false impression that the main contributing lifestyle factor is smoking. We were aware of other head and neck cancer screening clinics being run in hospitals which recruited volunteer patients who consisted mostly of hospital staff, visitors and some members of the public. We wanted to stage an event that was held off a hospital campus in order to engage with a broader cross section of the general public. The date for WHNCD is July 27 which meant that in 2019 WHNCD fell on a Saturday. Sports fields and shopping centres seemed like good options and we knew we wanted the screenings to be free. We had plenty of ideas but the difficulty was putting them into action.

Teamwork – look for partners and supporters

Fortunately for us we have been working for some time with Jennifer Holland and the team at Holland Healthcare. Jennifer is the inventor of Throat Scope, a tongue depressor with a light in it. Otolaryngology Head and Neck Surgeons (ENTs) routinely use specially designed light sources wen examining the mouth and throat. Not every doctor or clinician has access to this equipment. Throat Scope is a fantastic tool which enables GPs, dentists and other clinicians who regularly examine the mouth to complete a thorough oral examination without the need for a separate light source. Jennifer and her team had previously run an oral screening event in 2017 at the V8 Super Cars Newcastle. She offered to use her contacts to help us find a suitable venue to run our screening clinic on World Head and Neck Cancer Day. Jennifer did not disappoint and secured a spot for us at Bankwest Stadium among the pre-game activity during the National Rugby League premiership season when the Parramatta Eels played the New Zealand Warriors. We were stationed outside the main entrance. Thousands of people had to walk past our marquee to enter the stadium.

Before giving the project the green light we also approached Anthony Schembri AM, CEO of St Vincent’s Sydney and Dr Julia Maclean, president of the Australian New Zealand Head and Neck Cancer Society for their support. All clinicians participating in the event are members of both the St Vincent’s Head and Neck Cancer MDT and the ANZHNCS so it made sense to approach these organisations. St Vincent’s Sydney not only provided in principle support but also worked with me to create a video about neck lumps, one of the major symptoms of head and neck cancer, to run on St Vincent’s TV across their website and social media platforms on WHNCD.

You need a great team on your side

In order to run our free screening clinic we needed the following personnel;

  1. Qualified clinicians to complete the screening. This included myself, Otolaryngology Head and Neck Surgeon Dr Julia Crawford, and Dental Surgeon Dr Peter Foltyn, all members of the St Vincent’s Sydney Head and Neck Cancer Multidisciplinary Team (MDT).
  2. Clerical and admin team. Running a free screening clinic has the same risks and responsibilities for clinicians as seeing patients in a regular practice setting. Our clerical and admin team greeted patients, made sure they completed the appropriate paperwork, kept supplies up to clinicians, and ensured those patients with a suspected underlying diagnosis were appropriately referred for follow up;
  3. Thank goodness for Jennifer and her team at Holland Healthcare. They provided the marquee, Throat Scopes and disposable blades, furniture, screen dividers, gloves, gauze, hand sanitizer, waste containers and every other piece of equipment we needed to perform examinations.
  4. Patient recruiters. We were lucky to have a great team of volunteer patient recruiters who not only approached members of the public for screening but also shared literature with them about the free clinic and head and neck cancers. Their friendly, pressure-free approach ensured that a number of members of the public who originally said ‘no thank you’ returned to participate once they had read more about the screening clinic on the information postcard.

Logistics and patient literature

One major advantage of screening for head and neck cancer over screening for cancers on other sites of the body is that very few items of clothing need to be removed. That said, I admired a lot of Parramatta Eels beanies and scarves. But we still wanted to provide privacy to patients and created individual screening booths. In addition to a weather proof marquee, examination equipment and furniture we also needed banners, signage and patient literature. The banners and signs communicated what we were doing and the literature ensured people understood the screening process, the signs and symptoms of head and neck cancer, and where to find more information. Jennifer had the great idea of putting this information in the form of a postcard which included a link to the excellent online Head and Neck Cancer resources at the NSW Cancer Council

Each clinician worked in a screened consultation area within the marquee.

Literature needs to be easy to read and provide links to authority sources.

Medico-legal risks and public liability

Running a pop up screening clinic is not risk free for patients, organisers or clinicians. We took advice from Avant Risk Management to ensure we understood what we were getting ourselves into. Patients who see clinicians at a free screening clinic like ours have the right to expect the same standard of care as they would if they were seeing the clinician at a pre-arranged appointment in a practice or hospital setting. We had to collect patient data, display a privacy policy explaining what would happen to that data, record the findings for each patient, and provide a letter for patients with an underlying suspected diagnosis to take to their regular GP for follow up. We only screened people over eighteen years of age. There was no power supply to our marquee so all of this had to be done by hand with pre-printed paper templates. Over the next few days my staff will enter all patient details into our patient database, scan and link records of each consultation to create a medical record, and follow up patients with a suspected underlying diagnosis to ensure they get the care they need. Medical records from the event will be retained in digital format in our secure system for the next seven years in accordance with medical record storage regulations and the paper versions will be appropriately destroyed in order to protect patient privacy. The staff at Bankwest Stadium were a pleasure to liaise with and made sure we met our responsibilities of providing a certificate of currency for public liability and that our marquee was weighted securely in case of severe wind gusts. We were very lucky with the weather, it was a spectacular winter’s day. We also had to remove our own rubbish and follow explicit set up instructions regarding access.

How did it go? What did we find?

We screened just over one hundred patients in two and a half hours, including the Parramatta Eels cheer squad, Life Education Ambassador Healthy Harold, being a giraffe his neck examination took a little longer than average, and three fine members of the NSW Police Force. There was no shortage of patients. The Parramatta Eels supporters were out in force with over 17,000 people attending the game. We identified four patients with suspected underlying diagnoses, 4% of our patient cohort. The findings included enlarged lymph nodes in the neck and lip lesions. These patients were either unaware of their symptoms or unaware their symptoms required further investigation. Not surprisingly the group of Eels supporters smoking around the corner from us were reluctant to participate in the screening clinic. To their credit, they did take our literature and thanked us for the invitation.

Dr Julia completing a slightly tricky examination.

Police officers participating in screening after checking the 17,000 strong crowd was safely in the stadium.

Was the day a success?

Yes, this event was definitely a success, we achieved our goal of raising awareness of head and neck cancers, not just among the patients we examined but also among people with whom we had conversations and to whom we distributed printed information. I will also say that it was not just the patients who benefitted. My team and I had an exhausting but uplifting day getting out of our regular environment and talking to a huge range of people about these rare cancers. It was rewarding to reassure those patients who were scared of what we might find when they volunteered to be examined, and it was delightful to screen patients who were happy and relaxed, an unusual experience for someone like me who spends most days diagnosing cancer. Our findings of four patients requiring follow up confirms that we interacted with a general cross section of the population.

Would we do it again?

Definitely. We look forward to doing other free Head and Neck Cancer screening events in the future. In the public conversation about cancer neither head and neck cancer nor head and neck cancer patients receive the attention or funding they deserve. Taking direct action to screen one hundred people may sound like a drop in the ocean but the success of the event only strengthened me and my teams’ resolve to keep working to raise awareness. If clinicians like me don’t do it who will.

The entire head and neck cancer clinic screening team – three support members to every one clinician.


About the Author

Hi Richard Gallagher’s my name and I’m a head and neck surgeon at St Vincent’s. I work at St Vincent’s Private Hospital, St Vincent’s Public Hospital, and at The Kinghorn Cancer Centre. I’ve worked at St Vincent’s since 1998. I finished my surgical training in 1995 and following that I did further training in head and neck cancer surgery. At the present time my practice is mainly looking after patients with cancer and head and neck cancer and looking after patients with complex airway problems. In 2011 I went and did further training in the United States in Philadelphia at the University of Pennsylvania in transoral robotic surgery. So that surgery’s used mainly for patients who havecancers at the back of the throat and oropharynx and is particularly useful for patients who have cancers due to the human papillomavirus or HPV. So that’s a large number of patients at the present time. On the campus I also wear several hats. I’m the Director of Cancer Services and I’m also the Director of the Head and Neck Cancer Service at St Vincent’s.


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Scope for achievement after Wynnum mum wins $50,000 | The Courier Mail | 8th December 2011

A WYNNUM mother-of-three is changing the face of medical technology just by taking her baby to see a doctor.

Former accountant Jennifer Holland, 29, last week won Queensland Government’s What’s Your Big Idea? competition which included $50,000.

Her invention, the Throat Scope, is a slim-line illuminated tongue depressor which can be used by medical doctors, veterinarians and the general public.

“I took my baby to the doctors in 2008 and noticed the doctor using a wooden tongue depressor and hand-held torch,” she said. “My baby moved his head and the doctor and I found it very difficult to hold his head in place, that’s when it hit me. Why didn’t they have a one handed device with a light?”

That night, Mrs Holland spent hours sketching designs and creating a name for her idea.

Mrs Holland, who has patented her invention, said she is now on the hunt for a manufacturer and hopes to spend her $50,000 on producing and distributing the Throat Scope.

“I have more ideas and they seem to be coming thick and fast now,” she said.

Read the original article HERE

Australia’s Quirkiest Patents in 2014 | SBS | 5th January 2015

Throat Scope illuminating the inside of a patient's mouth
“A tongue depressor for illuminating the oral cavity, and to methods of using the tongue depressor.”

Wooden objects are commonly used to press down a tongue. This device illuminates the mouth as well, rather than medical staff using a torch in their other hand.

Read original post HERE