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Pro-TEM

Pro-TEM™ Instructions For Use

Contents

  1. Intended Use and Types of Pro-TEM™ garment available
  2. When to wear your Jobskin® Pro-TEM™ garment
  3. Donning your Jobskin® Pro-TEM™ garment
  4. IndicationsContra­in­di­cations and Existing Medical Conditions
  5. Warnings and Precautions and In Case of Serious Incident
  6. Additional information
  7. Washing instructions
  8. Contact Details
  9. Definition of Symbols
  10. Storage and shelf life information and Disposal of your garment

Intended Use

Jobskin® Pro-TEM™ garments are assessment tools used to identify whether a made-to-measure SDO® garment will be of benefit. Our SDO® range including Pro-TEM™ garments can be used for patients with Neuromuscular or Musculoskeletal conditions. Pro-TEM™ are provided to assess the impact of increasing sensory and proprioceptive feedback, improving postural control and providing some musculoskeletal support.

The garment gives clinicians a tool to assess the potential value of dynamic compression in patients with but not limited to: poor postural control, decreased proximal stability, hyper mobility, increased or decreased tone and decreased sensory feedback. The best results are achieved when used in the assessment process prior to the provision of a made-to-measure SDO® garment.

Your new Jobskin® Pro-TEM™ garment has been designed and manufactured in Long Eaton, Nottingham in the UK and will have been recommended by an SDO® certified clinician.

Types of Pro-TEM™ Garment Available

Pro-TEM™ garments are off-the-shelf assessment tools. The types of Pro-TEM™ garment are broken down into the categories listed below:

  • Ax Suit
    • With Crotch
    • Without Crotch
  • Lumbar belt
  • Sleeve
  • Gauntlet
  • Sock
  • Full Assessment Kit includes:
    • Lumbar belt
    • Sleeve
    • Gauntlet

When to Wear your Jobskin® Pro-TEM™ garment

Please note

Please note this garment has been designed for use by a single patient and must be worn by the user only. It must not be applied to anyone else once already worn.

The garment should offer a snug fit and can be expected to cause red marks initially. These soft tissue marks should disappear within 30–40 minutes of removing the garment. If the marks persist for longer than 30–40 minutes do not increase the wearing time and inform your treating clinician directly.

This garment should be worn for a maximum of 4–6 weeks before deciding if an SDO® made-to-measure garment would be appropriate.

Wearing Schedule: 

  • On the first day of wear the Pro-TEM™ should be worn for a maximum of two hours at any one time. If after two hours there are no adverse reactions then increase the next wearing time by one hour.
  • Continue to increase wearing time by one hour until the minimum recommended wearing time of 6–8 hours is reached, or as recommended by the treating clinician.
  • It is advised that you should not sleep in the garment, unless the garment has been prescribed for night time use.
  • To obtain maximum benefit from the garment it is important that it is worn daily as prescribed by a certified clinician (unless any adverse effects/­contra­in­di­cations/­precautions identified).

 

Donning your Jobskin® Pro-TEM™ garment

Please follow the advice of your treating clinician before you wear this Pro-TEM™ garment.

For all Pro-TEM™ garments, please follow the standard instructions below before reading the specific donning instructions for your type of garment:

  • Read through the instructions, paying particular attention to Warnings and Precautions, and Additional Information regarding creams and oils, prior to donning your Pro-TEM™ garment.
  • Ensure your hands are clean with no sharp fingernails or toenails. Temporarily remove jewellery from hands, wrists and ankles if applicable

  • Open all fastenings

  • Avoid using your garment if you have any acute skin rashes or if a vascular/­circulation problem arises until cleared by your treating clinician

  • Watch for signs of discomfort and any change in hand/feet colour or temperature that may indicate problems with circulation. If this occurs remove the garment and contact your treating clinician immediately

  • If you have a medical condition that may be affected by wearing a Pro-TEM™ garment, please seek medical clearance

Fitting Instructions:

AX Suit

  • The Pro-TEM™ assessment suit is available in paediatric and adults sizing and can come with or without a crotch section. The garment encompasses the body to provide sensory and proprioceptive feedback.
  • Ensure shoulder clips are fastened before placing over your head
  • Check garment is central and no creasing to the tongue
  • Fasten the hook and loop straps around the body
  • Adjust the body section until a snug fit is achieved
  • Fasten crotch strap if available

Lumbar Belt

  • The Pro-TEM™ lumbar belt is used to identify whether there is diminished sensory and proprioceptive feedback to the core. The belt is fitted from the lower ribs to the anterior superior iliac spine (ASIS) to identify the effect on postural control and trunk stability.
  • Position the lumbar support from the lower ribs to the bony prominences (ASIS) at the front of the hips
  • Pull the support around the trunk until you have a snug fit (you should be able to get a flat two fingers between the belt and the body) and attach using the hook and loop fastening edge of the base support
  • Pull the rotation straps around to achieve the required correction and attach using the hook and loop fastening
  • Remove by first peeling off the rotation straps and then the base belt hook and loop edge

Sleeve

  • Fitted from just above the wrist to the axillary crease (armpit) and provides feedback through the arm.
  • Slip your hands through the entire sleeve keeping the seam in-line with your little finger, ease sleeve up the arm into position
  • Make sure the fabric is smoothed out evenly over the arm, do not fold up or down
  • Labels are positioned on the outside of the garment, away from the skin

Gauntlet

  • Fitted from the palmer crease including the thumb to the wrist to help identify the effects on hand position and function.
  • Slip your hand through the wrist of the gauntlet
  • Adjust the thumb by carefully pulling on the seams until the gauntlet fits snugly into the first web spaces
  • Make sure the fabric is smoothed out evenly over the thumb and hand. Hold the hand up to the light, you should not be able to see light through the web space if it is fitted and sized correctly
  • Labels are positioned on the outside of the garment, away from the skin

Sock

  • Fitted from the metatarsal heads in the foot to below knee to provide sensory and proprioceptive feedback to check the effects of muscle strength and tone.
  • Slip the foot into the sock and feed over the foot
  • Adjust the sock carefully until it fits snugly over the foot and ankle
  • Make sure that the fabric is smoothed out evenly over the foot and leg
  • Remove by peeling off the sock away from the skin

 

NOTE: When removing the garments, peel off gradually taking care not to place extreme pressure on seams.

NOTE: If your garments are tight, slack or damaged they will need to be replaced by your clinician/­provider immediately.

Indications

Neuromuscular and Musculoskeletal conditions including but not limited to:

  • Stroke 
  • Cerebral Palsy
  • Duchenne’s Muscular Dystrophy
  • Ehlers Danlos Syndrome
  • Multiple Sclerosis
  • Scoliosis
  • Autism

Contra­in­di­cations

  • Scleroderma 
  • Dislocated joints (not reduced)
  • Fixed contractures/­Soft tissue shortening 
  • Oedema
  • Skeletal conditions including Osteogenesis imperfecta
  • Open wounds

Existing Medical Conditions

Your clinician should be made aware of any existing medical conditions you may have so this can be considered when prescribing your Pro-TEM™ garment. If you have not alerted your clinician to any of the conditions below, please DO NOT wear this garment until your clinician confirms it is safe to do so. Existing medical conditions include but are not limited to:

  • Certain skin conditions e.g. Eczema 
  • Vascular/­Circulation problems 
  • Oedema 
  • Weight fluctuations 
  • Epilepsy

Warnings & Precautions

There are no known side affects when wearing this garment in the correct manner as directed by your treating clinician, surgeon or GP. If your medical condition deteriorates whilst wearing this garment, please consult your doctor or clinician immediately. 

The manufacturer is not liable for any damages, conditions or injuries that occur from handling or using this garment incorrectly. This includes any alterations or tampering by the user. Your garment must be regularly maintained to the maintenance schedule in this IFU.

Pro-TEM™ garments are not flame retardant, please avoid naked flames when wearing.

Please stop wear and contact your treating clinician if any of the below occur:

  • Allergic reaction 
  • Discolouration or a change in body temperature showing circulation or vascular problems 
  • Lasting redness or skin abrasions 
  • Raised temperature 

If you have any open wounds in the area to be treated, these need to be covered with an appropriate wound dressing or bandage, before the compression garment can be applied.

Please note: wearing your garment for extended periods, for example over 10 hours a day may encourage excessive muscle stimulation and therefore can cause fatigue.

In Case of Serious Incident

In the event of a serious incident that may result in the deterioration of a patient’s medical condition or may risk death, STOP using your garment immediately and contact:

  • The manufacturer Jobskin® Ltd. 
  • The relevant authority in the Member State
  • The UK Medicines and Healthcare products Regulatory Agency (MHRA)

Additional Information

Please follow instructions provided by your treating clinician and wear as prescribed to achieve optimum results. You may have to seek help with donning and doffing your garment and your treating clinician should be made aware of this.

Although Jobskin® garments are resilient to most creams and oils, please note the following as some creams may damage the fabric, reduce the elasticity and the effectiveness of your pressure garment.

  • Avoid using creams containing wax, paraffin or petroleum
  • Use water or silicone-based moisturiser or cream

Always check garment and skin daily before use. Do not use if you have hyper­sen­sitivity or an allergic response to the garment materials. Please report to your treating clinician urgently. 

When re-applying your garment after bathing, creaming and massaging, make sure the skin is dry and no residue cream remains on the skin.

If wearing your garment whilst swimming, you must rinse out the chlorine or sea-salt immediately afterwards to preserve and protect the fabric.

Important: Please do not remove the silk label within your garment as the warranty will be void.

Washing Instructions

Please follow the washing instructions below to maintain the elasticity and longevity of your garment, a copy of which is printed on the silk label sewn into your garment. 

Wash your garment separately for the first time to avoid any colour run. Jobskin® recommend turning your garment inside out and fastening any zips prior to washing as this helps to protect and prolong the life of your garment.

TIP: Using a laundry bag inside your washing machine helps to protect your new Pro-TEM™ garment.

TIP: After hand washing, tightly roll your garment inside a thick towel to remove excess moisture, then dry flat on a second dry towel.

Key points to note:

  • Wash dark colours separately 
  • DO USE a non-biological mild detergent 
  • Please do not use a fabric conditioner 
  • Please do not dry in direct sunlight 
  • Please do not dry on a radiator
  • Please do not dry in a tumble dryer
  • When hand washing, please rinse well and do not wring

 We advise that Jobskin® Pro-TEM™ garments are washed 2–3 days a week to help rejuvenate the fabric.

80% Hand wash   Hand Wash
80% 30 underline   Machine Wash at 30 degrees centigrade
80% Do not bleach   Do Not Bleach
80% Do not iron   Do Not Iron
80% Do not tumble dry   Do Not Tumble Dry
80% Do not dry clean   Do Not Dry Clean
80% Do not wring   Do Not Wring
80% Dry flat   Dry Flat
80% Drip dry   Drip Dry

Storage, shelf life and disposal

Please store your new garments in a dry place away from direct sunlight.

  • Do not place near any heat source.
  • Do not leave inside a car in hot weather.

Ready-to-wear Pro-TEM™ garments are recommended for immediate use as body measurements may change over time.

With the correct handling and care, your garment may last for up to 6 months repeated wearing (usage period), after which time you will need to consult your medical professional to be measured for a new garment.

Please contact your treating clinician if the following occurs:

  • You gain or lose a significant amount of weight
  • Your condition changes

  • Your garment has degraded and needs to be replaced

Should the above conditions apply, a new garment may be required before the 6 month period has elapsed. Please do not wear a garment that is too tight or too loose as this can cause delays in your therapeutic success.

Your new ready-to-wear Pro-TEM™ garment is for single patient usage only, please do not share this garment with a third party.

Disposal of your garment

There are no specific instructions for your garment disposal. Please dispose of your used garments in your household waste or clothing recycling bank.