Safety & Warnings

Last Updated: 28/09/2025

Please read these Safety & Warnings carefully. Contact PectusConnectUs at pectusconnectus@gmail.com with any questions or concerns about these.

CRITICAL NOTICE: PectusConnectUs is a medical device manufacturer, NOT a medical service provider. We are not doctors, and our facilities are not hospitals or medical clinics. All devices must be used under the supervision and guidance of your qualified healthcare professional.

About PectusConnectUs Devices

Custom Manufacturing Process

All PectusConnectUs devices are custom-made specifically for each client based on:

Photographs and videos provided by the client
3D modeling created from client-provided images
Individual measurements and specifications

Client Responsibility: You are responsible for providing accurate, clear, and complete photographs and videos. Device fit and effectiveness depend on the quality and accuracy of the information you provide.

Device Components & Materials

Vacuum Bell Devices:

Bell body: 3D printed PETG (Polyethylene Terephthalate Glycol)
Sealing flaps: Medical-grade silicone
Integrated one-way valve
Connection hose with vacuum pump and pressure gauge

Soft Brace Systems:

Base material: Neoprene
Structural plates: PETG plastic
Connectors: Metallic hardware
Compression system: Rubber bands

Hard Brace Systems:

Frame: Stainless steel
Structural plates: PETG plastic
Padding: Polyurethane foam

MANDATORY MEDICAL SUPERVISION REQUIREMENT

YOU MUST:

Undergo thorough medical examination by a qualified physician BEFORE using any PectusConnectUs device
Obtain medical clearance and prescription/recommendation for orthotic treatment
Use devices ONLY under ongoing medical supervision
Follow ALL guidance provided by YOUR healthcare professional
Attend regular medical check-ups (typically every 1-3 months)
Report all complications to YOUR medical provider immediately

WE ARE NOT:

Medical doctors or healthcare providers
Qualified to diagnose conditions or provide medical advice
Able to determine if treatment is medically appropriate for you
Responsible for monitoring your medical condition

MONTHLY PROGRESS PHOTOS: We require monthly progress photographs solely for tracking device effectiveness and correction progression. These photos are NOT used for medical diagnosis, assessment of complications, or identification of medical problems. Any medical concerns must be addressed with YOUR qualified healthcare provider.

LIMITATION OF LIABILITY & CLIENT ACKNOWLEDGMENT

Complete Disclaimer of Medical Liability

BY USING PECTUSCONNECTUS DEVICES, YOU EXPRESSLY ACKNOWLEDGE AND AGREE:

No Medical Advice: PectusConnectUs provides NO medical advice, diagnosis, or treatment. We manufacture custom devices only.
Your Medical Responsibility: YOU are solely responsible for:
- Obtaining appropriate medical evaluation and clearance
- Ensuring the device is medically appropriate for your condition
- Following your healthcare provider’s instructions
- Monitoring your own health and recognizing complications
- Seeking immediate medical attention when needed
Manufacturing Role Only: Our role is limited to manufacturing custom devices according to your specifications. We are not responsible for:
- Medical outcomes or treatment results
- Complications arising from device use
- Failure to achieve desired correction
- Medical decisions made by you or your healthcare provider
- Consequences of inadequate medical supervision
No Guaranteed Results: We provide NO guarantee, warranty, or representation regarding:
- Treatment effectiveness or outcomes
- Time required for correction
- Final aesthetic results
- Medical safety for your specific condition
Assumption of Risk: You acknowledge that you are voluntarily choosing to use our devices and assume all risks associated with their use, including but not limited to the side effects and complications listed in this document.

Device Fit Liability

Device fit and function are dependent on the accuracy of photographs, videos, and measurements YOU provide. PectusConnectUs is not liable for:

Improper fit due to inaccurate or poor-quality images
Changes in your body between measurement and device delivery
Failure to follow provided measurement instructions
Natural variations in body shape that affect device performance

VACUUM BELL DEVICES

How to Use Your Vacuum Bell

Application:

Position the vacuum bell on your chest over the pectus area
Ensure silicone flaps create a seal against your skin
Use the vacuum pump to gradually create negative pressure
Pump until sufficient vacuum is achieved to elevate the sternum
Monitor pressure using the integrated pressure gauge

Removal:

Place a finger under the silicone flap to break the seal
Allow air to enter gradually
Remove device once seal is broken and pressure equalized

NEVER: Pull or force the device off while under vacuum pressure

Absolute Contraindications (DO NOT USE)

STOP – Do not use vacuum bell devices if you have ANY of the following conditions:

Skeletal Diseases
- Osteogenesis Imperfecta (brittle bone disease)
- Osteoporosis (diminished bone density)
- Any condition affecting bone firmness or integrity
- History of spontaneous fractures
Vascular Conditions
- Marfan syndrome
- Ehlers-Danlos syndrome
- Aneurysm (abnormal arterial extensions)
- Any form of angiopathy or vascular fragility
- Uncontrolled hypertension
Blood Clotting Disorders
- Thrombopathy
- Haemophilia (bleeding disorder)
- Any coagulation dysfunction
- Current use of blood thinning medications (consult your doctor)
Other Conditions
- Active skin infections in treatment area
- Open wounds or recent surgical incisions on chest
- Severe cardiac conditions (consult cardiologist)
- Respiratory conditions that may be affected by chest pressure

Critical Safety Warnings

Reduced Ribcage Firmness

Using the vacuum bell may cause temporarily reduced firmness of the ribcage
You MUST avoid extreme physical stress to the ribcage during the entire treatment period
Activities to AVOID: boxing, wrestling, rugby, martial arts, contact sports, or any activity involving chest impact or collision

Situations Where Device Must NOT Be Used:

Within 24 hours after scuba diving
During air travel or rapid altitude changes
In pressurized or depressurized environments
While operating vehicles or machinery
During swimming or water activities
In the presence of open wounds
During or immediately after surgery

Age and Physical Considerations:

Older patients: Increased risk of rib/sternum fractures – medical clearance essential
Very young children: Use only with pediatric specialist supervision
Pronounced chest muscles: May affect seal and effectiveness
Significant body hair: May prevent proper seal (grooming may be necessary)

Vacuum Bell Side Effects & Management

SEEK IMMEDIATE MEDICAL ATTENTION IF:

Dark (black) haematomas (bruising) appear
Severe chest pain develops
Difficulty breathing occurs
Persistent pain continues after device removal
Signs of infection appear (fever, warmth, discharge)
Rib or sternum pain suggests possible fracture
Any alarming or unexpected symptoms develop

Common Side Effects & Prevention:

Dizziness/Vertigo at Start of Treatment
- Prevention: Lie down when first applying device; pump slowly and gradually
- Stand up cautiously after application
- Sit down immediately if dizziness occurs
- If persistent, discontinue use and consult doctor
Haematomas (Bruising/Discoloration)
- Appearance: Red, purple, or blue marks under the device
- Cause: Blood vessel response to vacuum pressure; may indicate micro-ruptures
- Prevention: Use lower vacuum pressure; shorter treatment times
- Action: Light bruising is common; DARK/BLACK bruising requires medical attention
- Natural remedy: Black comfrey root products (cream or oil) applied after showering may help speed resolution
- Medical option: Retinoids/Retinol creams (consult your doctor before use)
Skin Discoloration (Hyperpigmentation)
- Appearance: Darkened skin in treatment area (brown, tan, or darker than surrounding skin)
- Cause: Repeated vacuum pressure causing localized hyperpigmentation
- Duration: May persist during treatment; typically resolves gradually after treatment ends
- Prevention: Use appropriate vacuum pressure; avoid excessive force; shorter initial treatment times
- Natural remedy: Black comfrey root products (cream or oil) applied after showering to affected areas
- Medical option: Retinoids/Retinol creams may accelerate fading (consult your doctor before use)
- Note: This is typically a cosmetic issue that resolves over time but should be monitored
Muscle Soreness/Chest Discomfort
- Cause: Stretching of intercostal muscles and chest wall structures
- Prevention: Gradual pressure increase; shorter initial treatment times
- Management: May require several days of rest; over-the-counter pain relief if recommended by doctor
- Action: If severe or persistent, consult your healthcare provider
Temporary Back Discomfort
- Cause: Biomechanical changes as chest wall lifts
- Prevention: Shorter treatment times; gradual pressure increase
- Management: Usually resolves quickly; gentle stretching may help
Red or Purple Skin Under Device (Petechiae)
- Appearance: Dark red to violet discoloration during/immediately after use
- Cause: Temporary blood pooling under vacuum
- Action: Remove device after 15-20 minutes; wait several minutes before reapplying
- Prevention: Use lower vacuum pressure
Blood Droplets on Skin (Petechiae Hemorrhage)
- Appearance: Small pinpoint blood spots
- Cause: Capillary rupture from vacuum pressure
- Prevention: Lower vacuum pressure; shorter treatment times
- Action: Usually resolves on its own; if extensive, reduce pressure and consult doctor
Skin Swelling (Edema)
- Appearance: Puffy or swollen skin in treatment area
- Cause: Fluid accumulation in tissue
- Prevention: Shorter treatment times; lower vacuum pressure
- Action: Typically resolves within hours; elevate if possible
Abraded or Broken Skin
- Appearance: Raw, scraped, or damaged skin, especially at device edges
- Cause: Friction or excessive pressure, particularly during movement
- Prevention: Avoid physical activity while wearing device; ensure proper fit; use appropriate pressure
- Action: STOP all treatment immediately; wait several days until completely healed
- Warning: Using device on damaged skin will cause bleeding and may lead to infection
Arm Tingling or Numbness
- Location: Usually upper arms, occasionally forearms
- Cause: Nerve compression or circulation changes
- Prevention: Lower vacuum pressure; shorter treatment times
- Action: Should resolve quickly after removal; if persistent, consult doctor
Nipple Irritation
- Cause: Contact with device edge or vacuum pressure
- Prevention: Position device to completely cover one nipple while leaving the other uncovered, OR position to avoid both nipples
- Never: Allow device edge to cross nipple
- Action: If irritation occurs, adjust positioning
Gynaecomastia (Male Breast Enlargement)
- Appearance: Enlarged nipples or breast tissue in males
- Risk: Documented in adolescent and young adult males
- Cause: Possible hormonal stimulation from repeated nipple contact
- Action: SEEK MEDICAL ATTENTION IMMEDIATELY
- Treatment: May require temporary cessation of treatment or medical intervention
- Prevention: Careful positioning to minimize nipple contact
Respiratory Symptoms
- Rare occurrence: Febrile bronchitis reported in one case after first use
- Prevention: Keep upper body warm during treatment; avoid exposure to cold
- Action: If fever or respiratory symptoms develop, discontinue use and consult doctor

Vacuum Bell Application Best Practices

Treatment Timing:

Optimal: Before sleeping
Better after physical activity rather than before
Avoid immediately before strenuous exercise

Gradual Pressure Progression:

Start with minimal pressure that produces slight elevation
Increase gradually over days and weeks, not within single sessions
Taking 2-4 weeks to reach full pressure is NORMAL and RECOMMENDED
NEVER rush to maximum vacuum
Avoid extreme pressure variations

Treatment Duration:

Start with 15-30 minutes for first applications
Gradually increase to typical durations (1-3 hours for adults)
Listen to your body; pain means excessive pressure or duration
Consistency over time is more important than long single sessions

Maintenance:

Inspect device before EVERY use
Check for cracks, tears, or damage to any components
Ensure valve functions properly
Clean according to manufacturer instructions
Replace any damaged parts immediately

ORTHOTIC BRACES (Soft & Hard)

How to Use Your Brace

Soft Brace Application:

Position neoprene base over treatment area
Attach the plates over it
Adjust compression gradually using the rubber band system
Bend the connector piece if necessary

Hard Brace Application:

Position stainless steel frame correctly on torso
Ensure polyurethane foam pads sit comfortably against skin
Use the levers on the buckles to tighten ladder straps
Follow your healthcare provider’s adjustment instructions

DO NOT: Over-tighten or force excessive pressure immediately

General Precautions

Initial Adjustment Period:

Discomfort during first days/weeks is normal and expected
Gradual compression increase is ESSENTIAL – never rush
Follow prescribed wearing schedule exactly
Takes time for body to adapt to pressure
Patience is critical for safe, effective correction

Brace Side Effects & Management

SEEK IMMEDIATE MEDICAL ATTENTION IF:

Severe, unrelenting pain develops
Numbness or loss of sensation occurs
Skin breakdown or open wounds develop
Signs of infection appear
Breathing becomes restricted or difficult
Any alarming symptoms develop

Common Side Effects & Prevention:

Skin Rash (Very Common)
- Incidence: Occurs in approximately 70% of users
- Appearance: Red, irritated skin under pressure areas
- Cause: Friction, pressure, and moisture under brace
- Duration: Most cases resolve within a few months as skin adapts
- Prevention: Keep skin clean and dry; wear breathable clothing underneath if recommended
- Management: Usually improves with continued use; if severe, consult doctor
Skin Discoloration/Hyperpigmentation
- Incidence: Occurs in approximately 15% of users
- Appearance: Darkened skin (brown, tan, or darker) in pressure areas
- Cause: Excessive compression causing localized hyperpigmentation
- Duration: May persist during treatment; typically resolves gradually after treatment ends (may take several months post-treatment)
- Prevention: Ensure proper fit; avoid over-tightening; gradual pressure adjustment
- Natural remedy: Black comfrey root products (cream or oil) applied after showering to affected areas
- Medical option: Retinoids/Retinol creams may accelerate fading (consult your doctor before use)
- Note: This is typically a cosmetic issue that gradually improves after treatment completion
Pressure Points & Discomfort
- Common occurrence: Mild to moderate discomfort after pressure adjustments
- Prevention: Very gradual pressure increases; proper fit verification
- Management: Over-the-counter pain relief if recommended by doctor; rotate brace position slightly if allowed
- Action: Persistent severe pain requires medical evaluation and possible fit adjustment
Excessive Pressure Pain
- Warning sign: Severe pain indicates over-tightening
- Action: Loosen brace immediately; do not continue until properly adjusted
- Prevention: Follow prescribed adjustment schedule; never force rapid correction
Muscle Fatigue
- Cause: Postural changes and new muscle engagement patterns
- Normal: Mild muscle fatigue as body adapts
- Management: Typically improves with continued use; gentle stretching may help

Wearing Guidelines

Compliance = Success:

Treatment success depends heavily on consistent wearing
Chest wall flexibility is more important than deformity severity
Initial phase may require 20-23 hours per day (remove for showering/brief breaks)
Gradual reduction in wearing time as correction stabilizes
NEVER discontinue without medical supervision – regression can occur

Activity Modifications:

Follow YOUR healthcare provider’s specific activity recommendations
Contact sports: Usually requires brace removal
Swimming/bathing: Remove brace
Physical education: Discuss with your doctor
Sleep: May need to wear during sleep initially

Hygiene and Maintenance:

Keep skin clean and dry under brace
Shower/bathe with brace removed
Allow skin to breathe during breaks
Clean brace components regularly per instructions
Inspect all components regularly for wear, cracks, or damage
Report any damage immediately – do NOT use damaged brace

Never Modify Brace Yourself:

All adjustments must be made by qualified professionals
Do not attempt to modify stainless steel, PETG plates, or structural components
Do not substitute or modify rubber bands or connectors
Contact PectusConnectUs for any needed modifications

Age-Specific Considerations

Children and Adolescents:

Growing bodies may require periodic brace modifications
Parents/guardians must ensure compliance
Regular monitoring of growth and correction essential
Flexibility of chest wall typically makes treatment more effective

Adults:

Correction typically takes longer than in younger patients
Chest wall is less flexible with age
May require longer daily wearing times
Success is possible but requires commitment and patience

General Treatment Information

Realistic Expectations

No Guaranteed Outcomes – We Emphasize:

PectusConnectUs provides NO guarantee of treatment outcome
Results vary significantly between individuals based on multiple factors:
- Age and chest wall flexibility
- Type and severity of deformity
- Consistent device usage and compliance
- Individual anatomical variations
- Proper medical supervision
Treatment duration varies: Some see results in months; others require years
Partial correction is possible even when complete correction is not achieved

Progressive Nature of Treatment:

Correction occurs gradually over extended periods
Initial regression after device removal is NORMAL
Persistent daily use over many months is typically required
Permanent correction stabilizes over time
Progress is measured in weeks and months, not days

What Affects Success?

Factors YOU Can Control:

Consistent, compliant use of device as prescribed
Following medical guidance carefully
Proper device application and pressure
Patience and long-term commitment
Maintaining overall health and fitness
Attending regular follow-ups

Factors Beyond Control:

Natural chest wall flexibility (decreases with age)
Skeletal maturity and growth stage
Underlying connective tissue properties
Genetic factors
Severity of original deformity

Progress Monitoring

Monthly Progress Photos (Required):

You must submit monthly progress photographs to PectusConnectUs
Purpose: Track device effectiveness and correction progression ONLY
NOT used for: Medical diagnosis, complication assessment, or medical advice
Your responsibility: Send photos on schedule; note any concerns for YOUR doctor

Medical Check-ups:

Regular evaluation by YOUR healthcare provider (typically every 1-3 months)
Professional assessment of correction progress
Device adjustment as needed
Monitoring for complications
Adjustment of treatment plan

When to Contact YOUR Doctor:

Any severe or persistent pain
Signs of infection or skin breakdown
Breathing difficulties
Unexpected physical changes
Psychological distress related to treatment
Any concerns about safety or complications
Questions about appropriateness of continuing treatment

Psychosocial Considerations

Mental Health Matters:

Long-term treatment requires psychological resilience
Body image concerns are valid and should be addressed
Support from family, friends, or professionals can be beneficial
Frustration with slow progress is normal
Discuss compliance challenges openly with your support team

Device Safety & Maintenance

Pre-Use Inspection (MANDATORY BEFORE EVERY USE)

Vacuum Bell:

Check PETG body for cracks or damage
Inspect silicone flaps for tears, brittleness, or degradation
Test one-way valve for proper function
Examine hose for leaks or damage
Verify pressure gauge functions correctly
Ensure pump creates and maintains vacuum

Braces:

Inspect all structural components (steel frame, PETG plates)
Check metallic connectors for security and integrity
Examine rubber bands for wear, stretching, or damage
Verify polyurethane foam pads are intact and properly positioned
Check neoprene for tears or excessive wear
Ensure all fastening mechanisms function properly

DO NOT USE if any component is damaged – Contact us immediately for replacement parts

Cleaning & Care

Vacuum Bell:

Wipe PETG and silicone components with soft, damp cloth
Use mild soap and water for routine cleaning
Avoid water or dust to enter into the valve
Avoid harsh chemicals that may damage materials
Do not submerge pressure gauge or pump

Braces:

Wipe hard surfaces with damp cloth and mild soap
Clean foam pads gently; allow to dry completely
Follow specific care instructions provided with your device
Do not machine wash
Store in cool, dry place away from direct sunlight

Storage

Store devices in cool, dry environment
Avoid extreme temperatures
Keep away from direct sunlight (UV degrades materials)
Protect from physical damage
Keep away from pets and children when not in use

Emergency Situations & When to Stop

STOP USE IMMEDIATELY AND SEEK MEDICAL ATTENTION IF:

Life-Threatening Symptoms:

Severe chest pain or difficulty breathing
Signs of cardiac distress
Severe bleeding
Loss of consciousness
Severe allergic reaction

Serious Complications:

Dark/black bruising that doesn’t fade
Open wounds or skin breakdown
Signs of infection (fever, warmth, redness, pus, swelling)
Suspected bone fracture (severe pain, deformity, inability to move)
Persistent severe pain unrelieved by device removal

Moderate Concerns (Contact Doctor Same Day):

Extensive bruising or skin discoloration
Persistent numbness or tingling
Breathing changes or discomfort
Unexpected swelling
Any symptom that concerns you

Final Client Acknowledgments

By Purchasing and Using PectusConnectUs Devices, You Confirm:

Medical Supervision:

☐ I will obtain medical examination and clearance before use
☐ I will use devices only under ongoing medical supervision
☐ I understand PectusConnectUs is NOT a medical provider
☐ I will report complications to MY healthcare provider, not PectusConnectUs

Understanding of Risks:

☐ I have read and understood all warnings and contraindications
☐ I understand potential side effects and complications
☐ I understand there is NO guarantee of treatment success
☐ I accept responsibility for monitoring my own health

Device Responsibility:

☐ I provided accurate photographs/videos/measurements for custom manufacturing
☐ I understand device fit depends on accuracy of information I provided
☐ I will inspect device before every use
☐ I will follow all usage instructions
☐ I will maintain device properly

Assumption of Risk:

☐ I voluntarily choose to use these devices
☐ I assume all risks associated with their use
☐ I release PectusConnectUs from liability for medical outcomes and complications
☐ I understand PectusConnectUs role is limited to device manufacturing

Information Provided:

☐ Monthly progress photos are for progression tracking ONLY, not medical diagnosis
☐ I will seek medical attention for any complications, not rely on PectusConnectUs
☐ I understand I must make my own medical decisions with MY healthcare provider

This Safety & Warnings complements our Terms & Conditions and forms part of your agreement with PectusConnectUs.