Medical Certification (IEC 60601-1 & IEC 60601-1-2)
This guide contains the IEC 60601-1 and IEC 60601-1-2 medical certification information for the Link 4K.
Certified Camera Model SKUs
PTZOptics Certified Model SKUs:
| Move 4K | Link 4K | Move SE |
|---|---|---|
PT12X-4K-GY-G3PT12X-4K-WH-G3PT20X-4K-GY-G3PT20X-4K-WH-G3 | PT12X-LINK-4K-GYPT12X-LINK-4K-WHPT20X-LINK-4K-GYPT20X-LINK-4K-WH | PT12X-SE-GY-G3PT12X-SE-WH-G3PT20X-SE-GY-G3PT20X-SE-WH-G3PT30X-SE-GY-G3PT30X-SE-WH-G3 |
Certified Power Supply SKU
- PTZOptics SKU:
PT-PSB-M - Manufacturer Model:
EM1024QR(10)
Camera Technical Specifications
For full hardware specifications, power supply ratings, rear panel connections, and packing lists, see the Technical Specs for your camera model:
Manufacturer
- Haverford Systems Inc.
- 534 Trestle Place, Downingtown, PA 19355, USA
Installation, Operation & Safe Termination
Installation
The Responsible Organization (The hospital or healthcare facility that deploys this equipment) must ensure that the equipment is installed, used, and maintained in accordance with this document and with applicable requirements of IEC 60601-1 for medical electrical (ME) systems.
- Supported Mounting Methods: Desktop, wall mount (with wall bracket), or ceiling mount (requires enabling vertical image flip in the OSD menu).
- Qualification: Installation must be performed by qualified personnel (see Intended Use & Operators below). Confirm no obstacles are within the pan/tilt range and that all mounting hardware is mechanically secured before powering on.
Operation & Safe Termination
- Bringing into Operation: Connect the IEC 60601-1 certified power adapter (or PoE/PoE+ Ethernet cable) and video/network cables, power on the camera, and complete initial setup (IP address, stream parameters, and presets) via the web GUI or IR remote.
- Operating the Equipment: Control pan/tilt, zoom, presets, image parameters, and AI tracking via the IR remote or web GUI.
- Safe Termination of Operation:
- Stop any active recording or streaming session.
- Return the camera to standby via the IR remote or web GUI.
- To fully power off, unplug the external power adapter from the AC outlet or disconnect the PoE/PoE+ Ethernet cable. Do NOT disconnect power by pulling on the cable itself.
Cleaning, Disinfection, Service & Disposal
Cleaning & Low-Level Disinfection
warning
Disconnect ALL power supplies before performing any cleaning, disinfection, or maintenance work.
- Enclosure Cleaning: Wipe with a lint-free soft cloth moistened with diluted neutral detergent, then dry with a separate dry soft cloth.
- Lens Cleaning: Use professional lint-free lens-cleaning paper only. Do NOT spray liquid directly onto the lens surface.
- Prohibited Substances: Do NOT use solvents, alcohol, isopropyl alcohol, acetone, thinners, or aerosol spray cleaners.
- Low-Level Disinfection: If required by the healthcare facility, wipe external surfaces with a soft cloth lightly moistened with a compatible low-level disinfectant (such as a diluted quaternary ammonium compound), following the disinfectant manufacturer's instructions for concentration and contact time. Wipe dry afterward. Do NOT spray, immerse, autoclave, or sterilize.
- Sterilization: NOT required and NOT supported.
Technical Description, Servicing & Version Control
- Servicing & Replaceable Parts: There are no user-serviceable parts inside the housing and no field-replaceable components. All repairs or replacements must be performed by Haverford Systems Inc.
- Service Documentation: Upon request, the manufacturer will provide circuit diagrams, component part lists, descriptions, and calibration instructions to assist qualified Service Personnel.
- Revision Control: This information corresponds to Revision 2.0. Changes affecting safety or performance are revision-controlled; superseded versions must be removed from use.
End-of-Life Disposal
- Camera (WEEE): Contains printed circuit assemblies and electronic components. Do NOT dispose of with household waste. Follow local electronic-waste regulations and transfer the unit to an authorized e-waste recycling facility.
- Remote Control Batteries: Collect and recycle AAA batteries separately in accordance with local battery-recycling requirements; do NOT discard in general waste bins.
Intended Use & Operators
Intended Medical Applications
PTZOptics Move 4K, Link 4K, and Move SE IEC 60601-1 and IEC 60601-1-2 certified cameras may be deployed in medical environments for the following applications:
| Application | Description |
|---|---|
| Tele-medicine Consultation | Mounting on mobile medical carts for face-to-face video communication between medical staff and remote patients, or installing in hospital conference rooms for multi-provider case consultations. |
| Surgical Live Streaming & Teaching | Installing inside operating rooms to stream live surgical procedures and record footage for teaching and archiving. |
| Remote Patient Monitoring & Virtual Ward Rounds | Integrating with common monitoring software and mainstream patient monitoring systems to enable real-time visual observation inside patient rooms. |
| Sleep Monitoring Research | Enabling continuous patient observation during sleep studies in low-light or zero-light conditions using the switchable infrared-cut filter paired with IR illuminators. Move SE: Not supported |
| Medical Education & Training | Supporting remote medical training across different training venues with multiple optical zoom options. |
| AI-assisted Medical Device Identification | Using the camera feed with third-party AI and computer-vision platforms to identify medical instruments within the scene view, support hospital inventory management, and help prevent instrument misuse. |
warning
This camera functions solely as an audio/video image-acquisition device. Do NOT use it for life-sustaining applications. Video output is for visual reference only and must NOT be used as the sole basis for clinical diagnosis; clinical staff must always corroborate with other medical examinations and equipment.
Intended Patient Population & Applied Part
- Intended Patient Population: Patients involved in telemedicine consultation, surgical teaching, virtual ward rounds, and sleep-study research. The device does not classify or screen patients; the patient population is determined by the healthcare facility based on clinical need.
- Applied Part: None. The equipment is an image-acquisition peripheral and does NOT make direct contact with the patient. It performs no physiological measurement, treatment output, or energy transfer to the patient.
Intended Operators & Required Training
The patient is NOT an intended operator. Operators must read and understand this guide, including Medical Environment Warnings, Warnings & Precautions, Installation, Operation & Safe Termination, and Cleaning, Disinfection, Service & Disposal—before use.
| Operator Group | Description | Required Skills & Training |
|---|---|---|
| User 1: Clinical Staff (doctor, nurse, instructor) | Operates the camera via IR remote or web GUI | Basic electronic-device operation; trained on basic camera operation, intended use, and limits |
| User 2: Hospital IT / Biomedical Engineer | Installation, network configuration, periodic maintenance, and fault diagnosis | Networking and hardware fundamentals; trained on installation and maintenance |
| User 3: System Integration Engineer | Integration with third-party control systems, RS-232/RS-485 configuration, and preset setup | Communication protocols and control-system experience; trained on interface integration |
| User 4: Occasional User | Temporary basic operation after reading the applicable safety instructions | Basic power on/off operation only; must be briefed on intended use, limits, and emergency shutdown |
Prohibited Uses
The following uses are strictly prohibited:
- Using the video output as the sole basis for clinical diagnosis.
- Using the camera as part of a life-sustaining system.
- Direct contact with the patient body or invasive use.
- Outdoor use, rain exposure, or operation in high-humidity/splash environments (the equipment is not waterproof).
- Powering the unit with a non-original or non-IEC 60601-1 certified power adapter (see Certified Power Supply SKU above).
- User disassembly of the housing (no user-serviceable parts inside).
- Operation outside the rated
0 °C to +40 °Coperating temperature range.
Medical Environment Warnings
When deploying IEC 60601-1 and IEC 60601-1-2 certified Move 4K, Link 4K, or Move SE cameras in healthcare environments, operators and the Responsible Organization must also observe the following medical safety warnings (see Warnings & Precautions for general equipment warnings and the certification details above for full compliance details):
- Visual Reference Only: The camera is an audio/video image-acquisition device only. It does not contact the patient and is not a diagnostic or life-sustaining device. Its output must NOT be used as the sole basis for clinical diagnosis; clinical staff must always corroborate with other medical examinations and equipment.
- Certified Medical Power Adapter Required (
PT-PSB-M): You must purchase the IEC 60601-1 certified DC 12 V power supply separately (PTZOptics SKUPT-PSB-M, manufacturer modelEM1024QR(10)). The standard power adapter included with the camera is NOT IEC 60601-1 certified. Using a non-compliant adapter may cause electric shock or fire. - Keep Dry: The equipment is NOT waterproof. Do NOT spray or splash disinfectant or liquid directly onto the device.
- Secure Medical-Compliant Mounting: For ceiling or wall mounting in clinical areas, secure the camera firmly using medical-compliant mounting hardware, confirm no cables or obstacles are within the pan/tilt range, and complete installation before powering on.
- AI Auto-Tracking in Clinical Scenes: AI human-tracking may lose the target or drift. For surgical teaching and critical telemedicine scenes, disable AI auto-tracking and use manual presets instead.
- Wired Backup for Network Video Streams: Network video streams (RTSP, RTMP, SRT, NDI) may be interrupted by hospital network fluctuations. For critical medical operations, enable local hard-wired HDMI or 3G-SDI output as a backup; do NOT rely on network video alone.
- Reciprocal Electromagnetic Interference: Medical electrical (ME) equipment generates radio-frequency energy and may cause or be affected by electromagnetic interference during specific investigations or treatments. Keep portable RF communication devices and sources of strong electromagnetic interference at an adequate separation distance.
Classification, Symbols & Technical Parameters
Medical Device Classification (IEC 60601-1, Clause 6)
- Protection Against Electric Shock: Class I (Protective Earth).
- Applied Part: None (no patient contact).
- Ingress Protection: Ordinary equipment (not waterproof and not protected against liquid splashing).
- Anesthetic Safety: Not suitable for use with flammable anesthetic mixtures or in the presence of flammable or explosive gas atmospheres.
- Mode of Operation: Continuous operation.
Connected Equipment & Network Requirements
Only connect the camera's video, audio, serial, USB, and network ports to equipment that complies with applicable safety standards—such as IEC 62368-1 (or IEC 60950-1) for IT/AV equipment, or IEC 60601-1 for medical equipment. Combining the camera with other devices (such as displays, computers, controllers, or network switches) forms a Medical Electrical (ME) System; the healthcare facility (Responsible Organization) is responsible for ensuring that the complete combined system complies with IEC 60601-1.
Symbol Glossary
Safety symbols marked on the equipment and/or packaging:
| Symbol | Standard / Name | Meaning |
|---|---|---|
| General Warning (ISO 7010 W001) | Indicates a potential safety hazard; read the accompanying text. | |
| Caution (ISO 15223-1 5.4.4 / ISO 7000-0434A) | Indicates the need for the user to consult the instructions for use for important cautionary information. | |
| Fragile, Handle with Care (ISO 15223-1 5.3.1 / ISO 7000-0621) | Indicates a medical device that can be broken or damaged if not handled carefully. | |
| Keep Away from Rain (ISO 15223-1 5.3.4 / ISO 7000-0626) | Keep dry; protect the equipment and packaging from rain and moisture. | |
| This Way Up (ISO 7000-0623) | Indicates the correct upright position of the transport package. | |
| Stacking Limit by Number (ISO 7000-2403) | Indicates the maximum number of identical packages that may be stacked (5 maximum). | |
| European Conformity (CE) | Indicates conformity with applicable European Union health, safety, and environmental protection legislation. | |
| Federal Communications Commission (FCC) | Indicates compliance with FCC electromagnetic compatibility (EMC) regulations. | |
| WEEE Disposal | Do not discard with domestic household waste; dispose of via separate e-waste collection. |
EMC Declaration of Conformity
Guidance and Manufacturer’s Declaration – Electromagnetic Emission
| Emission test | Compliance |
|---|---|
| Conducted and Radiated RF emissions (CISPR 11) | Group 1 |
| Conducted RF emissions (CISPR 11) | Class B |
| Radiated RF emissions (CISPR 11) | Class B |
| Harmonic emissions (IEC 61000-3-2) | Class A |
| Voltage fluctuations and flicker emissions (IEC 61000-3-3) | Complies |
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
| Immunity test | IEC 60601-1-2 test level | Compliance level |
|---|---|---|
| Electrostatic discharge (IEC 61000-4-2) | ±8 kV contact; ±2 kV, ±4 kV, ±8 kV, ±15 kV air | ±8 kV contact; ±2 kV, ±4 kV, ±8 kV, ±15 kV air |
| Electrical fast transients/bursts (IEC 61000-4-4) | ±2 kV for AC power supply lines; ±1 kV for input/output lines; 100 kHz repetition frequency | ±2 kV for AC power supply lines; ±1 kV for input/output lines; 100 kHz repetition frequency |
| Surges (IEC 61000-4-5) | ±0.5 kV, ±1 kV line(s) to line(s); ±0.5 kV, ±1 kV, ±2 kV line(s) to earth | ±0.5 kV, ±1 kV line(s) to line(s); ±0.5 kV, ±1 kV, ±2 kV line(s) to earth |
| Rated power frequency magnetic fields (IEC 61000-4-8) | 30 A/m 50 Hz or 60 Hz | 30 A/m 50 Hz or 60 Hz |
| Voltage dips (IEC 61000-4-11) | 0 % UT; 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0° | 0 % UT; 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0° |
| Voltage interruptions (IEC 61000-4-11) | 0 % UT; 250/300 cycle | 0 % UT; 250/300 cycle |
note
UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (RF & Proximity Magnetic Fields)
| Immunity test | IEC 60601-1-2 test level | Compliance level |
|---|---|---|
| Conducted disturbances induced by RF fields (IEC 61000-4-6) | 3 Vrms in 0.15 MHz – 80 MHz; 6 Vrms in ISM and amateur radio bands between 0.15 MHz and 80 MHz a), f) 80 % AM at 1 kHz | 3 Vrms in 0.15 MHz – 80 MHz; 6 Vrms in ISM and amateur radio bands between 0.15 MHz and 80 MHz a), f) 80 % AM at 1 kHz |
| Radiated RF EM fields (IEC 61000-4-3) | 10 V/m 80 MHz – 2.7 GHz b) 80 % AM at 1 kHz | 10 V/m 80 MHz – 2.7 GHz b) 80 % AM at 1 kHz |
| Proximity magnetic fields (IEC 61000-4-39) d) | 30 kHz, CW modulation, 8 A/m 134.2 kHz, Pulse modulation 2.1 kHz e), 65 A/m f) 13.56 MHz, Pulse modulation 50 kHz e), 7.5 A/m f) | 30 kHz: 8 A/m 134.2 kHz: 65 A/m 13.56 MHz: 7.5 A/m |
Electromagnetic environment – guidance & notes:
- Electromagnetic environment – guidance (Conducted & Radiated RF): Portable and mobile RF communications equipment should be used no closer to any part of these devices, including cables, than the recommended separation distance (30 cm / 12 inches). Interference may occur in the vicinity of equipment marked with the following symbol: (((·))) (non-ionizing electromagnetic radiation symbol).
- Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
- Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
- a. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
- b. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which these devices are used exceeds the applicable RF compliance level above, these devices should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating these devices.
- c. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
- d. This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT.
- e. The carrier shall be modulated using a 50 % duty cycle square wave signal.
- f. r.m.s., before modulation is applied.
Proximity Fields from RF Wireless Communications Equipment (IEC 61000-4-3)
| Immunity test | IEC 60601-1-2 test level | Compliance level |
|---|---|---|
| Proximity fields from RF wireless communications equipment (IEC 61000-4-3) | See the following table | Complies |
| Test frequency (MHz) | Band a) (MHz) | Service a) | Modulation | Immunity Test Level (V/m) |
|---|---|---|---|---|
| 385 | 380 – 390 | TETRA 400 | Pulse modulation b) 18 Hz | 27 |
| 450 | 430 – 470 | GMRS 460, FRS 460 | FM c) ± 5 kHz deviation 1 kHz sine | 28 |
| 710 745 780 | 704 – 787 | LTE Band 13, 17 | Pulse modulation b) 217 Hz | 9 |
| 810 870 930 | 800 – 960 | GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 | Pulse modulation b) 18 Hz | 28 |
| 1 720 1 845 1 970 | 1 700 – 1 990 | GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS | Pulse modulation b) 217 Hz | 28 |
| 2 450 | 2 400 – 2 570 | Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | Pulse modulation b) 217 Hz | 28 |
| 5 240 5 500 5 785 | 5 100 – 5 800 | WLAN 802.11 a/n | Pulse modulation b) 217 Hz | 9 |
Notes:
- NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
- a) For some services, only the uplink frequencies are included.
- b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
- c) As an alternative to FM modulation, the carrier may be pulse modulated using a 50 % duty cycle square wave signal at 18 Hz. While it does not represent actual modulation, it would be worst case.
Essential Performance, Troubleshooting & Preventive Checks
Essential Performance (IEC 60601-1)
- Definition: Capturing and outputting real-time high-definition video for medical visual workflows, including teleconsultation, surgical teaching, patient monitoring, and recording.
- Loss of Essential Performance: Occurs if there is no video output, a persistent black screen, or a pan/tilt/zoom (PTZ) failure. If essential performance is lost, discontinue use in clinical workflows immediately and arrange equipment repair.
Fault Conditions & Troubleshooting
If a fault persists, contact Haverford Systems Inc. support. Do NOT attempt internal repair.
| Condition / Message | Possible Cause | Required Action |
|---|---|---|
| Smoke, unusual noise, or burning smell | Internal fault | Cut off ALL power immediately, discontinue use, and contact manufacturer support. |
| No video output / black screen | Cable, power supply, or input source selection | Verify cables and power; confirm the connected display/peripheral is functional; if the camera still fails, arrange service. |
| Image interruption on restart | Watchdog auto-restart (residual risk) | Wait for the reboot to complete and verify that video output restores. |
| Network stream interrupted | Hospital network fluctuation | Check network connectivity; use local HDMI or 3G-SDI backup output for critical clinical scenes. |
| Pan/tilt not responding | Physical obstacle, serial conflict, or loss of essential performance | Clear obstacles; disable unused external serial control; if persistent, arrange service. |
| Inverted image (ceiling mount) | Image flip not enabled | Enable OSD vertical flip (Flip). |
Preventive Inspection & Periodic Safety Checks
| Item / Check | Method | Recommended Frequency |
|---|---|---|
| Video output / Essential Performance check | Confirm live video output and PTZ response | Before each clinical use (and at least annually) |
| Pan/tilt movement range | Confirm pan/tilt range is free of obstacles | Before each use |
| Power cord / adapter | Visually inspect for damage, wear, or heat marks | Before each use / Monthly |
| Network and video cables | Visually inspect for damage or loose connections | Monthly |
| Ventilation openings | Remove dust accumulation with a dry soft cloth | Monthly (or as needed) |
| Electrical safety test | Performed by qualified Service Personnel per IEC 60601-1 | Per facility policy / Annually |