Surgeons Panels, including performance, operational procedures, training and maintenance.

Transcription

1 Guidance note: DRAFT Surgeons Panels, including perfmance, operational procedures, training and maintenance. 1. Introduction 1.1. Surgeons Panels theatre panels are very common, every operating theatre is provided with one, they are a vital communication interface between the engineering systems in the theatre and the user The auths of this guidance note have become acutely aware, of the following operational problems: Medical staff, commonly don t can t operate the functions on surgeons control panels crectly e.g. they are not able to turn on off the ventilation systems put them into set back, f all types of theatre. This because of: po training and not being familiar with the functions of the surgeons panel, po labelling/signage is not clear absent, the controls not wking only partly wking.

2 The medical staff, commonly do not understand there is a problem with one me of the engineering services provided in the operating theatre these include electrical supply, medical gas alarm, AGSS, Radiation, Laser, Fire alarm etc. because the alarm indicat f an alarm: has not been fitted, po training and not being familiar with the meaning of the alarms of the surgeons panel, po labelling/signage is not clear absent, has been fitted, but is not wking, either because it was never commissioned, installed crectly, the light has failed, it has failed f other reasons f example the air flow failure alarm not being installed commissioned crectly resulting in air flow failure not being indicated when the ventilation rate has fallen to an unsafe level f the patient. A common failure in most operating theatres. Medical teams are commonly not aware of the dangers to themselves and the patient if one me of the engineering services are not operating crectly have failed. One me of these problems are present in most theatres; resulting in the various engineering systems being operated increctly one me of the engineering systems required f the safe operation of the operating theatre not being available not wking crectly. Thereby potentially compromising the safety of the patient and the medical teams others wking in the operating theatre. The risks commonly include: electrocution of the patient staff, loss of power, leading to immediate imminent failure of supply to medical equipment, loss partial loss of ventilation, increasing the risk if the patient becoming infected, loss of medical gases only being picked up by the anaesthetist after the gas pressure has fallen significantly, loss of AGSS, resulting in high concentrations of anaesthetic agents higher than permitted by COSHH As can be seen from table 1 later, the various HTMs and HBN 26 outline requirements f the provision of alarms, but commonly do not make it clear how these are to be provided. from table 1 me alarms are clearly required to provide appropriate warnings of failing the loss of various engineering systems and to provide the medical teams clear warning of the failure of engineering systems. 2 of 28

3 This guidance note in table 1 and this document outlines the requirements of the HTMs and HBN 26 and where the gaps exist makes recommendations as to how these might be provided This document is intended to draw together the existing requirements of HTMs and HBN 26, including additional facilities (controls and alarms etc.) and to be used by: clinicians, theatre managers, project managers, engineering designers, manufacturers of surgeons panels, clerks of wks, authised persons, authising Engineers, including, staff with responsibility f testing, commissioning and maintaining surgeons panels and associated alarm systems The following attempts to outline the published requirements f the facilities and functions f surgeons control panels. 2. Legal and Requirements of guidance 2.1. Helpfully the DoH and other bodies publish HTM and other guidance, detailing the requirements? 2.2. Firstly, these include the statuty requirements often these are mandaty (they have to be provided) and are not to be provided only where reasonably practicable Any and that is the vast majity of services provided in an operating theatre and also nearly all alarms, these have to be provided as they are provided f patient safety, so if not provided and functioning crectly the health care ganisation would not be able to demonstrate providing a safe environment f the patient, required by the Health and Social Care Act (HaSCA) Similarly, The Wkplace (Health, Safety and Welfare) Regulations 1992 (WPR) in terms of f example provision of sufficient and appropriately purified air. Medical teams must be infmed by and alarm immediately on failure to e nsure operations are not started if the ventilation system is not wking crectly (failure to meet these requirements would also lead to a failure to meet the requirements of the health and social care act) Similarly, The Control of Substances Hazardous to Health Regulations 2002 (COSHH) in terms of f example provision of sufficient ventilation to control to safe levels bacteria and chemicals such as anaesthetic agents. This requires an immediate local alarm if the ventilation AGSS is not wking crectly. 3 of 28

4 2.6. The Electricity at Wk Regulations 1989 (EaWR), f example provision of safe and crectly operating electrical services to prevent electrocution of the patient either by traditional electric shock micro shock, that could cause ventricular fibrillation (without medical team in theatre being aware they electrical equipment had very likely electrocuted the patient) Many of the above relate to the operation of systems and services so if say the alarm system is very old does not provide the appropriate alarm the alarm warning was not installed, these would still be required as not to have it installed operating would put the patient at risk and therefe the healthcare ganisation would not be able to demonstrate they had provided a safe environment f the patient. An example would include the operation of an electrical system without appropriate earthing (as defined when the system is being operated) and an IPS system, as both are mandaty under regulation 8 of the electricity at wk regulations, where this regulation and others in this document are defined as absolute. Another example would include the crect operation of the ventilation system (e.g. air flow), as the system is designed to remove/control the level of harmful agents (bacteria, chemicals etc.) under the COSHH regulations; an alarm is required locally to infm those in the theatre there is a fault with the ventilation system, warning them there is a danger to the patient (typically infection) and to the staff (typically anaesthetic gases agents exceeding safe levels) so they can take appropriate action to manage the danger to themselves and the patient There has been a HTM f ventilation and other services f many years, much of the content f earlier editions as well as the current edition s are based on peer reviewed research that demonstrated that these systems are installed and perfmance if installed as detailed in the HTM reduce danger Therefe, the legislation and guidance in HTMs should be followed As discussed earlier, f some years the UK Government has been passing and updating legislation concerning the safe operation and provision of healthcare facilities in the UK, these f example suppted by: Building regulations, the wkplace (health, safety and welfare) regulations, Control of substances hazardous to health regulations, these suppted and giving details on how compliance can be achieved with legislation, the DoH (Department of Health) publishes f example HTMs f specific engineering topics and HBNs with requirements f specific departments e.g. Theatres. These, together with other requirements f ventilation systems in HTM 03, electrical services, HTM 06, medical gases, HTM 02. The following outlines the requirements where these concern the provision, maintenance and safe operation of surgeons panels in a healthcare facility Clearly adhering to the guidance outlined in the Health Technical Memandum (HTM) should be taken into account as evidence towards compliance with these legal requirements and 4 of 28

5 standards; And, where the principles of the guidance are not to be followed, ganisations should document how the expectations are being met by equal and alternative means The statuty and guidance requirements f designing new modifying ventilation systems on healthcare sites are demonstrably effective at removing infection & chemical hazards, providing a suitable environment f carrying out medical procedures f the patient and medical practitioners, there essential controls and alarms are discussed in this guidance note. Similar also applies to other service provisions it s wth discussing HTM 00 (Policies and principles of healthcare engineering), in chapter 1 makes many references to statute e.g. health and safety at wk act, COSHH, etc. inferring compliance with HTMs, complies with legal requirements Me directly in HTM 00:2014 (applicable to all other HTMs), clause 1.3 Adhering to the guidance outlined in this Health Technical Memandum (HTM) will be taken into account as evidence towards compliance with these legal requirements and standards. From this DoH are saying follow the HTMs and you have followed the legal requirements, if you don t follow HTM you won t be following legal requirements, effectively the HTMs are ACOPs, generally follow them and you have met legal aspects. Then in the following clause Where the principles of the guidance are not to be followed, ganisations should document how the expectations are being met by equal and alternative means As in clause 1.4 there is the documented, equal better route, this effectively means evidence based, research and the like, not in my view experience as these are just wds unless backed up by something substantial, not very likely as much in HTMs are evidence based Therefe, appropriate engineering services are required, backed up with alarms. These required to enable the medical teams (and Healthcare Organisation) take the appropriate action to preserve the safety of patients and staff. 3. Requirements of HTM and HBN guidance 3.1. The requirements of HTMs and HBN 26 are outlined in table 1, where there are no requirements in the various HTMs HBN 26 suggestions and recommendation have been made. These suggestions and recommendations are further added to in the text that follows; with the objective of providing a complete list of alarms and other facilities that are needed in a surgeons panel/theatre panel and f these to be well understood by medical teams that use the theatre. Therefe, enabling medical teams to make optimized decisions to protect the safety of the patient and staff when there are problems with the engineering services provided in an operating theatre. 5 of 28

6 Table 1 Signals and displays f surgeons / theatre control panel Engineering services No. Description User control type User indicat type Light colour Notes 1 Plant failure na RND RND Suggest text Plant failure indication light colour RED 2 Low air flow na RND RND Suggest text Low air flow indication light colour RED 3 Room temperatureindicating gauge 4 Room humidityindicating gauge 5 Room Temperature adjustment 6 Room humidity adjustment 7 Ventilationplant status indication na Analogue digital RND Suggested text Room Temperature should be large enough to be read from the nmal wking position na RND RND Suggested text Room Humidity clearly-readable to be read from nmal wking position Adjusta ble by user 8 Ventilation off Switch na na Suggested text Room temperature adjustment should be marked either raise and lower + and A control tolerance ±1 C Adjusta na na Suggested text Room ble by humidity adjustment %RH user humidity values should be graduated between 35% and 60% with a (calibrated) control knob, slider provided with set point read out na RND RND should also be located at the staff control base Light RED* RND, suggested text Ventilation off Could be combined with indicat light HTM/HBN clause number (where appropriate) HTM 03-01A 6.53 HTM 09-01A 6.53 HTM 03-01A 6.34, 7.79 & HBN 26: HTM 03-01A 7.79 & HBN 26: HTM 03-01A 6.33, 7.79 & HBN 26: HBN 26: HTM 03-01A 7.79 HTM 03-01A of 28

7 9 Ventilation setback Switch 10 Ventilation on Switch 11 Other rooms, temperature adjustment Adjusta ble by user Light AMBER * 12 UCV setback na Light AMBER * 13 UCV System off 14 AHU and UCV full speed Suggested text Ventilation setback, Could be combined with indicat light Light GREEN Suggest text Ventilation on Could be combined with indicat light na na Suggest text Room temperature adjustment e.g. in Lay-Up Preparation B Suggest text UCV setback To limit air supplied through terminal to > 25 air changes per hour na Light RED Suggest text UCV system off Switch off UCV and AHU UCV AHU failed na Light GREEN Suggest text Ventilation and UCV full speed Both AHU and UCV operating at full speed 15 UCV filter dirty na Light BLUE Suggested text UCV filter dirty UCV terminal s Low air flow C HTM 03-01A 7.79 HTM 03-01A 7.79 HTM HTM 03-01A 7.143, 7.93 HTM 03-01A HTM 03-01A HTM 03-01A Suggested text UCV low air flow 16 Refrigerant alarm na RND RND Suggest text refrigerant alarm D 17 Room Pressure na RND RND Suggested text theatre room pressure low indication light colour RED 18 X-Ray Warning lights 19 Laser Warning lights 20 Fire Alarm (warning) Switch Switch RND RND Suggested text theatre perimeter X-Ray warning light(s) indication light colour AMBER* RND RND Suggested text theatre perimeter laser warning light(s) indication light colour AMBER* na RND RND RND, suggested text Fire alarm nearby indication light colour AMBER, alternative flashing light frequency similar to medical gas alarm HTM 03-01A 3.54 HTM HBN 26: HBN 26: HTM Part B: of 28

8 21 Fire Alarm (evacuate) na RND RND RND, suggested text Fire alarm evacuate indication light colour RED HTM Part B: Clock na na na With sweep second hand E HBN 26: Time Lapse clock 24 Electric Socket Controls 25 Electric sockets 26 X-ray viewing screens 27 Staff to staff call point 28 Operating light controls (main light) 29 Operating light controls (satellite) 30 General lighting Switch Switch No switch control na na Control by switch switches suggested text Time lapse clock fmat digital minutes and second na na In the past these have been provided, these are not recommended f existing new panels na na If located in panel, should be completely electrically and mechanically segregated HBN 26: na na na Unlikely to be required HBN 26: Switch RND RND Suggested text Staff to HBN 26:2004 staff emergency call 6.6 indication light colour RED, panels also required at communications base and rest facilities (also with fault condition) Switch Switch Adjusta ble by user 31 UCV lighting Adjusta ble by user 32 Patient/staff music systems Adjusta ble by user RND RND Dimmable, suggest text main operating light control F RND RND Dimmable, suggest text satellite light control F RND RND Suggested text General lighting All should be individually collectively dimmable G RND RND Suggested text UCV lighting All should be individually collectively dimmable G na na F playing patient music provide background music f staff H na na HBN 26:2004 also see 7.115, & HBN 26:2004 also see 7.115, & HBN 26: HBN 26: HBN 26: & of 28

9 33 IPS Alarms na RND RND RND, suggested text Blue medical equipment only sockets safe to use indication colour light GREEN 34 IPS Alarms Na RND RND RND, suggested text Blue medical equipment only sockets unsafe to use indication colour light YELLOW J 35 IPS Alarms na RND RND RND, suggested text Blue medical equipment only sockets unsafe to use indication colour light RED 36 IPS alarm LCD Display 37 IPS Mute Switch 38 IPS Test Switch 39 IPS Menu Switch 40 IPS Scroll keys Switch na na na If provided should only give unambiguous text e.g. IT 1 Earth (Insulation) Fault, ITU bed 4, left side RND RND RND, Mutes, but does not reset warning sounder na na Button to test IPS operational and warning lights suggested text IPS light test na na Where provided, should not be operable by user (only appropriately trained electrical staff), users must not be able to read off technical infmation make alterations accept alarms of any type. na na Where provided, should only be usable to access the location of a fault as described in LCD display, users must not be able to read off technical infmation make alterations accept alarms of any type. 41 UPS available na RND RND Suggested text UPS available indicat colour GREEN Testing Testing Testing Testing Testing Testing Testing Testing testing of 28

10 42 UPS Fault na RND RND RND, suggested text UPS not available indicat colour RED, indicates with any fault, off line, including when in by pass 43 Mains fail/ups running 44 Emergency generat available 45 Emergency generat fault 46 Emergency generat supply on 47 Emergency power off, (EPO) 48 Medical gas alarm General Fault 49 Medical gas alarm warning na RND RND RND, suggested text Mains failed/ups running indicat colour RED na RND RND Suggested text Emergency generat available indicat colour GREEN, (when the generat(s) serving this medical location is available, light goes out when generat is taken off line goes offline na RND RND RND, suggested text Emergency generat not available indicat colour RED, illuminates if generat taken off line is not available na RND RND Suggested text Emergency Generat supply on indication light colour RED, (when the generat(s) serving this medical location are on and delivering power to any circuit connected to it) Contact na na RND RND Not nmally in panel, but required in some medical locations. example text Xray system Emergency Power Off. RND suggest RED indicat light suggested text X-ray system Emergency Power Off operated Light with sounder Light with sounder Red RND, suggested text General alarm medical gas services may be affected (12.31 communications/power failure etc.) testing & Testing Testing RND Testing R ND Testing RND Testing RND HTM testing Yellow Text as HTM HTM etc testing of 28

11 50 Medical gas alarm warning 51 AGSS (Anaesthetic Gas Scavenging System) 52 AGSS duty pump fail 53 AGSS system fail General Notes na RND Switch Light with sounder RED Text as HTM HTM etc testing RND RND RND, suggested text AGSS available indicat colour GREEN, light stays on if duty fail na RND RND RND, suggested text AGSS duty Fail indicat colour AMBER na RND RND RND, suggested text AGSS system fail indicat colour RED HTM testing HTM testing HTM testing na RND not applicable Required, no definition in HTM HBN Theatre air-conditioning control senss should be actively ventilated, located in a sampling duct mounted in the surgeon s panel and be accessible f cleaning and the removal of fluff and lint HTM 03-01A, 7.75, fan to draw air over senss. The switching devices and indicats should be incpated in the surgeon s panel and their functions clearly labelled HTM 03-01A, A Temperature adjustment this would be better adjustable with a graduated (calibrated) control knob, slider provided with set point read out. B Temperature adjustment this would be better adjustable with a graduated (calibrated) control knob. C UCV terminal s HEPA-filter resistance causes the air delivered to fall below 80% of the design flow rate (this often only achievable through velocity probe) note would apply to each fan section of UCV. D A refrigerant gas detect mounted in the base of the duct and an alarm system audible to the end-user will also need to be provided (as dictated by the COSHH Regulations). E Should be radio controlled ( otherwise synchronised), powered from essential lighting circuit. F Where me than one operating luminaire is provided, each luminaire should be separately supplied with no commonality of transfmer, rectifier, battery equipment control equipment also see EFAs e.g. DH (2010) 04, 06/05/2010. G Multi way switching at each entrance including from clean crid and disposal f example, should be fed from multiple circuits, emergency lighting to same levels as general lighting. 11 of 28

12 H Integral music systems are the preferred option, as there are potential hazards from crossinfection and interference with the existing power supply from stand-alone systems. The system should be integral to the engineering system and be located within the fabric of the building HBN 26:2004, connection to system to be by cable blue tooth, to tablet, phone (in flight mode) etc. J note where these lights illuminate, the user could not be sure the electrical system is safe f patient and staff, therefe the sockets should not be used. A light with no text is not a clear indicat as to the safety otherwise of the electrical system, so must be defined by a clear sign (text), no abbreviations given seriousness of potential fault to patient and staff. note f installations not complying with where a single IPS has been installed in a medical location with an alarm and no suppting LCD display giving a clear and unambiguous location of the fault the electrical sockets should not be used (with immediate effect, as medical staff could not be sure the system was safe). f systems where two me IPS have been installed to provide circuit protection and safety to a medical location unless there is an indicat to give a clear and unambiguous location of the fault warning the electrical sockets should not be used (with immediate effect, as medical staff could not be sure the system was safe). where the warning light can only illuminate if there is NO danger to patient and staff then the text could be changed to Blue medical equipment only sockets safe to continue use * should not be provided with sounder. Ventilation 3.2. The following requirements of HTM 03-01:2007 f controls and alarms in surgeons panels/theatre control panels are detailed in table Additionally, the perfmance and installation guidance would be best followed as detailed in the guidance on medical gas alarm panels in this document The objective is to ensure alarm and communication systems installations that are fit f purpose equal better than guidance such as HTMs, BS, BS ENs, industry standards and the like in addition, the following are based on the requirements of HTM 03 f controls and alarms in surgeons panels/theatre control panels COSHH 3.6. Regulation 13 Arrangements to deal with accidents, incidents and emergencies (1) Subject to paragraph (4) and without prejudice to the relevant provisions of the Management of Health and Safety at Wk Regulations 1999, in der to protect the health of his employees from an 12 of 28

13 accident, incident emergency related to the presence of a substance hazardous to health at the wkplace, the employer shall ensure that (a) procedures, including the provision of appropriate first-aid facilities and relevant safety drills (which shall be tested at regular intervals), have been prepared which can be put into effect when such an event occurs; (b) infmation on emergency arrangements, including (i) details of relevant wk hazards and hazard identification arrangements; and (ii) specific hazards likely to arise at the time of an accident, incident emergency, is available; and (c) suitable warning and other communication systems are established to enable an appropriate response, including remedial actions and rescue operations, to be made immediately when such an event occurs. (2) The employer shall ensure that infmation on the procedures and systems required by paragraph (1)(a) and (c) and the infmation required by paragraph (1)(b) is (a) made available to relevant accident and emergency services to enable those services, whether internal external to the wkplace, to prepare their own response procedures and precautionary measures; and (b) displayed at the wkplace, if this is appropriate. (3) Subject to paragraph (4), in the event of an accident, incident emergency related to the presence of a substance hazardous to health at the wkplace, the employer shall ensure that (a) immediate steps are taken to (i) mitigate the effects of the event; (ii) reste the situation to nmal; and (iii) infm those of his employees who may be affected; (b) only those persons who are essential f the carrying out of repairs and other necessary wk are permitted in the affected area and they are provided with (i) appropriate personal protective equipment; and (ii) any necessary specialised safety equipment and plant, which shall be used until the situation is rested to nmal; and (c) in the case of an incident accident which has may have resulted in the release of a biological agent which could cause severe human disease, as soon as practicable thereafter his employees their representatives are infmed of (i) the causes of that incident accident; and (ii) the measures taken to be taken to rectify the situation. (4) Paragraph (1) and, provided the substance hazardous to health is not a carcinogen, mutagen biological agent, paragraph (3) shall not apply where (a) the results of the risk assessment show that, because of the quantity of each substance hazardous to health present at the wkplace, there is only a slight risk to the health of employees; and (b) the measures taken by the employer to comply with the duty under regulation 7(1) are sufficient to control that risk. (5) An employee shall rept fthwith, to his employer to any other employee of that employer with specific responsibility f the health and safety of his fellow employees, any accident incident which has may have resulted in 13 of 28

14 the release of a biological agent which could cause severe human disease Electrical 3.8. The following requirements of HTM 06:2017 f controls and alarms in surgeons panels/theatre control panels are detailed in table Additionally, the perfmance and installation guidance would be best followed as detailed in the guidance on medical gas alarm panels in this document The objective is to ensure alarm and communication systems installations that are fit f purpose equal better than guidance such as HTMs, BS, BS ENs, industry standards and the like IPS fed Equipment, although the first fault to earth has been identified, it may only be a matter of time befe a second fault occurs. Therefe, upon second fault there is a risk that the final circuit will be lost along with any alarm signals. There is a significant risk to all using the equipment circuit(s) after the first fault alarm has been sounded as there is no way of predicting when the second electrical fault occurring e.g. the saline solution leaking into an adjacent part of the electrical installation. The immediacy and imptance of this risk should be reflected in the operations manual, the theatre departments operational procedure manual and medical teams training Where theatre control panels are provided, their power supply could be derived from a dedicated tertiary battery supply off the local theatre UPS. Note in of f operating lights the minimum autonomy should be 3 hours, this would clearly also be extended to any component circuits used to control deliver power to operating lights. This 3-hour requirement is a minimum and may be extended considerably to meet the requirements to provide sufficient time to close the patient as discussed in : discusses in many parts including chapter 4 and others the need to provide resilient electrical services and safety services e.g. clause BS 7671 also makes clear recommendations to the resilience of power supply to essential medical systems in chapter 56, these include circuits shall be independent of other circuits. Independent of other circuits meaning that any electrical fault any intervention modification in one system must not affect the crect functioning of the other. This may necessitate separation by fire-resistant materials different routes enclosures, this very likely to be applicable to services run through theatre control panels as any failure could render the essential facility unavailable e.g. operating light and any alarm e.g. ventilation, electrical, fire, medical gas etc. Fire The following requirements of HTM Part B f controls and alarms in surgeons panels/theatre control panels are detailed in table 1. Additionally the perfmance and installation guidance would be best followed as detailed in BS 5839 Parts and guidance on medical gas alarm panels in this document. The objective is to ensure alarm and communication systems installations that are fit f purpose 14 of 28

15 equal better than guidance such as HTMs, BS, BS ENs, industry standards and the like. Medical gas alarms HTM 02-01: The following requirements of HTM 02:2006 f controls and alarms in surgeons panels/theatre control panels are detailed in table Additionally, the perfmance and installation guidance would be best followed as detailed in the guidance in this section of the document The objective is to ensure alarm and communication systems installations that are fit f purpose equal better than guidance such as HTMs, BS, BS ENs, industry standards and the like Area warning systems are required as follows, these requirements based on those in HTM also have many perfmance and installation requirements that are applicable to other alarm perfmance and installation requirements as follows: Introduction These required as note 10 of table 11 to be Installed in the operating room in the main panel (surgeons/theatre control panel) The area warning system should give an alarm f each gas service there should be local pressure switches f low pressure; high pressure switches are also required when oxygen, nitrous oxide and medical air are installed together Area panels other functions carry no indication of the warnings f cylinder replacement and plant functions that are given on central indicat panels The HTM f medical gas alarms has many and very particular requirements, these include (these are also applicable to surgeons/theatre control panels): Labelling All visual signal panels should be permanently, labelled accding to their function, including clear identification of the areas, rooms departments served Visual signals Flashing visual signals should have alternate on and off periods, each of equal duration between 0.25 and 0.50 seconds. There should be two separately energised light sources f each signal, arranged so that the failure of one source does not affect the other. The light sources should have a design life of at least five years of continuous operation Audible signals All audible signal tones should be modulated equally at a rate of 4 Hz ±10% between two tones of 440 Hz ±10% and 880 Hz ±10% Automatic resetting When a warning alarm signal occurs and the system condition subsequently reverts to nmal, the cresponding visual and audible signals should automatically reset to nmal Tempary muting Means must be provided on each panel f the user to mute the audible signal. The signal must resound after a nominal 15-minute period if the fault condition still exists. 15 of 28

16 3.28. Operation of the mute on area alarm repeater panels should not be accompanied by a change from flashing to steady illumination Continuous muting An internally-mounted switch should be provided to allow continuous muting during periods of maintenance. Should auto reset on clearance of fault. When the system condition returns to nmal, the continuous muting should automatically reset to nmal operation. When The continuous muting is in operation on any alarm condition, it should not prevent the operation of the audible signal on other alarm conditions when a fault condition arises Electrical wiring All electrical wiring should be in accdance with IET regulations System integrity If extra low voltage (ELV), maximum 50 V, is superimposed on the signal communication circuit (f example by cross-connection), the system design should ensure that any damage to the system is limited to replaceable panel components and that such damage is indicated as a system fault The perfmance of the system should not be compromised by the use of multi-ce cabling that carries ELV and communication signals in adjacent ces The system should be designed to reject spurious radio frequency (RF) mains noise typically arising in hospitals, examples being diathermy equipment and current spikes caused by plant start-up etc. also has further guidance on EMC and interference Relay conditions If relays are used to transmit alarm signals, the relays should be energised in their nmal closed condition Mains power supply The mains electricity supply should be derived from the essential power supply (that is, must be on the emergency system) Safety extra low voltage/functional extra low voltage power supply The panel power may be designed either as a safety extra low voltage (SELV) system as a functional extra low voltage (FELV) system, as defined in Part 4 of the IET Wiring Regulations The ELV power supply may be housed either in the alarm panels in a separate metal enclosure. The power supply should be rated f the full load of the panel, with visual and audity signals on all nmal and alarm conditions Test facility Each panel should be provided with a means to test all visual and audible signals on that panel. The power supply should be capable of sustaining all indicats and audible signals. Warning and alarm system faults General A flashing red visual indicat and an audible signal should operate on all panels when any of the following conditions occur: a. line fault from the initiating device; 16 of 28

17 b. communication fault other wiring fault; c. mains power failure Line fault The system should monit the integrity of the lines between the initiating devices and the panel transmitter units. The alarm system fault condition should be indicated on loss of integrity, f example open sht circuits, together with the visual alarm indicat(s) associated with the faulty wiring Communication/wiring fault The system should indicate an alarm system fault in the event of loss of data transmission between panels and transmitters Mains power failure Failure of mains power should be shown by a flashing red indicat and an audible signal, which should be powered from an internal battery. The audible signal may be muted and not automatically reinstate as required under nmal power supply (see other paragraphs), but the visual indicat should continue to flash until either the fault has been rectified the battery has discharged Stand-by battery A battery should be provided with sufficient capacity to power the visual and audible alarm system fault signal f a minimum period of four hours. The battery should be sealed and exchangeable, and should automatically recharge within 72 hours. See also clause this discusses a minimum battery autonomy and suggests that the autonomy may be extended to allow patient closure, this is not defined, but should be obtained in writing from the medical teams using the facility (medical location) and should be based on the longest period to safely close a patient plus a safety margin to allow f an unexpected medical requirement, battery degradation, battery deteriation, and a period of time f the medical team to realise the emergency and fmulate a plan to make the patient s condition safe Legend The legend on this indicat should be alarm system fault. Indicat panel requirements f all systems (medical gas) Indicats Panels should be provided with all indicats f the gas services in local use. The visual indicats should be arranged vertically in priity der, with the nmal indicats at the top. The sequence of gas services should be, from left to right: a. medical oxygen (cryogenic and cylinders/ pressure swing adsber (PSA) systems); b. nitrous oxide; c. nitrous oxide/oxygen mixture; d. medical air 400 kpa (compress plant, cylinders and synthetic air); e. surgical air 700 kpa; f. medical vacuum (pumps); g. helium/oxygen mixture. In addition to the gas service signal indicats, each panel must include: a. a green power on indicat without an audible signal; b. a red alarm system fault indicat with an audible signal. 17 of 28

18 3.46. Labelling Panels should be labelled as follows: a. medical gas alarm; b. with the identification of the medical gas services indicated, and the areas and departments served. E.g. Theatre 1 (note f clarity there should not be multiple theatre 1s on any given hospital site) Construction The fascia panel should be removable to allow access to the rear of the fascia to the panel f maintenance purposes. The dos facias should be so suppted that one person can easily handle and move it, the panels dos should give clear and unrestricted access to facilitate all maintenance and repair activities, the access dimensions and distances required by and BS 7671 and suppting guidance notes and guidance should also be full adhered with. Access to the interi of the panel should be tamper-proof. It should be possible to replace the source of illumination without removing the legend. Panels should have electrical sections with protection at least equal to BS EN 60529:2013. Panels and their housings should be of adequate strength f their purposes and be manufactured from crosion-resistant materials. If gas services are brought into the panel, they should be housed in separate, enclosed compartments, which are vented to the outside. There should be gas-tight seals where electrical services pass through any gas compartment Remote audible sounder All panels should have provision f connection to a remote audible sounder. HBN 26 Operating Theatres The following requirements of HBM 26:2004 f controls and alarms in surgeons panels/theatre control panels are detailed in table 1 and in the following text. Additionally the perfmance and installation guidance would be best followed as detailed in the guidance on medical gas alarm panels in this document. The objective is to ensure alarm and communication systems installations that are fit f purpose equal better than guidance such as HTMs, BS, BS ENs, industry standards and the like. Theatre Control Panel The control panel should be fully recessed and ideally should be accessible f maintenance from outside the theatre. All internal cabling should be LSF insulated. 18 of 28

19 Room Pressure A room pressure alarm should be provided to give warning that the room pressure has fallen to unacceptable levels, the common areas of failure being dos left open into out of the theatre, the alarm should be delayed by 2 minutes to allow good time f the patient to be brought into the theatre and out of theatre at the end of their operation, and at other times staff to enter and leave the theatre. Computer Equipment Computer equipment is commonly incpated into surgeons/theatre control panels, these are commonly incpated to access patient recds, telemetry, the control of patient moniting equipment, creating and amending the patient recd, repting systems, etc. F these purposes, touch screen monits can be incpated, these should be of a suitable size to be able to be read from the centre of the theatre standing at the screen(s) as appropriate f each task, these where possible should also have a screen based key board. The screen(s) and key board should be so designed and installed to minimise the chance of dirt build up and cross infection, the surfaces should be easy clean; the same also applies to any cooling sampling fans installed in the panel and where the air is drawn from and to, these should be sealed such that an air tight seal is preserved at all times between the location of the fan and the theatre (typically by a seal between the front of the surgeon/theatre control panel and the surrounding wall). Swab count board(s) These may be incpated into the surgeon/theatre control panel, these to have a minimum size of 800mm x 600mm. the board should be permanently fixed and have no gaps (the seal should not be achieved by a proprietary builders sealant). Mounting height and position should facilitate access and visibility. Theatre warning light(s) These are often incpated in the surgeon/theatre control panel, these f example turn on X-Ray, Laser Warning lights at eye level outside all entrances to the operating theatre. These should be provided each having an activation switch and light confirming the lights have all illuminated coloured AMBER the suppting text should read theatre perimeter X-Ray warning light(s) similar f the laser lights. Note safety precautions regards the use of lasers should also comply fully with BS EN 60825, and the incpation of suitable interlocks preventing entry to the theatre when the laser is in use. Laser use, finishes and fittings In theatres where it is possible laser surgery could be carried out there should be no reflective surfaces in the area including the surgeon/theatre control panel. 19 of 28

20 Finishes Quality of finishes, should be of a high standard. Finishes should be robust enough to withstand accidental impact. Surface finishes and materials used in the panel should be suitable f cleaning with any cleaning agents used in healthcare facilities. Finishes, should be durable and able to withstand wet cleaning and the accidental impact. Especially vulnerable points should have additional protection. Protection measures should be incpated at the panel to prevent the need f regular maintenance which would require the unit to be closed f long periods. X-Ray Protection Walls in the panel and opening in walls to accommodate the panel should be constructed to provide radiation protection in accdance with SI 2000/1059 (with amendments 2006/2523 and 2011/1567) and SI 1999/3232. Modular and conventionally build operating theatres There is no difference in the requirements of a modular theatre with a conventionally constructed theatre, as they are subject to the same standards and regulations, therefe there are also no differences in the requirements of surgeons/theatre control panels (see also HBN 26:2004 appendix 1). Other alarm and condition warning systems The perfmance and installation guidance f other alarms should followed as detailed in the guidance on medical gas alarm panels in this document. The objective is to ensure alarm and communication systems installations that are fit f purpose equal better than guidance such as HTMs, BS, BS ENs, industry standards and the like. All other alarms should perfm as the other requirements and recommendations of this document. F system failure the light should be coloured red, f system warning(s) coloured amber alarms). Sounders, General, all systems When an alarm warning light operates (red amber, yellow blue light alarms respectively), this should operate a sounder with the following perfmance outputs: Audible signals All audible signal tones should be modulated equally at a rate of 4 Hz ±10% between two tones of 440 Hz ±10% and 880 Hz ±10%. 20 of 28

21 Automatic resetting When a warning alarm signal occurs and the system condition subsequently reverts to nmal, the cresponding visual and audible signals should automatically reset to nmal. Tempary muting Means must be provided on each panel f the user to mute the audible signal. The signal must resound after a nominal 15-minute period if the fault condition still exists. Operation of the mute on area alarm repeater panels should not be accompanied by a change from flashing to steady illumination. Continuous muting An internally-mounted switch should be provided to allow continuous muting during periods of maintenance. Should auto reset on clearance of fault. When the system condition returns to nmal, the continuous muting should automatically reset to nmal operation. When The continuous muting is in operation on any alarm condition, it should not prevent the operation of the audible signal on other alarm conditions when a fault condition arises. Sounders are required, as there would be no guarantee the medical team would see one of the lights had illuminated. Screen based, instruction, help and emergency instructions The unplanned failure of an engineering system can be very dangerous to a patient undergoing a procedure being cared f in any medical location. the sudden warning failure of a system needs to be understood clearly by all in the medical team treating and carrying f the patient often being kept alive by life suppt systems etc. The actions to be taken by the medical teams need to be agreed (between all) and recded f the immediate reference in an emergency to all medical personnel in the department. To facilitate prompt and reliable actions by medical teams in an emergency situation the use of screen based, instruction, help and emergency instructions is encouraged. The text should use high contrast colour text and backgrounds, to facilitate easy and reliable reading and understanding of the requirements by medical teams. The following is an example of fmat and instruction. 21 of 28

22 Suggested text fmat: Warning alarm condition. Limits of conditions. Description of risks to patient and then staff as appropriate using NON-TECHNICAL language. What actions to take on behalf of the patient to make them safe and then staff as appropriate using NON-TECHNICAL language. How to rept the alarm condition to Estates with description e.g. on call/help desk with number. Theatre operational procedure files should be accessible by all medical staff located to facilitate immediate reference. Validation and Verification Ventilation system alarms Each ventilation system should be Validated and Verified as follows: Each system shall be treated as specialist ventilation system as defined in chapter 7 of HTM Part A and commissioned and validated as required in chapter 8. Each and all test results to be recded on project specific signed test recd fms. Verification carried out to fully comply with HTM Part B and BESA SFG 20 HTM aligned (current edition), including a check of control functions where the crect operation of each control and alarm is verified annually. Verified as required by HTM Part B Electrical system alarms, shall be commissioned as required by :2017, including emergency generats, IPS, UPS, Indications and alarms: 22 of 28

23 All local and remote indications and associated alarm combinations f nmal use failure in operation should be demonstrated and recded. medical IT systems: Verification of alarm indicats, local and remote, should be demonstrated. Additionally: Testing of Generat alarms. Each and all test results to be recded on project specific signed test recd fms Medical Gas and AGSS alarms Medical gas alarm systems Commission alarm systems as and chapter using also commissioning recd fm B11. AGSS alarms The operation of user-controlled switches, power on indicats and alarm systems should also be checked. Each and all test results to be recded on project specific signed test recd fms Other alarms and functions controlled connected provided in the medical location. All other alarms listed in this document including those in table 1, should be commissioned and tested. Each and all test results to be recded on project specific signed test recd fms Sounders located in connected provided in the medical location. All sounders listed in this document including those in table 1, should be commissioned and tested. Each and all test results to be recded on project specific signed test recd fms. As-installed drawings Schematics should be provided in all HV/ LV panel locations and (in case of emergency switching requirements) show all points of isolation including interconnection points between all distribution power supplied from the PES and any SPS, generats tertiary power supplies within the installation. The following list provides a minimum acceptable level f the as-installed drawings. Project contract documentation should be written and agreed with the healthcare ganisation and should clearly indicate which drawings are relevant to the particular project and any additional drawings that fm part of the installation as required: The layout drawings should use the building s general arrangement as background. The layout drawing should show all containment sizes; 23 of 28

24 The schematic drawing should indicate all cable sizes, protective device ratings and settings, switchgear and fault levels at distribution boards; System and control wiring: where the project includes any associated electrical services (f example, fire alarms, nurse-call systems, emergency lighting, building management), then layout drawings (using the building s general arrangement drawing as a background) showing the location of any associated devices and a single-line schematic of the system should be provided, including any associated panel wiring diagrams; As many of the services associated with the theatre control panel would be considered as essential medical system safety services, BS 7671 in chapter 56 in clause etc. places me and additional requirements to provide detailed drawings and plans of the installation as installed, therefe the additional requirements should be complied with Recds should be kept of all alarms and outages of the UPS, and details from all tests and servicing. Operational and estates managers may wish to consider a standard fm to recd all test results from any UPS, inverter battery within the healthcare facility. The recd of alarms should be reviewed at the next electrical safety group meeting. Maintenance Ventilation systems alarms Maintenance, e.g. quarterly tests, annual tests, check of control functions as required by HTM 03-01, BESA SFG 20 HTM aligned Electrical systems alarms All to be fully tested and proved at least annually and as required by:, IET GN 3 and IET GN Medical Gas systems alarms All to be fully tested and proved at least annually and as required by HTM Other alarms and functions controlled connected provided in the medical location All to be fully tested and proved at least annually Sounders located in connected provided in the medical location All to be fully tested and proved at least annually. 24 of 28